MAQUET U.S. Healthcare Compliance Plan

A. INTRODUCTION

1. Adopted

Adopted as of June 30, 2011.

2. Title

U.S. Healthcare Compliance Plan (the “Compliance Plan”).

3. Purpose and Scope

Maquet Cardiovascular, LLC, Maquet Cardiovascular U.S. Sales, LLC, and Maquet, Inc. (collectively “Maquet”) are subsidiaries of the publicly listed Swedish group of global medical device companies GETINGE AB and one of the world’s leading suppliers of cardiac assist and cardiac surgery devices as well as surgical workplaces and vascular prosthetics. Maquet is committed to working collaboratively with the clinical community to improve care at a reasonable cost. As part of this mission, Maquet recognizes that adherence to ethical standards and compliance with applicable laws and regulations is critical to ensure that interactions with Healthcare Providers in the United States are responsible and within legal and regulatory requirements.

This Compliance Plan defines the process used at Maquet to promote honest, ethical and lawful conduct by all Employees of Maquet (as defined below) in their interactions with Healthcare Providers and in the provision of healthcare items and services reimbursable by third party payors. It is intended to (a) raise the awareness of Employees of the ethical and legal issues that may be encountered in interacting with Healthcare Providers and in providing items and services reimbursable by federal and state healthcare programs; and (b) describe the process to address these issues.

Maquet’s interactions with Healthcare Providers should conform to ethical and appropriate business practices. Maquet also recognizes the need for Healthcare Providers to make independent and objective decisions regarding product purchases and utilization for the benefit of patients without unlawful inducement.

For purposes of this Compliance Plan, the term “Healthcare Provider” includes any person or entity in a position to purchase, lease, recommend, use or arrange for the purchase or lease of Maquet products. This includes both clinical and non-clinical personnel who make decisions related to product purchase. It also includes decision-makers within group purchasing organizations. The definition is broad, and is intended to encompass anyone with material influence over purchasing decisions.

The Compliance Plan applies to all Maquet Employees in the United States plus Employees working outside of the U.S. on applicable U.S.-related Maquet business. The term “Employees” includes Maquet’s officers, directors, employees (full-time or part-time), agents, independent contractors, representatives, consultants and distributors.

The Compliance Plan covers a broad range of general principles and is one component of Maquet’s Code of Ethics and Conduct. Employees are required to apply these principles to their own conduct. The Maquet compliance program also includes policies and procedures to foster compliance with this Compliance Plan and ethical and appropriate conduct with Healthcare Providers. Maquet requires honest and ethical conduct from everyone subject to this Compliance Plan. Employees have a responsibility to all other Employees, owners of Maquet, and Maquet itself to act in good faith, responsibly, with due care, competence and diligence, without misrepresenting material facts or allowing independent judgment to be subordinated in any way. Employees must conduct themselves in accordance with the commitments Maquet has made in adopting this Compliance Plan.

Not every situation which may arise can be anticipated, and therefore a systematic approach is useful in determining the appropriate course of action. Below are the steps to take to ensure compliance when faced with a questionable situation:

• Make sure you have all the facts. To make an informed decision, you must understand the situation.
• Identify exactly what is being asked of you. Focus on the specific question you are faced with and identify what it is that concerns you.
• Clarify your responsibility and role. In most situations, there is shared responsibility. Make sure your colleagues are informed and discuss the problem with them.
• Discuss the problem with your supervisor. This should occur in nearly all situations. Your supervisor may be more knowledgeable about the question and may help you to clarify it. It is your supervisor’s responsibility to help solve problems and they will appreciate being part of the decision-making process.
• Seek help from the Local Compliance Contact. In the case where you may not be able to discuss an issue with your supervisor, discuss it with the local compliance contact.
• Always ask first, act later. If you are unsure of what to do in any situation, seek guidance before you act.

4. Questions regarding the Compliance Plan

Any questions regarding the appropriate application of the Compliance Plan, associated policies, or what is required by law in any given situation should be directed to Dennis Genito or Whitney Torning.

5. Sanctions

Violations of this policy will be addressed and may result in corrective action, up to and including discharge.

