sbp-mta3-mli.pdf

MTA 3.0 Master legal instrument + Project Agreement

MTA 3.0 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”) referencing this MTA 3.0 – Master Legal Instrument (referred to as the “Master Legal Instrument”) 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 hereof.

SWISS BIOBANKING PLATFORM Biopôle - Bâtiment Phényl Route de la Corniche 3A — 1066 Epalinges — Switzerland [email protected] - www.swissbiobanking.ch

TABLE OF CONTENT PREAMBLE 3

DEFINITIONS 3

ARTICLE 1 RESEARCH PROJECT 4

1.1 Scope

1.2 Ethics Committee Approval

1.3 Provider’s Warranties

ARTICLE 2 PROJECT LEADERS 4

2.1 Appointment

2.2 Replacement

ARTICLE 3 TRANSFER 4

3.1 Form

3.2 Transport, Insurance and Risks

ARTICLE 4 PROCESSING 4

4.1 Background IP

4.2 Foreground IP

ARTICLE 6 DISCLOSURE OF RESULTS AND PUBLICATIONS 5

6.1 Information about Results

6.2 Publication of Results

6.3 Provider’s Project Leader Review

6.4 Acknowledgement

ARTICLE 7 RESEARCH PARTICIPANT’S RIGHTS 5

7.1 Fundamental Rights

7.2 Rights of the Research Participants

7.3 Withdrawal of Consent

7.4 No Re-Identification

ARTICLE 8 FEES AND COSTS 6

ARTICLE 9 LIABILITY AND INDEMNIFICATION 6

9.1 In General

9.2 Use of Biological Resources

9.3 Use of Foreground IP or Results

ARTICLE 10 EXPIRATION AND TERMINATION 6

10.1 Expiration

10.2 Termination

10.3 Consequences

10.4 Survival Clauses

ARTICLE 11 MISCELLANEOUS 6

11.1 Entire Agreement and Hierarchy

11.2 Ad hoc DTUA

11.3 Amendments

11.4 Severability

11.5 Electronic Form

11.6 Governing Law and Dispute Resolution

PREAMBLE Project Leader means, for each Party, the individual designated by it under the Project Agreement who shall have the role This Master Legal Instrument is only valid if supplemented by described in the Master Legal Instrument. a Project Agreement. Progeny means unmodified descendant from the Original When signing the Project Agreement, the Parties shall abide by Biological Material, such as virus from virus, cell from cell, or all terms and conditions of this Master Legal Instrument, except organism from organism. for deviations expressly agreed in the Project Agreement Provider means the organization providing the Original Biological The symbol PA indicates a reference in the Project Agreement Resources as specified in the Project Agreement. document. Recipient means the organization receiving the Original Biological Resources as specified in the Project Agreement. DEFINITIONS Recipient’s Subcontractors means third parties listed in the For the purpose of the Agreement, capitalized terms, whether Project Agreement which are authorized by the Recipient to use used in singular or plural form, shall have the following meaning : and process the Biological Resources.

Research Participant means the natural person whose Biological Associated Data means collectively the Preanalytical Data and, Resources are processed (often equally referred to as “data if any (as specified in the Project Agreement) the Personal Data. subject”). Agreement means collectively this Master Legal Instrument and Research Project means the research project sets forth in the the Project Agreement. Project Agreement, as approved by the ethics committee, and Background Intellectual Property (Background IP) shall have for which the Original Biological Resources are transferred and the meaning set forth in Article 5 of the Master Legal Instrument. processed.

Biobank Regulation is a document that describes the biobank’s Results means, without limitation, Modifications and any other organization and defines its purpose, governance and operational output of the Research Project that are not Progeny or Unmodified processes. Derivatives, such as invention, data, software, algorithms, knowledge, know-how or information that is generated in the Research Biological Resources means collectively the Original Biological Project, whatever its form or nature, whether or not it can be Resources and Modifications. protected, as well as any rights attached to it, including Intellectual Coded means Personal Data and Original Biological Resources Property Rights. linked to a specific person via a code. Unmodified Derivatives means substances created by the Effective Date means the date of last signing of the Project Recipient, which constitute an unmodified functional subunit Agreement. or product expressed by the Original Biological Material. Some examples include subclones of unmodified cell lines, purified or Foreground Intellectual Property (Foreground IP) has the fractionated subsets of the Original Biological Material, proteins meaning set forth in Article 5 of the Master Legal Instrument. expressed by DNA/RNA supplied by Provider, or monoclonal anti- Intellectual Property Rights means all present and future legal bodies secreted by a hybridoma cell line. rights and prerogatives with the aim to protect the creations of the intellect, registered or unregistered, now or hereafter in force or recognized, including copyright, patents of invention, trade secrets and know-how.

