Compliance

Samsung Biologics fulfills our social roles and responsibilities as a CDMO company in the biologics industry by practicing legal and ethical compliance-oriented management principles and abiding by all applicable laws. To that end, we have a robust Compliance Program, which is the most fundamental aspect of fulfilling our company’s social responsibilities.

Through our education and system organization, we ensure compliance becomes the basis of all business activities and decision-making. In addition, our Compliance Program addresses management risks stemming from infringement of intellectual property rights, as well as strengthening our responsibility on the issues of human rights, safety, health, and the environment. We promote compliance with the laws to support our sustainable growth into a world-class company.

  • Our Compliance Program (CP) is composed of ongoing and integrated systems and activities, aimed at protecting the company and its employees and preventing/minimizing legal risks by requiring its employees to comply with laws and regulations when performing related tasks. of relevant laws and regulations by our employees.

  • Compliance Program Execution
    Compliance Program (CP) activities of Samsung Biologics are executed by our management through the following process : The establishment of CP standard procedures → Execution of education → Inspection and monitoring → Evaluation and reporting. The Legal & Compliance Management Department establishes and provides CP regulations, detailed guidelines, action standards, and manuals to employees. The department promotes legal compliance by continuous education and monitoring on daily basis. Additionally, it receives inquiries and reports regarding issues and concerns on the compliance of relevant laws and regulations by its employees.

Key CP Policies

Compliance practice for each category include: protection of confidential information, observance of fair trade, prevention of corruption, maintenance of environmental safety, protection of intellectual property, safeguard of information security, and protection of personal information.

Action Standards

The staff and executives of Samsung Biologics fully recognize the importance of compliance management. Samsung Biologics complies with all applicable laws and internal regulations, accomplishing the objectives including, but not limited to, the following:

1. Healthy Organizational Culture
We will respect the dignity and diversity of individual staff and executives, and comply with the laws related to personnel management.
2. Fair Competition
We will respect the free and fair market economic order and comply with the fair trade laws.
3. Working together with Subcontractors
We will work with cooperative companies as partners in business and not abuse our bargaining power.
4. Anti-Corruption
We will not improperly acquire business opportunities or receive benefits.
5. Accounting and Public Announcements
We will accurately record financial information according to internationally recognized accounting standards, and we will sincerely notify the public of required corporate information and important issues.
6. Confidential Information and Intellectual Property
We will protect confidential information and intellectual property rights.
7. Personal Information
We will protect personal information.
8. Safety, Health, and Environment
We will preserve the health and safety of our workers, the public, and the environment.

Reporting

For questions or comments regarding the legal & compliance management of Samsung Biologics, please contact us through the reporting channel.

We operate ISO 37001 ABMS (Anti-Bribery Management System) and ISO 37301 (Compliance Management System) certified compliance systems to ensure adherence to applicable laws and regulations, while promoting transparency throughout our business practices.

  • ISO 37001
    Anti-bribery Management Systems

    ISO 37001 is the international standard for anti-bribery management systems. The standard sets out requirements for measures to monitor and prevent bribery across the organization and its business activities.

  • ISO 37301
    Compliance Management Systems

    ISO 37301 is the international standard for compliance management systems. The standard sets out requirements for implementing policies and processes to ensure compliance with applicable laws and regulations.

We have received ISO 37001 and ISO 37301 certifications from the British Standards Institution (BSI).

Legal Compliance System

ABMS (Anti-Bribery Management System) & CMS (Compliance Management System)

Our Legal Compliance System, established and operated in accordance with the requirements of both the ABMS and CMS, effectively identifies and mitigates potential risks related to violations of laws and regulations, including bribery, throughout our business operations.

To maximize the effectiveness of our Legal Compliance System, we regularly conduct a variety of compliance activities, including training, monitoring, internal audits, and risk assessments. Additionally, we actively communicate our commitment to anti-bribery and compliance both internally and externally.

Compliance Policy

As a leading global CDMO, we are committed to complying with laws and ethical standards, maintaining a clean organizational culture, and fulfilling our responsibilities as a global corporate citizen.

To uphold these principles and promote compliance, we declare the following as our Compliance Policy.

  • The Company shall implement, operate, and continually improve its Anti-Bribery Management System (ABMS) and Compliance Management System (CMS)
  • The Company shall operate a whistleblowing channel through which concerns regarding bribery, corruption, and other compliance violations may be raised in good faith, and shall ensure that no harm comes to the whistleblower as a consequence of their actions.
  • Company shall designate the Compliance Officer as the person responsible for overseeing compliance governance and ensuring adherence to applicable obligations.
  • The Company shall take appropriate action against employees who violate compliance obligations, in accordance with internal policies and regulations.
  • Employees shall comply with company policies and applicable laws relevant to conducting company business.
  • Employees shall not engage in, or be complicit in, any acts of bribery.

