Introduction Standard 1 General Provisions Standard 2 Free or Reduced Charge Products: Discounts, Credits and Rebates, Samples, Demos, Loaners and Warranties Standard 3 Donations to Customers or Organizations Closely Affiliated With Customers Standard 4 Gifts Standard 5 Business Meetings and Associated Courtesies Standard 6 Consulting, Research, and Advisory Arrangements Standard 7 Training & Education Concerning Medtronic Products Standard 8 Medical Conferences, Congresses & Professional Meetings Sponsored by Organizations Other than Medtronic Standard 9 Co-Marketing Events and Approval Definitions

Click here to download the pdf version of the U.S. Business Conduct Standards Click here to download the Advamed Code of Ethics

Introduction

Medtronic is the world leader in medical technology. People of every age and nationality are alive today and living better because of pioneering therapies developed by Medtronic. The Medtronic Mission, to alleviate pain, restore health, and extend life and to continuously pioneer advances in biomedical engineering, has been the Company's driving force.

The development of cutting edge medical technology, as well as the improvement of existing products, is a collaborative process between medical device companies and physicians. Medtronic's collaborative relationships with its physician customers have been an integral part of its own success in bringing pioneering therapies to patients. Indeed, it was Earl Bakken's close working relationship with physicians at the University of Minnesota that gave him the opportunity to invent the first battery-powered, external pacemaker. Since then, physicians have helped the medical device industry take quantum leaps forward in the effort to alleviate human suffering. Medtronic's research partnerships and consulting relationships with physicians have been instrumental to the development of new therapies and the improvement of existing products. The company is committed to continuing collaboration with these physicians. It is also committed to providing programs designed to educate and train physicians on the safe and effective use of Medtronic products, instruction which allows these physicians to bring life-saving and life-enhancing therapies to patients worldwide. Compliance with the law and with the highest ethical standards is critical to Medtronic's continued collaboration with its physician customers.

Medtronic's Code of Conduct sets out Medtronic's policies for its relationships with customers worldwide. Because of the diverse legal and regulatory complexities in markets around the world, Medtronic has prepared country-specific Business Conduct Standards, like these for the U.S., which provide detailed local requirements for such relationships. The bolded language at the beginning of each Standard echoes the Code of Conduct language for the particular provision being addressed. The text which follows sets out requirements that fall under that provision. Adherence to Medtronic's Business Conduct Standards protects Medtronic and Medtronic's customers and is mandatory for all employees.

General Provisions

No Medtronic Employee or Agent may offer or give anything of value to a Customer with an explicit or implicit requirement to use or purchase Medtronic products, or as a reward for prior use or purchase of Medtronic products. To ensure that all Customer Interactions are legal and ethical, they must be consistent with these Standards.

Definitions. Terms that appear in bold (and that are not section headings) are defined terms; refer to the “Definitions” section of these Standards located at the end of the Standards.

Compliance with Standards. Compliance with these Standards is mandatory for all Customer Interactions. If you are unsure about the legality of a Customer Interaction or if the proposed Customer Interaction is not specifically allowed by these Standards, before entering into it, you must consult with a Medtronic Manager, the Medtronic Business Conduct Officer, Medtronic Legal Counsel or your Business Unit Compliance Officer, if this position exists within your Business Unit. All Employees and all Agents, to the extent relevant to their activities on behalf of Medtronic, must comply with these Standards, the Medtronic Code of Conduct, Medtronic policies and procedures and applicable law, including, for example, the antitrust, securities, FDA, and export control laws, and any policies and procedures adopted by their Business Unit, including policies and procedures that may be more restrictive than these Standards. Standards 1-9 do not apply to relationships with individual patients or to relationships with persons or other entities that are neither in the business of providing health care services nor Affiliated with such entities.

Standards are Country-Specific. These Standards apply to Customer Interactions with Customers who work in the U.S. Other country-specific Standards can be found at the Ethics and Compliance site on the Medtronic Intranet. The Standards of the country where the Customer works apply to that Customer.

Customer Interactions between U.S.-based Employees and Agents and EEMC Customers involving the provision of services require prior written notice of the proposed services and fees to the Area/Country or Business Manager, or to the EEMC Employee counterpart of the U.S. Employee in the country where the Customer works, before any commitment is made to the Customer. For Asia-Pacific Customers, such notice must be given either to the Country Manager, or to a Medtronic Legal Counsel or to the Asia-Pacific Employee counterpart of the U.S. Employee in the country where the Customer works. In addition, prior written approval must be obtained from the Compliance Group of the EEMC Legal Department or the Office of Asia-Pacific Counsel before services under a proposed agreement may begin. As part of this approval process, the identity of the OUS Employee to whom notice was given must be provided to either the EEMC Legal Department or the Office of Asia-Pacific Counsel, whichever is appropriate. For interactions with EEMC Customers, the approval process also includes approval of the written contract.

Interactions between OUS-based Employees and U.S. Customers involving the provision of services require prior written approval of the U.S. Business Unit Legal Department and of a U.S. Medtronic Vice President.

The giving of meals and gifts also requires notice to the Employee categories described above. However, it is not required that prior notice is given so long as the cost does not exceed the spending limits set forth in the Business Conduct Standards of the country where the Customer works.

Attribution. For expense reimbursement and tracking purposes, gifts, payments and other benefits must be attributed to a particular individual, and not to an institution or practice. Gifts, payments or other benefits given to persons employed by a Customer or to a member of a Customer’s Immediate Family are attributed to the Customer. Likewise, gifts, payments or other benefits that are given in the name of the Customer or to an organization Affiliated with a Customer are attributed to the Customer.

Compliance with Standards is required. All Medtronic Employees and Agents involved in Customer Interactions are expected to know and comply with these Standards, with any policies and procedures issued by Medtronic and with any interpretive guidance given to them by Medtronic (e.g., by a Medtronic Manager or Medtronic Legal Counsel) to the extent pertinent to their activities on behalf of Medtronic. Managers are responsible for ensuring compliance.

Violations of the Standards could expose the Medtronic Employee or Agent and Medtronic to civil and criminal liability. Adherence to the Standards is a condition of employment for every Employee and, to the extent relevant to their activities on behalf of Medtronic, must be included as a contractual obligation in every agreement with an Agent. Violations will be dealt with promptly and, for Employees, may result in disciplinary measures up to and including the termination of employment. Adoption of the Medtronic Business Conduct Standards Violations and Disciplinary Policy is mandatory and each Medtronic Business Unit is responsible for its implementation.

Interpretation of Standards. Any Employee or Agent in doubt about the meaning or application of a Standard should contact a Manager, Medtronic Legal Counsel or the Business Unit Compliance Officer, if this position exists within the Business Unit. Any Employee or Agent who is concerned that others may be engaging in, or requiring that the Employee or Agent engage in, conduct that is inconsistent with these Standards, must discuss the concern with a Medtronic Manager, the Medtronic Business Conduct Officer, the Business Unit Compliance Officer, if this position exists within the Business Unit, or Medtronic Legal Counsel or contact the Medtronic Compliance Hotline at 1-800-488-3125.

If the Company is restricted from doing something, so are its Agents and Employees. If these Standards restrict Medtronic’s interactions with a Customer, Medtronic Employees and Agents are likewise restricted, even if no request for reimbursement is made of Medtronic.

Payments to Customers may only be made by the Company. Except as specified below, payments to, or on behalf of, or to reimburse a Customer may be made only by Medtronic check or wire transfer. Any payment for Travel Expenses incurred by a Customer must be paid directly to the vendor (e.g., the hotel or airline) whenever practical. When reimbursement is made to the Customer, original receipts or other supporting documentation is required. When a Customer is expected to pay out-of-pocket for reimbursable Travel Expenses, the Customer should be provided with modest per-diem spending guidelines in advance. Neither Medtronic nor any Medtronic Employee or Agent may ever provide cash or a personal check to a Customer, except that Employees may use cash, personal checks or Medtronic credit cards to pay for permitted meals or refreshments at a cafeteria owned by an entity that may also be a Medtronic Customer, and may use Medtronic credit cards or personal checks (unless the Business Unit prohibits payment by personal check) to purchase tickets to fundraisers, to the extent permitted under Standard 3 and by any applicable Business Unit policies.