Modifications means any substances created by the Recipient, or the Recipient’s Subcontractors, which contain or incorporate the Original Biological Material in whatever form.

Original Biological Material means any material obtained or derived from a biological organism, any Progeny and Unmodified Derivatives thereof, that are to be delivered by the Provider to the Recipient, as described in the Project Agreement, excluding Modifications.

Original Biological Resources means Original Biological Material and Associated Data that are to be transferred by the Provider to the Recipient, as described in the Project Agreement.

Party means each of the Provider and the Recipient and Parties means both collectively.

Personal Data means all information relating to an identified or identifiable person, including health-related data.

Preanalytical Data means any data related to the collection, handling, storage and usage of the Original Biological Material (e.g. collection time, transport temperature, centrifuge speed, storing temperature, etc.).

ARTICLE 1 ARTICLE 4 .

RESEARCH PROJECT PROCESSING PA

1.1 Scope.The Provider will provide, and the Recipient shall use, 4.1 Due Care. The Recipient and the Recipient’s Project Leader the Original Biological Resources only for conducting the are aware that the Original Biological Materials (including its Research Project and under the conditions set forth in the Progeny) are experimental in nature and may have hazard- Agreement. ous properties or contain infectious agents, and must therefore be handled with all due care to avoid the propagation of

1.2 Ethics Committee Approval. The Recipient undertakes to

infectious agents. obtain any required approval from the competent ethic committee prior to using the Original Biological Resource as part 4.2 Limitations. The Recipient undertakes to use and process of the Research Project, as further described in the Project the Original Biological Resources under the direction and Agreement. direct supervision of the Recipient’s Project Leader:

1.3 Provider’s Warranties. The Provider warrants that it is – only in and from Switzerland through (i) its own researentitled to supply the Original Biological Resources, and that chers and (ii) any Recipient’s Subcontractor(s) designated such resources have been processed by it in compliance in the Project Agreement; with all applicable laws, rules and regulations. – for the sole purpose of, and only as required for, the The Provider does not warrant or guarantee that the completion of the Research Project (to the exclusion of any Biological Resources will be either safe or accurate, com- other research, commercial or noncommercial purpose); plete, or useful for any particular purpose. – in accordance with all applicable laws; and Furthermore, the Provider offers no warranty that the pro- – under any additional conditions, if any, specified in the cessing of Biological Resources will not infringe or violate Project Agreement, any patent or other proprietary rights of any third party. In addition, the Recipient and the Recipient’s authorized users shall not:

ARTICLE 2 – use the Original Biological Material as such for therapeutic purpose in humans. PROJECT LEADERS PA – provide any Results to third parties except as expressly 2.1 Appointment. Each Party shall act for all aspects pertaining permitted in the Agreement; or to the Research Project through its Project Leader desig- – sell, lease, sublicense, copy, transfer, make available or nated in the Project Agreement, who shall have the power provide the Biological Resources to any third party for any to represent and bind the Parties, and who shall act as main purposes whatsoever, except as expressly permitted in the contact point within their organization. Agreement. The Recipient’s Research Project shall be the person within

4.3 Modifications. All limitations stated in Article 4.2 above shall

the Recipient’s organization who takes responsibility for also apply to Modifications, unless otherwise specified in the the Research Project, as described in the Ordinance on Project Agreement. Human Research with the Exception of Clinical Trials of 20 September 2013. 4.4 Personal data. Each Party shall process Personal Data under this Agreement in compliance with applicable data

2.2 Replacement. Each Party may replace its Project Leader

protection laws. Each Party represents and warrants that from time to time by written notice to the other. any Personal Data of Research Participants required for use in the Research Project that are obtained, handled or used by it will be obtained, handled or used in accordance with all ARTICLE 3 relevant laws and regulations (and where applicable, ethical guidelines) regarding their collection, use, and subsequent TRANSFER PA disposal and that any ethics committee approvals and, as the case may be, informed consents required for performing

3.1 Form. The Provider shall provide the Recipient with Original

the Research Project will be obtained prior to the use in the Biological Resources in a Coded form, as described in the Research Project. The Personal Data shall not be kept by Project Agreement. To be considered Coded, the Original the Recipient longer than necessary for the purpose of the Biological Resources shall not be attributed to a specific Research Project, and the Personal Data processing must be Research Participant without the use of additional informalimited to the purpose pursued, provided that the Research tion (key), which shall be kept separately in a secure manner. Participant does not decide otherwise. The Recipient shall not have access to the key.

