**Exhibit10.21**

** **
| **Master Purchasing Agreement** | ** ** | **** |
|---------------------------------|------------|------|
|                            |       |
| **Philips Medical Systems**     | ** ** |

** **

**MasterPurchasing Agreement**

 

**(AgreementNo. P01-000132)**

 

between

 

Fischer Imaging

12300 North GrantStreet

Denver, Colorado80241

 

(Hereinafterreferred to as “**Fischer Imaging**”)

 

and

 

Philips MedicalSystems

DMC GmbH

Röntgenstrasse 24

22335 Hamburg

 

(hereinafterreferred to as “**PMS**”)

 

**PurchasingFrame Agreement**

 
| **PMS** DMC:  Einkauf PST |    |
|---------------------------|---------|
|                      | **PMS** | **Fischer imaging** |
|                           |         |  |

 

----

 

**Contents:**

 
| **1**                   | ** ** | **PREAMBLE**                                                       | ** ** |
|-------------------------|------------|--------------------------------------------------------------------|------------|
| ** **              | ** ** | ** **                                                         | ** ** |
| **2**                   | ** ** | **OBJECT  OF THE AGREEMENT**                                       | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| **3**                   | ** ** | **SUBCONTRACT**                                                    | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| **4**                   | ** ** | **PRODUCT  DEVELOPMENT AND PRODUCT UPDATING**                      | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| 4.1                     |       | DEVELOPMENT                                                        |       |
| 4.2                     |       | PRODUCT UPDATING  / PRODUCT MODIFICATION                           |       |
|                    |       |                                                               |       |
| **5**                   | ** ** | **PLANNING  AND ORDERING**                                         | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| 5.1                     |       | REQUIREMENTS  PLAN                                                 |       |
| 5.2                     |       | PURCHASE ORDERS                                                    |       |
|                    |       |                                                               |       |
| **6**                   | ** ** | **MANUFACTURE**                                                    | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| 6.1                     |       | SPECIFICATION                                                      |       |
| 6.2                     |       | TRACEABILITY                                                       |       |
| 6.3                     |       | DRAWINGS  AND TOOLS                                                |       |
| 6.4                     |       | DOCUMENTATION                                                      |       |
| 6.5                     |       | DOWN PAYMENTS AND SUPPLIES  (ITEMS PROVIDED BY THE CLIENT)         |       |
|                    |       |                                                               |       |
| **7**                   | ** ** | **DELIVERY**                                                       | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| 7.1                     |       | MODE OF  DELIVERY                                                  |       |
| 7.2                     |       | TAKING  RECEIPT OF GOODS                                           |       |
| 7.3                     |       | DELIVERY  IN GOOD TIME                                             |       |
| 7.4                     |       | PACKAGING                                                          |       |
| 7.5                     |       | INCOMING GOODS INSPECTION                                          |       |
| 7.6                     |       | COMPLAINTS                                                         |       |
|                    |       |                                                               |       |
| **8**                   | ** ** | **PRICES**                                                         | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| 8.1                     |       | PRICE  CALCULATION                                                 |       |
| 8.2                     |       | PRICE CHANGE, PRICE  REVIEW                                        |       |
| 8.3                     |       | COST  PRICE REDUCTION                                              |       |
| 8.4                     |       | RESULTS OF PRICE  CALCULATION                                      |       |
| 8.5                     |       | MOST-FAVORED-NATION CLAUSE                                         |       |
|                    |       |                                                               |       |
| **9**                   | ** ** | **INVOICING  AND PAYMENT**                                         | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| 9.1                     |       | INVOICING                                                          |       |
| 9.2                     |       | PAYMENT                                                            |       |
|                    |       |                                                               |       |
| **10**                  | ** ** | **SERVICING SUPPORT  AND SERVICING PARTS**                         | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| 10.1                    |       | SERVICING  SUPPORT                                                 |       |
| 10.2                    |       | COMMITMENT TO DELIVER  SPARE PARTS                                 |       |
| 10.3                    |       | TRAINING                                                           |       |
|                    |       |                                                               |       |
| **11**                  | ** ** | **QUALITY**                                                        | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| 11.1                    |       | QS-AGREEMENT                                                       |       |
| 11.2                    |       | INDUSTRIAL  STANDARDS AND COMPANY STANDARDS                        |       |
|                    |       |                                                               |       |
| **12**                  | ** ** | **COMPLIANCE  WITH THE REGULATIONS REGARDING THE ENVIRONMENT AND** | ** ** |
| **ECOLOGICAL  ASPECTS** | ** ** |
| ** **              | ** ** | ** **                                                         | ** ** |
| 12.1                    |       | LEGAL  REGULATIONS                                                 |       |

 

----

 
| 12.2       |       | BANNED  SUBSTANCES AND SUBSTANCES RELEVANT FOR THE ENVIRONMENT      |       |
|------------|------------|---------------------------------------------------------------------|------------|
| 12.3       |       | OTHER  REGULATIONS REGARDING THE ENVIRONMENT AND ECOLOGICAL ASPECTS |       |
|       |       |                                                                |       |
| **13**     | ** ** | **WARRANTY**                                                        | ** ** |
| ** ** | ** ** | ** **                                                          | ** ** |
| 13.1       |       | WARRANTY                                                            |       |
| 13.2       |       | SCOPE OF  WARRANTY                                                  |       |
| 13.3       |       | TERM OF  WARRANTY                                                   |       |
| 13.4       |       | EPIDEMIC  DEFECTS                                                   |       |
| 13.5       |       | REMEDYING EPIDEMIC DEFECTS                                          |       |
| 13.6       |       | INTERRUPTION  IN THE PERIOD OF LIMITATION                           |       |
| 13.7       |       | RECALLS                                                             |       |
|       |       |                                                                |       |
| **14**     | ** ** | **LIABILITY**                                                       | ** ** |
| ** ** | ** ** | ** **                                                          | ** ** |
| **15**     | ** ** | **LIABILITY  INSURANCE**                                            | ** ** |
| ** ** | ** ** | ** **                                                          | ** ** |
| **16**     | ** ** | **RIGHTS**                                                          | ** ** |
| ** ** | ** ** | ** **                                                          | ** ** |
| 16.1       |       | THIRD-PARTY PROPERTY RIGHTS                                         |       |
| 16.2       |       | RIGHTS OF USE                                                       |       |
| 16.3       |       | RIGHTS IN NAMES AND  TRADEMARKS                                     |       |
| 16.4       |       | SAFE-KEEPING OF SPARE PARTS                                         |       |
|       |       |                                                                |       |
| **17**     | ** ** | **SECRECY**                                                         | ** ** |
| ** ** | ** ** | ** **                                                          | ** ** |
| 17.1       |       | SECRECY                                                             |       |
| 17.2       |       | EXCEPTIONS                                                          |       |
|       |       |                                                                |       |
| **18**     | ** ** | **TERM OF  AGREEMENT**                                              | ** ** |
| ** ** | ** ** | ** **                                                          | ** ** |
| **19**     | ** ** | **TERMINATION**                                                     | ** ** |
| ** ** | ** ** | ** **                                                          | ** ** |
| 19.1       |       | TERMINATION  BECAUSE OF VIOLATION OF AN IMPORTANT OBLIGATION        |       |
| 19.2       |       | TERMINATION BECAUSE  OF MAJOR CHANGES                               |       |
|       |       |                                                                |       |
| **20**     | ** ** | **GENERAL  PROVISIONS**                                             | ** ** |
| ** ** | ** ** | ** **                                                          | ** ** |
| 20.1       |       | ENTIRE  AGREEMENT / WRITTEN FORM                                    |       |
| 20.2       |       | ASSIGNMENT                                                          |       |
| 20.3       |       | EXPORT CONTROL                                                      |       |
| 20.4       |       | STANDARD TERMS AND  CONDITIONS                                      |       |
| 20.5       |       | AUTHORITATIVE  PROVISIONS                                           |       |
| 20.6       |       | SAVING CLAUSE                                                       |       |
| 20.7       |       | FORCE MAJEURE                                                       |       |
| 20.8       |       | APPLICABLE LAW                                                      |       |
| 20.9       |       | PLACE  OF JURISDICTION                                              |       |
|       |       |                                                                |       |
| **21**     | ** ** | **LIST OF ANNEXES**                                                 | ** ** |

 

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# **1**              Preamble

# ** **

**FischerImaging**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**isinterested in forming a strategic partnership with **FischerImaging** to integrate the Fischer Imaging Subsystem into aPMS-branded digital imaging system that PMS will market, sell and support.   In addition, the parties will investigateavenues to broaden the relationship to develop, market and sell additional valuablemedical products and services.  Inaddition, both PMS and Fischer Imaging will leave the opportunity open for themutual development of future technology.

 

Toregulate their co-operation, the parties have resolved to conclude a masteragreement with the following provisions:

 

# **2**              Object of the agreement

# ** **

According to thismaster agreement **Fischer Imaging** shall deliver, inaccordance 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 itand/or deliver them to its customers directly. **FischerImaging** shall sell and deliver the Philips branded productsexclusively to **PMS** unless otherwise expresslystated in writing by **PMS**.

 

# **3**              Subcontract

# ** **

N.A.

 

# **4**              Product development and product updating

# ** **

## **4.1**          Development

## ** **

If **FischerImaging** develops products according to a specification authorized by**PMS** at its own expense on its ownaccount, a separate agreement shall be concluded regarding such co-operation ondevelopment. See **Annex E3**: “Development of Systems,....”.

 

## **4.2**          Productupdating /product modification

## ** **

**FischerImaging** undertakes, after commencing batch production, towork on the further development and technical improvement of the products andsubmit to **PMS** suitable suggestions for thefurther development/adjustment. **PMS** shall be entitledto suggest product improvements itself or, if necessary, demand them from **Fischer Imaging if this relates to the special requirements for Philipsbranding**. Suggestions for product improvements will be presented andnegotiated in good faith on a regular base between both parties. In order toensure that the products have a consistent, reproducible quality, **Fischer Imaging** shall not perform any modifications to itsproduct without written consent from **PMS**. Theproduct delivered by **Fischer 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**shallapply **(XMW – 11517)**.

 

If **FischerImaging** is not in a position to perform a product modificationrequested by **PMS** which has a major influence onthe competitiveness of the product, **PMS** may, afterdefinitive refusal by **Fischer Imaging**

 

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or after a reasonable periodof time after the request to modify the product has elapsed, serve notice toterminate the agreement.

 

In the event of extensivemodifications, **Fischer Imaging**and **PMS** shall conclude a separate Development agreement. In sucha case details shall be regulated in Annex E3: “Development of systems”

 

# **5**              Planning and ordering

# ** **

## **5.1**          Requirementsplan

## ** **

To beable to correctly plan the quantity of products required by PMS, PMS shall informFischer Imaging once a year of its market estimate with regard to sales potentialfor the coming calendar year. Fischer Imaging and PMS shall, by means of alogistics agreement (Annex O1), agree on the parameters of requirement planningfor each product delivered by Fischer Imaging and covered by this agreement.

 

**PMS**shall inform **Fischer Imaging** of the changedplanning figures for the coming year in good time prior to expiry of a calendaryear.

 

Quarterlymeetings between both parties shall be targeted to control the business.

 

## **5.2**          Purchase orders

## ** **

Purchaseorders (Details in Annex O1) are only valid if they have been made in writing.Inasmuch as written purchase orders or order changes are generatedautomatically by data processing equipment, the statements shall be valid evenif they have not been signed by **PMS**.

 

# **6**              Manufacture

# ** **

## **6.1**          Specification

## ** **

The manufacture of theproducts 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 theexclusive property of **Fischer Imaging.**

 

## **6.2**          Traceability

## ** **

For reasons ofquality assurance and product traceability **PMS** may request**Fischer Imaging** to give the products aserial number by means of which **Fischer Imaging**can document and evaluate/trace the production and supply data and by which **PMS** can document and evaluate/trace the utilization andquality data. The items will usually be safety-relevant parts/Products. Theserial numbers, which are defined by **PMS**, shall berecorded on all documents accompanying the goods.

 

In thespecification /parts list **(Annex E1)****Fischer Imaging** is informed which data are necessary to identifythe products, e.g.: product number, name, manufacturer, production date, serialnumber, technical parameters etc.

 

## **6.3**          Drawings andtools

## ** **

All the drawings,patterns and calculations lent for the purpose of executing orders shall remainthe property of **PMS**. They shall be kept secret,must not be reproduced or used for other purposes and shall be returned ifrequested by **PMS**. Tools, patterns, drawings andother aids which are made in order to execute orders and which will be chargedseparately by **Fischer Imaging** shall become **PMS**’ property at the time they are made. The transfer ofpossession is replaced by **Fischer Imaging**keeping them on behalf of **PMS** free ofcharge; they may only be used to execute the orders and shall be handed over to**PMS** immediately free of charge ifrequested to do so after the contract has been processed or in the event ofsupply difficulties. 

 

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**FischerImaging** shall clearly mark the aforementioned items as theproperty of **PMS** and draw the attention of anythird parties who wish to establish rights in them to **PMS**’title. It shall inform **PMS** of any suchevent immediately. The cost of intervention shall be borne by **Fischer Imaging**.

