1. When you register for the TigerStudy membership account having aforementioned institute /Hospital affiliation, legally represented by your first name and the last name, hereafter referred to as the “Supplier”
2. Amsterdam UMC (AMC) having its registered office and principal place of business at Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands, legally represented by the primary investigator of the Tigerstudy, hereinafter referred to as the “Recipient”
The foregoing entities are solely referred to as “Party” and collectively referred to as “Parties”.
- The Supplier owns the rights to certain clinical data derived from patient care and/or research on patients who underwent esophagectomy, and is willing to provide the Recipient with such data for the sTigerstudy (hereinafter: the “Research”) as set forth in Annex 1.
- The Recipient will also collect such clinical trial/cohort data from other parties. The full dataset in which all subdatasets are included will be used for the Research.
- The Parties now desire to enter into this Data Sharing Agreement (hereinafter: “Agreement”) to confirm the terms and conditions upon which the Recipient agrees to conduct the Research (defined below) and upon which the Supplier agrees to transfer the clinical trial/cohort data.
Now, therefore, in consideration of their mutual promises to each other, hereinafter stated, the Parties agree as follows:
- “Data” means the data as identified in Annex 1 which the Supplier will transfer to the Recipient. The Data will contain personal data - which will be pseudonymised - as described in Annex 2.
- “Confidential Information” means any proprietary information, know-how, data, or procedure related to the Data and disclosed by the Supplier to the Recipient pursuant to its rights or obligation under this Agreement.
- “Controller”, “Data subject”, “Personal data”, “Processing”, “Processor” and “Supervisory authority/authority” shall have the meaning as in the General Data Protection Regulation (EU) 2016/679 (hereinafter: “GDPR”).
- “Pseudonymised data” means Personal data which can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the Personal Data are not attributed to an identified or identifiable natural person.
Clause 1. The processing of Personal Data
- The Supplier will provide the Recipient with the Data in accordance with the terms of this Agreement. With respect to the Data, the Supplier and Recipient are both considered controllers for the processing of the personal data and will both act in accordance with Dutch Data Protection Act and as from 25 May 2018 with the GDPR and additional data protection laws in the Netherlands Both Supplier and Recipient shall implement appropriate technical and organizational measures to meet the requirements of the GDPR.
- The Supplier warrants and undertakes that:
- the Personal data have been collected, processed and transferred in accordance with the Dutch Data Protection Act and as from 25 May 2018 with the GDPR and additional data protection laws in the Netherlands.
- that the Data will only contain Pseudonymisied data and no directly identifing Personal data;
- it has obtained any regulatory or ethics approvals necessary to collect the Data and transfer the Data to the Recipient;
- it has full authority to transfer the Data to the Recipient;
- in accordance with 458 of the Dutch Medical Treatment Act (WGBO), informed consent of the Data subjects is not required. Data will be collected on opt-out basis.
1.3 The Recipient warrants and undertakes that:
- the Personal data will be processed in accordance with the laws applicable to the Recipient and as of 25 May 2018 in accordance with the GDPR and any (additional) applicable national law;
- the Data will be used for the sole purpose of the Research in accordance with the permitted uses of the Data specified in the opt-out form of the Data subjects from whom the Data was collected.
- appropriate technical and organisational measures are in place to protect the Personal data against accidental or unlawful destruction or accidental loss, alteration, unauthorised disclosure or access, and which provide a level of security appropriate to the risk represented by the processing and the nature of the data to be protected.
- all Personal data will be treated strictly confidentially and shall have in place procedures so that any third party it authorises to have access to the Personal data, including employees and (sub)Processors, will respect and maintain the confidentiality and security of the Personal data. Any person or organisation acting under the authority of the Recipient, including a (sub)Processor, shall be obligated to process the personal data only on instructions from the Recipient and in accordance with the permitted use under this Agreement. This provision does not apply to persons authorised or required by law or regulation to have access to the Personal data
- in the event a Data subject objects to the use of the Data, Recipient will – at the instruction of Supplier – immediately return or destroy the Data from that particular Data subject.
1.4 If either Party becomes aware of a personal data breach, that Party shall promptly notify the other Party/ies. In such a case Parties will fully cooperate with each other to remedy the personal data breach, fulfil the (statutory) notification obligations timely and cure the damages. A personal data breach refers to: 1) a personal data breach as meant in article 34a of the Dutch Data Protection Act, and 2) as of 25 May 2018 a personal data breach as meant in articles 33 and 34 of the European General Data Protection Regulation.
Clause 2. Confidentiality
2.1 Confidential Information is the sole property of the Supplier and shall be used by the Recipient solely for the purpose of the Analyses. The Recipient agrees not to disclose Confidential Information to third parties without the consent of the Supplier and under an agreement by the third party to be bound by the obligations of this Clause 2. The Recipient shall safeguard Confidential Information with the same standard of care that is used with Recipient’s own confidential information, but in no event less than reasonable care. The Data is not considered to be Confidential Information.
- The obligations under this Clause 2 shall not extend to any information:
- which is or becomes publicly available through no breach of this Agreement;
- which Recipient can demonstrate that it possessed free of any obligation of confidence prior to, or developed independently from, disclosure under this Agreement;
- which Recipient receives from a third party which is not legally prohibited from disclosing such information; or
- which Recipient is required by law to disclose.