Exceptions or amendments. In circumstances where conduct prohibited by these Standards does not implicate underlying legal or ethical concerns, it may be appropriate to grant infrequent, fact-specific exceptions. Exceptions must comply with all legal and regulatory requirements. There are two types of exceptions: Case-specific Exceptions and Blanket Exceptions.

Case-specific Exceptions require the prior written approval of a Medtronic Corporate Vice President and Medtronic Legal Counsel. Copies of Case-specific Exceptions must be provided to the Medtronic Business Conduct Officer within five business days of granting.

Blanket Exceptions require the prior written approval of the Medtronic General Counsel. A Blanket Exception may be obtained only as follows:

• With the approval of a Medtronic Corporate Vice President and a Legal Team Leader, a Legal Team Leader or the Medtronic Business Conduct Officer submits the proposed exception, together with, at a minimum, a brief legal analysis supporting the proposed exception to the Medtronic General Counsel.
• The Medtronic General Counsel consults with such personnel as he or she deems advisable and approves or rejects the proposed exception.

Decisions on Blanket Exceptions will be sent to the Medtronic Business Conduct Officer for distribution to the Legal Team Leaders. From time to time, but at least annually, the Medtronic General Counsel will determine whether any Blanket Exception should be included in these Standards by amendment.

Amendments or revisions to these Standards or to any of the limits or policies referred to in these Standards require the prior approval of the Medtronic General Counsel. Exceptions to Standard 6 also require prior written approval by the Medtronic Business Conduct Officer and Corporate Legal Regulatory.

Spending Limits. Medtronic has established Spending Limits, which incorporate applicable state law requirements. The Spending Limits address expenditures for Business Courtesies and other permitted Travel Expenses, meals and receptions, as well as gifts and Logo Items provided to Customers. Without limitation, the failure to abide by a Spending Limit is a violation of these Standards. Medtronic Employees and Agents are also required to take reasonable steps to be aware of and to comply with any more restrictive limits established by their Customers and by their Business Units. Medtronic must not give any gift that violates a Customer’s rules.

Additional Limits on meals and receptions, and recreation and entertainment. Subject to the Spending Limits:

Medtronic may pay for meals and receptions extended to Customers only as a Business Courtesy (subject to Standard 5), or in connection with a Consultant Meeting (subject to Standard 6), a Training and Education program (subject to Standard 7), a Qualifying Conference (subject to Standard 8), or a Co-Marketing Event (subject to Standard 9).

In the limited circumstances described in Standard 6, Medtronic may also pay for entertainment in connection with a Consultant Meeting.

Medtronic Employees may participate in recreation or entertainment with a Customer other than as allowed under Standard 6, but only if the activity is Modest and the Customer pays for the entire cost of his or her participation. In these situations, Medtronic may reimburse an Employee for the Employee’s own cost of participating, subject to any spending or other limits established by the relevant Business Unit. Except for incidental scheduling, unless Medtronic is permitted to pay for the recreation or entertainment for a Customer, Medtronic may not organize, arrange for, or promote the recreation or entertainment as part of, or ancillary to, any Medtronic event involving any Business Courtesy, meal, reception, or Travel Expense provided by Medtronic.

Except as may be required by law, expenses for activities that are inconsistent with these Standards will not be reimbursed under any circumstances. All meals and receptions provided to or engaged in with Customers must be Modest in Value and subordinate in time and focus to the purpose of the interaction.

No subsidy of Holiday and other non-business parties. Medtronic may not pay for, contribute to, or hold parties for Customers for the purpose of celebrating a non-business event, such as a Holiday.

No subsidy of spouses/guests. Medtronic may not pay for meals, receptions, recreation, entertainment or Travel Expenses for a spouse or other guest of a Customer, unless the spouse or guest would qualify as a Customer and has a bona fide, professional interest in the information being shared at that particular meeting, and the payments would be allowed under these Standards but for the fact that the person was a spouse or other guest of a Customer.

Limits on travel. Travel provided for Customers outside of the Continental U.S., other than travel to the Continental U.S. originating outside of the Continental U.S. or travel within a state located outside of the Continental U.S., must be approved by a Medtronic Vice President. Such travel may be allowed only if the location is necessary to accomplish the purpose of the trip (e.g., to bring Customers to a specialized lab when similar facilities are not available in the Continental U.S.), or if most of the anticipated attendees do not live in the Continental U.S. but do live convenient to the proposed location. For travel within a single continent, Medtronic-provided travel is limited to coach class travel and must be at a rate comparable to the Lowest Logical Fare for a coach class airfare (or a higher class of airfare, if allowed under Standard 6). Intercontinental travel is limited to business class airfare or its equivalent.

General limits on location and lodging in connection with Customer Meetings and Training and Eduction programs. The location of any Customer Meeting must be in the Continental U.S., except when substantially all of the attendees live in a U.S. state or territory outside of the Continental U.S. The location and lodging must be selected based upon program requirements, convenience of attendees, and cost savings to Medtronic. Any meeting facility or hotel where Customers will be lodged may not be a Resort, a Resort Location, or a Luxury Hotel. Medtronic Training and Education Programs requiring “hands-on” training in surgical procedures should be held at Bakken Educational Centers, surgical training facilities, medical institutions or other facilities appropriate for such purposes. Medtronic manufacturing or Medtronic R&D facilities satisfying all of the criteria outlined in this paragraph may be appropriate locations for Business or Consultant Meetings.

Exception for Customer Meetings sponsored by businesses headquartered in Resort Locations. Even though a facility located in a Resort Location does not qualify as an appropriate Medtronic Customer Meeting facility, a Business Unit with headquarters in a Resort Location may host a meeting and lodge its Customers in facilities within that Resort Location if the selected facility is (1) not a Luxury Hotel or a Resort and (2) not located on or immediately adjacent to a beach, golf course, destination spa or vineyard.

Process for approving facilities. Business Units must establish and use a process for determining whether a proposed facility is an appropriate Medtronic Customer Meeting facility. The process must involve consultation of and adherence to the List of Non-Qualifying Hotels and Locations (http://legaldoc.corp.medtronic.com:81/mitdoc3:/Compliance/Website/New_Hotel_Process) as well as an independent evaluation of any property not on the List of Non-Qualifying Hotels and Locations. Each Business Unit shall, at least quarterly, provide the Medtronic Spinal & Biologics Business Conduct Officer with the name of any unlisted facility it has determined does not qualify as an appropriate Medtronic Customer Meeting facility or location, after which the Medtronic Spinal & Biologics Business Conduct Officer will update the List of Non-Qualifying Hotels and Locations accordingly. In addition, each Business Unit shall, at least quarterly, provide the Medtronic Business Conduct Officer with a list of the facilities and locations it has used for Customer Meetings during the last quarter.

The Medtronic Spinal & Biologics Business Conduct Officer will make periodic recommendations to the General Counsel regarding categories of properties that should be added to the definitions of Luxury Hotel, Resort, or Resort Location, and the definitions will be updated periodically by way of amendment to these Standards.

