Master Purchasing Agreement (Agreement No. P01-000132) between Fischer Imaging 12300 North Grant Street Denver, Colorado 80241 (Hereinafter referred to as “Fischer Imaging”) and Philips Medical Systems Röntgenstrasse 24 22335 Hamburg (hereinafter...
Exhibit 10.21
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Philips Medical Systems |
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(Agreement No. P01-000132)
between
Xxxxxxx Imaging
00000 Xxxxx Xxxxx Xxxxxx
Xxxxxx, Xxxxxxxx 00000
(Hereinafter referred to as “Xxxxxxx Imaging”)
and
Philips Medical Systems
DMC GmbH
Xxxxxxxxxxxxxx 00
00000 Xxxxxxx
(hereinafter referred to as “PMS”)
Purchasing Frame Agreement
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PMS DMC: Einkauf PST |
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PMS |
Xxxxxxx imaging |
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BANNED SUBSTANCES AND SUBSTANCES RELEVANT FOR THE ENVIRONMENT |
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OTHER REGULATIONS REGARDING THE ENVIRONMENT AND ECOLOGICAL ASPECTS |
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1 Preamble
Xxxxxxx Imaging produces and develops a digital mammography system, the specification for which is set forth on Annex E1 (the “Specification”)
PMS manufactures medical equipment for worldwide distribution.
PMS is interested in forming a strategic partnership with Xxxxxxx Imaging to integrate the Xxxxxxx Imaging Subsystem into a PMS-branded digital imaging system that PMS will market, sell and support. In addition, the parties will investigate avenues to broaden the relationship to develop, market and sell additional valuable medical products and services. In addition, both PMS and Xxxxxxx Imaging will leave the opportunity open for the mutual development of future technology.
To regulate their co-operation, the parties have resolved to conclude a master agreement with the following provisions:
2 Object of the agreement
According to this master agreement Xxxxxxx Imaging shall deliver, in accordance with the purchase order, products and (servicing) spare parts (hereinafter referred to as “the products”) to PMS, which have been developed and/or manufactured by it.
PMS will process the products, integrate them into systems manufactured by it and/or deliver them to its customers directly. Xxxxxxx Imaging shall sell and deliver the Philips branded products exclusively to PMS unless otherwise expressly stated in writing by PMS.
3 Subcontract
N.A.
4 Product development and product updating
4.1 Development
If Xxxxxxx Imaging develops products according to a specification authorized by PMS at its own expense on its own account, a separate agreement shall be concluded regarding such co-operation on development. See Annex E3: “Development of Systems, ....”.
4.2 Product updating / product modification
Xxxxxxx Imaging undertakes, after commencing batch production, to work on the further development and technical improvement of the products and submit to PMS suitable suggestions for the further development/adjustment. PMS shall be entitled to suggest product improvements itself or, if necessary, demand them from Xxxxxxx Imaging if this relates to the special requirements for Philips branding. Suggestions for product improvements will be presented and negotiated in good faith on a regular base between both parties. In order to ensure that the products have a consistent, reproducible quality, Xxxxxxx Imaging shall not perform any modifications to its product without written consent from PMS. The product delivered by Xxxxxxx Imaging shall conform to that at the time of release by PMS upon assignment of the PMS code no. The procedure described in Annex E2 shall apply (XMW – 11517).
If Xxxxxxx Imaging is not in a position to perform a product modification requested by PMS which has a major influence on the competitiveness of the product, PMS may, after definitive refusal by Xxxxxxx Imaging
or after a reasonable period of time after the request to modify the product has elapsed, serve notice to terminate the agreement.
In the event of extensive modifications, Xxxxxxx Imaging and PMS shall conclude a separate Development agreement. In such a case details shall be regulated in Annex E3: “Development of systems”
5 Planning and ordering
5.1 Requirements plan
To be able to correctly plan the quantity of products required by PMS, PMS shall inform Xxxxxxx Imaging once a year of its market estimate with regard to sales potential for the coming calendar year. Xxxxxxx Imaging and PMS shall, by means of a logistics agreement (Annex O1), agree on the parameters of requirement planning for each product delivered by Xxxxxxx Imaging and covered by this agreement.
PMS shall inform Xxxxxxx Imaging of the changed planning figures for the coming year in good time prior to expiry of a calendar year.
Quarterly meetings between both parties shall be targeted to control the business.
5.2 Purchase orders
Purchase orders (Details in Annex O1) are only valid if they have been made in writing. Inasmuch as written purchase orders or order changes are generated automatically by data processing equipment, the statements shall be valid even if they have not been signed by PMS.
6 Manufacture
6.1 Specification
The manufacture of the products shall be based on the specification or drawings released by PMS in writing. (Annex E1). The intellectual property and patents of the product specified in E1 is the exclusive property of Xxxxxxx Imaging.
6.2 Traceability
For reasons of quality assurance and product traceability PMS may request Xxxxxxx Imaging to give the products a serial number by means of which Xxxxxxx Imaging can document and evaluate/trace the production and supply data and by which PMS can document and evaluate/trace the utilization and quality data. The items will usually be safety-relevant parts/Products. The serial numbers, which are defined by PMS, shall be recorded on all documents accompanying the goods.
In the specification /parts list (Annex E1) Xxxxxxx Imaging is informed which data are necessary to identify the products, e.g.: product number, name, manufacturer, production date, serial number, technical parameters etc.
6.3 Drawings and tools
All the drawings, patterns and calculations lent for the purpose of executing orders shall remain the property of PMS. They shall be kept secret, must not be reproduced or used for other purposes and shall be returned if requested by PMS. Tools, patterns, drawings and other aids which are made in order to execute orders and which will be charged separately by Xxxxxxx Imaging shall become PMS’ property at the time they are made. The transfer of possession is replaced by Xxxxxxx Imaging keeping them on behalf of PMS free of charge; they may only be used to execute the orders and shall be handed over to PMS immediately free of charge if requested to do so after the contract has been processed or in the event of supply difficulties.
Xxxxxxx Imaging shall clearly xxxx the aforementioned items as the property of PMS and draw the attention of any third parties who wish to establish rights in them to PMS’ title. It shall inform PMS of any such event immediately. The cost of intervention shall be borne by Xxxxxxx Imaging.
Xxxxxxx Imaging shall look after the aforementioned items, maintain them and minimize any normal wear and tear; Xxxxxxx Imaging shall have actual copies of drawings for manufacturing these items in safe-keeping (e.g. from fire and flood damage); the necessary cost is compensated for by the purchase price of the items.
To execute PMS orders, Xxxxxxx Imaging shall only commission a subcontractor to make products, parts, tools, and patterns, if permission has been obtained from PMS in writing. Xxxxxxx Imaging shall subject the subcontractor to his duties arising under this agreement. Xxxxxxx Imaging hereby assigns its claims vis-à-vis the subcontractor with regard to transfer of title in the tools and patterns to PMS in accordance with the obligations of this contract.
6.4 Documentation
Xxxxxxx Imaging shall make use of a device master record which contains all relevant documents, for instance, drawings, specifications, test protocols, calculations, engineering changes and software programming. The device master record shall be maintained systematically and in a clear order so that all relevant information and every delivery can be tracked and easily inspected.
Xxxxxxx Imaging shall have the device master record in safe-keeping for at least 13 years after the last manufacture of the product unless PMS requires the handing over. Xxxxxxx Imaging agrees that PMS can inspect and copy the device master record at all times.
After 13 years Xxxxxxx Imaging shall offer the device master record to PMS for safe-keeping before annihilation.
6.5 Down payments and supplies (items provided by the client)
Xxxxxxx Imaging undertakes to use any down payment (deposits) and supplies (items provided by the client) supplied by PMS solely for executing the orders.
PMS will supply Xxxxxxx with loaner equipment that will allow for testing of PMS systems in a simulated environment to their customer installations.
Xxxxxxx Imaging shall keep the supplies provided by PMS separately and xxxx the property of PMS on the supplies themselves and in its business records. It is agreed that the goods manufactured on the basis of the purchase orders from PMS, for which PMS has affected a down payment or supply, shall become its property. The transfer of possession shall be replaced by Xxxxxxx Imaging keeping the goods safely on behalf of PMS, with due commercial diligence and free of charge. For this purpose Xxxxxxx Imaging shall keep the manufactured goods separately from other stocks and indicate PMS’s ownership on the goods themselves and in the business records. Xxxxxxx Imaging shall give PMS confirmation of this in writing. Moreover, PMS shall be entitled at any time to convince itself of separate safe-keeping and proper identification of the goods/supplies on the spot. If the supplies of PMS are processed to make a new item, Xxxxxxx Imaging shall not acquire ownership of the same. Any processing shall take place by Xxxxxxx Imaging on behalf of PMS. If Xxxxxxx Imaging acquires co-ownership by combining or mixing the goods, it hereby assigns its portion of co-ownership to PMS. The transfer of possession shall be replaced by the fact that Xxxxxxx Imaging holds the item in safe-keeping on behalf of PMS free of charge.
Xxxxxxx Imaging shall notify to PMS any access by third parties to the goods belonging to PMS without delay and shall assist PMS in intervening in any manner, the cost of which shall be borne by Xxxxxxx Imaging. The duty to notify shall apply by analogy if composition or bankruptcy proceedings are initiated. Under no circumstances shall Xxxxxxx Imaging have a right of retention.
7 Delivery
7.1 Mode of delivery
Delivery shall be done FCA (free carrier, loading at sellers premises, Incoterms 2000), including packaging. Title, risk of loss and insurance risk related to the product shall pass to PMS at delivery to a qualified carrier.
7.2 Taking receipt of goods
PMS takes receipt of the products only under reservation with regard to quality, condition and quantity. An inspection of the products at the factory or warehouse of Xxxxxxx Imaging shall constitute neither delivery nor receipt.
PMS is under no obligation to accept incomplete Subsystems, but it will take receipt of and pay for the complete systems that may be less than the total number ordered. Notwithstanding any other legal or contractual entitlements PMS shall, in the event that Xxxxxxx Imaging violates the duty to deliver, be entitled to withhold payment related to incomplete products on the order until the delivery has been received in full.
PMS will not accept additional quantities or shortages.
If there are shortages in deliveries, Xxxxxxx Imaging shall inform PMS in good time and compensate PMS for the damage or loss due to the shortage.
Notwithstanding any other legal or contractual entitlements PMS shall, in the event that Xxxxxxx Imaging violates the duty to deliver, be entitled to withhold payment of the respective order until the delivery has been received in full. In any case the condition of payment are related to date of delivery of products received in full.
If the products arrive at PMS in damaged packaging, PMS shall be entitled to reject the delivery without examining the contents. The goods will be returned for the account and at the risk of Xxxxxxx Imaging.
7.3 Delivery in good time
Xxxxxxx Imaging is obliged to adhere to the agreed delivery dates under all circumstances. Otherwise PMS shall be entitled to refuse to take receipt of the delivery.
If the loading day varies by more than two days from the delivery date agreed between the two parties to the agreement, a penalty clause shall be agreed for every additional week by which delivery takes place before or after the agreed delivery date. PMS shall charge 2% of the price of delinquent product for each week or part of a week by which delivery takes place after the agreed delivery date. The penalty amount shall be limited to a maximum of 10% of the order sum. The order sum shall be calculated as the price multiplied by the quantity for each delivery batch.
Independent of penalty clause PMS can fix an extension for delivery. PMS may terminate the agreement with immediate effect if the period of grace (one week) is not observed and, if it is Xxxxxxx Imaging’s fault, demand compensation for non-performance. This applies mutatis mutandis to orders.
As soon as Xxxxxxx Imaging has reason to believe that it cannot provide the delivery or part of the delivery in good time, it shall inform PMS of this without delay. The additional expense incurred by PMS due to the delay shall be borne by Xxxxxxx Imaging. If PMS should declare itself willing to take receipt of the delivery despite the delay in delivery, Xxxxxxx Imaging shall bear the resulting additional cost, e.g. airfreight charges, express freight charges.
If the deadline agreed for delivery is not met and delivery carried out too early, for whatever reason, e.g. works holidays of Xxxxxxx Imaging - PMS may to refuse to take receipt of the delivery and insist on delivery later in good time.
