Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).
Regulatory Documentation means all (i) applications (including all INDs and Drug Approval Applications and other Major Regulatory Filings), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), and (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files in each case ((i), and (ii)) relating to a Licensed Product.
Regulatory Documentation means all applications for clinical studies and Regulatory Approvals, all registrations, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), and all Clinical Data and other data submitted to Regulatory Authorities, in each case for a particular product, including all regulatory drug lists, advertising and promotion documents, drug master files, adverse event files and complaint files for such product.
Examples of Regulatory Documentation in a sentence
Nanobiotix and Xxxxxxx acknowledge and agree that “embodiments” of intellectual property within the meaning of Section 365(n) include laboratory notebooks, product samples and inventory, research studies and data, INDs/CTAs, Drug Approval Applications, Regulatory Documentation and Marketing Approvals.
At any time upon Xxxxxxx’x request, Nanobiotix, on behalf of itself and its Affiliates, will and hereby does assign to Xxxxxxx all of Nanobiotix’s and its Affiliates’ right, title and interest in, to and under all Regulatory Documentation (including INDs/CTAs) relating to [***].
Upon Xxxxxxx’x request, Nanobiotix will reasonably cooperate with Xxxxxxx to provide regulatory assistance with respect to the Licensed Products, in order to facilitate submissions of Regulatory Documentation and communications with Regulatory Authorities in the Territory for the Licensed Products.
If Xxxxxxx makes such request, then Nanobiotix will transfer and assign the IND/CTAs and associated Regulatory Documentation to Xxxxxxx in accordance with Section 3.5.2 and sponsorship of the Ongoing Head and Neck Study will transfer to Xxxxxxx as described in Section 3.4.5(a).
If requested by Xxxxxxx, the foregoing cooperation will include assisting with 42 preparation of INDs/CTAs, Drug Approval Applications and other Regulatory Documentation for the Licensed Products.
More Definitions of Regulatory Documentation
Regulatory Documentation means all (a) applications (including all INDs and Drug Approval Applications and other regulatory filings), registrations, licenses, authorisations, and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files; and (c) pre-clinical and clinical data, and data contained or relied upon in any of the foregoing, in each case (a), (b), and (c) relating to Product.
Regulatory Documentation means all (a) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations and approvals (including all Market Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, Adverse Event files and complaint files and (c) Clinical Data and any other data contained in any of the foregoing, in each case ((a), (b) and (c)), relating to the Licensed Product.
Regulatory Documentation means all (i) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files, and complaint files; and (iii) clinical and other data contained or relied upon in any of the foregoing, in each case ((i), (ii), and (iii)) relating to a Product.
Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all clinical studies and tests, relating to any Licensed Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.
Regulatory Documentation means, with respect to each Licensed Product, all: (a) Regulatory Materials, including all data contained therein and all supporting documents created for, submitted to or received from an applicable governmental agency or Regulatory Authority relating to such Regulatory Materials; and (b) other documentation Controlled by a Party which is reasonably necessary in order to Commercialize Licensed Product in the Field in the Territory, including any registrations and licenses, regulatory drug lists, advertising and promotion documents shared with Regulatory Authorities, adverse event files, complaint files and Manufacturing records.
Regulatory Documentation means: all (i) applications (including all INDs and Biologics License Applications), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; and (iii) clinical and other data contained or relied upon in any of the foregoing; in each case ((i), (ii) and (iii)) relating to the Licensed Compound or a Licensed Product.
Regulatory Documentation means all Regulatory Filings, registrations, filings, applications, licenses, authorizations and approvals (including Regulatory Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authorities), and all supporting documents for clinical studies, data and supporting documents relating to the Product(s), and all data contained in any of the foregoing (including advertising and promotional and marketing documents, Adverse Event files, periodic safety update reports, medical event reports, compliant files and the like).