Customer subsidies of meals, receptions, and Travel Expenses. Occasionally, a Customer may ask that Medtronic pay up to the Spending Limits for a particular item (e.g., a Business Courtesy meal) and offer to pay any amount in excess of the Spending Limits. Medtronic may not agree to such arrangements, except that:

• With respect to meals — in the event that the average cost per participant would exceed the Spending Limits, the Customer may pay any meal overage (the amount that exceeds the applicable Spending Limit) that results from the Customer’s request or preference for an expensive meal (including expensive meals the Customer orders for other attendees at the event) or a particularly expensive item (e.g., a bottle of wine), that could not be ordered consistent with the limit. In either case, the amount covered by the Customer should be separately paid to the restaurant and this amount will not be counted toward the Spending Limits;
• With respect to travel — if the Lowest Logical Fare is upgradeable, the Customer may arrange and pay for an upgrade. Medtronic will not pay for any such upgrades for the Customer, and will not allow a Customer to take cash in lieu of a ticket or pay for a Customer’s gas or other costs of a private plane; and
• With respect to lodging — in the event that a Customer desires to upgrade Medtronic-provided lodging, Medtronic may contribute the amount that it would have paid for the original lodging, provided that the upgraded lodging is not provided at a Luxury Hotel, Resort or Resort Location.

Oversight. The Medtronic Business Conduct Officer, working with the Business Units including their compliance function, if applicable, and Medtronic Legal Counsel, shall direct and oversee the development and implementation of corporate-wide policies, processes and practices that support ethics and compliance throughout the organization. The Medtronic Business Conduct Officer shall serve as the Chair of the Medtronic Executive Compliance Committee, which meets at least quarterly to provide oversight, strategic direction and guidance to the Company’s compliance activities. Each Business President, Geography President, and Business General Manager is responsible for ensuring that:

• Compliance issues are addressed at least quarterly at their staff meetings or by a committee composed of high-level management and the chief financial and legal officers for their Business Unit;
• A comprehensive plan is in place to ensure that compliance issues are addressed throughout their organizations, including policies and procedures requiring appropriate documentation and monitoring of activities governed by these Standards; and
• All appropriate personnel receive training on these Standards.

The Medtronic Business Conduct Officer together with the Vice President of Corporate Audit shall develop and implement appropriate monitoring and assessment programs designed to assess and assure adherence to Medtronic’s compliance program. Key management Employees shall complete annual Certifications of Compliance in which they confirm that they are not aware of unreported violations of the Medtronic Code of Conduct or these Standards.

Accuracy in reporting reimbursement-related information. Any product-related cost or charge information provided by Medtronic to a government agency that may be used for the purpose of setting reimbursement rates, or in the case of a product subject to the Humanitarian Device Exemption for the purpose of determining regulatory compliance, must be accurate and, other than direct billings, must be reviewed by Medtronic Legal Counsel before it is provided to the agency.

Intellectual Property Agreements. Intellectual Property Agreements with Customers are governed by these Standards and may not be entered into with an implicit or explicit purpose to influence a Customer’s decision to purchase, use, order, or recommend a Medtronic product or as a reward for prior use or purchase of Medtronic products. All Intellectual Property Agreements entered into with Customers must comply with the Medtronic Policy for Review of Remunerative Arrangements with Customers in the United States posted at http://legaldoc.corp.medtronic.com:81/mitdoc3:/Compliance/Website/Remunerative_Arrangements.

Approval process. Where an approval process is required by these Standards (e.g., under Standard 3 for grants and Donations), no Employee or Agent may enter into or authorize an arrangement before obtaining all required approvals.

Free or Reduced Charge Products: Discounts, Credits and Rebates, Samples, Demos, Loaners and Warranties

Discounts furnished in the ordinary course of business are permitted, provided that they comply with this Standard.

Scope of Standard. This Standard addresses Discounts, Accessories, Samples, Demos, trial-period loans, Products with No Independent Value, product Donations for the use of Indigent Patients, and product given pursuant to Medtronic warranties, as well as other instances in which product may be provided to Customers without, or at a reduced, charge.

Discounts not permitted. The following Discounts are not permitted:

• Rebates paid in cash rather than by check;
• Signing and conversion bonuses;
• Discounts earned on products covered by a federal health care program, but applied to products that are not covered by the program;
• Discounts available when a product is covered by private payors, but not available when it is covered by a federal health care program;
• Credits earned on trade-ins, in excess of the fair market value of the item that is traded; and
• The provision of product to a Customer without charge, except in accordance with the approval processes required by this Standard.

Legal review required. Prior review by Medtronic Legal Counsel is required for Discount programs that:

• Are based on Medtronic’s “share of an account” or involving “exclusivity” or “sole vendor requirements”;
• Result in the reduction of the product price below cost;
• Are conditioned on the purchase of a package or bundle containing products that are not all the same;
• Involve multiple items with variable Discount rates;
• May not be applied at the discretion of the Customer (i.e., that require the Discount be applied for a particular purpose, for example, to fund the acquisition of another product, or to support a research or education program), except credits restricted to the purchase of more of the same product;
• Involve Discounts paid prior to the purchase of the products on which they are earned;
• Are in a form, other than a Discount taken at the time of sale, as a reduction of the invoice price, or a Discount paid later as a “rebate,” or as a credit for the same type of item;
• Extend for more than one year; or
• Involve Products with No Independent Value.

Prior review by Medtronic Legal Counsel is also required when:

• Paying unreimbursed expenses beyond a Medtronic warranty obligation;
• Free product is provided for analysis by a Consultant, or as part of a clinical trial or research project, to ensure that the underlying arrangement is consistent with Standard 6 and the value of the free product to the Customer is considered in setting fair market value compensation;
• Entering into an agreement with a group purchasing or similar organization; or
• Giving, loaning or consigning Medtronic products without charge except when the product is provided:
  • pursuant to a Medtronic warranty;
  • temporarily, while equivalent Medtronic product is being repaired;
  • as a replacement as the result of regulatory action, to eliminate the risk of failure, or for product that is accidentally damaged; or
  • consistent with the requirements set forth below for Samples, Demos, Accessories, or Indigent Patients.

Samples. A limited number (per evaluating physician) of Samples may be given to permit evaluation of products by Customers who are unfamiliar with the product. No-charge loaners may also be provided as Samples, but only for a reasonable evaluation period. Samples with a list price of over $2,500, other than no-charge loaners, require prior written approval by Medtronic Legal Counsel.

Demos. Demos may be given free of charge.

Accessories. Accessories may be provided free of charge only if they may be given without charge under another provision of this Standard, or they are of Nominal value, are not eligible for separate reimbursement under any federal health care program, are provided to any given Customer only occasionally, and are given as an incidental accommodation, without respect to the volume or value of business generated by the Customer.

Indigent Patients. Pursuant to Standard 3 and consistent with any Business Unit policies on Indigent Patients and any applicable Medtronic export policies, products may be given to a doctor or facility for the benefit of an Indigent Patient when the doctor and facility have agreed not to bill or collect payment for the product, associated procedures and facility charges.

Products with No Independent Value. Medtronic may give Products with No Independent Value to Customers. The recipient must acknowledge receipt, and, in the case of a loan, ownership by Medtronic.

Documentation. Product sold or given to a Customer with more than a Nominal price, other than Demos, must be invoiced. There must be:

• Disclosure. Discount terms must be set at the time of sale and reflected in a written agreement. When the amount of the Discount is known at the time of sale, the net price of each discounted item or information sufficient for the Customer to reasonably determine the net price of each item must be fully disclosed in writing to the Customer on the invoice. Otherwise, the invoice must make clear reference to another document provided to the Customer that contains such information. Each invoice for discounted product must include the notation that the price is net of any Discount, except that when the actual Discount is not known at the time of sale (e.g., in the case of a volume rebate), the invoice should include a statement that the purchase price may be subject to a Discount and, when the Discount becomes known, a written statement should be issued to the Customer noting the Discount and relating the Discount back to the original invoice(s). Additional disclosures may be required in connection with Discount programs designated above as requiring legal review.
• Medicare reporting notification. The invoice must state that the Customer may be obligated to report the Discount to Medicare, Medicaid or other federal health care programs.
• Responsibility for compliance with third-party reporting requirements. Customers may have reporting obligations to third parties, including Medicare, that require the allocation or classification of Discounts in accordance with particular reporting principles. Customers should be given written notice that they are solely responsible for accurately reporting and allocating Discounts in accordance with any applicable requirements, and that they should contact Medtronic in the event that they need additional information to enable them to report accurately.
• Sample-specific requirements. Invoices for Samples must indicate that the product is provided at “no charge.” When Samples are separately reimbursable, Medtronic should advise Customers in writing not to bill or collect from anyone for the product.
• Warranty-specific requirements. The invoice must accurately report the price reduction of an item provided under a Medtronic warranty and inform the Customer that it may have reporting obligations under federal law. In circumstances where Medtronic is aware that eligibility for a price reduction under a Medtronic warranty may be determined after the time of sale (at which time a warranty credit is issued), the invoice must accurately report the potential that additional price reductions may apply and inform the Customer that it may have reporting obligations. When the value of the warranty credit becomes known, Medtronic must provide the Customer with documentation of the warranty credit.
• Leases. Any product leased or loaned to a Customer, with or without charge, with more than a Nominal price must be the subject of a written lease agreement accurately stating all material terms of the lease (in the case of relatively low-value items, such as programmers, a letter from Medtronic setting forth the material terms and conditions upon which the item is loaned is sufficient).