 

**FischerImaging** shall look after the aforementioned items, maintainthem and minimize any normal wear and tear; **FischerImaging** shall have actual copies of drawings for manufacturing theseitems in safe-keeping (e.g. from fire and flood damage); the necessary cost iscompensated for by the purchase price of the items.

 

To execute **PMS** orders, **Fischer Imaging**shall only commission a subcontractor to make products, parts, tools, andpatterns, if permission has been obtained from **PMS**in writing.**Fischer Imaging**shall subject thesubcontractor to his duties arising under this agreement. **FischerImaging** hereby assigns its claims vis-à-vis the subcontractor withregard to transfer of title in the tools and patterns to **PMS**in accordance with the obligations of this contract.

 

## **6.4**          Documentation

## ** **

**FischerImaging** shall make use of a device master record whichcontains all relevant documents, for instance, drawings, specifications, testprotocols, calculations, engineering changes and software programming. Thedevice master record shall be maintained systematically and in a clear order sothat all relevant information and every delivery can be tracked and easily inspected.

 

**FischerImaging**shall have the device master record in safe-keeping **for at least 13 years** after the last manufacture of theproduct unless **PMS** requires the handing over. **Fischer Imaging** agrees that **PMS**can inspect and copy the device master record at all times.

 

After13 years **Fischer Imaging** shall offer the devicemaster record to **PMS** for safe-keeping before annihilation.

 

## **6.5**          Downpayments and supplies (items provided by the client)

## ** **

**FischerImaging** undertakes to use any down payment (deposits) andsupplies (items provided by the client) supplied by **PMS**solely for executing the orders.

 

PMSwill supply Fischer with loaner equipment that will allow for testing of PMSsystems in a simulated environment to their customer installations.

 

**FischerImaging** shall keep the supplies provided by **PMS** separately and mark the property of **PMS**on the supplies themselves and in its business records. It is agreed that thegoods manufactured on the basis of the purchase orders from **PMS**, for which **PMS** hasaffected a down payment or supply, shall become its property. The transfer ofpossession shall be replaced by **Fischer Imaging**keeping the goods safely on behalf of **PMS,** with duecommercial diligence and free of charge. For this purpose **Fischer Imaging**shall keep the manufactured goods separately from other stocks and indicate **PMS**’s ownership on the goods themselves and in the businessrecords.**Fischer Imaging** shall give **PMS** confirmation of this in writing. Moreover, **PMS** shall be entitled at any time to convince itself ofseparate safe-keeping and proper identification of the goods/supplies on thespot. If the supplies of **PMS** areprocessed to make a new item, **Fischer Imaging**shall not acquire ownership of the same. Any processing shall take place by **Fischer Imaging** on behalf of **PMS**.If **Fischer Imaging** acquires co-ownershipby combining or mixing the goods, it hereby assigns its portion of co-ownershipto **PMS**. The transfer of possession shallbe replaced by the fact that **Fischer Imaging**holds the item in safe-keeping on behalf of **PMS**free of charge.

 

**FischerImaging** shall notify to **PMS** any accessby third parties to the goods belonging to **PMS** withoutdelay and shall assist **PMS** inintervening in any manner, the cost of which shall be borne by **Fischer Imaging**. The duty to notify shall apply by analogyif composition or bankruptcy proceedings are initiated. Under no circumstancesshall **Fischer Imaging** have a right ofretention.

 

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# **7**              Delivery

# ** **

## **7.1**          Mode ofdelivery

## ** **

Delivery shall be done FCA (free carrier, loading at sellers premises,Incoterms 2000), including packaging. Title, risk of loss and insurancerisk related to the product shall pass to PMS at delivery to a qualifiedcarrier.

 

## **7.2**          Takingreceipt 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 orwarehouse of **Fischer Imaging** shall constituteneither delivery nor receipt.

 

PMS isunder no obligation to accept incomplete Subsystems, but it will take receiptof and pay for the complete systems that may be less than the total numberordered.  Notwithstanding any other legalor contractual entitlements **PMS** shall, inthe event that **Fischer Imaging**violates the dutyto deliver, be entitled to withhold payment related to incomplete products onthe order until the delivery has been received in full.

 

**PMS**will not accept additional quantities or shortages.

 

If there are shortages indeliveries, **Fischer Imaging** shall inform **PMS** in good time and compensate **PMS**for the damage or loss due to the shortage.

 

Notwithstanding any otherlegal or contractual entitlements **PMS** shall, inthe event that **Fischer Imaging**violates the dutyto deliver, be entitled to withhold payment of the respective order until thedelivery has been received in full. In any case the condition of payment arerelated 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 withoutexamining the contents. The goods will be returned for the account and at therisk of **Fischer Imaging**.

 

## **7.3**          Delivery ingood time

## ** **

**FischerImaging** is obliged to adhere to the agreed delivery datesunder all circumstances. Otherwise **PMS** shall beentitled to refuse to take receipt of the delivery.

 

If the loading day variesby more than two days from the delivery date agreed between the two parties tothe agreement, a penalty clause shall be agreed for every additional week bywhich delivery takes place before or after the agreed delivery date. **PMS** shall charge 2% of the price of delinquent product foreach week or part of a week by which delivery takes place after the agreeddelivery date. The penalty amount shall be limited to a maximum of 10% of theorder sum. The order sum shall be calculated as the price multiplied by thequantity for each delivery batch.

 

Independent ofpenalty clause PMS can fix an extension for delivery. **PMS**may terminate the agreement with immediate effect if the period of grace (oneweek) is not observed and, if it is **Fischer Imaging**’sfault, demand compensation for non-performance. This applies mutatis mutandisto orders.

 

As soon as **Fischer Imaging** has reason to believe that it cannot providethe delivery or part of the delivery in good time, it shall inform **PMS** of this without delay. The additional expense incurredby **PMS** due to the delay shall be borne by **Fischer Imaging**. If **PMS** shoulddeclare itself willing to take receipt of the delivery despite the delay indelivery, **Fischer Imaging** shall bear the resultingadditional cost, e.g. airfreight charges, express freight charges.

 

If the deadlineagreed for delivery is not met and delivery carried out too early, for whateverreason, e.g. works holidays of **FischerImaging** - **PMS** may torefuse to take receipt of the delivery and insist on delivery later in goodtime.

 

If **Fischer Imaging** plans to carry out thedelivery too early, it shall inform PMS as soon as possible. If PMS decides totake receipt of the delivery, Fischer Imaging shall bear the resultingadditional costs, e.g. freight charges, cost of stock keeping.

 

In any case thecondition of payment are related to the date of delivery originally planned.

 

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## **7.4**          Packaging

## ** **

**FischerImaging** shall effect delivery in packaging suitable for theproduct, taking into consideration the relevant rules and legal regulations,particularly the environmental protection regulations. The packaging and thedelivery documents shall bear the necessary information such as

 

•Type number (Philips article no.)

•Description

•Number of packages

•Serial number

 

In addition, informationshall be provided in accordance with the specification.

 

## **7.5**          Incominggoods inspection

## ** **

The parties have agreedthat **Fischer Imaging** shall perform anincoming goods inspection on behalf of **PMS**. The scopeshall be according to the test specifications defined by **PMS**in accordance with **Annex O2**. Thecost of this inspection is included in the price of the products ordered.

 

The transfer of theinspection duty to **Fischer Imaging**and the waiving of the duty to file a complaint in accordance with §§ 377 f. ofthe German Commercial Code (“HGB”) shall not constitute the waiving ofcontractual or legal guarantee and compensation rights.

 

## **7.6**          Complaints

## ** **

**PMS**will check the products delivered by **Fischer Imaging**for external intactness and completeness within a reasonable period, but notlater than 30 days following delivery at the designated PMS or customerdestination. **PMS** will normally report anyapparent defects within six (6) weeks after receipt of goods and report anyconcealed defects without delay after they have been discovered. Payment of thegoods shall not constitute their acceptance by **PMS**as conforming to the agreement and being devoid of defects.

 

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# **8**              Prices

# ** **

## **8.1**          Pricecalculation

## ** **

The parties shallnegotiate the prices to be paid by **PMS** for theproducts taking their respective interests into account and shall define themin 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 bereviewed and negotiated on a quarterly basis in good time prior immediatelyfollowing the expiry of each calendar quarter.

 

If after pricecalculation in accordance with para. 8.1 (price calculation) circumstancesshould 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, currencymovements, etc., the parties shall commence negotiations even within a priceperiod, and agree to what extent the prices must be adjusted to take account ofthe new situation. The change shall be laid down in writing. Currency moveshave to be taken into account as follows: Should the EUR fluctuate more than3.5% from the set rate as per contract date for a minimum period of 30 days,than Fischer Imaging and PMS each will incur 50% of the total difference in thefluctuation above 3.5% of the contracted rates. Starting date and starting ratewill be fixed in **Annex P1** (Prices)

 

This adjusted price shallbe effective with the first firm PO received by FIC following the adjustment.

 

## **8.3**          Cost pricereduction

## ** **

**FischerImaging** undertakes to perform cost price reduction of hisproducts and procedures continuously to maintain the competitiveness of theproducts of PMS. **Fischer 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 withPMS to find reasonable measures of cost price reduction and realize them in acoordinated manner. **Fischer Imaging**shall reduce the prices of its deliveries to PMS according these cost reductionmeasures in a share of 50%.

 

The annualsavings realized will at least meet the annual price erosion of the PMSproducts, of which the products of **FischerImaging** are part of. PMS and **FischerImaging** agree upon transparency of cost calculation as preconditionto realize the targets of this cost price reduction.

 

## **8.4**          Resultsof price calculation

## ** **

If the parties donot reach an agreement on the prices during the negotiations according para 8.1(Price calculation), Either party can give extraordinary notice of withdrawalof the master purchasing agreement and the orders of products concerned with atime 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-nationclause

## ** **

**FischerImaging** shall offer**PMS** the mostadvantageous prices and conditions compared to other customers of the same orsimilar products and the same or similar terms. These prices and conditions arealso in force if the concerned products are ordered but not yet delivered.

 

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# **9**              Invoicing and payment

# ** **

## **9.1**          Invoicing

## ** **

**FischerImaging** 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 aboveprerequisites are fulfilled, payment by **PMS** will beeffected within sixty (60) days End of Month after receipt of invoice.

 

Vis-à-vis **Fischer Imaging****PMS** shall beentitled to set off amounts against credit notes issued by **FischerImaging** or accounts receivable from companies related to **PMS** which have all authorized **PMS**to set off amounts.

 

**FischerImaging** 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 anextended reservation of title, agreed by **Fischer Imaging**with subcontractors, **PMS** now herebygives its consent with the proviso that it is also allowed to set off theamount against the counterclaim acquired after notification of assignment.

 

# **10**           Servicing support and servicing parts

# ** **

## **10.1**        Servicingsupport

## ** **

In as much as it isnecessary, **Fischer 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**        Commitmentto deliver spare parts

## ** **

**FischerImaging**shall supply **PMS** with allservicing parts for the products delivered under this agreement for at leastten (10) years after delivery of the product concerned. This shall also applybeyond the term of the agreement. **Fischer Imaging**guarantees **PMS** reasonable prices for theservicing parts in accordance with **Annex S1****(Servicing Agreement)**.

 

A sufficient stockof spare parts is to be kept by **FischerImaging** shall be delivered within 24h. Different agreements to bemade **Annex S1****(ServicingAgreement)**

 

Forrepairable assemblies or the complete unit, an exchange procedure with pricesnot exceeding 60% of the part-/unit price shall be agreed upon.

 

## **10.3**        Training

## ** **

**FischerImaging** shall train the staff of PMS with regard toinstallation, commissioning and maintenance of the products in accordance withAnnex S1 (Servicing Agreement). For complex systems, a free training for PMSemployees (reasonable group) before delivery of the serial models shall besupplied by **Fischer Imaging.**Tuitionwill not be charged and it is assumed that PMS will pay all expenses associatedwith travel and lodging.  Fischer willprovide a service-training specialist to support at least 1 training session atthe PMS training facility in Europe.

 

Fischer European basedservice engineers will support the first PMS installations (reasonable number)in Europe by assisting in the installations with the PMS engineers.

 

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# **11**           Quality

# ** **

## **11.1**        QS-Agreement

## ** **

Withinits quality improvement program PMS follows a zero-fault strategy for theproducts.

 

**PMS**expects **Fischer Imaging** to commit itself to azero-fault strategy for its products. **FischerImaging** is obliged to establish the conditions for the delivery offaultless products by continuously improving, supervising and assessing itswork procedures.

 

**FischerImaging**shall receive a quality fault report and an advice ofdebit for any product that are faulty. The respective procedure is described in**Annex O3**.

 

Upon request **Fischer Imaging** shall hand over a detailedaction list with scheduled improvement measures to **PMS**.

 

**FischerImaging** agrees to set in agreement with **PMS**for each product QS targets and to pursue these targets if requested by **PMS**. **Fischer Imaging**agrees to let **PMS** examine the respectivedocuments verifying the achievement of the QS targets.

 

## **11.2**        Industrial standards and company standards

## ** **

**FischerImaging** shall be responsible for ensuring that the productsdelivered by it conform to the requirements of the relevant legal regulations,industrial standards and company standards.

 

Particularly the MedicalProducts Law, environmental protection regulations, accident prevention andsafety-at-work regulations, the generally recognized rules of engineering andthe state of the art shall be observed.

 

In addition, thefollowing 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) **Fischer Imaging**shall, on request, make the necessary documents available to **PMS** in English.