If Xxxxxxx Imaging plans to carry out the delivery too early, it shall inform PMS as soon as possible. If PMS decides to take receipt of the delivery, Xxxxxxx Imaging shall bear the resulting additional costs, e.g. freight charges, cost of stock keeping.
In any case the condition of payment are related to the date of delivery originally planned.
7.4 Packaging
Xxxxxxx Imaging shall effect delivery in packaging suitable for the product, taking into consideration the relevant rules and legal regulations, particularly the environmental protection regulations. The packaging and the delivery documents shall bear the necessary information such as
• Type number (Philips article no.)
• Description
• Number of packages
• Serial number
In addition, information shall be provided in accordance with the specification.
7.5 Incoming goods inspection
The parties have agreed that Xxxxxxx Imaging shall perform an incoming goods inspection on behalf of PMS. The scope shall be according to the test specifications defined by PMS in accordance with Annex O2. The cost of this inspection is included in the price of the products ordered.
The transfer of the inspection duty to Xxxxxxx Imaging and the waiving of the duty to file a complaint in accordance with §§ 377 f. of the German Commercial Code (“HGB”) shall not constitute the waiving of contractual or legal guarantee and compensation rights.
7.6 Complaints
PMS will check the products delivered by Xxxxxxx Imaging for external intactness and completeness within a reasonable period, but not later than 30 days following delivery at the designated PMS or customer destination. PMS will normally report any apparent defects within six (6) weeks after receipt of goods and report any concealed defects without delay after they have been discovered. Payment of the goods shall not constitute their acceptance by PMS as conforming to the agreement and being devoid of defects.
8 Prices
8.1 Price calculation
The parties shall negotiate the prices to be paid by PMS for the products taking their respective interests into account and shall define them in the price calculation sheet in accordance with Annex P1 with regard to amount and term of validity.
8.2 Price change, price review
Changes in price shall be reviewed and negotiated on a quarterly basis in good time prior immediately following the expiry of each calendar quarter.
If after price calculation in accordance with para. 8.1 (price calculation) circumstances should arise which exert a considerable influence on the cost situation, e.g. product change, change in demand, change in the cost of labor and materials, currency movements, etc., the parties shall commence negotiations even within a price period, and agree to what extent the prices must be adjusted to take account of the new situation. The change shall be laid down in writing. Currency moves have to be taken into account as follows: Should the EUR fluctuate more than 3.5% from the set rate as per contract date for a minimum period of 30 days, than Xxxxxxx Imaging and PMS each will incur 50% of the total difference in the fluctuation above 3.5% of the contracted rates. Starting date and starting rate will be fixed in Annex P1 (Prices)
This adjusted price shall be effective with the first firm PO received by FIC following the adjustment.
8.3 Cost price reduction
Xxxxxxx Imaging undertakes to perform cost price reduction of his products and procedures continuously to maintain the competitiveness of the products of PMS. Xxxxxxx Imaging shall make proposals during the price change and price review meeting (acc. Para 8.2 Price change, price re-view), take actions by itself and together with PMS to find reasonable measures of cost price reduction and realize them in a coordinated manner. Xxxxxxx Imaging shall reduce the prices of its deliveries to PMS according these cost reduction measures in a share of 50%.
The annual savings realized will at least meet the annual price erosion of the PMS products, of which the products of Xxxxxxx Imaging are part of. PMS and Xxxxxxx Imaging agree upon transparency of cost calculation as precondition to realize the targets of this cost price reduction.
8.4 Results of price calculation
If the parties do not reach an agreement on the prices during the negotiations according para 8.1 (Price calculation), Either party can give extraordinary notice of withdrawal of the master purchasing agreement and the orders of products concerned with a time limit of 12 months. Until the last delivery those prices are in force, which were paid finally. Para 16.4 (Safe-keeping) is not applicable.
8.5 Most-favored-nation clause
Xxxxxxx Imaging shall offer PMS the most advantageous prices and conditions compared to other customers of the same or similar products and the same or similar terms. These prices and conditions are also in force if the concerned products are ordered but not yet delivered.
9 Invoicing and payment
9.1 Invoicing
Xxxxxxx Imaging undertakes to perform the invoicing of PMS only when the order has been properly and completely executed. Invoicing shall take place according to Annex O1.
9.2 Payment
In as much as the above prerequisites are fulfilled, payment by PMS will be effected within sixty (60) days End of Month after receipt of invoice.
Vis-à-vis Xxxxxxx Imaging PMS shall be entitled to set off amounts against credit notes issued by Xxxxxxx Imaging or accounts receivable from companies related to PMS which have all authorized PMS to set off amounts.
Xxxxxxx Imaging may assign its claims vis-à-vis PMS only with the latter’s prior consent in writing; this shall also apply to factoring. With regard to any debt assignments, which take place on the basis of an extended reservation of title, agreed by Xxxxxxx Imaging with subcontractors, PMS now hereby gives its consent with the proviso that it is also allowed to set off the amount against the counterclaim acquired after notification of assignment.
10 Servicing support and servicing parts
10.1 Servicing support
In as much as it is necessary, Xxxxxxx Imaging shall provide PMS with servicing support in accordance with Annex S1 (Servicing Agreement) of this agreement so that PMS can meet its commitments to its customers.
10.2 Commitment to deliver spare parts
Xxxxxxx Imaging shall supply PMS with all servicing parts for the products delivered under this agreement for at least ten (10) years after delivery of the product concerned. This shall also apply beyond the term of the agreement. Xxxxxxx Imaging guarantees PMS reasonable prices for the servicing parts in accordance with Annex S1 (Servicing Agreement).
A sufficient stock of spare parts is to be kept by Xxxxxxx Imaging shall be delivered within 24h. Different agreements to be made Annex S1 (Servicing Agreement)
For repairable assemblies or the complete unit, an exchange procedure with prices not exceeding 60% of the part-/unit price shall be agreed upon.
10.3 Training
Xxxxxxx Imaging shall train the staff of PMS with regard to installation, commissioning and maintenance of the products in accordance with Annex S1 (Servicing Agreement). For complex systems, a free training for PMS employees (reasonable group) before delivery of the serial models shall be supplied by Xxxxxxx Imaging. Tuition will not be charged and it is assumed that PMS will pay all expenses associated with travel and lodging. Xxxxxxx will provide a service-training specialist to support at least 1 training session at the PMS training facility in Europe.
Xxxxxxx European based service engineers will support the first PMS installations (reasonable number) in Europe by assisting in the installations with the PMS engineers.
11 Quality
11.1 QS-Agreement
Within its quality improvement program PMS follows a zero-fault strategy for the products.
PMS expects Xxxxxxx Imaging to commit itself to a zero-fault strategy for its products. Xxxxxxx Imaging is obliged to establish the conditions for the delivery of faultless products by continuously improving, supervising and assessing its work procedures.
Xxxxxxx Imaging shall receive a quality fault report and an advice of debit for any product that are faulty. The respective procedure is described in Annex O3.
Upon request Xxxxxxx Imaging shall hand over a detailed action list with scheduled improvement measures to PMS.
Xxxxxxx Imaging agrees to set in agreement with PMS for each product QS targets and to pursue these targets if requested by PMS. Xxxxxxx Imaging agrees to let PMS examine the respective documents verifying the achievement of the QS targets.
11.2 Industrial standards and company standards
Xxxxxxx Imaging shall be responsible for ensuring that the products delivered by it conform to the requirements of the relevant legal regulations, industrial standards and company standards.
Particularly the Medical Products Law, environmental protection regulations, accident prevention and safety-at-work regulations, the generally recognized rules of engineering and the state of the art shall be observed.
In addition, the following standards and specifications shall apply: ISO 13485, FDA / DHH S, UL / CSA, CE labeling and IEC standards. For fulfillment of American standards (FDA /DHH, VL / CSA) Xxxxxxx Imaging shall, on request, make the necessary documents available to PMS in English.
Xxxxxxx Imaging gives an assurance that in development and manufacture it has taken the monitoring measures necessary to meet these requirements. It undertakes to provide evidence upon request by PMS on this by supplying written documents or by taking other suitable measures such as local inspection, spot checks, audits etc.
12 Compliance with the regulations regarding the environment and ecological aspects
12.1 Legal regulations
In addition to the compliance with legal regulations, decrees and standards regarding the environment and ecological aspects, the respective state of the art shall be employed to keep the pollution of environment and resources as low as possible. Compliance with regulation EWG 1836/93 is complied with by Xxxxxxx Imaging or being worked at.
12.2 Banned substances and substances relevant for the environment
A list of the banned substances and the relevant substances is attached to this agreement as Annex X.
Xxxxxxx Imaging confirms that the products and their packaging do not contain any of the banned substances and agrees to declare any relevant substances to PMS according to the attachment.
12.3 Other regulations regarding the environment and ecological aspects
Xxxxxxx Imaging agrees to support PMS in realizing the Philips environmental program.
This program comprises:
• The reduction of packaging material
• The construction according to ecological principles (Eco-design)
• The elimination of banned substances as well as dangerous or toxic materials
• The recycling of the products or parts of them
• Xxxxxxx Imaging assures PMS of the fact that the disposal of the products and their packaging can take place without any special safety measures needed.
13 Warranty
13.1 Warranty
Xxxxxxx Imaging guarantees that the products are devoid of faults that they do not have any defect affecting their value or their suitability and that no guaranteed property is missing. Xxxxxxx Imaging also guarantees that the products delivered are devoid of defects in design, materials and manufacture.
13.2 Scope of warranty
If there are any defects in the products delivered, PMS can at its discretion demand free replacement or elimination of defects. In urgent cases PMS may also eliminate the defects itself at Xxxxxxx Imaging’s expense after informing Xxxxxxx Imaging in advance. If an elimination of defects requested by PMS is to no avail even after expiry of a reasonable period of grace, PMS may demand a reduction in the agreed price, serve notice to terminate the agreement with immediate effect and demand compensation for non-performance. Any further warranty and compensation rights, including consequential damage, shall not be affected thereby. In particular, PMS may demand reimbursement of the costs it has incurred due to the examination, if PMS is forced, on account of above-average occurrence of defects, to perform an incoming goods inspection itself in contradiction to the provision contained in Paragraph 7.6 or have it performed by commissioned third parties. PMS may either hold any goods about which a complaint has been filed in safe-keeping or return them to Xxxxxxx Imaging for the account and at the risk of Xxxxxxx Imaging. On the date when PMS sends the notice regarding the returned goods, the title in the goods shall return to Xxxxxxx Imaging. The transfer is replaced by the fact that PMS holds the goods in safe-keeping for Xxxxxxx Imaging.
Any defects which are only found during processing of the products by integration or during operation shall entitle PMS to also demand reimbursement of the costs expended to no avail.
Reporting of defects is done by “Quality Fault Report for Purchased Parts” and “List of costs” as now are or hereafter may be in force. Details are described in Annex O3.
13.3 Term of warranty
The term of the warranty shall be twelve (12) months from date of installation (end of installation) or fifteen (15) months from date of shipment, whatever comes first.
Replacement or elimination of defects will prolong the term of warranty of the replaced or repaired product for another twelve (12) months, as the case may be. The term of warranty for service and spare parts shall be eighteen (18) months from date of shipment.
13.4 Epidemic defects
Epidemic defects are defects, of the same nature or with the same cause, which in relation to a continuous period of 3 calendar months or more, occur in more than 5% of the products delivered. The basis of this shall be the statistics kept up to date by PMS. If an epidemic defect is found, PMS will notify Xxxxxxx Imaging in writing without delay. Epidemic defects must relate to failures of the product to comply with the Specifications, and must relate to a set of products that exceeds five (5) in number. PMS will provide Xxxxxxx Imaging with all documentation necessary to verify the epidemic defect. In response to the notice received from PMS, Xxxxxxx Imaging shall create a corrective action plan that shall be reviewed and approved by PMS.
13.5 Remedying epidemic defects
In the case of epidemic defects PMS shall be entitled to free replacement of the product (including any exchange necessary locally) and to payment of an all-in handling charge by PMS (see Annex O3). Xxxxxxx Imaging shall bear all the costs incurred as a result of the occurrence of the epidemic defect and shall hold PMS harmless from all third-party rights in this respect.
