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MEDTRONIC MINIMALLY INVASIVE THERAPIES* (“Medtronic”) CUSTOM PROCEDURE TRAY MANUFACTURER (“CPTM”) POLICIES AND PROCEDURES *THESE CPTM POLICIES AND PROCEDURES ONLY PERTAIN TO MEDTRONICS MINIMALLY INVASIVE THERAPIES GROUP CONSISTING OF ITS SURGICAL INNOVATIONS AND PATIENT MONITORING AND RECOVERY SEGMENTS

M I T (“Medtronic”) P T M (“CPTM”) P · medtronic minimally invasive therapies* (“medtronic”) custom procedure tray manufacturer (“cptm”) policies and procedures *these

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Page 1: M I T (“Medtronic”) P T M (“CPTM”) P · medtronic minimally invasive therapies* (“medtronic”) custom procedure tray manufacturer (“cptm”) policies and procedures *these

MEDTRONIC MINIMALLY INVASIVE THERAPIES*

(“Medtronic”)

CUSTOM PROCEDURE TRAY MANUFACTURER

(“CPTM”) POLICIES AND PROCEDURES

*THESE CPTM POLICIES AND PROCEDURES ONLY PERTAIN TO MEDTRONIC’S MINIMALLY INVASIVE THERAPIES GROUP

CONSISTING OF ITS SURGICAL INNOVATIONS AND PATIENT MONITORING AND RECOVERY SEGMENTS

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TABLE OF CONTENTS A. MITG PRODUCT LISTING ..................................................................... ……… 3

B. CUSTOMER SERVICE AND CONTACT INFORMATION……… ................ ……… 4

C. BACK OFFICE OPERATION CONTACT INFORMATION ......................... ……… 5

D. ADVERTISING AND COMMUNICATIONS CONTACTS ........................... ……… 6

E. DEFINITIONS ....................................................................................... …… … 7

F. GENERAL REQUIREMENTS ................................................................. …….… 8

G. ADMINISTRATIVE REQUIREMENTS ..................................................... ……..… 9

H. REQUIREMENTS FOR

DISTRIBUTION OF PRIVATE-LABEL PRODUCT .............................. …….… 10

I. CONTRACT PRICING REBATE PAYMENT PROCESSING PROCEDURE………… 11

J. CONTRACT REBATE (CHARGE BACK) RESUBMISSION PROCEDURE . ………. 12

K. LOGISTICAL PROVISIONS ................................................................... ..…….… 13

L. TABLE OF MEDTRONIC TERMS (Standard Orders and Annual Purchases) ....................................... ……….… 14

M. FREIGHT TERMS ................................................................................. ……….... 15

N. RETURNED GOODS ............................................................................. ……….… 16

O. DAMAGE, SHORTAGE & OVERAGE PROCEDURES ............................. …….…… 17

P. E-BUSINESS TRANSACTIONS .............................................................. …….…… 18

Q. GENERAL PROVISIONS ....................................................................... …….…… 20

EXHIBIT A – AFFILIATE LIST .................................................................... …….…… 24 EXHIBIT B – INFORMATION REQUIREMENTS .......................................... …….…… 24 EXHIBIT C – MEDTRONIC STANDARD EXCEL FORMAT… ........................ …..…… 25 EXHIBIT D – SAMPLE OF SALES ROUNDING PROCEDURES…… .............. …….…… 26 EXHIBIT E – RETURNED GOODS POLICY ................................................. …….…… 27 EXHIBIT F – REDRESS/RESTOCKING FEES SCHEDULE…………….,,,,,,…….………. 28 EXHIBIT G – MEDTRONIC’S GUIDING PRINCIPLES FOR E-BUSINESS……….…….… 29 EXHIBIT H – CARRIER CONTACT INFORMATION…………………….……………………… 30

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A. MITG PRODUCT LISTING

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B. CUSTOMER SERVICE AND CONTACT INFORMATION To order: To implement electronic ordering, preferred method, contact the IS EDI team at [email protected] For online ordering, log onto www.covidienconnect.com and click on “Register Now” or email [email protected]. *Call: 800-962-9888, option 2, option 6 Email: [email protected] Fax: 800-637-9775 *$160 manual order charge applies to orders that can be placed electronically. See pg. 14 for exceptions and clarifications.

Remanufactured/Reprocessed Pulse Oximetry Sensors Call: 844-268-2583 Email: [email protected] Fax: 508-452-1900 To report a discrepant (shortage, overage, mispick, damaged, wrong product) order: Log onto [email protected] *Call: 800-962-9888, option 2, option 6 Email: [email protected] *Discrepant orders reported via CovidienConnect are prioritized.

For Returned Material Authorizations (“RMA”): Call: 800-962-9888, option 2, option 6 Email: [email protected] Fax: 800-637-9775 To get the status of or to request a new RMA, log onto www.covidienconnect.com For Service and Warranty Maintenance (“SWM”) assistance: Respiratory and Monitoring Solutions division Call: 800-962-9888, option 1, option 1 Email: [email protected] Fax: 800-966-4955 Patient Recovery (Thermometry & Enteral Feeding) Call: 800-962-9888 option 1, option 2 Email: [email protected] Fax: 800-724-1324 Patient Recovery (SCD & AVI) Call: 800-962-9888 option 1, option 3 Email: [email protected] Fax: 800-724-1324

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Surgical Innovations (Surgical, Valleylab, & RF Surgical) Call: 800-962-9888 option 1, option 5 Email: [email protected] Fax: 800-724-1324

