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Compliance


ChemCon is a contract development and manufacturing organization based in Freiburg, Germany. The company specializes in the development and production of rare, but often life-saving active pharmaceutical ingredients in small quantities for medical applications.

1. Function and objectives of this compliance guideline (code of conduct)

This guideline presents responsible care measures for health, safety, working conditions, environmental protection and free market developments, to which ChemCon is committed at all times. It is addressed to all employees and especially to the management. Its aim is to ensure compliance with all legal regulations and internal guidelines through clear rules of conduct. It focuses on essential aspects that are important for the daily work. Appropriate advice must be sought in case of further questions. ChemCon informs every employee about these guidelines. The entire team is working together to comply with laws and internal guidelines. Therefore, all employees must read and understand this guideline.

2. Responsibility

Responsibility for ChemCon’ reputation

The company’s reputation is strongly influenced by the appearance, actions and behavior of each individual employee. Illegal or inappropriate behavior – of even just one employee - can already cause considerable damage for the company. Every employee is obliged to take care of ChemCon’s positive image and to maintain and promote it.

Management, responsibility and supervision

Integrity and compliance with legal requirements begin at the top of the company’s hierarchy. The following gives employees an idea of what leadership and support they can expect from their line-manager. Every manager has organizational and supervisory duties. Every manager is responsible for the employees entrusted to him or her and has an important role-model function. Managers must gain recognition through exemplary personal behavior, performance, openness and social competence. This means, among other things, that every manager must always emphasize the importance of ethical behavior and compliance with these guidelines in his or her daily work, make them a topic of discussion and promote them through their management style and training. It is also a manager's task to set clear and realistic goals and to be a positive example with their own action.

A manager must give his employees as much personal responsibility and freedom of action as possible. At the same time, he or she must clearly demonstrate that compliance with the law and internal guidelines is the top priority at all times and under all circumstances. The manager must be available for employees in case of any uncertainties regarding compliance with legal regulations, but also to answer any questions or to address any professional or personal concerns. However, the responsibility of the manager does not release the employees from their own responsibility.

The manager is responsible for ensuring that no violations of the law occur in his or her area of responsibility that could have been prevented by appropriate control. They also retain responsibility for tasks that have been individually delegated.

The manager’s duties are:

  1. The manager must carefully select employees according to their personal and professional qualifications and suitability for the position. The due diligence increases with the importance of the task that the employee has to perform (duty of selection).
  2. The manager must define tasks precisely, completely and bindingly, in particular with regard to compliance with the legal policies (duty of instruction).
  3. The manager must ensure that compliance with legal policies is continuously monitored (duty of supervision).
  4. The manager must clearly communicate to his employees the importance of integrity and compliance with legal regulations in daily business and stress that violation of the law is not accepted and will result in disciplinary measures (duty of communication). 
3. Business integrity and fair competition

ChemCon only conducts business in accordance with fair competition. ChemCon does not tolerate corruption, blackmail and embezzlement. Employees may not pay or accept bribes or participate in any illegal interaction or influence regarding business relations.

Fair competition:

Fair competition is a prerequisite for free market development and the associated social benefits. Accordingly, the principle of fairness also applies to the competition for market share. Every employee is obliged to comply with the rules of fair competition. Employees are therefore not permitted to, for example:

  • collude with competitors on prices, output, capacity, sales, tenders, profit, profit margins, costs, methods of distribution or other factors which determine or influence the competitive behavior of the company with the aim to persuade the competitor to a similar behavior.
  • enter into any agreements regarding a waiver of competition, the restriction of business relations with suppliers or the submission of sham offers in connection with tenders.
  • acquire competition-relevant information through espionage, bribery, theft or wiretapping or to knowingly spread false information about a competitor or its products or services.

Avoiding conflicts of interest:

ChemCon's employees are obliged to take business decisions in the company’s best interests rather than based on personal interests. Conflicts of interest arise when employees pursue their own activities or personal interests at the expense of the company's interests. No employee may accept private assignments from companies with which he or she has dealings in the course of his or her business tasks if this could result in an advantage for the employee. This also applies to business relationships with or investments in a competitor or customer as well as to sideline activities of employees that prevent them from fulfilling their tasks at ChemCon in accordance with their duties.