If any epidemic defects cannot be remedied or cannot be remedied within a short space of time by replacement deliveries, PMS shall, in addition to the rights regulated by Para. 13.2, also be entitled to postpone the scheduled acceptance dates until the epidemic defect can be proved to have been remedied.
13.6 Interruption in the period of limitation
Limitation of the aforementioned warranty shall be interrupted as soon as PMS has sent Xxxxxxx Imaging a written notice regarding the existence of a defect.
13.7 Recalls
If, owing to the occurrence of a defect, the safety of the product is jeopardized or affected so that PMS decides, as a responsible manufacturer, to hold a recall campaign, PMS shall inform Xxxxxxx Imaging of it without delay. The parties shall endeavor to work out an inexpensive procedure jointly without the safety interests of the end-user being neglected and without risking causing damage to the reputation of the parties. Xxxxxxx Imaging shall be liable to PMS for any resulting damage in accordance with para. 14 (liability).
14 Liability
Xxxxxxx Imaging shall be liable to PMS for all damage incurred by PMS and shall indemnify PMS with respect to all third-party compensation claims for damage which is due to defects in its production area or in that of its agents. This shall also apply to the compensation (including any other costs which have become necessary to assert legal rights according to the purpose), which PMS declared itself willing to provide out of court, taking due consideration of the interests of Xxxxxxx Imaging.
Xxxxxxx Imaging’s liability is limited to damages resulting from Xxxxxxx Imaging product defects, and Xxxxxxx Imaging will have no liability to PMS or any third party related to products or services not provided by Xxxxxxx Imaging nor its subcontractors. To the extent PMS has negotiated limitations of liability in customer or partner agreements, Xxxxxxx Imaging’s liability to PMS will be equivalently limited. Prior to settling any potential claims for which PMS will seek indemnification, PMS must obtain the consent of Xxxxxxx Imaging, which will not be unreasonably withheld.
15 Liability insurance
Xxxxxxx Imaging gives an assurance that it has taken out adequate employer’s liability insurance cover and is willing to provide evidence of this upon request from PMS by presenting the policy.
16 Rights
16.1 Third-party property rights
Xxxxxxx Imaging gives an assurance that the products are free of third-party property rights. If nevertheless third parties file any justified claim resulting from property rights, Xxxxxxx Imaging shall in agreement with PMS endeavor to find a technical solution as a remedy or at its expense acquire a license on behalf of PMS. Xxxxxxx Imaging undertakes to release PMS from any claims resulting from the violation of property rights and provide compensation for the resulting loss.
16.2 Rights of use
Xxxxxxx Imaging grants PMS a cost-free, worldwide, unrestricted, irrevocable, unlimited, non-exclusive, transferable right of use in the industrial property rights belonging to the product along with authorization to be able to transfer this right as a non-transferable right to the customers of PMS.
The companies affiliated to the PMS Group shall have the same rights
16.3 Rights in names and trademarks
Xxxxxxx Imaging is allowed to use the brand name, the protected trademark of “Philips” and the Philips logo only with explicit written consent from PMS. Xxxxxxx Imaging acknowledges the rights of PMS in the trademarks/brand names and declares that it derives no rights of use whatsoever, either for its own products or for advertising purposes, from the permission to use under this agreement. The rights and obligations of the parties under this Section shall be mutual.
16.4 Safe-keeping of spare parts
After completion of a prototype of the product, Xxxxxxx Imaging shall deposit with PMS all the available documents, data and other information media, which are necessary for manufacturing the agreed spare parts for the product. The depositing is intended to enable PMS to independently continue manufacturing the product if Xxxxxxx Imaging discontinues the production activity or if notice is served by PMS in accordance with Para. 19.
This is conditional upon PMS itself abiding by the agreement.
Xxxxxxx Imaging undertakes to grant PMS, for the aforementioned cases, a cost-free, worldwide, unrestricted, irrevocable, unlimited, non-exclusive right of use of the documents, data and other information media belonging to the product, including the right to process.
Xxxxxxx Imaging shall deposit such materials with a third-party escrow agent for the benefit of PMS. PMS shall be entitled to the release of such materials if the following conditions are met: (i) PMS sells 50 or more units of the product; and (ii) Xxxxxxx Imaging is unable or unwilling to meet its contractual requirements to supply spare parts for any reason.
17 Secrecy
17.1 Secrecy
Each party shall treat confidentially the embodied information which is marked as being confidential and all other information which is transmitted confidentially and has been marked in writing as being confidential within thirty (30) days after transmission, which it has received from the other party, and must not reproduce, disclose, copy or use it. This shall not apply if under this agreement a disclosure is necessary or the disclosing party has given prior written consent.
This arrangement shall not apply to the exchange of information within the companies affiliated to the PMS Group. The commitment to secrecy shall also remain valid after termination of this agreement.
This Section is superseded by the Confidentiality Agreement between the parties dated August, 31st, 2001, which shall continue in full force and effect.
17.2 Exceptions
The commitment to secrecy shall not apply to information which:
• Is known or which was already in the receiving party’s possession before transmission by the disclosing party;
• Has been made available to the receiving party by a source other than the disclosing party or which has become public domain in a manner other than by violation of this commitment;
• Has been prepared independently by the receiving party;
• Has been disclosed by law.
18 Term of agreement
This agreement shall come into effect as soon as both parties have signed it and shall apply for a period of 3 years. After that the term will be automatically extended by another year unless PMS serves 3 months notice in writing to take effect at the end of a calendar month or notice is served in accordance with Para. 19. Either party may elect not to renew this agreement beyond its initial three-year term by serving written notice on the other party nine (9) months prior to the end of the initial term or any renewal thereof.
19 Termination
19.1 Termination because of violation of an important obligation
In the event of any violation of an important obligation under this agreement by either party, the other party shall be entitled to serve notice with immediate effect if the violation of the agreement has not been discontinued within thirty (30) days after receipt of a written warning. The party entitled to serve notice may decide whether an order placed but not yet executed is to be cancelled or delivered. In the event of culpable violation compensation claims may be filed. Para. 16.4 shall apply.
19.2 Termination because of major changes
Xxxxxxx Imaging shall inform PMS without delay about any major circumstances which threaten to jeopardize delivery not just temporarily. This shall particularly apply in the case of Xxxxxxx Imaging’s insolvency or initiation of composition or bankruptcy proceedings against it.
If any of these circumstances should apply, PMS shall be entitled to serve notice with immediate effect and file compensation claims. Para. 15.5 shall apply.
20 General provisions
20.1 Entire agreement / written form
This agreement is the result of all preceding negotiations between the parties. It regulates the supply relationship entirely and definitively. Amendments and additions to this agreement shall be made in writing. This shall also apply to the waiving of the requirement for written form.
20.2 Assignment
PMS is entitled to assign its rights under this agreement and transfer performance of obligations to third parties.
20.3 Export control
If the products are subject to export control, Xxxxxxx Imaging shall inform PMS of this in writing and announce the applicable export control number (“ECCN”).
20.4 Standard Terms and Conditions
During the term of this agreement the Parties waive application of their respective Standard Terms and Conditions.
20.5 Authoritative provisions
In the event of any contradiction between a provision in this agreement and a provision in an Annex, the provisions of this agreement shall be authoritative.
20.6 Saving clause
If any provision in this agreement shall be or become invalid, it shall not affect the validity of the remaining agreement. The Parties shall replace the invalid provision by one, which commercially fulfils the object of the agreement.
20.7 Force Majeure
Should one of the parties to the agreement be prevented from fulfilling in good time his obligations arising out of this agreement by the occurrence of unforeseen circumstances which despite the exercise of reasonable care according to the circumstances of the case he has not been able to circumvent (Force Majeure, in particular war, blockade, industrial disputes, sabotage, civil commotion and administrative order), the deadline for supplies and services shall be extended accordingly.
In such a case, he shall advise the other party to the agreement without delay of the type and consequences of the incidence of Force Majeure or other exceptional circumstances. The parties to the agreement shall thereupon without delay, on the basis of the principle of equity and good faith, make joint arrangements to deal with the business affected by the aforementioned circumstances.
Should the incidence of Force Majeure last for more than three months; the party to the agreement who has thereby been prejudiced shall be entitled to terminate the agreement with immediate effect.
20.8 Applicable law
The laws of the Federal Republic of Germany shall apply.
The provisions of the Vienna Uncitral Treaty on international sale-of-goods contracts, issued on 11th April 1980, shall not apply.
20.9 Place of jurisdiction
The place of jurisdiction for all disputes resulting from this agreement shall be Hamburg, Germany.
20.10 Dispute Resolution.
In the event that there is a dispute between the parties related to this transaction, the parties will seek to resolve the dispute as follows:
• The responsible managers for each party will meet and discuss the difference for no less than five (5) days;
• If no resolution is reached, the dispute will then be referred to the chief executive officers of each party, who will meet and discuss the difference for no less than five (5) days;
• If the dispute is not resolved at this point, either party may seek a remedy to the dispute before a court that has jurisdiction over the matter as fixed in § 20.9.
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Philips Medical Systems DMC GmbH |
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Xxxxxxx Imaging |
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21 List of Annexes
For each product which is included in this master agreement (place a cross as applicable):
Xxxxxxx Imaging and PMS shall keep the following List of Annexes up to date. It shall always be the latest List of Annexes signed by both parties, which shall apply:
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Description |
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Applicable |
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NO |
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Date of |
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Product-related Annexes: |
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E1 |
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Specification |
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E3 |
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Development Contract |
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E4 |
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Declaration of Exclusiveness |
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O1 |
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Logistics Agreement |
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O2 |
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Incoming Goods Inspection |
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O3 |
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Xxxx-xxxxxx-xxxxxxxx |
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Xxxxxxx |
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P1 |
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Price List (products and servicing parts) |
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Servicing Agreement: |
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Servicing support, servicing parts, repair, servicing training |
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S2 |
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Field Problem Reports |
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General Annexes |
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E2 |
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Change procedure incl. change application and resolution forms |
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P2 |
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Price calculation sheet |
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Environmental protection agreement: forbidden and notifiable substances Sustainability |
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Contacts and Organigram |
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Philips Medical Systems - FIC |
PMS - FIC |
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Annex O3: Service Agreement |
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Master Purchasing Agreement PMS and FIC |
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ANNEX S 1
SERVICE
1. Definitions
Capitalised terms without definition shall have the same meaning as defined in the Agreement.
1.1 “DOA” means Dead on Arrival, a situation when a Product does not function within the Product acceptance period as defined in Article 9.6 (Acceptance) of the Agreement:
1.2 “FCO” means Field Change Order;
1.3 “FRU” means Field Replaceable Unit;
1.5 “Service Documentation” means the accurate technical, installation, operation and maintenance documentation relevant for the Product, including the operators manual;
2. Responsibilities
Unless agreed to otherwise in writing, PMS is responsible for:
• Installation and commissioning of the Product;
• Training of the user;
• Maintenance and repair at the end user’s site;
• Regular training of the PMS-engineers;
• FCO implementation;
• Delivery of Service Parts to end users;
• Delivery of repairable Service Parts to XXXXXXX IMAGING;
• Registration and supervision of follow-up by XXXXXXX IMAGING of field problem reports;
and XXXXXXX IMAGING is responsible for:
• Delivery (free of charge) of Service Documentation;
• Delivery (free of charge) of any possible software/ hardware updates/ upgrades (excluding additional features)
• Service Parts supply to PMS;
• Repair of Products or Service Parts thereof;
• Support of PMS-service-staff;
• Provision of FCO modification kits, including technical, installation, operation and maintenance documentation (if applicable).
• Initial training (free of charge) of PMS service personnel (train-the-trainer- concept)
3. Product delivery
3.1. Service Documentation
XXXXXXX IMAGING together with PMS shall mutually agree upon the content of the Service Documentation, that shall be in conformity with applicable laws and regulations as specified in the Agreement especially FDA regulation e.g. “0-level” documentation.
When Service Parts are defined XXXXXXX IMAGING shall, as part of the Service Documentation, provide PMS with the complete proforma per Service Part as specified in the service parts list of the Agreement.
