EQUAL CARE Certification

• Certification valid 31-Oct-2024 until 31-Dec-2025

• Publication on EQUAL CARE website

• Digital labels and QR codes to use on product presentation

• Announcement of certification across EQUAL CARE social media channels

• Reach to healthcare professionals and experts in the field of gender medicine especially in women's health, cardiology and neurology

• Long-term reduction of adverse events of intervention due to more diligent treatment decision

• Positive impact on ESG criteria of removing gender-bias, enhancing accessibility and equality as well as governance

Terms and Conditions for EQUAL CARE Certifications

1. Introduction

• Company Information: EQUAL CARE AG, Baarmatterstr. 8b, 6340 Baar Switzerland.

• Purpose: The purpose of these terms and conditions for the sale and use of EQUAL CARE certifications.

2. Definitions

• Certification: The EQUAL CARE certification entails, that an intervention has a gender-specific approach in development and application to the patient, where applicable.

• Certification Types: There are different intervention types that are certified following the appropriate set of certification criteria. Certification types are Medication/ Diagnostic/ Treatment. Digital Diagnostics/Treatments, AI-supported Diagnostics/ Treatments, FemTech/MaleTech.

3. Eligibility

• Customer Eligibility: Any provider that offers a medical intervention

• Data Requirements: The provider needs to make available sufficient data and information about the intervention to enable an appropriate evaluation by EQUAL CARE. Only the result of the evaluation is published. Evaluation data sets will remain undisclosed.

4. Certification Process

• Application Procedure: To obtain an EQUAL CARE certification a pre-check can be requested via http://www.equal-care.org. In the pre-check availability of data and high-level requirements are evaluated. After the pre-check is passed the certification can be purchased and the evaluation and issuance process start.

• Evaluation: Based on certification criteria and provided data the evaluation is performed. The results will be peer reviewed. Before publication an approval of the purchasing provider will assure that publication of the evaluation result is agreeable to both parties.

• Issuance of Certification: Details on how certifications are issued upon successful evaluation on the EQUAL CARE website. Moreover, labels and QR codes are provided for marketing, labeling and promotional purposes of the intervention.

5. Validity and Renewal

5.1 Certification Validity

• Duration: The certification issued by EQUAL CARE AG is valid for a period stated in the ales contract.

• Scope: The certification applies solely to the specific medical intervention and clinical data reviewed and approved by EQUAL CARE AG. Any changes to the medical intervention or significant updates to the clinical data may require re-evaluation.

5.2 Conditions of Validity

• Compliance: The certification remains valid as long as the certified entity continues to comply with the criteria and standards set forth by EQUAL CARE AG at the time of certification.

• Ongoing Obligations: Certified entities must promptly notify EQUAL CARE AG of any changes in the clinical data, or any adverse events related to the certified medical intervention that may impact the certification.

5.3 Renewal Process

• Renewal Application: Certified entities must apply for renewal at least 1 month before the expiration of the current certification. The renewal application must include updated clinical data and any other documentation required by EQUAL CARE AG.

• Re-Evaluation: The renewal process includes a re-evaluation of the clinical data and any changes to the medical intervention to ensure continued compliance with EQUAL CARE AG's certification standards.

• Renewal Fee: A renewal fee, as specified in the pricing section, must be paid at the time of application for renewal. The fee covers the costs of re-evaluation and processing.

5.4 Expiration and Lapse

• Expiration: If the certification is not renewed before the expiration date, it will automatically expire, and the certified entity must cease using the certification mark immediately.

• Reinstatement: If a certification lapses, the entity may apply for reinstatement by submitting a new application and undergoing the full certification process, including payment of applicable fees.

5.5 Updates to Certification Criteria

• Periodic Review: EQUAL CARE AG periodically reviews and updates its certification criteria to reflect current best practices and advancements in medical research.

• Notification of Changes: Certified entities will be notified of any significant changes to the certification criteria. Continued validity of the certification may require compliance with the updated criteria.

 

6. Fees and Payment

• Pricing: as of 5^th of July the price per certification is CHF 2500 and CHF 500 for qualified startups.

• Payment Terms: Upon purchase

• Refund Policy: Conditions under which refunds may be issued.

6.1 Pricing

• Certification Fee: The fee for initial certification is dependent on the market size of the intervention and is payable at the time of application submission. This fee covers the costs of evaluating the clinical data and issuing the certification.

• Renewal Fee: The fee for renewal of certification is payable at the time of the renewal application. This fee covers the costs of re-evaluating updated clinical data and processing the renewal.

6.2 Payment Terms

• Payment Schedule: Payment for certification and renewal fees must be made in full at the time of application submission. Applications will not be processed until full payment is received.

• Invoice Issuance: An invoice will be issued upon receipt of the application and payment. The invoice will include a breakdown of the charges and confirmation of payment.

6.3 Late Payment Penalties

• Late Fees: Payments not received by the due date will incur a late fee of 10% per month on the outstanding balance.

