#  Data Management Plan Overview

This document constitutes the Deliverable 3.2 “Data Management Plan” of the
project “Building a 3D innervated and irrigated muscle on a chip.”,
hereinafter referred to as MyoChip, funded by the European Union’s
H2020-FETOPEN-2016-2017, under the Grant Agreement number 801423\. According
to the European Commission suggested guidelines, participating projects are
required to develop a Data Management Plan (DMP). This Data Management Plan
describes the types of data that will be generated during the project,
standards that will be used to generate and store data, the ways data will be
shared, reused and preserved. It is very important to note that the DMP is not
a closed document, on the contrary, it will be adjusted/corrected throughout
the duration of the project.

#  Open Research Data Pilot

The Open Research Data Pilot is part of the Open Access to Scientific
Publications and Research Data Program in H2020. It aims to improve and
maximize access to data generated by Horizon 2020 as well as to promote its
reutilization. As mentioned in article 29.3 of the grant agreement this pilot
also takes into account the need to carefully balance openness with protection
of scientific information. Taking all of this into consideration MyoChip
consortium will decide what information will be made public in a case to case
basis, always making a careful analysis of potential conflicts against
commercialization, intellectual property rights protection, etc.

Effective Dissemination and exploitation of MyoChip results depends on proper
management of data and its intellectual property. The terms and conditions
pertaining to ownership, access rights, exploitations of background and
dissemination of results, are defined in the Consortium Agreement signed by
all the partners.

Some examples of sections on our Consortium Agreement are:

  8. Section: Results 

    1. Ownership of Results 

  
  

  

  

Results are owned by the Party that generates them. Where Results are
generated from work carried out jointly by two or more Parties and it is not
possible for the purpose of applying for, obtaining and/or maintaining the
relevant patent protection or any other intellectual property right, to
separate the contributions made by the respective Parties to such Results,
those Parties shall have joint ownership of such Results.

  2. Joint ownership 

  

  

Joint ownership is governed by Grant Agreement Article 26.2 with the following
additions:

Unless otherwise agreed:each of the joint owners shall be entitled to use
their jointly owned Results for non-commercial research activities on a
royalty-free basis, and without requiring the prior consent of the other joint
owner(s), and

Joint ownership agreements should be formalized between the specific partners,
before the first exploitation act of the Joint Results concerned, to regulate
the share, protection and commercial exploitation of project results.

  3. Transfer of Results 

  

  

8.3.1

Each Party may transfer ownership of its own Results following the procedures
of the Grant Agreement Article °30.

8.3.2

It may identify specific third parties it intends to transfer the ownership of
its Results to in Attachment (3) to this Consortium Agreement. The other
Parties hereby waive their right to prior notice and their right to object to
a transfer to listed third parties according to the Grant Agreement Article
30.1.

8.3.3

The transferring Party shall, however, at the time of the transfer, inform the
other Parties of such transfer and shall ensure that the rights of the other
Parties will not be affected by such transfer. Any addition to Attachment (3)
after signature of this Agreement requires a decision of the General Assembly.

8.3.4

The Parties recognize that in the framework of a merger or an acquisition of
an important part of its assets, it may be impossible under applicable EU and
national laws on mergers and acquisitions for a Party to give the full 45
calendar days prior notice for the transfer as foreseen in the Grant
Agreement.

8.3.5

The obligations above apply only for as long as other Parties still have - or
still may request - Access Rights to the Results.

8.4 Dissemination

8.4.1

For the avoidance of doubt, nothing in this Section 8.4 has impact on the
confidentiality obligations set out in Section 10. 8.4.2 Dissemination of own
Results

8.4.2.1

During the Project and for a period of 2 year after the end of the Project,
the dissemination of own Results by one or several Parties including but not
restricted to publications, presentations, data and related metadata, shall be
governed by the procedure of Article 29.1 of the Grant Agreement subject to
the following provisions.

Prior notice of any planned publication shall be given to the other Parties at
least 45 calendar days before the publication. Any objection to the planned
publication shall be made in accordance with the Grant Agreement in writing to
the Coordinator and to the Party or Parties proposing the dissemination within
30 calendar days after receipt of the notice. If no objection is made within
the time limit stated above, the publication is permitted.

8.4.2.2

An objection is justified if

(a) the protection of the objecting Party's Results or Background would be
adversely affected (b) the objecting Party's legitimate interests in relation
to the Results or Background would be significantly harmed.

