Document ID: chunk:federal_register_of_legislation:C2015A00008:clause:1_136f
Version: federal_register_of_legislation:C2015A00008
Segment Type: clause
Provision Reference: sch 1 cl 136F
Character Range: 19068–20898

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).