Transfer of NDAs and ANDAs; Regulatory Responsibility Transfer Sample Clauses

Transfer of NDAs and ANDAs; Regulatory Responsibility Transfer. (i) On the Closing Date, the Parties shall file with the FDA all of the documents and information required by the FDA to effect the transfer of the Product Intellectual Property, including the NDAs and ANDAs from Forest or any Affiliate of Forest to Caraco or an Affiliate of Caraco designated by Caraco. Forest shall file and shall cause its Affiliates to file all of the documents and the information required of a former owner, including but not limited to a letter acknowledging the transfer of ownership of the Product Intellectual Property, including the NDAs and ANDAs, and Caraco shall file the information required of a new owner. Each of Caraco and Forest shall take any and all other actions required by the FDA or other relevant Governmental Authorities, if any, to effect the transfer of the Product Intellectual Property, including the NDAs and ANDAs from Forest or its Affiliate to Caraco or its designated Affiliate as soon as reasonably practicable. Forest may retain an archival copy of the Product Intellectual property, including the NDAs and ANDAs, including supplements and records that are required to be kept under 21 C.F.R. Sec.314.81. In addition to the foregoing, the Parties shall file with the FDA any documentation and information required to transfer to Caraco any agency status Forest may have with respect to any in-licensed Products. (ii) From and after the Closing Date, Caraco shall assume from Forest or its Affiliate all responsibility for any and all post-Closing fee obligations for holders or owners of approved NDAs and ANDAs relating to the Products, including, but not limited to, those defined under the Prescription Drug User Fee Act of 1992, as the same may be amended from time to time. (iii) From and after the Closing Date, Caraco shall assume all regulatory responsibility with respect to the Products including those related to (A) the marketing and promotion of the Product; (B) Adverse Drug Reaction reporting relating to the Products; and (C) the filing of NDAs and ANDAs and/or supplements to NDAs and ANDAs for product line extensions, extensions of the expiry date and additional product claims or additions to the labeling of the Products.
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