EXTEDO GmbH, represented by its managing directors, with the place of business located in Einsteinstraße 30, 85521 Ottobrunn, Germany (hereinafter referred to as "EXTEDO"), has developed the software eSUBmanager. It is a web-based Software offered by EXTEDO as a SaaS solution (the “SaaS Solution” or “the Services”), in particular for the areas related to e-Regulatory compliance.
This Agreement is entered into force once EXTEDO sends You a confirmation of Your subscription and grants You with access to the SaaS Solution.
Definitions: the following terms shall be understood as follows:
- “SaaS Solution” or “Services” mean the SaaS provided by EXTEDO for the software(s) eSUBmanager, in a subscription basis.
- “Update” means any change to the SaaS Solution’s environment.
- “Upgrade” means any change to the EXTEDO software version.
- “Connectors” for the SaaS Solution provides integration functionality.
- “Customer” or “You” means the company, legal entity, or individuals providing professional services who subscribe to the SaaS Solution. Only Companies as defined in Section 14 of the German Civil Code (BGB) and professional services providers must be understood as Customer according to this Agreement.
- “User” means all the access rights per Customer for which the Customer is fully responsible to ensure the proper use in accordance with this Agreement. You, as the Customer, must ensure that the Users comply with all the obligations set out herein.
- “Customer Data” means all data and information, including text files, that is inserted into EXTEDO’s software(s) during the use of the Services. This might include personal data.
- “Technical Data” means all the information related to the Customer’s systems that EXTEDO needs in order to optimize and operate the system.
- “Order” means the request by the Customer in written-electronic form when subscribing to the SaaS Solution or when modifying its current subscription terms.
- “Activation Date” means the date on which the actual access to the SaaS Solution is given to the Customer. In a regular basis this date shall occur within two (2) working days after the subscription was processed.
- "Billing Period" means the period for which You agree to prepay fees under an Order form, which will be the same as or shorter than the subscription term.
- "Consulting Services" mean the professional services provided to You by EXTEDO which may include but are not limited to training, installation, migration or other consulting services. Consulting Services are always billed on time and material.
- “EXTEDO Subscription Portal” means the portal where You get access after initial Order. There You have the possibility to change subscriptions based on the defined terms, view remunerations, update payment information and view invoices.
- “EXTEDO Customer Portal” means the portal where You get access to product-related information.
- “Solution Description” means the document defining the services, functionalities and Software options subject to the SaaS Solution.
- “Trial Environment” means the version made available to the Customer for a limited period of time as defined by EXTEDO. The Trial Environment may have limited functionality.
1. Subject matter
1.2. Additional Features. You may subscribe to additional features of the Subscription Services by placing an additional Order or activating the additional features from within Your EXTEDO Subscription Portal account (if this option is made available by EXTEDO). This Agreement will apply to all additional Order(s) and all additional features that You activate from within Your EXTEDO Subscription Portal account.
1.3. Consulting Services. You may purchase Consulting Services by placing an Order with EXTEDO. Unless EXTEDO otherwise agrees, the Consulting Services provided are described in the Order and will be delivered in English language. Fees for these Consulting Services are in addition to Your subscription fee. If You purchase Consulting Services that recur, they will be considered part of Your subscription and will renew in accordance with Your subscription.
1.4. All Consulting Services are performed remotely, unless You and EXTEDO otherwise agree.
1.5. For Consulting Services performed on-site, you will reimburse EXTEDO reasonable costs for all expenses incurred in connection with the Consulting Services. Any invoices or other requests for reimbursements will be due and payable within thirty (30) days of the date of the invoice.
1.6. If there is a specific number of hours included in the Consulting Services purchased, those hours will expire as indicated in the applicable description, which expiration period will commence upon purchase (the “Expiration Period”). If there are deliverables included in the Consulting Services purchased, it is estimated that those deliverables will be completed within the time period indicated as the delivery period in the applicable description, which delivery period will commence upon purchase (the “Delivery Period”). If there is no Expiration Period or Delivery Period indicated, then it will be one hundred and eighty (180) days from purchase. If the Consulting Services provided are not complete at the end of the Delivery Period due to Your failure to make the necessary resources available to EXTEDO or to perform Your obligations, such Consulting Services will be deemed to be complete at the end of the Delivery Period. If the Consulting Services provided are not complete at the end of the Delivery Period due to failure of EXTEDO to make the necessary resources available to You or to perform EXTEDO’s obligations, the Delivery Period will be extended to allow EXTEDO to complete such Consulting Services.