B. Interactions with Healthcare Providers

1. Maquet-Conducted Product Training and Education

Maquet has a responsibility to make training and education on its products available to Healthcare Providers. Maquet may also provide education to Healthcare Providers. “Training” means training on the safe and effective use of Maquet medical products and technologies. “Education” means communicating information directly concerning or associated with the use of Maquet’s medical products or technologies (e.g., information about disease states and the benefits of such products or technologies to certain patient populations). Training and education programs include, but are not limited to, “hands on” training sessions, workshops, lectures and presentations, and grand rounds. The U.S. Food and Drug Administration mandates training and education to facilitate the safe and effective use of Maquet’s products.

Maquet will adhere to the following principles when conducting training and education programs concerning its medical products and technologies for Healthcare Providers:

• Programs and events will be conducted in settings that are conducive to the effective transmission of information. These may include clinical, educational, conference or other settings, such as hotels, Maquet’s facilities or other commercially available meeting facilities. It may also be appropriate for a Maquet Employee to provide training and education at the Healthcare Provider’s location.
• Programs providing “hands on” training on products and technologies will be held at training facilities, medical institutions, laboratories or other appropriate facilities including Maquet’s facilities. The training staff used by Maquet will have the proper qualifications and expertise to conduct such training. Training staff may include field sales Employees or other agents who have the technical expertise necessary to perform the training.
• Maquet may provide Healthcare Provider attendees with reasonable meals and refreshments in connection with these programs. Any such meals and refreshments will be reasonable in value and subordinate in time and focus to the training and/or educational purpose of the meeting and will be provided in accordance with all applicable state laws and regulations.
• Where there are business reasons to support the need for out-of-town travel to deliver training and education efficiently on products and technologies, Maquet may pay for reasonable travel and lodging costs of the attending Healthcare Providers. Maquet will not pay for the travel and lodging costs or other expenses for guests of Healthcare Providers or for any other person who does not have a bona fide professional interest in the information being shared at the meeting.

2. Supporting Third-Party Educational Conferences

Bona fide independent, educational, scientific and policymaking conferences promote scientific knowledge, medical advancement and the delivery of effective healthcare. These typically include conferences sponsored by national, regional or specialty medical associations and conferences sponsored by accredited continuing medical education providers. Compliance with Accreditation Council for Continuing Medical Education (ACCME) Guidelines satisfies these guidelines. Maquet may support these conferences in various ways:

• Conference Grants. Maquet may provide a grant to the conference sponsor to reduce conference costs. Maquet may also provide grants to a training institution or the conference sponsor to allow attendance by medical students, residents, fellows and others who are Healthcare Providers in training. Maquet may provide grants when: (a) the gathering is primarily dedicated to promoting objective scientific and educational activities and discourse; and (b) the training institution or the conference sponsor selects the attending Healthcare Providers who receive training. Such grants will be paid only to organizations with a genuine educational function and may be used to reimburse only the legitimate expenses for bona fide educational activities. Such grants will be consistent with applicable standards established by the conference sponsor and anybody accrediting the educational activity. The conference sponsor should independently control and be responsible for the selection of program content, faculty, educational methods and materials.
• Conference Meals and Refreshments. Maquet may provide funding to the conference sponsor to support the provision of meals and refreshments to conference attendees. In addition, Maquet may provide meals and refreshments for Healthcare Provider attendees if such meals and refreshments are provided: (a) to all Healthcare Provider attendees (with the limited exception noted below), and (b) in a manner that is consistent with applicable standards established by the conference sponsor and the body accrediting the educational activity. Meals and refreshments may be provided to fewer than all Healthcare Provider attendees if all other principles related to meals set forth in Part B, Section 7 of this Compliance Plan are satisfied. Any meals and refreshments will be reasonable in value, subordinate in time and focus to the purpose of the conference. The meals should be provided at times separate from the continuing medical education portion of the conference.
• Faculty Expenses. Maquet may make grants to conference sponsors for reasonable honoraria, travel, lodging and modest meals for Healthcare Providers who are bona fide conference faculty members.
• Advertisements and Demonstration. Maquet may purchase advertisements and lease booth space for member displays at conferences.

3. Sales, Promotional and Other Business Meetings

Maquet may conduct sales, promotional and other business meetings with Healthcare Providers to discuss, for example, medical product and technology features, sales terms or contracts. These meetings often occur close to the Healthcare Provider’s place of business. It is also appropriate to pay for reasonable travel costs of attendees when necessary (e.g., for plant tours or demonstrations of non-portable equipment) and/or to provide occasional reasonable meals and refreshments in connection with such meetings. However, it is not appropriate to pay for travel or lodging costs of guests of Healthcare Providers or any other person who does not have a bona fide professional interest in the information being shared at the meeting. See Part B, Section 7 for additional principles related to the provision of meals associated with Healthcare Provider business interactions. Some states may have more restrictive limitations on the provision of meals and payment of travel expenses for Healthcare Providers. In these states, Maquet Employees will act in accordance with applicable state laws.

