136FPPI compulsory licences—terms

#### 136F PPI compulsory licences—terms (1) A PPI order must direct that the PPI compulsory licence is granted on the following terms: (a) no more than the quantity of the pharmaceutical product that is determined by the Federal Court to be necessary to meet the needs of the eligible importing country is manufactured; (b) the entirety of the pharmaceutical product manufactured for that purpose is exported to that country; (c) the pharmaceutical product is labelled and marked in accordance with the regulations; (d) before shipment of the pharmaceutical product begins, the shipment information prescribed by regulation is made available on a website by, or on behalf of, the licensee for a minimum period prescribed by regulation; (e) the duration of the licence is only for the period of time determined by the Federal Court to be necessary to address the public health problem concerned; (f) the licence does not give the licensee, or a person authorised by the licensee, the exclusive right to exploit the patented pharmaceutical invention; (g) the licence is to be assignable only in connection with an enterprise or goodwill in connection with which the licence is used; (h) the licensee must give the Commissioner the information prescribed by regulation in relation to the licence in accordance with the regulations. (2) A PPI order may also direct that the licence is to be granted on any other terms specified in the order, including terms covering: (a) other requirements relating to the labelling and marking of the pharmaceutical product; and (b) other information to be made available by the licensee and the way in which it is to be made available. (3) However, a term specified in a PPI order must not be inconsistent with any regulations prescribed for the purposes of paragraph (1)(c), (d) or (h).