C. BACK OFFICE OPERATION CONTACT INFORMATION Price List Email: [email protected] Rebates & Chargebacks Assigned per CPTM - one single R&T point of contact per CPTM Covidien.DistributorRebates&[email protected] Covidien.DistributorRebates&[email protected] Covidien.DistributorRebates&[email protected] *Contact Wendy Luca [email protected] if you have questions about your single point of contact. GPO Contracts Patient Recovery Email: [email protected] Surgical Innovations Email: [email protected] Respiratory and Monitoring Solutions Email: [email protected] Individual Contracts Patient Recovery Email: [email protected] Surgical Innovations Email: [email protected] Respiratory and Monitoring Solutions Email: [email protected] GPO Rosters, Memberships & LOCs Email: [email protected]

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D. ADVERTISING AND COMMUNICATIONS CONTACTS Patient Recovery Ruth Kane, Director - Marketing Communications [email protected] Surgical Innovations Bryan Snow, Director - Marketing Communications [email protected] Respiratory and Monitoring Solutions Pamela Lee, Director - Marketing Communications [email protected]

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E. DEFINITIONS “Affiliate” shall mean a Medtronic division or business, or an operating Company owned by Medtronic, which operates under common control with Medtronic named on the Affiliate list attached hereto as Exhibit A. “Authorized Contract CPTM” shall mean any CPTM that has been approved to access individual or group Rebate (Charge Back) Contracts. “Additional Billing” shall mean any document, such as an invoice, charge-back, or letter generated by Medtronic notifying a CPTM of funds owed. “Contract” shall mean a written agreement (specifically excluding a Purchase Order submitted by or on behalf of a Customer and accepted by Medtronic or an Affiliate) between Medtronic, or one of its Affiliates, and a Customer for the purchase of Products subject to the terms of these Policies and Procedures. “Contract Price” shall mean the price charged to a Customer or Participants for Products under a Group Purchasing Organization Rebate (Charge Back) Contract. “CPTM Purchase Price” shall mean the amount charged to CPTM for Products covered on Medtronic price list. “Customer” shall mean a third party entity that has a Contract with Medtronic or one of its Affiliates, for the purchase of Products. “CPTM Purchase Price” shall mean the amount charged to CPTM for Products covered on Medtronic price lists. “Participant” shall mean an entity that is eligible to purchase Products under a Contract between Medtronic (or an Affiliate) and any group purchasing organization of which such entity is a member or participant. “Products” shall mean any products sold by Medtronic or an Affiliate that are distributed in accordance with the terms of these Policies and Procedures. “Rebate (Charge Back)” shall mean a reimbursement paid to CPTM by Medtronic via credit memo, in the amount, if any, by which the CPTM Purchase Price for any Product exceeds the applicable Contract Price for such Product. “Rebate (Charge Back) Claim” shall mean a reimbursement submission made by CPTM to Medtronic for a reimbursement in accordance with the terms of these Policies and Procedures.

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F. GENERAL REQUIREMENTS

1) Each CPTM must maintain a minimum annual purchase requirement of $100,000 in order to be an Authorized Direct CPTM of Medtronic Products.

2) Medtronic reserves the right to suspend or refuse orders from a CPTM if

such CPTM is not meeting the requirements as outlined in these Policies and Procedures.

3) CPTM shall implement and maintain adequate procedures to ensure that

Medtronic confidential information provided to such a CPTM is maintained as confidential with no less than the same degree of care and protection afforded to such CPTMs’ own confidential information but in any event no less than reasonable care and protection.

4) CPTM shall not disclose any Medtronic confidential information (including

sales data) to third parties without Medtronic’s prior written consent (which may be withheld for any reason, in Medtronic’s sole discretion). For the purposes of this provision, Medtronic agrees that disclosure of confidential information such as sales data to a group purchasing organization may be made only with respect to contract sales of Medtronic Products with such group purchasing organization.

5) CPTM shall purchase Medtronic Products only directly from Medtronic.

Purchasing Medtronic Products from the secondary markets or from an account under contract pricing is prohibited.

6) CPTM shall not sell Product(s) to any other CPTM or reseller of products

unless value has been added via use in kit, package, or form or unless otherwise approved in writing in advance by Medtronic.

7) Medtronic shall have the right to limit the quantities of Products

purchased by any CPTM during any month to a quantity, measured in units and/or dollars, at Medtronic’s discretion, equal to one hundred and ten percent (110%) of one-twelfth of the quantity of Products purchased by such CPTM during the preceding fiscal year of Medtronic. Note, Medtronic may monitor monthly purchase compliance at the product center/market section level as well as total purchases.

8) Each CPTM shall limit sales of Medtronic products to qualified customers

approved by Medtronic to purchase such products and shall not resell, exchange, ship, export, or otherwise transfer any Products to any entity that is not located within the fifty states of the United States of America or the District of Columbia (thus excluding any other territories or possessions of the United States and any foreign country) without the prior written consent of Medtronic.

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9) Audit – Medtronic and each CPTM who fully and completely complies with all of the terms and conditions of these Policies and Procedures shall each have the right, upon written request, to audit the books and records of the other party, upon reasonable advance notice and during regular business hours, to determine whether such party is in compliance with these Policies and Procedures. Such audits shall be limited to not more than one in any twelve month period and, in each instance, the records required to be provided and the period subject to audit contemplated hereunder will be limited to the two-year period immediately preceding the request therefore.

10) Each CPTM is responsible for notifying Medtronic, in writing, within seven (7) days of all Customer initiated audits. Upon written notice of a Customer initiated audit, Medtronic and CPTM will mutually agree on audit process, timelines and outcomes.

11) Regulatory Approvals - Without modifying any terms and conditions related to single use device, product transfer and use, or resale, if any Product is modified, packaged, repackaged, or resold by CPTM, the following provisions shall apply: CPTM (i) is responsible for all regulatory approvals for the manufacture and the marketing, distribution and sale of Medtronic products under CPTM’s name and (ii) must execute all regulatory activities including, but not limited to, medical device listing and establishment registration, as applicable to commercialized markets for such products. By purchasing Products for resale or repackaging, CPTM acknowledges and agrees that CPTM’s regulatory and quality system activities for the manufacture and the marketing, distribution and sale of such products are the sole responsibility of CPTM and Medtronic hereby disclaims any responsibility or liability associated with such activities and such products.

