Whole genome sequencing and somatic mutation profiles and whole genome transcription files of pediatric medulloblastoma

Data Access Committee for Pediatric Medulloblastoma

DATA USE AGREEMENT THIS DATA USE AGREEMENT (this “Agreement”) is entered into by and between Seoul National University Hospital (“SNUH”) and [***] (the “Institution”) as follows. Article 1 (Purpose) The purpose of this Agreement is to set forth rights and obligations of the Institution, which intends to use SNUH’s data for “ (IRB No. )” (the “Research”), and SNUH, which intends to provide the Institution with the Target Data (as defined below), and other miscellaneous matters. Article 2 (Definitions) ① The following terms used in this Agreement shall have the meanings set forth below: 1. “Data” means raw data owned by SNUH and any and all information created from processing the raw data. 2. “Target Data” means data that are pseudonymized or anonymized to be ultimately provided to the Institution, as described in Exhibit 1 attached hereto. ② Any term not specifically defined in paragraph ① above shall be defined in accordance with the Personal Information Protection Act, the Enforcement Decree and the Enforcement Rules of the same Act, the Standards for Measures for Securing Safety of Personal Information, the Standard Personal Information Protection Guideline, and the Healthcare and Medical Data Guideline (January 2021). Article 3 (Term) The term of this Agreement shall commence on the execution date of this Agreement and shall remain in full force and effect until [**][**], 20[**]. Article 4 (Prohibition of Use Other Than for Intended Purpose) ① The Institution shall use the Target Data provided by SNUH only for the purpose of the Research and shall not use the same for any other purposes. ② The Institution shall not deliver the Target Data provided by SNUH to a third party that is not directly related to the Research or disclose the same to the outside, without prior written approval of SNUH. In addition, the Institution shall cause all of its employees, who access the Target Data under direct control and supervision of the Institution, to acknowledge and accept the terms and conditions of this Agreement. Article 5 (Prohibition of Re-identification) ① The Institution shall not take any action that is intended to identify a particular individual after receiving the Target Data. ② If any information that can identify a particular individual is generated or in any event where a particular individual is likely to be re-identified in the course of processing the Target Data, the Institution shall immediately suspend processing of the Target Data and notify SNUH of such fact, and shall provide necessary cooperation including immediate destruction of the relevant Target Data. ③ The Institution shall bear civil and criminal liabilities for any and all consequences arising from its non-performance of the matters in paragraphs ① and ② above. Article 6 (Obligation to Manage the Target Data) ① The Parties shall take technical, managerial and physical measures necessary to secure safety of personal information in accordance with Articles 23(2), 28-4(1) and 29 of the Personal Information Protection Act and the relevant provisions of the Enforcement Decree of the same Act. ② The Institution shall separately keep information that can identify a particular information when it is combined with the Target Data. ③ The Institution shall not correct, add or remove any of the Target Data unless expressly set forth in this Agreement. ④ The Institution shall take measures to ensure that the person in charge of processing pseudonymized information complies with obligations under this Agreement, such as by training the person on the compliance matters in this Article 6 and the applicable laws and regulations. ⑤ The Parties shall comply with laws and regulations that may apply in connection with processing of pseudonymized information or anonymized information, including the Personal Information Protection Act and the Bioethics and Safety Act, in addition to complying with the matters expressly set forth in this Article 6. Article 7 (Report of Status of Use) ① The Institution shall report to SNUH regarding its status of use of the Target Data at least once every six (6) months. ② Apart from the Institution’s report in paragraph ① above, SNUH may require the Institution to report its status of use in order to confirm whether the use of the Target Data by the Institution is proper, and the Institution shall comply with such request unless there are justifiable reasons. ③ If any of the reports in paragraphs ① and ② above indicates that the Target Data has been divulged or used for any purpose other than the intended purpose, or that there is a breach of this Agreement or violation of applicable laws or regulations, SNUH may require the Institution to cure such divulgence, use, breach or violation and the Institution shall comply with such request unless there are justifiable reasons. ④ If it is deemed insufficient to verify the status of use of the Target Data by the Institution, SNUH may conduct an on-site audit of the status of use of the Target Data in the premises of the Institution by giving a written notice seven (7) business days in advance. ⑤ In the event of paragraph ④ above, the Institution may request for an audit to be conducted by a third party for reasons such as protection of the Institution’s trade secrets. ⑥ In the event of paragraph ④ above, SNUH may charge the Institution any and all costs incurred by the on-site audit separately from a claim for damage. Article 8 (Restrictions on Use) ① The Institution shall return to SNUH, or destruct, in accordance with the instructions of SNUH, any and all information relating to the Target Data, including the original copy of the Target Data provided to the Institution, data that have been processed or transformed during the research process, and research deliverables, if any of the following applies: 1. If the Institution uses the Target Data not in compliance with this Agreement; 2. If it is determined that the purpose, method, or details of use of the Target Data is illegal or improper; 3. If the Institution does not continue to conduct the research utilizing the Target