 

**FischerImaging** gives an assurance that in development andmanufacture it has taken the monitoring measures necessary to meet theserequirements. It undertakes to provide evidence upon request by **PMS** on this by supplying written documents or by takingother suitable measures such as local inspection, spot checks, audits etc.

 

# **12**           Compliance with the regulations regarding theenvironment and ecological aspects

# ** **

## **12.1**        Legalregulations

## ** **

In addition to thecompliance with legal regulations, decrees and standards regarding theenvironment and ecological aspects, the respective state of the art shall beemployed to keep the pollution of environment and resources as low as possible.Compliance with regulation EWG 1836/93 is complied with by **Fischer Imaging**or****being workedat.

 

## **12.2**        Banned substances and substances relevant for the environment

## ** **

A list of the bannedsubstances and the relevant substances is attached to this agreement as **Annex U**.

 

**FischerImaging**confirms that the products and their packaging do notcontain any of the banned substances and agrees to declare any relevantsubstances to **PMS** according to the attachment.

 

## **12.3**        Other regulations regarding the environment and ecological aspects

## ** **

**FischerImaging** agrees to support **PMS**in realizing the Philips environmental program.

 

This programcomprises:

 

•      The reductionof packaging material

•      Theconstruction according to ecological principles (Eco-design)

 

----

 

•      The eliminationof banned substances as well as dangerous or toxic materials

•      The recyclingof the products or parts of them

•        FischerImaging assures PMS of the fact that the disposal of the products and theirpackaging can take place without any special safety measures needed.

 

# **13**           Warranty

# ** **

## **13.1**        Warranty

## ** **

**FischerImaging** guarantees that the products are devoid of faultsthat they do not have any defect affecting their value or their suitability andthat no guaranteed property is missing. **Fischer Imaging**also guarantees that the products delivered are devoid of defects in design,materials and manufacture.

 

## **13.2**        Scope ofwarranty

## ** **

If there are any defectsin the products delivered, **PMS** can at itsdiscretion demand free replacement or elimination of defects. In urgent cases **PMS** may also eliminate the defects itself at **Fischer Imaging**’s expense after informing **Fischer Imaging** in advance. If anelimination of defects requested by **PMS** is to noavail even after expiry of a reasonable period of grace, **PMS**may demand a reduction in the agreed price, serve notice to terminate theagreement 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 ofabove-average occurrence of defects, to perform an incoming goods inspectionitself in contradiction to the provision contained in Paragraph 7.6 or have itperformed by commissioned third parties. **PMS** may eitherhold any goods about which a complaint has been filed in safe-keeping or returnthem to **Fischer Imaging** for the account and atthe risk of **Fischer Imaging**. On the date when **PMS** sends the notice regarding the returned goods, the titlein the goods shall return to **Fischer Imaging**.The transfer is replaced by the fact that **PMS** holds thegoods in safe-keeping for **Fischer Imaging**.

 

Any defects which areonly found during processing of the products by integration or during operationshall entitle **PMS** to also demand reimbursementof the costs expended to no avail.

 

Reporting of defects isdone by “Quality Fault Report for Purchased Parts” and “List of costs” as noware or hereafter may be in force. Details are described in Annex O3.

 

## **13.3**        Term ofwarranty

## ** **

The term of the warrantyshall be twelve (12) months from date of installation (end of installation) orfifteen (15) months from date of shipment, whatever comes first.

 

Replacement orelimination of defects will prolong the term of warranty of the replaced orrepaired product for another twelve (12) months, as the case may be. The termof warranty for service and spare parts shall be eighteen (18) months from dateof shipment.

 

## **13.4**        Epidemicdefects

## ** **

Epidemic defects aredefects, of the same nature or with the same cause, which in relation to acontinuous period of 3 calendar months or more, occur in more than 5% of theproducts delivered. The basis of this shall be the statistics kept up to dateby **PMS**. If an epidemic defect is found, **PMS** will notify **Fischer Imaging**in writing without delay. Epidemic defects must relate to failures of theproduct to comply with the Specifications, and must relate to a set of productsthat exceeds five (5) in number.  PMS willprovide Fischer Imaging with all documentation necessary to verify the epidemicdefect.  In response to the noticereceived from PMS, Fischer Imaging shall create a corrective action plan thatshall be reviewed and approved by PMS.

 

----

 

## **13.5**        Remedyingepidemic defects

## ** **

In the case of epidemicdefects **PMS** shall be entitled to freereplacement of the product (including any exchange necessary locally) and topayment of an all-in handling charge by PMS (see Annex O3). **Fischer Imaging** shall bear all the costs incurred as aresult of the occurrence of the epidemic defect and shall hold **PMS** harmless from all third-party rights in this respect.

 

If any epidemic defectscannot be remedied or cannot be remedied within a short space of time byreplacement deliveries, **PMS** shall, inaddition to the rights regulated by Para. 13.2, also be entitled to postponethe scheduled acceptance dates until the epidemic defect can be proved to havebeen remedied.

 

## **13.6**        Interruption in the period of limitation

## ** **

Limitation of the aforementionedwarranty shall be interrupted as soon as **PMS** has sent **Fischer Imaging** a written notice regarding the existence ofa defect.

 

## **13.7**        Recalls

## ** **

If, owing to theoccurrence of a defect, the safety of the product is jeopardized or affected sothat **PMS** decides, as a responsiblemanufacturer, to hold a recall campaign, **PMS** shallinform **Fischer Imaging** of it without delay.The parties shall endeavor to work out an inexpensive procedure jointly withoutthe safety interests of the end-user being neglected and without riskingcausing damage to the reputation of the parties. **FischerImaging** shall be liable to **PMS** for anyresulting damage in accordance with para. 14 (liability).

 

# **14**           Liability

# ** **

**FischerImaging** shall be liable to PMS for all damage incurred by PMSand shall indemnify PMS with respect to all third-party compensation claims fordamage 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 havebecome necessary to assert legal rights according to the purpose), which PMSdeclared itself willing to provide out of court, taking due consideration ofthe interests of **Fischer Imaging.**

 

**FischerImaging’s** liability is limited to damages resulting from **Fischer Imaging** product defects, and **Fischer Imaging** will have no liability to **PMS** or any third party related to productsor services not provided by **Fischer Imaging**nor its subcontractors.  To the extent **PMS** has negotiated limitations of liabilityin customer or partner agreements, **FischerImaging’s** liability to **PMS**will be equivalently limited.  Prior tosettling any potential claims for which **PMS**will seek indemnification, **PMS**must obtain the consent of **Fischer Imaging**,which will not be unreasonably withheld.

 

# **15**           Liability insurance

# ** **

**FischerImaging** gives an assurance that it has taken out adequateemployer’s liability insurance cover and is willing to provide evidence of thisupon request from **PMS** bypresenting the policy.

 

# **16**           Rights

# ** **

## **16.1**        Third-partyproperty rights

## ** **

**FischerImaging** gives an assurance that the products are free ofthird-party property rights. If nevertheless third parties file any justifiedclaim resulting from property rights, **Fischer Imaging**shallin agreement with **PMS** endeavor tofind a technical solution as a remedy or at its expense acquire a license onbehalf of **PMS**. **FischerImaging** undertakes to release **PMS** from anyclaims resulting from the violation of property rights and provide compensationfor the resulting loss.

 

----

 

## **16.2**        Rights of use

## ** **

**FischerImaging** grants **PMS** acost-free, worldwide, unrestricted, irrevocable, unlimited, non-exclusive,transferable right of use in the industrial property rights belonging to theproduct along with authorization to be able to transfer this right as anon-transferable right to the customers of **PMS**.

 

The companies affiliatedto the **PMS** Group shall have the same rights

 

## **16.3**        Rightsin names and trademarks

## ** **

**FischerImaging** is allowed to use the brand name, the protectedtrademark of “Philips” and the Philips logo only with explicit written consentfrom **PMS**. **FischerImaging** acknowledges the rights of **PMS**in the trademarks/brand names and declares that it derives no rights of usewhatsoever, either for its own products or for advertising purposes, from thepermission to use under this agreement. The rights and obligations of theparties under this Section shall be mutual.

 

## **16.4**        Safe-keepingof spare parts

## ** **

After completion of aprototype of the product, **Fischer Imaging**shall deposit with **PMS** all theavailable documents, data and other information media, which are necessary formanufacturing the agreed spare parts for the product. The depositing isintended to enable **PMS** toindependently continue manufacturing the product if Fischer Imagingdiscontinues 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.

 

**FischerImaging** undertakes to grant **PMS**,for the aforementioned cases, a cost-free, worldwide, unrestricted,irrevocable, unlimited, non-exclusive right of use of the documents, data andother information media belonging to the product, including the right toprocess.

 

**FischerImaging** shall deposit such materials with a third-partyescrow agent for the benefit of **PMS**.  **PMS**shall be entitled to the release of such materials if the following conditionsare met: (i) **PMS** sells 50 or moreunits of the product; and (ii) **FischerImaging** is unable or unwilling to meet its contractual requirementsto supply spare parts for any reason.

 

# **17**           Secrecy

# ** **

## **17.1**        Secrecy

## ** **

Each party shall treatconfidentially the embodied information which is marked as being confidentialand all other information which is transmitted confidentially and has beenmarked in writing as being confidential within thirty (30) days aftertransmission, which it has received from the other party, and must notreproduce, disclose, copy or use it. This shall not apply if under thisagreement a disclosure is necessary or the disclosing party has given priorwritten consent.

 

This arrangement shallnot apply to the exchange of information within the companies affiliated to thePMS Group. The commitment to secrecy shall also remain valid after terminationof this agreement.

 

This Section issuperseded 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 secrecyshall not apply to information which:

•      Isknown or which was already in the receiving party’s possession before transmissionby the disclosing party;

•      Has been madeavailable to the receiving party by a source other than the disclosing party orwhich has become public domain in a manner other than by violation of thiscommitment;

•      Has beenprepared independently by the receiving party;

•      Has beendisclosed by law.

 

----

 

# **18**           Term of agreement

# ** **

This agreement shall comeinto effect as soon as both parties have signed it and shall apply for a periodof **3 years**. After that the term will beautomatically extended by another year unless **PMS**serves 3 months notice in writing to take effect at the end of a calendar monthor notice is served in accordance with Para. 19. Either party may elect not torenew this agreement beyond its initial three-year term by serving writtennotice on the other party nine (9) months prior to the end of the initial termor any renewal thereof.

 

# **19**           Termination

# ** **

## **19.1**        Termination because of violation of an important obligation

## ** **

In the event of anyviolation of an important obligation under this agreement by either party, theother party shall be entitled to serve notice with immediate effect if theviolation of the agreement has not been discontinued within thirty (30) daysafter receipt of a written warning. The party entitled to serve notice maydecide whether an order placed but not yet executed is to be cancelled ordelivered. In the event of culpable violation compensation claims may be filed.Para. 16.4 shall apply.

 

## **19.2**        Terminationbecause of major changes

## ** **

**FischerImaging** shall inform **PMS** without delayabout any major circumstances which threaten to jeopardize delivery not justtemporarily. This shall particularly apply in the case of **FischerImaging**’s insolvency or initiation of composition or bankruptcyproceedings against it.

 

If any of these circumstancesshould apply, **PMS** shall be entitled to servenotice with immediate effect and file compensation claims. Para. 15.5 shallapply.

 

# **20**           General provisions

# ** **

## **20.1**        Entireagreement /written form

## ** **

This agreement is theresult of all preceding negotiations between the parties. It regulates thesupply relationship entirely and definitively. Amendments and additions to thisagreement shall be made in writing. This shall also apply to the waiving of therequirement for written form.

 

## **20.2**        Assignment

## ** **

**PMS**is entitled to assign its rights under this agreement and transfer performanceof obligations to third parties.

 

## **20.3**        Export control

## ** **

If the products aresubject to export control, Fischer**Imaging** shallinform **PMS** of this in writing and announce theapplicable export control number (“ECCN”).

 

## **20.4**        StandardTerms and Conditions

## ** **

During the term of thisagreement the Parties waive application of their respective Standard Terms andConditions.

 

## **20.5**        Authoritativeprovisions

## ** **

In the event of anycontradiction between a provision in this agreement and a provision in anAnnex, the provisions of this agreement shall be authoritative.

 

----

 

## **20.6**        Saving clause

## ** **

If any provision in thisagreement shall be or become invalid, it shall not affect the validity of theremaining 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 partiesto the agreement be prevented from fulfilling in good time his obligationsarising out of this agreement by the occurrence of unforeseen circumstanceswhich despite the exercise of reasonable care according to the circumstances ofthe case he has not been able to circumvent (Force Majeure, in particular war,blockade, industrial disputes, sabotage, civil commotion and administrativeorder), the deadline for supplies and services shall be extended accordingly.

 

In such a case, heshall advise the other party to the agreement without delay of the type andconsequences of the incidence of Force Majeure or other exceptionalcircumstances. The parties to the agreement shall thereupon without delay, onthe basis of the principle of equity and good faith, make joint arrangements todeal with the business affected by the aforementioned circumstances.

 

**Shouldthe incidence of Force Majeure last for more than three months; the party tothe agreement who has thereby been prejudiced shall be entitled to terminatethe agreement with immediate effect.**

 

----

 

## **20.8**        Applicable law

## ** **

The laws of the FederalRepublic of Germany shall apply.