XXXXXXX IMAGING shall provide PMS, free of charge, with Service Documentation in electronic format, or, upon PMS’s request, in hardcopy, for PMS’s approval. PMS is entitled to process and integrate the Service Documentation into its overall system documentation.
Service Documentation will be made available to PMS in the English language. XXXXXXX IMAGING herewith grants PMS the unconditional right to translate the Service Documentation in other languages as such is required by law or regulation.
The Service Documentation shall contain at a minimum the following sections:
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PMS DMC: Einkauf |
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PMS |
FIC |
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• Technical Data;
• Installation (if applicable);
• Setting-to-work (if applicable);
• Acceptance: Specification checks and data applicable for field service;
• Planned maintenance data (if applicable);
• Corrective maintenance data (diagnostic procedures for fault identification; adjustment procedures; instructions for (dis) assembly, removal and replacement; procedures after repair or replacement and simplified drawings to facilitate fault findings);
• Service Parts list including PMS’s 12 digit code numbers (“12 NC” numbers);
• Specification of required tools (if any), to be classified for (pre-) installation, setting-to-work, acceptance and maintenance.
Unless the Agreement provides otherwise, XXXXXXX IMAGING shall be solely responsible for the cost and expense of the development and provision of the Service Documentation. Exception: Additional requirements from PMS.
The Service Documentation will be timely updated and maintained by XXXXXXX IMAGING during the lifetime of the Product to include all implemented changes and modifications pertaining to the Product. Corrections will be furnished to PMS without additional charges.
XXXXXXX IMAGING shall forward to PMS the revised Service Documentation at least forty (40) days prior to the first shipment of new/changed Products, so as to enable PMS to review, edit, and approve such new documents before regular shipments will take place.
3.2. Data carrier
All information, including but not limited to Service Documentation will be available on one of the following data carriers, the version to be agreed between PMS and XXXXXXX IMAGING:
• MS-EXCEL
• MS-WORD
• GIF for photo’s & drawings
3.3. Software
The test- and diagnostic software, if any, used by field service personnel will be made available in source, documentation and object code by XXXXXXX IMAGING on a carrier suitable for the Product.
If PMS requires other than regular -advanced-test- and diagnostic software, both in source and object code, XXXXXXX IMAGING will supply them at a reasonable price to be agreed upon.
The test- and diagnostic software will be updated by XXXXXXX IMAGING during the lifetime of the Product to include all implemented changes and modifications pertaining to the Product. Corrections will be furnished to PMS without additional charges. XXXXXXX IMAGING will supply new test- and diagnostic software at least thirty (30) days before the first delivery of Products changed.
3.4. Product delivery for Service
Each Service Part (if applicable) shall be delivered by XXXXXXX IMAGING with:
• Spare fuses in case of power supplies;
• An up-to-date configuration record showing all FRU’s containing PMS part numbers and revision levels;
• Service key stickers showing the location of each component inside the unit.
• Configuration of ie jumper settings
4. Support
XXXXXXX IMAGING agrees to respond to PMS’s request for technical support within one business day. XXXXXXX IMAGING agrees to provide on-site support at PMS or PMS’s end user sites to resolve technical issues that can not be resolved by other means. The decision to go on-site will be by mutual agreement and ultimately within 5 business days of PMS’s request to visit PMS or the end user site.
Support costs for in warranty technical issues are borne by XXXXXXX IMAGING. Issues resolved to be non-XXXXXXX IMAGING problems and out of warranty support costs are reimbursable to XXXXXXX IMAGING including reasonable
2
material and travel expenses and labor cost up to an amount to be agreed in writing between the parties. Travel and waiting time shall not be billable to PMS.
5. Maintenance
5.1. Repair Policy
Repair will be made by replacing FRU’s including but not limited to PCB’s, keyboards, power supplies, motors, and disc drives. The amount and the level of the FRU’s may change over the lifetime of the Product.
5.2. Reporting by XXXXXXX IMAGING about Reliability
XXXXXXX IMAGING and PMS will exchange free of charge, all such relevant data regarding reliability of the Product and Service Parts, such as, but not limited to:
• mean time between failure- and mean time to repair figures (if applicable);
• problem reports at Product and Service Part level;
• field failures;
• Spare part consumption for PM/ CM.
• Call rate
XXXXXXX IMAGING will issue free of charge on a monthly basis a repair report to PMS, which should include all relevant data such as (but not limited to):
• Service Part name;
• XXXXXXX IMAGING code / PMS code;
• in / out of warranty;
• manufacturing data;
• serial number;
• repair activity description.
6. Field Change Order (FCO), Problem Reporting and Service Information
6.1. Field Change Orders
6.1.1. Modification kits
Field modifications, if any, will be made available to PMS in a form of individual modification kits and in the required amount / lead time as decided by PMS after consultation with XXXXXXX IMAGING.
In case of software modifications XXXXXXX IMAGING shall work together with PMS to establish the medium on which the kit is being released.
These kits will at a minimum contain:
• List of applicable Products and their serial numbers
• Implementation instructions
• Material and Service Parts
• Special tools (if any)
• updates of Service Documentation
Kits for the field modifications in the categories of “mandatory action” and “action for performance” will be provided by XXXXXXX IMAGING to PMS without charge, unless agreed in writing otherwise.
6.1.2. Categories and implementation of FCOs
Four (4) categories are distinguished:
• Mandatory action
• Action for performance
• Proactive
• Retrofit on failure
• Service recommendation
• Documentation change
These categories are defined as follows:
3
1. Mandatory action
Corrective actions required to eliminate potential or materialized unsafe situations. They must be given the highest priority and must be performed within the indicated time limit.
2. Action for performance
Corrective actions required to eliminate potential major deficiencies in functional performance that might affect the satisfaction of the end user and by consequence influence our brand image. They must be given high priority.
3. Service recommendation
A “Service recommendation” is an action being neither a “Mandatory action” nor an “Action for performance” which the Sales and Service Districts are recommended to perform. This action may involve updating, upgrading or correcting the functioning of installed products.
4. Documentation change
This kind of corrective actions does not affect the technical state of a Product. It gives instructions and it delivers material to update the Service Documentation.
Classification into any of these categories and terms and conditions of any action will be decided by PMS upon consultation with XXXXXXX IMAGING. Classification will take into account applicable law and regulations.
6.2. Field Problem Reporting by PMS
PMS will report all problems using a Field Problem Report Form sheet (see Annex 1 to this Attachment). In order to shorten turnaround times, PMS may report by telephone, fax or e-mail. Telephone reports must be promptly confirmed by a written Field Problem Report.
The categories of Problems are defined as very urgent problems, urgent problems, routine problems and production stop:
VERY URGENT PROBLEMS
• Disables the use of the Product or causes an abnormal end of the application program.
• Causes danger for the patient being examined or personnel operating the Product.
URGENT PROBLEMS
• Disables the use of the Product under certain conditions
• Disables the use of certain function(s) of the Product
ROUTINE PROBLEMS
• Problems other than VERY URGENT or URGENT
PRODUCTION STOP
• The Production at PMS or any of PMS’s Affiliated Companies is stopped, caused by a Product delivered by XXXXXXX IMAGING.
The Corrective Maintenance shall be provided by XXXXXXX IMAGING by:
1. Delivering as soon as possible solutions for VERY URGENT, URGENT DEFECTS and PRODUCTION STOP in the form of preliminary solutions (temporary fixes only, no corrections to the Product) and definite solutions (corrections to the Product) if necessary in an unscheduled revision Level of the Software. Component failures to be resolved by mutual agreement.
2. Delivering solutions for routine defects in the form of definite solutions as part of the next Level of the Product delivery.
The time schedule for response to PMS and solution delivered to PMS, are given in below diagram.
4
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Error/Defect |
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initial |
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preliminary |
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definite |
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VERY URGENT |
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12 hours |
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2 weeks |
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6 weeks |
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URGENT |
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24 hours |
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4 weeks |
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16 weeks |
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ROUTINE |
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48 hours |
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N.A. |
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next level |
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PRODUCTION STOP |
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8 working hrs |
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2 working days |
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Note: The hours mentioned in initial response are meant to be business hours. The other mentioned timeframes are referring to calendar days/weeks.
If XXXXXXX IMAGING cannot provide a definite solution without violating the Specifications of the Product, then XXXXXXX IMAGING shall timely inform PMS in writing, together with a comprehensive explanation of the reasons and consequences. XXXXXXX IMAGING shall refrain from any activity to implement such a definite solution unless PMS has accepted the proposed solution in writing.
Both preliminary and definite solutions will be made available to PMS as soon as possible after XXXXXXX IMAGING has produced and tested these solutions. The solutions shall be documented and made available to PMS by fastest means of communication and/or transportation.
For all categories, XXXXXXX IMAGING will work continuously during regular business hours and with first priority on such problem until it is solved.
Outline of Maintenance and Support Services:
To streamline customer support and accelerate resolution of issues, the following escalation process will be followed. PMS will employ this escalation process and all reasonable efforts will be applied to resolving the issues at the lowest possible level, before escalating to the next.
Philips will provide Level 1 and Level 2 support to its customers. Xxxxxxx Imaging will provide Level 3 and Level 4 support to Philips Technical Support Group. Xxxxxxx Imaging will not be required or expected to provide support directly to Philip’s customers or field service engineers.
Level 1 Support: Direct Customer Support – This covers on site as well as phone support of the end user in addressing issues concerning applications, workflow, functions, features or failures.
Level 2 Support: Technical Support – This applies to technical support of field engineers and end users. Examples would be in collecting data or error logs remotely for the purpose of diagnosing issues or replicating problems.
Level 3 Support: Factory Technical Support – This applies to issues that remain unresolved and Philips field and technical support have replicated the problem and exhausted all other courses of action.
Level 4 Support: Engineering Support – This covers software and hardware engineering to correct design defects.
6.3. Service information
XXXXXXX IMAGING shall include PMS in the distribution list for technical information bulletins via XXXXXXX IMAGING’s Extranet.
7. Configuration Management
XXXXXXX IMAGING will maintain a Configuration Record for each Product and Service Part delivered (Excel-file), indicating:
• Product and Service Part serial number
• Hardware configuration and firmware level (if any)
• Identification of assemblies and sub-assemblies contained in the Product by Service Part numbers and serial number.
5
8. Service Parts
8.1. Service Parts List
XXXXXXX IMAGING shall provide PMS with a list of Service Parts containing the following information:
• Part number with revision level where applicable;
• Description of the Service Part;
• Identification of critical items in close co-operation with PMS;
• Identification of strategic parts ECCN (Export Control Classification Number);
• Repair or replacement cost per Service Part;
• Identification of repairable and exchangeable items and delivery time.
8.2. Stock Recommendations
XXXXXXX IMAGING will provide PMS with recommendations for the stocking of Service Parts required to support and maintain the Products and update such information as required.
PMS shall inform Xxxxxxx Imaging once a year of its estimate with regard to Service parts potential for the coming calendar year.
XXXXXXX IMAGING will ensure availability of Service Parts prior to the first dispatch of Products.
8.3. Ordering and Delivery Time for Service Parts
8.3.1. Priority 1 orders (P1)
Service Parts to be delivered under “priority 1 order” (breakdown and out of stock situation) will be shipped by XXXXXXX IMAGING within a period of twenty-four (24) hours after notification using courier service (or within longer period as agreed in writing).
8.3.2. Priority 2 orders (P2)
Service Parts to be delivered under “priority 2 orders” may be placed by PMS during the term of this Agreement. These Service Parts will have a Delivery Time of three (3) days.
8.3.3. Normal (replenishment) orders (P3)
Delivery time for Service Parts will be 30 days after receipt of the Purchase Order.
8.4. Repair
8.4.1. Repair Services
Service Parts which are identified as repairable items, may be returned “as is” by PMS to XXXXXXX IMAGING for repair, and will be -if allowed by applicable law and regulations- repaired to the highest configuration level within 6 (six) calendar weeks or, at PMS’s option, be replaced within 1 (one) week.
PMS may return a broken Service Part within a reasonable time, irrespective of the supply by XXXXXXX IMAGING of the replacing Service Parts.
Service Parts returned already two times to XXXXXXX IMAGING will be taken out of circulation. The Service Part will be replaced by a new one.
