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GENERAL PATIENT AGREEMENT AND ACKNOWLEDGMENT OF TREATMENT

This General Patient Agreement (hereinafter referred to as the “Agreement”) is made between: SIA "Pallas Clinic" a medical institution compliant with the statutory requirements of the Republic of Latvia, registration No. 42103111641, Code: 1300-00104, with its registered office at Mārupe, Jaunzemu iela 4-1, LV2167, hereinafter referred to as the "Clinic," and The Patient, whose details are provided in the Patient’s Application Form.

By submitting the electronic form and acknowledging this Agreement via the checked box, the Patient agrees to the terms and conditions specified below.

1. TERMINOLOGY

1.1 Clinic – A duly registered medical institution in the Republic of Latvia, compliant with Latvian and EU healthcare regulations.

1.2. Dendritic Cell Therapy (DCT) – A personalized immunotherapy where dendritic cells are harvested from the Patient’s blood, modified to boost their cancer-fighting potential, and reintroduced to target specific cancer cells. This therapy can only be performed at the request of the patient and is tailored specifically to their health condition and in accordance with regulatory requirements.

1.3. Cytokine-Induced Killer (CIK) Cells – Immunotherapy using modified immune cells, designed to kill cancer cells by enhancing the body’s immune response. This therapy is performed only at the specific request of the patient and is personalized based on the patient’s individual medical needs and regulatory requirements.

1.4. Peptide Therapy – A treatment using short chains of amino acids to stimulate specific biological responses in the body, potentially enhancing immune function and targeting cancer. This therapy is provided at the request of the patient, based on individual health requirements, and tailored in accordance with relevant regulations.

1.5. NK Cells (Natural Killer Cells) – A type of white blood cell and a critical component of the immune system. NK cell therapy enhances the body's innate ability to detect and destroy abnormal cells, such as cancerous or virus-infected cells.

1.6. T-Cell Therapy – A therapy that uses a patient’s own or donor T-cells to help fight cancer. T- cells are modified and expanded in the lab to improve their ability to recognize and target cancer cells before being infused back into the patient.

1.7. Mistletoe Therapy – A complementary cancer treatment using extracts from the mistletoe plant. It is believed to stimulate the immune system, enhance quality of life, and potentially improve the effectiveness of conventional cancer therapies.

1.8. IV Stem Cell Infusions – Infusion of stem cells directly into the bloodstream, aiming to promote regeneration and repair of damaged tissues. This therapy may be used for a variety of degenerative conditions and immune modulation.

1.9. Exosome Infusions – Exosomes are small vesicles secreted by cells that carry proteins, lipids, and genetic material. Exosome therapy uses these vesicles to promote tissue regeneration and healing, particularly for inflammatory and degenerative conditions.

1.10. Placenta Treatments – Placenta-based therapies involve the use of stem cells or other growth factors derived from the human placenta to support healing, regeneration, and immune modulation.

1.11. Advanced Therapeutic Medicinal Products (ATMPs) – Innovative treatments that include gene therapy, cell therapy (such as DCT, CIK, NK, and T-cells), and tissue-engineered products. These therapies are regulated by the European Medicines Agency (EMA) under Directive 2001/83/ EC and Regulation (EC) No 1394/2007. ATMPs are cutting-edge treatments often used for complex or rare conditions, including cancer and genetic disorders.

1.12. IV Therapy – Intravenous therapy used to administer nutrients, medications, and fluids directly into the bloodstream. The Clinic offers a variety of IV therapies aimed at improving immune function, replenishing essential nutrients, and boosting energy levels.

1.13. Ozone Therapy – A medical treatment that introduces ozone (O₃) into the body to promote oxygenation and stimulate the immune system for overall health improvement. Ozone therapy may be applied as part of cancer treatments or as an adjunct therapy for chronic conditions.

1.14. Telemedicine – Remote medical services provided through communication technologies, enabling consultations, treatment recommendations, and follow-up care without requiring in-person visits. The Clinic ensures that telemedicine services comply with the same confidentiality and data protection standards as traditional medical consultations. By consenting to telemedicine, the Patient acknowledges that certain limitations may apply to telemedicine services, including the inability to conduct certain diagnostic procedures remotely. Telemedicine services may require a follow-up in-person consultation as deemed necessary by the treating physician.

1.15. Treatment Services – The range of medical treatments provided to the Patient, including DCT, CIK, NK cell therapy, T-cell therapy, peptide therapy, IV stem cell infusions, exosome infusions, placenta treatments, IV therapy, ozone therapy, and ATMPs, among others. Treatments are not limited to those specified in this Agreement and may include other services based on the Patient’s medical needs.