Finance Department responsibilities. Medtronic Global Business Solutions and the Finance Department for the applicable Medtronic Business Unit must ensure that invoicing and documentation of any Discounts or other arrangements described in this Standard are in accordance with these requirements and Medtronic financial policies.

Donations to Customers or Organizations Closely Affiliated With Customers

Donations to Customers or organizations Affiliated with Customers are permitted only if the Donation is intended to benefit society and promote better health care, demonstrate good corporate citizenship, or serve a genuine educational function, and, except in rare instances, only where the recipient is a tax-exempt Charity.

Purpose of Donations. Donations are contributions to a Charity for charitable purposes, or in rare instances, to individuals engaged in a genuine charitable mission. Donations may not be linked, implicitly or explicitly, to an agreement to use, order, recommend or make a referral for Medtronic products or used to reward prior purchases. Donations may not result in a personal benefit to a Customer. Product Donations for use outside of the U.S. must comply with applicable export control laws.

Payments by Medtronic in return for items or services, and research grants or other payments made to entities that are not Charities, should be evaluated under Standards 6 or 8. Donations made to a Charity to sponsor or support attendance at Qualifying Conferences are also subject to Standard 8.

Support of education. Donations that meet the requirements of this Standard may be made for educational purposes, including:

• Supporting an endowed chair at an academic institution;
• Subsidizing the education of fellows participating in accredited fellowship programs, provided there is evidence that the funds will be dedicated to fund educational activities, or in fellowship programs with an academic affiliation;
• Subsidizing medical congresses and conferences; and
• Educating the public on health care topics.

Support of research. Donations that meet the requirements of this Standard may be made to support specific scientific research projects. These might include, for example, Donations to support basic scientific research. Support for research connected to Medtronic therapies typically should be addressed under Standard 6.

Other permissible purposes. Donations that meet all of the requirements of this Standard may be made for other genuine philanthropic and charitable purposes that demonstrate good corporate citizenship and represent a benefit to society; for example, support of activities directed at providing services or products to Indigent Patients.

Fundraising events. Support of fundraising events is only permitted when at least a portion of the Donation qualifies for a charitable tax deduction. Sponsorship of either Customer participation in (e.g., the entrance fee to a charitable golf tournament), or Customer attendance at (e.g., tickets for a charitable gala) fundraising events is prohibited, except where the Donation is approved through the Business Unit’s Donation Approval Process (see “Approval Process” below) and the participants or attendees are selected by the donee or where the event involves only a meal or reception that qualifies as a Business Courtesy under Standard 5 (in which case Medtronic may select the attendees).

Employees may, without prior approval through the Donation Approval Process but consistent with Business Unit policy, spend no more than $2,500 per event to purchase tickets for bona fide Charity fundraising events to benefit tax-exempt Charities. Tickets purchased by Employees must be expensed and, except as permitted in the preceding paragraph, may not be given to Customers. If an Employee becomes aware that another Medtronic Employee has purchased tickets to an event, the Employee must seek approval pursuant to the Donation Approval Process, prior to purchasing any tickets to the event. An Employee who purchases tickets to a bona fide Charity fundraising event must submit a canceled check or receipt in accordance with the Required Documentation section of this Standard (see below).

Support for lobbying. Donations to organizations affiliated with Customers that engage in lobbying activities that meet all other requirements of Standard 3 are permitted even when the recipient will apply some or all of the Donation to lobbying activities. However, prior review by the appropriate Medtronic government affairs office is required to ensure that these initiatives are consistent with Medtronic legislative goals and are likely to be effective.

Product Donations for the Benefit of Indigent Patients. Product may be donated to a Customer for the sole benefit of Indigent Patients, even if the Customer is not a Charity. Product Donations may be approved through the Donation Approval Process or through an alternative approval process designated by a Business Unit. In addition to the documentation requirements outlined below, product Donations on account of indigency require that the Customer certify in writing that: (1) the patient who will use the product qualifies for free services from the Customer pursuant to the Customer’s reasonable indigency policy; and (2) no charges of any kind will be billed by the Customer or its medical staff to the patient or the patient’s insurer nor will be collected from the patient or the patient’s insurer on account of the implantation or other delivery of the product to the patient.

Mechanics of payment. Except as expressly permitted by these Standards, Donations may be made only by wire transfer to the recipient’s official bank account or by a Medtronic check payable to the official name of the Charity. Sales personnel may not deliver Donations, other than product donations, to Customers. Reimbursement for monetary Donations made through the use of expense reports is expressly prohibited, except as provided in connection with the Employee purchase of tickets to certain fundraisers (see Fundraising Events above).

Transmittal letter and Delivery of Donation. Except as provided in this Standard, a transmittal letter from Medtronic clearly explaining the purpose of the Donation must be sent prior to or with the Donation. The transmittal letter must be approved by Medtronic Legal Counsel or, if the payment is less than $15,000, be in a form that has been approved by Medtronic Legal Counsel and used without material modification. No transmittal letter is required for Employee purchases of tickets to fundraising events, as permitted above. (See Fundraising Events above.)

Donation Approval Process. Each Business Unit must establish a Donation Approval Process. There is also a Medtronic corporate Donation Approval Process for Donations that are not made from Business Unit budgets. All Donations are subject to prior written approval through the applicable Donation Approval Process, except product donations for the benefit of Indigent Patients as described above (see Product Donations for the Benefit of Indigent Patients) and purchases of tickets to certain fundraisers, as described above (see Fundraising events). Except with respect to product Donations for the benefit of Indigent Patients, personnel that are part of the sales organization may not be involved in the Donation Approval Process except to respond to a Customer’s questions about where to submit an application for a Donation; however, sales personnel may provide input about the suitability of a proposed recipient or program, so long as that input is not related to gaining or maintaining a Customer’s business. Each Business Unit should establish procedures to facilitate such input and discourage inappropriate communication. Budgets for Donations may not reside in the sales organization.

All Donations that exceed $1,000, the equivalent fair market value or, in the case of a Medtronic product, the equivalent list price, other than the tickets purchased by Employees described above, must have prior written approval of a Medtronic Vice President. Donations that exceed $15,000 or the equivalent fair market value must have the prior written approval of a Corporate Vice President.

Required documentation. The disposition of each request for a Donation must be documented. All Donations (whether monetary or non-monetary items such as products or equipment) must be supported by documentation demonstrating that: 1) the recipient is a Charity (this will normally require evidence of the entity’s tax-exempt status); 2) the Donation will be used for an appropriate purpose (described above); 3) the amount of the Donation is appropriate for the proposed purpose (e.g., not in excess of the anticipated costs of a proposed project or event); and 4) the Donation has been received by the Charity (i.e., a receipt or acknowledgment from the recipient, or, if specified in the transmittal letter stating the purpose of the Donation, or in the case of an Employee purchase, a canceled check or a receipt).