1.7. EXTEDO might provide some or all elements of the Consulting Services through third party service providers.
1.8. Consulting Services are non-cancellable and all fees for Consulting Services are non-refundable.
2. Rights of the Customer
2.1. Right to access and use. Subject to this Agreement, and during the period of the subscription, EXTEDO grants You as a Customer with a non-exclusive and non-transferable right of access and use the SaaS Solution with the applicable limitations and rights defined in the Order(s).
2.2. Updates. EXTEDO will update the SaaS Solution at any time whenever required to improve the functionalities of the SaaS Solution. Whenever possible according to the circumstances, you will be informed about any of these updates in due time.
2.3. Modifications. We modify the Subscription Services from time to time, including by adding or deleting features and functions, in an effort to improve Your experience. For EXTEDO’s paid Subscriptions, EXTEDO will not make changes to the Subscription Services that materially reduce the functionality provided to You during the subscription term. For the Trial Environment, EXTEDO may make changes that materially reduce the functionality provided to You during the subscription term.
2.4. Availability. The SaaS Solution will be available 24 hours a day, 7 days a week except for planned down-time for maintenance. EXTEDO will make business reasonable effort to make the SaaS Solution available 24 hours a day, 7 days a week.
3. Obligations of the Customer
3.2. No misuse. You shall not misuse or allow the misuse of the SaaS Solution for any purpose other than the one for which it is addressed. You shall refrain from any attempt, on Your own or through unauthorized third parties, to retrieve any information or data without authorization, to interfere with programs that are operated by EXTEDO or to allow such interference, or to access the data networks of EXTEDO without authorization.
3.3. Number of Users. You must ensure that only Users that You have previously authenticated can have access to the SaaS Solution. No more than the allowable maximum number of Users can have access.
3.4. Technical requirements. You have the sole responsibility for ensuring that the Users of the SaaS Solution have access to an internet connection as well as appropriate software and hardware equipment. You are solely responsible for the maintenance of these technical requirements. In particular, when using the SaaS Solution You must ensure that the pre-requisites and any other requirements specified in the Solution Description are covered. EXTEDO will not assume any responsibility for malfunctioning of the Services provided in case the system requirements are not met as a consequence of inability or incapability of the Customer.
3.5. Protected access. You shall protect Your User access authorization as well as the identification and authentication backups provided to You against unauthorized access. If You have the evidence that Your access and use have been unlawfully obtained or could be abused by a third party, you are obliged to inform EXTEDO about such incidence.
3.6. Error communication. You must inform EXTEDO immediately of any errors or malfunctions on the Services, indicating how and under which circumstances the error or defect has occurred, by sending an email to email@example.com.
4. Remuneration and payment for the subscription
4.1. The remuneration fee for the subscription to the SaaS Solution will be described in the specific Order. A minimum usage may apply for the different SaaS Solution. This minimum is described in the applicable service description or in the Order.
4.2. Billing process. The billing cycle is set up on a monthly basis, starting from the Order Date. Add-ons that are ordered during a subscription period are billed with a pro-rated amount with the Order. The complete amount is then included in the next subscription renew billing. EXTEDO reserves the right to change the billing process at any time.
4.3. Payment methods.
4.3.1.Payment by credit card for monthly subscriptions. If You are paying by credit card, you authorize EXTEDO to charge Your credit card or bank account for all fees payable during the Subscription term. You further authorize EXTEDO to use a third party to process payments and consent to the disclosure of Your payment information to such third party.
4.3.2.Payment against invoice for yearly subscriptions. If You are paying by invoice, EXTEDO will invoice You no more than forty-five (45) days before the beginning of the subscription term and each subsequent Billing Period and other times during the subscription term when fees are payable. All amounts invoiced are due and payable within thirty (30) days from the date of the invoice, unless otherwise specified in the Order Form.
