The EATRIS Innovation Helpdesk helps life science researchers access real-time legal support and partnering advice from the EATRIS community. Our Helpdesk service acts as an expertise center that provides access to essential tools and resources for collaboration such as guidelines on intellectual property rights, open innovation and legal agreement templates.
EATRIS Innovation Helpdesk services include:
- Real-time advice
- Template documents for frequently occurring technology transfer situations (MTA, CDA, etc)
- Guidelines and assistance with cross-infrastructure, industry/academia collaboration and knowledge sharing
- Access to specialist knowledge in relation to business development and legal and regulatory aspects
- On a case-by-case basis, hands-on involvement by Innovation Office staff with real collaboration and negotiation cases
- Workshops and webinars on various aspects of public-private research collaboration
Innovation Helpdesk for technology transfer offices (TTOs)
Local technology transfer offices (TTOs) are the first point of contact for innovation at the individual institute level. The EATRIS Innovation Helpdesk is designed to complement the local TTOs and focus on adding value in situations involving:
• A number of institutes within an infrastructure
• Industry-academia research collaboration across a range of parties
• Cross-RI interactions, with and without industry partners
Note that this service is available to both public and private parties.
Examples of requests include:
- How to plan orphan drug development for a drug I want to repurpose?
- With which company should I partner to develop my new therapy?
- Is it useful to set up a clinical trial for an extremely rare disease?
- Does my compound qualify as a foodstuff or a medicine?
This section contains advice on the main aspects to consider when setting up collaborations. It is not an exhaustive treatment of the main types of agreements, since this can be found in many other sources, but it does attempt to introduce the overall context and the features, which need to be addressed.
Research collaboration requires detailed arrangements for who does what, who pays for what, and what rights and obligations apply. A good agreement will greatly increase the chance of successful technology transfer of benefit to the parties involved and to society in general. Although template agreements do exist for this it is almost invariably a tailor-made process. There are a number of useful sources of information on agreements, in particular licensing agreements, and we limit ourselves here to some of the main elements, and some relatively new concepts.
In this section, you will also find an introduction to Expert Centres, a new concept, which is being considered to streamline and simplify data sharing among large consortia.
Introductory elements about collaboration and licensing agreements
- Agreements made should reflect the objectives of the respective parties and be clear as to what happens if objectives should be achieved or if they should fail to be realized.
- The scope of the partnership should be considered, in terms of the nature of research to be carried out or resources shared, the types of products aimed for, and the areas of application if commercialized later.
- How many parties can best be involved?
- Is the ideal collaboration one involving relatively free exchange of data and resources, one built around intellectual property rights, or a hybrid form?
- If intellectual property is involved, what rights to the Background and Foreground IP will apply?
- Access to data. The principles by which data, materials or resources are to be shared, including ownership, use rights, ethical and privacy issues need to be established.
- Is the model one of free sharing or are there restrictions and/or intellectual property issues?
- Publication of results. Academic institutes need freedom to publish results (and allow PhD candidates to publish and defend their theses). How is this to be organised to protect the interests of both industry and academia?
More information can be obtained from the documents below:
- Best Practices Guide to Academia-Industry Collaboration
- Basic Aspects for Budgeting
- Compendium on Elements of Collaboration and Licensing Agreements
- Guidelines for Technology Transfer and Partnering
- Good Negotiating Practice
- Features of Intellectual Property
- Approaches to Life Science Evaluation
- IP issues in Open Science, pre-competitive Research and Open Innovation doi:10.5281/zenodo.1109265
Cutting edge research as well as further innovations in the life science industry will strongly depend on transnational access to high quality information for academia and industry in an efficient and secure manner. Additionally it is becoming more and more important to take into account the whole spectrum of medical, scientific and technological issues related to personalized medicine. Novel solutions for data and knowledge exchange will improve industry’s access to research infrastructures thereby improving infrastructure’s impact on innovation. This could be achieved by so called ‘Expert Centres’.