4. Consulting Arrangements with Healthcare Providers

Maquet may engage Healthcare Providers to provide a wide-range of valuable, bona fide consulting services through various types of arrangements, such as contracts for research, product development, development and/or transfer of intellectual property, marketing, participation on advisory boards, presentations at Maquet-sponsored training events, and other services. Maquet may pay consultants fair market value compensation for performing these types of services, provided that they are intended to fulfill a legitimate business need and do not constitute an unlawful inducement. Maquet will comply with the following standards in connection with consulting arrangements with Healthcare Providers:

• Consulting agreements will be written and describe all services to be provided. When Maquet contracts with a consultant to conduct clinical research services, there will be a written research protocol.
• Consulting arrangements will be entered into only where a legitimate need for the services is identified in advance and documented.
• Selection of a consultant should be made on the basis of the consultant’s qualifications and expertise to meet the defined need.
• Compensation paid to a consultant should be consistent with fair market value in an arm’s length transaction for the services provided and should not be based on the volume or value of the consultant’s past, present or anticipated business.
• Maquet will only pay compensation for a consultant’s services if the services are actually performed.
• Maquet may pay for documented, reasonable and actual expenses incurred by a consultant that are necessary to carry out the consulting arrangement, such as costs for travel, meals and lodging.
• The venue and circumstances for Maquet meetings with consultants will be appropriate to the subject matter of the consultation. These meetings will be conducted in clinical, educational, conference or other settings, including hotel or other commercially available meeting facilities, conducive to the effective exchange of information.
• Maquet-sponsored meals and refreshments provided in conjunction with a consultant meeting will be reasonable in value and will be subordinate in time and focus to the primary purpose of the meeting. Maquet will not provide recreation or entertainment in conjunction with these meetings.
• Maquet’s sales personnel may furnish the name of a proposed consultant to management and may furnish objective information about a proposed consultant upon request, but sales personnel will not influence or in any manner control the decision to engage a particular Healthcare Provider as a consultant.

5. Provisions on Payment of Royalties.

Arrangements involving the payment of royalties to a Healthcare Provider will meet the contractual standards set forth above. Healthcare Providers, acting individually or as part of a group in which they are an active participant, often make valuable contributions that improve medical products and technologies. Healthcare Providers may develop intellectual property, for example, patents, trade secrets, or know-how, under a product or technology development or intellectual property licensing agreement. Maquet will enter into a royalty arrangement with a Healthcare Provider only where the Healthcare Provider is expected to make or has made a novel, significant, or innovative contribution to, for example, the development of a product, technology, process or method. A significant contribution by an individual or group, if it is the basis for compensation, will be appropriately documented. The calculation of royalties payable to a Healthcare Provider in exchange for intellectual property should be based on factors that preserve the objectivity of medical decision-making and avoid the potential for improper influence. For example, royalties paid in exchange for intellectual property should not be conditioned on: (a) a requirement that the Healthcare Provider purchase, order or recommend any product or medical technology of Maquet or any product or technology produced as a result of the development project; or (b) a requirement to market the product or medical technology upon commercialization. Maquet may, however, elect to enter into separate agreements with Healthcare Providers for marketing services if such services meet the requirements set forth in this Section 4 above.

6. Prohibition on Entertainment and Recreation

Maquet’s interactions with Healthcare Providers will be professional in nature and should facilitate the exchange of medical or scientific information that will advance medical care and benefit patients. To ensure the appropriate focus on an educational and/or informational exchange and to avoid the appearance of impropriety, Maquet will not provide or pay for any entertainment or recreational event or activity for any Healthcare Provider. Such activities include, for example, theater, sporting events, golf, skiing, hunting, sporting equipment, other leisure time activities or vacations. Such entertainment or recreational events, activities, or items should not be provided, regardless of: (1) their value; (2) whether Maquet engages the Healthcare Provider as a speaker or consultant; or (3) whether the entertainment or recreation is secondary to an educational purpose.