G. ADMINISTRATIVE REQUIREMENTS

1) CPTM must pay all invoices from Medtronic within standard, cash-payment terms. Medtronic offers net 30 days payment term options for all CPTMs.

2) CPTM must request all Proof of Deliveries from Medtronic in writing

within 30 days of invoice date. Shortage claims will not be accepted if more than seven (7) calendar days have passed since delivery was made.

3) CPTM must resolve all Medtronic additional billings for disputed items

within 60 days of add-bill date. 4) CPTM must provide a detailed written deduction explanation or debit

memo for all adjustments to invoices from Medtronic within 30 days of invoice date.

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5) CPTM must submit all requests for credit, in writing, within 60 days of invoice date.

6) CPTM must provide, at minimum, a monthly sales tracing report

detailing all CPTM sales of Medtronic products during the preceding month. This report must be in the Medtronic standard electronic format (see Exhibit C) and provided within the first ten (10) days of each month, at no charge to Medtronic.

7) If requested, CPTM must provide, at minimum, a monthly report within 10 (ten) days of the end of each calendar month that contains CPTM inventory of Medtronic’s Products for the preceding month.

H. REQUIREMENTS FOR DISTRIBUTION OF PRIVATE-LABEL PRODUCTS

Medtronic recognizes that, under some circumstances, a CPTM, or affiliates of such CPTM, may also choose to manufacture, market, or sell products of their own which, directly or indirectly, compete with Medtronic’s Products. The following guidelines and requirements are intended to protect the integrity of the manufacturer CPTM relationship where such a situation exists. They are not intended in any way to preclude or hinder CPTMs from carrying competitive products. Instead, they are necessary to ensure that CPTMs who do so are properly (appropriately) dedicated to the Medtronic Products and the consumers to which they are ultimately sold. 1) CPTM shall utilize Medtronic confidential information, including pricing

information, only for the distribution of Medtronic Products. 2) CPTM will implement adequate procedures to ensure that Medtronic

confidential information disclosed to a CPTM is maintained as confidential with no less than the same degree of care and protection afforded to CPTM’s own confidential information and in no event less than reasonable care and in no event less than reasonable care.

3) CPTM must disseminate Medtronic confidential information to only CPTM’s

employees who have a “need to know” such information in order for CPTM to effectively distribute Medtronic Products.

4) CPTM will only use Medtronic Product contracts, agreements, and

information for the purpose of the distribution of Medtronic Products to customers.

5) CPTM shall not communicate or disseminate any misleading information to

customers concerning Medtronic Product availability and service.

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6) CPTM shall refrain from false or derogatory comments concerning Medtronic Product quality, availability, service, or support.

7) If requested, CPTM must provide a written report that certifies to Medtronic

the foregoing and summarizes the steps the CPTM has taken to comply with the foregoing requirements for distribution of private-label products.

I. CONTRACT PRICING REBATE PAYMENT PROCESSING

PROCEDURES 1) Minimum Rebate – CPTM must submit a minimum of $500 per month

and/or $6,000 per twelve month period of Rebate (Charge Back) claims to be eligible for rebate contract status. a) Actual Rebate - Authorized Contract CPTMs shall submit consolidated

Rebate (Charge Back) Claims in an acceptable format by the 10th day of each month for the previous month’s sales. Medtronic validates each claim and identifies any discrepancies, which should be reported to the CPTM for resolution or provision of additional supporting documentation. Rebate (Charge Back) calculation is as follows:

i. First, convert CPTM sales units to the equivalent Medtronic sales

units and round to four decimals; and

ii. Then, calculate the Rebate (Charge Back) amount based on equivalent Medtronic sales units from above, multiplied by the Rebate (Charge Back) amount. (See Exhibit D – Sales Rounding Procedures, attached hereto.)

b) All Rebate (Charge Back) amounts and contract payments will be

calculated on CPTM-provided sales to end-users (not to exceed Medtronic shipments), based on invoice and/or ship date, not order date. Authorized corrections or additions to contract sales will result in appropriate changes to the Rebate (Charge Back) amount.

c) If a Customer returns Product to the CPTM, the return must be reported

as a negative sales tracing and a negative Rebate (Charge Back) Claim. Receiving more than one Rebate (Charge Back) for any sale is not permitted.

d) No Rebate (Charge Back) Claim will be processed if received more than 90

days from the date of the CPTM’s invoice to the Customer. Any Rebate (Charge Back) Claims received after such date will be considered invalid.

e) Prior accounting periods cannot be considered closed without the written

consent of the Medtronic.

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2) Custom Products - Custom Products are intended for sale to the Customer specified on the Product label, and are made to the specifications and requirements of the individual Customer. These Products may not be sold or rebated to any other Customer without the prior written approval of Medtronic.

3) Price Changes - In the event of a list price change, Medtronic will begin

calculating and paying Rebates (Charge Backs) at the new list price for orders shipped by CPTM on or after the effective date of change. In the event of an overall list price decrease, Medtronic will determine if a market-wide Rebate (Charge Back) adjustment is appropriate to offset the impact of monetary loss due to inventory devaluation. In the event of an extraordinary CPTM list price increase, Medtronic reserves the right to add bill the CPTM for the increased value of the CPTM’s on-hand inventory and in-transit inventory, on the effective date of the price change. If the CPTM does not provide on-hand inventory and in-transit inventory, a 30-day calculation will be used. Note, Medtronic will make commercially reasonable efforts to provide at least 60-days’ prior notice in the event of a CPTM list price change.