PMS will receive a full refund for unused obsolete Service Parts, meaning Service Parts in its original package, if those Service Parts are returned as a result of a mandatory FCO, within 90 days of receipt of FCO.
DOA Service Parts will be returned to XXXXXXX IMAGING for functional check. Those items found to be acceptable will be returned to PMS at no charge. If an item is returned a second time as DOA, PMS will receive a new replacement item free of charge. The DOA Service Part will be discarded upon the second return.
A Service Part returned by XXXXXXX IMAGING to PMS will be replenished by XXXXXXX IMAGING with all parts necessary to complete the original delivery. (e.g. spare fuses for power supply)
Hard Disc Assemblies (HDA) returned for repair and still containing data shall not be read by XXXXXXX IMAGING. When the HDA is reused, the contents on disc will be erased by XXXXXXX IMAGING before re-shipping.
6
8.4.2. Repair at PMS
If PMS would elect to start repair of exchangeable Service Parts in its own workshops, then XXXXXXX IMAGING will transfer free of charge to PMS, all relevant information concerning:
• Trouble shooting
• Component specifications (names and addresses of vendors included)
• Adjustment procedures
• Tools and repair aids (specifications and prices)
• Initial training (if applicable)
• Test equipment
• Test and diagnostic software (both in source and object code)
To maintain warranty on Products and Service Parts, PMS must acquire prior approval to start repair of exchangeable Service Parts in its own workshop or an approved third party.
8.5. Restocking fees
PMS is entitled to return all up to date Service Parts in their original package which Service Parts shall be accepted by XXXXXXX IMAGING, for a restocking fee of 90% of original purchase price to PMS.
8.6. Packing and storage
In addition to the conditions as stated in article 9 of the Agreement, each Service Part will be packed in such a way, that it can be reused and stored without re-packing (if necessary, electrostatic discharge-packing is to be used).
XXXXXXX IMAGING will specify the storage conditions for Service Part(s), such as but not limited to temperature, humidity, shelf life and air pressure, for any Service Part(s) for which there are special requirements in this regard.
8.7. Affiliated companies and subcontractors involved
The service logistics branch of Affiliated Companies if they so desire, or the subcontractors appointed by PMS, are entitled to deal directly with XXXXXXX IMAGING in the areas of ordering Service Parts and returning Service Parts for repair to XXXXXXX IMAGING. PMS will provide prior notice of those subcontractors.
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Philips Medical Systems |
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XXXXXXX Imaging |
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DMC GmbH |
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7
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Philips Medical Systems - FIC |
PMS - FIC |
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Annex S1: Service |
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Master Purchasing Agreement PMS and FIC |
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Annex 1 to ATTACHMENT G
For the purpose of this Annex, PMS is refered to as “PMS”.
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PMS |
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XXXXXXX IMAGING
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8
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Incoming Goods Inspection |
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Philips Medical Systems |
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Annex to the Master Purchasing Agreement
(Agreement No. P01-000132)
regarding
Service
Comprising Incoming Goods Inspections
in accordance with §§ 377 - 378 of the German commercial code (“HGB”)
between
Xxxxxxx Imaging
00000 Xxxxx Xxxxx Xxxxxx
Xxxxxx, Xxxxxxxx 00000
(hereinafter referred to as “FIC”)
and
Philips Medical Systems
DMC GmbH
Xxxxxxxxxxxxxx 00
00000 Xxxxxxx
(hereinafter referred to as “PMS”)
Subject of the agreement
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PMS DMC: Einkauf PST |
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PMS |
FIC |
1
Performance of the incoming goods inspection in accordance with §§ 377 - 378 of the German commercial code (“HGB”)
The contracting parties agree on an incoming goods inspection (GRI) on behalf of PMS.
The incoming goods inspection shall be explicitly commissioned for each purchase order; the cost of the inspection shall be included in the price of the articles ordered.
The scope of the inspection shall be based on the test specifications prescribed by PMS or agreed with it, which are an integral part of the Specification.
The contracting parties waive in agreement PMS’s duty to inspect and file a complaint in accordance with §§ 377 – 378 of the German commercial code although the contractual and statutory entitlement to compensation shall remain. The obligation shall be replaced by the detached, explicitly agreed incoming goods inspection at the contractor’s premises.
If defects occur at PMS earlier or later, which are due to an inadequate incoming goods inspection, PMS may take recourse to the contractor. The scope of the warranty and the periods thereof shall be based on the purchasing conditions of PMS. In the event of any faults occurring, the contractor shall without delay adept the incoming goods inspection to the new requirements and ensures that the sources of error are eliminated.
Notwithstanding the above agreements, PMS shall identify the goods, establish the quantity and check the consignment with regard to apparent damage in transit.
The contractor shall perform the specified inspections as a routine inspection, document them individually and file the documents for at least 10 years. The documents filed shall be made available to PMS on request.
Place of jurisdiction
The place of jurisdiction for any disputes resulting from the contract shall be Hamburg, Germany.
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XXXXXXX Imaging |
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DMC GmbH |
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2
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Philips Medical Systems - FIC |
PMS - FIC |
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Annex O3: Quality Cost Agreement |
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Master Purchasing Agreement PMS and FIC |
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Annex of Master Purchasing Agreement
(Agreement No. P01-000132)
concerning
Quality Cost Agreement
between
Xxxxxxx Imaging
00000 Xxxxx Xxxxx Xxxxxx
Xxxxxx, Xxxxxxxx 00000
(hereinafter referred to as “FIC”)
and
Philips Medical Systems
DMC GmbH
Xxxxxxxxxxxxxx 00
00000 Xxxxxxx
Xxxxxxx
(hereinafter referred to as “PMS”)
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PMS DMC: Einkauf |
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PMS |
FIC |
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Object of the Agreement
1 Quality Cost Agreement
The goods delivered shall be inspected by PMS for apparent undamaged condition and completeness within an appropriate time. Notification of evident defects shall as a rule be effected within 6 weeks from receipt of the goods. Notification of hidden defects shall be effected immediately after their discovery. Payment for the goods shall not signify their approval as complying with the contract and free of defects.
PMS has established the zero defect strategy within its Quality Management Program. PMS expects from FIC to support the PMS strategy and observe the zero defect strategy for all the products and services of FIC, too. FIC shall support the delivery of products without any defect by continuous improvement, supervision, and analysis of all of its production and working processes.
For each purchased product FIC shall, on request of PMS, list and follow up quality assurance targets reconciled with PMS. The proof of reaching these targets shall be transparent and proved to PMS by giving PMS access to the respective documents.
The Supplier warrants that the goods delivered comply with the agreed specification, that they have no defects which impair their value or their suitability, and that they do not lack any promised characteristics. The Supplier also warrants that the goods supplied are free of design, material and manufacturing faults and are in accordance with the latest state of the art.
In the event of defects in the goods supplied FIC receives a Quality Faults Report of Purchased Products and a List of Costs (see below).
In the event of defects in the goods supplied, we shall be entitled at our option to demand replacement free of charge or correction of such defect. In urgent cases, we shall be entitled to remedy such defects ourselves at the cost of the Supplier. If we have requested correction of a defect and such correction is still not successfully effected after expiry of a reasonable period of grace, we shall be entitled to demand a reduction of the agreed price, or to rescind the contract in whole or in part, and to claim damages for non-fulfilment. Any further rights that we have to warranty or the payment of damages - including for consequential damage - shall remain unaffected thereby. In particular, we shall be entitled to claim reimbursement of the costs incurred by us for inspection if the above-average occurrence of faults compels us to conduct incoming inspections over and above the usual level of random sample inspections (Master Purchasing Agreement, par. 7.6).
We shall be entitled to place nonconforming goods in storage or to return them to the Supplier at the latter’s cost and risk. Title to such goods shall revert to the Supplier on the date of sending of the notification of the return shipment of the nonconforming
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goods. Transfer of possession of the goods shall be replaced by our safekeeping of the goods for the Supplier.
In the event of defects, which are not noticed until the goods are machined or processed, we shall also be entitled to claim reimbursement of any cost incurred by us to no avail.
In the event of rework or replacement delivery, the warranty period shall start again for the reworked part or for the replaced goods. (See Master Purchase Agreement)
For retention of our warranty claims beyond the warranty period, it shall suffice if we have notified the Supplier of the defect within the warranty period.
Our rights as set out above shall not be affected by a quality agreement (e.g. ppm, zero defects).
2 Place of jurisdiction
The place of jurisdiction for all disputes resulting from this Agreement shall be Hamburg, Germany.
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Hamburg, |
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Denver, |
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Philips Medical Systems |
XXXXXXX Imaging |
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DMC GmbH |
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Annex: Qualitätsmängelbericht (Quality
Fault Report for Purchased Parts)
Kostenaufstellung (List of costs)
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Quality Fault Report for Purchased Parts |
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TPAI |
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(Qualitätsmängelbericht) |
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PMG |
Copy: |
Accounting Dpt. |
PK 152 |
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Report-No.: |
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Initial Purchasing Dpt. |
PK 145 |
Philips Medical Systems • D-22331 Hamburg/ Germany
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Philips Medical Systems |
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An die Geschäftsleitung |
DMC GmbH |
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Xxxxxxxxxxxxx 00 |
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X-00000 Xxxxxxx/ Xxxxxxx |
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Tel.: + 49 40 50 78 {Quality manager} |
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Your order No. |
of |
Our Ref. |
Extension |
Hamburg |
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Name: |
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Defects have been detected on the product manufactured by you:
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PMS-12 NC: |
Designation: |
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Amount: |
Series number: |
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Date of delivery: |
Delivery note No.: |
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Our order No.: |
Buyer: |
Date:
Description of the defect: See attachment {Fault Report}
o Production shutdown
Due to the defects described PMS proposes the following measures:
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o PMS eliminates the defect |
o Scrapping by PMS with request for replacement delivery free of charge |
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o Immediate return with the request for replacement delivery of the product or repair by you until |
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To be filled out by the supplier: |
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Supplier agrees |
o yes |
o no |
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Supplier repairs at PMS |
o yes |
o no |
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Return delivery No. |
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Commission No. |
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Quality Fault Report page I
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Quality Fault Report for Purchased Parts |
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TPAI |
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Report-No.: |
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We are asking you to inform PMS in written form (within no later than five work days) what measures have been taken by you to avoid such defects in the future.
We are also asking you to inform PMS in written form whether any other products might be affected.
Please send this form sheet to PMS to the above fax number within 24 hours.
Elimination of the error: (see attachment) {answer of supplier}
The accounting department will send you a debit note over the amount of EUR for any costs incurred for PMS .
Any costs that cannot be foreseen at the moment will later on be debited by PMS.
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First name, name |
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First name, name |
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First name, name |
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Philips Medical Systems |
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Philips Medical Systems |
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Philips Medical Systems |
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DMC GmbH |
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DMC GmbH |
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DMC GmbH |
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Date |
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Date |
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Date |
Quality Fault Report page II
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Philips Medical Systems - (NN) |
PMS - (NN) |
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Anhang O3: Quality Cost Agreement |
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zum Rahmenvertrag zwischen PMS and (NN) |
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List of costs:
(Kostenaufstellung)
1. Fixed charges for return shipments
• Fault report internal
• Fault report external
• Administration, shipment, transport
• Incoming/outgoing goods, administration,
• Final check & completion of comlaint
Subtotal |
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200.- EUR |
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200.- EUR |
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2. Extra work costs |
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• Fault report of defective product |
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• Disassembly of defective product |
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• Assembly of a new product |
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• Test of a new product |
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• Process disturbances |
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• Additional requirements for a new test as a result of the insufficient quality |
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• Refinishing work |
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• Material costs incl. cost for scrapping |
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Total of hours x 50.- EUR/h |
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Subtotal work costs |
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3. Fixed charges for shipments that are not returned |
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• Fault report internal |
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• Fault report external |
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• Administration, final test completion of complaint |
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Subtotal |
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100.- EUR |
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100.- EUR |
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Total costs: |
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EUR |
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First name, name (Operationsmanager) |
First name, name (PMS employee) |
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(signature) |
(signature) |
Quality Fault Report page III
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PMS DMC: Einkauf GEN |
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PMS |
FIC |
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Philips Medical Systems - FIC |
PMS - FIC |
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Annex O1: Logistic Procedure |
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Master Purchasing Agreement PMS and FIC |
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Logistic Procedure
Annex O1 to Master Purchasing Agreement (Agreement No. P01-000132)
between
Philips Medical Systems and Xxxxxxx Imaging
1. Planning & forecasting
• PMS will provide a rolling 4-quarter, non-binding forecast. Regular delivery of the product will start in Q3 2005.