4.4. Payment Information. You will keep Your contact information, billing information and credit card information (where applicable) up to date. Changes may be made on Your Billing Page within Your EXTEDO Subscription Portal account. All payment obligations are non-cancelable, and all amounts paid are non-refundable, except as specifically provided for in this Agreement. All fees are due and payable in advance throughout the subscription term. If You are an EXTEDO Partner that purchases on behalf of a client, you agree to be responsible for the Order Form and to guarantee payment of all fees.
4.5. Payment after cancelation. After cancelation of the subscription the Customer will be billed for the periods outstanding corresponding to the notice of termination (e.g. one month after the notification of the cancellation).
4.7. Tax. All fees under this section shall be understood excluding VAT and any other withholding taxes. Upon EXTEDO’s request, you will provide EXTEDO with the VAT registration number under which You are registered in Your member state.
5. Contractual term, cancellation of the subscription and suspension
5.1. Term. Your subscription period will be on a monthly basis and will be automatically renewed in the same terms as is made in the last Order or request. To prevent renewal of the subscription, a notice of termination shall be sent to EXTEDO. The required notice must be provided either in the EXTEDO Subscription Portal or in writing to our EXTEDO contact through firstname.lastname@example.org. This notice will terminate the subscription and have complete effects after one (1) calendar month. That month after notice of termination will be effectively billed. We do not provide refunds if You decide to stop using the SaaS Solution during Your subscription term.
5.2. Renewal. The renewal pricing set forth in Your Order will apply. If renewal pricing is not included in Your Order, then the standard pricing available in EXTEDO’s price list on the date of renewal will apply. If You use the Trial Environment, EXTEDO will make it available to You free of charge until earlier of (i) the date on which Your free subscription period ends or (ii) the start date of Your paid subscription.
5.3. Cancellation. EXTEDO may terminate this Agreement for cause, as to any or all Subscription Services upon thirty (30) days’ notice to You of a material breach if such breach remains uncured at the expiration of such period. EXTEDO may also terminate this Agreement for cause on thirty (30) days’ notice if EXTEDO determine that You are acting, or have acted, in a way that has or may negatively reflect on or affect EXTEDO, EXTEDO’s prospects, or EXTEDO’s Customers. This Agreement may not otherwise be terminated prior to the end of the subscription term. The right of You and EXTEDO to terminate this Agreement for a compelling reason under a claim of extraordinary termination under the German Civil Code shall remain unaffected.
5.4. Suspension for non-payment. EXTEDO will be allowed to suspend the provision of the SaaS Solution if after sending two reminders You do not fulfil Your remuneration obligation under section 4. The suspension of the Services for non-payment will include the deletion of all the Customer Data You inserted into the SaaS Solution if after (set up a grace period for payment within the suspension period) the outstanding amounts have not yet been affected.
6. Disclaimers, Limitation of liability
6.1. Disclaimer of Warranties. OUR SUBSCRIPTION SERVICES AND CONSULTING SERVICES WILL BE PROVIDED IN A PROFESSIONAL MANNER IN ACCORDANCE WITH CUSTOMARY INDUSTRY STANDARDS UTILIZING REASONABLE CARE AND SKILL. WE AND OUR AFFILIATES AND AGENTS MAKE NO REPRESENTATIONS OR WARRANTIES ABOUT THE SUITABILITY OF THE SUBSCRIPTION SERVICES, DATA MADE AVAILABLE FROM THE SUBSCRIPTION SERVICES, OR THE CONSULTING SERVICES FOR A PARTICULAR PURPOSE NOR ON A SPECIFIC RELIABILITY, AVAILABILITY, TIMELINESS, SECURITY OR ACCURACY OF THE SUBSCRIPTION SERVICES, DATA MADE AVAILABLE FROM THE SUBSCRIPTION SERVICE, OR THE CONSULTING SERVICES, EXCEPT IF AGREED SEPARATELY.
APPLICATION PROGRAMMING INTERFACES (APIs) MAY NOT BE AVAILABLE AT ALL TIMES.
OUR TRIAL ENVIRONMENT, INCLUDING APIs, ARE PROVIDED "AS IS" WITHOUT WARRANTY OR CONDITION OF ANY KIND. WE DISCLAIM ALL WARRANTIES AND CONDITIONS OF ANY KIND, WHETHER EXPRESS, IMPLIED OR STATUTORY, WITH REGARD TO THE SUBSCRIPTION SERVICES AND THE CONSULTING SERVICES, INCLUDING ALL IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT.