Research grant requests must be accompanied by an explanation of the purpose of the research, a detailed research protocol or other appropriate documentation, and a detailed budget or description of how the requested funds will be applied. Educational grant requests must be accompanied by a detailed explanation of the particular educational program involved, including date, place, and program description, and a detailed budget or description of how the requested funds will be applied.

Gifts

With certain limited exceptions, the giving of gifts is prohibited.

Type and purpose of gifts. Medtronic may give gifts that benefit patients or serve a genuine educational function. Gifts that do not meet this standard, such as gifts of food, flowers, wine, or other refreshments, are prohibited, except that:

Medtronic may make a Donation in honor of, or send appropriate gifts (e.g., flowers or food) to a Customer or Customer’s Immediate Family, when the Customer or member of a Customer’s Immediate Family experiences a Major Life Event; and

Medtronic may occasionally give Logo Items. When given, Logo Items must be related to the Customer’s work or benefit patients. Items such as golf balls and T-shirts are not related to the Customer’s work or patient benefit, and are therefore prohibited. Refer to the Spending Limits to determine when a Logo Item qualifies as being of minimal value.

Except in the context of a Major Life Event, where gift certificates/cards to event-appropriate stores such as toy or baby stores may be given, gifts may not be given in the form of cash, cash equivalents or gift certificates/cards.

Value of Gifts. Gifts are subject to Spending Limits. For purposes of applying the Spending Limits, the value of gifts should be calculated at retail cost (i.e., the cost at which they would normally be available to a person buying only one of the items from a retail vendor) exclusive of sales tax and shipping and handling costs.

Documentation. The description and purpose of gifts should be documented and approved on an expense report or through the utilization of another comparable authorization process. Expenses for gifts must be clearly identified as such and coded as directed by Finance.

Coordination with other Standards. Samples and other transactions described under Standard 2 should be considered under Standard 2 rather than under this Standard. Items of value given to Customers in exchange for services should be treated not as a gift but as compensation and must conform to Standard 6. Gifts may not be given as a gesture of appreciation for the purchase of product. Except with respect to donations in an amount less than $100, Donations made in connection with a Major Life Event must be made in accordance with Standard 3.

Business Meetings and Associated Courtesies

Business Courtesies provided to a Customer in the context of a Business Meeting must be modest in amount and related to a legitimate Business Purpose. Medtronic-sponsored entertainment and recreation is not permitted in connection with Standard 5 events.

Business Courtesies During Business Meetings. Subject to Standard 1, meals, receptions and Travel Expenses may be provided in connection with a Business Meeting. Unless a Business Meeting has a permissible Business Purpose and a Medtronic Employee or independent sales representative is in attendance, the meeting is not a Business Meeting and the courtesy is a prohibited gift under Standard 4 (unless the courtesy may be extended under Standard 6 or 8).

Payment for Travel Expenses. A Customer may be invited to travel to an out-of- town Business Meeting for Medtronic’s convenience. Medtronic may cover the costs of these trips only if they are to Medtronic offices or to other function-appropriate locations selected by Medtronic because of practical concerns or cost savings to Medtronic. Examples of appropriate reasons for trips are plant tours or product demonstrations (where the product is not reasonably portable) when there is a real and substantial business need for such a tour or demonstration.

Documentation of Business Courtesies. The description and Business Purpose of all Business Meetings, along with the nature and amount of any Business Courtesies, the full names of those in attendance, including the employment, agency or staff affiliation of any individual Customer, must be documented and approved on an expense report or through the utilization of another comparable authorization process. However, for group events where the expense does not exceed the “per attendee” limit of $25 and the “total” event limit of $1,000, it is not necessary to include the names and affiliation of individual attendees; however, the purpose of the event and the number of attendees must still be included on the expense report.

Consulting, Research, and Advisory Arrangements

Medtronic may compensate Customers for consulting, research, advisory, and other services rendered, and reasonable costs incurred, where the services have value to Medtronic and are paid at no more than fair market value. Such arrangements must be in writing, in a form approved by Medtronic Legal Counsel and comply with local Business Conduct Standards. Consistent with Standard 1, Medtronic may provide Travel Expenses, meals and receptions and entertainment and recreation to Consultants in connection with Consultant Meetings.

Purpose and payment. Agreements with Consultants may be entered into only for services for which there is a legitimate Medtronic need.

Requirements in connection with research agreements. Consulting Agreements entered into in connection with clinical trials, including post-market or outcomes studies, must be based on a demonstrable need for data (e.g., for product approval, reimbursement, or supplemental efficacy claims). Payments to support studies sponsored by Consultants are permissible if knowing the outcome, or the availability, of data from the proposed study is likely to be of use to Medtronic (see Standard 3 for charitable Donations to support research). Consultants contracting with Medtronic must be well qualified for the contemplated service, in terms of facilities available to them, their education and/or experience.

Limits on use of Consultants. Consultants may not be paid to endorse or otherwise recommend the sale, lease or use of Medtronic products. Subject to these limitations, and to any FDA restrictions on off-label promotion, Medtronic may retain Consultants to speak, write and provide Training and Education to audiences, including to healthcare professionals, on topics related to Medtronic products and therapies and related disease states. While Medtronic may not pay Consultants to act as Faculty (see Standard 8), it may pay Consultants for research or consulting services, even if the end product will be presented by them as Faculty. However, Medtronic may not pay Consultants for their appearance at or preparation for a third-party conference presentation. Consultants may also provide technical expertise on behalf of Medtronic; for example, they may be involved in advocacy efforts with payors for reimbursement for Medtronic products. Consultants must affirmatively and effectively disclose their affiliation with Medtronic when interacting with third parties on behalf of Medtronic, whether as an educator or otherwise (e.g., appearing on behalf of Medtronic before a government agency or payor to explain the utility of a product). Consultants may not be paid to speak at a Co-Marketing Event at which the Consultant promotes his or her own practice (see Standard 9).

Payment. Compensation may not exceed the fair market value of services provided, and may not be extended to the Consultant as a reward for prior business or as an inducement for future business. Compensation must be structured on a measurable basis, such as payment based on a daily, hourly or per-project rate, deliverables or milestones. The fee may not be related to the volume or value of any product sold by Medtronic. Medtronic may reimburse Consultants for authorized reasonable expenses if supported by appropriate documentation.

Consulting Agreement Approval Process. Each Business Unit must establish a Consulting Agreement Approval Process for oversight and approval prior to the execution of any agreement with a Consultant by personnel qualified to assess and evaluate the proposed arrangement according to criteria consistent with this Standard. There is also a Medtronic corporate Consulting Agreement Approval Process for all consulting agreements that are not funded by Business Unit budgets. The Consulting Agreement Approval Process must be consistent with the Medtronic Policy for Review of Remunerative Arrangements with Customers in the United States. The Consulting Agreement Approval Process must require, at a minimum, and before any commitment is made to the Customer: 1) review and approval by a qualified non-sales business representative to evaluate the business opportunity presented by the Consulting Agreement to Medtronic and the fairness of the price Medtronic is paying for the contracted services; and 2) legal review and approval of the substance of any Consulting Agreement, or in the case of a multi-site clinical agreement, legal review and approval of the Consulting Agreement template and site selection criteria, by the Legal Department of the Business Unit entering into the Consulting Agreement.

If the actual or potential value (taking into account the actual or potential value of all related agreements or the full value of any consolidated/restated agreements) is $400,000 or more, prior written approval by the Medtronic Business Conduct Officer and Corporate Legal Regulatory is required. Prior written approval from the Medtronic Business Conduct Officer and Corporate Legal Regulatory is also required when an exception to a requirement of this Standard is requested.

In addition, the final written agreement must be approved in advance by the Legal Department of the Business Unit entering into the Consulting Agreement, except where the aggregate annual payment under the agreement is less than $2,500, and the agreement is in a form that has been approved by Medtronic Legal Counsel and used without material modification.

