I. Introductory Provisions and Definitions of Certain Terms
These Business Terms and Conditions (hereinafter “BTC”) shall regulate the relationships between Institut biostatistiky a analýz, s.r.o., ID: 02784114, a company with its registered office at Poštovská 68/3, 602 00 Brno, Czech Republic, entered in the Commercial Register maintained by the Regional Court in Brno under File No. C 82448 (hereinafter the "Licensor") and a natural or legal person (hereinafter the “Licensee”) under Section 420 et seq. of Act No. 89/2012Coll., of the Civil Code, as amended (hereinafter “CC”) arising from the conclusion of the license agreement through the Internet portal www.obsernis.com (hereinafter the “e-shop”).
The Licensor is the owner of all proprietary rights to the ObserNIS product (hereinafter the “Software”), where such proprietary rights shall also include the right to license the Software to other persons for a fee.
The Software, which is the subject matter of the License Agreement between the Licensor and the Licensee, is determined by the order made by the Licensee via the e-shop. Both the Licensor and the Licensee acknowledge that the Software and thereby the subject matter of this agreement may change over time as a result of e.g. the Licensee’s interest in obtaining additional services from the e-shop.
II. Subject Matter of the Agreement
The Licensor, through an agreement entered into in accordance with Article III of these BTC, shall provide the Licensee with the right to use the Software (hereinafter the "License", to the extent and in the manner as defined below in these BTC.
The Licensee undertakes to pay the Licensor the royalty (hereinafter referred to as the "Royalty") as well as to comply with other obligations set forth in these BTC.
III. Conclusion of the Agreement
The Licensor and the Licensee have entered into a license agreement, with Software being the subject matter thereof.
All licensing opportunities placed on the Licensor’s e-shop shall be a tender under Section 1731 et seq. of the Civil Code (CC). The location of the licensing opportunity at the e-shop shall therefore be a binding proposal for the conclusion of an agreement by the Licensor.
The Licensee will make an order via the e-shop. By sending the order, the Licensee shall express, in a binding manner, his will to enter into a contractual relationship regarding the relevant software. The agreement shall be concluded by delivering the order to the Licensor. The Licensee will be forthwith informed of the conclusion of the contract by e-mail.
If the Licensor is unable to perform for any reason he shall contact the Licensee without any unreasonable delay in order to agree on the further procedure.
IV. License
Upon registration, the Licensee shall obtain access to the web interface where it is possible to purchase and make accessible individual packages, i.e. the Software.
The Licensee's authorization to use the Software shall be provided for an indefinite period of time. In the case of software under section 8.2. of this Agreement, the Licensee's right to use the Software shall be granted for the duration of the contractual relationship under Article VIII. of this Agreement.
Along with the right to use the Software, the right to use other parts of the subject matter of the Agreement shall also be granted, such as documentation generated by the Software, and so on.
The license has been agreed as unlimited in territorial terms, so the subject matter of the license can be used irrespective of territory.
The license has been agreed as unlimited in terms of number of uses and at the same time, the Licensee is not obliged to use the license. However, the Licensee shall be the only beneficiary of the license.
The Licensee shall have no right to use the subject matter of the Agreement to the extent other than specified by these BTC and as results from the text or the nature of the contractual relationship. The Licensee shall not be in particular entitled to make any copies of the Software, to modify, reverse engineer, decompile or disassemble the program code of the Software or any parts thereof, or to unblock, disturb or circumvent any Software security features. An attempt to exceed the extent of use shall be considered an unauthorized interference with the Licensor’s rights.
The Licensee shall not be entitled to use the Software for the purpose of generating profits (e.g. creating Software copies, granting other licenses, etc.). However, this shall be without prejudice to the Licensee’s right to use the Software for his/her own business.
The Licensee shall not be entitled to sublicense the Software. The Licensee shall not be entitled to assign the license to any other person.
The Licensor shall be authorized to check the compliance with the scope as defined in the License Agreement and these BTC.
