sbp_mta2.0_master-legal-instrument.pdf

MTA 2.0 MASTER LEGAL INSTRUMENT FOR THE TRANSFER AND USE OF HUMAN BIOLOGICAL MATERIAL AND ASSOCIATED DATA IN SWITZERLAND

Upon execution of a project agreement (referred to as the “Project Agreement”) in the form attached that specifies, among others, the research project and the human biological material and associated data to be transferred, the involved organizations agree to be bound by the terms of the MTA 2.0 – Master Legal Instrument (referred to as the “Master Legal Instrument”).

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TABLE OF CONTENT PREAMBLE 3

DEFINITIONS 3

ARTICLE 1 RESEARCH PROJECT 4 Scope Ethics Committee Approval Provider’s Warranties

ARTICLE 2 ORIGINAL BIOLOGICAL RESOURCES 4

ARTICLE 3 TRANSFER 4 Confidentiality Insurance

ARTICLE 4 PROCESSING 4 Due Care Limitations Security

ARTICLE 5 INTELLECTUAL PROPERTY RIGHTS 4 Background IP Foreground IP

ARTICLE 6 RESEARCH PARTICIPANT’S RIGHTS 5 Fundamental Rights Withdrawal of Consent No Re-Identification

ARTICLE 7 LIABILITY AND INDEMNIFICATION 5

ARTICLE 8 EXPIRATION AND TERMINATION 5 Expiration Termination Consequences Survival Clauses

ARTICLE 9 AMENDMENTS AND SEVERABILITY CLAUSE 5 Amendments Severability

PREAMBLE Original Biological Material means any material obtained or derived from a biological organism, any Progeny and Unmodified This Master Legal Instrument is supplemented by a Project Derivatives thereof, that are to be delivered by the Provider to the Agreement. Recipient, as described in the Project Agreement. Jointly, these two documents regulate the transfer and use of specific human biological material and associated data (referred to as Original Biological Resources means Original Biological Material the “Original Biological Resources”) between organizations. and Associated Data that are to be transferred by the Provider to Any organization planning to sign a Project Agreement regulatthe Recipient, as described in the Project Agreement. ing the transfer of Original Biological Resources for a particular research project (referred to as the “Research Project”) must Personal Data means all information relating to an identified or agree to be bound by the terms of the Master Legal Instrument identifiable person, including health-related data. beforehand. The organization providing the Original Biological Resources is Preanalytical Data means any data related to the collection, hanreferred to as the “Provider”, and the organization receiving the dling, storage and usage of the Original Biological Material (e.g. Original Biological Resources is referred to as the “Recipient”. collection time, transport temperature, centrifuge speed, storing They are also referred to individually as a “Party” or collectively temperature, etc.). as the “Parties”. Processing means any operation or set of operations which is The Project Agreement displays the options the organizations’ performed on Original Biological Resources, whether or not by project leaders (referred to as the “Provider’s / Recipient’s Projautomated means, such as collection, recording, organization, ect Leader”) can select to meet the Research Project’s particular structuring, storage, adaptation or alteration, retrieval, consultaneeds. tion, use, handling, disclosure by transmission, dissemination or When signing the Project Agreement, the Project Leaders, as well otherwise making available, alignment or combination, restriction, as their respective organizations, shall abide by all terms and conerasure or destruction. ditions of this Master Legal Instrument.

Progeny means unmodified descendant from the Original The PA symbol indicates a reference in the Project Agreement Biological Material, such as virus from virus, cell from cell, or document. organism from organism.

Provider means the organization providing the Original Biological DEFINITIONS Resources.

Provider’s Project Leader means the Provider’s person who For the purpose of this Master Legal Instrument and the Project takes responsibility for the project as described in the Ordinance Agreement, capitalized terms, whether used in singular or plural on Human Research with the Exception of Clinical Trials of 20 form, shall have the following meaning: September 2013.

Background Intellectual Property (Background IP) shall have Recipient means the organization receiving the Original Biological the meaning set forth in Article 5 of the Master Legal Instrument. Resources.