4) Credit and Re-Bill Corrections - CPTM is responsible for credit and re-bill

correction to the Customer for identified price discrepancies. Also, any credit and re-bill transactions must be reported in the CPTM Sales tracing and rebate.

5) Direct Purchase Only - CPTM is eligible to receive a contract Rebate (Charge Back) only if the contracted Product is purchased by CPTM directly from Medtronic. No “gray-market/overstocked dealer” purchases are applicable.

6) Unauthorized Rebate (Charge Back) Payments – In the event that the

CPTM claims and receives an unauthorized Rebate (Charge Back) payment as a result of a violation of the Policies and Procedures, Medtronic reserves the right to recover monies paid by reducing future Rebate (Charge Back) credits, deducting any incentive monies earned by the CPTM or by direct payment to Medtronic. Medtronic also reserves the right to deny future Rebate (Charge Back) Claims and to charge the CPTM for reasonable costs associated with audit procedures.

J. CONTRACT REBATE (CHARGE BACK) RESUBMISSION PROCEDURES

All Rebate (Charge Back) discrepancy additional billings require payment within terms. If CPTM wishes to resubmit a Rebate (Charge Back) Claim that has been denied, then the following procedure should be pursued. Discrepancies not on the resubmission should be paid within terms.

1) Resubmission must be received within 60 days of add bill.

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2) The format used for the resubmission must be the same as that of the original Rebate (Charge Back) denial (i.e. Charge Back discrepancy report). The CPTM should make comments on each line describing the reason that the CPTM does not agree with the Rebate (Charge Back) denial.

3) Once received by Medtronic, resubmissions will be processed within 60 days, and sent back to CPTM for review.

4) CPTM will have 30 days to review and make final payment on remaining denials.

5) A second resubmission will not be accepted.

K. LOGISTICAL PROVISIONS

1) Consolidated Ship Day – CPTM will, based on volume, select up to two

consolidated ship days per week for its stocking orders. All orders placed will consolidate and ship out to the CPTM each week on this designated ship day(s). The number of consolidated ship days for each CPTM shall not exceed two (2) days per week. This will maintain an efficient shipping process and provide a consistent delivery pattern. Medtronic will contact CPTM to make arrangements for consolidated ship days.

2) CPTM Pick Up Policy – CPTMs are not allowed to pick up Medtronic

Products at Medtronic distribution centers.

3) Unloading Policy – Medtronic will not make arrangements with carriers to provide CPTM’s with a “dropped” trailer unload for any delivery. All CPTM’s are expected to take delivery as a “live” driver present unload. Should CPTM’s choose to make such arrangements with any carrier to drop their delivery, it is with the understanding that Medtronic will not accept financial responsibility for the service.

4) Receipt of Palletized Goods – For goods shipped on pallets, CPTMs

must sign the Bill of Lading or Delivery Receipt in Pallet count, not case or piece count. Claims for shortages and/or concealed damages will be processed per the guidelines in the “O. Damage, Shortage & Overage Procedure” section of these policies and procedures. Signing the Bill of Lading or Delivery Receipt, “Subject to Count,” or similar language will not be considered valid for purposes of claims raised after the notification period. CPTM will report full pallet overages/shortages and/or damages noticed upon delivery on the applicable carrier’s documentation.

5) Sort and Segregate – Medtronic will not make arrangements with

carriers to provide CPTMs with ‘Sort and Segregate” services. If these services are required, Medtronic will provide carrier “Point of Contact” information so CPTMs can arrange for the service. Should CPTMs choose to make such arrangements, it is with the understanding that Medtronic will not accept financial responsibility for the service.

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6) Minimum Order Requirements – Minimum order requirements are outlined in the Table of Medtronic Specific Terms below. The minimum order fee will be charged to any purchase order that does not satisfy the minimum invoice amount.

7) Drop-Shipment Policy - A drop shipment is defined as an order that is

invoiced by Medtronic to the CPTM and shipped directly by Medtronic to the CPTM’s Customer. Drop-ship fees will be assessed to the CPTM to cover additional handling and shipping costs per the Table of Medtronic Terms below. In addition to the “Drop-Ship Fees” listed, applicable airfreight and handling charges will be assessed to the CPTM. Medtronic reserves the right to classify a Product as “drop ship only” and waive the drop ship fee. Due to the additional processing required for drop shipments, CPTMs are requested to use the drop-ship alternative as a last alternative to traditional distribution channels.

8) Recall Policy – In the event of a Medtronic recall, Medtronic will notify

CPTM. CPTM will notify impacted customers and instruct customers to return product affected by recall to CPTM. CPTM will issue a credit to the customer for the recalled product and process a negative sale, and rebate, if appropriate, to Medtronic. CPTM will send all recalled product to Medtronic and Medtronic will issue credit to CPTM.

L. TABLE OF MEDTRONIC TERMS Standard Orders and Annual Purchases

Order Terms*

Minimum-Purchase Order Terms

Drop-Ship Terms

Annual

Minimum Purchase

Terms

Manual Order Fee

Minimum

(Gross Dollars)

Below

Minimum Fee

Drop Ship Fee

Annual

Minimum Requirement

$160 per order

$1,500

$160 per order

$160 per order and applicable freight** $25 per order for

custom Shiley Tracheostomy

Tubes

$100,000

1) Exceptions to $160 manual order terms*

a) Reprocessed Sensor Codes - Reprocessed sensor codes must be ordered manually, by phone, fax or email, and will not incur the $160 manual order charge. The reprocessed sensor codes are: MAXAR, MAXALR, MAXIR, MAXNR and MAXPR

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b) Order Changes – Decreasing quantities on an order, canceling an order, or canceling a code on an order due to a backorder, must be handled by phone and will not incur the $160 manual order charge.

c) Promotional Code Orders – Orders that contain promotional codes must be ordered manually, by phone, fax or email, and will not incur the $160 manual order charge.

