GSDB definition

GSDB has the meaning set forth in Section 6.3.
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Examples of GSDB in a sentence

  • Exchange of ICSRs (Processed Data) Before GSDB transfer Any ICSRs prior to Day 120 before the Completion Date or after Day 120 where DoA is not allowed, will be processed by AstraZeneca.

  • For instance, if Takeda reports ten (10) cases a year for the Territory and the total amount of cases reported worldwide is one hundred (100), then Takeda shall pay only ten percent (10%) of the costs for the maintenance of the GSDB.

  • Serious Adverse Drug Reactions Non serious AstraZeneca sending to Everest 9 calendar days from AstraZeneca’s initial Receipt Date After the GSDB transfer After the transfer of the Product GSDB to Everest, ICSRs will be exchanged as described below until MA transfer is complete for Territories where DoA is not allowed.

  • For clarification, the Pharmacovigilance Agreement shall govern with respect to matters in connection with the pharmacovigilance administration for the Compound and Licensed Product; provided that the cost allocation of such pharmacovigilance system administration and GSDB shall be governed by this Section 6.3.

  • Everest will process all initial ICSRs from Day 120 after Completion Date where DoA is allowed and forward those to AstraZeneca from day 120 to transfer of GSDB, according timelines shown below.

  • Serious Adverse Events Non-Serious and Non-Valid Events Everest sending to AstraZeneca 9 calendar days from Everest initial Receipt Date 21 calendar days from Everest initial Receipt Date After Day 120 after Completion Date and before the GSDB transfer if DoA is allowed AstraZeneca will process and send the case to Everest according the timelines as specified below.

  • The Parties intend for [***] to be the global safety database holder (“GSDB Holder”) and [***] shall become GSDB Holder at the time set forth in the [***].

  • Exchange of ICSRs (Unprocessed Data) Any ICSRs received by AstraZeneca after the transfer of the GSDB will be provided to Everest local affiliates by the AstraZeneca local affiliate as detailed below.

  • The relevant MAH will be responsible for preparing responses to Regulatory Authority queries and requests with regards to post-marketing safety however by Day 120 after Completion Date Everest will provide responses to Regulatory Authorities with provision of data from the GSDB.

  • Takeda shall pay Sucampo for all costs for the maintenance of the GSDB and the generation and compiling PSUR/PBERER and DSUR on a prorata basis of the number of cases reported by Takeda for the Territory over the total number of cases reported worldwide but in no event shall Takeda, including its Affiliates, […***…] and under the Collaboration and Licence Agreement between Takeda Pharmaceutical Company Limited and Sucampo Pharmaceuticals, Inc.