Definitions

1. For the purposes of this Regulation, the following definitions shall apply:

‘research and development agreement’ means an agreement entered into between two or more parties which relates to the conditions under which those parties pursue any of the following:

joint research and development of contract products or contract technologies which:

does not include joint exploitation of the results of that research and development; or

includes joint exploitation of the results of that research and development;

paid-for research and development of contract products or contract technologies which:

does not include joint exploitation of the results of that research and development; or

includes joint exploitation of the results of that research and development;

joint exploitation of the results of research and development of contract products or contract technologies carried out pursuant to a prior agreement falling under point (a) between the same parties;

joint exploitation of the results of research and development of contract products or contract technologies carried out pursuant to a prior agreement falling under point (b) between the same parties;

‘agreement’ means an agreement between undertakings, a decision by an association of undertakings or a concerted practice;

‘research and development’ means activities aimed at acquiring know-how relating to products, technologies or processes, the carrying out of theoretical analysis, systematic study or experimentation, including experimental and demonstrator production, technical testing of products or processes, the establishment of the necessary facilities up to demonstrator scale and the obtaining of intellectual property rights for the results;

‘product’ means a good or a service, including both intermediary goods or services and final goods or services;

‘contract technology’ means a technology or process arising out of the joint or paid-for research and development;

‘contract product’ means a product arising out of the joint or paid-for research and development or produced by applying the contract technologies;

‘exploitation of the results’ means the production or distribution of the contract products or the application of the contract technologies or the assignment or licensing of intellectual property rights or the communication of know-how required for such production, distribution or application;

‘intellectual property rights’ include industrial property rights, for example patents and trademarks, as well as copyright and neighbouring rights;

‘know-how’ means a package of practical information, resulting from experience and testing, which is:

‘secret’, meaning that it is not generally known or easily accessible;

‘substantial’, meaning that it is significant and useful for the production of the contract products or the application of the contract technologies; and

‘identified’, meaning that it is described in a sufficiently comprehensive manner so as to make it possible to verify that it fulfils the criteria of secrecy and substantiality;

‘joint’, in the context of activities carried out under a research and development agreement, means activities where the work involved is:

carried out by a joint team, organisation or undertaking;

jointly entrusted to a third party; or

allocated between the parties by way of specialisation in the context of research and development or specialisation in the context of exploitation;

‘specialisation in the context of research and development’ means that each of the parties is involved in the research and development activities covered by the research and development agreement and they divide the research and development work between them in any way that they consider appropriate; this does not include paid-for research and development;

‘specialisation in the context of exploitation’ means that the parties allocate between them individual tasks such as production or distribution, or impose restrictions upon each other regarding the exploitation of the results, such as restrictions in relation to certain territories, customers or fields of use; this includes a scenario where only one party produces and distributes the contract products or applies the contract technologies on the basis of an exclusive licence granted by the other parties;

‘paid-for research and development’ means research and development that is carried out by one party and financed by a financing party;

‘financing party’ means a party financing paid-for research and development while not carrying out any of the research and development activities itself;

‘competing undertaking’ means an actual or a potential competitor:

‘actual competitor’ means an undertaking that is supplying a product, technology or process capable of being improved, substituted or replaced by the contract product or the contract technology on the relevant geographic market;

‘potential competitor’ means an undertaking that, in the absence of the research and development agreement, would, on realistic grounds and not just as a mere theoretical possibility, be likely to undertake, within not more than 3 years, the necessary additional investments or incur the necessary costs to supply a product, technology or process capable of being improved, substituted or replaced by the contract product or contract technology on the relevant geographic market;

‘relevant product market’ means the relevant market for the products capable of being improved, substituted or replaced by the contract products;

‘relevant technology market’ means the relevant market for the technologies or processes capable of being improved, substituted or replaced by the contract technologies;

‘active sales’ means all forms of selling other than passive sales;

‘passive sales’ means sales made in response to unsolicited requests from individual customers, including delivery of products to the customer, without the sale having been initiated by actively targeting the particular customer, customer group or territory, and including sales resulting from participating in public procurement or responding to private invitations to tender.

2. For the purposes of this Regulation, the terms ‘undertaking’ and ‘party’ shall include their respective connected undertakings. ‘Connected undertakings’ means:

undertakings in which a party to the research and development agreement, directly or indirectly, has one or more of the following rights or powers:

the power to exercise more than half the voting rights;

the power to appoint more than half the members of the supervisory board, board of management or bodies legally representing the undertaking;

the right to manage the undertaking’s affairs;

undertakings which directly or indirectly have, over a party to the research and development agreement, one or more of the rights or powers listed in point (1);

undertakings in which an undertaking referred to in point (2) has, directly or indirectly, one or more of the rights or powers listed in point (1);

undertakings in which a party to the research and development agreement together with one or more of the undertakings referred to in points (1), (2) or (3), or in which two or more of the latter undertakings, jointly have one or more of the rights or powers listed in point (1);

undertakings in which one or more of the rights or powers listed in point (1) are jointly held by:

parties to the research and development agreement or their respective connected undertakings referred to in points (1) to (4); or

one or more of the parties to the research and development agreement or one or more of their connected undertakings referred to in points (1) to (4) and one or more third parties.

COMMISSION REGULATION (EU) 2023/1066 of 1 June 2023 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of research and development agreements