V. Royalties, Payment Terms and Delivery of the Subject Matter
The Licensee is obliged to pay the Licensor the royalties in a proper and timely manner according to the chosen payment method and the agreed due dates. The terms of the chosen payment method shall become a part of the License Agreement. Unless otherwise specified, royalty for the entire duration of the license shall be payable within 7 days from the date of conclusion of the Agreement.
The amount of the royalty and any fees specified in the e-shop are shown exclusive of VAT, unless otherwise specified. The cost of the payment method chosen shall not be included in the royalties specified in the e-shop.
The license is provided electronically, i.e. by accessing the web interface of the Software and unlocking the relevant Software with documentation. The Licensor is obliged to make the license available to the Licensee no later than the next business day after delivery of the first payment for the Software to the Licensor's bank account.
The Licensee is obliged to protect the access data to the Software (or to the web interface) against access by any third party or loss. Otherwise, he shall be responsible for any damage incurred therefrom.
VI. Other Provisions
The Licensor undertakes that the Software will be available to the Licensee 97% of time in the calendar month (service availability period, hereinafter SAP). This obligation shall not be deemed violated if the Licensee is prevented from access as a result of an impediment that has emerged independently of the Licensor’s will and conditions. The period for which the service is not available to the Licensee shall start from the moment the Licensor receives the information about the unavailability of the service from the Licensee to the email address: helpdesk@obsernis.com, until the Licensee receives the relevant information about the renewed availability of the service.
The Licensor is responsible that the Software, the information contained therein and the information contained in the documents generated by the Software are processed with due diligence, taking into account the current legal status and the spectrum of expert opinions
as of the day the agreement is concluded for the Software paid on a one-off basis,
as of the date of provision of the information for the Software paid on a regular basis,
as of the date of document generation for software-generated documents.
However, the Licensor shall be responsible only to the extent of reasonably foreseeable activities identified based on properly completed backgrounds and questions and based on close cooperation between the Licensor and the Licensee. If the Licensee completes incorrectly the questionnaires, forms or other background for document generation, or if the Licensee's activities are different or beyond the reasonable assumptions, from the answers given in the documents, the Licensor shall not be deemed responsible for the content of the Software and for any documents generated therefrom.The Licensee expressly declares he is aware of the fact that, in view of the need for a high degree of individualization in the management of clinical trial issues, the Licensee is obliged to cooperate closely with the Licensor when using the Software and generating and using the documents generated therefrom. The Licensee is obliged to familiarize himself with the content of the document immediately after its generation and assess whether it corresponds to the performed and intended activity of the Licensee, including its scope, technical and organizational security, personnel issues and internal processes. In case of any doubts about the content, completeness or suitability of information from the Software, documents or their content, the Licensee is obliged to notify the Licensor thereof without any unreasonable delay. In the event of failure to comply with this obligation, the Licensee disclaims any liability for defects of the Software and software-generated documents.
In the event that the Licensee suffers any damage caused by a breach of contractual obligations, the Licensee is entitled to claim damages from the Licensor up to the amount of the monthly royalty for the month that the Licensee has paid to the Licensor in the billing period, in which the Licensor's obligations were breached. The rights resulting from liability for defects in the subject matter of the agreement shall be limited to a discount on the price, to the same extent.
If the Licensee uses the subject matter of the Agreement improperly and if damage is caused by such incorrect use, the Licensor shall not be liable for it.
In the event of a delay in the payment of a monetary debt, the Parties have agreed on default interest at the rate of 0.05% of the amount overdue for each commenced calendar day of delay.
VII. Protection of Information Provided
The Licensor undertakes to protect the content inserted by the Licensee, to not handle such Content or use it for himself or for any other person and not disclose such Content to any third party without the prior written consent of the Licensee. This shall be without prejudice to the Licensor's right to inspect the Software, including the data provided as part of technical support or other assistance.