• The forecast will be updated every quarter for the upcoming 4 quarters on the first day of the month prior to the beginning of that quarter. It will be PMS’s most accurate expectations for shipment requirements.
• The forecast for the most current quarter will not exceed current in house orders with confirmed shipping dates within that quarter plus an additional 30% for forecasts units, where orders are not yet confirmed, but are expected with delivery required in that quarter.
• Xxxxxxx will inform Philips about general slot planning.
2. Delivery times
• Lead-time for the product is 21 calendar days from receipt of purchase order until day of shipment.
• For volumes higher than forecasted (more than additional 30%) every reasonable effort will be made to meet the lead-time for additional volumes.
• If reasonable volumes are reached (approximately 100 units per year) both parties agree to establish a consignment stock at PMS premises.
• All orders shall be considered firm and non-cancelable 21 days prior to the requested shipping date
• In case of move outs PMS will inform Xxxxxx and vice versa. Xxxxxxx will send a new confirmation within 2 days
• Xxxxxxx will take express costs for transportation in case of late deliveries.
3. Tender Business
• Any single order for more than 5 systems will be considered a “Tender Order”.
• Tender business shall be regarded as additional business to the forecast.
• Every reasonable effort will be made to meet the shipping requirements, but the orders will not be subject to the 21-day shipping requirement for forecasted orders. Both parties will agree on a delivery schedule for every individual tender that meets the tender requirements.
4. Shipment procedures
• PMS preferred carriers are Panalpina or Menlo. (Contact addresses/phone number are listed at the end of this annex) Xxxxxxx will deliver all systems through these carriers to a Uni_Data Depot in Frankfurt. Uni_Data will consolidate goods from Hamburg and USA (Xxxxxxx) and will deliver as one lot shipment to final customer in Europe.
• Shipments procedures to destinations outside Europe will be described in a separate annex to be added, when such deliveries will start.
• Packing will be in heat-treated wood. This standard packing is included in the system price.
• Packing will only bear Philips name and logo.
• In case special packing is required (e.g. water proof, etc.) PMS will bear the cost.
• Xxxxxxx will hand over the goods to the carrier at the committed delivery date with company neutral paperwork ( no Xxxxxx labels, signs or Xxxxxx invoices are to be attached to the shipment) . On all paperwork the customer order number and the Philips code numbers have to be visible.
5. Order procedures
PMS will send a call off to Xxxxxxx preferably by Email or by fax with following contents:
• Customer order number
• Type number
• Required delivery date (ex works)
• Quantity
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PMS DMC: Einkauf |
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PMS |
FIC |
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PMS will receive an order confirmation within 2 days by Xxxxxxx preferably by EMAIL or fax with following contents:
• Customer order number
• Type number
• Confirmed delivery date
• Quantity
PMS will send a delivery advise to Uni_Data and to Panalpina / Menlo with following contents:
• Customer order numbers
• Date and time of arrival at destination
• Address of final destination
Xxxxxxx will advise the carrier (Menlo, Panalpina) when the goods shall be picked up at Xxxxxxx Imaging. Reference is the customer order number.
Latest the day when the carrier picks up the material, Xxxxxxx will send a delivery note to Philips with following contents:
• Final customer order number
• Philips code numbers
• Philips description
• Serial number
• Amount of parcels, sizes and weight
6. Addresses:
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Panalpina Inc. |
Unidata - Frankfurt |
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Global Account Division |
UPS SCS GmbH & Co OHG |
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American Region |
Hessenring 23 |
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000 Xxxxxx Xxxxxx |
00000 Xxxxxxxxxx-Xxxxxxx |
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Xxx Xxxxxx Xxxxxxx, XX 00000 – USA |
Germany |
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Menlo Worldwide |
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0000 Xxxxx Xxxxxx |
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Xxxxxx, XX 00000 |
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Tel. 000 000-0000 |
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Fax. 000 000-0000 |
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Philips Medical Systems - FIC |
PMS - FIC |
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Annex H1: Sustainability |
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Master Purchasing Agreement PMS and FIC |
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ATTACHMENT H1
SUSTAINABILITY REQUIREMENTS
For the purpose of this Attachment, BUYER is also referred to as “PMS” or “Philips Medical Systems”.
SECTION A: APPLICABILITY AND SCOPE
1.0. This Attachment incorporates the Royal Philips Supply Standard on Sustainability and as such establishes minimum requirements of behavior expected of Philips Medical Systems’ (PMS) suppliers of Products, as well as components, parts, including Service Parts (altogether “Parts”) and packaging (“Packaging”) with regard to sustainability and sustainable development.
1.1 This Attachment establishes Royal Philips and PMS’ specific environmental requirements for purchased Parts, Products and Packaging that are incorporated into or part of PMS Products.
1.2 This Attachment is not intended to be a listing of all product content limitations or restrictions that may be established as a matter of law. SUPPLIER’s compliance with this Attachment does not relieve or diminish SUPPLIER’s obligation to comply with all applicable laws.
1.2.1 Precedence: Except as noted below, if a conflict should occur between this Attachment and any identified standard or regulation, this Attachment shall prevail. Should a conflict occur between this Attachment and a PMS Product or Part Specifications, the PMS Product or Part Specifications shall prevail.
1.2.2 Exception: Legal and/or regulatory requirements for the countries where these purchased Parts and Products are to be used take precedence over of this Attachment.
1.3 This Attachment is an addition to and does not in any way limit or supersede any Product Specifications that may be established by PMS.
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Xxxx Xxxxxxx |
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PMS |
FIC |
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SECTION B: PHILIPS SUPPLY STANDARD ON SUSTAINABILITY
SUPPLIER represents and warrants full compliance with Philips Supply Standard on Sustainability as follows:
GENERAL
SUPPLIER is committed to act fairly and with integrity toward its stakeholders and is expected to comply with all applicable local rules and regulations.
ENVIRONMENT
SUPPLIER shall have ISO14001 certification or a plan to become certified. Alternatively SUPPLIER must provide documented objective evidence of an operational environmental management system for ISO14001 or demonstrate equivalency, which shows continual environmental improvement. SUPPLIER must comply with requirements of the respective Product Division, including banned/hazardous substances content.
HEALTH AND SAFETY
SUPPLIER shall do all that is reasonable and practicable to:
• Protect the health and safety of employees and contract labor and minimize any adverse work conditions;
• Implement safe and healthful work practices to prevent injury, illness and property damage;
• Minimize occupational exposures to potentially hazardous materials and unsafe work conditions by maintaining appropriate safety systems and effective controls;
• Implement an emergency response program that addresses the most likely anticipated emergencies;
• Train managers and employees to assure their continued commitment to their own health and safety and that of their co-workers;
• Involve employees at all levels in the health and safety program; assure their accountability for injury and illness prevention.
CHILD LABOR
SUPPLIER shall not employ children in violation of convention 138 and 182 of the International Labor Organization. In case of child labor, SUPPLIER shall take immediate remedial action in consultation with Philips, considering the interests of the children employed. This action will include:
• Minimally acceptable employment conditions for the children employed (such as education, working hours, wages, medical facilities etc.)
• The obligation of SUPPLIER not to employ any more children
• A time period within which SUPPLIER will comply with the mentioned ILO norms.
FORCED LABOR
Employment should be freely chosen. Under no circumstances will SUPPLIER make use of forced or bonded labor – such as forced labor performed by persons placed in an institution, or compulsory labor including labor as a means of political coercion or education – to design, manufacture or assemble products and services for Philips.
RIGHT TO ORGANIZE
SUPPLIER shall recognize and respect the freedom of its employees to choose whether or not to establish or to associate with any organization of their own choosing (including labor unions) without SUPPLIER’s prior authorization. The employment of a worker shall not be contingent upon the condition that he/she not join a union or be forced to relinquish trade union membership. Furthermore, union membership shall not be the cause for the dismissal of – or otherwise prejudice against – a worker. . SUPPLIER will not interfere with or finance labor organizations or take other actions with the intent of placing such organization under the control of SUPPLIER.
COLLECTIVE BARGAINING
SUPPLIER shall respect – within the framework of law, regulations and prevailing labor relations and employment practices – the right of its employees to be represented by labor unions and other employee organizations. SUPPLIER will engage in negotiations, either on its own behalf or through employers’ associations, with a view toward reaching agreement on employment conditions.
DISCRIMINATION
SUPPLIER shall treat its employees equally in employment and occupation, and will ensure that each has equal opportunities. SUPPLIER shall offer equal pay for equal work performed at equal levels. No form of harassment or discrimination in respect of employment and occupation will be tolerated, such as discrimination based on race, color, sex, age, language, religion, political or other opinion, national or social origin, property, birth or other status.
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Declaration to be signed by Xxxxxxx Imaging: |
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Philips & Xxxxxxx Imaging |
Umbrella Purchasing Agreement No tbd |
SECTION C: PHILIPS MEDICAL SYSTEMS’ ENVIRONMENTAL SPECIFICATIONS FOR PRODUCTS, PARTS AND PACKAGING
1.0 ENVIRONMENTAL DECLARATION, BANNED AND RELEVANT SUBSTANCES AND SPECIFIC ADDITIONAL LEGISLATION
1.1 SUPPLIER represents and warrants that on the Effective Date, the Products, Parts and Packaging do not contain Banned Substances and comply with the Additional Environmental Legislation as specified in Annex 1 of this Attachment, except for certain Products specifically identified. For these identification purposes, SUPPLIER agrees to complete and sign the “Environmental Declaration For Products, Parts And Packaging” (Form A) of this Attachment and indicate whether or not Products, Parts and Packaging delivered to PMS contain Banned Substances and comply with the Additional Environmental Legislation identified in Annex 1. In case some Products contain Banned Substances or do not comply with the Additional Environmental Legislation identified in Annex 1, either as from the Effective Date or otherwise during the Term of the Agreement, SUPPLER shall, on the Effective Date or prior to the first delivery of such Products, Parts and Packaging, submit a “Request for Dispensation” (Form B) of this Attachment to BUYER. Without prejudice to the provisions of Section A, 1.2 and the provisions below, BUYER may, at its sole discretion, provide in writing such a dispensation per Product and for a defined period of time.
1.2 SUPPLIER is responsible to inform BUYER on the Effective Date onward and prior to the first delivery, of the presence of Relevant Substances that are contained in Products, Parts and Packaging in excess of the thresholds listed in Form C of this Attachment, by using the “Declaration of Relevant Substances”, Form C of this Attachment.
1.3 SUPPLIER agrees to actively search for alternatives to eliminate Banned Substances and reduce and/or eliminate Relevant Substances contained in Products, Parts and Packaging.
1.4 SUPPLIER agrees to eliminate any non compliance with Additional Environmental Legislation related to Products, Parts and Packaging.
2.0 GENERAL ENVIRONMENTAL REQUIREMENTS
2.1 SUPPLIER shall comply with all applicable environmental laws, rules, regulations, ordinances, covenants, standards and the like, and BUYER’s implementation thereof (collectively herein referred to as “Environmental Regulations”) concerning the Products, Parts and Packaging thereof (including correct labeling) as well as plant operations and shipments in connection therewith, enabling BUYER to distribute on a world-wide basis Products, Parts and Packaging without restrictions.
2.2 Without prejudice to the representation and warranty of SUPPLIER as described in paragraph 2.1, in the event any new Environmental Regulation is promulgated after the date of signing of this Attachment, the parties hereto will negotiate to establish within a reasonable period of time equitable terms to prevent or remedy any non-compliance by SUPPLIER of said warranty and representation as a consequence of such promulgation.
2.3 To ensure continuous compliance with Environmental Regulations, the BUYER shall have the right to audit the implementation and adherence to this Attachment.