Coding means the processing of Original Biological Resources in Recipient’s Project Leader means the Recipient’s person who such a manner that they can no longer be attributed to a specific takes responsibility for the project as described in the Ordinance Research Participant without the use of additional information, on Human Research with the Exception of Clinical Trials of 20 provided that such additional information is kept separately and September 2013. is subject to technical and organizational measures to ensure that Research Participant means the natural person whose Biological the Original Biological Resources are not attributed to an identi- Resources are processed. fied or identifiable natural person. Research Project means the project of research as set forth in Associated Data include Preanalytical Data and Personal Data. the Project Agreement, as approved by the Ethics Committee, and for which the Original Biological Resources are transferred and Biobank Regulation is a document that describes the biobank’s processed. organization and defines its purpose, governance and operational Results means, without limitation, any output of the Research processes. Project that are not Progeny or Unmodified Derivatives, such as Effective Date means the date of last signing of the Project invention, data, software, algorithms, knowledge, know-how or Agreement. information that is generated in the Research Project, whatever its form or nature, whether or not it can be protected, as well as Foreground Intellectual Property (Foreground IP) shall have the any rights attached to it, including Intellectual Property Rights. meaning set forth in Article 5 of the Master Legal Instrument. Unmodified Derivatives means substances created by the Intellectual Property Rights means all legal rights granted with Recipient, which constitute an unmodified functional subunit the aim to protect the creations of the intellect, registered or or product expressed by the Original Biological Material. Some unregistered, now or hereafter in force or recognized, including examples include subclones of unmodified cell lines, purified or trade secrets and know-how. fractionated subsets of the Original Biological Material, proteins

Modifications means any substances created by the Recipient, expressed by DNA/RNA supplied by Provider, or monoclonal antior the Recipient’s co-partners, which contain or incorporate the bodies secreted by a hybridoma cell line. Original Biological Material in whatever form.

ARTICLE 1 ARTICLE 4 RESEARCH PROJECT PROCESSING

4.1 Due Care. The Recipient and the Recipient’s Project Leader

1.1 Scope. PA The Parties agree that the research to be

are aware that the Original Biological Material and its conducted by the Recipient, through its Project Leader, with Progeny are experimental in nature and may have hazardthe Original Biological Resources is limited to the Research ous properties or contain infectious agents, and must there- Project described in the Project Agreement. fore be handled with all due care to avoid the propagation of The Original Biological Resources may not themselves infectious agents. be commercialized and are to be processed solely by the

4.2 Limitations. PA The Original Biological Resources will be

Recipient and the Recipient’s co-partners1, under the direcprocessed only (i) under the conditions, if any, specified by tion of the Recipient’s Project Leader. the Provider’s Project Leader in the Project Agreement, and 1.2 Ethics Committee Approval. PA The Recipient and the (ii) as provided for by law. Recipient’s Project Leader acknowledge that the Research The Recipient and the Recipient’s authorized users shall not Project has to be reviewed and approved by the Ethics (i) provide any Results to third party, except as expressly Committee in charge, as further described in the Project permitted in this Agreement; or (ii) sell, lease, sublicense, Agreement. copy or provide the Biological Resources to any third party, 1.3 Provider’s Warranties. The Provider warrants that it is except as expressly permitted in this Agreement. entitled to supply the Original Biological Resources, and that It is expressly understood that the Original Biological Material such resources have been processed in compliance with all and Modifications as such may not be used for therapeutic applicable laws, rules and regulations. purpose in humans. It is expressly agreed that the Provider does not warrant Furthermore, the Parties agree that the Original Biological or guarantee that the Original Biological Resources will be Resources shall not be transferred to or accessed by any either safe or accurate, complete, or useful for any particular third party, for any purposes whatsoever, without the prior purpose. written agreement of the Provider and in compliance with Furthermore, the Provider offers no warranty that the pro- the Research Participant’s informed consent. cessing of Original Biological Resources and/or Modifications

4.3 Security. PA The Recipient shall process the Original

will not infringe or violate any patent or other proprietary Biological Resources and Modifications in a manner that rights of any third party. ensures an appropriate level of security, including protection against unauthorized or unlawful access or processing and against accidental loss, destruction or damage, ARTICLE 2 through appropriate organizational and technical measures as described in the Project Agreement and aligned with the ORIGINAL BIOLOGICAL Biobank Regulation. RESOURCES PA Secure Original Biological Resources and Modifications access shall be guaranteed at all stages of the process.

2.1 The Original Biological Resources include the Original

Biological Material and Associated Data that are to be trans- The Recipient agrees to immediately report (i) any actual ferred for the Research Project. or suspected data protection breach, including a breach against applicable data protection regulation or data protec-

2.2 The Original Biological Resources are further described in

tion aspects of this Agreement, (ii) any actual or suspected the Project Agreement. impairment or inadequacy of the Recipient in fulfilling data protection requirements of this Agreement, and (iii) any application to receive, or any actual access to, data by an ARTICLE 3 authority, unless such reporting is not admissible under statutory provisions for important reasons of public interest. TRANSFER PA

3.1 Confidentiality. The Provider shall provide the Recipient with

Original Biological Resources in a coded form, as described in the Project Agreement. The recipient shall not have the key. ARTICLE 5 3.2 Insurance. The Recipient shall be in charge of the transport INTELLECTUAL PROPERTY insurance. RIGHTS

5.1 Background IP. The Parties agree that each Party shall

retain all the right, title and interest in and to its respective Intellectual Property Rights, as of the Effective Date (referred to as the “Background IP”). Unless otherwise

To be listed in the Project Agreement (if applicable)

agreed, nothing in this Master Legal Instrument or Project ARTICLE 8 Agreement shall be construed as a transfer, license, and/ or assignment by a Party to the other Party of ownership of, EXPIRATION AND TERMINATION right, title and interest in and to its respective Background IP.