The objection has to include a precise request for necessary modifications.

8.4.2.3

If an objection has been raised the involved Parties shall discuss how to
overcome the justified grounds for the objection on a timely basis (for
example by amendment to the planned publication and/or by protecting
information before publication) and the objecting Party shall not unreasonably
continue the opposition if appropriate measures are taken following the
discussion.

8.5

The objecting Party can request a publication delay of not more than 90
calendar days from the time it raises such an objection. After 90 calendar
days the publication is permitted.

8.5.1 Dissemination of another Party’s unpublished Results or Background

A Party shall not include in any dissemination activity another Party's
Results or Background without obtaining the owning Party's prior written
approval, unless they are already made public.

8.5.2 Cooperation obligations

The Parties undertake to cooperate to allow the timely submission,
examination, publication and defence of any dissertation or thesis for a
degree that includes their Results or Background subject to the
confidentiality and publication provisions agreed in this Consortium
Agreement.

8.5.3 Use of names, logos or trademarks

Nothing in this Consortium Agreement shall be construed as conferring rights
to use in advertising, publicity or otherwise the name of the Parties or any
of their logos or trademarks without their prior written approval.

  9. Section: Access Rights 

  

  

9.1 Background included

9.1.1

In Attachment 1, the Parties have identified and agreed on the Background for
the Project and have also, where relevant, informed each other that Access to
specific Background is subject to legal restrictions or limits.

Anything not identified in Attachment 1 shall not be the object of Access
Right obligations regarding Background.

9.1.2

Any Party may add further own Background to Attachment 1 during the Project by
written notice to the other Parties. However, approval of the General Assembly
is needed should a Party wish to modify or withdraw its Background in
Attachment 1. 9.2 General Principles

9.2.1

Each Party shall implement its tasks in accordance with the Consortium Plan
and shall bear sole responsibility for ensuring that its acts within the
Project do not knowingly infringe third party property rights.

9.2.2

Any Access Rights granted expressly exclude any rights to sublicense unless
expressly stated otherwise.

9.2.3

Access Rights are granted on a non-exclusive basis.

9.2.4

Results and Background shall be used only for the purposes for which Access
Rights to it have been granted.

9.2.5

Requests for Access Rights shall be made, and Access Rights granted, in
writing. The granting of Access Rights may be made conditional on the
acceptance of specific conditions aimed at ensuring that these rights will be
used only for the intended purpose and that appropriate confidentiality
obligations are in place.

9.2.6

The requesting Party must show that the Access Rights are Needed.

9.3 Access Rights for implementation

9.3.1 Access Rights to Results and Background Needed for the performance of
the own work of a Party under the Project shall be granted on a royalty-free
basis, unless otherwise provided for in Attachment 1.

9.3.2

If the Background or Results take the form of non-consumable materials,
including but not limited to instruments, databases, software, protocols, said
background or Results will be returned to the providing Party by the receiving
Party at the end of the project, and eventual copies of said materials will be
destroyed by the receiving party. Notwithstanding the above provisions, the
Receiving and the providing party may negotiate conditions in which said
materials will be kept by the receiving Party, at fair and reasonable
conditions

9.4 Access Rights for Exploitation

9.4.1 Access Rights to Results

Access Rights to Results if Needed for commercial Exploitation of a Party's
own Results shall be granted on Fair and Reasonable conditions.

Provided the Party(ies) (co) owner(s) of the Results concerned gives its prior
written consent, Access rights to Results for internal and/or non-commercial
collaborative research activities shall be granted on a royalty-free basis for
academic Parties and on financial conditions for industrial Parties.

9.4.2

Access Rights to Background if Needed for Exploitation of a Party’s own
Results, including for research on behalf of a third party, shall be granted
on Fair and Reasonable conditions.

9.4.3

A request for Access Rights may be made up to twelve months after the end of
the Project or, in the case of Section 9.7.2.1.2, after the termination of the
requesting Party’s participation in the Project. 9.4.4

A Member which can show that its own liabilities, intellectual property rights
or other legitimate interests would be severely affected by the granting of
such access right, or that granting such access right would infringe its legal
obligations, will have the right to refuse such access right to Results or
Background.

The Member that wishes to exercise the veto must identify the exact rights
that will be affected by the decision, quantify the damages and identify the
moment when the damages will actually occur.