Data; or 4. If any material breach of this Agreement is found. ② In the event of the destruction under paragraph ① above, the Institution shall destruct all of the original copy of the Target Data provided to the Institution, data that have been processed or transformed during the research process, and research deliverables, and then submit to SNUH a certificate of confirmation verifying such destruction within thirty (30) days after SNUH has taken measures to restrict use of the Target Data. Article 9 (Authorization to Use the Target Data) This Agreement shall not restrict SNUH’s use of the Target Data, and SNUH possesses and continues to possess all rights to authorize a third party other than the Institution to use the Target Data. Article 10 (Measures upon Occurrence of Information Divulgence) ① If the Target Data have been divulged to a third party, or if there is a suspicion of such divulgence, the Institution shall immediately notify SNUH of such fact and shall take measures to prevent divulgence or recurrence of such divulgence and to minimize damage arising from such divulgence. ② In the event of divulgence of the Target Data due to reasons attributable to the Institution, the Institution shall be responsible for confirming the the divulgence of the Target Data and for any and all costs incurred therein, and if it is confirmed that the divulgence of the Target Data has occurred, the Institution shall review the cause of such divulgence and establish measures to prevent recurrence of such divulgence and shall report the same to SNUH. Article 11 (Confidentiality Obligation) ① SNUH and the Institution shall keep confidential all information of the other Party acquired during the course of performance of their duties, and shall not disclose, provide or divulge to a third party or use such confidential information for any purpose other than the purpose of this Agreement without prior written consent of the other Party; provided, that disclosure of the confidential information required in order to comply with court rulings, compulsory investigation by investigatory agencies, orders by the administrative authorities, or applicable laws and regulations shall not be deemed a breach of the confidentiality obligation contained herein. ② Notwithstanding the foregoing, confidential information does not include information that corresponds to any of the following: 1. Information that has been already owned by the disclosing party at the time of disclosure; 2. Information that has been developed by the disclosing party independently of and without reference to any confidential information; 3. Information that is known at the time of disclosure; 4. Information that entered the public domain subsequent to the time it was disclosed, without reasons attributable to the disclosing party; or 5. Information disclosed by a third party that has legitimate rights and is not bound by the confidentiality obligation. ③ The Institution shall cause the in-charge personnel, who has the authority to access the Target Data, to execute a confidentiality agreement, and upon request from SNUH, the Institution shall submit a copy of such confidentiality agreement. ④ The confidentiality obligation under this Article 11 shall survive the termination of this Agreement and for shall remain in effect for five (5) years after the expiration date of this Agreement. Article 12 (Warranties) ① SNUH hereby warrants that it possesses all rights to lawfully own and provide the Target Data, that it does not infringe any intellectual property right of any third party during the course of processing the Target Data, and that it has complied with the Personal Information Protection Act and other applicable laws and regulations. ② The Institution acknowledges that the Target Data are experimental, that the Target Data are provided without any express or implied warranty of merchantability or fitness for a particular purpose, and that SNUH shall not be liable for any consequence that arises from the processing of the Target Data. Article 13 (Retention of Rights to the Target Data) No right to the Target Data granted under this Agreement shall be construed as being retained by the Institution, and any and all rights in and to the Target Data including any intellectual property rights shall be retained by SNUH. Article 14 (Retention of Rights to Results of the Research) ① The matters regarding retention of the results of the Research shall be in accordance with a research agreement separately executed by and between SNUH and the Institution. ② Upon acquiring the results of the Research that has utilized the Target Data, the Institution shall promptly notify SNUH of such fact and consult with SNUH regarding retention of rights to, utilization of, and subsequent treatment of, the results of the Research regardless of whether any intellectual property right may be asserted regarding the results of the Research. ③ The Institution shall submit a summary report on the results of the Research to SNUH one month prior to the date of completion of the Research. In the report, the Institution shall specifically describe the method, process, etc. of the Research so that the details and process of the Research can be fully understood. Article 15 (Announcement of the Results of Research) ① In order for SNUH to protect the Target Data, the Institution shall notify SNUH of proposed submission or oral announcement of any research paper containing the results of the Research that has utilized the Target Data and shall submit the relevant materials to SNUH by no later than one (1) month prior to such proposed submission or oral announcement of the research paper, and SNUH may review the relevant materials in order to protect its rights in and to the Target Data. ② In all forms of announcement of the results of the Research, including written submission or oral announcement, the Institution shall indicate that such results have been obtained from the Research that has utilized the data provided by SNUH. Article 16 (Prohibition of Use of Name, etc.) The Institution shall not use any information acquired by it in connection with this Agreement or any original copy, reproduction, or copies of any or all of reports or documents provided by SNUH to