Samsung’s Sample Clauses

Samsung’s responsibilities for the Products shall include: (i) receiving and processing all post-marketing spontaneous adverse experience reports that originate in the Territory with respect to the Products, which reports shall be processed in accordance with Samsung’s Standard Operating Procedures for adverse experience reporting; (ii) with respect to any adverse experience (as defined in the Pharmacovigilance Agreement) report that is initially made to or received by Samsung, obtaining follow-up information thereon (with the understanding that if any follow-up information is received by Merck, it shall be forwarded to Samsung within the same timelines as for the initial information); (iii) making regulatory and safety contacts with the Regulatory Authorities in the Territory as the holder of the relevant Marketing Authorization; (iv) producing and submitting post-marketing periodic safety update reports to the Regulatory Authorities in the Territory as required by applicable laws and regulations; and (v) contacting Merck in the Territory, including prompt communication to Merck of a significant new safety signal with respect to the Products.
Sample 1
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