This Agreement dated is made by and between Controller (1) to Controller (2):

(1) EGYPTIAN ASSOCIATION OF VASCULAR BIOLOGY AND ATHEROSCLEROSIS (EAVA) as to where the COORDINATING CENTRE for the EUROPEAN ATHEROSCLEROSIS SOCIETY LIPID REGISTRY OF AFRICA’S ACUTE CORONARY SYNDROME PROJECT (EAS-LIPRA ACS) is based and whose registered C/O address is ICOM, EL ASDEKAA BUILDING (2), MASGED EL ASDEKAA ST, GARDEN CITY SMOUHA, ALEXANDRIA, EGYPT (hereinafter referred to as “Data Recipient”).

And

(2)

as to where the NATIONAL LEAD INVESTIGATOR for the country of

is based and whose registered address is

(hereinafter referred to as “Data Provider”

In recognising a mutual interest in the development and delivery of the EAS-LIPRA ACS Project.

The signature section of the parties entering into this Agreement is on the last page of this document.

1. Definitions of Terms used in this Agreement

Project, EAS-LIPRA ACS study and all its activities pertaining to the delivery of this study.

European Atherosclerosis Society (EAS), primary stakeholder that adopted and supports the Project.

Principal Investigator, overall Lead Investigator of the Project.

Coordinating Centre / Data Recipient, study sponsor, located at EAVA as to where the Principal Investigator is based, responsible for the delivery of the Project.

National Lead Investigator, local Investigator responsible for national contributions to the Project including providing data.

Data Provider, Institution/Site(s) as to where the National Lead Investigator is based.

Data / Incoming Data, variables collected via an electronic Case Report File (eCRF) in accordance with an approved protocol pertaining to the Project.  

Registry, database of pooled Incoming Data pertaining to the Project hosted and managed in a secure data warehouse at ICOM-Group via the Coordinating Centre. 

Results, outputs of analyses conducted on the data in the Registry pertaining to the Project.

Confidential Information, information exchanged or provided between parties entering into this Agreement in a written form or other tangible forms that at the time of provision is marked or otherwise designated to show expressly or by necessary implication that it is imparted in confidence.

2. Purpose

This Agreement outlines the clauses pertaining to the responsibilities, and terms and conditions under which the Data Provider will share specific data with the Data Recipient to enable the Data Recipient to deliver the Project on behalf of all parties entering into this Agreement.

3. Scope

The Data Recipient will grant the Data Provider free access to a secure online system for the Data Provider to upload specific variables via an eCRF as a means of local contribution to this Project in accordance with an approved protocol registered as an observational study on clinicaltrials.gov under identification number NCT06238375.

4. Terms and Conditions

(a) It is the responsibility of both parties, as controller-to-controller, entering into this Agreement to adhere to the mutual guidelines outlined in the approved protocol pertaining to the delivery of the Project.

(b) It is the responsibility of the Data Recipient to lead all regional activities pertaining to the overall delivery of the Project.

(c) It is the responsibility of the Data Provider to lead all local activities pertaining to national contributions to the Project.

(d) The Data Provider shall comply with all their local ethical laws and policies when contributing to the Project. This includes, but not limited to, obtaining Research Ethics Committee (REC) approvals for their site(s) to contribute to the Project and obtaining written, signed, informed consent from patients eligible and willing to volunteer as a study participant. All essential documents pertaining to the above must be retained securely by the Data Provider. The Data Provider will provide written confirmation of their compliance with their local ethical laws and policies to the Data Recipient.

(e) The Data Provider shall ensure that all local data that they contribute to the Project is accurate and complete. The Data Provider shall at all times maintain the anonymity of the participants and upload all data in a pseudo-anonymised format with all obvious identifiers removed. At no point shall the Data Provider disclose any obvious patient identifiers to the Data Recipient.

(f) The Data Recipient shall comply with all their local ethical laws and policies in the delivery of the Project. This includes, but not limited to, compliance with all applicable laws, regulations, and standards related to data protection and privacy. At no point shall the Data Recipient make a request to the Data Provider to disclose any obvious patient identifiers.

(g) The Data Recipient shall at all times ensure that the security, confidentiality, and integrity of the individual-level incoming data is maintained, and take all necessary measures to prevent unauthorised access, use, or disclosure.

