Ethics Policy

InSphero Due Diligence & Ethics Policy Statement

This Ethics Policy applies to InSphero AG, 8952 Schlieren, Switzerland, and to InSphero Inc., Brunswick, ME 04011, USA, and underlies the business of InSphero in terms of the development and production of biological products based on animal and human cells in compliance with applicable regulatory standards and ethical principles.

On April 24, 2024, the EU Parliament approved the Corporate Sustainability Due Diligence Directive (CSDDD). The CSDDD, also called the CS3D, obliges companies to carefully manage social and environmental impacts along their entire value chain, including direct and indirect suppliers and their own operations.

InSphero, belonging to the group of “Small and Medium-Sized Enterprises (SME)” with <1000 employees, will not be directly affected by CS3D. CS3D is currently in a 2-year transition period (2024-2026), in which EU member states will have to transpose the directive into national law and will then apply the law to larger-sized companies in a staged approach over an expected 3-5 year period. InSphero views this as an opportunity to voluntarily position and prepare itself at an early stage. InSphero has and will continue to implement provisions of CS3D in supporting its customers to comply with due diligence obligations.

The ethical sourcing of cells is a key aspect of InSphero’s due diligence in complying with CS3D. InSphero sources anonymized human biological samples exclusively via accredited third parties, which have received consented donations in compliance with all applicable national regulatory standards and ethical principles, such as those governed by the

• Organ Donation Legislation and Policy of the US Department of Health & Human Services
• The Swiss Human Research Act 810.30 (status 01Jan2020), Chapter 5, Articles 36 and 37, which requires consent of the deceased person prior to his/her death, or as applicable, consent by the next-of-kin.

InSphero never sources human biological samples from prisoners or from patients who are unable to consent or, respectively, whose next of kin are unable to consent.

In compliance with the Swiss Human Research Act 810.30 (status 01Jan2020), Chapter 2_2(b), InSphero does not require itself to receive ethical approval in using the sourced human biological samples in the development and production of its biological products, because those samples were received anonymized and/or de-identified and do not provide patient information that is considered Protected Health Information as defined in the US Health Insurance Portability and Accountability Act of 1996 (HIPAA).

All aspects of InSphero's work are governed by the respect for people, animals, and the environment. To this end, InSphero does

• promote ethical awareness at InSphero, and when interacting with business partners;
• give preference to suppliers from origins with acceptable global ratings with respect to ethical, environmental, and other risks;
• operate by high ethical standards in research and production involving materials of animal and human origin;
• require adherence to all applicable regulatory standards and ethics principles by our business partners, contract research organizations, and suppliers, and monitor their performance;
• address ethical dilemmas openly and honestly to find solutions for all stakeholders;
• comply with laws, regulations, standards and other relevant requirements and does act in accordance with international conventions;
• is an equal opportunity provider, treating all employees with respect and courtesy;
• uphold a company culture in which all Employees are expected to behave in a professional manner, exhibiting understanding and responsibility at all times;
• has implemented a Human Rights Officer who will be involved in investigating and resolving potential CS3D complaints, of which InSphero has been made aware.
  
  
  

  InSphero AG
  

  July 19, 2024/ Marion Bavand, PhD, MBA/ Head QA & General H&S/ Member of the Information Security Society Switzerland (ISSS)