7. Reasonable Meals Associated with Provider Business Interactions

Maquet’s business interactions with Healthcare Providers may involve the presentation of scientific, educational, or business information and include, but are not limited to, the different types of interactions described in Part B, Sections 1 through 4 of this Compliance Plan. Such exchanges may be productive and efficient when conducted in conjunction with meals. Accordingly, reasonable meals may be provided as an occasional business courtesy consistent with the limitations in this section. All meals will be provided in compliance with applicable state laws and regulations. Some states may have more restrictive limitations on the provision of meals to Healthcare Providers. In these states, Maquet Employees will act in accordance with applicable state laws.

Purpose. The meal will be incidental to the bona fide discussion of scientific, educational, or business information and provided in a manner conducive to the discussion of such information. The meal will not be part of an entertainment or recreational event.

Setting and Location. Meals will be in a setting that is conducive to bona fide scientific, educational, or business discussions. Meals may occur at the Healthcare Provider’s place of business. However, in some cases the place of business may be a patient care setting that is not available for, or conducive to, such scientific, educational or business discussions. In other cases, it may be impractical or inappropriate to provide meals at the Healthcare Provider’s place of business, for example, (a) where the medical product or technology cannot easily be transported to the Healthcare Provider’s location, (b) when it is necessary to discuss confidential product development or improvement information, (c) where a private space cannot be obtained onsite, or (d) where the demands of a Healthcare Provider’s practice dictate limited opportunities for interactions or meetings at other than offsite locations (e.g., during non-business hours or non-work days). In such cases, meals may be provided in an off-site location that is conducive to bona fide scientific, educational or business discussions to the extent permissible under applicable state laws and regulations.

Participants. Maquet may provide a meal only to Healthcare Providers who actually attended a meeting. Maquet will not provide a meal for an entire office staff where everyone does not attend the meeting. Maquet will not provide a meal where its representative is not present (such as a “dine & dash” program). Maquet will not invite spouses or guests of Healthcare Providers or any other person who does not have a bona fide professional interest in the information being shared at the meeting and will not provide meals to such persons except, in the rare circumstances, where it is unavoidable as a matter of civility and common courtesy.

Other principles. Depending on the type of business interaction or meeting, additional principles may apply, as described in other sections of the Compliance Plan. Specifically:

• Part B, Section 1: Maquet-Conducted Product Training and Education.
• Part B, Section 2: Supporting Third-Party Educational Conferences.
• Part B, Section 3: Sales, Promotional, and Other Business Meetings.
• Part B, Section 4: Consulting Arrangements with Healthcare Providers.

8. Medically-Relevant Items; Prohibition on Personal Gifts

Maquet occasionally may provide items to Healthcare Providers that benefit patients or serve a genuine medically-relevant function for Healthcare Providers. Other than medical textbooks, anatomical models or other similar medically-relevant items useful to the advancement of medical care, any such item should have a fair market value of less than $100. Maquet will not provide items that are for personal use by the Healthcare Provider (or his or her family members, office staff or friends). For example, a DVD player, computer or digital music player. Maquet will not provide Healthcare Providers with personal gifts such as cookies, wine, flowers, chocolates, gift baskets, holiday gifts or cash or cash equivalents. Further, Maquet will not give Healthcare Providers any type of non-educational branded promotional items, even if the item is of minimal value and related to the Healthcare Provider’s work or for the benefit of patients. Examples of non-educational branded promotional items include pens, notepads, mugs and other items that have Maquet’s name, logo, or the name of one of its medical technologies. Maquet Employees’ personal funds should not be used to provide gifts or items to Healthcare Providers that would otherwise be prohibited by this Section 8. This section is not intended to address the legitimate practice of providing products for evaluation and demonstration purposes, which is addressed in Part B, Section 11 of this Compliance Plan.

9. Provision of Coverage, Reimbursement and Health Economics Information

As medical products and technologies have become increasingly complex, so have payor coverage and reimbursement policies. Patient access to necessary medical products and technology may be dependent on Healthcare Providers and/or patients having timely and complete coverage, reimbursement, and health economic information. Consequently, Maquet may provide such information regarding its medical products and technologies if it is accurate and objective. Maquet may collaborate with Healthcare Providers, patients and organizations representing their interests, to achieve government and commercial payor coverage decisions, guidelines, policies, and adequate reimbursement levels that allow patients to access its products and technologies. Permissible activities involving the provision of coverage, reimbursement and health economic information may include, but are not limited to:

