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8. Research collaborations with third parties

8. Research collaborations with third parties

8.1 Introduction

AMC and VUmc collaborate with a broad spectrum of partners, such as academic parties, industries, national governmental agencies, charities and the European Commission. Both UMCs encourage such collaborations as an important part of scientific research. Sharing experiences, knowledge and resources is crucial for advancing scientific knowledge and innovations.

These collaborations impose on the UMC the task to carefully weigh the interests of their collaborating partners against its own academic teaching and research obligations, as well as the interests of its patients and of society. In all collaborations with third parties, conflicts of interest should be avoided. The general principles of research integrity, transparency and independence remain to be respected, see also the Montreal statement of the 3rd World Conference on Research Integrity . It follows from this that collaborations with third parties should be open or controllable, that the research aim and questions should serve a scientific purpose, and that methods pursued and results reported are truthful and timely rather than serving commercial or political interests.

8.2 Ruling principles

When the UMC enters into research agreements with third parties, certain principles should be adhered to, to safeguard academia's role and responsibility:

1. Reasonable Efforts
Since the course of state-of-the-art research is by its nature unpredictable and research results are inherently uncertain, UMC research is generally conducted on a reasonable efforts basis, performed at a standard that is consistent with research at the UMC.

2. Work Plan
This is by far the most important part of the agreement. The statement of work is attached to the agreement as an appendix to the actual agreement.

In drafting the work plan, the parties must work together closely. Within the statement of work, there should be a section stating the project's scientific objectives. Each objective in the statement of work should be followed by a description of the methodologies and approaches to be used to address the scientific questions involved. Further, each objective must include very clearly what each partner (the institute scientists and the company scientists) will be doing, separately and collaboratively.

Another point to consider is to quantify the work that is to be done. It may not be necessary to use exact, but do insert general guidance about the size and scope of the research project.

Benchmarks are important to help measure work progress. They specify that at a certain point both parties expect certain pieces of data to have been generated, certain parts of the experiments to have been completed, or certain questions to have been answered.

3. Conflicting Obligations
The UMC does not knowingly enter into research agreements that involve commitments and obligations, which are in conflict with those accepted under other research agreements of the UMC. Special procedures for dealing with actual or potential conflicts may, in appropriate cases, be included in research agreements. The UMC does not, however, accept blanket provisions that preclude the principal investigator or the UMC from performing research for other sponsors in related areas.

4. Publications
Disseminating results through scientific publication is the way in which UMC's fulfil their obligation to share research results with society. By publishing results, they can be tested by other researchers and, in the case of certain type of results, be applied in the medical treatment of patients. In addition, scientific publication through journals and conferences is important to the career prospects of all UMC researchers.
It is fundamental to the UMC that the scientific publication of results is guaranteed. On the other hand, there may be a need to protect sensitive information and intellectual property rights (IP). Therefore, it is necessary to determine in an early stage of the negotiations how a proposed publication may be amended and how long it may be delayed in order to accommodate the needs of all parties. Delay should be for a reasonable period and in general not be longer than 90 days from first submission to the reviewing party (thus including the review period).

5. Intellectual Property and economic valorisation
It is important to verify whether it is necessary to give the contracting partners access to the UMC's existing know-how, materials and/or intellectual property rights (Intellectual Property/ IP), and whether access can be granted and, if so, under what conditions. On the other hand, researchers have to make sure that no IPR licensed to the UMC by a third party outside the scope of the project (including materials obtained under a MTA), will be used in the project without the third party's prior consent.
While the UMC customarily grants a royalty-free license to the sponsor to make internal use of any written reports and data that arise from the research project, in principle the UMC retains ownership of all inventions and discoveries, arising from UMC-conducted research whether or not patentable, see also Chapter 7. UMC will grant a sponsor a first right to negotiate a reasonable commercial license to use the technology arising from the research, which may include the right of the sponsor to obtain exclusive rights.
In appropriate cases, more favourable conditions may be agreed with respect to IPR (set out licenses or assignments). Such agreements should always be negotiated in good faith between the parties upon market conform conditions. The basic objectives of the UMC's intellectual policy policies are to promote the progress of science and technology, assure that discoveries and inventions are utilized in ways most likely to benefit the public. Therefore, it is necessary that such agreements contain clear anti-shelving clauses, i.e. obligations to further develop the results created by the UMC. UMC will always retain the right to use any results for research and educational purposes.

6. Funding and pricing
UMC's sponsored research projects are generally conducted on the basis of full cost recovery, including payment of indirect costs at UMC's established rate and Intellectual Property fees.
Prepayment or early payment may be necessary since the UMC does not utilize its working capital to finance large expenditures incurred in the course of sponsored research.