1.16. Personalized Therapies – Some therapies, such as DCT, CIK, peptide therapy, NK cell therapy, T-cell therapy, and certain IV stem cell or exosome infusions, may need to be individually tailored or personalized according to the Patient’s medical condition and specific regulatory requirements. These therapies are offered only after a full evaluation of the Patient’s health condition and upon request.

1.17. Treatment Plan – A comprehensive medical document prepared by an approved medical doctor that outlines the recommended course of treatment for the Patient. The Treatment Plan is created based on the evaluation of the Patient’s medical records, blood tests, diagnostic results, and overall health condition, ensuring that all treatments are personalized and in compliance with relevant medical guidelines and regulations

1.18. Ownership of Biological Material and ATMP Products – All biological materials and products derived from the Patient’s own biological material, including but not limited to ATMP products such as Dendritic Cell Therapy (DCT), Cytokine-Induced Killer (CIK) cells, Natural Killer (NK) cell therapy, T-cell therapy, and others, are the property of the Patient. The Clinic provides storage facilities and administration of these products in accordance with the relevant product certificates, treatment plans, and applicable rules and regulations. The Patient agrees that any costs associated with the storage, transportation, or handling of ATMP products are calculated separately from treatment costs and are the responsibility of the Patient as the owner of these products. The Clinic will provide detailed cost estimates for these services, which must be covered by the Patient in addition to treatment fees.

1.19. Additional Treatment Services – Unforeseen medical interventions, diagnostics, and consultations required during the course of treatment that were not initially planned.

1.20. Monitoring – Remote medical observation of the Patient, including analysis of blood tests and assessment of disease progression. Results will be communicated to the Patient through their assigned Patient Manager.

1.21. Medical Consultation – Consultations offered before or during treatment, outside the standard package, to address specific questions or concerns the Patient may have.

1.22. Patient's Application Form – A document completed by the Patient prior to treatment, detailing personal information, diagnosis, health history, and consent. This form may include the appointment of an authorized representative and a list of individuals authorized to receive health- related information.

2. SUBJECT

2.1 The Clinic undertakes to provide the Treatment Services, including but not limited to ATMP, DCT, CIK, NK cell therapy, T-cell therapy, peptide therapy, IV stem cell infusions, exosome infusions, placenta treatments, IV therapy, and ozone therapy, in accordance with the statutory requirements of the Republic of Latvia and applicable EU regulations. All treatments are based on an approved medical doctor's treatment plan, which is created after evaluating the Patient's medical records, blood work, other diagnostic tools, and overall health condition. Some therapies may need to be tailored specifically to the patient’s health and regulatory requirements. The Clinic works exclusively with laboratories that are GMP (Good Manufacturing Practice) certified and/or FDA (Food and Drug Administration) approved.

2.2 The Patient agrees to pay for these services as outlined in the Clinic’s invoice.

3. PROCEDURE OF PROVIDING SERVICES

3.1 Payment and Approval: Advance payment made by the Patient according to the Clinic's invoice constitutes approval of the treatment package, including all specified therapies and costs.

3.2 Provision of Treatment: The Clinic guarantees that all treatments will be carried out by certified doctors and qualified medical personnel. Where necessary, the Clinic may collaborate with other medical institutions to provide specialized treatments.

3.3 Post-Treatment Instructions and Monitoring: Upon completion of the treatment, the Clinic's doctor will provide the Patient with instructions for follow-up care. Thereafter, the Clinic will monitor the Patient’s progress remotely, as agreed upon.

4. PAYMENTS

4.1 The Patient shall pay for the Treatment Services as specified in the Clinic’s invoice. Paymentsmust be made prior to the commencement of treatment.

4.2 Any Additional Treatment Services required due to unforeseen medical circumstances will be billed separately. The Patient will be consulted beforehand unless an emergency prevents obtaining prior consent.

4.3 If the Patient cancels or delays treatment after payment has been made, the Clinic reserves the right to retain the payment to cover costs incurred, particularly where materials or vaccines have been ordered from third parties.

5. RIGHTS AND OBLIGATIONS

5.1 Rights and Obligations of the Patient:

5.1.1 The Patient agrees to provide complete and accurate information about their health history, including current treatments, symptoms, and medications. The Clinic shall not be liable for any adverse effects resulting from incomplete or inaccurate information.

5.1.2 The Patient is required to follow the medical personnel’s instructions and abide by the Clinic’s internal regulations.