2) Clarifications concerning the $160 manual order terms

a) Splitting orders to ship via different methods (i.e. standard ground and expedited overnight) will no longer be accepted. Codes that require different shipping methods will be considered new, separate orders and each order, if placed manually, will be subject to the $160 manual order charge and any applicable minimum or expedited charges.

b) Adding a code to an order or increasing quantities of an existing code on an order that has already been placed will no longer be accepted. Once an order is placed, any additional codes requested or increases in quantities will be considered new, separate orders and each order, if placed manually, will be subject to the $160 manual order charge and any applicable minimum or expedited charges.

c) Reporting a Damaged/Out of Spec Product, Mispick, Overage, Shortage, or

Ordered Wrong Product/Qty and requesting a reshipment or credit, must be handled thru CovidienConnect.

3) Clarification to drop ship terms**

a) Expedited drop shipments, at CPTM’s request, will incur a fee for premium

service. The fee will reflect the current published rate for designated carrier and mode of transportation less a 20% discount.

M. FREIGHT TERMS

Standard Orders – Standard orders will be shipped FOB destination, freight prepaid, by the preferred method of Medtronic including, but not limited to, common carrier, parcel or air, depending on size of order, customer location and product requirements. Expedited Orders – Expedited orders will be shipped FOB shipping point, freight prepaid and add, using most timely and efficient delivery option based on carriers delivery schedules to customers location. Orders expedited at request of the distributor will be billed at the current published rate for the designated carrier and mode of transportation less a 20% discount.

Hawaii Orders – For Medtronic Patient Recovery products only – Hawaii orders will be shipped FOB CA CPTM destination, freight prepaid, by the preferred

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method of Medtronic including, but not limited to, common carrier, parcel or air, depending on size of order, CPTM location and product requirements.

Lift Gate Policy - For standard or expedited orders that require a lift gate for delivery, a $75 per order lift gate service fee will be assessed.

N. RETURNED GOODS

Subject to the following policies for returned goods and credit apply for Medtronic:

1) All standard saleable Products may be returned for credit. Credit is

issued based upon the reason for the return (see Exhibit F for credit amount). Product must be returned in original packaging with return label placed in an open area of the package to receive credit. Medtronic reserves the right to refuse any return.

2) All returns must be authorized by Medtronic Customer Service or

Returned Goods Department. All Product returns must be sent freight prepaid unless prior approval from Medtronic is granted.

3) Overstock returns must be authorized by Medtronic Customer Service. Customer Service will assign a Product return authorization number once the following information is provided:

a) Reason for return, b) Item number, c) Quantity of item, d) Original invoice number, e) Purchase order number, f) Lot number, if applicable

Customer Service will forward a copy of the Product-Return Authorization to the appropriate Customer contact along with return instructions. The Product Return Number and return goods packing list must be included with all paper work.

4) CPTMs should not return Product per the conditions below. Credit will

not be given and the Product will not be returned to the CPTM:

a) All Made-To-Order or Custom-Manufactured Products, b) Discontinued Products, divested Products, and Products not listed

in current price lists, c) Expired Products within Medtronic “required months from

expiration” (see Exhibit E). d) Used Products or unreported damaged Products. e) Products that are not in original packaging - standard selling unit-

of-measure (i.e., full, unopened cases of Product). f) Products that were not purchased directly from Medtronic.

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g) Products for which no “authorization to return” has been given.

O. DAMAGE, SHORTAGE & OVERAGE PROCEDURES

1) To ensure appropriate credit is issued in the event goods are damaged in

transit, Distributor should accept all Products delivered by carrier, note visible damages on the carrier’s delivery documents and contact the carrier for reimbursement.

2) To ensure appropriate credit is issued in the event a shortage occurs in transit, CPTM should accept all Products delivered by carrier, note visible shortages on the carrier’s delivery documents and contact Medtronic Customer Service.

a) Medtronic will make arrangements for a replacement shipment, if requested by customer.

b) Medtronic will investigate shortage claims by reviewing carrier Proof of Delivery, pallet architecture (for pallet shipments) and distribution center product cycle count.

c) Medtronic will issue a credit for shortages if Medtronic concludes the shortage is validated and subject to the following conditions:

i) Shortages must be reported to the Medtronic Customer Service Department within 7 calendar days of delivery. This applies to dropped trailers, live unload palletized and small package shipments, and includes shortages within an over-packed corrugate. Note CPTM must sign for number of pallets received.

ii) Shortages within full cases should be reported to Medtronic Customer Service immediately when encountered.

3) To ensure appropriate processing (billing or return authorization) is completed in the event an overage occurs in transit, CPTM should accept all Products delivered by carrier, note visible overage on the carrier’s delivery document and report the overage to Medtronic Customer Service.

a) Medtronic will make arrangements for a carrier to pick up the over-shipped Product(s) within a reasonable timeframe.

b) Medtronic will issue an invoice for over-shipped Product(s) at CPTM request.

c) Overages must be reported to the Medtronic Customer Service Department within 7 calendar days of delivery. This applies to dropped trailers, live unload palletized and small shipments and includes overages within an over-packed corrugate.

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4) Returned Goods Authorization Numbers not utilized within 30 days are cancelled or null and void. CPTM must contact Medtronic Customer Service for a new Returned Goods Authorization Number after 30 days have lapsed.

