definiens: shall mean the data and information, including the Registration Program Data, owned orControlled by [COMPANY], or any of its Affiliates arising out of the [COMPANY] Development Program, that is ( i ) collectedunder the requirements of Good Clinical Practice, Good Laboratory4 * * * Text Omitted and Filed Separately with the Securities and ExchangeCommission . Confidential Treatment Requested Under17 C.F.R. Sections 200.80(b)(4 ) and 240.24b-2 Practice or Good Manufacturing Practice ( as defined by Regulatory Authorities ) whether or not such data andinformation is submitted to Regulatory Authorities in Rest of World by [COMPANY] or any of its Affiliates or the ROWPartner and ( ii ) non - clinical and CMC ( chemistry, manufacturing and controls ) data to the extent submitted in RegulatoryFilings in the Rest of World . [COMPANY] Program Data will include data and information owned or Controlled byNeurocrine ’s ROW Partner(s ) to the extent such data and information is Necessary for DSP to obtain and maintainRegulatory Approval of the IR Product ( and upon exercise of the MR Option, the MR Product ) in the Territory . For thepurposes of this Agreement, data and information will be deemed for Regulatory Approval of the IR Product [ ... * * * ... ] in the Territory if [ ... * * * ... ], based on requirements and precedents with similar products . For the avoidance ofany doubt, such Necessary data and information will be owned or Controlled by [COMPANY] or any of its Affiliates