6.2. Full Liability. We will be liable to You without limit for loss or damage which You actually suffer that is caused by: (i) our fraudulent action, (ii) our willful action, (iii) our gross negligence, (iv) our damage to life, body or health, or (v) our action that would give rise to a claim under the German Product Liability Act and/or (vi) from a guarantee of characteristics (“zugesicherte Eigenschaft”). Provided however, the limitations otherwise set forth below shall apply to: (i) our Trial Environment, (ii) those losses or damages caused by our slight negligence, (iii) those losses or damages caused by gross negligence of employees who are not legal representatives or senior employees, and (iv) our strict liability that may arise from material defects in the Subscription Service that were already in existence at the commencement of Your subscription. The claims for which EXTEDO will be liable to You without limit in accordance with this section are collectively referred to as “Full Liability Claims”.
6.3. No Indirect Damages. EXCEPT FOR FULL LIABILITY CLAIMS, TO THE EXTENT PERMITTED BY LAW, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES, OR LOSS OF PROFITS, REVENUE, DATA OR BUSINESS OPPORTUNITIES.
6.4. Limitation of Liability. EXCEPT FOR YOUR LIABILITY FOR PAYMENT OF FEES, YOUR LIABILITY FOR VIOLATION OF OUR INTELLECTUAL PROPERTY RIGHTS, AND OUR LIABILITY FOR FULL LIABILITY CLAIMS, YOUR AGGREGATE LIABILITY WILL BE LIMITED TO THE LESSER OF FIVE THOUSAND EURO OR THE TOTAL AMOUNTS YOU HAVE ACTUALLY PAID FOR THE SUBSCRIPTION SERVICE IN A TWELVE MONTH PERIOD PRECEDING THE EVENT GIVING RISE TO A CLAIM; PROVIDED HOWEVER, THIS LIMITATION SHALL NOT APPLY TO YOU IF YOU ONLY USE THE TRIAL ENVIRONMENT, AND IN THIS CASE, IF WE ARE DETERMINED TO HAVE ANY LIABILITY TO YOU OR ANY THIRD PARTY ARISING FROM YOUR USE OF THE TRAIL SERVICES, THEN OUR AGGREGATE LIABILITY WILL BE LIMITED TO ONE THOUSAND EURO. Liability for loss of data shall be limited to the typical expenses for recovery which would have been incurred if regular and appropriate back-ups had been made. You are solely responsible for the back-up of Your data. In no case the liability of EXTEDO for loss of data shall exceed 5.000 EUR.
6.5. Third Party Products. WE DISCLAIM ALL LIABILITY WITH RESPECT TO THIRD-PARTY PRODUCTS THAT YOU USE.
6.6. EXCEPT FOR FULL LIABILITY CLAIMS, THE PERIOD OF LIMITATION FOR ANY WARRANTY AND LIABILITY CLAIMS SHALL BE ONE YEAR.
6.7. Any imposition of fines or penalties (punitive damages) is excluded.
7. Liability for defects
7.1. Defects. If the Subscription Service is determined to have a defect, You will notify EXTEDO in writing. We will remedy material reproducible defects in a reasonable period of time. If EXTEDO cannot, then EXTEDO will refund to You the pro-rata amount of fees actually paid applicable to the unremedied material defect. You cannot deduct this amount from Your subscription fee, unless Your claim is undisputed or has been confirmed by a final court judgment. You will not have a claim for a defect under this section if: (i) it is caused by Your use of the Subscription Service in violation of this Agreement, or (ii) is a defect relating to our Trail Environment that has not been maliciously concealed by EXTEDO. Subject to the limitation of liability set forth in this Agreement, the refund described in this section is Your sole and exclusive remedy for defect claims.
7.2. Compliance with Laws. We will comply with all E.U. Regulations (where applicable) in our provision of the Subscription Service, the Consulting Services and our processing of Customer Data. We reserve the right at all times to disclose any information as necessary to satisfy any law, regulation, legal process or governmental request. You will comply with all laws in Your use and receipt of the Subscription Service and Consulting Services, including any applicable export laws. You will not directly or indirectly export, re-export, or transfer the Subscription Service or Consulting Services to prohibited countries or individuals or permit use of the Subscription Service or Consulting Services by prohibited countries or individuals.