The following situations are exceptions from section 7.1:
the Licensor is entitled and in this case also obliged to provide information inserted in the Software in the event such provision is required by the law, or possibly by legally issued decision of a public authority;
the Licensor is entitled to provide information, when such information becomes publicly available for any reasons other than a breach of the obligations resulting from the agreement or from these BTC;
the Licensor may also disclose information in cases where such disclosure protects the Licensor's rights and legitimate interests in arbitration or in proceedings before courts or other public authorities.
VIII. Duration of the contractual relationship
The contractual relationship based on a license agreement between the Licensor and the Licensee has been concluded for an indefinite period of time.
The Licensee and the Licensor are entitled to terminate the contractual relationship related to the Software (or its partial functions), which is covered by regular payments, by giving notice without showing any reasons, and the notice period is hereby agreed to be 2 months. However, termination of the contractual relationship by the notice from the Licensee may only occur at the end of the calendar quarter.
The Licensor is entitled to terminate the contractual relationship even by giving notice without any notice period, in case the Licensee seriously breaches his obligations under the agreement or under these BTC. This means in particular:
delay in payment of royalty for more than 1 month,
violation of the provisions of Section 4.6 of these BTC,
violation of the provisions of Section 4.7 of these BTC.
The Licensee is also entitled to terminate the contractual relationship if the Licensor changes the BTC under Section 10.5. In such a case, the notice period shall be set such that the contractual relationship will be terminated by expiry of the last day of the effectiveness of the current BTC.
IX. Protection of the Licensee’s Personal Data
The Licensor undertakes to handle any personal data of the Licensee in accordance with the applicable legal regulations. First of all, the Licensor undertakes to handle personal data to the minimum possible extent in view of the nature of this Agreement and the requirements for the fulfillment thereof.
The personal data protection is further regulated in the Personal Data Protection Policy.
X. Processing of Personal Data by the Licensor
When providing the Software, the Licensor, as a processor, may process personal data of data subjects, whose data are processed by the Licensee as their administrator through the Software. The data subjects affected by the processing shall include, in particular, employees and business partners of the administrator, who are identified by the Licensee as responsible persons or as recipients of personal data when working with the Software. The subject matter of processing may include in particular the identification data and contact details of the data subjects.
These BTC shall regulate the obligations of the Licensor and the Licensee arising from the processing of personal data of data subjects in accordance with Article 28 of the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46 / EC (hereinafter “GDPR”).
The Licensor declares that he has adopted appropriate technical and organizational measures so that the processing of personal data complies with the GDPR requirements and that the rights of the data subjects concerned are protected.
The Licensor is entitled to engage other processors in the processing, but shall always inform the Licensee of any intended changes concerning the addition or replacement of other processors, thereby giving the Licensee the opportunity to object to such changes, and if the Licensee makes no such objections without any unreasonable delay, it is considered that he has agreed with the change. The Licensor shall bind other processors to the same data protection obligations as those set forth in these BTC.
The personal data of the data subjects will be processed by the Licensor during the period of Software provision, in particular as a result of their storage in the Software and in the case of service interventions, also in the form of an inspection, solely for the purpose of fulfilling the License Agreement and these BTC.
The processing will always proceed only based on the demonstrable instructions of the Licensee given to the Licensor through the Software under the license agreement and these BTC.
No specific categories of personal data will be processed when providing the Software. The Licensee is obliged to ensure that none of the special category personal data will be provided to the Licensor through the Software.