Expert Centres provide a framework to integrate pre-competitive public and private research and development by facilitating integrated access to medical and scientific data and knowledge. Furthermore access is facilitated to a broad spectrum of complementary expertise from each of the participating BMS RIs (Biological and Medical Sciences Research Infrastructures) and industry partners. The aim is to reduce fragmentation through harmonisation of procedures, improve quality by implementing common standards and foster high-level collaboration. This novel framework for data and knowledge exchange will create a win-win situation between academia and industry by enhancing collaborative research, sharing data, technologies, expertise and increasing competitiveness.
With the help of reliable (quality-defined) and open data we generate a huge common resource of knowledge, which is key to boosting the knowledge-based economy. Although as much data and knowledge as possible should be open and freely available to everybody there are some restrictions to be considered, such as ethical and legal issues on the data side, and IP issues on the knowledge side (Fig.1).
To make data open and freely available the ethical and legal basis has to be clarified, particularly when data relate or can be related to individuals, such as health data. Furthermore a lack of reproducibility of scientific data is a major threat for society and industry, resulting in losses of billions of EURO spent on R&D every year. Therefore, reliability of data sources needs to be ensured and data quality standards implemented. A dedicated governance and technical infrastructure has to be implemented to facilitate access. Another important element is the establishment of a proper incentive system, both for academia and industry, to sharing data and knowledge and to make it available and accessible.
This principle should be applicable to all BMS RIs since the generation of data and knowledge is a common product relevant for every research infrastructure.
Here are some Considerations for a distributed, federated Expert Centre.
Example: BBMRI-ERIC Expert Centres
BBMRI-ERIC faces the challenge that human biological samples are finite resources and providing access is subject to a series of ethical and legal restrictions, thus requiring innovative solutions for efficient utilisation. Therefore, BBMRI-ERIC developed the concept of Expert Centres as public-private partnerships in the precompetitive, non-profit field to provide a new structure to perform research projects under a novel model of academic-industry collaboration.
BBMRI-ERIC Expert Centres function as a common entity of the public and the private sectors (Fig. 2).
Examples of Expert Centres that currently exist
- EXCEMET (an Expert Centre for metabolomics): The goal of EXCEMET is to further develop technologies and standardize procedures for broad application of metabolomics in biological and medical research, as well as medical diagnostics. The work includes the further development and refinement of harmonization of SOPs and the establishment of a common quality assurance system. It´s a not-for-profit public-private partnership based on a consortium agreement between participants from academia and industry. EXCEMET is a distributed Expert Centre of leading institutions in different countries.
- SciLifeLab (Science for Life Laboratory): Is an Expert Centre which provides access to a broad range of large-scale molecular analyses, state-of-the-art as well as unique technologies and resources developed by the partners, and with bioinformatics support to assist in the interpretation of results. The services are available for academic and industry users and the centre has a strong ambition to also develop new technologies and reagent resources.
For the main elements and principles to be considered in research collaboration and technology transfer agreements please refer to the Guidelines section. Such agreements are almost always tailor-made and great caution should be exercised before using pre-existing templates. Always consult business developers and/or legal experts in your organisation or network, such as TTO staff or alternatively the CORBEL Innovation Office Team can be called upon for advice.
A good collaboration must be mutually beneficial and based on an actual win-win relationship in which all parties benefit from the work that will be done. Effective collaborative agreement will help all parties understand and accept mutual benefit as a goal, so it is of crucial importance to invest time and effort in preparing the negotiations and Collaboration Agreement (CA) text. The objective of CA is to clarify for all parties what they are trying to accomplish together and to clearly set forth the rules that will govern the collaborative effort. More detailed arrangements are needed on who does what and what rights and obligations apply among the participating parties.
Although agreements for setting up collaborations are almost inevitably a tailor- made process, this Collaboration Agreement Template Tool with Commentary aims to serve as a guidance to identify some of the Collaboration Agreement (CA) main components and assist those who need to assemble a Collaboration Agreement.
Secrecy agreements, known as Confidential Disclosure Agreements or Non-disclosure Agreements, are a standard vehicle for entering into discussions to explore some possibility or enable sharing of confidential information in support of some purpose or goal, usually at an early stage in the partnering process.