(h) The Data Recipient shall notify the Data Provider of any data breach or unauthorized access to the incoming data within 72 hours of such breach becoming known to the Data Recipient.

(i) The Data Recipient shall use the incoming data solely for the purposes specified in this Agreement for the fulfilment of the Project in accordance with the approved protocol and will not disclose nor transfer individual-level data to third parties or use the individual-level data provided for any other purpose without prior written permission from the Data Provider.

5. Intellectual Property Ownership

(a) The Data Provider shall retain the intellectual property of the local/national data that they contribute to the Project.

(b) The Data Recipient shall retain the intellectual property of the overall regional data pooled from the participating countries in Africa housed in the Registry for the purpose of delivering the Project on behalf of all parties, committees, investigators, collaborators, and stakeholders involved in the Project.

6. Publication Policy

(a) The publication of results derived from analyses of the Registry’s regional data pertaining to the Project will be in the form of conference abstracts and journal article publications.

(b) The drafting of abstracts and manuscripts shall be led by the Principal Investigator or their delegates for whom shall ensure adherence to the ethics in publishing guidelines by the International Committee of Medical Journal Editors (ICMJE). The Principal Investigator or their delegates shall therefore have authority to make the final decision on the finalising of abstracts and manuscripts, and their submission.

(c) The National Lead Investigator will be eligible to be involved in publications provided their Institution/Site(s) have contributed local data to the Project at the time of data analyses pertaining to the publications.

(d) The Principal Investigator or their delegates shall provide fully drafted abstracts and manuscripts to the National Lead Investigator for whom will form part of the writing group for further contributions in the form of critique and approval for submission within a month turnaround of receipt. Failure to respond could result in proceeding with publication in the absence of the National Lead Investigator. If any disagreements over the material in the abstracts and manuscripts were to arise and not resolved after a two-week course of discussion, then clause 6(b) shall prevail.

(e) Recognition of the writing group’s contributions to the abstracts and manuscripts shall be in the form of co-authorship, where possible. The list of co-authors shall be concluded with “on behalf of EAS-LIPRA Investigators” to recognise its wider African network.

(f) The National Lead Investigator, provided they are eligible for co-authorship themselves in accordance with clauses 6(c) and (d), shall provide the Principal Investigator or their delegates with a list of their contributing local collaborators that wish to be listed in an “Appendix of Acknowledgements” accompanying the manuscripts.

7. Confidentiality

Both parties shall maintain the confidentiality of any non-public information or background received from the other party during the course of this Agreement and shall not disclose such information to any third party without prior written consent.

8. Term and Termination

This Agreement shall commence on the Effective Date stated at the top of the first page and shall remain in effect until terminated by either party with 30 days written notice. Termination of the Agreement shall not relieve the parties of their obligations regarding the confidentiality and return/destruction of shared data.

9. Governing Law

This Agreement shall be governed by and construed in accordance with the laws of Egypt, as to where the Coordinating Centre is based, without regard to its conflicts of law principles.

10. General

(a) Neither party will be liable for any loss or damage resulting from its failure nor delay in performing its obligations hereunder to the extent that such failure or delay arises from circumstances beyond its control.

(b) The liability of either party for any breach of this Agreement or arising in any other way out of the subject matter of this Agreement, will not extend to loss of business or profit, or any indirect or consequential damages or losses.

(c) This Agreement contains the entire agreement, and supersedes any previous agreements, between the parties as to its subject matter and may only be amended by a written agreement between the parties referring to this Agreement, expressly stating that it varies and signed on behalf of both parties.

(d) No waiver of any term or condition of this Agreement shall be effective unless made in writing and signed by the party against whom enforcement of the waiver is sought. The waiver of any breach of this Agreement shall not be construed as a waiver of any subsequent breach of the same or a different nature.

(e) If any clauses of this Agreement or its application shall be invalid or unenforceable, the remaining clauses of this Agreement shall remain unaffected.

(f) Each of the parties agrees to comply with all applicable anti-corruption, anti-bribery, and local employment laws, as well as any other applicable legislation, laws, and regulations in connection with their performance under this Agreement. In the case of the Coordinating Centre, it undertakes to comply with all Egypt legislation that may be applicable in carrying out the project. Either party’s failure to comply with any provision of this clause is considered to be a breach of this Agreement.

Signatories of the respective parties enter into this Agreement by signing below: