Biogenity's Code of Conduct

Biogenity’s Code of Conduct – Third party obligations

Under Biogenity’s Code of Conduct Third Parties are professionals and entities performing activities within Biogenity’s core business areas either on behalf of or in the material interest of Biogenity. The activities performed by Third Parties include, but are not limited to, non-clinical safety research and other research activities, clinical research, interactions with authorities e.g. customs or agencies, market access activities, medical information or promotional activi-ties, sales and marketing activities including distribution and public relations activities.

To the extent relevant for its exercise of rights and performance of obligations under the agreement(s) entered into with Biogenity (the “Agreement”), a Biogenity Third Party must undertake to comply with the obligations below:

The version of these obligations in effect at the time of execution of the Agreement or amendment thereof shall apply (see Biogenity’s website for the latest version).

A Biogenity Third Party shall ensure that all relevant employees are aware of their below obli-gations and trained as needed. A Biogenity Third Party shall promptly notify Biogenity, if it suspects or becomes aware of any acts or omissions by its employees that conflict with its below obligations. In case of inconsistency between the terms and conditions of the Agree-ment and the below requirements, the terms and conditions which represent the strictest obli-gations on a Biogenity Third Party shall apply.

Biogenity shall have the right to audit relevant books, records, facilities etc. of a Biogenity Third Party to ensure compliance with the below obligations. A Biogenity Third Party shall as-sist in good faith and make all appropriate personnel, procedures, books, records etc. availa-ble to Biogenity auditors during any such audits.

Responsible and Transparent Interactions

A Biogenity Third Party shall perform its obligations under the Agreement with professionalism and without bias or conflicts with its own professional or personal interests. Furthermore, a Biogenity Third Party must only interact with Public Officials when this is necessary, legitimate and mutually beneficial.

This signifies that the interaction shall always have a professional purpose, be conducted in a manner that is transparent, free from undue influence or conflicts of interest, and shall benefit both Biogenity and society. Furthermore, all such interactions including any related expenses must be in accordance with applicable laws and regulations.

Fair and Open Competition

A Biogenity Third Party shall comply with all applicable laws, regulations, guidelines and in-dustry standards in order to preserve and protect free and open competition and to avoid abu-sive behavior that may restrain competition.

Anti-corruption

A Biogenity Third Party has not and shall not engage directly or indirectly in bribery including small amount bribes or facilitation payments.

Furthermore, a Biogenity Third Party has not and shall not engage directly or indirectly in fi-nancial fraud against Biogenity, its partners or government entities. A Biogenity Third Party shall maintain accurate books and records relating to its performance under the Agreement and ensure that there are adequate internal controls in place with respect to prevent such fraud and corruption.

Interactions with healthcare professionals and patient organisations

A Biogenity Third Party shall ensure that all interactions with healthcare professionals, healthcare organizations and patient organizations are for legitimate reasons and in accordance with applicable laws, regulations and industry standards.

Specifically, when interacting with healthcare professionals, healthcare organizations and pa-tient organizations a Biogenity Third Party shall

1. be able to document the legitimate need for and professional purpose of any interac-tion;
2. ensure that any interaction is free of conflicts of interest;
3. ensure that a written agreement is in place before the commencement of any collabo-ration or fee for service arrangement and the compensation offered reflects the fair market value;
4. ensure that only appropriate locations and venues that are conducive to the professional purpose of events are selected or sponsored;
5. not provide any entertainment leisure or social activities at events and ensure that no spouses, family members and other companions are invited;
6. only pay for travel, meals, accommodation and registration fees if inviting participants to events and keep all related costs reasonable;
7. not supply, offer or promise any gift or pecuniary advantage (in cash or benefit in kind) to healthcare professionals, healthcare organizations and patient organizations; and
8. maintain systems and procedures to ensure all transfers of value to healthcare profes-sionals, healthcare organizations and patient organizations are recorded, reported or disclosed according to applicable regulations and standards

Donations and grants

A Biogenity Third Party shall ensure that any donations or grants provided by such Biogenity Third Party under the Agreement are subject to written approval by Biogenity on a case by case basis. Furthermore, all donations and grants

1. must be provided for bona-fide purposes;
2. shall not be given to obtain business advantages; and
3. must adhere to applicable laws, regulations, guidelines and industry standards

Animal Research

A Biogenity Third Party shall maintain animal research policies and procedures that comply with applicable laws, regulations, guidelines and industry standards.

Furthermore, a Biogenity Third Party shall ensure that all of its employees working with animals have received appropriate and documented education and training.

Clinical Research

A Biogenity Third Party shall ensure that all clinical research activities are performed in ac-cordance with applicable laws, regulations, guidelines and industry standards, including, with-out limitation, international guidelines, Good Clinical Practice (GCP) and ethical standards that meet international requirements.

Furthermore, a Biogenity Third Party shall ensure that all of its employees have been trained in relevant study procedures prior to being involved in clinical research activities.

Promotional Activities

A Biogenity Third Party shall ensure that all promotional activities performed by such Biogeni-ty Third Party fully adhere to applicable laws, regulations, guidelines and industry standards. Specifically, a Biogenity Third Party shall

1. never offer any undue or inappropriate benefits in exchange for prescribing, recom-mending purchasing, supplying or administering medicinal products;
2. only use promotional materials that are updated, complete and clearly give references to the source of information;
3. only use promotional materials approved following Medical, Legal and Regulatory re-view;
4. only carry out promotion of products that have a valid market authorization in the coun-try where such Biogenity Third Party operates;
5. never engage in off-label promotional activities;
6. only provide off-label information in accordance with applicable local laws, regulations and local Biogenity procedures; and
7. ensure that all samples provided to healthcare professionals are only provided upon re-quest, controlled and can be accounted for

A Biogenity Third Party’s relevant employees shall complete appropriate promotional practic-es/activities compliance training as reasonably required by Biogenity.

The Safety of Our Patients

A Biogenity Third Party shall maintain an effective pharmacovigilance system that meets ap-plicable international and national laws, regulations, guidelines and industry standards. A Bi-ogenity Third Party shall promptly report to Biogenity any suspected adverse events associated with the use of Biogenity’s products.

Furthermore, a Biogenity Third Party shall promptly report to Biogenity any detected incidenc-es of counterfeit or suspected counterfeit Biogenity products or research.

Human Resources

A Biogenity Third Party shall ensure that it complies with applicable national and international laws relating to human rights and labor rights. Specifically, a Biogenity Third Party shall en-sure that it

1. provides their employees with at least a minimum amount of income to meet their basic needs;
2. provides their employees with the right to rest;
3. protects employees against discrimination in the workplace;
4. protects employees against coercion and degrading treatment;
5. respects employees right to freedom of association; and
6. upholds the effective abolition of child labor

Health, Safety and Environment

A Biogenity Third Party shall ensure that

1. it maintains health, safety and environment procedures to ensure compliance with ap-plicable laws, regulations, guidelines and industry standards; and
2. its employees have the working conditions and required knowledge to carry out their jobs in a healthy and safe manner and to minimize the impacts on the environment.