 

The provisions of theVienna Uncitral Treaty on international sale-of-goods contracts, issued on 11thApril 1980, shall not apply.

 

## **20.9**        Place ofjurisdiction

## ** **

The place of jurisdictionfor all disputes resulting from this agreement shall be Hamburg, Germany.

 

## **20.10**      Dispute Resolution.

## ** **

In the event that thereis a dispute between the parties related to this transaction, the parties willseek to resolve the dispute as follows:

 

•      The responsiblemanagers for each party will meet and discuss the difference for no less thanfive (5) days;

•      If noresolution is reached, the dispute will then be referred to the chief executiveofficers of each party, who will meet and discuss the difference for no lessthan five (5) days;

•      If the disputeis not resolved at this point, either party may seek a remedy to the disputebefore a court that has jurisdiction over the matter as fixed in § 20.9.

 
| Hamburg dated                     |   |            |   |   |   |
|-----------------------------------|--------|-----------------|--------|--------|--------|
|                              |   |            |   |
|                              |   |            |   |
|                              |   |            |   |
| Philips Medical Systems  DMC GmbH |   | Fischer Imaging |   |

 

# **21**           List of Annexes

# ** **

For each product which isincluded in this master agreement (place a cross as applicable):

 

**Fischer Imaging**and **PMS** shall keep the following List ofAnnexes up to date. It shall always be the latest List of Annexes signed byboth parties, which shall apply:

 

 
| **ID. of the  Annex**    | ** ** | **Description**                           | ** ** | **Applicable  YES** | ** ** | **NO** | ** ** | **Date of  signing** | ** ** |
|--------------------------|------------|-------------------------------------------|------------|---------------------|------------|--------|------------|----------------------|------------|
| Product-related Annexes: |       |                                      |       |                |       |   |       |
| E1                       |       | Specification                             |       | ý              |       | o      |       |                 |       |
| E3                       |       | Development Contract                      |       | o                   |       | ý |       |                 |       |
| E4                       |       | Declaration of Exclusiveness              |       | o                   |       | ý |       |                 |       |
| O1                       |       | Logistics Agreement                       |       | ý              |       | o      |       |                 |       |
| O2                       |       | Incoming Goods Inspection                 |       | ý              |       | o      |       |                 |       |
| O3                       |       | Zero-defect-strategy                      |       | ý              |       | o      |       |                 |       |
| O4                       |       | Quality                                   |       | ý              |       | o      |       |                 |       |
| P1                       |       | Price List (products and servicing parts) |       | ý              |       | o      |       |                 |       |
| S1                       |       | Servicing Agreement:                      |       | ý              |       | o      |       |                 |       |

 

----

 
|            |   | Servicing support, servicing parts, repair,  servicing training                         |   | o      |   | o      |   |   |   |
|-----------------|--------|-----------------------------------------------------------------------------------------|--------|--------|--------|--------|--------|--------|--------|
| S2              |   | Field Problem Reports                                                                   |   | ý |   | o      |   |   |   |
| General Annexes |   |                                                                                    |   | o      |   |   |   |
| E2              |   | Change procedure incl. change application and  resolution forms                         |   | ý |   | o      |   |   |   |
| P2              |   | Price calculation sheet                                                                 |   | o      |   | ý |   |   |   |
| H1              |   | Environmental protection agreement: forbidden and  notifiable substances Sustainability |   | ý |   | o      |   |   |   |
|            |   | Contacts and  Organigram                                                                |   | ý |   | o      |   |   |   |

 

----

 
| **Philips Medical Systems - FIC**                | **PMS - FIC** |
|--------------------------------------------------|---------------|
| Annex O3: Service Agreement                      |          |
| Master Purchasing Agreement **PMS**  and **FIC** |          |

 

**ANNEX S 1**

** **

**SERVICE**

** **

# **1.**             Definitions

# ** **

**Capitalisedterms without definition shall have the same meaning as defined in theAgreement.**

** **

1.1           “DOA”means Dead on Arrival, a situation when a Product does not function within theProduct acceptance period as defined in Article 9.6 (Acceptance) of theAgreement:

 

1.2           “FCO”means Field Change Order;

 

1.3           “FRU”means Field Replaceable Unit;

 

1.5           “ServiceDocumentation” means the accurate technical, installation, operation andmaintenance documentation relevant for the Product, including the operatorsmanual;

 

# **2.**             Responsibilities

# ** **

Unless agreed tootherwise in writing, PMS is responsible for:

•    Installation and commissioning ofthe Product;

•    Training of the user;

•    Maintenance and repair at the enduser’s site;

•    Regular training of thePMS-engineers;

•    FCO implementation;

•    Delivery of Service Parts to endusers;

•    Delivery of repairable Service Partsto FISCHER IMAGING;

•    Registration and supervision offollow-up by FISCHER IMAGING of field problem reports;

 

and****FISCHERIMAGING****is responsible for:

•    Delivery (free of charge) of ServiceDocumentation;

•    Delivery (free of charge) of anypossible 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 (ifapplicable).

•    Initial training (free of charge) ofPMS service personnel (train-the-trainer- concept)

 

# **3.**             Product delivery

# ** **

## ***3.1.****        **Service Documentation*

## ** **

FISCHER IMAGING togetherwith PMS shall mutually agree upon the content of the Service Documentation,that shall be in conformity with applicable laws and regulations as specifiedin the Agreement especially FDA regulation e.g. “0-level” documentation.

 

When Service Parts aredefined FISCHER IMAGING shall, as part of the Service Documentation, providePMS with the complete proforma per Service Part as specified in **the service parts list** of the Agreement.

 

FISCHER IMAGING shallprovide 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 theService Documentation into its overall system documentation.

 

Service Documentationwill be made available to PMS in the English language. FISCHER IMAGING herewithgrants PMS the unconditional right to translate the Service Documentation inother languages as such is required by law or regulation.

 

The Service Documentationshall contain at a minimum the following sections:

 
| **PMS** DMC:  Einkauf |          |
|-----------------------|---------------|
|                  | **PMS**  | **FIC** |
|                       |               |  |

 

1

----

 

•      Technical Data;

•      Installation(if applicable);

•      Setting-to-work(if applicable);

•      Acceptance: Specificationchecks and data applicable for field service;

•      Plannedmaintenance data (if applicable);

•      Correctivemaintenance data (diagnostic procedures for fault identification; adjustmentprocedures; instructions for (dis) assembly, removal and replacement;procedures after repair or replacement and simplified drawings to facilitatefault findings);

•      Service Partslist including PMS’s 12 digit code numbers (“12 NC” numbers);

•      Specificationof required tools (if any), to be classified for (pre-) installation,setting-to-work, acceptance and maintenance.

 

Unless the Agreementprovides otherwise, FISCHER IMAGING shall be solely responsible for the costand expense of the development and provision of the Service Documentation.Exception: Additional requirements from PMS.

 

The Service Documentationwill be timely updated and maintained by FISCHER IMAGING during the lifetime ofthe Product to include all implemented changes and modifications pertaining tothe Product. Corrections will be furnished to PMS without additional charges.

 

FISCHER IMAGING shallforward to PMS the revised Service Documentation at least forty (40) days priorto 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 ofthe following data carriers, the version to be agreed between PMS and FISCHERIMAGING:

•    MS-EXCEL

•    MS-WORD

•    GIF for photo’s & drawings

 

## ***3.3.****        **Software*

## ** **

The test- and diagnosticsoftware, if any, used by field service personnel will be made available insource, documentation and object code by FISCHER IMAGING on a carrier suitablefor the Product.

 

If PMS requires otherthan regular -advanced-test- and diagnostic software, both in source and objectcode, FISCHER IMAGING will supply them at a reasonable price to be agreed upon.

 

The test- and diagnosticsoftware will be updated by FISCHER IMAGING during the lifetime of the Productto include all implemented changes and modifications pertaining to the Product.Corrections will be furnished to PMS without additional charges. FISCHERIMAGING will supply new test- and diagnostic software at least thirty (30) daysbefore the first delivery of Products changed.

 

## ***3.4.****        **Product delivery forService*

## ** **

Each Service Part (ifapplicable) shall be delivered by****FISCHERIMAGING****with:

•      Spare fuses incase of power supplies;

•      An up-to-dateconfiguration record showing all FRU’s containing PMS part numbers and revisionlevels;

•      Service keystickers showing the location of each component inside the unit.

•      Configurationof ie jumper settings

 

# **4.**             Support

# ** **

FISCHER IMAGING agrees torespond to PMS’s request for technical support within one business day. FISCHERIMAGING agrees to provide on-site support at PMS or PMS’s end user sites toresolve technical issues that can not be resolved by other means. The decisionto go on-site will be by mutual agreement and ultimately within 5 business daysof PMS’s request to visit PMS or the end user site.

 

Support costs for inwarranty technical issues are borne by FISCHER IMAGING. Issues resolved to benon-FISCHER IMAGING problems and out of warranty support costs are reimbursableto FISCHER IMAGING including reasonable

 

2

----

 

material and travel expensesand 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 byreplacing 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 overthe lifetime of the Product.

 

## ***5.2.****        **Reporting by FISCHERIMAGING about Reliability*

## ** **

FISCHER IMAGING and PMSwill exchange free of charge, all such relevant data regarding reliability ofthe Product and Service Parts, such as, but not limited to:

•    mean time between failure- and meantime to repair figures (if applicable);

•    problem reports at Product andService Part level;

•    field failures;

•    Spare part consumption for PM/ CM.

•    Call rate

 

FISCHER IMAGING willissue free of charge on a monthly basis a repair report to PMS, which shouldinclude all relevant data such as (but not limited to):

•    Service Part name;

•    FISCHER 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, ifany, will be made available to PMS in a form of individual modification kitsand in the required amount / lead time as decided by PMS after consultationwith FISCHER IMAGING.

 

In case of softwaremodifications****FISCHER IMAGING****shall work together with PMS to establish the medium onwhich the kit is being released.

 

These kits will at aminimum contain:

•    List of applicable Products andtheir serial numbers

•    Implementation instructions

•    Material and Service Parts

•    Special tools (if any)

•    updates of Service Documentation

 

Kits for the fieldmodifications in the categories of “mandatory action” and “action forperformance” will be provided by FISCHER IMAGING to PMS without charge, unlessagreed in writing otherwise.

 

### **6.1.2.**       Categories and implementation of FCOs

### ** **

Four (4) categories aredistinguished:

•    Mandatory action

•    Action for performance

•    Proactive

•    Retrofit on failure

•    Service recommendation

•    Documentation change

 

These categories are definedas follows:

 

3

----

 

1.     Mandatoryaction

 

Corrective actionsrequired to eliminate potential or materialized unsafe situations. They must begiven the highest priority and must be performed within the indicated timelimit.

 

2.     Actionfor performance

 

Corrective actionsrequired to eliminate potential major deficiencies in functional performancethat might affect the satisfaction of the end user and by consequence influenceour brand image. They must be given high priority.

 

3.     Servicerecommendation

 

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 actionmay involve updating, upgrading or correcting the functioning of installedproducts.

 

4.     Documentationchange

 

This kind of correctiveactions does not affect the technical state of a Product. It gives instructionsand it delivers material to update the Service Documentation.

 

Classification into anyof these categories and terms and conditions of any action will be decided byPMS upon consultation with FISCHER IMAGING. Classification will take intoaccount applicable law and regulations.

 

## ***6.2.****        **Field Problem Reportingby PMS*

## ** **

PMS will report allproblems using a Field Problem Report Form sheet (see Annex 1 to thisAttachment). In order to shorten turnaround times, PMS may report by telephone,fax or e-mail. Telephone reports must be promptly confirmed by a written FieldProblem Report.

 

The categories ofProblems are defined as very urgent problems, urgent problems, routine problemsand production stop:

VERY URGENTPROBLEMS

•    Disables the useof the Product or causes an abnormal end of the application program.

•    Causes danger forthe patient being examined or personnel operating the Product.

 

URGENT PROBLEMS

•    Disables the useof the Product under certain conditions

•    Disables the useof certain function(s) of the Product

 

ROUTINE PROBLEMS

•    Problems otherthan VERY URGENT or URGENT

 

PRODUCTIONSTOP

•      TheProduction at PMS or any of PMS’s Affiliated Companies is stopped, caused by aProduct delivered by FISCHER IMAGING.

 

The Corrective Maintenance shall be provided byFISCHER IMAGING by:

 

1.     Deliveringas soon as possible solutions for VERY URGENT, URGENT DEFECTS and PRODUCTIONSTOP in the form of preliminary solutions (temporary fixes only, no correctionsto the Product) and definite solutions (corrections to the Product) ifnecessary in an unscheduled revision Level of the Software. Component failuresto be resolved by mutual agreement.

 

2.     Deliveringsolutions for routine defects in the form of definite solutions as part of thenext Level of the Product delivery.

 

Thetime schedule for response to PMS and solution delivered to PMS, are given inbelow diagram.