the Institution, for advertisement, marketing and other promotional purposes or as litigation materials and shall not imply or use the name of SNUH for the aforementioned purposes and any other purposes. Article 17 (Termination) ① A Party (the “affected party” in this paragraph ①) may terminate this Agreement if the other Party is in breach of this Agreement and fails to cure such breach within a specified period as demanded by the affected party in writing. ② A Party may immediately terminate this Agreement by giving a written notice to the other Party without making the demand in paragraph ① above if any of the following events occurs to the other Party: 1. If the other Party is subject to, or is likely to be subject to, a transaction suspension order by a financial institution, or any bills or checks issued by the other Party are dishonored or are likely to be dishonored, or the other Party is subject to, or is likely to be subject to, compulsory enforcement (including preliminary attachment and preliminary injunction) by a third party; 2. If the other Party is subject, or is likely to be subject, to a business cancellation or suspension order by the monitoring authority; 3. If there is a reason that renders impossible to maintain this Agreement including the other Party’s petition for bankruptcy, winding-up or rehabilitation; or 4. If the other Party is merged to or acquired by a third party. ③ The exercise of the termination right under this Article 17 shall not affect the right to claim for damage. ④ If SNUH or the Institution intends to terminate this Agreement during the term of this Agreement, it shall give a written notice by no later than one (1) month prior to the termination of this Agreement. Article 18 (Effect Following Expiration or Termination of this Agreement) ① Articles 7, 14, 17, 19 and 20 and other provisions that are intended to be applicable even after termination (including expiration of the term) of this Agreement due to the nature of such other provisions shall remain effective even after the termination of this Agreement, and Article 11 shall effectively survive for five (5) years after the termination date of this Agreement. ② Upon termination of this Agreement, the Institution shall destruct any and all information relating to the Target Data including the original copy of the Target Data provided to the Institution, any data that has been processed or transformed during the course of research, and any research deliverables, and submit a certificate of confirmation on such destruction to SNUH within thirty (30) days after the termination date of this Agreement. Article 19 (Compensation for Damage) ① If a Party is in breach of any of its obligations under this Agreement due to reasons attributable to it and causes damage to the other Party, the Party in breach shall be liable for such damage. ② If a Party is in breach of any of its obligations under this Agreement due to reasons attributable to it and causes damage to a third party (including the data subject), the Party in breach shall be liable for such damage. Article 20 (Limitation of Liabilities) ① Each Party shall bear legal liabilities for its violation of relevant laws or regulations or its tort in connection with this Agreement. ② In the event of any legal dispute between the Institution and a third party in relation to processing of the Target Data, the Institution shall immediately notify SNUH in writing of such fact, and SNUH shall cooperate with the Institution to a reasonable extent in order to resolve the dispute. ③ In the event of any damage to or expenses incurred by SNUH (including attorneys’ fees) (the “damage, etc.”) in connection with the legal dispute in paragraph ② above, the Institution shall reimburse such damage, etc. except when such legal dispute has been caused by SNUH’s fault. Article 21 (Force Majeure) ① If there is any interference with a Party’s performance of this Agreement due to acts of God, natural disasters, labor dispute, war or other unpredictable causes that are beyond reasonable control of the Party (force majeure), the Party shall not be liable therefor. ② The Party who is not able to perform its duties under this Agreement due to the reasons in paragraph ① above shall notify the other Party of the event of force majeure and shall make reasonable efforts to perform its duties under this Agreement. ③ If the interference with the performance of debt obligation continues for sixty (60) days or more due to the reasons in paragraph ① above, a Party may immediately terminate this Agreement by giving a written notice to the other Party. Article 22 (Amendment) ① This Agreement may be amended or revised only by written agreement between the Parties. ② In the event of enactment or amendment of applicable laws, regulations or SNUH policies, SNUH may amend or revise this Agreement. Article 23 (Restriction on Assignment of Rights and Obligations) The Institution may not assign all or part of its rights and obligations under this Agreement unless the Institution has obtained prior written consent from SNUH. Article 24 (Dispute Resolution) Any dispute between the Parties that arises in connection with this Agreement shall be resolved by consultation in good faith. If the dispute is not resolved by consultation, such dispute shall be resolved by litigation and shall be subject to the jurisdiction of the Seoul Central District Court. IN WITNESS WHEREOF, the Parties shall sign or seal this Agreement in duplicate, and SNUH and the Institution shall keep each copy thereof. ____. ____. 20 . “SNUH” Seoul National University Hospital 101, Daehak-ro, Jongro-gu, Seoul President Yon Su Kim (seal) Research Manager (seal) “Institution” [Company Name] [Address] Representative Director (seal) Research Manager (seal)   [Exhibit 1] Details of Target Data 1. Composition of “Target Data” to Be Provided: - Video materials: Surgery videos - Data: CT (DICOM files) 2. Method for Providing “Target Data” - Enter the method for transmission of files, etc. 3. Expenses Associated with Provision of “Target Data” and Method for Payment of the Expenses - Expenses: KRW - Payment method: Enter the type of payment such as lump-sum payment / payment on a monthly basis or running guarantee, remittance, etc.