Terms of Service

These terms and conditions ("Terms") apply to the access to, and the use of the  UDI Connect / UDI Hub solution and related services (together the "Services"), available on www.udihub.io ("Website"), offered by p36 GmbH, Hof Meisebach, 36251 Bad Hersfeld, Germany ("Company").

To access or use the Services, you ("Customer") have to agree to these Terms. The Customer agrees to these Terms by acceptance.

These Terms, together with all other referenced documents, form a legally binding agreement ("Agreement") between the Company and the Customer.

If the Customer does not agree to these Terms, the Customer may not use or access the Services.

By providing access to the Services, the Company offers a managed software solution that enables entities in the medical device sector to maintain, validate, and manage the submission of UDI-related product master data in accordance with regulatory requirements across selected markets.

The Company provides the Customer with several Service options as offered on the Website, and the Services are separated into different service plans, including different sets of features and modules. A complete overview of the Services, Service Plans, and related modules, as well as pricing and related information, can be found on the Website. Upgrades and downgrades of Service Plans are possible at under the conditions set forth in this Agreement.

Based on the applicable Service  Plan, the Customer may need to register one or more user account(s) to access and use all or part of the Services. During the registration process, the Customer needs to accept the Terms and further documents, e.g. Privacy Policy and Data Processing Agreement, by clicking the respective check-box.

The Customer must provide accurate, current, and complete information during the registration process and keep their account information up-to-date. Admin accounts controlled by the Customer will be responsible for their related user accounts. Accounts registered by bots or automated methods are not authorized and will be terminated. The Customer is responsible and liable for activities conducted through their account and must immediately notify the Company if there is any suspicion that their credentials have been lost, stolen, or their account is otherwise compromised.

Customer shall use the Services through its own employees, agents and/or duly authorised representatives only and for its own business purposes and shall take appropriate steps to ensure compliance with this Agreement by such users.

The Customer is responsible for maintaining the confidentiality and security of their account credentials and may not disclose their credentials to any third party.

The Customer is responsible and liable for activities conducted through their account by the users and the Admin Account and must immediately notify the Company if there is any suspicion that their credentials have been lost, stolen, or their account is otherwise compromised.

A one-time, fourteen-day free trial ("Free Trial") is available to new Customers. Each Employee of the Customer may open one trial account for a Free Trial. The Customer may, at its discretion, invite additional Employees to collaborate in a shared trial environment; in that case, the Free Trial begins with the first registration and ends fourteen (14) days thereafter for all participants in that shared trial environment, irrespective of when individual Employees joined.

During the Free Trial, the Customer receives access to the functional scope of the Service Plan selected at registration, including any otherwise chargeable add-ons, for evaluation purposes only. Certain features and the Services may be limited or disabled during the Free Trial. In particular, data transmissions to third parties or public authorities are not possible while the Free Trial is active.

The Free Trial ends automatically after fourteen (14) days and does not automatically convert into a paid Service Plan. The Customer may request an extension of the Free Trial; such extension requires the Company’s prior written confirmation and may be refused at the Company’s sole discretion.

The Company will send a reminder at least two (2) days before the Free Trial expires, indicating the remaining time and explaining how to continue under a paid Service Plan. If the Customer subscribes to a paid plan, access continues under that plan and is limited to the features included therein; features not contained in the selected plan become inaccessible unless the Customer upgrades. If the Customer does not subscribe, all access to the Services terminates at the end of the Free Trial.

The Company reserves the right to verify eligibility for the Free Trial and to deny or terminate a Free Trial in case of misuse, fraud, or any breach of these Terms.

Customer may upgrade to a higher-tier Service Plan or to customizable feature(s) at any time during the Term. Upon upgrading:

• The new fees will be prorated based on the remaining period in the current billing cycle.
  
• The upgraded plan features will become available immediately upon confirmation of the upgrade.
  
• The Customer agrees to pay any difference in fees resulting from the upgrade for the remainder of the current Cycle (as defined in section 5), as well as for any subsequent Cycles.
  

Unless otherwise specified, the upgrade will not alter the renewal date of the subscription term.

Customers may request a downgrade within a Service Plan or to a lower Service Plan only at the end of each Cycle by providing at least 30 days' written notice prior to the renewal date.

Individual customizations – such as feature adaptations, integrations, or developments tailored to the Customer’s specific requirements – are not included in the standard Service Plans and are only available upon separate agreement between the parties. The scope, delivery timeline and fees for such Customizations shall be governed exclusively by such individual agreement.