All Consulting Agreements with Customers must be signed by a Medtronic Vice President. A Medtronic Vice President may delegate signature authority with the approval of a Medtronic Corporate Vice President and Legal Team Leader, with a copy of the delegation notice to the Medtronic Ethics and Compliance Office.

Personnel in the sales organization may be involved in the Consulting Agreement Approval Process only to the extent necessary to supply information about Consultant qualifications or interest. Budgets for agreements with Consultants may not reside in the sales organization. Members of the sales organization may not deliver payment to Consultants.

Form of agreements. Agreements with Consultants must: 1) be entered into prior to the start of the services and payment; 2) be in writing; 3) except as specifically approved by Medtronic Legal Counsel, be signed by both parties; and 4) specify the services to be provided, the term of the agreement, the method of payment, and any obligation to reimburse for Travel Expenses and other related expenses. Each agreement must specify a mechanism to verify that the required services are performed (e.g., periodic progress reports or a final written study report). Consulting Agreements should comply with the personal services safe harbor to the extent practicable. Agreements providing for services on an as-needed basis with payment prior to receipt of services are prohibited.

Required documentation. Each Business Unit must develop an effective mechanism for substantiating and documenting that contracted services were provided (e.g., Manager review), or that there is a documented, legitimate reason that the services were not provided. This mechanism must be administered by a business person outside of the sales organization. Files on all Consulting Agreements must be maintained by the Business Unit and must include the written agreement, rate of compensation, the basis for selecting the Consultant (including the Consultant’s particular qualifications), and justification for the services (copies of minutes generated during the Consulting Agreement Approval Process will suffice if they adequately address this issue). Consultants must represent and acknowledge in writing that they have properly notified, and have received all necessary permissions from, all required parties (e.g., hospital, employer, and regulators) if those parties are not signatories to the agreement.

Consultant Meetings. Consultants invited to Consultant Meetings must have written Consulting Agreements in effect describing the services to be provided at the Consultant Meeting. Medtronic personnel with a bona fide interest in, and in a position to use, the advice given by the Consultants must be in attendance at each Consultant Meeting. Meals, receptions, recreation and entertainment should not compete with, nor take precedence over, the purpose of the Consultant Meeting. Copies of the agenda and minutes of any Consultant Meeting must be maintained in each of the attending Consultant’s files (referenced above) and the agenda for group Consultant Meetings, together with any contemplated entertainment, must be reviewed by Medtronic Legal Counsel prior to issuing invitations. Any Consultant Meeting held in connection with a Qualifying Conference must be approved in advance by Medtronic Legal Counsel and a Medtronic Corporate Vice President.

Subject to Standard 1, Medtronic may provide Consultants with meals, receptions, entertainment, and recreation and may pay for Travel Expenses in connection with a Consultant Meeting. Entertainment and recreation may be offered only on days during which at least five hours of bona fide Consultant Meetings are scheduled. Customers who are in attendance at a Consultant Meeting in a capacity other than as a Consultant may not be entertained or provided with any recreation by Medtronic, and the provision of any meals or receptions to, or payment of Travel Expenses for, these Customers is permitted only if allowed by some other Standard.

The locations of Consultant Meetings must meet the criteria set out in Standard 1. Medtronic may pay reasonable Travel Expenses for Consultants in connection with a Consultant Meeting, which may exceed coach class if necessary to secure a Consultant’s services. Medtronic may not pay for the travel or other expenses (including the cost of meals, receptions, recreation or entertainment) of guests of Consultants, or of any other person who is not a bona fide contributor to the meeting.

Payment. Payment made for services provided under a Consulting Agreement may be made after the appropriate Business Unit Employee at a Manager level or above has determined the existence of an approved written, executed agreement, and that there is evidence of performance of the agreement prior to payment for services. Payments must be made by check or wire transfer to the official name and address or account of the Consultant contracting with Medtronic.

Training & Education Concerning Medtronic Products

Medtronic has a responsibility to make available instruction, education, and training on the safe and effective use of its products to health care providers. Consistent with Standard 1, Medtronic may provide Travel Expenses and meals and receptions to participants in connection with Training and Education.

Training and Education meetings. Medtronic may provide Training and Education to Customers who are in a position to benefit from it. Training and Education will typically be provided by Medtronic rather than a third party.

To qualify as a Training and Education program for which Medtronic may provide meals and receptions or Travel Expenses, Training and Education must be the purpose for the program. Meals and receptions should not compete with or take precedence over the educational program. Travel Expenses may not be provided in connection with a Training and Education program, unless, other than on a travel day, the program involves Training and Education of not less than five hours for each program day. All Training and Education must be adequately documented, including the agenda and a report on the costs, participants, and faculty.

Oversight responsibilities. Each Business Unit is responsible for establishing and maintaining a review and approval process for the Training and Education programs it sponsors. The review process must include prior written approval of the course content, agenda (covering all events from arrival to departure), location and faculty. Payments to faculty may only be made under a Consulting Agreement entered into consistent with Standard 6.

Location of meetings. The locations for Training and Education must be consistent with Standard 1.

Charging for CEU & CME Credits. In circumstances where Medtronic has arranged for CEU credits to be offered at a Training and Education Program, Medtronic is required to charge nurse attendees only if the fair market value of the CEU credits exceeds $100. In the rare circumstance where Medtronic provides support to a CME provider for a course on indications or therapies appropriate for use of a Medtronic product, a fair market value fee must be charged for the credits, unless the CME provider’s normal practice is not to charge a fee for similar courses and the provider advertises the course to a broad audience beyond the Medtronic invitees.

Reimbursement Support programs. Medtronic may provide Reimbursement Support to Customers but only with respect to Medtronic products and services. Medtronic may not provide general practice management advice of material value to Customers without charging fair market value. For example, except in exchange for fair market value, it is not permissible to provide personnel or services to a Customer in situations that relieve the Customer of hiring such personnel or purchasing such services. It is also not appropriate to provide customized advice that is not product-focused.

Medical Conferences, Congresses & Professional Meetings Sponsored by Organizations Other than Medtronic

Medtronic has an interest in building awareness and understanding of its products and related disease states through support for third-party scientific forums. For these purposes, Medtronic may underwrite the cost of such third-party conferences or meetings and may subsidize the attendance of health care professionals-in-training.

Permissible subsidies. Medtronic may support third-party Qualifying Conferences to the extent permitted in this Standard. Subsidies may be provided to the Qualifying Conference sponsor to reduce overall Qualifying Conference costs, support Modest meals or receptions or allow attendance by medical students, residents, fellows, or other health care professionals-in-training (see selection requirements under “Scholarships” below).

While Medtronic funds may be applied to pay costs and expenses associated with Faculty selected and retained by the Qualifying Conference sponsor, except as specifically provided in Standard 6 or in this Standard, no payment of fees, costs or expenses may be made by Medtronic directly to Faculty for fees, costs or expenses associated with attendance, preparation or presentation at a Qualifying Conference. The selection of Faculty must be at the sole discretion of the sponsor. However, in the case of Qualifying Conferences held outside of the US, where the third-party conference sponsor declines to undertake the administration of subsidies to pay costs and expenses associated with Faculty selected by the third-party sponsor, and with the prior approval of the Medtronic Legal Department covering the country where the Qualifying Conference will be held, Medtronic may make payment directly to such Faculty. Payment or subsidy of transportation or other expenses related to spouses or other guests of attendees is not permitted.

Subsidy Approval Process. Each Business Unit must establish a Subsidy Approval Process. There is also a corporate Subsidy Approval Process for subsidies that are not provided from the Business Unit budgets. All subsidies provided under this Standard are subject to prior approval through the Subsidy Approval Process. The participation of sales personnel in the Subsidy Approval Process is limited in the same manner as is their participation in the Donation Approval Process. Each Business Unit should establish procedures to facilitate such input and discourage inappropriate communication. Budgets for Donations may not reside in the sales organization.