5) Exceptions to Returned Goods Policies

a. Any Customer reports of defective Product received by the CPTM must be communicated to Medtronic’s Customer Service Department within 24 hours, providing all information below. Medtronic will contact the Customer, investigate the problem, and notify the CPTM of the outcome and any action taken.

i. Name and address of Customer,

ii. Customer contact and phone number,

iii. Product catalog number and description,

iv. Lot number, if applicable

v. Nature of problem and quantity involved.

vi. PO Number

P. E-BUSINESS TRANSACTIONS

Current technology provides the tools to rapidly automate manual business processes and transactions throughout the health-care supply chain. Increased use of this automation will streamline product selection, purchasing, and utilization for the mutual benefit of all parties. A full statement of Medtronic’s E-Business principles is included. (See Exhibit G – Guiding Principles for E-Business attached.)

1. Medtronic utilizes the EDI standard HIBCC subset of the ANSI X.12 format.

2. E-Business solution is via the EDI X12 standard. Medtronic supports

transactions via Global Health Exchange (GHX). GHX offers a variety of connection solutions for our distribution partners.

Business

Transaction

Preferred Format

Acceptable

Format

Availability

Status

Non-

conformance Fee

End-user Sales

X.12 Direct, EDI or via

GHX

EDI 867/844 Currently available

None

Purchase Order

X.12 Direct, EDI or via

GHX

EDI 850

Currently available

None X.12 Direct,

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Medtronic is committed to the use of electronic automation (E-Business), and is willing to comply with any of the open E-Business and EDI standards. CPTM’s E-business will be implemented according to the aforementioned schedule. Medtronic will not pay third party EDI testing process fees or monthly fees for EDI document processing. 1) End-User Sales (Transaction Set #867)

a. To improve Product flow through the supply chain, Medtronic requires approved E-Business CPTMs to supply rebates and tracings, at no charge to Medtronic for all transactions. This requirement applies to both contracted and non-contracted Products, as follows:

i. End-user sales (including the end-customer invoice for regular

and drop-ship sales), ii. Product returns (from Customer to CPTM/ from CPTM to

Medtronic), iii. Product transfers, iv. Any other changes to inventory, or v. Credit re-bills/price adjustments.

b. Rebate and tracing reports must contain standard information needed by

Medtronic. (See Exhibit B – Information Requirements, attached hereto). c. If a CPTM manufactures kits containing Medtronic products, sales must

be reported by Medtronic component product code numbers. d. Non-EDI CPTMs must report all transactions through the last calendar

day of the month within 10 days following the close of the calendar month. EDI transactions should be sent daily, but not less than monthly.

2) Purchase-Order (Transaction Set #850) - The electronic transmission of

purchase order data using industry standard format HIBCC approved version of ANSI x .12 or XML.

3) Purchase-Order Acknowledgement (Transaction Set #855) - The electronic transmission of purchase-order confirmation data using industry standard format.

Purchase Order Acknowledgement

EDI or via GHX

EDI 855

Currently available

None

Invoice

X.12 Direct, EDI or via

GHX

EDI 810 Currently available

None

Payment

Order/Remittance Advice

Direct from the bank

EDI 820

Currently available

None

Advanced Ship Notice

X.12 Direct, EDI or via

GHX

EDI 856 Currently available

None

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4) Invoicing (Transaction Set #810) - The electronic transmission of invoice

information from Medtronic to the CPTM. This data will be provided in industry approved ANSI x.12 format, and will enable the CPTM to automatically match invoices to the original purchase order and receipt.

5) Funds Transfer (Transaction Set #820) - Electronic Funds Transfer

provides a means for a CPTM to electronically transfer funds and remittance data from the CPTM to Medtronic. The data would be provided in industry-approved banking standards (CTX). Medtronic can provide support for working through the necessary testing and communications with the CPTM’s bank to help facilitate the setup of this transaction.

6) Additional electronic business transactions supported by Medtronic are:

Contract, Advance Ship Notice, Pricing, and Availability. Please contact Medtronic E-Business Group for specifics.

Q. GENERAL PROVISIONS

1) A breach of the Policies may result in the CPTM’s forfeiture of access to

Medtronic rebate contracts, Affiliate programs, Medtronic terms and conditions, and possible termination of authorized CPTM status.

2) Medtronic Affiliates reserve the right to maintain their own policies and

criteria regarding CPTM sales and business partners, including suitability of CPTM for certain divisions. Accordingly, not all CPTMs may be qualified to serve as CPTMs of Products of all Medtronic Affiliates.

3) Changes in Products - If the regulatory status of a Product (e.g., “may be

dispensed by prescription only”) changes, then Medtronic may delete that Product from the Product list by notice to CPTM. Medtronic may discontinue or modify any Product at any time. Medtronic may, at its sole and exclusive discretion, restrict the sale of specific Products to CPTM.

4) Terms - The Policies shall remain in full force and effect until amended or

terminated by Medtronic. Medtronic may amend or terminate all or part of the Policies by giving a 30-day notice to the CPTM. The terms of these General Provisions and any other terms hereof, which, by their nature or in order to be effective for their stated purpose, must survive amendment or termination of the Policies shall survive.

5) Notices - Any notice given in connection with the Policies shall be sufficient

if in writing and delivered by messenger, by postage-prepaid mail, or by facsimile to the CPTM, and any such notice or communication shall be effective when received by, or otherwise known to the recipient or its legal representative. The methods of delivery described above are not intended to be exclusive, and any written notice actually received shall be sufficient.

6) Modification by Medtronic - Medtronic may modify the “Availability Status”

and “Non-conformance Fees” in the “E-Business Transactions” section,

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Payment Terms, Table Specific Terms, Returned Goods Policies, and any Exhibit by notice to CPTM per the previous paragraph. The Policies may be modified only by Medtronic. The terms of any purchase order, invoice, or similar document related to implement these policies and procedures, shall not modify the Policies and shall be subject to the Policies.

7) Relationship of Parties - The relationship of CPTM to Medtronic is that of

independent contractor. The Policies do not create a partnership, association, or other business entity. Neither party has the right to bind the other.