No employee may use his professional position to demand, accept, obtain or be promised advantages. This does not include the acceptance of gifts of symbolic value or meals or events of reasonable value, providing that local customs are respected. Without consulting their supervisor, employees may only accept gifts of up to 35 Euros. All gifts, meal or event invitations exceeding this amount must be declined.

Prohibition of insider trading and the use of non-public information:

ChemCon's employees may come across important, non-public information about (listed on the stock market) customers while working on a project. The purchase or sale of shares of a company with knowledge of such important, non-public information is considered "insider trading" and is not permitted to ChemCons employees. Furthermore, employees may not pass on such important, non-public information to other persons for personal gain ("tips"). Information is considered important non-public information if there is a reasonable likelihood that an investor would consider it important in deciding for or against buying or selling a share.

Unfair competition:

ChemCons employees must not attempt to obtain information from or about customers or suppliers or competitors in an illegal or unfair manner. It is also strictly prohibited to steal proprietary company information, possess confidential business information acquired without the owner's consent, or request past or present employees to disclose such information. Furthermore, all employees are already subject to strict confidentiality obligations under their employment contracts.

Business relations with suppliers

ChemCon expects its suppliers to share ChemCon's value principles and to comply with all legal regulations. Furthermore, ChemCon expects its suppliers to apply the following principles:

  • compliance with all applicable laws,
  • the renunciation of corruption,
  • respect for the human rights of its employees,
  • compliance with the laws against child labor,
  • assuming responsibility for the health and safety of employees,
  • compliance with the relevant national laws and international standards on environmental protection and
  • the demand that these value principles are also implemented / adhered to in the own supply chain.

Fighting corruption:

ChemCon is subject to regulations and principles on bribery and anti-corruption and expects its employees to comply with the spirit and terms of these guidelines. In addition, no supplier and no person working on behalf of ChemCon may offer or accept bribes, slush money or other improper payments. Further, ChemCon’s employees are prohibited from providing any benefit of any kind that is intended to improperly influence a business decision or to give - or even appear to give - an unfair competitive advantage. This does not include occasional gifts of token value or meals and entertainment of reasonable value, providing that local customs are respected.

ChemCon wins contracts fairly on the basis of the quality and price of its services and not by offering or promising improper advantages.

Trade control:

ChemCon employees must agree to comply with all applicable laws regarding imports, re-imports, exports, re-exports, and diversion of products, goods, services, and technical data/specifications, including import and customs laws, export controls, economic sanctions, blacklists, anti-boycott laws, and product diversion.

Reporting concerns

ChemCon’s employees are urged to report illegal actions of colleagues in connection with their work to the management.

4. Work environment

Principles

ChemCon’s employees practice ethically correct working methods and procedures. Supervisors' responsibility for ChemCon’s employees includes raising awareness and understanding of human rights and compliance with employment and labor laws and practices. By incorporating these principles into policies and procedures, all employees are expected to fulfill their basic responsibility to their colleagues and others. ChemCon’s employees must support and respect the protection of internationally recognized human rights and also ensure that they are not complicit in human rights violations.

Protection against harassment, discrimination and abuse in the workplace

ChemCon offers all employees jobs that are free of harassment, discrimination, punitive and/or inhuman treatment. Harassment is defined as any physical or verbal act that creates an aggressive, hostile or intimidating work atmosphere. Discrimination is any action in the workplace, such as hiring, firing, demotion and promotion that results in unfair treatment of employees based on prejudice of any kind. Harassment or discrimination based on ethnic origin, color, age, gender, sexual orientation, disability, religion, political affiliation, union membership or marital status is not condoned or tolerated.

Punitive and/or inhuman treatment includes, but is not limited to, all forms of sexual harassment, sexual abuse, corporal punishment, mental or physical coercion, abuse or threats of such treatment.

Violence of any kind in the workplace, including violence or threats of violence against another person, intentional damage of a person's property or conduct that makes others feel unsafe, is strictly prohibited and will be punished without exception.

