Compliance Brochure

Last updated on 1 November 2023

Compliance For Planetree Business Partners

Introduction

Planetree International Inc. (hereinafter also “Planetree”) is committed to ethical interactions and to be compliant with all applicable laws, regulations, and industry codes. Planetree requires the same commitment from its Business Partners. The term “Business Partner” refers to any person or organization with which Planetree interacts that is not an affiliate, officer, director, or employee of Planetree.

Our valued Business Partners play a vital role in our success, but these relationships are not without risk for Planetree. Planetree and its affiliated companies may beheld responsible for the actions of its Business Partners. To mitigate this risk, Planetree insists that integrity be a central element of its relationships with Business Partners.

Planetree also insists that ethical conduct form the baseline for anything that a Business Partner does on behalf of Planetree or in connection with its business. This brochure provides information about Planetree’s expectations concerning ethical business practices to facilitate a successful relationship with its Business Partners.

A Joint Commitment

At Planetree we strive every day to improve the lives of patients, staff, and community around the world through superior products and services. Our patients, customers, payors, investors, and regulators expect our business to be conducted with integrity and in compliance with all applicable laws, regulations, and industry codes, and our continued success and reputation depend on our commitment to act accordingly.

Our business is highly regulated and subject to several complex laws, regulations, and industry codes. We are committed to growing our business in compliance with these standards, and we expect you – our Business Partners – to follow the principles detailed in this brochure, the Planetree Code of Ethics and Business Conduct(“Code”), and the guidelines of Planetree and policies that apply to your business. Failure to do so could expose you, Planetree, and the individuals involved to fines, loss of licenses, or other serious sanctions.

At Planetree, we take compliance seriously, and we insist that our Business Partners do so too. Planetree’s employees are guided by the Code, policies, and guidelines in their day-to-day work. Planetree does not require its Business Partners to follow the letter of its Code, policies, or guidelines, but it does expect its Business Partners to follow the principles of good business ethics that those documents articulate in addition to all applicable laws, regulations, and industry codes.

We are committed to growing our business in compliance with applicable laws, regulations, and industry codes because we believe this is the right thing todo. By acting with integrity, we earn the trust of our stakeholders, including customers, healthcare professionals, regulators, and our Business Partners. Trust is the key driver for our success. Mutual trust and compliance with the applicable standards are indispensable elements of a successful relationship for Planetree and its Business Partners.

Our success –that of Planetree and our Business Partners – depends on meeting our commercial objectives and how we meet them. By adhering to the highest ethical standards, we can raise the standard in our industry and our performance.

Please read this brochure carefully. You can also use it as a resource in case you have a question. If this brochure does not provide the information you are looking for, please do not hesitate to contact your Planetree business contact. You may also choose to submit your query on Planetree’s website, www.planetree.org,where you will also find further information on compliance at Planetree.

Our Expectations & Your Responsibilities

Your are responsible for:

1.      Acting with integrity to protect your reputation and our reputation too.

2.      Reading, understanding, and acting in accordance with the principles in the Code, Planetree guidelines and policies that we provide, and the letter and spirit of all legal, regulatory, and industry code obligations that apply to you.

3.      Asking questions when you are unsure how to approach a situation that may involve a law, regulation, industry code, or behavior described in the Code or this brochure. Planetree encourages you to address questions with your Planetree business contact or directly via our website.

4.      Reporting any suspected or actual violation of the law, regulations, industry codes, or the Planetree Code, guidelines, or policies. You can do so by getting in touch with your local Planetree business contact or by reaching out to us via our website.

5.      Cooperating with investigations and auditing/monitoring procedures that measure your adherence to the applicable standards, including those agreed to in your contract, and implementing any corrective measures.

Why are we asking you to make compliance a priority?

Because it is in OUR interest: As a company, we cannot afford to be associated with unethical or illegal business practices, nor can we afford to do so. We therefore need to know who we are working with and be certain that our partners are equally committed to impeccable business conduct.

