Regulatory Documentation definition

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).

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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 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 (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.

Examples of Regulatory Documentation in a sentence

Vir Bio and its Affiliates have conducted, and, to Vir Bio’s Knowledge, their respective contractors and consultants have conducted, all Development of the Licensed Compounds and the Licensed Products (including the generation, preparation, maintenance, submission, and retention of all Regulatory Documentation) in compliance with Applicable Law.
The Transition Plan shall include the assignment of Data, Licensed Know-How, and transfer of oversight and responsibility for the Ongoing Phase 1 Clinical Study and all Regulatory Documentation in accordance with Section 5.1.2 (Transfer of Regulatory Responsibilities).
Promptly after the Effective Date and in accordance with the timelines set forth in the Transition Plan, Vir Bio shall transfer to Company or its designee copies of all Regulatory Documentation (including all Regulatory Approvals) with respect to the Licensed Compounds or Licensed Products, including a copy of the IND for the Ongoing Phase 1 Clinical Study.
Vir Bio will have the right to retain copies of certain transferred Regulatory Documentation (including the IND) in accordance with Vir Bio’s record retention policies and as otherwise required by Applicable Law or Regulatory Authority, in each case, solely for the purpose of performing any obligations or exercising any rights under this Agreement with respect to Licensed Compounds or Licensed Products, or archival or compliance with Applicable Law purposes.
Each Party will support the Regulatory Lead, as applicable, as may be reasonably requested by the Regulatory Lead in connection with the Regulatory Lead’s (i) preparation of regulatory strategy, (ii) preparation of Regulatory Documentation and for planned meetings with Regulatory Authorities, (iii) submission of Regulatory Documentation to Regulatory Authorities, and (iv) maintenance of Regulatory Documentation, with respect to (i)-(iv), for Licensed Compounds and Licensed Products.

More Definitions of Regulatory Documentation

Regulatory Documentation means any and all (a) applications, registrations, licenses, authorizations and approvals (including Regulatory Approvals); and (b) correspondence, reports and other submissions submitted to or received from Regulatory Authorities and all supporting documents with respect thereto, including all adverse event files and complaint files.

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 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.

Regulatory Documentation means all (i) applications (including all INDs), registrations, licenses, authorizations, and 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, 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 Licensed Compound.

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, including the manufacturing batch records, relating to the 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 all (a) applications (including all INDs and Drug Approval Applications and other regulatory filings), registrations, licenses, authorizations, 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, with respect to the Collaboration, all INDs, NDAs, and other regulatory applications submitted to any Regulatory Authority, Regulatory Approvals (if any), pre-clinical and clinical data and information, regulatory materials, drug dossiers, master files (including Drug Master Files, as defined in 21 C.F.R. 314.420 and any non-United States equivalents), and any other data, reports, records, regulatory correspondence and other materials relating to Development or Regulatory Approval of the Licensed Products, or required to Manufacture, distribute or sell the Licensed Products, including any information that relates to pharmacology, toxicology, CMC, Manufacturing and controls data, batch records, safety and efficacy, and any safety database.