2.4 SUPPLIER agrees to control the environmental aspects of the design and manufacture of Products, Parts and Packaging through an adequate and effective environmental management system that complies with ISO 14001 referenced in the Philips Supply Standard on Sustainability.
2.5 Where SUPPLIER is not certified to ISO 14001 nor has an equivalent environmental management system in place, SUPPLIER shall provide to and agree on with BUYER a plan and time schedule to achieve an operational environmental management system or equivalent.
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Xxxx Xxxxxxx |
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BUYER |
SUPPLIER |
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3.0 DESIGN AND MANUFACTURING
3.1 SUPPLIER undertakes that Products, Parts and Packaging are designed and manufactured to comply with the objectives of the Waste Electrical and Electronic Equipment Directive (WEEE) (2002/96/EC).
3.2 Upon request, SUPPLIER will provide PMS with environmentally-related information regarding all materials included in the Products, Parts and Packaging including as a minimum:
3.2.1 Necessary information for disassembling, recycling, reusing and treating Products, Parts and Packaging at end of life;
3.2.2 The location of dangerous substances and preparations in Products, Parts and Packaging;
3.2.3 Appropriate markings in accordance with the WEEE Directive requirements.
3.3 On the basis of best effort, SUPPLIER undertakes to participate in Philips’ and/or BUYER’s environmental programs, such as
3.3.1 Reduction of the weight and volume of Packaging and Packaging materials to as low as possible and to the technically necessary minimum, while maintaining basic Packaging functions including transportability, protection and communication of information;
3.3.2 Environmentally Conscious Design (EcoDesign), i.e., reducing the integral environmental impact of the product over its entire life cycle;
3.3.3 Reusability of Products, Parts and Packaging.
4.0 CHEMICAL SUBSTANCES
4.1 Chemical Registration Requirements
4.1.1 SUPPLIER represents and warrants that each chemical substance, as defined in Toxic Substances Control Act, contained in Products, Parts and components sold to PMS is on the inventory of chemical substances compiled and published by the United States Environmental Protection Agency pursuant to the Toxic Substances Control Act (TSCA) and complies with chemical registration and pre-manufacture notification requirements in other countries that have enacted chemical registration requirements including but not limited to Xxxxxxxxx, Xxxxxx, Xxxxx, Xxxxx, Xxxxx Xxxxx, Xxxxxxxxxxx and the countries of the European Union.
4.2 Chemical Labeling and Materials Safety Data Sheet Requirements
4.2.1 SUPPLIER represents and warrants that each hazardous chemical, as defined by the United States Occupational Safety and Health Administration Hazard Communication Standard, contained as a chemical in Products, Parts and components complies with the labeling and Material Safety Data Sheet (MSDS) provisions of 29 CFR 1910.1200, ISO 11014-1 and 91/155/EC in that:
4.2.1.1 All hazardous chemicals are appropriately labeled;
4.2.1.2 An MSDS is provided to BUYER prior to and with the first delivery of the hazardous chemical, and whenever changes are made to the MSDS.
4.3 Carcinogen and Reproductive Toxicant Labeling Requirements
4.3.1 As determined by the State of California- Safe Drinking Water and Toxic Enforcement Act or 1986, List of Chemicals Known to Cause Cancer or Reproductive Toxicity, California Code of Regulations, Title 22, Division 2, Part 2, Subdivisions 1, Chapter 3, Section 12000 –Chemicals Known to Cause Cancer or Reproductive Toxicity, products, accessories, parts, components or cables that contain chemical substances that exceed their
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• No Significant Risk Levels (NSRLs) to cause cancer, or
• No Observable Effect Levels (NOELs) to cause reproductive harm
must be labeled with a clear and reasonable content warning.
5.0 OZONE DEPLETING SUBSTANCES
5.1 SUPPLIER represents and warrants that neither any of the Products, Parts or Packaging, nor any component thereof contain or have been “manufactured with a process that uses” any ozone depleting substances as specified in the U.S. Clean Air Act, 40 CFR 82.
5.2 In case SUPPLIER cannot meet the above requirements, BUYER’s written approval is required prior to delivery and SUPPLIER must submit notification of non- conformance via the Request for Dispensation (Form B), and label the Products, Parts and Packaging in accordance with applicable regulatory requirements.
6.0 PACKAGING
6.1 Content restrictions that apply to Packaging refer to all Packaging materials purchased by PMS including those used to package PMS products for sale as well as those used to transport Products, Parts and components to the factory to be incorporated into PMS products, after which time, the Packaging would be discarded as waste.
6.2 Packaging must comply with the objectives of the European Directive 94/62/EC on Packaging and Packaging waste. European Commission Decision 97/129/EC establishes a Packaging identification system.
6.3 All packaging materials, including pallets, shall be free of pests and comply with regulations regarding Solid Wood Packaging Materials (SWPM) where applicable. Wood originating in Canada, China, Japan and the United States must comply with European Legislation 1999/355/EC and 2001/219/EC with respect to treating and marking coniferous wood.
6.4 Timber used as crates, pallets and in containers as lining, flooring and skids, and any other articles described as Packaging and dunnage being exported to Australia must satisfy Australian Quarantine and Inspection Service (AQIS) requirements prior to entry.
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Initials: |
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Initials: |
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Philips Medical Systems |
Xxxxxxx Imaging |
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5
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Philips & Xxxxxxx Imaging |
Umbrella Purchasing Agreement No tbd |
ANNEX 1 To Section C of Attachment H1
Royal Philips Electronics
List of Banned Substances (CSO -BP01-2004-1)
Revision date: 2004-07-15
Articles (i.e. materials, components, subassemblies, products) delivered to Royal Philips must be free of the “Banned substances” as mentioned in this list.
|
Substances |
|
Declaration threshold |
|
Legal date entry |
|
|
Cadmium and –compounds |
|
20 |
|
Immediately |
|
|
Mercury and –compounds |
|
2 |
|
Immediately |
|
|
Lead and – compounds |
|
1000 |
|
1 July 2006 |
|
|
Lead and – compounds in outer sleeves of cables, according to proposition 65 legislation, USA |
|
300 |
|
Immediately |
|
|
Hexavalent Chromium (Cr 6+) and compounds |
|
1000 |
|
1 July 2006 |
|
|
Asbestos (all types) |
|
10 |
|
Immediately |
|
|
CFCs, Chlorofluorocarbons |
|
1 |
|
Immediately |
|
|
HCFCs, Hydrogenated chlorofluorocarbons |
|
1 |
|
Immediately |
|
|
Halons |
|
1 |
|
Immediately |
|
|
CHCs, Chlorinated hydrocarbons, |
|
1 |
|
Immediately |
|
|
Methyl Bromide |
|
1 |
|
Immediately |
|
|
HBFCs, Hydrobromofluorocarbons |
|
1 |
|
Immediately |
|
|
1,1,1-Trichloroethane |
|
1 |
|
Immediately |
|
|
Carbon tetrachloride |
|
1 |
|
Immediately |
|
|
Xxxxxxxxxxxxxxx (XX0Xx0) |
|
1 |
|
Immediately |
|
|
Trichloroethylene (C2HCl3) |
|
1 |
|
Immediately |
|
|
Perchloroethylene (C2Cl4) |
|
1 |
|
Immediately |
|
|
PCBs, polychlorinated biphenyls |
|
10 |
|
Immediately |
|
|
PCTs, polychlorinated terphenyls |
|
10 |
|
Immediately |
|
|
PCP, Pentachlorophenol and its salts and esters |
|
10 |
|
Immediately |
|
|
Polybrominated diphenyl ethers (2) (PBDEs) |
|
1000 |
|
Immediately |
|
|
Polybrominated biphenyls (PBBs) |
|
1000 |
|
Immediately |
|
|
Ugilec 141 (mono methyl tetrachlorodiphenyl methane) |
|
10 |
|
Immediately |
|
|
Ugilec 121 (or Ugilec 21) (monomethyl dichlorodiphenyl methane) |
|
10 |
|
Immediately |
|
|
DBBT (monomethyl dibromodiphenyl methane) |
|
10 |
|
Immediately |
|
Product packaging must be free from the above-mentioned substances AND the following:
|
Substances |
|
Declaration threshold |
|
Legal date entry |
|
|
PVC and PVC blends |
|
1000 |
|
Immediately |
|
|
Sum of Heavy metals (Cd, Hg, Cr(6+) and Pb) |
|
100 |
|
Immediately |
|
Note:
For Product Division (PD) additional banned substances and specific exemptions on above list, see appendix to this Royal Philips Electronics list of Banned Substances.
(1) In fact, banned substances are not to be intentionally used, that is, Royal Philips Electronics accepts that certain materials contain a certain amount of naturally occurring banned substances. Thresholds can represent legal limits, or refer to currently accepted analysing thresholds.
Furthermore these thresholds should be declared on component level. Substances are measured in homogeneous materials.
(2) Poly Brominated Biphenyl Ether are same as Poly Brominated Diphenyl Ether (PBDE) and Poly Brominated Diphenyl oxides (PBDO) and Poly Brominated Biphenyl oxides (PBBO)
|
|
|
|
BUYER |
SUPPLIER |
6
|
Philips Medical Systems - FIC |
PMS - FIC |
|
Annex H1: Sustainability |
|
|
Master Purchasing Agreement PMS and FIC |
|
Appendix in addition to Royal Philips Electronics list of Banned Substances CSO-BP01-2004-1
Additional Banned Substances and specific exemption per Product Division (PD)
Philips Consumer Electronics (CE)
|
Additional Substance(s)
and |
|
Declaration |
|
Entry into |
|
Remark |
|
Short-chain chlorinated paraffins |
|
10 |
|
Immediately |
|
(C10-C13) used in paints and as flame retardant in PVC |
|
Organostannic compounds |
|
10 |
|
Immediately |
|
Organic Tin compounds (TBT, TPT and TBTO compounds) |
|
TBBA (tetrabromobisphenol-A) |
|
10 |
|
1 Jan 2006 |
|
Applied as FR in Laminates of printed wiring boards (PWBs) also in plastics |
|
Azocolourants |
|
30 |
|
Immediately |
|
Applied in leather and textiles in prolonged skin contact |
|
Nickel and nickel alloys |
|
0,5µg/cm2/week |
|
Immediately |
|
Only in prolonged skin contact, |
|
Tris-(1-aziridinyl) phosphinoxide |
|
10 |
|
Immediately |
|
Applied in leather and textiles in prolonged skin contact |
|
Tris-(2,3-dibromo-propyl) phosphate |
|
10 |
|
Immediately |
|
Applied in leather and textiles in prolonged skin contact |
|
Lead and - compounds |
|
1000 |
|
1 Jan 2005 |
|
This is before the legal date (EU Directive RoHS 2002/95/EC) |
|
Hexavalent Chromium (Cr 6+) and compounds |
|
1000 |
|
1 Jan 2005 |
|
This is before the legal date (EU Directive RoHS 2002/95/EC) |
CE Requirements to phenol in laminates of printed wiring boards:
1. Smell Emission : <200 odor unit/m2/day
Test method: Measured in duplo according to NVN2820 (or NEN-EN 13725:2003) by TNO Apeldoorn, the Netherlands, with 10 dm2 of single sided copper cladded laminate after 3 days at room temperature in a PTFE bag of approximately 40 l.
2. Phenol monomer : <50 mg/l phenolics
Test method : Phenolics content in water (according to ISO 6439) after shaking for 23 hours a mixture of 75 g of milled (to 3 mm)
laminate in 1.5 l of demineralized water at pH 4).
Philips Domestic Appliance and Personal Care (DAP)
|
Additional Substance(s)
and |
|
Declaration |
|
Entry into |
|
Remark |
|
EPS (Expanded Polystyrene) |
|
1000 |
|
Immediately |
|
Banned for Product Packaging (with a product weight of less than 20 kg) |
Exemption information:
DAP is re-enforcing its limit for the cadmium-threshold from 100 ppm to 20 ppm. Final entry into force of this new more stringent value is January 1st, 2006.