8) No Third-Party Beneficiaries - Unless specifically provided elsewhere

herein, nothing in the Policies are intended to benefit any person or entity not a party hereto.

9) Publicity - CPTM shall not permit or generate any publicity, advertising, nor

promotion concerning the Policies without the prior written consent of Medtronic.

10) Force Majeure - Non-compliance with any obligation under these Policies

and Procedures for reasons of force majeure (such as: acts, regulations, or laws of any government; war or civil commotion; destruction of production facilities or materials; fire, earthquake or storm; labor disturbances; failure of public utilities or common carriers; and any other causes beyond the reasonable control of the party affected) shall not constitute a breach of these Policies and Procedures.

11) Legal Compliance - CPTM will comply with all applicable federal, state, and local laws, rules and regulations in connection with the purchase and sale of any Products hereunder by CPTM. The Policies, or any Contract, may involve a discount or other reduction in price with respect to one or more Products under 42 USC 1320A-7B§ 1128B(b) (3) (A) of the Social Security Act (42 USC § 1320a-1128B(b)(3)(A), and regulations issued thereunder. Under such circumstances, CPTM or the relevant Customer is responsible for accurately reporting and/or providing information on any such discounts, including rebates or reductions in price, to reimbursement agencies (including Medicare and Medicaid) and other entities in accordance with all applicable laws and regulations, including, without limitation, 42 CFR § 1001.952(h). CPTM agrees that it shall properly disclose and appropriately reflect any discount or other reduction in price in its cost claimed under Medicare or any State Health Program and shall advise any Customer of its responsibilities under such laws. If the use of the Products sold hereunder require the reporting of costs on a cost report, then the benefit of any discount will be claimed in the fiscal year and CPTM and/or Customer (as applicable) will fully and accurately report any such discount in the applicable cost report.

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12) Trademarks and Proprietary Information

a) Packaging and labeling of Products shall contain Medtronic’s trademarks and trade names. Medtronic’s and the respective Affiliates’ trademarks and trade names shall remain their exclusive property, and nothing herein shall be construed as transferring any right, title, or interest of any kind or nature whatsoever thereto, to CPTM. Except as specifically provided herein, CPTM shall not use the trademarks or trade names of Medtronic or any Affiliate in any way, and will not do any act which would in any way infringe upon or be in derogation of the validity of such trademarks or trade names, and will notify Medtronic of any conflicting claims that challenge any such trademarks or trade names of which it is aware.

b) CPTM shall hold in confidence Proprietary Information supplied to it by Medtronic, and shall not divulge the same to any other person or entity without the prior permission of Medtronic. The confidentiality obligations in this section shall not apply to Proprietary Information which:

a) becomes public other than through CPTM;

b) Is already known to CPTM prior to its disclosure by Medtronic as evidenced by CPTM’s written records;

c) becomes known by CPTM in the future from another source which is under no obligation of confidentiality to Medtronic; or

d) is subsequently developed by CPTM in a manner that it can conclusively establish was independent of the disclosure hereunder.

The obligations of CPTM pursuant to the provisions of this Section, shall survive indefinitely.

For purposes of the Policies, “Proprietary Information” shall mean all data and other information relating to Medtronic’s business that could reasonably be expected to be valuable to a competitor, a potential competitor, or a CPTM for any such competitor of Medtronic, including, without limitation, any product specifications.

13) Product Tracing/Incident Notification - To facilitate any necessary

Product tracing or recall, CPTM shall maintain a written recall procedure in effect and shall make available, upon request, the lot number (or serial number, if applicable) with

a) Customer name, b) Address shipped to, and c) Date of shipment for each Product sold.

If lot numbers or serial numbers are not available, CPTM shall provide a comprehensive list of all Customers to whom shipments of the affected Product were made during the timeframe Medtronic shall request, including

a) Address,

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b) Shipped to, and c) Shipment dates.

In addition, CPTM shall:

1) Immediately notify Medtronic of:

a) Any event that might require Medtronic to file a report or otherwise comply with any applicable law, rule, or regulation governing medical devices,

b) Any Product malfunction which, were it to recur, would be likely to cause serious injury or death, or

c) Any serious device effects to a patient and/or operator, and 2) Report all Product and service complaints to Medtronic, including the

following information:

a) Product model number, b) Product serial number (if applicable and available), c) Nature of complaint or situation, d) Any action taken, and e) Confirmation by CPTM of stated complaint or situation.

14) Additional CPTM policies and procedures may be set forth in any Contract

between Medtronic and a CPTM or in attachments /schedules incorporated in any such Contract or transaction for the purchase and sale of goods.

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EXHIBIT A - AFFILIATE LIST

• PATIENT RECOVERY

• RESPIRATORY AND MONITORING SOLUTIONS • SURGICAL INNOVATIONS

EXHIBIT B - INFORMATION REQUIREMENTS

(Refer to HIBCC Subset of ANSI x 12.867 Transaction)

1) CPTM Branch Number, 2) CPTM Customer “Bill To and Ship To” Number or Health

Industry Number (HIN), 3) Customer “Bill To and Ship To” Name, 4) Complete Customer “Bill To and Ship To” Address:

• Street • City • State • Zip

5) Medtronic Product Code, 6) CPTM Unit of Measure, 7) Quantity Shipped, 8) Invoice Number, 9) Invoice or Ship Date,

10) CPTM Cost or Selling Price,

11) Expected Rebate (Charge Back) Amount,

12) Type of activity transaction, e.g., direct sale to Customer, warehouse transfer, returns from CPTM to Medtronic, or returns from Customer to CPTM,

13) Contract Number (where contract/rebated sale), 14) Debit memo number,

15) Medtronic’s Lot/Serial Number for shipped Products.

