“EU” means the member states of the European Union including the United Kingdom.
“FDA” means the United States Food and Drug Administration, or any successor thereto, having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States.
“Field” means [***]
“Insolvency Event” means, for a party, being in liquidation or provisional liquidation or under administration, having a controller (as defined in the Corporations Act) or analogous person appointed to it or any of its property, being taken under section 459F(1) of the Corporations Act to have failed to comply with a statutory demand, being unable to pay or stops or suspends or threatens to stop or suspend payment of its debts, entering into a compromise or arrangement with, or assignment for the benefit of, any of its members or creditors, or any analogous event.
“Intellectual Property Rights” means all Confidential Information, Know-how and industrial and intellectual property rights including, without limitation, any rights in respect of or in connection with any copyright, patents, trademarks, design rights or eligible layout rights (whether registered or not) and any rights to apply for registration of any of the foregoing rights.
“Know-how” means scientific, pre-clinical, clinical, regulatory, practical, manufacturing, marketing, financial, technical and commercial information and data (including knowledge, experience, inventions resulting from experience and testing and processes), that is not generally available to the public (even though parts of it may be known), and whether communicated in writing or orally or by any other method (but excluding information disclosed in or claimed by a Licensed Patent).
“Licence” means the licence granted to Licensee pursuant to clause 2(a).
“Licensed IP” means Licensed Patents and Licensed Technology.
“Licensed Patents” means:
[***]
“Licensed Product” means any good or application within the Field which applies, or is made according to, the Licensed IP or any part of it.
“Licensed Technology” means [***]
“Marketing Authorisation” means the required regulatory licence or authority under which a medicinal product may be marketed and sold in a territory, arising from assessment of a party’s application dossier for marketing authorisation (such as, a New Drug Application (NDA) in the United States of America or Marketing Authorisation Application (MAA) in the European Union and other countries).
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