7.3. Any technical data, specifications and details of performance contained in public statements, in particular sales materials, shall not constitute descriptions of qualities. The functionality and features of the SaaS Solution shall, in the first instance, be determined by the Solution Description. In addition, the SaaS Solution will be suitable for the purposes set out in this Agreement.
7.4. Any case reported to EXTEDO may be corrected by EXTEDO within the reaction time set out in the Customer Support Guidelines and any additional future Order(s) to this Agreement following appropriate notification of the defect. The same shall apply to any other disruption to the possibility of using the Software insofar as this disruption is originated in the sphere of responsibility of EXTEDO.
7.5. Any strict liability for damages in relation to defects already existing at the time of the conclusion of this Agreement is excluded.
7.6. The User shall support EXTEDO in identifying and correcting any defects in accordance with Section 3.6 of this Agreement.
8. Intellectual property
8.1. IP from EXTEDO. EXTEDO’s Intellectual Property rights include (i) source code and copyright, (ii) trademarks and designs, (iii) any licensed third party rights retained therein (e.g. licensed third party stock logos or artwork and licensed restorable software components), (iv) any pre-existing, EXTEDO-owned, reusable data that is required for the ongoing conduct of EXTEDO’s business and that is not proprietary to Customer (e.g. reusable program source code, EXTEDO-owned software programs, generic logos or artwork and workflow methodology), and (v) any other products, services, processes or other intellectual property developed or utilized by EXTEDO and offered generally by EXTEDO to its customers, including, without limitation, any enhancements or improvements thereto, whether developed by EXTEDO during the term of the subscription (collectively, the “Retained Property”).
8.2. IP from Customer Data. You own, control and retain exclusive worldwide rights and titles related to all work, patents, trade secrets, trademarks or designs (Your “Intellectual Property Rights”) that might be included in the content You generate by uploading, submitting or inserting Your Customer Data into EXTEDO’s SaaS Solution or Services. You shall be responsible for Your Business Data and the Intellectual Property Rights that might be contained therein, and You must ensure that such Customer Data does not infringe any third party intellectual property rights or violate any legislation or applicable laws in force at that time. In case of breach of the aforementioned obligation, You shall be responsible for and will indemnify EXTEDO for all claims, suits, proceedings, losses, liabilities, damages, costs and expenses (including attorney’s fees) made against or incurred by EXTEDO.
9. Data Protection, Customer and Technical data
9.1. Data Protection
9.1.1.EXTEDO as controller. EXTEDO is collecting and processing some of Your contact details that You provide to EXTEDO with the main purpose of managing the Customer relationship. Further details about such processing can be found at any time under our Privacy Statement, which is periodically updated. EXTEDO is committed to follow the highest standards on privacy and pursuing the requirements of GDPR. You can exercise Your rights as data subject by sending an e-mail to email@example.com.
9.1.2.EXTEDO as Processor. In consideration with the provision of the Services that EXTEDO is delivering to You, EXTEDO is acting as a processor on Your behalf for the data You upload to EXTEDO’s SaaS Solution (Your Customer Data), as long as it contains personal data therein. You accept that whenever personal data is included in Your Customer Data, there is a processing relationship that shall be governed by a separate document pursuant to Article 28 (3) of the GDPR. You accept and agree that EXTEDO will process personal data on Your behalf in accordance to the instructions set up on the Data Processing Agreement that can be download here. You are aware and agree that the Services of EXTEDO will be provided with the involvement of subcontractors.
9.1.3.Notwithstanding the above, within the framework of this Agreement and the current processing relationship, You are acting as a controller for Your Customer Data and (i) shall be responsible for ensuring the compliance with the EU Regulations and/or any other statutory requirements whenever applicable, (ii) shall attain the necessary consent of the concerned data subjects or the legal basis whenever You collect and process personal data within the scope of using EXTEDO’s Services and (iii) shall collaborate with EXTEDO whenever EXTEDO requires customer information about the processing activities handled by the Customer and hosted within the SaaS Solution.