Because it is in YOUR interest: As our Business Partner, you need to be aware of potential pitfalls. Your commitment to compliance is critical for your success in dealing with us (and other companies). You, as a company, and your employees may expose yourselves to potential risks, including prosecution and negative impact on you or your business, if you do not actively take measures to avoid improper conduct.

Because WE ALL have a vital interest: As corporate citizens, we have a responsibility to contribute to a society that is corruption-free. In addition, it is not enough to disapprove of illegal or unethical business conduct. We expect ourselves and our partners to prevent, detect, and respond to such conduct with zero tolerance.

Anti-Corruption / Anti-Bribery (ABC)

Planetree does not tolerate any form of corruption, regardless of whether it involves a healthcare professional, government official, private party, or the purchase or sale of goods or services by Planetree. We expect our Business Partners to make business and regulatory decisions and otherwise perform their responsibilities on the basis of price, quality, and service.

As a global company, Planetree must comply with the anti-corruption laws of many jurisdictions, including:

·        The U.S. Foreign Corrupt Practices Act (FCPA)

·        The U.K. Bribery Act (UKBA)

·        The German Criminal Code

·        The anti-corruption laws of each country in which we operate

ABC Laws prohibit:

·        Offering, promising, authorizing, or giving anything of value (including any good, service, or anything else, whether in the form of a personal benefit/favor or otherwise) to any person (government official, healthcare professional, or their family members, etc.), directly or indirectly through our Business Partners, in order to secure an improper advantage or obtain or retain business.

·        The request or agreement to receive or accept anything of value personally or for any other person or entity in order to secure an improper advantage or influence a business decision

A bribe is anything of value offered, promised, or provided to or received from anyone in order to improperly influence a decision or to reward them for past inappropriate conduct. Bribes can include:

·        Cash and cash equivalents

·        Gifts (in cash or in kind)

·        Meals, entertainment, event sponsorship

·        Travel expenses, etc.

All of our Business Partners are expected to comply with the letter and spirit of all applicable laws, regulations, and industry codes. This brochure notes that our Business Partners’ failure to do so can result in liability for Planetree. For example, Planetree may face FCPA liability for improper payments that our Business Partners make in connection with Planetree business. We will not maintain relationships with Business Partners engaged in any unlawful or unethical practices.

Conflicts of Interest

Conflicts of interest (COIs) are separate from bribery and corruption, but frequently go hand in hand with corruption. The existence of corruption or bribes frequently also implies (undisclosed) personal relationships – and vice versa. A COI arises when personal interests either influence, have the potential to influence, or may be perceived to influence your business judgment or decision-making. Such situations should be avoided.

Examples of COIs may include:

·        Personal relationships with a Planetree employee that improperly influence how you or the employee perform your/their work

·        Referring one of your relatives for employment at Planetree and leveraging your commercial position to ensure that the relative receives the position

·        Serving on the board of directors or advisory board of a Planetree competitor or customer and using information you have as a Business Partner to benefit the competitor

·        Working for a Planetree customer while also actively supporting sales business to that customer to the benefit of Planetree

·        Being employed by Planetree in addition to being a Planetree customer or sales intermediary and misusing internal information to Planetree’s detriment and to benefit your position as a customer/sales intermediary

Handling COIs

Transparency is key. Potential and actual COIs should be disclosed to Planetree. We will assess whether the relationships can exist in parallel, and if controls or safeguards need to be applied to ensure that fair, unbiased business decisions are made. Please reach out to your Planetree business contact.

Third Parties in a Position of Influence

Avoiding corruption and conflicts of interest starts with being mindful about our relationships with and approach toward individuals and bodies that could influence our business. Those who have the authority to decide on or influence a decision about business awarded to Planetree or its Business Partners, for example, should not be unduly influenced or “convinced” to act. Arguments in favor of Planetree and our Business Partners should be based on fair terms, market pricing, service, and products, and should not be derived from anything other than an ethical business relationship. Care should be taken that decisions are made without any unjust bias in favor of Planetree or our Business Partners.