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EXHIBIT C

Medtronic Standard Excel Format

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EXHIBIT D - SAMPLE OF SALES ROUNDING PROCEDURES 1. CONTRACT NOTIFICATION

Medtronic Product Code Sales Unit Quantity Rebate (Charge Back) Amount

123 Case (cs) 1 $ 23.31/case (cs) 2. END-USER SALES REPORTED

Product Code CPTM U.O.M. Quantity 87123 Each (ea.) 1

3. UNIT CONVERSION

Product Code Sales Unit Stated in Dist. Units 123 Case (cs) 3 Each (ea.)

4. REBATE (CHARGE BACK) CALCULATION

Rebate (Charge Back) for one [1] each = $23.31/cs x .3333 cs (rounded to four [4] decimals using rule of five [5] = $7.7692 = $7.77 (rounded to two [2] decimals using the rule of five [5]).

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EXHIBIT E - RETURNED GOODS POLICY

AFFILIATE

MONTHS PRIOR TO

EXPIRATION FOR

ACCEPTABLE RETURNED PRODUCT

MANUFACTURING DATE

IDENTIFICATION

EQUIPMENT/ PRODUCTS REQUIRING

SALES REPRESENTATIVE

RETURN AUTHORIZATION

RETURN LOCATION

REDRESS/

RESTOCKING FEES

Patient Recovery

6 months

Contained in lot number or stamped on product package. Contact Customer Service for more information

Contact your Sales Representative or call 1-800-962-9888

Will be provided by Customer Service upon receiving return authorization

See Exhibit F

Respiratory & Monitoring Solutions

12 months Stamped on Product Packaging

Contact your Sales Representative or call 1-800-962-9888

Will be provided by Customer Service upon receiving return authorization

See Exhibit F

Surgical Innovations

12 months

Contained in lot # or batch # - contact Customer Service for more information

Contact CPTM Sales or call 1-800-962-9888

Will be provided by Customer Service upon receiving return authorization

See Exhibit F

1Disposition or need for redress is determined by Medtronic and is deducted from the credit amount.

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EXHIBIT F - REDRESS/RESTOCKING FEES SCHEDULE

* For equipment returns, call for schedule

Patient Recovery*

Respiratory

and Monitoring Solutions*

Surgical Innovations

Defective Product –Sales Representative must initiate and authorize.

Invoiced price Invoiced price

Suture credit on invoiced price – AS credit on invoiced price or replacement upon receipt

Affiliate Shipping error

Invoiced price within 90 days

Invoiced price within 90 days

Invoiced price within 90 days

Affiliate Order error Invoiced price within 90 days

Invoiced price within 90 days

Invoiced price within 90 days

Order damaged in transit – claim made within 7 days of delivery.

Invoiced price Invoiced price Invoiced price

Customer order error

Invoiced price less 20% Restock fee

Invoiced price less 20% Restock fee

Invoiced price less 20% Restock fee

Refused shipment (not Affiliate error)

Invoiced price less 20% Restock fee

Invoiced price less 20% Restock fee

Invoiced price less 20% Restock fee

CPTM Stock Reduction – Sales Representative must initiate and authorize return.

Invoiced price less 20% Restock fee

Invoiced price less 20% Restock fee

Invoiced price less 20% Restock fee

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EXHIBIT G Medtronic’s Guiding Principles for E-Business At Medtronic, meeting our Customer needs is our top priority. We are committed to making available internet enabled purchasing services at no incremental cost to our Customers. Medtronic believes that supply chain efficiencies derived from E-Business will be reallocated over time throughout the entire supply chain. We also believe this will make product selection, purchase and utilization more efficient for all connected parties. To this end, Medtronic will allocate resources to all mutually beneficial initiatives. The following are our guiding principles: • Medtronic will work with its Customers to create quantifiable savings and

efficiencies in our E-Business efforts.

• Medtronic is committed to holding down supply chain costs and will not pay incremental fees that will result in increased supply chain costs.

• Medtronic will accept transactions from e-commerce companies when our Customers request it.

• Medtronic cannot be responsible for keeping information up-to-date on any third party or e-commerce company’s websites or portals, as it will only increase the costs and inefficiencies of doing business.

• Medtronic does not approve, condone, nor authorize transaction or pricing data to be available to any parties other than the purchaser involved in the transaction.

• Medtronic will support industry data standardization efforts if they measurably benefit all constituents in the supply chain.

• All e-commerce messages and transactions to Medtronic must be either X12 Direct, EDI or via GHX.

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EXHIBIT H

Carrier Contact Information CPTM must file claims within nine months of the date of delivery for acceptance as is referenced by the laws governing Medtronic Standard Bills of Lading.

CARRIER Link

A. DUIE PYLE, INC. http://www.aduiepyle.com/publicdocs/pdf/PyleClaim.pdf

AVERITT EXPRESS https://www.averittexpress.com/secure/claims/tl

DAYTON FREIGHT LINES, IN https://www.daytonfreight.com/Shipping/Forms.aspx

FEDEX https://www.fedex.com/apps/onlineclaims/?locale=en_US

JA FRATE, INC. http://www.jafrate.com/contact

OLD DOMINION FREIGHT LIN https://www.odfl.com/fillprintforms/ClaimForm.pdf

ROSS EXPRESS, INC. http://rossexpress.com/contact/

UPS https://wwwapps.ups.com/webClaims/create?loc=en_US

USF HOLLAND INC. http://www.hollandregional.com/pdf/Loss_Damage%20Claim%20Form_Holland_fillable1.pdf

WILSON TRUCKING CORPORATE http://www.wilsontrucking.com/claims/claims.htm

CARRIER Contact InformationESTES

Richard Beckmann US Transportation UPS-SCS 100 Port Street Newark, NJ 07114 856-366-0566 [email protected]