9.2. Customer and Technical data
9.2.2.Aggregated Data. EXTEDO may monitor Your Company as our Customer when using the SaaS Solution and use the information gathered in an aggregated and anonymous manner in order to get statistics of Your Company’s needs regarding the Software in order to enhance Your user experience. You agree that EXTEDO may use such information, provided that such information does neither incorporate any Customer Data nor identifies any natural person.
9.2.3.Safeguards. We will maintain commercially appropriate administrative, physical and technical safeguards to protect Customer Data.
9.2.4.Returning of Customer Data. You shall be solely responsible for exporting the data until the end of the subscription period.
10.1. Customer and EXTEDO shall treat as confidential all technical and non-technical information in an oral, visual or written form or exchanged / transferred by data carriers, any knowledge or results thereby achieved, written documents, drawings, plans, specifications, company secrets, methods, formula, exchanged knowhow, as well as any materials and other objects (hereinafter called "Confidential Information") which is labelled as confidential in relation to the respective receiving Party or must be considered confidential by its nature.
10.3. Confidential Information may be disclosed to third parties only with the written approval of the party which originally provided such Confidential Information. In this case, the receiving party shall ensure that the third party complies with the provisions of this Agreement.
10.4. Neither EXTEDO nor the Customer shall be bound by a duty of confidentiality when receiving Confidential Information if such Confidential Information
a) is generally known at the time of disclosure;
b) becomes generally known without the receiving party having breached any duty to protect confidentiality;
c) was already in the possession of the receiving party at the time of disclosure or was not obtained directly or indirectly from the disclosing party;
d) simultaneously with or after the disclosure such was lawfully obtained from a third party and such third party had not directly or indirectly obtained the information from the disclosing party or was authorized to disclose such information in relation to the disclosing party;
e) was derived from own work in the possession of the receiving party or was obtained through own work at a later stage without the persons involved in such work having access to the disclosed confidential information;
f) must be disclosed because of a binding order of an authority whereby the party receiving the information shall notify the disclosing party of such case without unreasonable delay and upon request shall advise of any information necessary for any appeal or objection.
10.5. Any publication in which Confidential Information may be mentioned is to be approved by the affected Party in well in advance.
10.6. The obligation to maintain confidentiality shall expire 3 years from the date of the respective information being disclosed. In relation to information for submissions (= information concerning products in terms of authorization procedures), the obligation of confidentiality shall expire 5 years from the date of the respective information being disclosed.
11. Final provisions
11.2. Force Majeure. Neither party will be responsible for failure or delay of performance if it is caused by (i) an act of war, hostility, or sabotage, (ii) an act of God (iii) an electrical, internet, or telecommunication outage that is not caused by the obligated party, (iv) government restrictions or (v) other event outside the reasonable control of the obligated party. Each party will use reasonable efforts to mitigate the effect of a force majeure event.
12. Specific terms for the Trial Environment
12.1. If You are using our Services in a Trial Environment with demo data (“Trial Environment”) the following specific provisions will apply.
12.2. Only companies within the meaning of Section 14 of the German Civil Code (BGB) can request the Services as a Customer or potential Customer. EXTEDO will allow the access to the Trial Environment to certain users at its own discretion.
12.3. During the Trial Period, EXTEDO grants You with a non-exclusive and non-transferable right to access the Trial Environment on the system in the data center of the hosting partner of EXTEDO. Any rights on the Software shall not be transferred to You.
12.4. You have the right to use the Software only for internal test and demonstration purposes for a trial period of 45 days, free of charge and for a maximum number of 5 users per Customer.
12.5. If EXTEDO provides new versions, updates or upgrades of the Trial software during the trial period, the above right of access shall apply accordingly.
12.6. You shall use the Trial software strictly for the purposes for which it is meant to: the evaluation and test of the functionalities and usability of the Trial Environment and how it matches business needs for submission, viewing and reviewing. You shall not misuse the Trial Software or allow it to be misused. You shall refrain from any attempt, on Your own or through unauthorized third parties, to retrieve any information or data without authorization, to interfere with programs that are operated by EXTEDO or to allow such interference, or to access the data networks of EXTEDO without authorization. You are not entitled to use, reproduce, download nor make available the Trial Software to third parties.
12.8. You must inform EXTEDO immediately of any errors in the Trial software by sending an email to firstname.lastname@example.org, indicating how and under which circumstances the error or defect has occurred.