• Identifying the clinical value of Maquet’s products and technologies and the services and procedures in which they are used when providing coverage, reimbursement and health economics information and materials to Healthcare Providers, professional organizations, patient organizations, and payors.
• Collaborating with Healthcare Providers, their professional organizations, and patient groups to conduct joint advocacy on coverage, reimbursement and health economics issues; supporting Healthcare Providers and their professional organizations in developing materials and otherwise providing direct or indirect input into payor coverage and reimbursement policies.
• Promoting accurate Medicare and other payor claims by providing accurate and objective information and materials to Healthcare Providers regarding Maquet’s products and technologies, including identifying coverage, codes and billing options that may apply to those products and technologies or the services and procedures in which they are used.
• Providing accurate and objective information about the economically efficient use of Maquet’s products and technologies, including where and how they can be used within the continuum of care.
• Providing information related to Maquet products and technologies regarding available reimbursement revenues and associated costs.
• Providing information related to changes in coverage or reimbursement amounts, methodologies and policies and the effects of such changes in order to facilitate a Healthcare Provider’s decision to buy or use the Maquet’s products or technologies.
• Providing accurate and objective information designed to offer technical or other support intended to aid in the appropriate and efficient use or installation of Maquet products or technologies.
• Facilitating patient access to Maquet’s products or technologies by providing Healthcare Providers with assistance in obtaining patient coverage decisions from payors. This assistance may include providing information and/or training on payor policies and procedures for obtaining prior authorization, and providing sample letters and information on medical necessity and appeals of denied claims.

Maquet will not interfere with a Healthcare Provider’s independent clinical decision making or provide coverage, reimbursement and health economics support as an unlawful inducement. For example, Maquet will not provide free services that eliminate an overhead or other expense that a Healthcare Provider would otherwise of business prudence or necessity have incurred as part of its business operations. Any contract to provide services of value to Healthcare Providers will be consistent with fair market value for legitimate reasonable and necessary services. Further, Maquet will not suggest mechanisms for billing for services that are not medically necessary, or for engaging in fraudulent practices to achieve inappropriate payment. In addition, Maquet will not provide reimbursement support services in connection with any other service or program that confers a benefit on a Healthcare Provider. For example, Maquet will not couple reimbursement support services with an income guarantee, or any other promise whereby a Healthcare Provider’s normal financial risks are eliminated.

10. Research and Educational Grants and Charitable Donations

Maquet may provide research and educational grants and charitable donations. However, Maquet will not provide such grants or donations as an unlawful inducement. Therefore, Maquet has: (a) adopted objective criteria for providing such grants and donations that do not take into account the volume or value of purchases made by, or anticipated from, the recipient; (b) implemented appropriate procedures to ensure that such grants and donations are not used as an unlawful inducement; and (c) ensured that all such grants and donations are appropriately documented. To reduce the risks that a grant program or charitable donation is used improperly to induce or reward product purchases or to market product inappropriately, Maquet will separate its grant making and charitable donations functions from its sales and marketing functions. Maquet’s sales personnel will not provide input about the suitability of a proposed grant or charitable donation recipient or program, and sales personnel will not control or influence the decision of whether a particular Healthcare Provider or institution will receive a grant or donation or the amount of such grant or donation. In the event Maquet’s sales personnel receive any request from a Healthcare Provider for a research or educational grant, or a charitable donation, such sales personnel may provide the Healthcare Provider with the contact information of an appropriate contact within Maquet.

• a. Research Grants

  Research provides valuable scientific and clinical information, improves clinical care, leads to promising new treatments, promotes improved delivery of healthcare and otherwise benefits patients. In furtherance of these objectives, Maquet may provide research grants to support independent medical research with scientific merit. Such activities should have well-defined objectives and milestones and may not be linked directly or indirectly to the purchase of Maquet products or technologies.
  
  

• b. Educational Grants

  Educational grants may be provided for legitimate purposes, including, but not limited to, the examples below. Maquet will not make educational grants as an unlawful inducement.
  
  Continuing Medical Education. As noted in Part B, Section 2, Maquet may support conferences sponsored by accredited continuing medical educational providers in various ways.
  
  Graduate and Post-Graduate Medical Education. Maquet may make grants to support the genuine medical education of physicians, medical students, residents, and fellows participating in fellowship programs that are charitable or have an academic affiliation, or to support the health education of other medical personnel.
  
  Public Education. Maquet may make grants for the purpose of supporting education of patients or the public about important healthcare topics.
  
