Approval of such product (including label expansion), including clinical trials initiated following receipt of Regulatory Approval or any clinical trial to be conducted after receipt of Regulatory Approval that was mandated by the applicable regulatory authority as a condition of such Regulatory Approval with respect to an approved formulation or indication (such as post-marketing studies, observational studies, pediatric studies, implementation and management of registries and analysis thereof, in each case, if required by any regulatory authority in any region worldwide to support or maintain Regulatory Approval for a pharmaceutical, biologic, or Product in such region). “Develop”, “Developing”, “Development”, and “Developed” / “have Developed” will be construed accordingly.
A-12 “Development Plan” has the meaning set forth in Section 3.01 (b).
A-13 “Exploit” means to make, use, offer to sell, sell, Develop, have developed, Manufacture, perform Medical Affairs, Commercialize or have Commercialized and other allied activities the Product. When used as a noun, exploitation means any and all activities involved in Exploiting.
A-14 “First Commercial Sale” means, with respect to the Product in any country or region, the first sale of the Product to a third party for distribution, use, or consumption in such country or region after receipt of Regulatory Approval for such Product in such country or region.
A-15 “Governmental Authority” means any legislative, executive, or judicial unit of any governmental authority or instrumentality (international, national, federal, state, provincial, or municipal, in any country or other jurisdiction), or any tribunal, department, agency, board, bureau, commission, official, or other regulatory, administrative, or judicial authority thereof, including any administrative or regulatory agency or commission, and any court or arbitration tribunal, in each instance having legal jurisdiction over the subject matter before it.
A-16 “GreenLight Proprietary Rights” shall mean all proprietary rights, including any and all Intellectual Property Rights, in the GreenLight Technology, and GreenLight Technology Improvements.
A-17 “GreenLight Technology” has the meaning set forth in Section 1.01.
A-18 “GreenLight Technology Improvement” has the meaning set forth in Section 1.04.
A-19 “GreenLight Technology Patent Rights” shall mean and include any Patent Rights associated with GreenLight Technology.
A-20 “GreenLight Technology Know-How” shall mean and include all Know How and allied data with respect to the GreenLight Technology.
A-21 “GreenLight Territory” means the countries of United States of America, European Union (EU) 27 member states (i.e. Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and Sweden), United Kingdom, Australia, Japan, New Zealand, Canada, South Korea, and Greater China (China, Hong Kong, Macau, and Taiwan).