To access our confidentiality agreement template, click here.
Some important features and issues:
- These agreements safeguard the transfer of confidential or sensitive information but do not cover rights to its use except for the, usually limited, stated purpose.
- Thought must be given to whether the agreements should involve disclosure by one or both parties (“1-way” or “2-way”).
- The scope of what is to be disclosed should be carefully described. A too narrow scope can prevent useful interchange and lead to friction. A too broad scope exposes too much of a party’s intellectual activity to potential disclosure and may commit research groups outside the sphere of the intended purpose.
- Another issue is often called “contamination” and refers to potential harm a party may incur by exposing itself to the other party’s confidential information. If a particular subject should turn out to be at a comparable phase of development within both parties, the disclosure may have the effect of restricting a party’s freedom to undertake its “own” development.
- In most cases of interaction between academic institutions and/or industry parties the parties to the agreements should be the legal entities themselves rather than individuals. Personal secrecy undertakings should be avoided wherever possible, for a number of reasons.
- The duration of the secrecy is often an issue. In general, the longer a party is under the obligation for secrecy the more inconvenient it may become and the greater is the risk of accidental disclosure in breach of the agreement. For academic institutions with publication of their own results likely in the short to medium term (relieving the other party of the secrecy obligation) a long duration is unlikely to be required, but industry parties may require longer periods of non-disclosure. Many situations result in a 3-5 year secrecy period.
- Finally, the issue of large penalties for a party disclosing information in breach of the agreement arises sometimes as a requirement, particularly by industry. Although there may be cases where disclosure can arguably result in substantial damage to a company, an academic party will generally be unable to entertain this kind of risk (with public funds).
Material Transfer Agreements
At an early stage of investigation, or to explore a possible sideline to ongoing research, it may be desirable to transfer materials (substances, cell lines, biological materials, mouse models, etc.) between parties.
Material and data transfer agreements (MTA/DTA) exist to facilitate the exchange of materials and associated personal data between researchers, as well as to protect the interests of the researchers and their institutions. MTA/DTA is a type of legally enforceable contract setting the terms under which materials and associated personal data may be obtained and used. It provides a mechanism to protect the interests of the owners of discoveries and inventions, while promoting data and material sharing in the research community. MTA/DTA is crucial in health research where human biosamples accompanied by associated personal data need to be transferred and made available for research. If personal data to be transferred is not fully anonymized, transfer and processing of such falls under the GDPR (Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 which came into force on May 25th 2018) which provides for the requirements that must be observed in such transfers.
- To access our material transfer agreement template, please click here.
- To access our MTA/DTA for transfer of human biosamples template, please click here.
- A tool to design a core material transfer agreement can be downloaded here.
Material Transfer Agreements (MTAs) cover issues relating to the transfer and use of the materials, among which:
- The ownership and rights to the materials and any inventions resulting from their use;
- The scope of their intended use, generally for laboratory or clinical trials within a well-defined scope;
- Safe and ethical practices to be adopted in their use;
- Return of materials after use or agreed disposal procedures;
- Use/publication of results.
Some particular issues, which can arise:
- Rights to any improvements, derivatives or progeny should be carefully agreed;
- Rights of the receiving party to use commercially (licenses) are generally excluded at this stage of collaboration. Nothing should be included which implies such a license;
- The party providing the samples must be clear that in so doing it does not infringe pre-existing agreements of other parties (including within its own organisation) or limit its freedom to conduct its (research) operations.
In case of doubt it may be better to opt for a more comprehensive form of collaboration agreement even at an early stage. This will take longer to negotiate than a “template” MTA but may in the long term be preferable.
Here are some links to helpful websites on agreements, technology transfer and intellectual property.
This list will be regularly updated:
To find out more or apply for support from the EATRIS Innovation Helpdesk, email innovation[at]eatris.eu. You will then be contacted by a member of our team who will assess the possibilities and provide further information.
*The Innovation Helpdesk was successfully piloted under the H2020 funded project CORBEL (grant number 654248).