Philips Lighting
|
Additional Substance(s)
and |
|
Declaration |
|
Entry into |
|
Remark |
|
Antimony in soda lime glass |
|
1000 |
|
Immediately |
|
The antimony is present as an impurity, not intentionally added to the glass. |
|
Polycyclic aromatic hydrocarbons (PAHs) |
|
5 |
|
Immediately |
|
All applications. (like potting material for electronic ballast) |
|
TBBA (tetrabromobisphenol-A) |
|
10 |
|
1 Jan 2006 |
|
Applied as FR in Laminates of printed wiring boards (PWBs) also in plastics. |
Exemption information:
Mercury is allowed only in gas discharge lamps with certain conditions referred in European Directive RoHS 2002/95/EC. This restriction applies only for lamps placed on the European market since 1st July, 2006.
Philips Medical Systems (PMS)
|
Additional Substance(s)
and |
|
Declaration |
|
Entry into |
|
Remark |
|
Arsenic compounds |
|
10 |
|
Immediately |
|
Banned for wood Packaging |
Exemption information:
Lead and compounds, and Hexavalent Chromium (Cr 6+) and compounds are only mentioned in the new European Directive RoHS
2002/95/EC and not in any other legislation. Presently Medical equipment is exempt from this RoHS Directive. Therefore these
substances are not Banned for PMS and no Request for Dispensation is required.
This exemption does not include Lead in outer sleeves of cables in accordance with proposition 65 .
Philips Semiconductors
|
Additional Substance(s)
and |
|
Declaration |
|
Entry into |
|
Remark |
|
Short-chain chlorinated paraffins |
|
10 |
|
Immediately |
|
(C10-C13) used in paints and as flame retardant in PVC |
|
Organostannic compounds |
|
10 |
|
Immediately |
|
Organic Tin compounds (TBT, TPT and TBTO compounds) |
|
Polychloronaphtalenes |
|
10 |
|
Immediately |
|
> 3 Cl atoms as stabilizer and flame retardant in plastics |
|
Benzene |
|
100 |
|
Immediately |
|
As residual solvent in materials |
|
Formaldehyde |
|
0.1 |
|
Immediately |
|
As residue in plastics, resins |
|
Lead and - compounds |
|
1000 |
|
1 Jan 2005 |
|
This is before the legal date (EU Directive RoHS 2002/95/EC) |
|
Hexavalent Chromium (Cr 6+) and compounds |
|
1000 |
|
1 Jan 2005 |
|
This is before the legal date (EU Directive RoHS 2002/95/EC) |
|
|
PMS |
FIC |
7
Additional Environmental Legislation Applicable to PMS Products, Parts and Packaging (Based on international legislation)
Additional Legislation Applicable to PMS Products, Parts and Packaging
|
Batteries |
|
- |
|
European Council Directive 91/157/EEC, 93/86/ EEC and the U.S. Regulation H.R. 2024 on Batteries (if product contains batteries) |
|
|
|
|
|
|
|
Packaging |
|
- |
|
European Legislation 1999/355/EC and 2001/299/EC with respect to treating and marking coniferous wood originating in Canada, China, Japan and the United States |
|
|
|
- |
|
European Council Directive 94/62/EC on Packaging |
|
|
|
|
|
|
|
Electric & Electronic Equipment |
|
- |
|
European Council Directive 2002/96/EC on Waste Electric and Electronic Equipment (WEEE) |
|
|
|
|
|
|
|
Chemicals |
|
- |
|
United States
(State of California) – Safe Drinking Water and Toxic Enforcement Act of 1986
List of Chemicals Known to Cause Cancer or Reproductive Toxicity - California Code of Regulations, Title 22, Division 2, Part 2,
Subdivisions 1, Chapter 3, Section 120000 – Chemicals Known to Cause Cancer
or Reproductive Toxicity |
|
|
|
|
|
|
|
Ozone Depleting Chemicals |
|
- |
|
U.S. Clean Air Act and Amendments (CAAA) and U.S. Significant New Alternative Policy (SNAP-rule); 40 CFR 82 |
8
Instructions to Complete Forms A, B and C
Form A: Environmental Declaration For Products, Parts And Packaging Sold To Philips Medical Systems (PMS)
SUPPLIER shall complete, sign and return Form A to BUYER. To complete Form A, SUPPLIER shall check Box 1 or 2 under each section “Banned Substances Applicable to Products, Parts and Packaging” and “Additional Environmental Legislation Applicable to PMS Products, Parts and Packaging” to indicate whether Products, Parts and Packaging sold to BUYER comply with the Philips environmental requirements.
Form B: Request for Dispensation
If SUPPLIER has indicated a non compliance on Form A, SUPPLIER shall additionally complete, sign and return Form B.
One Form B must be completed for each Product, Part and Packaging that does not comply with Philips environmental requirements. To complete Form B, SUPPLIER shall indicate the Part, Product or Packaging and corresponding Banned Substance(s) and/or Additional Environmental Legislation to which it does not comply.
Form C: Declaration of Relevant Substances
This Form must be completed, signed and returned by SUPPLIER only if Products, Parts or Packaging delivered to PMS contain any of the Relevant Substances listed on Form C.
9
FORM A
ENVIRONMENTAL DECLARATION
FOR PRODUCTS, PARTS AND
PACKAGING SOLD TO PHILIPS MEDICAL SYSTEMS (PMS)
|
To be filled out by Supplier |
For PMS use only |
||||
|
|
|
||||
|
Supplier: |
|
||||
|
|
|
||||
|
Supplier Address: |
|
||||
|
|
|
||||
|
Supplier Phone: |
|
||||
|
|
|
||||
|
|
|
||||
|
Banned Substances Applicable to Products,
Parts and Packaging (Based on international legislation and Philips |
|||||
|
|
|
||||
|
(1) |
SUPPLIER warrants that on the execution date of this Declaration, the Products, Parts and Packaging supplied to PMS do not contain Banned Substances in excess of the thresholds listed in Annex 1 of Attachment H1 of the Umbrella Purchasing Agreement as numbered above. |
||||
|
(2) |
SUPPLIER warrants that on the execution date of this Declaration, the Products, Parts and Packaging supplied to PMS do not contain Banned Substances in excess of the thresholds listed in Annex 1 of Attachment H1 of the Umbrella Purchasing Agreement as numbered above, except those Products, Parts, Packaging for which dispensation is requested. Any deviation is specified on the “Request for Dispensation” (Form B) for each Product, Part and Packaging delivered to PMS that contains one or more Banned Substance. |
||||
|
|
|
||||
|
Additional Environmental Legislation Applicable to PMS Products, Parts and Packaging (Based on international legislation) Please check box #1 or #2 below that applies. |
|||||
|
|
|
||||
|
(1) |
SUPPLIER herewith declares that the Products, Parts and Packaging supplied to PMS are in compliance with the Additional Environmental Legislation listed in Annex 1 of Attachment H1 of the Umbrella Purchasing Agreement as numbered above. |
||||
|
(2) |
SUPPLIER herewith declares that the Products, Parts and Packaging supplied to PMS are in compliance with the Additional Environmental Legislation listed in Annex 1 of Attachment H1 of the Umbrella Purchasing Agreement as numbered above, except those Products, Parts, Packaging for which dispensation is requested. Any deviation is specified on the “ Request for Dispensation” (Form B) for each Product, Part and Packaging delivered to PMS that does not fully comply with the Additional Environmental Legislation. |
||||
|
|
|
||||
|
Supplier must complete a Request for Dispensation (Form B) for any non compliance with the Banned Substances or Additional Environmental Legislation listed specified in Annex 1 of Attachment H1 of the Umbrella Purchasing Agreement as numbered above. A separate Form B must be completed for each Product, Part and Packaging that deviates from any of these requirements. |
|||||
|
|
|
||||
|
For future deliveries, Supplier warrants to implement effective controls to assure continuous compliance with the above requirements and agrees to accept PMS compliance audits on these requirements. |
|||||
|
|
|
||||
|
Responsible Manager: |
|
Signature: |
|||
10
|
Function: |
|
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|
|
|
|
|
|
FORM B
REQUEST FOR DISPENSATION
(To be filled out by supplier for each applicable Product, Part and Packaging)
|
Product Number |
|
For Philips Medical |
|
||
|
|
|
|
|
||
|
Check all that apply: |
|
|
|
||
|
|
|
|
|
||
|
Royal Philips Electronics Banned Substances for Products, Parts and Packaging: |
|||||
|
|
|
|
|
||
|
With respect to the “ Environmental Declaration of
Products, Parts and Packaging sold to Philips Medical Systems”, dispensation
is requested to use Banned Substance(s) in excess of the thresholds listed in
Annex 1 of Attachment H1 of the Umbrella Purchasing Agreement as numbered
above. |
|||||
|
|
|
|
|
||
|
Additional Legislation: |
|
|
|||
|
|
|
|
|
||
|
Dispensation is requested
for non compliance(s) to Additional Environmental Legislation listed in Annex
1 of Attachment H1 of the Umbrella Purchasing
Agreement as numbered above. |
|||||
|
|
|
|
|
||
|
Additional Information: Please indicate below the amount of time for which dispensation is requested, and describe the deviation, reason for it and possible alternatives. |
|||||
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||
|
Product, Part, |
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||
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||
|
Dispensation requested for the period: |
From: |
To: |
|||
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|
Description of application: |
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||
|
Reason for use: |
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11
|
Possible alternatives: |
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|
Responsible Manager: |
|
|
Signature: |
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Function: |
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Date: |
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|
12
FORM C
DECLARATION OF RELEVANT
SUBSTANCES
( To be filled out by supplier for each applicable product, part and packaging)
|
SUPPLIER: |
|
Supplier Number: |
||||||||||
|
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|||||||||
|
Relevant Substances: (Request for dispensation is not required) |
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|||||||||||
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|||||||||
|
SUPPLIER confirms that, on the execution date of this Declaration, the Product, Part or Packaging indicated below as supplied to PMS contains Relevant Substance(s) in excess of the thresholds identified in the List of Relevant Substances for Product, Parts and Packaging below. |
||||||||||||
|
• |
For environmental improvements, end of life and customer information, a relevant substance in excess of the threshold must be declared. |
|||||||||||
|
• |
Only declare relevant substances in the Product, Part or Packaging when the concentration is above the threshold levels as indicated in the List of Relevant Substances for Products, Parts, Packaging below. |
|||||||||||
|
Product (Philips Numbering Code): |
|
SUPPLIER code: |
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Product weight: |
kg / gr: |
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|||||||||
|
Please check all that apply |
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|||||||||
|
Relevant Substances for Products, Parts and Packaging |
|
Threshold
value |
|
Amount |
||||||||
|
Aromatic Hydrocarbons, Halogenated |
|
10 |
|
|
||||||||
|
Antimony and -compounds |
|
10 |
|
|
||||||||
|
Arsenic and -compounds |
|
10 |
|
|
||||||||
|
Beryllium and -compounds |
|
10 |
|
|
||||||||
|
Chromium(VI) -compounds |
|
1000 |
|
|
||||||||
|
Cobalt and -compounds |
|
10 |
|
|
||||||||
|
Lead and -compounds (Cables and Printed Circuit Boards excepted) |
|
1000 |
|
|
||||||||
|
Selenium and -compounds |
|
10 |
|
|
||||||||
|
Tellurium and -compounds |
|
10 |
|
|
||||||||
|
Thallium and -compounds |
|
10 |
|
|
||||||||
|
Organic Tin and -compounds |
|
100 |
|
|
||||||||
|
Tungsten and -compounds |
|
100 |
|
|
||||||||
|
Cyanides |
|
10 |
|
|
||||||||
|
Formaldehyde |
|
100 |
|
|
||||||||
|
PAHs (Polycyclic aromatic hydrocarbons) |
|
10 |
|
|
||||||||
|
PAHs, oxidized (Polycyclic aromatic hydrocarbons) |
|
100 |
|
|
||||||||
|
Phenol and phenolic compounds |
|
100 |
|
|
||||||||
|
Phthalate (All) |
|
100 |
|
|
||||||||
|
PFCs (Perfluorocarbons) (All) |
|
10 |
|
|
||||||||
|
Toluene |
|
10 |
|
|
||||||||
|
Xylenes |
|
10 |
|
|
||||||||
|
Epichlorohydrin (Monomer) |
|
10 |
|
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||||||||
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|
Responsible Manager: |
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Signature: |
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|
Function: |
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|
Date: |
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13