The Company will provide the Customer with the Services as agreed in the Agreement.

The Company:

• makes the Services available to the Customer and uses reasonable care and skill in the performance of the Services and in keeping the Services free from viruses and other malicious software programs.
  
• regularly carries out maintenance or improvements to the Services and its infrastructure, but does not guarantee that the Services will function without any interruption or disruption. The Customer acknowledges that this may result in temporary delays and interruption from time to time. Where reasonably possible, the Company will inform the Customer about potential interruptions in advance.
  
• provides support for and availability of the Service as set out in the Service Level Agreement ("SLA") available at www.udihub.io/trust/sla.
  
• may subcontract third parties for all its obligations under these Terms.
  
• is liable to the Customer for its subcontractors and ensures that subcontractors are bound to appropriate confidentiality and data protection obligations. 
  
• is permitted and possibly required by law to suspend access to the Services or the Customer's account based upon reasonable determination of the occurrence or potential for occurrence of illegal or wrongful activity, fraudulent use or attempted fraudulent activity. In case of a suspension, the Customer remains liable for all charges and fees incurred during the suspension period.
  

As part of the Services, the Company provides each Customer with access to two separate system environments: a test environment for previewing and validating upcoming features before live deployment ("Preview System"), and an operational environment used for the Customer’s live, day-to-day activities ("Productive System").

Each new release of the Services is first deployed to the Preview System. No later than four (4) weeks thereafter, the corresponding release is rolled out to the Customer’s Productive System. The Company aims to follow a bi-monthly release cycle, meaning the Productive System is typically updated every two (2) months. The Company reserves the right to skip a release or adjust the deployment schedule for operational or technical reasons.

The Company may make changes or adjustments to the Services and their features beyond what is strictly necessary to maintain contractual compliance, provided there is a valid reason. Such a reason exists in particular where the change is required to reflect new legal or regulatory requirements, adapt to technical developments (e.g. system environment or operational needs), respond to market changes such as increased user volumes, or where the change brings improvements for the Customer, for example by enhancing usability or security.

These changes will not result in any additional charges for the Customer.

If a change only concerns urgent security updates or minor aspects of the Services (such as layout or display changes) and does not materially affect how the Services are used, the Company will provide clear and understandable notice within the Customer account. In all other cases, the Company will inform the Customer by email at least four (4) weeks before is deployed to the Preview System ("Change Notice"). The Change Notice will include details on the nature and timing of the change and, where relevant, inform the Customer of available options and the consequences of inaction.

If a change has a significant impact on the Customer’s ability to access or use the Services in the usual way, the Customer may terminate the Agreement free of charge by giving thirty (30) days’ notice. The notice period begins upon receipt of the Change Notice, or, if later, on the effective date of the change. This termination right does not apply if the Customer can continue using the unchanged version of the Services without additional cost. If the Customer does not exercise the termination right within the notice period, the change shall be deemed accepted. The Company will expressly inform the Customer of this consequence in the Change Notice. These Terms shall apply accordingly to the Services as amended.

The Company reserves a right to ask the Customer to provide feedback through forms, questionnaires, and polls in order to improve their Services ("Feedback"). The Company may use, or not use, any such Feedback, without any obligation, whether financial or otherwise, to the Customer. The Customer assigns all rights (including but not limited to intellectual property rights), title, and interest in the Feedback to the Company and acknowledges it has no claim in relation to the Feedback.

The Customer shall be solely responsible for the use of the Services, including any use by its employees or other authorised users. To the extent permitted by applicable law, the Company assumes no responsibility for the Customer’s use of the Services or any consequences arising therefrom.

The Customer remains solely responsible for the content, accuracy, and legality of any data or information uploaded to or transmitted through the Services, including any transmission to third parties. The Company does not monitor such transmissions and accepts no liability in this respect.

The Customer acknowledges and agrees that the Company may engage third-party service providers, including infrastructure and software providers, in order to provide the Services. The Company remains responsible for the contractual performance of such providers.

The Customer agrees to use the Services in compliance with the Agreement and all legal and moral obligations applicable in the territory where they are located. The Customer is obliged to cooperate in the performance of this Agreement to the necessary extent free of charge.