 

4

----

 
|            | **Error/Defect  classification** | ** **    | **initial  response solution** | ** ** | **preliminary  solution** | ** **     | **definite** |   |
|-----------------|----------------------------------|---------------|--------------------------------|------------|---------------------------|----------------|--------------|--------|
|            |                             |          |                           |       |                      |           |         |   |
|            | VERY URGENT                      |          | 12 hours                       |       | 2 weeks                   |           | 6 weeks      |   |
|            |                             |          |                           |       |                      |           |
| URGENT          |                             | 24 hours      |                           | 4 weeks    |                      | 16 weeks       |
|            |                             |          |                           |       |                      |           |
| ROUTINE         |                             | 48 hours      |                           | N.A.       |                      | next level     |
|            |                             |          |                           |       |                      |           |
| PRODUCTION STOP |                             | 8 working hrs |                           |       |                      | 2 working days |
|                 |                                  |               |                                |            |                           |                |              |        |  |  |

 

Note:      Thehours mentioned in initial response are meant to be business hours. The othermentioned timeframes are referring to calendar days/weeks.

 

If FISCHER IMAGING cannotprovide a definite solution without violating the Specifications of theProduct, then FISCHER IMAGING shall timely inform PMS in writing, together witha comprehensive explanation of the reasons and consequences. FISCHER IMAGINGshall refrain from any activity to implement such a definite solution unlessPMS has accepted the proposed solution in writing.

 

Both preliminary anddefinite solutions will be made available to PMS as soon as possible afterFISCHER IMAGING has produced and tested these solutions. The solutions shall bedocumented and made available to PMS by fastest means of communication and/ortransportation.

 

For all categories,FISCHER IMAGING will work continuously during regular business hours and withfirst priority on such problem until it is solved.

 

Outline of Maintenanceand Support Services:

 

To streamline customersupport and accelerate resolution of issues, the following escalation processwill be followed. PMS will employ this escalation process and all reasonableefforts will be applied to resolving the issues at the lowest possible level,before escalating to the next.

 

Philips will provideLevel 1 and Level 2 support to its customers. Fischer Imaging will provideLevel 3 and Level 4 support to Philips Technical Support Group. Fischer Imagingwill not be required or expected to provide support directly to Philip’scustomers or field service engineers.

 

Level 1 Support: DirectCustomer Support – This covers on site as well as phone support of the end userin addressing issues concerning applications, workflow, functions, features orfailures.

 

Level 2 Support:Technical Support – This applies to technical support of field engineers andend users. Examples would be in collecting data or error logs remotely for thepurpose of diagnosing issues or replicating problems.

 

Level 3 Support: FactoryTechnical Support – This applies to issues that remain unresolved and Philipsfield and technical support have replicated the problem and exhausted all othercourses of action.

 

Level 4 Support:Engineering Support – This covers software and hardware engineering to correctdesign defects.

 

## ***6.3.****        **Service information*

## ** **

FISCHER IMAGING shallinclude PMS in the distribution list for technical information bulletins viaFISCHER IMAGING’s Extranet.

 

# **7.**             ConfigurationManagement

# ** **

FISCHER IMAGING willmaintain a Configuration Record for each Product and Service Part delivered(Excel-file), indicating:

•    Product and Service Part serialnumber

•    Hardware configuration and firmwarelevel (if any)

•    Identification of assemblies andsub-assemblies contained in the Product by Service Part numbers and serialnumber.

 

5

----

 

# **8.**             Service Parts

# ** **

## ***8.1.****        **Service Parts List*

 

FISCHER IMAGING shallprovide PMS****with a list of Service Partscontaining the following information:

•      Part numberwith revision level where applicable;

•      Description ofthe Service Part;

•      Identificationof critical items in close co-operation with PMS;

•      Identificationof strategic parts ECCN (Export Control Classification Number);

•      Repair orreplacement cost per Service Part;

•      Identificationof repairable and exchangeable items and delivery time.

 

## ***8.2.****        **Stock Recommendations*

## ** **

FISCHER IMAGING willprovide PMS with recommendations for the stocking of Service Parts required tosupport and maintain the Products and update such information as required.

 

PMS shall inform **Fischer Imaging** once a year of its estimate with regard toService parts potential for the coming calendar year.

 

FISCHER IMAGING willensure availability of Service Parts prior to the first dispatch of Products.

 

## ***8.3.****        **Ordering and DeliveryTime for Service Parts*

## ** **

### **8.3.1.**       Priority 1 orders (P1)

### ** **

Service Parts to bedelivered under “priority 1 order” (breakdown and out of stock situation) willbe shipped by FISCHER IMAGING within a period of twenty-four (24) hours afternotification using courier service (or within longer period as agreed inwriting).

 

### **8.3.2.**       Priority 2 orders (P2)

### ** **

Service Parts to bedelivered under “priority 2 orders” may be placed by PMS during the term ofthis Agreement. These Service Parts will have a Delivery Time of three (3)days.

 

### **8.3.3.**       Normal (replenishment) orders (P3)

### ** **

Delivery time for ServiceParts will be 30 days after receipt of the Purchase Order.

 

## **8.4.**         Repair

## ** **

### ***8.4.1.****     **RepairServices*

### ** **

Service Parts which areidentified as repairable items, may be returned “as is” by PMS to FISCHERIMAGING 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 brokenService Part within a reasonable time, irrespective of the supply by FISCHERIMAGING of the replacing Service Parts.

 

Service Parts returnedalready two times to FISCHER IMAGING will be taken out of circulation. TheService Part will be replaced by a new one.

 

PMS will receive a fullrefund for unused obsolete Service Parts, meaning Service Parts in its originalpackage, if those Service Parts are returned as a result of a mandatory FCO,within 90 days of receipt of FCO.

 

DOA Service Parts will bereturned to FISCHER IMAGING for functional check. Those items found to beacceptable will be returned to PMS at no charge. If an item is returned asecond time as DOA, PMS will receive a new replacement item free of charge. TheDOA Service Part will be discarded upon the second return.

 

A Service Part returnedby FISCHER IMAGING to PMS will be replenished by FISCHER IMAGING with all parts****necessary to complete the original delivery. (e.g. sparefuses for power supply)

 

Hard Disc Assemblies (HDA) returned for repair and still containing datashall not be read by FISCHER IMAGING. When the HDA is reused, the contents ondisc will be erased by FISCHER IMAGING before re-shipping.

 

6

----

 

### ***8.4.2.****     **Repair at PMS*

### ** **

If PMS would elect tostart repair of exchangeable Service Parts in its own workshops, then FISCHERIMAGING will transfer free of charge to PMS, all relevant informationconcerning:

•    Trouble shooting

•    Component specifications (names andaddresses of vendors included)

•    Adjustment procedures

•    Tools and repair aids(specifications and prices)

•    Initial training (if applicable)

•    Test equipment

•    Test and diagnostic software (bothin source and object code)

 

To maintain warranty onProducts and Service Parts, PMS must acquire prior approval to start repair ofexchangeable Service Parts in its own workshop or an approved third party.

 

## **8.5.**         Restocking fees

## ** **

PMS is entitled to returnall up to date Service Parts in their original package which Service Partsshall be accepted by FISCHER IMAGING**,** for arestocking fee of 90% of original purchase price to PMS.

 

## **8.6.**         Packing and storage

## ** **

In addition to theconditions as stated in article 9 of the Agreement, each Service Part will bepacked in such a way, that it can be reused and stored without re-packing (ifnecessary, electrostatic discharge-packing is to be used).

 

FISCHER IMAGING willspecify the storage conditions for Service Part(s), such as but not limited totemperature, humidity, shelf life and air pressure, for any Service Part(s) forwhich there are special requirements in this regard.

 

## **8.7.**         Affiliated companies and subcontractorsinvolved

## ** **

The service logisticsbranch of Affiliated Companies if they so desire, or the subcontractorsappointed by PMS, are entitled to deal directly with FISCHER IMAGING in theareas of ordering Service Parts and returning Service Parts for repair toFISCHER IMAGING. PMS will provide prior notice of those subcontractors.

 

 
| Hamburg,                    |   |                 |   | Denver, |   |   |
|-----------------------------|--------|----------------------|--------|---------|--------|--------|
|                        |   |                 |
|                        |   |                 |
|                        |   |                 |   |    |
| **Philips Medical Systems** |   | **FISCHER  Imaging** |
| DMC GmbH                    |   |                 |

 

7

----

 
| **Philips Medical Systems - FIC**                | **PMS - FIC** |
|--------------------------------------------------|---------------|
| Annex S1: Service                                |          |
| Master Purchasing Agreement **PMS**  and **FIC** |          |

#### ** **

#### **Annex 1 to ATTACHMENT G**

#### ** **

For the purpose of this Annex, PMS is refered to as “PMS”.

 
| **PMS****Reference number:** | ** ** | ** **               | ** ** | **FISCHER IMAGING****Reference number:** |
|------------------------------|------------|--------------------------|------------|------------------------------------------|
| ** **                   | ** ** | ** **               | ** ** | ** **                               |
| **Name:**                    | ** ** | ** **               | ** ** | **Name:**                                |
| **Phone:**                   | ** ** | ** **               | ** ** | **Phone:**                               |
| ** **                   | ** ** | ** **               | ** ** | ** **                               |
| **Date:**                    |       |                     |       |                                     |
| **Product:**                 |       |                     |       |                                     |
| **Serial number:**           |       |                     |       |                                     |
| ** **                   |       |                     |       |                                     |
| **Problem area:**            | ** ** | **Application Software** | ** ** |                                     |
|                         |       | **Diagnostic software**  |       |                                     |
|                         |       | **Hardware**             |       |                                     |
|                         |       | **Documentation**        |       |                                     |
|                         |       | ** **               |       |                                     |
| **Problem description:**     |       |                     |       |                                     |
|                         |       |                     |       |                                     |
|                         |       |                     |       |                                     |
|                         |       |                     |       |                                     |
| **Solution:**                |       |                     |       |                                     |
|                         |       |                     |       |                                     |
|                         |       |                     |       |                                     |
|                         |       |                     |       |                                     |

 

8

----

 
| **Incoming Goods Inspection  (Annex O2 of Master Purchasing Agreement)** | ** ** | **** |
|--------------------------------------------------------------------------|------------|------|
|                                                                     |       |
| **Philips Medical Systems**                                              | ** ** |

 

**Annex tothe Master Purchasing Agreement**

**(AgreementNo. P01-000132)**

regarding

 

**ServiceComprising Incoming Goods Inspections in accordance with §§ 377 - 378 of the German commercial code (“HGB”)**

 

between

 

Fischer Imaging

12300 North GrantStreet

Denver, Colorado80421

(hereinafterreferred to as “**FIC**”)

 

and

 

Philips MedicalSystems

DMC GmbH

Röntgenstrasse 24

22335 Hamburg

 

(hereinafterreferred to as “**PMS**”)

 

**Subjectof the agreement**

 
| **PMS** DMC:  Einkauf PST |    |
|---------------------------|---------|
|                      | **PMS** | **FIC** |
|                           |         |  |

 

1

----

 

# **Performanceof the incoming goods inspection in accordance with §§ 377 - 378 of the Germancommercial code (“HGB”)**

# ** **

The contracting partiesagree on an incoming goods inspection (GRI) on behalf of **PMS**.

 

The incoming goodsinspection shall be explicitly commissioned for each purchase order; the costof the inspection shall be included in the price of the articles ordered.

 

The scope of theinspection shall be based on the test specifications prescribed by **PMS** or agreed with it, which are an integral part of theSpecification.

 

The contracting parties waive in agreement **PMS**’sduty to inspect and file a complaint in accordance with §§ 377 – 378 of the Germancommercial code although the contractual and statutory entitlement tocompensation 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 inadequateincoming goods inspection, **PMS** may takerecourse to the contractor. The scope of the warranty and the periods thereofshall be based on the purchasing conditions of **PMS**.In the event of any faults occurring, the contractor shall without delay adeptthe incoming goods inspection to the new requirements and ensures that thesources of error are eliminated.

 

Notwithstanding the aboveagreements, **PMS** shall identify the goods,establish the quantity and check the consignment with regard to apparent damagein transit.

 

The contractor shallperform the specified inspections as a routine inspection, document themindividually and file the documents for at least 10 years. The documents filedshall be made available to **PMS** on request.

 

# **Placeof jurisdiction**

# ** **

**The place of jurisdiction for anydisputes resulting from the contract shall be Hamburg, Germany.**

** **

** **
| Hamburg,                    |       |                | Denver, |   |   |
|-----------------------------|------------|---------------------|---------|--------|--------|
|                        |       |                |
|                        |       |                |
|                        |       |                |    |
| **Philips Medical Systems** | ** ** | **FISCHER Imaging** |
| DMC GmbH                    | ** ** | ** **          |
|                             |            |                     |         |        |        |  |

 

2

----

| **Philips Medical Systems - FIC**                | **PMS -  FIC** |
|--------------------------------------------------|----------------|
| Annex O3: Quality Cost Agreement                 |           |
| Master Purchasing Agreement **PMS**  and **FIC** |           |

 

 

**Annexof Master Purchasing Agreement**

**(AgreementNo. P01-000132)**

concerning

 

**QualityCost Agreement**

 

 

between

 

FischerImaging

12300North Grant Street

Denver,Colorado 80241

 

(hereinafterreferred to as “**FIC”**)

 

 

and

 

 

PhilipsMedical Systems

DMCGmbH

Röntgenstrasse24

22335Hamburg

Germany

 

(hereinafterreferred to as “**PMS**”)

 
| **PMS** DMC: Einkauf |          |
|----------------------|---------------|
|                 | **PMS**  | **FIC** |
|                      |               |  |

 

1

----

 

**Objectof the Agreement**

 

# **1**      Quality CostAgreement

# ** **

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 fromreceipt of the goods. Notification of hidden defects shall be effectedimmediately after their discovery. Payment for the goods shall not signifytheir approval as complying with the contract and free of defects.