  

• c. Charitable Donations

  Maquet may make monetary or product donations for charitable purposes, such as supporting indigent care, patient education, public education, or the sponsorship of events where the proceeds are intended for charitable purposes. Donations will be motivated by bona fide charitable purposes and should be made only to bona fide charitable organizations or, in other instances, to individuals engaged in genuine charitable activities for the support of a bona fide charitable mission. Maquet will exercise diligence to ensure the bona fide nature of the charitable organization or charitable mission.

11. Evaluation and Demonstration Products

Providing products to Healthcare Providers at no charge for evaluation or demonstration purposes can benefit patients in many ways. These benefits include improving patient care, facilitating the safe and effective use of products, improving patient awareness, and educating Healthcare Providers regarding the use of products and technologies. Under certain circumstances described below, Maquet may provide reasonable quantities of products to Healthcare Providers at no charge for evaluation and demonstration purposes. This section is limited to providing evaluation and demonstration products only and is not intended to address any other arrangement. Member products that may be provided to Healthcare Providers for evaluation include single use (e.g., consumable or disposable products) and multiple use products (sometimes referred to as “capital equipment”). These products may be provided at no charge to allow Healthcare Providers to assess the appropriate use and functionality of the product and determine whether and when to use, order, purchase, or recommend the product in the future. Maquet’s products provided for evaluation are typically expected to be used in patient care.

Single Use/Consumables/Disposables. The number of single use products provided at no charge will not exceed the amount reasonably necessary for the adequate evaluation of the products under the circumstances.

Multiple Use/Capital. Multiple use products provided without transfer of title for evaluation purposes will be furnished only for a period of time that is reasonable under the circumstances to allow an adequate evaluation. The terms of an evaluation of such multiple use products will be set in advance in writing. Maquet will retain title to such multiple use products during the evaluation period and should have a process in place for promptly removing such multiple use products from the Healthcare Provider’s location at the conclusion of the evaluation period unless the Healthcare Provider purchases or leases the products.

Demonstration. Demonstration products are typically unsterilized single use products or mockups of such products that are used for Healthcare Provider and patient awareness, education, and training. For example, a Healthcare Provider may use a demonstration product to show a patient the type of device that will be implanted in the patient. Demonstration products typically are not intended to be used in patient care. Demonstration products also are typically identified as not intended for patient use by use of such designations as “Sample,” “Not for Human Use,” or other suitable designation on the product, the product packaging, and/or documentation that accompanies products or technologies. If Maquet provides evaluation and demonstration products to Healthcare Providers, Maquet will furnish such Healthcare Providers with documentation and disclosure regarding the no charge status of such evaluation and demonstration products.

12. Discounts, Rebates and Other Price Concessions

Improperly structured discounts, rebates and other price concessions have the potential to improperly influence a customer’s decision-making regarding Maquet’s products. It is important that Maquet properly structure any discounts, rebates and price concessions that are given to customers to avoid possible violations of the Anti-Kickback Statute, the False Claims Act and other Federal and state laws and regulations.

• Providing Discounts to Customers
  Discounts may only be provided contemporaneously at the time of the product purchase or retrospectively in the form of a rebate. The basis of determining the discount must be established prior to the first sale of the product to which the discount applies. No up-front payment may be offered or made to a customer in lieu of a discount or rebate. Maquet may not provide cash payments or other benefits to a customer in exchange for a customer’s agreement to change to Maquet’s products from a competitor’s products (i.e., product switching).
  
  
• Disclosure of Discounts
  To comply with Federal guidelines, all discounts and rebates will be appropriately disclosed to customers as follows:
  
  
  - Maquet must provide written disclosure to the customer which appropriately reports the discount.
  
  
  - Discounts must be reflected on product invoices or statements where the amount of the discount is known at the time of the sale.
  
  
  - For arrangements where the amount of the discount is not known at the time of the sale (e.g., rebate arrangements or bundled pricing arrangements), Maquet must report the existence of the discount program on product invoices or statements, and must provide the buyer with documentation of the calculation of the discount, including identification of the specific goods or services purchased to which the discount will be applied, once such details become known, but in no event later than one year after the year in which the discount is earned.

Customers must be informed that they may have an obligation to reflect discounts on cost reports or claims submitted to Federal healthcare programs to the extent required and retain discount documentation and make it available to state or Federal healthcare program officials upon request.