The Customer may not:

• circumvent or attempt to circumvent any security protection of the Services;
  
• use the Services in unlawful or fraudulent ways or for any unlawful or fraudulent purpose or effect; 
  
• access the Services via any automated system or take any action that may impose an unreasonable load on the Company's infrastructure; 
  
• bypass the measures that the Company may use to prevent or restrict access to or use of the Services;
  
• sell, sublicense, allow access or make the Services or any part of it otherwise available to third parties
  

The Customer agrees it will not, unless with the Company's prior written permission: 

• try to decompile or reverse engineer the Services or any part of it, or derive the source code;
  
• copy, modify, distribute, reproduce, translate, disassemble or use in any other way any information, text, graphics, images, software obtained from the Services, or any other part of the Services;
  
• create derivative works based on the whole or any part of the Services or any content available on the Services.
  

The Customer shall pay the fees applicable to the selected Service Plan (“Service Fees”) in accordance with these Terms and the prices published on the Website at the time of conclusion of the Agreement. The available Service Plans and corresponding fees are displayed on the Website.

Unless otherwise agreed, all Service Fees are payable in advance for each Cycle (as defined in Section 6). The Customer may choose between a monthly or annual billing cycle. The initial Service Fee shall become due within fourteen (14) days of conclusion of the Agreement. Thereafter, payment for each subsequent Cycle is due by the last day of the preceding Cycle.

Invoices will be issued electronically to the Customer for each Cycle. Payment shall be made using the payment methods offered by the Company.

All prices are stated in EUR and exclusive of statutory VAT, unless expressly indicated otherwise.

In the event of default in payment, the Company is entitled to charge default interest in accordance with § 288 German Civil Code, amounting to nine (9) percentage points above the applicable base interest rate. In addition, the Company may, after prior written notice of default, restrict or suspend the Customer’s access to the Services. The Customer remains liable for all Service Fees incurred during any such suspension period.

If the Services are provided on a recurring basis and not for a fixed term (e.g. monthly or annually) and the Free Trial has expired, the Company may adjust the Service Fees to reflect increased costs of providing the Services. This includes, in particular, changes to Service features, the addition or improvement of functionalities, or external market factors (such as labour costs, exchange rate fluctuations, changes in taxes or regulations, inflation, licence fees, or infrastructure and administrative costs).

The Company shall inform the Customer of any such price adjustment at least thirty (30) days before it takes effect. The notification shall include the reasons for and the extent of the price change, as well as information on the Customer’s right to terminate the Services in accordance with section 5 before the change takes effect. Depending on the Customer’s location, the Company may require the Customer’s express consent to the change. If the Customer does not give such consent, the Services shall end at the end of the current billing period or on the effective date of the price change. In all other cases, the Company shall inform the Customer that the new price will apply unless the Customer terminates the Services, and shall remind the Customer of the applicable termination procedure.

Service Fees are generally non-refundable. This applies in particular where the Customer terminates the Agreement or ceases use of the Services before the end of a paid billing cycle.

Refunds shall only be issued (i) where required by applicable law, or (ii) upon written request by the Customer and subject to the Company’s express approval at its sole discretion. The Customer has no entitlement to a refund beyond these limited cases.

In the event a refund is granted, the Company shall process the refund using the same payment method and currency used by the Customer. The Company reserves the right to deduct from the refund amount any proportionate fees for the period during which the Services were used, including any usage-based add-ons or charges already incurred.

The Customer must submit any refund request in writing, setting out the relevant circumstances and the reason for the request. The Company will review the request and inform the Customer of its decision within a reasonable period. A refund issued in one instance does not create a precedent or entitlement for future cases.

The Agreement enters into force upon the earlier of (i) the Customer’s registration for a Free Trial or (ii) the Customer’s subscription to a Service Plan via the Website.

If the Customer begins with a Free Trial, the Agreement applies during the trial period. The Free Trial ends automatically after the period set out in Section 2.4, unless (a) it is extended by the Company in writing or (b) terminated earlier for cause in accordance with this Section 6. If the Customer upgrades to a Service Plan during or after the Free Trial, the Agreement continues seamlessly under the conditions of the selected Service Plan without interruption.

If the Customer subscribes directly to a Service Plan, or upgrades to one from a Free Trial, the Agreement continues for the billing cycle selected by the Customer (monthly or annual) ("Initial Term"), starting on the date the subscription to a Service Plan is confirmed. If the Customer decides to change the billing cycle from monthly to yearly or from yearly to monthly, this change will only become effective at the end of the current billing cycle.

Unless terminated in accordance with these Terms, the term of the Agreement shall automatically renew for successive billing cycles of the same duration ("Renewal Term") under the conditions and Service Fees applicable at the time of renewal.