Special caution should be applied when we interact with government officials and healthcare professionals (who sometimes are government officials at the same time, especially if they work at public hospitals). Many legal frameworks impose more severe sanctions when government officials are targeted improperly by companies with illegal propositions. In addition, the threshold for what is impermissible to offer a government official may be significantly lower than when dealing with private individuals. The following section defines some of the key terms, followed by guidance about how relationships with influential Third Parties should be dealt with.

Government Official: A government official is any individual, whether elected, appointed, or employed in public service, acting on behalf of any local, regional, state, or national government (such as health, customs, tax, or judicial officials or administrators), as well as (i) individuals acting on behalf of a government-owned or government-controlled enterprise (such as doctors and staff of public hospitals or universities), (ii) individuals who represent political parties or are candidates for political office, and (iii) individuals acting on behalf of public international organizations (such as the United Nations, World Bank, or Organization for Economic Co-Operation and Development (OECD).

Healthcare Professional: Any individual who is a member of the medical, dental, pharmaceutical, or nursing professions AND who, in the course of his/her professional activities, may prescribe, purchase, supply, recommend or administer a medical device or a medicinal product. For the purpose of this definition, the term “healthcare professionals” includes: (i) any official or employee of a government, agency, or other organization (whether in the public or private sector) that may prescribe, purchase, supply, recommend, or administer medical devices or medicinal products and (ii) any employee of Planetree whose primary occupation is that of a practicing healthcare professional, but excludes both (a) all other employees of Planetree and (b)wholesalers or distributors of medical devices or medicinal products.

Potential Referral Source: A potential referral source is a person or entity who is in a position to refer patients or business to Planetree. Examples include physicians, physicians’ immediate family members, physician assistants, hospitals, nursing homes, skilled nursing facilities, rehabilitation hospitals, and hospital staff or administrators, among others.

When dealing with a someone in a position to influence Planetree’s business, the following principles apply:

·        Bona fide and documented business should exist for the proposed good or service that Business Partners are considering providing.

·        An engagement should not correspond to an improper incentive or reward for a past, current, or future Planetree business transaction.

·        Any Business Partner engaged to further Planetree’s business must have the experience, expertise, and resources to provide the required services in an appropriate, accurate, and timely manner.

·        No business engagements may be entered into with spouses, immediate family members (parent, sibling, child, or in-law), or close associates for the purpose of indirectly influencing or rewarding them for their action.

·        Goods or services must always be provided or obtained at fair market value, and the decision must be based on quality and price.

Travel & Lodging Expenses

The following principles apply in connection with travel and lodging:

·        Travel and lodging expenses should be connected to a legitimate business purpose and provided in accordance with applicable local laws, regulations, and industry codes.

·        Reimbursement can only be granted for travel and lodging expenses, which are reasonable in value (e.g., no luxury accommodations) and appropriate for the business purpose.

·        Travel and lodging expenses should not be offered or paid with the intention of securing or rewarding an improper benefit or business advantage.

·        Paying any expenses, including travel and lodging expenses, for a spouse, family member, or guest of a Business Partner is not allowed.

·        Travel and lodging expenses for individuals in a position of influence should be subject to monitoring and oversight.

·        Travel and lodging expenses incurred should be completely and accurately recorded in your books and records

Please refer to the Planetree travel policy for further information on reimbursable expenses.

Business Gifts, Meals & Entertainment

Business gifts and hospitality, such as meals and entertainment for government officials, frequently play a big role in corruption and bribery cases. Luxurious meals, entertainment, and gifts offered to valued customers, decision-makers or Business Partners designed to “motivate” them to decide in favor of a certain proposal or project, or to reward them for a past decision, are commonplace incorruption and bribery cases.

It is therefore essential that any gifts, meals, or entertainment are provided in compliance with applicable laws, regulations, and industry codes. Planetree encourages its Business Partners to avoid even the appearance of improper conduct. Ask yourself: What impression does the gift, meal, or entertainment create in the mind of a neutral bystander?

Gifts: Gifts include any item of monetary or non-monetary value provided as a token of appreciation. Gifts DO NOT include product promotions, donations, or sponsorships, which are addressed in other Planetree policies. Planetree will educate you on the principles of those policies if you engage in such practices in connection with Planetree business.