8.1 Expiration. The Project Agreement will automatically expire:

5.2 Foreground IP. PA All the right, Intellectual Property (i) on completion of the Research Project it describes; or (ii) Rights, title and interest in and to the Results (referred to as three (3) years from the Effective Date, unless the Project the “Foreground IP”) are set forth in the Project Agreement. Agreement is extended in writing. It is the responsibility of the Recipient’s Project Leader to seek such an extension.

8.2 Termination. Either Party may terminate the Project

ARTICLE 6 Agreement at any time giving a thirty (30) -day prior written notice to the other Party, stating one of the following grounds: RESEARCH PARTICIPANT’S – if the Recipient ceases, is likely to cease, or threatens to RIGHTS cease carrying on business;

6.1 Fundamental Rights. The Provider and the Recipient war- – in case the other Party is in material breach of this Master rant to each other that they will protect, in their respective Legal Instrument and/or the Project Agreement, and has not areas of responsibility under applicable law and both the remedied such a breach by the end of the notice period. Master Legal Instrument and the Project Agreement, the

8.3 Consequences. On expiration or termination of the Project

personality and the fundamental rights of the Research Agreement for any reason, the grant of rights to the Recipient, Participants, including (i) the protection of privacy and (ii) the Recipient’s Project Leader, and the Recipient’s co-partners the right to autonomy and informational self-determination. under the Master Legal Instrument and the Project Agreement 6.2 Withdrawal of Consent. In case of Research Participant’s will be automatically terminated. full or partial withdrawal of consent, the Provider shall In such cases, the Recipient and the Recipient’s Project inform the Recipient of such a withdrawal in writing, without Leader agree to discontinue any processing of the Original delay. Upon notification, the Recipient shall stop using the Biological Resources. In accordance with the Provider’s Research Participant’s Original Biological Resources. directions, the Recipient and the Recipient’s Project Leader Furthermore, according to the Research Participant’s choice shall immediately, and at their own cost, return or destroy as reported by the Provider, the Recipient shall immediately the Original Biological Resources, including any remaining either anonymize or destroy at its own cost all the Original Original Biological Material, and shall notify the Provider in Biological Material and Data for which consent was with- writing upon destruction. drawn, and shall notify the Provider in writing upon ano- The Recipient and the Recipient’s Project Leader ensure that nymization or destruction. their co-partners abide by the above rules.

6.3 No Re-Identification. The Recipient shall refrain from trac-

8.4 Survival Clauses. The provisions concerning publications, ing or identifying any Research Participant who provided the Intellectual Property Rights, due care, warranties, liability, Original Biological Resources. and indemnification as well as those intended to protect the Research Participants’ rights, shall survive the Project Agreement expiration or termination. ARTICLE 7 LIABILITY AND INDEMNIFICATION ARTICLE 9 AMENDMENTS AND Each Party shall be liable to, and indemnify, the other Party SEVERABILITY CLAUSE 7.1 for actual costs, charges, damages, expenses or losses suffered by the other Party resulting from any of the first

9.1 Amendments. This Master Legal Instrument and the Project

Party’s violation of this Master Legal Instrument and/or of Agreement constitute the entire agreement and understandthe Project Agreement. ing of the Parties and supersede any prior agreements or 7.2 The Recipient shall assume all and any liability, and shall hold understandings relating to the subject matter hereof. They harmless the Provider for any loss, claim, damage of whatso- may not be modified, except by a written instrument signed ever kind or nature, which could be raised by the Recipient, or by all Parties. made against the Recipient by any third party, due to, or in con-

9.2 Severability. In the event any provision of this Master Legal

nection with, the Recipient’s processing of the Original Biological Instrument and/or of the Project Agreement is deemed invalid Resources and Modifications, except to the extent caused by the or unenforceable, in whole or in part, that part shall be sev- Provider’s gross negligence or willful misconduct. ered from the remainder of the Master Legal Instrument and/ 7.3 The Parties shall use the Foreground IP at their own risk. A or the Project Agreement and all other provisions should con- Party using any of the Foreground IP shall, to the fullest extent tinue in full force and effect as valid and enforceable. In such permitted by the applicable law, defend, indemnify and hold event, a valid provision that comes closest to the intended the other Party harmless against third party claims (including purpose of the unenforceable or invalid provision shall be but not limited to claims based on mandatory product liability agreed to replace it. law), which are based on the Party’s use of the Foreground IP.