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Certain sectors are highly regulated (such as bio-pharmaceuticals and medical devices, food and energies & utilities). Depending on your field of business, you may need certain permits and authorisations (eg, marketing authorisation, CE mark, pricing decision, GMP/GDP/ISO certificates). Your company may also be subject to regular audits by the competent authorities.
If your company processes personal data (ie any data pertaining to an identified or identifiable individual), it must comply with the rules on personal data protection. Personal data may relate to information about employees, clients prospective clients, patients, service providers, etc.
Health-related data and other special categories of data (trade union membership, political convictions, ethnic origin, race, etc) are considered sensitive and their processing, if allowed, is subject to more stringent requirements.
Compliance with the personal data protection rules requires, amongst other things, the following:
- a legal basis for processing the personal data, which can consist of the data subject's free and informed consent, a statutory obligation, a contractual duty to the data subject, a legitimate interest, etc;
- information of the data subjects of the reason(s) for the processing of their personal data, the recipients of their data, their right to access and correct their personal data, etc;
- the implementation of adequate technical and organisational measures to protect the data against loss, disclosure, and any other form of unlawful or unauthorised processing;
- if processors (ie service providers that process personal data on the company's behalf) are used, they must be contractually bound to the company;
- if personal data are transferred to (or accessible from) abroad (in particular countries outside the European Economic Area), additional measures (such as data transfer agreements) may be required.
Subject to certain (limited) exceptions, processing activities must be notified to the Belgian Privacy Commission prior to the start thereof.
It is important to bear in mind that permits may be required for the approval and reimbursement of certain products. The same applies to M&A transactions and licensing agreements.
It is first necessary to check whether the agreement contains specific termination clauses.
Agreements are concluded for either a fixed term or an indefinite period of time.
Under Belgian law, it is not possible for parties to be perpetually bound to one another under an agreement. It is therefore always possible for a party to put an end to an indefinite or open-ended agreement, provided the other party
is given a reasonable notice period or compensation in lieu thereof, depending on the circumstances.
Every situation is unique and you should therefore be careful when using templates, in particular US/UK templates, which are not always suitable for European transactions.
When dealing with NDAs, at least the following aspects should be borne in mind:
- What information should be kept confidential?
- Are both parties bound by secrecy or only one (two-way or one-way NDA)?
- What is the term of the agreement?
- What are the sanctions in the event of breach?
Two-way agreements, in which both parties transfer confidential information, entail a greater risk of contamination, ie the transfer of information may have an adverse effect on the independency of a future invention.
MTAs should at least cover the following issues:
- ownership of the material;
- the purposes for which the material can be used;
- the precautions with which the material can be used (eg, confidentiality and no transfer to other parties, limited access rights, no reverse engineering);
- which party shall own the rights to results obtained from using the material and which party shall be allowed to commercially exploit the results;
- sanctions for misuse of or damage to the material, and;
- fate of the material upon termination of the agreement. It is important to cover any liability you might have (when transferring or using material) by means of appropriate insurance policies.
Know-how is only valuable if kept strictly secret. In order to do so, measures must be put in place to ensure that information remains confidential:
- Employees must be reminded of their duty not to disclose trade secrets or any confidential information.
- Similar precautions must be taken with regard to subcontractors, freelancers and (potential) commercial contacts. An NDA should be entered into prior to any meeting with the latter.
- If possible, access to confidential information should be restricted to persons who absolutely need to access it. Specific security measures may need to be put in place (password protection for documents or files, safe lockers, restricted access to labs, etc). Extremely important information can even be kept in a safe deposit box at a bank.
It is extremely important that the company be able to establish that it has taken all possible measures to keep its confidential information and know-how secret.
It is not always easy to identify an infringement of a third party's rights. Much will depend on the IP right concerned since, for some types of rights, information is publicly available, while for others (such as copyright), there are no public databases.
For patents, patent attorneys can provide assistance by conducting prior art searches and preparing an FTO (freedom to operate) report.
In order to avoid or dispute infringement claims, it is very important to keep track of the dates and times at which IP is created, so as to be able to establish prior rights, if necessary.