Each billing cycle, including the Initial Term and the Renewal Term constitutes a contract term and service period ("Cycle") and entitles the Customer to use the Services for the duration of that Cycle.

Service Fees must be paid in advance for each Cycle in accordance with section 4 . The Services will be made available to the Customer only for the duration of a valid Cycle for which payment has been received in full.

Either party may terminate the Agreement for cause with immediate effect if the other party commits a material breach of the Agreement and fails to remedy such breach within seven (7) days of written notice. A material breach includes, without limitation, (i) the Customer’s failure to pay any due fees and (ii) the initiation of insolvency or comparable proceedings against the other party.

In all other cases, either party may terminate the Agreement for convenience by giving notice in text form at least thirty (30) days prior to the end of the current Cycle. The termination becomes effective upon expiry of that Cycle.

Termination shall not affect any rights or obligations that have accrued prior to the effective date of termination or that by their nature are intended to survive termination, including without limitation payment obligations incurred up to the effective date.

Each party retains all rights, titles, and interests to its own intellectual property, including all copyrights, inventions, trademarks, designs, domain names, know-how, trade secrets, data and other intangible property rights ("Intellectual Property Rights"). All Intellectual Property Rights in the Services or any part of it remain vested in the Company.

Where applicable and only to the extent necessary, each Party grants the other Party a limited, revocable, non-exclusive, non-transferable, non-sublicensable license to the Intellectual Property Rights required to fulfil the Agreement.

The Company may collect, generate, and derive performance, analytical, or usage data relating to the Customer's access to or use of the Services ("Usage Data"). Usage Data will not include any data, text, and any other works (collectively "Customer Data") that the Customer submits, uploads, or otherwise posts to or transmit.

The Company will only use Usage Data for the performance of the Agreement, to monitor the performance and stability of the Services, and to prevent or address technical issues with the Services. The Company may also anonymize Usage Data, aggregate it with other data, and use that aggregated, anonymized data to improve its products and Services.

During this Agreement, the parties may disclose confidential information to each other. "Confidential Information" means all information that is either expressly marked or designated as confidential, or which – by its nature or the circumstances of its disclosure – ought reasonably to be considered confidential and attributable to one of the parties. This includes, in particular, information relating to the internal organisation of the parties or their business relationships with third parties.

The obligation of confidentiality does not apply to information:

• that has been independently developed by the receiving party without reference to the disclosing party’s Confidential Information;
  
• that is or becomes publicly known without a breach of these Terms;
  
• that was lawfully obtained from third parties who are not bound by a confidentiality obligation toward the disclosing party.
  

Each party shall protect the other party’s Confidential Information with at least the same degree of care it uses to protect its own confidential information, but in any event with no less than reasonable care.

Disclosure of Confidential Information to third parties is permitted only:

• with the prior consent of the disclosing party;
  
• where required by law;
  
• in the context of judicial or arbitral proceedings or pursuant to final court orders or binding regulatory decisions;
  
• to the receiving party’s independent auditors, legal counsel or tax advisors, provided such persons are subject to a confidentiality obligation.
  

Each party shall limit access to Confidential Information to those of its employees who require such access for the performance of their duties under these Terms and shall impose appropriate confidentiality obligations on such persons, including post-employment confidentiality to the extent permitted by applicable labour law.

The obligations under this section shall remain in effect even after termination of the Agreement.

The Company collects and processes personal data as described in its Privacy Policy available at www.udihub.io/trust/privacy. The Company protects the collected personal data by means of appropriate technical and organizational measures and in accordance with the data protection legislation applicable in the European Union.

The Parties may further define their duties regarding data protection in a data processing agreement, in which case the provisions of the data processing agreement prevail.

The Company shall be liable without limitation for damages caused by intent or gross negligence, as well as for damages resulting from culpable injury to life, body, or health.

In all other cases, the Company’s liability for damages caused by slight negligence shall be limited to breaches of essential contractual obligations, i.e. obligations whose fulfilment is a prerequisite for the proper performance of the Agreement and on whose compliance the Customer may regularly rely. In such cases  

• no liability shall arise for loss of profit, lack of economic success, or any indirect or consequential damages and
  
• the parties further agree that the aggregate, typical and foreseeable damages per contract year shall be capped at the total Service Fees paid by the Customer to the Company for that same year in which the claim arises.

The limitations set out above shall not apply to liability under the Product Liability Act or in the event of liability arising from a written guarantee expressly assumed by the Company.

The limitations of liability in this clause shall also apply for the benefit of the Company’s employees, representatives, and corporate bodies.