 

**PMS** has established the zero defect strategy within its QualityManagement Program. **PMS** expectsfrom **FIC**to support the **PMS**strategy and observe the zero defect strategy for all the products and servicesof **FIC**, too. **FIC**shall support the delivery of products without any defect by continuousimprovement, supervision, and analysis of all of its production and workingprocesses.

 

For each purchased product**FIC** shall, onrequest of **PMS**, list and follow up qualityassurance targets reconciled with **PMS**. The proofof reaching these targets shall be transparent and proved to **PMS** by giving **PMS** access tothe respective documents.

 

The Supplier warrants that the goods delivered comply with the agreedspecification, that they have no defects which impair their value or theirsuitability, and that they do not lack any promised characteristics. TheSupplier also warrants that the goods supplied are free of design, material andmanufacturing faults and are in accordance with the latest state of the art.

 

In the event of defects in the goods supplied FIC receives a QualityFaults Report of Purchased Products and a List of Costs (see below).

 

In the event of defects in the goods supplied, we shall be entitled atour 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 thecost of the Supplier. If we have requested correction of a defect and suchcorrection is still not successfully effected after expiry of a reasonableperiod of grace, we shall be entitled to demand a reduction of the agreedprice, or to rescind the contract in whole or in part, and to claim damages fornon-fulfilment. Any further rights that we have to warranty or the payment ofdamages - including for consequential damage - shall remain unaffected thereby. In particular, we shall be entitled toclaim reimbursement of the costs incurred by us for inspection if theabove-average occurrence of faults compels us to conduct incoming inspectionsover and above the usual level of random sample inspections (Master PurchasingAgreement, par. 7.6).

 

We shall beentitled to place nonconforming goods in storage or to return them to theSupplier at the latter’s cost and risk. Title to such goods shall revert to theSupplier on the date of sending of the notification of the return shipment ofthe nonconforming

 

2

----

 

goods.Transfer of possession of the goods shall be replaced by our safekeeping of thegoods for the Supplier.

 

In the eventof defects, which are not noticed until the goods are machined or processed, weshall also be entitled to claim reimbursement of any cost incurred by us to noavail.

 

In the event of rework or replacementdelivery, the warranty period shall start again for the reworked part or forthe replaced goods. (See Master Purchase Agreement)

 

For retentionof our warranty claims beyond the warranty period, it shall suffice if we havenotified the Supplier of the defect within the warranty period.

 

Our rights asset out above shall not be affected by a quality agreement (e.g. ppm, zerodefects).

 

# **2**      Place ofjurisdiction

# ** **

The place ofjurisdiction for all disputes resulting from this Agreement shall be Hamburg,Germany.

 

 
| Hamburg,                     |                 |   | Denver, |   |   |
|------------------------------|----------------------|--------|---------|--------|--------|
|                         |
|                         |
|                         |                 |   |    |
| **Philips  Medical Systems** | **FISCHER  Imaging** |
| DMC GmbH                     |
|                              |                      |        |         |        |        |  |  |

 

 

Annex:   Qualitätsmängelbericht (QualityFault Report for Purchased Parts)Kostenaufstellung (List of costs)

 

3

----

 
| **Quality Fault Report for Purchased Parts** |   |                     | TPAI    |
|----------------------------------------------|--------|--------------------------|---------|
| (Qualitätsmängelbericht)           |   |                     |    |
| **PMG**                                      | Copy:  | Accounting  Dpt.         | PK  152 |
|                                         |   |                     |    |
| Report-No.:                                  |   | Initial  Purchasing Dpt. | PK 145  |

 

 Philips Medical Systems • D-22331 Hamburg/ Germany

 
|                                   | Philips Medical Systems                                                         |
|----------------------------------------|---------------------------------------------------------------------------------|
| ** An die Geschäftsleitung** | DMC GmbH                                                                        |
|                                   | Röntgenstraße 24                                                      |
|                                   |                                                                            |
| ** **                             | **D-22335 Hamburg/ Germany**                                                    |
|                                   |                                                                            |
|                                   | Tel.:        + 49 40 50 78 {Quality manager} |

 
| Your order No. | of     | Our Ref. | Extension | Hamburg |
|----------------|--------|----------|-----------|---------|
|           |   | Name:    |      |    |

 

Defects have beendetected on the product manufactured by you:
| PMS-12 NC:         | Designation:        |
|--------------------|---------------------|
|               |                |
| Amount:            | Series number:      |
|               |                |
| Date of  delivery: | Delivery note  No.: |
|               |                |
| Our order No.:     | Buyer:              |

 

Date:

 

Description of thedefect: See attachment {Fault Report}

 

 

o  Production shutdown

Due to the defectsdescribed *PMS proposes the following measures*:

 
| o    PMS  eliminates the defect                                                                         | o    Scrapping  by PMS with request for replacement delivery free of charge |
|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|
|                                                                                                                   |                                                                                       |
| o    Immediate  return with the request for replacement delivery of the product or repair by  you until |

 
| **To be  filled out by the supplier:** |                    |                   |
|----------------------------------------|-------------------------|------------------------|
|                                   |                    |                   |
| Supplier agrees                        | o    yes | o    no |
|                                   |                    |                   |
| Supplier repairs  at PMS               | o    yes | o    no |
|                                   |                    |                   |
| Return delivery  No.                   |                    |                   |
|                                   |                    |                   |
| Commission No.                         |                    |                   |

 

4

----

 

Quality Fault Report   page I

 
| **Quality Fault Report for Purchased Parts** |   |   | TPAI   |
|----------------------------------------------|--------|--------|--------|
|                                         |   |   |   |
| Report-No.:                                  |   |   |   |

 

We areasking 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 toinform PMS in written form whether any other products might be affected.

 

Please send this formsheet to PMS to the above fax number within **24 hours**.

 

Elimination of the error:(see attachment) {answer of supplier}

 

 

 

The accounting departmentwill send you a debit note over the amount of             EUR for any costs incurred for PMS .

 

Any costs thatcannot be foreseen at the moment will later on be debited by PMS.

 

 
|                    |   |                    |   |                    |
|-------------------------|--------|-------------------------|--------|-------------------------|
| First name, name        |   | First name, name        |   | First name, name        |
| Philips Medical Systems |   | Philips Medical Systems |   | Philips Medical Systems |
| DMC GmbH                |   | DMC GmbH                |   | DMC GmbH                |
|                    |   |                    |   |                    |
|                    |   |                    |   |                    |
|                    |   |                    |   |                    |
| Date                    |   | Date                    |   | Date                    |

 

Quality Fault Report   page II

 

5

----

 
| **Philips Medical Systems - (NN)**               | **PMS - (NN)** |
|--------------------------------------------------|----------------|
| Anhang O3: Quality Cost Agreement                |           |
| zum Rahmenvertrag zwischen **PMS**  and **(NN)** |           |

 

**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**                                                                                                                                                        | ** ** | **200.- EUR** | ** ** | **200.- EUR** |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|---------------|------------|---------------|
| ** **                                                                                                                                                          | ** ** | ** **    | ** ** | ** **    |
| **2.****     Extra work costs**                                                                                                                 |       |          |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Fault report of defective product                                                                                              |       |  (hours) |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Disassembly of defective product                                                                                               |       |  (hours) |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Assembly of a new product                                                                                                      |       |  (hours) |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Test of a new product                                                                                                          |       |  (hours) |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Process disturbances                                                                                                           |       |  (hours) |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Additional requirements for a new test as a result of the  insufficient quality                                                |       |  (hours) |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Refinishing work                                                                                                               |       |  (hours) |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Material costs incl. cost for scrapping                                                                                        |       | EUR           |       |  EUR     |
|                                                                                                                                                                |       |          |       |          |
| **Total of                      hours  x 50.- EUR/h** | ** ** | ** **    | ** ** | ** **    |
| ** **                                                                                                                                                          | ** ** | ** **    | ** ** | ** **    |
| **Subtotal work costs**                                                                                                                                             | ** ** | **EUR**       | ** ** | ** EUR** |
| ** **                                                                                                                                                          | ** ** | ** **    | ** ** | ** **    |
| **3.****     Fixed  charges for shipments that are not returned**                                                                               |       |          |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Fault report internal                                                                                                          |       |          |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Fault report external                                                                                                          |       |          |       |          |
|                                                                                                                                                                |       |          |       |          |
| •      Administration, final test completion of complaint                                                                             |       |          |       |          |
|                                                                                                                                                                |       |          |       |          |
| **Subtotal**                                                                                                                                                        | ** ** | **100.- EUR** | ** ** | **100.- EUR** |
| ** **                                                                                                                                                          | ** ** | ** **    | ** ** | ** **    |
| **Total costs:**                                                                                                                                                    | ** ** | ** **    | **EUR**    | ** **    |
|                                                                                                                                                                     |            |               |            |               |  |  |

## ** **

| **First name, name  (Operationsmanager)** | **First name, name  (PMS employee)** |
|-------------------------------------------|--------------------------------------|
| (signature)                               | (signature)                          |

 

QualityFault Report    page III

 
| **PMS** DMC: Einkauf GEN |          |
|--------------------------|---------------|
|                     | **PMS**  | **FIC** |
|                          |               |  |

 

6

----

 
| **Philips Medical Systems - FIC**                | **PMS -  FIC** |
|--------------------------------------------------|----------------|
| Annex O1: Logistic Procedure                     |           |
| Master Purchasing Agreement **PMS**  and **FIC** |           |

 

**LogisticProcedure**

**AnnexO1 to Master Purchasing Agreement (Agreement No. P01-000132)**

**between**

**PhilipsMedical Systems and Fischer Imaging**

** **

**1.**** ****Planning & forecasting**

•      PMS willprovide a rolling 4-quarter, non-binding forecast. Regular delivery of theproduct will start in Q3 2005.

•      The forecast will be updated everyquarter for the upcoming 4 quarters on the first day of the month prior to thebeginning of that quarter. It will be PMS’s most accurate expectations forshipment requirements.

•      Theforecast for the most current quarter will not exceed current in house orderswith confirmed shipping dates within that quarter plus an additional 30% forforecasts units, where orders are not yet confirmed, but are expected withdelivery required in that quarter.

•      Fischerwill inform Philips about general slot planning.

 

**2.**** ****Delivery times**

•      Lead-timefor the product is 21 calendar days from receipt of purchase order until day ofshipment.

•      For volumeshigher than forecasted (more than additional 30%) every reasonable effort willbe made to meet the lead-time for additional volumes.

•      Ifreasonable volumes are reached (approximately 100 units per year) both partiesagree to establish a consignment stock at PMS premises.

•      All ordersshall be considered firm and non-cancelable 21 days prior to the requestedshipping date

•      In case ofmove outs PMS will inform Fisher and vice versa. Fischer will send a newconfirmation within 2 days

•      Fischerwill take express costs for transportation in case of late deliveries.

 

**3.**** ****Tender Business**

•      Any singleorder for more than 5 systems will be considered a “Tender Order”.

•      Tenderbusiness shall be regarded as additional business to the forecast.

•      Everyreasonable effort will be made to meet the shipping requirements, but theorders will not be subject to the 21-day shipping requirement for forecastedorders. Both parties will agree on a delivery schedule for every individualtender that meets the tender requirements.

 

**4.**** ****Shipment procedures**

•      PMSpreferred carriers are Panalpina or Menlo. (Contact addresses/phone number arelisted at the end of this annex) Fischer will deliver all systems through thesecarriers to a Uni_Data Depot in Frankfurt. Uni_Data will consolidate goods fromHamburg and USA (Fischer) and will deliver as one lot shipment to finalcustomer in Europe.

•      Shipmentsprocedures to destinations outside Europe will be described in a separate annexto be added, when such deliveries will start.

•      Packingwill be in heat-treated wood. This standard packing is included in the systemprice.

•      Packingwill only bear Philips name and logo.

•      In casespecial packing is required (e.g. water proof, etc.) PMS will bear the cost.

•      Fischerwill hand over the goods to the carrier at the committed delivery date withcompany neutral paperwork ( no Fisher labels, signs or Fisher invoices are tobe attached to the shipment) . On all paperwork the customer order number andthe Philips code numbers have to be visible.

 

**5.**** ****Order procedures**

PMS will send a call off to Fischer preferably byEmail or by fax with following contents:

•      Customerorder number

•      Type number

•      Requireddelivery date (ex works)

•      Quantity

 
| **PMS** DMC: Einkauf |          |
|----------------------|---------------|
|                 | **PMS**  | **FIC** |
|                      |               |  |

 

1

----

 

PMS will receive an order confirmation within 2 daysby Fischer preferably by EMAIL or fax with following contents:

•      Customerorder number

•      Type number

•      Confirmeddelivery date

•      Quantity

PMS will send a delivery advise to Uni_Data and toPanalpina / Menlo with following contents:

•      Customerorder numbers

•      Date andtime of arrival at destination

•      Address offinal destination

 

Fischerwill advise the carrier (Menlo, Panalpina) when the goods shall be picked up atFischer Imaging. Reference is the customer order number.