7. Confidentiality
UMC encourages open discussion and exchange of ideas. At times, however, it may be necessary to provide an umbrella of protection to preserve or maintain the confidentiality of disclosed information. This will then be arranged in a Confidentiality Agreement.

8. Warranties, liability and risks
UMC generally is unable to accept contractual provisions that establish rigid deadlines or deliverables, impose penalties for failure to progress at a certain pace, or provide for withholding of payment if the sponsor is not satisfied with the results. UMC research agreements will have express provisions disclaiming liability and indemnification obligations, including without limitation liability for sponsor business losses, such as lost profits.

8.3 Types of research agreements

Depending on the nature of the research and its scope, duration and degree of formality, tailored agreements are required to address the different needs of the parties. In general, six types of research collaborations with third parties can be distinguished. Each represents a step in a continuum from basic, curiosity-driven research to targeted, application-driven research.

  1. Research grant
  2. Collaborative research agreement
  3. Sponsored research agreement
  4. Research service agreement
  5. Clinical research agreement
  6. Consultancy/advisory agreement.

8.3.1 Research grant
A research grant is a funding agreement typically focusing on basic, curiosity-driven research. Grants typically come from government or charity granting councils, but there are also industrial research grants. Especially research grants provided to consortia of research groups with commercial parties face complex financial, legal and intellectual property regulations.

Typical features:

  • Research proposal and project control lies with the researcher.
  • Rights to publish research results not restricted.
  • Payment in advance or based/partly based on deliverables.
  • Ownership of any intellectual property resides with the UMC.
  • Granting body is provided with a copy of the final research report.

8.3.2 Collaborative research agreement
Collaborative research agreements cover collaborative or joint research of mutual interest to the UMC and the collaborator. The research can be fundamental or applied in nature. This type of research arrangement is often co-funded by industry.

Typical features:

  •  Defined scope of work/research plan.
  • Publication is not restricted, but the agreement generally allows the company to preview any publications prior to public disclosure in order to remove any confidential information or to allow for a reasonable delay for patent protection (90 days maximum).
  • Payment may be made tied to milestones/deliverables.
  • Background intellectual property and ownership are clearly defined. The UMC retains ownership of new intellectual property, although the sponsor is given rights to use results for non-commercial purposes and the sponsor is granted the option to acquire a license (on terms negotiated in good faith and appropriate to the industry sector).
  • The UMC retains rights to use results for research and education (non-commercial) purposes.
  • Termination provisions are included.
  • Insurance and indemnification provisions are included to protect the UMC and the persons involved in the research (researchers, visiting scientists, students and interns).
  • Indirect cost assessment varies according to the nature of the project and a reasonable compensation based upon market conditions for the use of UMC intellectual property needs to be paid by the sponsor to the UMC.

8.3.3 Sponsored research agreement
Sponsored research agreements cover well-defined research of specific interest to the sponsor. The research is performed solely by the UMC (no collaborative research) but the sponsor often has input or directs how the project is to be conducted. The project is usually initiated by the UMC but the sponsor provides a financial contribution to the UMC and/or provides access to the sponsor's proprietary IP rights, materials, software or other valuable background IP. The research is more often applied in nature and is directed at answering questions that are of interest to the sponsor. Sponsored research agreements have the same general terms as collaborative research agreements; however, there is more room for negotiation, particularly with respect to the ownership of research results and the financial contribution to be provided by the sponsor.

8.3.4 Research services agreement (contract research)
This is an agreement that facilitates the delivery of specialized services, the use of the institution's equipment and the reporting of results to the sponsor. The service provided by the UMC might include the testing, evaluation or analysis of materials owned by the sponsor. There is little or no research involved and the service seldom leads to publishable results. Therefore, a due balance of interest should be stipulated in the agreement. If the service encompasses advisory activities only, this may be a consulting agreement (see 8.3.6).

Typical features:

  • Use of existing know-how and/or IP rights to provide the service.
  • Use of UMC facilities, resources and time.
  • Start and end dates of the project are defined. 
  • Payment can be made after the services are rendered or tied to deliverables; holdback often required.
  • Service results are the property of the sponsor; UMC has the right to use the results for teaching and non-commercial research projects.
  • The UMC owns any know-how it developed for or utilized in the provision of services.
  • Insurance and indemnification provisions are included to protect the UMC and the persons involved in the research (researchers, visiting scientists, students and interns).
  • Indirect cost assessment varies according to the nature of the project and a reasonable compensation based upon market conditions for the use of UMC intellectual property needs to be paid by the sponsor to UMC.