5. Occupational Health and Safety

The health and safety of the employees at their workplace receives upmost priority at ChemCon. Every employee has a shared responsibility to support ChemCon in its efforts to create safe working conditions. Responsibility towards employees and colleagues requires the best possible precautions against hazards through accidents and applies to:

  • the technical planning of laboratories, workplaces, technical equipment and processes,
  • the safety management, and
  • the personal behavior during day-to-day working routines.

The working environment must meet the requirements of a health-oriented design. Every employee is sensitized to pay constant attention to occupational health and safety.

Protection of staff

ChemCon’s employees are trained and instructed to protect colleagues in the workplace and in other facilities provided by the company from contact with chemical, biological and physical hazards and not to impose unreasonably physically demanding tasks on them. ChemCon ensures that all employees who come into contact with hazardous substances wear appropriate personal protective equipment and perform according tasks on the basis of safety guidelines and risk assessments.

Process safety and risk assessments

ChemCon has implemented processes and measures to prevent or react to catastrophic chemical or biological releases in case of an accident. The programs correspond to the risks of the facility and equipment and comply to or exceed local laws.

For all processes facilities/equipment/machines/premises used, appropriate risk assessments and, if necessary, standard operating instructions are prepared before operation. All employees concerned in the operation are being trained regarding personal protection measures identified in the risk assessments. Protection measures are made comprehensible through instruction and must be observed by all employees concerned. Operating instructions must be observed as a matter of principle. Every employee is requested to report any shortcomings in protective measures, instructions or operating instructions found during operation to his or her supervisor.

Emergency and hazard prevention

ChemCon’s employees are trained in reacting to emergencies affecting the workplace and are urged to minimize potential adverse effects on their workplace by implementing and maintaining procedures that prevent hazards. The management is committed to reviewing deficiencies identified by ChemCon’s safety officers and, if necessary, to assist in rectifying them. Safety-awareness trainings, safety drills or other types of safety training will be provided as required according to local fire-safety and security regulations.

Safety information regarding hazardous activities or substances

Employees are obliged to read and follow all relevant safety information relating to hazardous activities before starting work, in particular with hazardous substances and machinery, in order to protect themselves and others from danger. In case of any uncertainties, employees are obliged to consult their supervisors or occupational safety officer.

6. Environmental protection

Environmental protection and the conservation of natural resources are important corporate goals for ChemCon. Every employee is required to contribute to these goals through his or her own conduct. ChemCon's employees are encouraged to conserve and preserve natural resources, to handle environmentally hazardous substances with care and to reduce their use to a necessary minimum. They are also encouraged to promote activities that allow materials to be reused.

Environmental licenses

ChemCon commits to comply with all applicable environmental laws, regulations and requirements of the responsible authorities. Employees must ensure that all required environmental permits (in Germany according to the Federal Ambient Pollution Control Act, BImSchG) are available. All operational reporting obligations must be complied with and data requested by the authorities must be submitted.

Waste and emissions

ChemCon and the employees must ensure that appropriate systems are set up to guarantee the safe handling, movement and storage of waste, especially chemical waste. Whenever possible, recycling or reuse will be pursued in compliance with safety regulations. The discharge of waste water that has a potential adverse effect on human health or the environment into the public sewerage system or into is not permitted. Emissions of exhaust gases harmful to health or the environment are being minimized, if necessary by using technical means such as gas scrubbers. 

Leaks and releases

ChemCon and its employees ensure that necessary systems are in place to prevent or to react quickly in the case of leakages and releases into the environment. 

Restricted and controlled substances 

ChemCon and its employees are obliged to comply with all applicable laws, regulations and authority requirements regarding substances with restricted use, e.g. according to BImSchG, REACH (Registration, Evaluation, Authorization and Restriction of Chemicals manufactured in or imported into the European Union) or BtMG (German Narcotics Act). Prior to the procurement of substances, it is the obligation of ChemCon and its employees to obtain information about these restrictions of use from the respective company contact persons. All internal and legal regulations for documentation, labelling, recycling and disposal must be complied with.

Freiburg, May 12, 2020