 

Latestthe day when the carrier picks up the material, Fischer will send a deliverynote to Philips with following contents:

•      Finalcustomer order number

•      Philipscode numbers

•      Philipsdescription

•      Serialnumber

•      Amount ofparcels, sizes and weight

 

6.Addresses:

 
| Panalpina  Inc.                         | Unidata  - Frankfurt       |
|-----------------------------------------|----------------------------|
| Global  Account Division                | UPS  SCS GmbH & Co OHG |
| American  Region                        | Hessenring  23             |
| 800  Arthur Avenue                      | 64546  Moorfelden-Waldorf  |
| Elk Groove Village, IL 60007 – USA | Germany                    |
|                                    |                       |
| Menlo  Worldwide                        |                       |
| 4790  Paris Street                      |                       |
| Denver,  CO 80239                       |                       |
| Tel.  303 375-1457                      |                       |
| Fax.  303 375-1470                      |                       |

 

2

----

 
| **Philips Medical Systems - FIC**                | **PMS -  FIC** |
|--------------------------------------------------|----------------|
| Annex H1: Sustainability                         |           |
| Master Purchasing Agreement **PMS**  and **FIC** |           |

 

ATTACHMENTH1

 

SUSTAINABILITYREQUIREMENTS

 

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 RoyalPhilips Supply Standard on Sustainability and as such establishes minimumrequirements of behavior expected of Philips Medical Systems’ (PMS) suppliersof Products, as well as components, parts, including Service Parts (altogether “Parts”)and packaging (“Packaging”) with regard to sustainability and sustainabledevelopment.

 

1.1           This Attachment establishes Royal Philipsand PMS’ specific environmental requirements for purchased Parts, Products andPackaging that are incorporated into or part of PMS Products.

 

1.2           This Attachment is not intended to be alisting of all product content limitations or restrictions that may beestablished as a matter of law. SUPPLIER’s compliance with this Attachment doesnot relieve or diminish SUPPLIER’s obligation to comply with all applicablelaws.

 

1.2.1        Precedence:  Except as noted below, if a conflict shouldoccur between this Attachment and any identified standard or regulation, thisAttachment shall prevail.  Should aconflict occur between this Attachment and a PMS Product or PartSpecifications, the PMS Product or Part Specifications shall prevail.

 

## **1.2.2**        Exception:  Legal and/or regulatory requirements for thecountries where these purchased Parts and Products are to be used takeprecedence over of this Attachment.

## ** **

## **1.3**           This Attachment isan addition to and does not in any way limit or supersede any ProductSpecifications that may be established by PMS.

 
| Jens Homfeld |   |   |
|--------------|--------|--------|
|         |   |   |
|         | PMS    | FIC    |

 

1

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## **SECTION B: PHILIPS SUPPLY STANDARD ON SUSTAINABILITY**

## ** **

*SUPPLIER represents and warrants full compliance with Philips SupplyStandard on Sustainability as follows:*

 

# **GENERAL**

SUPPLIER is committed to act fairly and withintegrity toward its stakeholders and is expected to comply with all applicablelocal rules and regulations.

 

# **ENVIRONMENT**

SUPPLIER shallhave ISO14001 certification or a plan to become certified.  Alternatively SUPPLIER must providedocumented objective evidence of an operational environmental management systemfor ISO14001 or demonstrate equivalency, which shows continual environmentalimprovement. SUPPLIER must comply with requirements of the respective ProductDivision, including banned/hazardous substances content.

 

# **HEALTH AND SAFETY**

SUPPLIER shalldo all that is reasonable and practicable to:

•      Protect the health and safety of employees and contract labor andminimize any adverse work conditions;

•      Implement safe and healthful work practices to prevent injury,illness and property damage;

•      Minimize occupational exposures to potentially hazardous materialsand unsafe work conditions by maintaining appropriate safety systems andeffective controls;

•      Implement an emergency response program that addresses the mostlikely anticipated emergencies;

•      Train managers and employees to assure their continued commitment totheir 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 theInternational Labor Organization**.**  In case of child labor, SUPPLIER shall takeimmediate remedial action in consultation with Philips, considering theinterests of the children employed. This action will include:

•      Minimallyacceptable employment conditions for the children employed (such as education,working hours, wages, medical facilities etc.)

•      Theobligation of SUPPLIER not to employ any more children

•      A time period within which SUPPLIER will comply with the mentionedILO norms.

 

# **FORCED LABOR**

Employment should befreely chosen. Under no circumstances will SUPPLIER make use of forced orbonded labor – such as forced labor performed by persons placed in aninstitution, or compulsory labor including labor as a means of politicalcoercion or education – to design, manufacture or assemble products andservices for Philips.

 

# **RIGHT TO ORGANIZE**

SUPPLIER shall recognizeand respect the freedom of its employees to choose whether or not to establishor to associate with any organization of their own choosing (including laborunions) without SUPPLIER’s prior authorization. The employment of a workershall not be contingent upon the condition that he/she not join a union or beforced to relinquish trade union membership.  Furthermore, union membership shall not be the cause for the dismissalof – or otherwise prejudice against – a worker. . SUPPLIER will not interferewith or finance labor organizations or take other actions with the intent ofplacing such organization under the control of SUPPLIER.

 

# **COLLECTIVE BARGAINING**

SUPPLIER shall respect –within the framework of law, regulations and prevailing labor relations andemployment practices – the right of its employees to be represented by laborunions and other employee organizations. SUPPLIER will engage in negotiations,either on its own behalf or through employers’ associations, with a view towardreaching agreement on employment conditions.

 

# **DISCRIMINATION**

SUPPLIER shall treat itsemployees equally in employment and occupation, and will ensure that each hasequal opportunities. SUPPLIER shall offer equal pay for equal work performed atequal levels. No form of harassment or discrimination in respect of employmentand occupation will be tolerated, such as discrimination based on race, color,sex, age, language, religion, political or other opinion, national or socialorigin, property, birth or other status.

 
| ** ** | **Declaration to be signed by Fischer Imaging**: |
|------------|--------------------------------------------------|
|       |                                             |
|       | Name:                                            |   |   |
|       | (Company  stamp)                                 |
|       |                                             |
|       |                                             |
|       | Function:                                        |   |   |
|       |                                             |
|       | Date:                                            |   |   |
|       | Signature:                                       |   |   |
|            |                                                  |  |  |  |  |  |  |  |

 

2

----

 
| Philips & Fischer Imaging | Umbrella  Purchasing Agreement No tbd |
|-------------------------------|---------------------------------------|

 

# **SECTION C:**            PHILIPS MEDICAL SYSTEMS’ ENVIRONMENTALSPECIFICATIONS FOR PRODUCTS, PARTS AND PACKAGING

# ** **

**1.0****          ENVIRONMENTAL DECLARATION, BANNED AND RELEVANT SUBSTANCES ANDSPECIFIC ADDITIONAL LEGISLATION**

 

1.1           SUPPLIERrepresents and warrants that on the Effective Date, the Products, Parts andPackaging do not contain Banned Substances and comply with the Additional EnvironmentalLegislation as specified in Annex 1 of this Attachment, except for certainProducts specifically identified. For these identification purposes, SUPPLIERagrees to complete and sign the “Environmental Declaration For Products, PartsAnd Packaging” (Form A) of this Attachment and indicate whether or notProducts, Parts and Packaging delivered to PMS contain Banned Substances andcomply with the Additional Environmental Legislation identified in Annex 1. Incase some Products contain Banned Substances or do not comply with theAdditional Environmental Legislation identified in Annex 1, either as from theEffective Date or otherwise during the Term of the Agreement, SUPPLER shall, onthe Effective Date or prior to the first delivery of such Products, Parts andPackaging, submit a “Request for Dispensation” (Form B) of this Attachment toBUYER.  Without prejudice to theprovisions of Section A, 1.2 and the provisions below, BUYER may, at its solediscretion, provide in writing such a dispensation per Product and for adefined period of time.

 

1.2           SUPPLIERis responsible to inform BUYER on the Effective Date onward and prior to thefirst delivery, of the presence of Relevant Substances that are contained inProducts, Parts and Packaging in excess of the thresholds listed in Form C ofthis Attachment, by using the “Declaration of Relevant Substances”, Form C ofthis Attachment.

 

1.3           SUPPLIERagrees to actively search for alternatives to eliminate Banned Substances andreduce and/or eliminate Relevant Substances contained in Products, Parts andPackaging.

 

1.4           SUPPLIERagrees to eliminate any non compliance with Additional EnvironmentalLegislation related to Products, Parts and Packaging.

 

**2.0****          GENERAL ENVIRONMENTAL REQUIREMENTS**

 

2.1           SUPPLIERshall comply with all applicable environmental laws, rules, regulations,ordinances, covenants, standards and the like, and BUYER’s implementationthereof (collectively herein referred to as “Environmental Regulations”)concerning the Products, Parts and Packaging thereof (including correctlabeling) as well as plant operations and shipments in connection therewith,enabling BUYER to distribute on a world-wide basis Products, Parts andPackaging without restrictions.

 

2.2           Withoutprejudice to the representation and warranty of SUPPLIER as described inparagraph 2.1, in the event any new Environmental Regulation is promulgatedafter the date of signing of this Attachment, the parties hereto will negotiateto establish within a reasonable period of time equitable terms to prevent orremedy any non-compliance by SUPPLIER of said warranty and representation as aconsequence of such promulgation.

 

2.3           Toensure continuous compliance with Environmental Regulations, the BUYER shallhave the right to audit the implementation and adherence to this Attachment.

 

2.4           SUPPLIERagrees to control the environmental aspects of the design and manufacture ofProducts, Parts and Packaging through an adequate and effective environmentalmanagement system that complies with ISO 14001 referenced in the Philips SupplyStandard on Sustainability.

 

2.5           WhereSUPPLIER is not certified to ISO 14001 nor has an equivalent environmentalmanagement system in place, SUPPLIER shall provide to and agree on with BUYER aplan and time schedule to achieve an operational environmental managementsystem or equivalent.

 
| Jens Homfeld |   |     |
|--------------|--------|----------|
|         |   |     |
|         | BUYER  | SUPPLIER |

 

3

----

 

**3.0****          DESIGN AND MANUFACTURING**

 

3.1           SUPPLIERundertakes that Products, Parts and Packaging are designed and manufactured tocomply with the objectives of the Waste Electrical and Electronic EquipmentDirective (WEEE) (2002/96/EC).

 

3.2           Uponrequest, SUPPLIER will provide PMS with environmentally-related informationregarding all materials included in the Products, Parts and Packaging includingas a minimum:

 

3.2.1        Necessaryinformation for disassembling, recycling, reusing and treating Products, Partsand Packaging at end of life;

 

3.2.2        Thelocation of dangerous substances and preparations in Products, Parts andPackaging;

 

3.2.3        Appropriatemarkings in accordance with the WEEE Directive requirements.

 

3.3           On thebasis of best effort, SUPPLIER undertakes to participate in Philips’ and/orBUYER’s environmental programs, such as

 

3.3.1        Reductionof the weight and volume of Packaging and Packaging materials to as low aspossible and to the technically necessary minimum, while maintaining basicPackaging functions including transportability, protection and communication ofinformation;

 

3.3.2        EnvironmentallyConscious Design (EcoDesign), i.e., reducing the integral environmental impactof the product over its entire life cycle;

 

3.3.3        Reusabilityof Products, Parts and Packaging.

 

**4.0****          CHEMICAL SUBSTANCES**

 

4.1           **Chemical Registration Requirements**

4.1.1        SUPPLIERrepresents and warrants that each chemical substance, as defined in ToxicSubstances Control Act, contained in Products, Parts and components sold to PMSis on the inventory of chemical substances compiled and published by the UnitedStates Environmental Protection Agency pursuant to the Toxic Substances ControlAct (TSCA) and complies with chemical registration and pre-manufacturenotification requirements in other countries that have enacted chemicalregistration requirements including but not limited to Australia, Canada,China, Japan, South Korea, Switzerland and the countries of the European Union.

 

4.2           **Chemical Labeling and Materials Safety Data SheetRequirements**

4.2.1        SUPPLIERrepresents and warrants that each hazardous chemical, as defined by the UnitedStates Occupational Safety and Health Administration Hazard CommunicationStandard, contained as a chemical in Products, Parts and components complieswith the labeling and Material Safety Data Sheet (MSDS) provisions of 29 CFR1910.1200, 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 ofthe hazardous chemical, and whenever changes are made to the MSDS.

 

4.3           **Carcinogen and Reproductive Toxicant LabelingRequirements**

 

4.3.1        Asdetermined by the State of California- Safe Drinking Water and Toxic Enforcement Act or 1986, List of ChemicalsKnown 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 thatexceed their

 

4

----

 

•      No Significant Risk Levels (NSRLs) tocause cancer, or

 

•      No Observable Effect Levels (NOELs) tocause reproductive harm

 

must be labeled with aclear and reasonable content warning.

 

**5.0****          OZONE DEPLETING SUBSTANCES**

 

5.1           SUPPLIER represents and warrants that neither anyof the Products, Parts or Packaging, nor any component thereof contain or havebeen “manufactured with a process that uses” any ozone depleting substances asspecified in the U.S. Clean Air Act, 40 CFR 82.

