Article 10 — Obligations of the licensee

1. The licensee shall be authorised to exploit the protected invention covered by the Union compulsory licence only where the licensee complies with the following obligations: (a) the licensee shall ensure that the quantity of the crisis-relevant products manufactured or marketed under the Union compulsory licence does not exceed the maximum quantity determined in accordance with Article 8, point (h); (b) the licensee shall carry out relevant activities concerning the crisis-relevant products solely for ensuring the adequate supply of the crisis-relevant products in the Union; (c) the licensee shall ensure that the crisis-relevant products manufactured or marketed under the Union compulsory licence are clearly identified, through specific labelling or marking, as being manufactured or marketed pursuant to a Union compulsory licence granted under this Regulation; (d) the licensee shall keep regular records of the quantities of crisis-relevant products manufactured or marketed under the Union compulsory licence; (e) the licensee shall ensure that the crisis-relevant products manufactured or marketed under the Union compulsory licence can be distinguished from products manufactured or marketed by the right holder or under a voluntary licence granted by the right holder by means of special packaging, colouring or shaping, unless such distinction is not feasible or has a significant impact on the price of the crisis-relevant products; (f) the licensee shall ensure that the packaging of the crisis-relevant products manufactured or marketed under the Union compulsory licence and any associated marking or leaflet indicate that those products are subject to a Union compulsory licence granted under this Regulation and specify clearly that they are exclusively for distribution in the Union and are not to be exported; (g) before marketing the crisis-relevant products covered by the Union compulsory licence, the licensee shall make available on a website the following information: (i) the quantities of the crisis-relevant products manufactured under the Union compulsory licence per Member State of manufacturing; (ii) the quantities of the crisis-relevant products to be supplied under the Union compulsory licence per Member State of destination; (iii) the distinguishing features of the crisis-relevant products covered by the Union compulsory licence. The licensee shall communicate the address of the website referred to in point (g) to the Commission. The Commission shall communicate the address of the website to the Member States. 2. In the event of a failure by the licensee to fulfil any of the obligations laid down in paragraph 1 of this Article, the Commission may: (a) terminate the Union compulsory licence in accordance with Article 14(3); (b) impose fines or periodic penalty payments on the licensee in accordance with Article 15 or 16. 3. Where there are sufficient grounds to suspect that the licensee has failed to fulfil the obligations laid down in paragraph 1, the Commission, in cooperation with the relevant national authorities of the Member States, may, based on information from those authorities or from the right holder, request access to books and records kept by the licensee as necessary for the purpose of checking compliance with the licensee’s obligations laid down in paragraph 1. 4. The Commission shall, by means of implementing acts, establish rules for the specific labelling or marking referred to in paragraph 1, point (c), of this Article, and for the packaging, colouring and shaping referred to in paragraph 1, point (e), of this Article, as well as rules for their use and, where relevant, their positioning on the crisis-relevant products. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 23(2).