definiens: means the set of specifications for the applicati on of a dossier for the registration of medicines formatted according to th e International Conference on Harmonization ( ICH ) o f technical requirements for registration of pharmace uticals for human use 3.4.2 Regulatory Filings and Market Approvals . [COMPANY] will own all right, title and interest in and to any and all Regulatory Filings and Market Approv als for Products in the Licensed Fields . Translate Bio will execute all documents and take all actions as are reasonably requested by [COMPANY] to vest such tit le in [COMPANY] . Where Page 18 of 96 applicable, Translate Bio will grant a ( as defined in 21 C.F.R. § 314.3(b ) ) or other applicable right with respect to its Regulato ry Filings for Products as necessary for [COMPANY] to prepare, submit and maintain Regulatory Filings for Products . Where required, the Parties shall execute any pow er of attorney or other instrument necessary to give e ffect to this Section 3.4.2 ( Regulatory Filings and Market Approvals )