5.1.3 The Patient retains the right to refuse or withdraw from treatment at any time. This refusal or withdrawal must be presented in writing to the Clinic. If the Patient refuses to follow the treatment recommended by the Clinic’s doctor and opts to undergo only a portion of the proposed treatment, the Clinic may require a written form of withdrawal for the declined parts of the treatment plan. The Patient acknowledges that this decision may have consequences for their health.

5.1.4 The Patient may designate individuals authorized to access their medical records, should they become unable to make decisions themselves.

5.1.5 Emergency Contact Information: The Patient agrees to provide the contact information of an emergency contact person who may be reached in case of any urgent medical situation during their treatment.

5.1.6 Ownership of Biological Material: The Patient acknowledges and agrees that all biological material produced from their own body, including ATMPs, DCT, CIK, and other related materials, is their property. The Clinic will provide appropriate storage facilities and ensure that all such materials are managed according to the agreed treatment plan, product certificates, and any applicable laws or regulations. The Patient is responsible for any decisions regarding the administration or further use of these materials, and the Clinic will act in accordance with the Patient's consent and directions, subject to relevant laws and guidelines.

5.1.7 Compliance with Medical Recommendations: The Patient agrees to follow all medical recommendations, treatment plans, and instructions provided by the Clinic. The Clinic shall not be held liable for any adverse effects or failure of treatment resulting from the Patient’s refusal to follow or comply with such recommendations and instructions.

5.2 Rights and Obligations of the Clinic:

5.2.1 The Clinic shall assess the suitability of the Patient for the proposed Treatment Services, including any risks associated with ATMP, IV, ozone, NK cell therapy, T-cell therapy, exosome infusions, and placenta treatments.

5.2.2 The Clinic shall provide the Patient with treatment recommendations aimed at improving their health condition, based on medical evaluations.

5.2.3 The Clinic reserves the right to refuse treatment if the Patient’s health condition does not meet the criteria for safe treatment.

5.2.4 The Clinic will document the Patient’s treatment in compliance with statutory requirements and maintain the confidentiality of the Patient’s personal data.

5.2.5 The Clinic operates strictly within the legal framework of the Republic of Latvia, including compliance with the Patient Rights Law, General Data Protection Regulation (GDPR), and all other relevant Latvian and EU laws and regulations governing healthcare services.

6. DATA PROTECTION

6.1 The Clinic collects, processes, and stores the Patient’s personal and medical data in full compliance with the General Data Protection Regulation (GDPR) and EU data protection laws.

6.2 The data will be used solely for the purposes of treatment, monitoring, and legal compliance. No personal information will be disclosed to third parties unless required by law or with the Patient’s explicit consent.

6.3 The Clinic ensures the secure storage of all data and the anonymization of medical information used for scientific research.

6.4 The Patient retains the right to request access to their personal data, request corrections, or withdraw consent for data processing at any time.

7. WARRANTIES AND REPRESENTATIONS

7.1 The Patient acknowledges that they have been fully informed about the nature, risks, andpotential benefits of ATMP therapies, including DCT, CIK, NK cell therapy, T-cell therapy, peptide therapies, IV stem cell infusions, exosome infusions, placenta treatments, IV therapy, and ozone therapy.

7.2 The Patient agrees to the use of their anonymized data for scientific or educational purposes, as permitted under GDPR and EU laws.

7.3 The Clinic advises the Patient that the outcome of any treatment may vary based on individual health conditions, medical history, and the specific therapies applied. The Clinic makes no guarantees regarding the success of any specific treatment and encourages the Patient to discuss any concerns with the medical team before commencing treatment.

8. EMERGENCIES

8.1 In the event of unexpected health deterioration during treatment, the Clinic is authorized tocontact emergency services to ensure the Patient's safety.

8.2 Third-Party Healthcare Provider Liability: In cases where emergency services or third-party healthcare providers are involved, the Clinic shall not be liable for any actions, delays, or complications caused by those external providers. The Clinic will collaborate with these providers to ensure the best possible outcome for the Patient.

9. INFORMED CONSENT FOR TREATMENT

9.1 The Patient acknowledges that they have received all necessary information regarding the treatment options available, including potential risks, side effects, and expected outcomes. This information was provided verbally and/or in writing by the medical team.

9.2 The Patient confirms their understanding that treatments involving ATMPs, NK cell therapy, T-cell therapy, IV stem cell infusions, exosome infusions, placenta treatments, IV therapies, and ozone therapy must comply with the European Medicines Agency (EMA) and EU healthcare regulations. The Patient acknowledges that these treatments are provided in accordance with established medical guidelines and relevant regulatory approvals.