4.5 Security. The Recipient shall use and process the Biological

3.2 Transport, Insurance and Risks. Unless otherwise speci-

Resources in a manner that ensures an appropriate level fied in the Project Agreement, the Recipient shall assume all of security, including protection against unauthorized or risks and costs for the transport of the Original Biological unlawful access or processing and against accidental loss, Materials and shall pay appropriate insurance coverage for destruction or damage, through appropriate organizatheir transport. tional and technical measures as described in the Project

Agreement and if the Recipient is a biobank aligned with its limitation, copies of relevant summaries and reports. The Biobank Regulation. Provider’s Project Leader agrees to keep these Results confidential until publication. In particular, secure access to the Biological Resources shall be guaranteed at all stages of the process. 6.2 Publication of Results. As the main purpose of the Original Biological Resources’ use is scientific research, the Recipient The Recipient agrees to immediately report (i) any actual shall ensure that its Project Leader make every effort to pubor suspected breach of security, including a breach against lish its Results in a timely manner. applicable laws on research, data protection or the rights of Research Participants, (ii) any actual or suspected impair- 6.3 Provider’s Project Leader Review. The Recipient’s Project ment or inadequacy of the Recipient in fulfilling statutory Leader shall be free to disclose and publish the Results, prorequirements described in the Agreement, and (iii) any vided the proposed disclosure is submitted to the Provider’s application to receive, or any actual access to, Biological Project Leader for review at least thirty (30) days prior to Resources by an authority, unless such reporting is not the scheduled submission for publication or disclosure. admissible under statutory provisions for important reasons The Provider shall have the right to provide comments on of public interest. the manuscript no later than 15 days before the proposed 4.6 Compliance. The Recipient shall have in place procedures submission. The Parties shall discuss in good faith to incorso that any person it authorizes to use and process the porate any reasonable comments into the publication or Biological Resources, including the Recipient Project Leader disclosure. and the Recipient’s Subcontractors, comply with the terms of Failure to respond within the above-mentioned periods is the Agreement and maintain the confidentiality and security considered as approval of the publication by the Provider. of the Biological Resources. The Recipient is responsible for their acts in the performance of this Agreement. 6.4 Acknowledgement. The Recipient shall acknowledge the Provider’s Project Leader as the co-author of the publication, and/or to acknowledge the Provider as the source of

the Original Biological Resources in all written publications, ARTICLE 5 posters or oral presentations. This applies to any publication on Biological Resources that discloses or relates in any way INTELLECTUAL PROPERTY to the Recipient’s processing of the Biological Resources, RIGHTS PA unless otherwise agreed in writing by the Parties.

5.1 Background IP. 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 ARTICLE 7 IP”). Unless otherwise agreed, nothing in this Master Legal Instrument or any Project Agreement shall be construed as RESEARCH PARTICIPANT’S a transfer, license, and/or assignment by a Party to the other RIGHTS Party of ownership of, right, title and interest in and to its respective Background IP. 7.1 Fundamental Rights. The Provider and the Recipient warrant to each other that they will protect, in their respec-

5.2 Foreground IP. Ownership in, and license to, the Intellectual

tive areas of responsibility under applicable law and the Property Rights in and to the Results (referred to as Agreement, the personality and the fundamental rights of the the “Foreground IP”) shall be as set forth in the Project Research Participants, including (i) the protection of person- Agreement. ality rights and (ii) the right to autonomy and informational self-determination.

7.2 Rights of the Research Participants. The Provider shall

ARTICLE 6 secure the exercise of the Research Participants’ rights. The Parties shall respond to requests from the Research DISCLOSURE OF RESULTS Participants within one month after having received the AND PUBLICATIONS PA 1 notification.

7.3 Withdrawal of Consent. In case of Research Participant’s

6.1 Information about Results. The Recipient’s Project Leader

full or partial withdrawal of consent, the Provider shall agrees to keep complete and accurate accounts, notes, data inform the Recipient of such a withdrawal in writing, without and records of the Research Project. delay. In such case, in accordance with Art. 10 HRO2, the Upon completion of the Research Project or on the Provider’s Recipient shall – after data evaluation has been completed – Project Leader request, the Recipient’s Project Leader will immediately stop using the Biological Resources and either disclose to the Provider’s Project Leader all Results obtained (at the option of the Provider) anonymize or destroy them at from conducting the Research Project, which relate to the its own costs, and shall notify the Provider in writing upon processing of the Biological Resources including, without anonymization or destruction.

Note : this Article will not apply in case the Parties have executed a DTUA (See Article 11.2 below) Human Research Ordinance (RS 810.301)

7.4 No Re-Identification. The Recipient shall refrain from trac- – for cause in case the other Party is in material breach of ing or identifying any Research Participant whose Biological the Agreement, and such breach is either incapable of Resources relate to. remedy or has not been remedied within a 30-day notice period.