 

5.2           In case SUPPLIER cannot meet the aboverequirements, BUYER’s written approval is required prior to delivery andSUPPLIER must submit notification of non- conformance via the Request forDispensation (Form B), and label the Products, Parts and Packaging inaccordance with applicable regulatory requirements.

 

**6.0****         ****PACKAGING**

 

6.1           Content restrictions that apply to Packagingrefer to all Packaging materials purchased by PMS including those used topackage PMS products for sale as well as those used to transport Products,Parts and components to the factory to be incorporated into PMS products, afterwhich time, the Packaging would be discarded as waste.

 

6.2           Packagingmust comply with the objectives of the European Directive 94/62/EC on Packagingand Packaging waste.   EuropeanCommission Decision 97/129/EC establishes a Packaging identification system.

 

6.3           Allpackaging materials, including pallets, shall be free of pests and comply withregulations regarding Solid Wood Packaging Materials (SWPM) where applicable.Wood originating in Canada, China, Japan and the United States must comply withEuropean Legislation 1999/355/EC and 2001/219/EC with respect to treating andmarking coniferous wood.

 

6.4           Timberused as crates, pallets and in containers as lining, flooring and skids, andany other articles described as Packaging and dunnage being exported toAustralia must satisfy Australian Quarantine and Inspection Service (AQIS)requirements prior to entry.

 

 
| Signature:                  | Signature:          |
|-----------------------------|---------------------|
|                        |                |
| Name:                       |                |   | Name: |   |   |
|                        |                |
| Title:                      |                |   | Title: |   |   |
|                        |                |
| Date:                       |                |   | Date: |   |   |
|                        |                |
| Initials:                   |                |   | Initials: |   |   |
|                        |                |
| **Philips Medical Systems** | **Fischer Imaging** |
|                             |                     |  |  |  |  |  |  |  |  |  |  |

 

5

----

 
| Philips & Fischer Imaging | Umbrella  Purchasing Agreement No tbd |
|-------------------------------|---------------------------------------|

 

**ANNEX 1 To Section C of Attachment H1**

 

**Royal Philips ElectronicsList 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 ofthe “Banned substances” as mentioned in this list.

 
| **Substances**                                                                                            | ** ** | **Declaration threshold  ppm (mg/kg)****(1)** | ** ** | **Legal date entry  into force** | ** ** |
|-----------------------------------------------------------------------------------------------------------|------------|-----------------------------------------------|------------|----------------------------------|------------|
| 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                      |       |
| Dichloromethane  (CH2Cl2)                                                                                 |       | 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 theabove-mentioned substances **AND**thefollowing:

 
| **Substances**                               | ** ** | **Declaration threshold  ppm (mg/kg)** | ** ** | **Legal date entry  into force** | ** ** |
|----------------------------------------------|------------|----------------------------------------|------------|----------------------------------|------------|
| PVC  and PVC blends                          |       | 1000                                   |       | Immediately                      |       |
| Sum  of Heavy metals (Cd, Hg, Cr(6+) and Pb) |       | 100                                    |       | Immediately                      |       |

 

 

**Note:**

**For Product Division (PD) additionalbanned substances and specific exemptions on above list, see appendix to thisRoyal Philips Electronics list of Banned Substances.**

 

----

(1)    In fact, banned substances are notto be intentionally used, that is, Royal Philips Electronics accepts thatcertain materials contain a certain amount of naturally occurring bannedsubstances. Thresholds can represent legal limits, or refer to currentlyaccepted analysing thresholds.

Furthermore these thresholds should be declared oncomponent level. Substances are measured in homogeneous materials.

(2)    Poly Brominated Biphenyl Ether aresame as Poly Brominated Diphenyl Ether (PBDE) and Poly Brominated Diphenyloxides (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 toRoyal Philips Electronics list of Banned Substances CSO-BP01-2004-1**

*AdditionalBanned Substances and specific exemption per Product Division (PD)*

 

**Philips Consumer Electronics (CE)**

 
| **Additional Substance(s)  and  different legal dates** | ** ** | **Declaration  threshold  ppm (mg/kg)** | ** ** | **Entry into  force** | ** ** | **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)                |

 

**CERequirements to phenol in laminates of printed wiring boards:**

**1. SmellEmission : <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 singlesided copper cladded laminate after 3 days at room temperature in a PTFE bag ofapproximately 40 l.

 

**2.Phenol monomer : <50 mg/l phenolics**

Test method : Phenolics content in water (accordingto ISO 6439) after shaking for 23 hours a mixture of 75 g of milled (to 3 mm)

laminate in 1.5 l ofdemineralized water at pH 4).

 

**Philips Domestic Appliance andPersonal Care (DAP)**

 
| **Additional Substance(s)  and  different legal dates** | ** ** | **Declaration  threshold  ppm (mg/kg)** | ** ** | **Entry into  force** | ** ** | **Remark**                                                               |
|---------------------------------------------------------|------------|-----------------------------------------|------------|-----------------------|------------|--------------------------------------------------------------------------|
| EPS (Expanded Polystyrene)                              |       | 1000                                    |       | Immediately           |       | Banned for Product  Packaging (with a product weight of less than 20 kg) |

 

**Exemptioninformation:**

DAP is re-enforcing its limit for thecadmium-threshold from 100 ppm to 20 ppm. Final entry into force of this newmore stringent value is January 1st, 2006.

 

**Philips Lighting**

 
| **Additional Substance(s)  and  different legal dates** | ** ** | **Declaration  threshold  ppm (mg/kg)** | ** ** | **Entry into  force** | ** ** | **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 withcertain conditions referred in European Directive RoHS 2002/95/EC. Thisrestriction applies only for lamps placed on the European market since 1stJuly, 2006.

 

**Philips Medical Systems (PMS)**

 
| **Additional Substance(s)  and  different legal dates** | ** ** | **Declaration  threshold  ppm (mg/kg)** | ** ** | **Entry into  force** | ** ** | **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 forPMS and **no**Request forDispensation is required.

**This exemption does not include Leadin outer sleeves of cables in accordance with proposition 65 .**

 

**Philips Semiconductors**

 
| **Additional Substance(s)  and  different legal dates** | ** ** | **Declaration  threshold  ppm (mg/kg)** | ** ** | **Entry into  force** | ** ** | **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 EnvironmentalLegislation Applicable to PMS Products, Parts and Packaging***(Based oninternational legislation)*

** **

**Additional LegislationApplicable 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   120000 – Chemicals Known to the State to Cause Cancer or Reproductive  Toxicity  arcinogen and Reproductive Toxicant Requirements as determined by State of  California |
| ** **                                         | ** ** | ** ** |   |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           |
| **Ozone Depleting  Chemicals**                     | ** ** | **-**      |   | U.S. Clean Air  Act and Amendments (CAAA) and U.S. Significant New Alternative Policy  (SNAP-rule); 40 CFR 82                                                                                                                                                                                                                                                                                                                                                                                                                  |

 

8

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## **Instructions to Complete Forms A, B and C**

## ** **

**Form A:*****Environmental Declaration For Products, Parts AndPackaging Sold To Philips Medical Systems (PMS)***

SUPPLIER shallcomplete, sign and return Form A to BUYER.  To complete Form A, SUPPLIER shall check Box 1 or 2 under each section **“Banned SubstancesApplicable to Products, Parts and Packaging”**and **“Additional EnvironmentalLegislation Applicable to PMS Products, Parts and Packaging”**toindicate whether Products, Parts and Packaging sold to BUYER comply with thePhilips environmental requirements.

 

**Form B:*****Request for Dispensation***

If SUPPLIERhas 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, Partand Packaging that does not comply with Philips environmental requirements. Tocomplete Form B, SUPPLIER shall indicate the Part, Product or Packaging andcorresponding Banned Substance(s) and/or Additional Environmental Legislationto which it does not comply.

 

***Form C****:  **Declaration of Relevant Substances***

This Form mustbe completed, signed and returned by SUPPLIER only if Products, Parts orPackaging delivered to PMS contain any of the Relevant Substances listed onForm C.

 

9

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**FORM A**

 

**ENVIRONMENTAL DECLARATIONFOR PRODUCTS, PARTS ANDPACKAGING SOLD TO PHILIPS MEDICAL SYSTEMS (PMS)**

 
| **To be filled out by Supplier**                                                                                                                                                                                                                                                                                                                                                                                     | For PMS use only**Supplier number :**                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| Supplier:                                                                                                                                                                                                                                                                                                                                                                                                            |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
|                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| Supplier Address:                                                                                                                                                                                                                                                                                                                                                                                                    |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
|                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| Supplier Phone:                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
|                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
|                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| **Banned Substances Applicable to Products,  Parts and Packaging***(Based on international legislation and Philips  Directives)**           **Please check box #1 or #2 below that applies.***                                                                                                                                                                     |
|                                                                                                                                                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              |
| (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:****(**Print name)                                                                                                                                                                                                                                                                                                                                                                             |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              | **Signature:** |
|                                                                                                                                                                                                                                                                                                                                                                                                                      |                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   |  |  |  |  |

 

10

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| **Function:** |   |   |
|---------------|--------|--------|
| ** **    |   |   |
| **Date:**     |   |   |

 

**FORM B**

 

**REQUEST FOR DISPENSATION(To be filled out by supplier for each applicable Product, Part and Packaging)**

 
| **Product Number****(Philips Numbering Code):**                                                                                                                                                                                                                                                                                                                                                                              |   | **For Philips Medical  Systems (PMS) only****SUPPLIER Number:** |   |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------------------------------------------------------|--------|
|                                                                                                                                                                                                                                                                                                                                                                                                                         |   |                                                            |   |
| *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.  Please list the Banned Substance(s) and concentration for which dispensation  is requested in the space below: |
|                                                                                                                                                                                                                                                                                                                                                                                                                         |   |                                                            |   |
| **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.Please list applicable legislation in  the space below:                                                                                                                                                                                 |
|                                                                                                                                                                                                                                                                                                                                                                                                                         |   |                                                            |   |
| **Additional Information: Please  indicate below the amount of time for which dispensation is requested, and  describe the deviation, reason for it and possible alternatives. **                                                                                                                                                                                                                                       |
|                                                                                                                                                                                                                                                                                                                                                                                                                         |   |                                                            |   |
| Product, Part,  Packaging:                                                                                                                                                                                                                                                                                                                                                                                                   |   |                                                            |   |
|                                                                                                                                                                                                                                                                                                                                                                                                                         |   |                                                            |   |
| Dispensation requested for the period:                                                                                                                                                                                                                                                                                                                                                                                       | From:  | To:                                                             |
|                                                                                                                                                                                                                                                                                                                                                                                                                         |   |                                                            |   |
| Description of application:                                                                                                                                                                                                                                                                                                                                                                                                  |   |                                                            |   |
|                                                                                                                                                                                                                                                                                                                                                                                                                         |   |                                                            |   |
|                                                                                                                                                                                                                                                                                                                                                                                                                         |   |                                                            |   |
| Reason for use:                                                                                                                                                                                                                                                                                                                                                                                                              |   |                                                            |   |
|                                                                                                                                                                                                                                                                                                                                                                                                                         |   |                                                            |   |
|                                                                                                                                                                                                                                                                                                                                                                                                                         |   |                                                            |   |
|                                                                                                                                                                                                                                                                                                                                                                                                                              |        |                                                                 |        |  |  |

 

11

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| Possible alternatives:                 |   |   |           |
|----------------------------------------|--------|--------|----------------|
|                                   |   |   |           |
|                                   |   |   |           |
| **Responsible Manager:  (**Print name) |   |   | **Signature:** |
|                                   |   |   |           |
| **Function:**                          |   |   |           |
|                                   |   |   |           |
| **Date:**                              |   |   |           |

 

12

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**FORM C**

 

**DECLARATION OF RELEVANTSUBSTANCES( To be filled out by supplier for each applicable product, part and packaging)**

 
| **SUPPLIER:**                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                 | **Supplier Number:***For Philips  Medical  Systems (PMS) only* |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
|                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                 |                                                           |   |
| **Relevant Substances:***(Request for dispensation is not  required)*                                                                                                                                                                                                                         |                                                                                                                                                                                                                 |
|                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                 |                                                           |   |
| 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:                                                 |   |
| Product weight:                                                                                                                                                                                                                                                                               | kg  /  gr:                                                                                                                                                                                                 |                                                           |   |
|                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                 |                                                           |   |
| *Please check all that apply*                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                 |                                                           |
|                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                 |                                                           |   |
| **Relevant Substances for Products, Parts and  Packaging**                                                                                                                                                                                                                                    | ** **                                                                                                                                                                                                           | **Threshold  value  in ppm (mg / kg)**                         | ** ** | **Amount  present in grams** |
| 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                                                             |   |   |
|                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                 |                                                           |
| **Responsible Manager:  (**Print name)                                                                                                                                                                                                                                                        |                                                                                                                                                                                                                 | **Signature:**                                                 |
|                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                 |                                                           |
| **Function:**                                                                                                                                                                                                                                                                                 |                                                                                                                                                                                                                 |                                                           |
|                                                                                                                                                                                                                                                                                          |                                                                                                                                                                                                                 |                                                           |
| **Date:**                                                                                                                                                                                                                                                                                     |                                                                                                                                                                                                                 |                                                           |
|                                                                                                                                                                                                                                                                                               |                                                                                                                                                                                                                      |                                                                |  |  |  |  |  |  |  |  |  |  |

 

13

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