9.5 Access Rights for Affiliated Entities

Affiliated Entities have Access Rights under the conditions of the Grant
Agreement Articles 25.4 and 31.4. if they are identified in Attachment 4
(Identified Affiliated Entities) to this Consortium Agreement.

Such Access Rights must be requested directly by the Affiliated Entity from
the Party that holds the Background or Results.

Alternatively, the Party granting the Access Rights may individually agree
with the Party requesting the Access Rights to have the Access Rights include
the right to sublicense to the latter's Affiliated Entities listed in
Attachment 4. Access Rights to Affiliated Entities shall be granted on Fair
and Reasonable conditions and upon written bilateral agreement.

Affiliated Entities which obtain Access Rights in return fulfil all
confidentiality and other obligations accepted by the Parties under the Grant
Agreement or this Consortium Agreement as if such Affiliated Entities were
Parties.

Access Rights may be refused to Affiliated Entities if such granting is
contrary to the legitimate interests of the Party which owns the Background or
the Results.

Access Rights granted to any Affiliated Entity are subject to the continuation
of the Access Rights of the Party to which it is affiliated, and shall
automatically terminate upon termination of the Access Rights granted to such
Party.

Upon cessation of the status as an Affiliated Entity, any Access Rights
granted to such former Affiliated Entity shall lapse. Further arrangements
with Affiliated Entities may be negotiated in separate agreements.

9.6 Additional Access Rights

The Parties agree to negotiate in good faith any additional Access Rights to
Results as might be asked for by any Party, upon adequate financial conditions
to be agreed.

9.7 Access Rights for Parties entering or leaving the consortium

9.7.1 New Parties entering the consortium

As regards Results developed before the accession of the new Party, the new
Party will be granted Access Rights on the conditions applying for Access
Rights to Background.

9.7.2 Parties leaving the consortium

9.7.2.1 Access Rights granted to a leaving Party

9.7.2.1.1 Defaulting Party

Access Rights granted to a Defaulting Party and such Party's right to request
Access Rights shall cease immediately upon receipt by the Defaulting Party of
the formal notice of the decision of the General Assembly to terminate its
participation in the consortium.

9.7.2.1.2 Non-defaulting Party

A non-defaulting Party leaving voluntarily and with the other Parties' consent
shall have Access Rights to the Results developed until the date of the
termination of its participation.

It may request Access Rights within the period of time specified in Section
9.4.3.

9.7.2.2 Access Rights to be granted by any leaving Party

Any Party leaving the Project shall continue to grant Access Rights pursuant
to the Grant Agreement and this Consortium Agreement as if it had remained a
Party for the whole duration of the Project.

9.8 Specific Provisions for Access Rights to Software

For the avoidance of doubt, the general provisions for Access Rights provided
for in this Section 9 are applicable also to Software.

Parties’ Access Rights to Software do not include any right to receive source
code or object code ported to a certain hardware platform or any right to
receive respective Software documentation in any particular form or detail,
but only as available from the Party granting the Access Rights.

9.8.1 Definitions relating to Software

“Application Programming Interface”

means the application programming interface materials and related
documentation containing all data and information to allow skilled Software
developers to create Software interfaces that interface or interact with other
specified Software.

"Controlled Licence Terms" means terms in any licence that require that the
use, copying, modification and/or distribution of Software or another work
(“Work”) and/or of any work that is a modified version of or is a derivative
work of such Work (in each case, “Derivative Work”) be subject, in whole or in
part, to one or more of the following:

  1. (where the Work or Derivative Work is Software) that the Source Code or 

  

  2. other formats preferred for modification be made available as of right to any third party on request, whether royaltyfree or not; 

  

  3. that permission to create modified versions or derivative works of the Work or Derivative Work be granted to any third party; 

  

  4. that a royalty-free licence relating to the Work or Derivative Work be granted to any third party. 

  

  

For the avoidance of doubt, any Software licence that merely permits (¬but
does not require any of) the things mentioned in (a) to (c) is not a
Controlled Licence (and so is an Uncontrolled Licence).

“Object Code” means software in machine-readable, compiled and/or executable
form including, but not limited to, byte code form and in form of machine-
readable libraries used for linking procedures and functions to other
software.

“Software Documentation” means software information, being technical
information used, or useful in, or relating to the design, development, use or
maintenance of any version of a software programme.