8.3.5 Clinical trial agreements
Clinical trials might be investigator initiated (sponsored by direct or indirect government funding or charities) or sponsored by for-profit parties. A clinical trial agreement (CTA) is a legally binding agreement that manages the relationship between the sponsor, which might be providing the study drug or device, and the UMC performing the clinical research project. CTAs can be industry initiated or UMC investigator initiated.
It is important to have a CTA in order to allocate risks, responsibilities, funds and obligations, and to protect academic, legal, intellectual property and integrity. For the general rules and regulations on clinical research, see Chapter 5.

8.3.6  Consultancy agreement (advisory agreement)
A consultancy agreement is a contract under which advisory activities are provided by UMC employees to third parties (e.g. participation in an advisory board). See section 12.4 about the rules on external employment (nevenfuncties) and the regulations in Article 9.3 of the Collective Agreement for University Medical Centres (CAO, 1 March 2011-1 April 2013).

8.4  Supporting agreements in research collaboration

Material transfer agreements (MTAs), confidentiality or non-disclosure agreements (NDAs) and visiting scientist agreements are supporting agreements that are designed to ensure protection of your research or to protect confidential information or materials shared with a third party.

8.4.1 Material transfer agreements
Biological materials can have substantial commercial value. Therefore, it is important not to provide such material to third parties unconditionally. A material transfer agreement (MTA) is a legal document that defines the basis upon which you transfer or obtain access to biological or chemical compounds (ranging from specific molecules - such as pharmaceuticals, nucleic acids or proteins - to biological research tools, such as cell cultures, cell lines, plasmids, transgenic plants or animals). The MTA controls the use of transferred materials when material is sent or received by UMC.

MTAs regulate the terms of material exchanges, in particular:

  • What the recipient is allowed to do with the material.
  • What the property situation is.
  • Who is liable for damages.
  • How to proceed in the case of publications and inventions.

Human material derived from patients may be transferred to academic collaborators under MTAs. The UMCs do not transfer human material derived from patients to companies under an MTA. If researchers want to set up a research collaboration involving human material derived from patients with a company, a collaborative research agreement is necessary

8.4.2 Confidentiality agreements (non-disclosure agreements)
Before entering into a collaboration, a level of trust between the parties must be established. This trust is the basis for a confidentiality agreement (CDA), which is often the first step in developing mutually advantageous relationships.

CDAs obligate the receiving party to keep the information confidential and thus enable the parties to discuss the outlines of the collaboration and to share information regarding project proposals, budgets and IP matters. A non-patented research discovery may be disclosed to another person, organization or company provided there is a CDA between the UMC and the organization/person to which/whom the invention is disclosed.

8.4.3  Visiting scientist agreement
A visiting scientist agreement is intended to safeguard the IP rights and duty of confidentiality with regard to confidential information for temporary scientific staff and scientific trainees (see also Chapter 7).

8.5 How to prepare for collaboration with third parties

All research agreements are executed by the executive board, which is authorized to sign agreements on behalf of the UMC. Any agreement should be signed in accordance with the institutional authorization procedures (bevoegdhedenregeling). Discussions between sponsor representatives and UMC researchers are preliminary only and no understandings or agreements are legally binding until reflected in a duly-executed written agreement. Researchers are therefore not entitled to be a party to such agreements.

When considering collaboration with third parties, researchers must ask themselves whether the research objectives and questions pertain to relevant and new medical/scientific insights. Regarding the research project itself, the researcher needs to verify that the performance of the project and the commitments stipulated in the contract with the third party do not conflict with other commitments of the UMC that are already in place. A researcher who is to perform research that is part of a protocol drawn up by other people is still responsible. He/she must determine whether he/she agrees with all details of the intended research. Researchers are responsible for the analysis of data, even if this is done elsewhere, and must have insight into the manner in which the data are processed.

First draft agreements are often proposed by collaborators; however, to speed up and facilitate the process of research-related agreements, the UMCs' research contract and IP lawyers have developed template contracts which could be used as a starting point for the negotiations. Innovation Exchange Amsterdam (IXA, previously  Technology Transfer Office TTO) will assist you with the preparation and with selecting the best contract model and negotiating your research collaboration. A business developer will collaborate with an internal research contract lawyer during the contract negotiations. To process agreements promptly, researchers will be requested to complete an agreement intake form that helps to determine what type of agreement, IP proposition and budget is best suited to the needs in a particular set of circumstances. Questions to be addressed include:

  1. Who is the funding party?
  2. What type of research will the project undertake?
  3. Who contributed to the development of the protocol/research plan?
  4. Is the funding sufficient to cover all costs related to the project?
  5. Does the project conflict with other projects?
  6. Is the focus of the project the testing or analysis of the sponsor's information, data, materials and/or IP rights ('background IP')?