10.3 Consequences. On expiration or termination of the Project

ARTICLE 8 Agreement for any reason:

FEES AND COSTS PA – Original Biological Resources: the right for the Recipient to process and use the Original Biological Resources shall be Unless otherwise specified in the Project Agreement: (i) no fee automatically terminated. In accordance with the Provider’s shall be due by a Party to the other under this Agreement; and directions, the Recipient shall immediately, and at its own (ii) each Party shall bear its own costs associated with this cost, return or destroy the Original Biological Resources Agreement. and shall notify the Provider in writing upon destruction.

– Modifications: unless otherwise specified in the Project Agreement, the right for the Recipient to process and use ARTICLE 9 the Modifications shall also be automatically terminated and the Recipient shall immediately, and at its own cost, destroy LIABILITY AND the Modifications and shall notify the Provider in writing INDEMNIFICATION upon destruction.

10.4 Survival Clauses. The provisions concerning publications,

9.1 In General. Subject to Articles 9.2 and 9.3 below, the Parties

Intellectual Property Rights, due care, warranties, liability, assume no liability for any damages, including but not limited and indemnification as well as those intended to protect the to any indirect or consequential loss or similar damage (e.g. Research Participants’ rights, shall survive expiration or terloss of profit, loss of revenue or loss of contracts) suffered in mination of the Agreement. connection with the Agreement, provided such damage was not caused by a willful intent or act of gross negligence. .

9.2 Use of Biological Resources. Except to the extent prohibited

by law, the Recipient assumes all liability for damages that may arise from its use, storage or disposal of the Biological ARTICLE 11 Resources. The Provider will not be liable to the Recipient for any loss, claim or demand made by the Recipient, or made MISCELLANEOUS PA

against the Recipient by any other party, due to or arising

11.1 Entire Agreement and Hierarchy. Subject to Article 11.2, the

from the use of the Biological Resources by the Recipient, Agreement, including this Master Legal Instrument and the except when caused by the gross negligence or willful mis- Project Agreement (together with any document referenced conduct of the Provider or breach of its warranties in Article therein or schedule attached thereto) constitute the entire 1.3 of this Master Legal Instrument. agreement and understanding of the Parties and super- 9.3 Use of Foreground IP or Results. The Parties shall use the sede any prior agreements or understandings relating to Foreground IP and Results at their own risk. A Party using the subject matter hereof. In case of conflict or discrepancy, any of the Foreground IP or Results shall, to the fullest extent the Project Agreement shall prevail over the Master Legal permitted by applicable law, defend, indemnify and hold the Agreement. other Party harmless against third-party claims (including

11.2 Ad hoc DTUA. If the Parties have executed for the same

but not limited to claims based on mandatory product liability Research Project a Data Transfer And Use Agreement law), which are based on the Party’s use of the Foreground (“DTUA”) based on the template provided by SPHN, the IP or Results. Parties agree that:

– the definition of (Original) Biological Resources in this Master Legal Instrument shall be deemed to refer only to ARTICLE 10 (Original) Biological Material, excluding any Associated EXPIRATION AND Data;

TERMINATION PA – all aspects pertaining to the processing of Associated Data (which include both Preanalytical Data and Personal Data) 10.1 Expiration. The Project Agreement will automatically expire: shall be governed by the DTUA and the provision of the (i) on completion of the Research Project; or (ii) 3 years from Agreement shall not apply to the Associated Data; and the Effective Date, unless the Project Agreement is extended – Article 6 (Disclosure of Results and Publications) of this in writing. It is the responsibility of the Recipient, acting Master Legal Instrument shall not apply and be replaced through its Project Leader, to seek such an extension. entirely by the provisions of the DTUA, which for clarity 10.2 Termination. Either Party may terminate the Project shall be deemed to cover Modifications and any other Agreement: output of the Research Project that are not Progeny or Unmodified Derivatives. – without cause at any time with a 3-month prior written notice to the other Party; or

11.3 Amendments. The Agreement may not be modified, except

by a written instrument signed by all Parties.

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

Instrument and/or of the Project Agreement is deemed invalid or unenforceable, in whole or in part, that part shall be severed from the remainder of the Master Legal Instrument and/ or the Project Agreement and all other provisions should continue in full force and effect as valid and enforceable. In such event, a valid provision that comes closest to the intended purpose of the unenforceable or invalid provision shall be agreed to replace it.

11.5 Electronic Form. An original signature or a copy thereof, including a “portable document format” or PDF copy, or a signature generated by industry standard electronic signature software (e.g. Docusign), which is transmitted by email shall constitute an original signature for purposes of the Agreement and shall have the same legal force and effect as the exchange of original signatures; while the term “in writing” shall include communications by email or other electronic forms.

11.6 Governing Law and Dispute Resolution. Unless otherwise

specified in the Project Agreement, the Agreement shall be governed by Swiss laws, excluding it conflict of laws provisions and any dispute arising out of or related to the Agreement shall be submitted to the competent courts at the registered office of the Provider.