“Source Code” means software in human readable form normally used to make
modifications to it including, but not limited to, comments and procedural
code such as job control language and scripts to control compilation and
installation.

9.8.2 General principles

For the avoidance of doubt, the general provisions for Access Rights provided
for in this Section 9 are applicable also to Software as far as not modified
by this Section 9.8.

Parties’ Access Rights to Software do not include any right to receive Source
Code or Object Code ported to a certain hardware platform or any right to
receive Source Code, Object Code or respective Software Documentation in any
particular form or detail, but only as available from the Party granting the
Access Rights.

The intended introduction of Intellectual Property (including, but not limited
to Software) under Controlled Licence Terms in the Project requires the
approval of the General Assembly to implement such introduction into the
Consortium Plan. 9.8.3 Access to Software

Access Rights to Software that is Results shall comprise: Access to the Object
Code; and,

where normal use of such an Object Code requires an Application Programming
Interface (hereafter API), Access to the Object Code and such an API; and,

if a Party can show that the execution of its tasks under the Project or the
Exploitation of its own Results is technically or legally impossible without
Access to the Source Code, Access to the Source Code to the extent necessary.

Background shall only be provided in Object Code unless otherwise agreed
between the Parties concerned.

9.8.4 Software licence and sublicensing rights

9.8.4.1 Object Code

9.8.4.1.1 Results - Rights of a Party

Where a Party has Access Rights to Object Code and/or API that is Results for
Exploitation, such Access shall, in addition to the Access for Exploitation
foreseen in Section 9.4, as far as Needed for the Exploitation of the Party’s
own Results, comprise the right:

to make an unlimited number of copies of Object Code and API; and

to distribute, make available, market, sell and offer for sale such Object
Code and API as part of or in connection with products or services of the
Party having the Access Rights;

provided however that any product, process or service has been developed by
the Party having the Access Rights in accordance with its rights to exploit
Object Code and API for its own Results.

If it is intended to use the services of a third party for the purposes of
this Section 9.8.4.1.1, the Parties concerned shall agree on the terms thereof
with due observance of the interests of the Party granting the Access Rights
as set out in Section 9.2 of this Consortium Agreement.

9.8.4.1.2 Results - Rights to grant sublicenses to end-users

In addition, Access Rights to Object Code shall, as far as Needed for the
Exploitation of the Party’s own Results, comprise the right to grant in the
normal course of the relevant trade to end-user customers buying/using the
product/services, a sublicense to the extent as necessary for the normal use
of the relevant product or service to use the Object Code as part of or in
connection with or integrated into products and services of the Party having
the Access Rights and, as far as technically essential:

  * to maintain such product/service; 

  

  * to create for its own end-use interacting interoperable software in accordance with the Directive 2009/24/EC of the European Parliament and of the Council of 23 April 2009 on the legal protection of computer programs 

  

9.8.4.1.3 Background

For the avoidance of doubt, where a Party has Access Rights to Object Code
and/or API that is Background for Exploitation, Access Rights exclude the
right to sublicense. Such sublicensing rights may, however, be negotiated
between the Parties.

9.8.4.2 Source Code

9.8.4.2.1 Results - Rights of a Party

Where, in accordance with Section 9.8.3, a Party has Access Rights to Source
Code that is Results for Exploitation, Access Rights to such Source Code, as
far as Needed for the Exploitation of the Party’s own Results, shall comprise
a worldwide right to use, to make copies, to modify, to develop, to
create/market a product/process and to create/provide a service.

If it is intended to use the services of a third party for the purposes of
this Section 9.8.4.2.1, the Parties shall agree on the terms thereof, with due
observance of the interests of the Party granting the Access Rights as set out
in Section 9.2 of this Consortium Agreement.

9.8.4.2.2 Results – Rights to grant sublicenses to end-users

In addition, Access Rights, as far as Needed for the Exploitation of the
Party’s own Results, shall comprise the right to sublicense such Source Code,
but solely for purpose of adaptation, error correction, maintenance and/or
support of the Software. Further sublicensing of Source Code is explicitly
excluded.

9.8.4.2.3 Background

For the avoidance of doubt, where a Party has Access Rights to Source Code
that is Background for Exploitation, Access Rights exclude the right to
sublicense. Such sublicensing rights may, however, be negotiated between the
Parties.