Meals: Meals refer to any food or beverage expenses

Entertainment: Entertainment refers to any cultural, social, sporting, leisure, or recreational event.

Hospitality: Hospitality includes payment for or provision of meals and entertainment. Hospitality does NOT include travel or lodging, which is addressed in the section above.

Key considerations include:

·        You should not give, offer, or accept any gift or hospitality with the intention of an improper benefit or business advantage.

·        Care should be taken that providing or receiving a gift or hospitality will not be construed as a bribe.

·        Gifts and hospitality should be given or accepted in an open and transparent manner and not via intermediaries.

·        Gifts of cash or a cash equivalent (such as gift cards, checks, or vouchers) should never be offered, given, or accepted.

·        Gifts and hospitality should not be provided to spouses, relatives, or friends of anyone unless the recipients independently have a legitimate business reason to receive them.

·        If offered, meals should be modest and appropriate given recipient’s position and occasion.

·        Venues should be conducive to informational communication and business discussion.

·        We encourage our Business Partners to prohibit entertainment, regardless of value, and expect them to appropriately record it in their books and records

Customers, Advertising & Promotion

The manner in which Planetree conducts its business and promotes its products and services is sometimes regulated. Planetree has developed specific policies to ensure that business practices, as well as marketing and promotional activity, comply with applicable laws, regulations, and industry codes. All promotional material regarding Planetree products or services should be handled carefully.

When discussing our products and services, we expect Business Partners and their employees, affiliates, and contractors to:

·        Always be truthful, accurate and not misleading in describing products and services

·        Provide a fair and balanced description of the benefits and risks

·        Only make statements that are supported by appropriate clinical or operational information

·        Ensure that all promotional statements are consistent with the product uses approved or cleared by their country’s government, and that their content and manner of dissemination follow the applicable laws, rules, and regulations

·        Avoid benefits that could be seen as an attempt to bribe or influence the recipient

Books & Records

All records related to Planetree business should accurately and fairly reflect the true nature and purpose of each transaction. Every transaction related to Planetree should be transparently and promptly recorded in the proper accounts.

We expect you to maintain internal accounting controls to protect the integrity of the financial records and accounts related to Planetree’s business. We expect you to maintain all paper and electronic records in accordance with applicable laws on data retention and as instructed by Planetree. You may not create, submit, or approve any false, misleading, or inaccurate records in connection with Planetree’s business. These requirements apply even if you believe that other behaviors would benefit Planetree.

Reporting Potential Violations

Planetree actively encourages its Business Partners to promptly report potential and actual violations of law, regulation, industry codes, or our Code of Ethics and Business Conduct.

What is a potential violation?

Potential compliance violations include the following:

·        Bribery or corruption, fraud, theft, or documentfalsification

·        Inappropriate disclosures of patient or companyinformation

·        Unethical behavior such as violations of thelaw, regulations, industry codes, or Planetree’s Code of Ethics and BusinessConduct

·        Any other matter which the reporter believes in good faith could cause substantial harm to the business or integrity of Planetree

Can reporters stay anonymous?

Yes. However, anonymous reports may not be allowed under local law in some countries (e.g., Spain). Also, it may help to further the investigation if a reporter discloses his or her identity and supports further contact to deal with clarifying questions. Even if reporters state their names, we will make every effort legally possible and appropriate to protect their confidentiality.

What should I do if I see or experience a potential violation?

Business Partners should not look the other way if they experience a situation that does not seem right. Often, it may be the right course of action to inform supervisors or compliance staff. Sometimes, however, it may not be entirely clear whom to trust with a sensitive matter or who might be in a position to provide appropriate guidance. If in doubt, or in situations where it may seem that reports to senior personnel are not being dealt with appropriately, we encourage our Business Partners to communicate via the Planetree compliance email at legal@planetree.org.

What if Planetree becomes aware of illegal conduct by its Business Partners?

We expect our Business Partners to conduct their business legally and ethically. If any of our Business Partners violate laws, regulations, industry codes, or applicable Planetree compliance policies, they may face suspension or termination of business relationship with Planetree or prosecution as per their governing authorities.

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