9.3 The Patient confirms their voluntary consent to proceed with the treatment based on the information provided and has had the opportunity to ask questions and seek clarifications.

9.4 The Patient further acknowledges that they are aware of their right to withdraw from treatment at any point, and this withdrawal must be presented in writing to the Clinic.

9.5 Post-Treatment Liability Waiver: The Clinic shall not be liable for any medical issues arising more than 1 month after the completion of treatment, unless such issues are the result of gross negligence or malpractice on the part of the Clinic or its staff.

10. PATIENT RIGHTS AND DATA PROTECTION ACKNOWLEDGMENT

10.1 The Patient acknowledges that their personal and medical data will be handled in strict compliance with the General Data Protection Regulation (GDPR) and all relevant EU laws.

10.2 The Patient confirms they have been informed of their rights under GDPR, including the right to access, amend, or delete their personal data, and the right to withdraw consent for data processing at any time.

10.3 The Clinic ensures that all data is stored securely and may only be accessed by authorized personnel for the purposes of treatment, monitoring, and legal compliance. The Patient acknowledges that their medical records may be shared with external healthcare providers or laboratories solely for the purpose of facilitating their treatment, and in compliance with applicable laws.

11. DIAGNOSTIC PROCEDURES

11.1 The Clinic may recommend and facilitate a variety of diagnostic procedures essential for determining the most appropriate treatment plan for the Patient. These procedures may include but are not limited to:

  • Blood Analysis – To assess overall health and identify specific biomarkers that inform treatment decisions
  • Biopsy – To examine tissue samples for diagnostic purposes, particularly in cases of cancer or other serious conditions.
  • Liquid Biopsy – A less invasive diagnostic method that analyzes circulating tumor cells or DNA fragments from a blood sample to gather information on cancer or other diseases.
  • PET (Positron Emission Tomography) – An imaging test that helps reveal how tissues and organs are functioning.
  • CT (Computed Tomography) – Detailed imaging that uses X-rays to create cross-sectional images of the body.
  • MRI (Magnetic Resonance Imaging) – A non-invasive imaging technique that provides detailed pictures of organs and tissues.
  • Other Diagnostic Methods – Additional diagnostic techniques as recommended by the Clinic’s medical team based on the Patient’s health condition.

11.2 External Diagnostic Facilities: The above-mentioned diagnostic services may be provided at external facilities that meet the required legal and medical standards. The Clinic ensures that it only collaborates with reputable diagnostic centers or laboratories that adhere to GMP (Good Manufacturing Practice) standards and, where applicable, FDA (Food and Drug Administration) approvals.

11.3 Results and Responsibility: The Clinic is not responsible for interpreting the diagnostic results; this responsibility lies with the external treatment facilities and their doctors. The Clinic only reads and utilizes the results as part of the Patient’s treatment plan. Any errors, delays, or discrepancies arising from the diagnostic provider will be addressed in collaboration with the external provider to ensure the best possible care.

11.4 The Patient acknowledges and consents to the use of external diagnostic services, understanding that these services are integral to determining the most appropriate course of treatment.

12. TREATMENT RISKS AND ALTERNATIVES

12.1 The Patient acknowledges that the Clinic’s medical team has fully explained the potential risks associated with the proposed treatments, as well as the benefits.

12.2 The Patient confirms that alternative treatment options, where applicable, have been explained by the Clinic’s medical team. The Patient is encouraged to ask further questions if there are any concerns or doubts about proceeding with the recommended treatment plan.

13. PATIENT COMPLAINT MECHANISM

13.1 Right to Lodge a Complaint: The Patient has the right to file a complaint regarding any aspect of their treatment or the services provided by the Clinic. The Patient should submit their complaint in writing to the Clinic’s administration.

13.2 Response and Resolution: The Clinic is committed to addressing and resolving any patient complaints within a reasonable timeframe, not exceeding 30 days from the receipt of the complaint. The Clinic will provide a written response to the Patient regarding the resolution of the issue.

13.3 External Complaints: If the Patient is not satisfied with the Clinic’s resolution, they have the right to file a complaint with the relevant regulatory authorities in Latvia, in accordance with Latvian law.

13.4 Time Limit for Filing Complaints: The Patient agrees that any complaints or disputes regarding the Clinic’s treatment or services must be submitted in writing within 1 month of the date the treatment or service was provided. Complaints submitted after this period will not be considered.

14. ACKNOWLEDGMENT AND CONSENT

By checking the acknowledgment box in the Patient Application Form, the Patient confirms their understanding and acceptance of the terms and conditions outlined in this Agreement.