When processing personal data, the Licensor, as a processor, undertakes:
to process personal data only for the purposes and using methods resulting from these BTC and from the contractual arrangements,
to Ensure that persons authorized to process personal data are bound by confidentiality or subject to the statutory duty of confidentiality,
to adopt any and all appropriate technical and organizational measures in accordance with Article 32 of the GDPR that are necessary to ensure the processing of personal data and are in line with the nature of the processing and the associated risk, to prevent inter alia, unauthorized or accidental access to personal data, their alteration, destruction or loss, unauthorized transmissions, or their other unauthorized processing, as well as to any other misuse of personal data,
after terminating the provision of services related to the personal data processing, to hand over all personal data processed to the Licensee and delete all their existing copies, if any,
to assist the Licensee, through appropriate technical and organizational measures, in fulfilling his obligation as an administrator to respond to requests for the exercise of the rights of the data subject,
to assist the Licensee in ensuring compliance with the duty of safeguarding data processing, in reporting violations of personal data protection to the Office for Personal Data Protection, in reporting breaches of personal data protection of data subjects, in assessing the impact on personal data protection, and in prior consultation with the Office for Personal Data Protection,
to promptly inform the Licensee when, in his opinion, an instruction violates the provisions of GDPR or other EU or Member State data protection laws,
to assist the Licensee in ensuring compliance with the GDPR Articles 32 to 36, taking into account the nature of the processing and information available to the Licensor,
to provide the Licensee, based on his written instruction, with all the necessary information to demonstrate that the Licensor’s obligations under Article 28 of the GDPR have been fulfilled, and to allow for audits, including inspections, carried out by the controller or other auditor delegated by the controller, and to contribute to these audits,
to provide the Licensee, at his written request, with any and all information necessary to demonstrate that the obligations set forth in Article 28 of the GDPR have been fulfilled.
The Licensee hereby expressly undertakes to comply with any and all obligations resulting for him, as a personal data controller, from these BTC, contractual arrangements, GDPR provisions, applicable laws and other generally binding legal regulations. The Licensee's obligation under the preceding clause shall include, inter alia, his obligation to disclose to the Licensor, through the Software, only personal data with a valid legal title within the meaning of Article 6 GDPR, subject to all the principles set forth in Article 5 GDPR and related legal obligations. For this purpose, the Licensee undertakes, inter alia, to ensure that the processing of personal data in the form of its storage will have a valid legal title in compliance with the GDPR requirements and other legal regulations throughout the processing.
Irrespective of the legal title, based on which the personal data are processed, the Licensee undertakes to fulfill his obligation to provide information to data subjects under Article 13 et seq. GDPR.
In the event of a breach of any obligation under this article of the BTC, the Licensee undertakes to compensate the Licensor for any damages (material and non-material) resulting from or related to the breach.
XI. Final Provisions
These BTC are available at the Licensor's e-shop. The Licensee had the opportunity to familiarize himself with their text prior to sending the order.
The legal relationships between the Licensor and the Licensee shall be governed by the Czech law, in particular, by the Civil Code. The use of the Licensee’s business terms and conditions is excluded.
In the event of any dispute, the License Agreement shall have priority over these BTC.
Any disputes arising out of the agreement will be decided, unless otherwise agreed by the parties, exclusively by the courts of the Czech Republic having subject-matter, local and functional jurisdiction.
The Licensor is entitled to continuously update these BTC, including their replacement with new BTC. The Licensor is obliged to publish the new version of these BTC no later than 15 days before the change takes effect. The Licensor is obliged to inform the Licensee in writing (i.e. via e-mail) of any changes made. The Licensee is obliged to familiarize himself with the new wording of the BTC, and unless he expresses to the Licensor a clear disagreement with the new wording no later than on the last effective day of the existing BTC, the new OP shall be considered to be mutually approved and effective as of the date specified in the respective notice of efficacy of the new BTC.
If any provision of the Agreement and/or these BTC becomes invalid or ineffective, the validity and effectiveness of the other provisions of the Agreement and/or BTC will remain unaffected. The parties undertake to replace the invalid or ineffective provisions of the Agreement and/or BTC with new provisions, whose content and purpose correspond best to the content and purpose of the original provisions.
The Licensor is entitled to conduct any and all communication with the Licensee via e-mail sent to the e-mail address specified in the order by the Licensee, the accuracy of which shall be guaranteed by the Licensee. The Licensor is also entitled to communicate with the Licensee via online support tools provided to the user within the Software or via telephone.
