definiens: means, with respect to each LicensedProduct in any country in the Territory, any period of data, market or other regulatory exclusivity ( otherthan PatentCONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT . THE COPY FILEDHEREWITH OMITS THE INFORMATION SUBJECT TO A CONFIDENTIALITY REQUEST . OMISSIONS AREDESIGNATED [ * * * ] . A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THESECURITIES AND EXCHANGE COMMISSION.***Text Omitted and Filed SeparatelyConfidential Treatment RequestedUnder 17 C.F.R. § § 200.80(B)(4 ) and 240.24b-2exclusivity ) granted or afforded by Applicable Law or by a Regulatory Authority in such country thatconfers exclusive marketing rights with respect to such Licensed Product in such country or preventsanother party from using or otherwise relying on any data supporting the approval of the NDA orsupporting the MAA for such Licensed Product without the prior written consent of the NDA - holder orMAA - holder, as applicable, such as new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, non - patent related paediatric exclusivity or anyother applicable marketing or data exclusivity, including any such periods listed in the FDA ’s OrangeBook or any such periods under national implementations in the EU of Article 10 of Directive2001/83 / ED, Article 14(11 ) of Parliament and Council Regulation ( EC ) No . 726/2004, Parliament andCouncil Regulation ( ED ) No . 141/2000 on orphan medicines, Parliament and Council Regulation ( ED)No . 1901/2006 on medicinal products for paediatric use and all international equivalents of any of theforegoing