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Ellen Gielen


Newtonlaan 203
3584 BH Utrecht
PO Box 85250
3508 AG Utrecht
Languages English, Dutch

Ellen Gielen is head of the Life Sciences & Healthcare group in The Netherlands and she works at the Commercial Law practice at CMS, concentrating on general contract and commercial law, both contentious and non contentious. Her special area of activity covers commercial contracts such as agency representation, distribution and manufacturing, together with general terms and conditions.​

Ellen has extensive experience in the drafting and reviewing of general terms and conditions for companies in various branches, such as the life science and the chemical industry. ​

Ellen is a frequent lecturer on topics that relate to (international) contracting (agency and distribution agreements).

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‘Ellen Gielen is very focused and delivers practical advise moving our business forward. Has a thorough understanding of the health sector.’

The Legal 500 EMEA, 2020

"Has extensive experience of regulatory regimes."

The Legal 500, 2019

Relevant experience

  • Representing a global cardiovascular company which has its global marketing and sales headquarters in the Netherlands. We have drawn up all their commercial agreements such as distribution agreements, agency agreements, sales agreements and their general terms and conditions. Assisting this client with any issues regarding the termination of such agreements.
  • Acting for a global medical device company in the drafting and negotiating of a cooperation agreement with a hospital in the Netherlands. Focus of this partnership is the provision of services to the hospital which are designed to maximise operational efficiency through effective management and modernisation programmes, thus generating sustainable efficiencies to critical operational departments, so-called hospital solutions. It was the first agreement of its kind in the Netherlands and brought a number of challenges with it, on issues like liability, competition law and regulatory guidelines for medical devices.
  • Acted for a global medical device company. We have drawn up their commercial agreements. We also support this client on regulatory matters. 
  • Acting for a global bio-pharmaceutical company. We support them on a large number of agreements, including all their commercial agreements.
  • Advising a USA based medical device company on regulatory issues for medical device clinical trials.
  • Advises on legal classification, import and distribution of human-derived (engineered) tissue products.
  • Advises on setting up a cross-border internet/mail order pharmacy business.
  • Advises on the set-up of so-called health management services in the Netherlands, including drafting all agreements related to the project. Health management services are pharmaceutical company services which enable them to provide added value to patients, health care providers and health insurance funds to improve patient outcomes and reduce the disease-related burden for all stakeholders. 
  • Advises on the set-up of a subsidiary of a global pharmaceutical company in the Netherlands, which involved assisting them with obtaining the necessary licenses, drafting agreements, such as LSP agreements, service agreements etc.
  • Advises a manufacturer on their new distribution structure, setting up the required network, including the drafting of the new distribution agreements. Assists them, including litigation, in the termination of existing contracts with their distributors.
  • Over the last several years, assisting several clients on their new distribution structure.  The above project is the most recent example of our expertise in this area.
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  • Dutch Law (Company Law), Erasmus University
  • Business Administration, Erasmus University
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  • Complaints Committee of a BOPZ Institution, an institution governed by the Psychiatric Hospitals Compulsory Admission Act
  • Dutch Pharmaceutical Law Association
  • Appeal Committee of the Royal Dutch Hockey Association (KNHB)
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