9.8.5 Specific formalities

Each sublicense granted according to the provisions of Section 9.8.4 shall be
made by a traceable agreement specifying and protecting the proprietary rights
of the Party or Parties concerned.

#  FAIR Data

Beneficiaries must ensure that their research data respect FAIR principles,
i.e. they are Findable, Accessible, Interoperable and Reusable (FAIR).

##  Findable

Partners agree to label all data with name, date and keywords to facilitate
data search & find. Also, all metadata files should be kept together with raw
data.

We are currently working with iMM’s Communication and IT teams to create the
new MyoChip website. In the website there will be a web platform that will
allow access to data stored in a server protected by login and password for
each partner.

##  Accessible

Data will be made "as open as possible, as closed as necessary". Open data
will be made accessible by publishing and/or deposited on repository such as
Zenodo

(https://zenodo.org)

Decisions on specific identification of closed data, or data subject to
embargo related to IP policies will be defined at due time.

##  Interoperable

All partners will use vocabularies that follow FAIR principles, being
accessible and broadly applicable. Data/Metadata files should include clear
references to other Data/Metadata files.

##  Re-usable

Licensing policies will be defined when the general dissemination, IP
protection and exploitation policies will be more clearly drawn. Usually,
after acceptance of relevant publications, a 6-12 months’ embargo can be
considered. Data will be made available and reusable through open data
repositories for periods of up to 10 years.

#  MyoChip Data Set Description

The MyoChip project will generate mainly electronic data, however some data
records can also be found handwritten as lab books for example. MyoChip
project will ensure that all electronic files follow the FAIR policy as
explained earlier. Expected size of data among all partners could amount close
to 100TB during the entire project. The majority of data will come from
software use for experimental setup, equipment and data analysis software. All
partners have identified the datasets that will most likely be produced during
the different phases of the project. These will be updated when necessary in
the next versions of the DMP. All types of data are listed in the table below.  
  
<table>  
<tr>  
<th>

**Type of**

**Data**

</th>  
<th>

**Formats used on MyoChip**

</th>  
<th>

**Source**

</th> </tr>  
<tr>  
<td>

**Documents**

</td>  
<td>

.docx, .doc,.xlsx, .xls, .pptx,

.ppt, .pdf, .txt

</td>  
<td>

  * Protocols elaborated by the partners 

  

  * Project meetings (minutes, presentations, other supporting documents), exchange of ideas 

  

  * Group meeting discussions 

  

  * Literature review: references in an Zotero, Endnote, Mendeley or other database; 

  

  * Word documents with search details (databases, strategies, results) and reviews 

  

</td> </tr>  
<tr>  
<td>

**Video files**

</td>  
<td>

.gif, .avi, .mov ,.mp4, .m4p,

.mpe, .czi

</td>  
<td>

Different microscopes and analysis software.

</td> </tr>  
<tr>  
<td>

**Digital images**

</td>  
<td>

.tif, .tiff, .gif, .jpeg, jpg, .jif,

.jfif, .jp2, .jpx, .j2k, .j2c, .fpx,

.pcd, .png, .pdf, .czi. ,.sld, .ai, .lsm,

</td>  
<td>

Different microscopes and analysis software.

</td> </tr>  
<tr>  
<td>

**CAD files**

</td>  
<td>

.dwg, .dxf, .gds, .cif, .stl, .step

</td>  
<td>

Computer Assisted Design (CAD) files

</td> </tr>  
<tr>  
<td>

**Code**

</td>  
<td>

</td>  
<td>

Development of software

</td> </tr>  
<tr>  
<td>

**Database**

**files**

</td>  
<td>

.sqlite, .enl, .data

</td>  
<td>

Literature reference software such as Zotero, Endnote or Mendeley

</td> </tr>  
<tr>  
<td>

**Raw data**

</td>  
<td>

.csv

</td>  
<td>

Measurements / sensor outputs

</td> </tr> </table>  
<table>  
<tr>  
<th>

**Reusing and Sharing**

</th>  
<th>

**Archiving and preserving (including storage and backup)**

</th> </tr>  
<tr>  
<td>

All types of data are accessible to all the partners on demand. Partners share
and reuse data. Files will be shared at meetings.

</td>  
<td>

The data will be stored by the partner collecting it (on their own computers
and/or institutional servers).

</td> </tr> </table>