• Suspension of Services: Failure to pay the certification or renewal fees on time may result in the suspension of certification services and revocation of the certification until the outstanding fees are paid.

6.4 Refund Policy

• Non-Refundable Fees: Certification and renewal fees are non-refundable once the evaluation process has begun, regardless of the outcome of the application.

• Cancellation: If an application is withdrawn before the evaluation process starts, a refund minus a processing fee of 20% will be issued.

6.5 Additional Costs

• Extra Services: Any additional services requested by the customer, such as expedited processing or additional copies of certification documentation, may incur extra charges as specified in the pricing schedule.

• Re-evaluation Fees: If re-evaluation is required due to significant changes in the clinical data or the medical intervention, additional fees may apply. These will be communicated to the customer in advance. 

7. Use of Certification

• Permitted Uses: How the certification can be used in marketing, labeling, and promotional materials.

• Prohibited Uses: Any restrictions on the use of the certification, including misrepresentation or use beyond the validity period.

7.1 Permitted Uses

• Marketing and Promotion: Certified entities are permitted to use the certification mark in their marketing, advertising, and promotional materials to indicate that their medical intervention meets the gender-representation standards certified by EQUAL CARE AG.

• Documentation: The certification mark may be used on product packaging, brochures, websites, and other relevant documentation to signify the certification status.

7.2 Prohibited Uses

• Misrepresentation: Certified entities must not misrepresent the scope, validity, or implications of the certification. The certification mark should not be used in a manner that implies broader approval or endorsement than actually granted.

• Expired or Revoked Certification: The certification mark must not be used once the certification has expired, been suspended, or revoked. Certified entities must promptly remove the mark from all materials and platforms upon such events.

• Unauthorized Alteration: The certification mark must not be altered in any way. Any modifications to the mark are strictly prohibited unless approved in writing by EQUAL CARE AG.

7.3 Compliance with Guidelines

• Branding Guidelines: The use of the certification mark must comply with the branding guidelines provided by EQUAL CARE AG. These guidelines will detail the correct usage, size, color, and placement of the certification mark.

• Regular Monitoring: EQUAL CARE AG reserves the right to monitor the use of its certification marks and to act against any misuse or unauthorized use.

8. Revocation and Suspension

8.1 Conditions for Revocation

• Non-Compliance: Certification may be revoked if the certified entity fails to comply with the terms and conditions set forth by EQUAL CARE AG, including but not limited to maintaining the required standards of gender representation in clinical data.

• Fraudulent Data: Discovery of fraudulent or misleading data in the certification application or any subsequent submissions will result in immediate revocation of the certification.

• Adverse Events: Significant adverse events related to the certified medical intervention, which were not disclosed at the time of certification, may also lead to revocation.

8.2 Suspension Procedures

• Investigation: In cases where there is a suspicion of non-compliance or issues affecting the validity of the certification, EQUAL CARE AG may temporarily suspend the certification pending a full investigation.

• Notification: The certified entity will be notified in writing of the suspension, the reasons for the suspension, and any actions required to resolve the issues.

• Resolution: The certified entity must address the identified issues within a specified time frame to lift the suspension. Failure to do so may result in revocation of the certification.

8.3 Appeals Process

• Right to Appeal: Certified entities have the right to appeal any decision to suspend or revoke their certification. Appeals must be submitted in writing within 10 days of the decision, providing detailed reasons and any supporting evidence.

• Review Process: Appeals will be reviewed by an independent panel within 10 days. The decision of the review panel will be final and binding.

8.4 Reapplication

• Post-Revocation: Entities whose certification has been revoked may reapply for certification after addressing the reasons for revocation. A new application and associated fees must be submitted for re-evaluation.

• Conditions for Reapplication: Reapplication will only be considered if the entity can demonstrate significant changes or improvements that address the previous non-compliance issues.

9. Liability and Disclaimers

• Limitation of Liability: Limits on your company’s liability in relation to the certification, including any disclaimers of warranties.

• Indemnification: Customer’s agreement to indemnify and hold your company harmless from any claims arising from their use of the certification.

9.1 Limitation of Liability

• No Warranties: The certifications provided by EQUAL CARE AG are offered “as is” without any warranties of any kind, either express or implied. EQUAL CARE AG makes no representations or warranties regarding the accuracy, reliability, or completeness of the certification or the clinical data on which it is based.

• Scope of Liability: To the fullest extent permitted by applicable law, EQUAL CARE AG shall not be liable for any direct, indirect, incidental, special, consequential, or punitive damages, including but not limited to loss of profits, data, or goodwill, arising out of or in connection with the use of the certification or the inability to use the certification, even if EQUAL CARE AG has been advised of the possibility of such damages.

• Monetary Cap: In no event shall the total liability of EQUAL CARE AG, whether in contract, warranty, tort (including negligence), or otherwise, arising out of or relating to these terms or the use of the certification exceed the amount paid by the customer for the certification in the twelve (12) months preceding the event giving rise to the liability.

