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1. Subject to adequate protection of the legitimate interests of the licensee, a compulsory licence granted pursuant to this Regulation may be terminated by a decision of the competent authority or by one of the bodies referred to in Article 17 if the licence conditions are not respected by the licensee. The competent authority shall have the authority to review, upon reasoned request by the rights-holder or the licensee, whether the licence conditions have been respected. This review shall be based on the assessment made in the importing country where appropriate.

2. Termination of a licence granted under this Regulation shall be notified to the Council for TRIPS through the intermediary of the Commission.

3. Following termination of the licence, the competent authority, or any other body appointed by the Member State, shall be entitled to establish a reasonable period of time within which the licensee shall arrange for any product in his possession, custody, power or control to be redirected at his expense to countries in need as referred to in Article 4 or otherwise disposed of as prescribed by the competent authority, or by another body appointed by the Member State, in consultation with the rights-holder.

4. When notified by the importing country that the amount of pharmaceutical product has become insufficient to meet its needs, the competent authority may, following an application by the licensee, modify the conditions of the licence permitting the manufacture and export of additional quantities of the product to the extent necessary to meet the needs of the importing country concerned. In such cases the licensee's application shall be processed in accordance with a simplified and accelerated procedure, whereby the information set out in Article 6(3), points (a) and (b), shall not be required provided that the original compulsory licence is identified by the licensee. In situations where Article 9(1) applies but the derogation set out in Article 9(2) does not apply, no further evidence of negotiation with the rights-holder will be required, provided that the additional amount requested does not exceed 25 % of the amount granted under the original licence. In situations where Article 9(2) applies, no evidence of negotiation with the rights-holder will be required.