2.3 The obligations of this Clause 2 shall survive this Agreement for a period of three (3) years after termination or expiration of this Agreement. Upon the request of the Supplier, the Recipient agrees to return the Data to the Supplier or destroy, at the option of the Supplier, all copies of Confidential Information; provided, however, that Recipient shall be entitled to retain one copy of Confidential Information solely to ensure compliance with its rights and obligations hereunder.
Clause 3. Results
3.1 All discoveries, developments, databases, inventions (whether patentable or not), methods, reports, know-how, or trade secrets which are made by the Recipient as a result of the conduct of the Analyses (hereinafter: “Results”) shall be the solely property of the Recipient.
3.2 The Supplier shall be entitled to submit an application to a steering committee established by Recipient to use the Results for its own research proposal(s).
Clause 4. Publication
4.1 Parties will jointly publish the Results in one or more articles in peer reviewed journals, which publication shall be coordinated by the Recipient. The local investigator and the residents who were responsible for entering the data in the database will be mentioned in the publication as part of the Collaborative Study Group.
4.2. Supplier will not publish its Results independently, unless such intended publication is submitted for review to the steering committee established by the Recipient. Submission for review must occur at least 60 days prior to the intended publication.
Clause 5. Representations and warranties
5.1 Other than the warranties set out in section 1.2, the Data is provided by the Supplier to the Recipient without any warranties whatsoever, express or implied, including any warranties for merchantability or fitness for a particular purpose.
5.2 Nothing in this Agreement shall be construed as granting to Recipient, either expressly or by implication, any right or licence to the Data, under any patent, patent application, trade secret, know how, confidential information, trade or service mark, copyright, or other intellectual and/or industrial property rights Supplier possesses or may possess, nor any option to any such right or license.
Clause 6. Liabilities and indemnification
6.1 The Recipient assumes the risk of any damage, loss, or expense associated with or resulting from the conduct of the Analyses or Recipient’s use of the Data, unless such damage or loss is caused by the gross negligence or wilful misconduct of the Supplier.
6.2 The Recipient will indemnify and hold the Supplier, its directors or employees harmless against all claims of any kind whatsoever that may arise or result from the use of the Data.
6.3 The Supplier shall not be liable toward the Recipient for any claims, costs or damages that may result, directly or indirectly, out of Recipient’s use of the Data and/or Results, unless and to the extent that damage is caused by gross negligence and/or due to wilful misconduct by the Supplier.
6.4 The Parties shall in no case be liable for any indirect, incidental or consequential damages (including without limitation, lost business or profits, or loss of use of equipment) suffered by another Party.
Clause 7. Duration and termination of the Agreement
7.1 This Agreement shall become effective on the date of the last Party’s signature below, and shall remain in force for a period of 15 years, unless terminated earlier in accordance with section 7.2. The Parties agree that the term may be extended by mutual written agreement.
7.2 This Agreement can be terminated earlier by either Party with immediate effect by receipt of written notice:
a. Upon a material breach of this Agreement by the other Party, if it is not cured within thirty (30) days after the breaching Party has received written notice of such material breach.
b. in the event the other Party is in state of bankruptcy or suspension of payment or a petition to that effect is filed by or against that Party;
c. in the event the business of the other Party will be winded up or closed down;
d. in case of force majeure - as determined in clause 11 below - if the force majeure situation will last over ninety (90) days.
7.3 The Recipient agrees, on termination of this Agreement (whether as a result of its breach or otherwise) to cease all use of the Data and shall within fifteen (15) days return all Data to Supplier or destroy all Data at the sole discretion of Supplier, or to deal immediately with the Data in accordance with Supplier’s written instructions.
7.4 Clauses 1-6, 8 and sections 7.4 shall survive expiration or early termination of this Agreement, as well as any terms that by their nature would be expected to survive expiration or early termination of this Agreement shall survive such expiration or early termination.
Clause 8. Publicity
Neither Party will use the logo or name of the other Party or the name of an employee of the other Party, for promotional purposes, in any publicity, advertising or news release, without prior written approval of the Party whose name is to be used.
Clause 9. Modifications
Modifications, changes and extensions to this Agreement are only binding after these have been agreed upon in writing between the Parties.
Clause 10. Assignment
The rights and obligations as determined in the Agreement may not be assigned by a Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed.
Clause 11. Force Majeure
In case of force majeure the concerning Party is entitled to suspend the obligations for the duration and extent of the force majeure, provided that the other Party has been notified in writing of the force majeure. Force majeure situations will concern those situations which prevent the execution of the Agreement and which are not imputable to the concerning Party pursuant to law, Agreement or according to generally accepted standards and as a result will not be attributable to that Party.
Clause 12. Severability
The invalidity or unenforceability of any particular provision of this Agreement shall not affect any other provisions therein. The Agreement shall be construed in all respects as if such invalid or unenforceable provision were omitted.
Clause 13. Governing law
13.1 This Agreement will be governed by Dutch law.
13.2 In the event a disputes may arise from the Agreement, or from the execution of the Agreement, Parties will first try to settle such dispute amicably. If the dispute cannot be settled amicably, it will be submitted to the competent court in the district of Amsterdam, the Netherlands.
Clause 14. General Terms and conditions
No general conditions will apply to this Agreement.