9.2 Indemnification

• Customer Responsibility: The customer agrees to indemnify, defend, and hold harmless EQUAL CARE AG, its officers, directors, employees, agents, and affiliates, from and against all claims, liabilities, damages, losses, costs, expenses, or fees (including reasonable attorneys’ fees) that arise from or relate to:

• (a) The customer’s use of the certification,

• (b) Any breach of these terms and conditions by the customer,

• (c) The customer’s violation of any applicable laws or regulations, or

• (d) Any claims that the customer’s use of the certification infringes upon the rights of any third party.

9.3 Disclaimers

• No Endorsement: The certification provided by EQUAL CARE AG does not constitute an endorsement, approval, or recommendation of any medical intervention, product, or service. It is the responsibility of the healthcare provider or the customer to conduct their own assessment and due diligence before using or promoting any medical intervention.

• Accuracy of Data: While EQUAL CARE AG makes reasonable efforts to ensure the accuracy and reliability of the clinical data used for certification, EQUAL CARE AG does not guarantee the completeness or correctness of such data. Any reliance on the certification is at the customer’s own risk.

• Regulatory Compliance: The certification provided by EQUAL CARE AG does not imply compliance with any regulatory requirements or standards. Customers are responsible for ensuring that their medical interventions comply with all applicable laws and regulations.

9.4 Exclusions

• Excluded Damages: EQUAL CARE AG shall not be liable for any damages resulting from:

• (a) The customer’s failure to comply with the terms and conditions,

• (b) Unauthorized use or misuse of the certification,

• (c) Any modification or alteration of the certification by the customer without prior written consent from EQUAL CARE AG.

9.5 Force Majeure

• Force Majeure Events: EQUAL CARE AG shall not be liable for any failure to perform its obligations under these terms and conditions if such failure is caused by events beyond its reasonable control, including but not limited to acts of God, war, terrorism, riots, embargoes, acts of civil or military authorities, fire, floods, accidents, strikes, or shortages of transportation facilities, fuel, energy, labor, or materials. 

10. Confidentiality

10.1 Data Privacy

• Compliance with Laws: EQUAL CARE AG complies with all applicable data protection and privacy laws. The collection, use, and processing of personal data are governed by our Privacy Policy, which is incorporated by reference into these terms and conditions.

• Data Collection: EQUAL CARE AG collects only the data necessary to process certification applications and to maintain records of certified entities. This may include contact details, clinical data, and other relevant information.

• Data Usage: Personal data and clinical information provided by customers are used solely for the purposes of evaluating and issuing certifications, maintaining records, and communicating with customers regarding their certifications.

10.2 Confidentiality Obligations

• Protection of Information: EQUAL CARE AG agrees to maintain the confidentiality of all non-public information provided by customers in connection with the certification process. This information will not be disclosed to any third party without the customer’s prior written consent, except as required by law or as necessary to provide the certification services.

• Customer Obligations: Customers agree to keep confidential any non-public information received from EQUAL CARE AG, including proprietary methodologies, evaluation criteria, and any other confidential information.

11. Intellectual Property

11.1 Ownership

• Certification Marks: EQUAL CARE AG retains all rights, title, and interest in and to its certification marks, logos, and any other intellectual property related to the certification services.

• Proprietary Information: All methodologies, criteria, tools, and processes used in the certification process are proprietary to EQUAL CARE AG and are protected by intellectual property laws.

11.2 License

• Grant of License: Upon issuance of a certification, EQUAL CARE AG grants the certified customer a limited, non-exclusive, non-transferable license to use the certification mark(s) solely in connection with the certified medical intervention, subject to compliance with these terms and conditions.

• Restrictions: Customers may not modify, alter, or misrepresent the certification marks. The use of certification marks must comply with EQUAL CARE AG's branding guidelines and any applicable laws.

12. Governing Law and Dispute Resolution

12.1 Governing Law

• Jurisdiction: These terms and conditions are governed by and construed in accordance with the laws of Zurich, Switzerland without regard to its conflict of law principles.

12.2 Dispute Resolution

• Negotiation: In the event of any dispute arising out of or in connection with these terms and conditions, the parties agree to first attempt to resolve the dispute through good faith negotiations.

• Mediation: If the dispute cannot be resolved through negotiation, the parties agree to attempt to resolve the dispute through mediation before initiating any formal legal proceedings.

13. Modification of Terms

13.1 Right to Modify

• Amendments: EQUAL CARE AG reserves the right to modify these terms and conditions at any time. Any changes will be effective immediately upon posting the revised terms on our website.

• Notification: EQUAL CARE AG will notify customers of significant changes to the terms and conditions by email or through a notice on our website.

13.2 Acceptance of Modifications

• Continued Use: Continued use of the certification services after any modifications to the terms and conditions constitutes acceptance of the revised terms. If a customer does not agree to the modified terms, they must cease using the certification services.

14. Contact Information

14.1 Customer Support

• Support Channels: For any questions or support needs related to the certification services, customers can contact EQUAL CARE AG through the following channels:

• mail@equal-care.org

• EQUAL CARE AG, Baarmatterstr.8b, 6340 Baar, Switzerland