Samsung Biologics President & CEO
John Rim

Anti-Corruption and Bribery Policy

Purpose

Samsung Biologics conducts its business by taking its responsibility as a global corporate citizen and complying with anti-corruption laws worldwide to uphold the business principles of complying with legal and ethical standards and maintaining a transparent organizational culture. Samsung Biologics has a zero-tolerance policy against corruption and bribery and it does not deliberately ignore nor overlook any corruptive acts. This Anti-Corruption and Bribery Policy (”Policy”) provides detailed anti-corruption guidelines and standards for directors, officers, and employees relating to all business activities of Samsung Biologics.

Application

This Policy applies to all directors, officers, and employees (including all permanent and temporary employees, contract workers, and corporate advisors) at Samsung Biologics Co. Ltd., and its subsidiaries and affiliated companies worldwide (collectively “Samsung Biologics”). Anti- corruption laws vary among countries. Therefore, certain subsidiaries or affiliated companies may have their own anti-corruption policies. In such case, both this Policy and the local policy must be followed. In case of any conflict in terms between the policies, the stricter standard will apply.

Definitions

  • ‘Government officials’ are broadly defined to include public officials (individuals engaged in the legislative, administrative, or judicial affairs of the government, whether appointed or elected), candidates for government offices, executives of political parties, employees of corporations that are government-owned or effectually operated by a government, employees of public institutions or organizations established to carry out public affairs, employees of international organizations (e.g. IMF, and etc.), an official agent or consultant of a government, and employees of other public service-related organizations or an individual entrusted with public affairs.
  • ‘Unfair business profit’ means any profit that is acquired in an unjustifiable way against laws, and etc.
  • ‘Anything of value’ means any tangible or intangible economic benefit provided in a favorable manner, and may include, but are not limited to: gifts, entertainment, cash, or securities.

Basic Principles

Compliance with Laws, Policies and Guidelines

Samsung Biologics’ executives and employees are responsible for complying with all applicable anti-corruption and bribery laws, and this Policy.

  • In addition to the local laws, applicable anti-corruption and bribery laws may include the US Foreign Corrupt Practices Act (“FCPA”), UK Bribery Act (“UKBA”), and the Improper Solicitation and Graft Act of Korea.

Prohibited Activities

  • No Bribery: Do NOT receive or request illegal money or valuables in connection with your work
  • Prohibition of providing illegal money or valuables to government officials, and etc.: Do NOT provide, offer, nor promise to give, money or anything of value, directly or through a third party to government officials, in exchange for an improper business interests.
  • Prohibition of improper solicitation: Do NOT make any illegal requests or make request that elicits abuse of authority, when dealing with government officials.
  • Prohibition on payment of facilitation fee: ‘Facilitation fee’ refers to a small amount of money paid to government officials for the purpose of expediting or facilitating the routine government services. DO NOT pay such fee.

Providing Gifts Hospitality and other Benefits

Gifts or hospitality provided to serve legitimate business purposes, or to maintain business relationships, are permissible if all of the following principles are met:

  • Conform to all applicable laws and the policies of a recipient’s organization
  • Have a legitimate business purpose and appearance of propriety
    * When there is a pending issue (e.g. admission, license, inspection, pending contract), providing a gift or hospitality requires extreme caution and providing cash is strictly prohibited.
  • Be reasonable in value and frequency
    * Gifts and hospitality should be nominal, infrequent, and appropriate under the circumstances, so that it does not exert improper influence on the recipient’s decision making.

* Particular care is required when offering gifts or hospitality to a government official and must be in compliance with the internal processes.

Donations, Contributions, and Sponsorships

Political Donations

Illegal political donations using Samsung Biologics’ assets are strictly prohibited.

Charitable Donations, Contributions, and Sponsorships

It is permissible to make legitimate charitable donations, contributions, or sponsorships to credible institutions and organizations. However, there must be no improper advantage or undue influence, and must be made in compliance with the internal processes.

Books and Records

Executives and employees must manage books and records in detail and accurately, through reflecting various transactions. Executives and employees must prepare accounting and financial reports fairly and appropriately in accordance with relevant laws and regulations, and must not record untrue or falsified information or omit information that should be recorded. In addition, the company must maintain and manage the integrity of data to prevent recorded contents from being forged, altered, or deleted during storage.

Implementation of Policy

Anti-Bribery Management System (ABMS)

Samsung Biologics will operate and continuously improve its ISO 37001 certified Anti-Bribery Management System, in order to effectively implement and enforce this Policy.

Reporting

Any Samsung Biologics employee, who knows of or suspects a violation of this Policy, or any anti-corruption and bribery laws of relevance, should report such violations to Samsung Biologics.

Reports may be made anonymously through e-mail (bio.cp@samsung.com or sbl.audit@samsung.com) or through the Samsung Biologics webpage. The whistleblower’s personal information will be kept confidential, and the contents of the report will also remain confidential. There will be no retaliation against a whistleblower who reports in good faith.

Disciplinary Actions and Others

Matters and procedures not specified in this Policy such as inspection and monitoring of compliance with the guideline and anti-corruption and bribery laws shall be subject to the company’s regulations and compliance program. Failure to comply with this Policy and anti-corruption and bribery laws will be grounds for disciplinary action according to the internal standards, up to and including termination of employment.

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