Required documentation. Medtronic may only support a Qualifying Conference where the sponsor has submitted an agenda demonstrating that the Qualifying Conference or a portion thereof is dedicated to education on Medtronic products or related disease states.

CME and CEU Credits. If Medtronic supports a conference where CME or CEU credits are granted, there must be a fair market value fee charged of attendees for any credits granted, except that Medtronic may support Qualifying Conferences if it is not the sole corporate sponsor, or in the case of Grand Rounds even if Medtronic is the sole corporate sponsor, where no fee is charged of attendees for CEU or CME credits.

Spending Guidelines. If a Customer sponsors a meeting, Medtronic must confirm and document that the net meeting costs will be equal to or greater than the sum of all subsidies from Medtronic and any other source of subsidies (unless any overage has been approved as a Donation under Standard 3). If Medtronic is funding any meals and receptions, it must confirm and document that any meals and receptions provided in connection with the meeting will be Modest and, if Medtronic is the sole corporate sponsor, that the meeting will be held at a Modest location. If a focus of the meeting is promotional rather than scientific, it must also comply with the requirements of Standard 9. If Medtronic sponsors the meeting, Standard 7 applies.

Scholarships to health care professionals-in-training. Subsidies for attendance at Qualifying Conferences by medical students, residents, fellows, or other health care professionals-in-training may be provided by Medtronic to bona fide training institutions or the Qualifying Conference sponsor. In either case, the selection of subsidized attendees shall be at the discretion of the institution or sponsor.

Meetings with Customers in Connection with Conferences. A Qualifying Conference can be an efficient place to interact with Customers. Subject to Standard 1, Medtronic may provide Modest meals and receptions to Customers in connection with a Qualifying Conference by hosting, for example, Business Meetings (also subject to Standard 5) and Training and Education (also subject to Standard 7). Any Medtronic-sponsored Training and Education provided immediately before or after a Qualifying Conference must be approved in advance in writing by a Medtronic Legal Counsel and a Medtronic Corporate Vice President. In those circumstances where the conference sponsor extends invitations to a spouse or other guest of a Customer for one or more events and subsidizes their attendance and Medtronic is not the sole corporate sponsor, Medtronic has no obligation to collect payment for the cost of the spouse or other guest as is required in the paragraph below.

Participation of spouses and other guests in off-agenda meals and receptions. Medtronic may invite spouses or other guests of Customers to Medtronic-sponsored off-agenda meals and receptions, but only if there is a robust mechanism to collect payment for the cost of the spouse or other guest (e.g., the invitation requests that a check be forwarded in advance of the conference and there is someone checking payment at the door). Such events should not compete with or take precedence over the educational portion of the Qualifying Conference.

Co-Marketing Events and Approval

Medtronic may not pay Customers’ marketing costs. Medtronic may pay fair market value for Medtronic advertising at third-party conferences, and subsidize educational activities that qualify for support under Standard 3 as charitable contributions, or under Standard 8 as support for third-party conferences. Medtronic may also pay the costs of its own Training and Education events, including fair market value honoraria to Consultants (pursuant to an arrangement that qualifies under Standards 6 and 7).

Co-Marketing Events. Medtronic may participate in and pay an equitable portion of the costs for Co-Marketing Events. Medtronic may not pay the Customer or person representing the Customer who is jointly putting on the Co-Marketing Event an honorarium or fee for time preparing or presenting at these events, but may consider the value of that time in apportioning costs.

Determining whether an event is a Co-Marketing Event. To qualify as a Co-Marketing Event, the involved Customer must, at the event, be promoting either the Customer’s practice or the institution where the Customer practices. For purposes of this section, a Customer will be considered to be promoting either the Customer’s practice or the institution where the Customer practices if the Customer is speaking in the Customer’s geographic area to an audience primarily composed of potential patients. With respect to events where the audiences are primarily composed of referral sources, a Customer will not be considered to be promoting either the Customer’s practice or the institution where the Customer practices if the Customer will not seek referrals and three or more of the following factors are present:

1. The invitations are issued in the name of Medtronic alone.
2. The invitees are selected by Medtronic alone.
3. The location and venue are selected by Medtronic alone, and neither the venue nor the location is Affiliated with the Customer’s practice or institution.
4. There are other sponsors (e.g., organizations or associations) for the meeting in addition to Medtronic and the Customer.
5. Individuals associated with different practices or institutions speak at the event.
6. The Customer-speaker has been or will be retained by Medtronic to make similar presentations to audiences in other geographic areas.

If at least three of the above factors are not present, then the event involves either the promotion of the Customer’s practice or the promotion of the institution where the Customer practices unless Medtronic Legal Counsel concludes that the event or series of events that have been specifically identified are not designed to promote the Customer’s practice or the institution where the Customer practices.

Definitions

Accessories are items that facilitate the use or operation of Medtronic products purchased by a Customer and may sometimes be sold to Customers by Medtronic.

An organization is Affiliated with a Customer if it is controlled by or under common control with the Customer, or if the Customer is on the governing Board of the organization, receives material compensation from, or has a significant investment interest in the organization.

Agents or Medtronic Agents are persons, including independent sales representatives, acting within the scope of their engagement, expressly authorized to act on behalf of Medtronic under a contract or relationship of agency to sell or market Medtronic products and services, and who are subject to the control and consent of Medtronic to act on its behalf.

Blanket Exceptions are all permitted exceptions to the Business Conduct Standards that do not qualify as Case-specific Exceptions.

The Medtronic Business Conduct Officer is the Vice President who is responsible for Medtronic policies and procedures related to business practices, including these Business Conduct Standards. The Medtronic Business Conduct Officer, through the Medtronic Office of Ethics and Compliance, also has responsibility for leading Medtronic’s training and education activities in this area.

Business Courtesies are expenditures made by Medtronic for meals, receptions or Travel Expenses under Standard 5.

A Business Meeting is a meeting held for a Business Purpose.

Business Purpose means for the purposes of: 1) explaining the features, use or other important aspects of Medtronic products; 2) understanding the product-related service or other concerns, needs or demands of a Customer; 3) explaining the services and terms available from Medtronic; or 4) negotiating sales contracts and sales terms.

Business Unit Compliance Officer is the employee who has responsibility at the Business Unit level to develop policies and procedures to ensure compliance with these Standards.

Case-specific Exceptions are exceptions to the Business Conduct Standards, either for a particular instance of an event or action, or for a list of events or actions that are known and can be specifically identified at the time the exception is granted.

Charities are tax-exempt organizations and individuals engaged in genuine charitable missions. For example, Charities include organizations with federal 501(c)(3), and (c)(6) tax exempt status. A list of 501(c)(3) tax exempt organizations is available at www.guidestar.org. In addition, state-owned institutions with state tax exemptions may qualify as Charities.

Co-Marketing Events are events jointly put on by Medtronic and a Customer in which a person representing the Customer promotes the Customer’s practice or institution and Medtronic promotes its products.

Consultants are Customers whom Medtronic pays under the procedures outlined in Standard 6 to provide services (e.g., training, educating, consulting, research, clinical study, focus group and physician advisory board service).

Consultant Meetings are meetings called for the purpose of obtaining previously contracted services from Consultants.

A Consulting Agreement is an agreement for the purchase of services, including without limitation, clinical, research, consulting, education, training, honoraria, product development and other advisory agreements.

Consulting Agreement Approval Process is the process for prior written approval of agreements with Consultants required by Standard 6.

The Continental United States means the 48 contiguous states.

Customer(s) is any person, other than an individual patient, including, without limitation, any medical or health care professional or entity in a position to purchase, lease, recommend, use, influence or arrange for the purchase or lease of, or prescribe Medtronic products.

Customer Interactions are all interactions involving a transfer of anything of value from Medtronic to a Customer.

