definiens: means all amounts that are included in the Develo pment Plan Budget ( unless incurred by Jazz pursuant to Se ction 6.2.2 ) and that are paid or payable to Third Parties in connection with the Development of the Licensed Pro duct under the Development Plan or pursuant to Sect ion 6.2.2 related to seeking, obtaining or maintaining Regulatory Approval in the United States or the EU, including : ( a ) out - of - pocket costs payable by either Pa rty to [ * * * ] pursuant to [ * * * ] after the [ * * * ] in consideration for the [ * * * ] or [ * * * ] t o [ * * * ] that is [ * * * ], including [ * * * ] and [ * * * ], provided, with respect to any such [ * * * ] that is also [ * * * ] that s uch Party or its Affiliates or licensees is [ * * * ], then ( i ) with respect to any payment made pursuant to [ * * * ] that [ * * * ], t he [ * * * ] of such payment shall be [ * * * ] this Sectio n 1.30(a ), ( ii ) with respect to any payment made pursuant to [ * * * ] that [ * * * ], the [ * * * ] of such payment shall be [ * * * ] this Section 1.30(a ), and ( iii ) with respect to any othe r payment made pursuant to [ * * * ] ( such as [ * * * ] ), t he out - of - pocket costs to be included in this Section 1.30(a ) shall [ * * * ] to reflect [ * * * ] to which [ * * * ] ( e.g., if [ * * * ], then [ * * * ] of such payment shall be [ * * * ] this Section 1 .30(a ) ), further provided that this Section 1.30(a ) shall [ * * * ] any costs payable pursuant to [ * * * ] after the [ * * * ] that [ * * * ] in writing pursuant to [ * * * ] to [ * * * ] t he Licensed Intellectual Property ; ( b ) out - of - pocket costs for conducting clini cal studies of the Licensed Product ( to the extent not captured below ) ; -8- Portions of this Exhibit, indicated by the mark were omitted and have been filed separately w ith the Securities and Exchange Commission pursuant to the Registrant ’s application requesting confidential tr eatment pursuant to Rule 24b-2 of the Securities Exchange A ct of 1934, as amended