A Customer Meeting is a Medtronic-sponsored Business Meeting, Medtronic Training and Education Program or Consultant Meeting.

Demos are products used for demonstration purposes (functional or mock-up) and are labeled “Not for Human Use.”

A Discount is any reduction from list price of the amount charged for the purchase, lease or loan of any Medtronic product, including items provided or leased or loaned free of charge, credits and rebates. Demos and items provided as in-kind payment for items or services or as consideration for a release are not Discounts.

A Donation means a contribution made by Medtronic to a Charity to support a charitable purpose.

The Donation Approval Process is the Business Unit or corporate approval process required by Standard 3, pursuant to which the Business Unit or Medtronic receives, reviews and acts on Donation proposals according to pre-established criteria consistent with Standard 3.

Employee, Employees or Medtronic Employees are all persons employed by any division of Medtronic.

Faculty means any person who presents information at a third-party Qualifying Conference by lecture, or in some other form, such as an abstract or a poster paper.

A Holiday is a day established by law, custom, or religion to commemorate or celebrate a particular event.

Immediate Family means the Customer, the Customer’s spouse or life partner, their children and the parents of the Customer, the Customer’s spouse or life partner.

An Indigent Patient is a patient without the financial resources to pay for the product, as determined under applicable Business Unit policy (including a policy that relies on reasonable Customer policies for determining indigency).

Intellectual Property Agreements means all IP licensing or IP acquisition agreements or any agreement under which payment is provided for IP rights, including those providing lump sum payment(s) and payments which vary with the value or volume of sales (e.g., milestone or royalty-based payments).

The List of Non-Qualifying Hotels and Locations is a list developed and maintained by the Vice President and Senior Legal Counsel, or designee, of the Medtronic Spinal & Biologics and Navigation Divisions, of facilities that do not qualify as approved Medtronic Customer Meeting facilities because they have been identified either as a Resort, a Resort Location, or a Luxury Hotel. This list is available at http://legaldoc.corp.medtronic.com:81/mitdoc3:/Compliance/Website/New_Hotel_Process.

Logo Items are minimal-value, Medtronic-branded, promotional items related to the Customer’s work or for the benefit of patients. Examples include pens and notepads.

The Lowest Logical Fare is defined as the most economical airfare available at the time of booking that enables business objectives to be met and ensures effective use of the traveler’s time.

Luxury Hotel means any property that, at the time the reservation for the meeting is made, has been awarded or included in any of the following: 4 or 5 stars by the Mobil Travel Guide, 5 diamonds by AAA, a “Luxury” rating in the Michelin Guide, the International Guide of the Relais & Chateaux Association, or the Condé Nast Traveler “Annual Gold List” or “Top U.S. Hotels” list. Hotels that are substantially similar to those above in terms of price, amenities or other objective criteria, including certain AAA 4 diamond hotels, will also be considered Luxury Hotels.

Major Life Event means marriage, birth or adoption of a child, permanent retirement from the practice of medicine, death, or serious illness or injury.

A Manager is any Medtronic Employee who has supervisory responsibilities over other Medtronic employees.

The Medtronic Business Conduct Standards Violations and Disciplinary Policy establishes a system for addressing and resolving alleged violations of these Standards and for determining the appropriate discipline when a violation of these Standards has occurred. The policy is located at http://legaldoc.corp.medtronic.com:81/mitdoc3:/Compliance/Website/BCS_Discipline_Policy.

A Medtronic Training and Education Program is a program that is described under Standard 7.

Medtronic Vice President, Medtronic Corporate Vice President and Medtronic Legal Counsel. References throughout the Standards to a Medtronic Vice President mean any Vice President of Medtronic, Inc. A list of the Medtronic Corporate Vice Presidents is on the Medtronic Compliance website. References to Medtronic Legal Counsel are to the Medtronic-employed lawyers providing services to the Business Units and geographies.

Modest or Modest in Value means (1) with respect to meals and receptions and any other expense for which there are established Spending Limits, an amount consistent with the Spending Limits; (2) with respect to all recreation or entertainment and Travel Expenses, an amount within limits that are consistent with these Standards and reasonable for the circumstances; and (3) with respect to lodging and location, facilities that do not fall within the definition of a Resort, a Resort Location, or a Luxury Hotel.

Nominal means less than $100 retail or, in the case of a Medtronic product, less than $100 list price.

On-Agenda means an event that is open and publicized to all attendees of a Qualifying Conference under Standard 8 and is typically paid for through a subsidy to the conference sponsor.

Products with No Independent Value are products that are determined by Medtronic Legal Counsel to be ancillary to and facilitate the use or operation of Medtronic products purchased by a Customer (e.g., product-specific tools). These products must not have any value independent of the primary product and must not be of personal use to the Customer. Products do not qualify as having “no independent value” if they are not equally available at no charge to all Customers.

Qualifying Conferences are:

• Nationally or regionally recognized meetings. These are meetings that are nationally or regionally recognized, bona fide, independent, educational, scientific or policy-making conferences, congresses and professional meetings that have a relationship to Medtronic businesses or products.
• Grand Rounds, as that term is normally understood.
• Scientifically valuable roundtables or discussion groups. These are high-caliber, scientifically valuable roundtables, panels or discussion groups directed at advancing the state of medical knowledge about Medtronic therapies or meaningfully addressing disease states or technology of interest to Medtronic.

Reimbursement Support involves the provision of accurate information to Medtronic Customers to promote responsible Customer billing practices in connection with billing Medicare and other payors for Medtronic products and related medical procedures. This term also involves the provision of information to Medtronic Customers about the cost-effective use of Medtronic products. Reimbursement Support includes: 1) providing Customers with information about the economically efficient use of Medtronic products (e.g., explaining where the product can most efficiently be used in the continuum of care and how the product can be offered in a cost-effective manner); 2) providing coverage, coding and billing information regarding Medtronic products and/or related services or procedures; and 3) providing technical or other support intended to aid in the appropriate and efficient use or installation of Medtronic products.

Resort means any property that is on the Condé Nast Traveler “Top Resorts,” “Best Golf Resorts” or “Top Spas” list, or Golf Digest “Best Golf Resorts” list, any property that has received a rating from the Zagat Resorts Guide higher than a level 23, and any property that is substantially similar to those properties in terms of price, amenities and appeal as a Resort destination.

Resort Location means Santa Fe, New Mexico; Aspen, Colorado; Napa Valley and Pebble Beach, California; Naples, Florida; and other locations, not generally within major metropolitan areas as defined by the U.S. Census Bureau (areas with a population of greater than 500,000), that are primarily known as recreation or vacation destinations (e.g., ski destinations; wine country or vineyard destinations; horseback riding, beach, golfing, hunting or fishing destinations).

Samples are products that are given or loaned to Customers free of charge to permit evaluation of products by Customers who are unfamiliar with the product.

Spending Limits are the limits for expenditures permitted under these Standards, posted at http://legaldoc.corp.medtronic.com:81/mitdoc3:/Compliance/Website/BCS_Limits_chart. Spending Limits for meals and receptions are calculated on the basis of an average cost per meal attendee.

Subsidy Approval Process is the Business Unit or corporate approval process required under Standard 8, pursuant to which the Business Unit or Medtronic receives and acts upon requests for subsidies, according to pre-established criteria that are consistent with Standard 8.

Training and Education means training and education to explain the safe and effective use of Medtronic products, including 1) training on how to use or implant a Medtronic product; 2) training on indications or therapies appropriate for use of a Medtronic product, including education regarding product-related disease states and the appropriate use of the product in the continuum of care; and 3) training on the quality, properties and/or design characteristics of a Medtronic product, to the extent that such training provides health care professionals information on how to use that product safely and effectively. In addition, programs designed to provide Reimbursement Support also qualify as Training and Education.

Travel Expenses are Modest expenses incurred by a Customer for lodging, meals or transportation.