Regulatory Dossier definition

Regulatory Dossier means the technical, medical and scientific registrations, authorizations and approvals (including approvals of NDAs, supplements and amendments, pre- and post- approvals, pricing and Third Party reimbursement approvals, and labeling approvals) of any Regulatory Authority necessary for the Development (including the conduct of clinical studies), Manufacture, distribution, marketing, promotion, offer for sale, use, import, reimbursement, export or sale of a product in a regulatory jurisdiction, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each NDA, including all Regulatory Materials and drug master file(s) (if any).

Regulatory Dossier has the meaning set forth in Section 6.3.1.

Regulatory Dossier means in relation to the Product and/or Optional Product, the technical registration dossier produced in relation to that Product and/or Optional Product (including any and all information, processes, techniques, data and Intellectual Property Rights) in an electronic format which allows for compilation into the relevant country format according to the regulatory requirements necessary to obtain and maintain Marketing Authorizations for the relevant Product in any country in the Territory and outside of the Territory.

Examples of Regulatory Dossier in a sentence

• Adamis and its Affiliates and licensees shall have the right to use all data and information contained or referenced in the NDA and any other Regulatory Dossier, and to cross-reference the NDA and any other Regulatory Dossier, in connection with developing, filing for, obtaining and maintaining regulatory approval of, and/or commercializing the Product outside the Territory.

• Adamis shall prepare and file, at its own expense, the NDA and any other Regulatory Dossier required to be made in connection with obtaining and maintaining the Regulatory Approval of the 0.3mg Product from the FDA and any other applicable Regulatory Authority in the Territory.

• Adamis shall use Commercially Reasonable Efforts to (i) file the NDA and any other applicable Regulatory Dossier for the 0.30 mg Product and, subject to completion of development of the [*] Product in accordance with Article 3, the [*] Product with the FDA and any other applicable Regulatory Authority in the Territory as soon as reasonably practicable, and (ii) maintain each such NDA and other applicable Regulatory Dossiers after the FDA’s and/or other applicable Regulatory Authority’s approval thereof.

• DAEWOONG, under Step-in Rights, shall transfer to STOCOSIL as soon as possible after its decision to permanently stop with the Development and/or Commercialization the Product and/or Optional Product in a particular country outside the Territory, the ownership of the respective Marketing Authorisation, Regulatory Dossier and Regulatory Documentation.

• Subject to completion of development of the [*] Product in accordance with Article 3, Adamis shall prepare and file, at its own expense, the NDA and any other Regulatory Dossier required to be made in connection with obtaining and maintaining the Regulatory Approval of the [*] Product from the FDA and any other applicable Regulatory Authority in the Territory.

More Definitions of Regulatory Dossier

Regulatory Dossier means all files regarding the Regulatory Approvals, including but not limited to correspondence, records, applications (including without limitation ANDAs), supplements, annual reports, adverse event reports, clinical studies and pre-clinical studies to the extent related to the Product.

Regulatory Dossier means the technical, medical and scientific registrations, authorizations and approvals (including, without limitation, approvals of NDAs or foreign equivalents, supplements and amendments, pre- and post- approvals, pricing and third party reimbursement approvals, and labeling approvals) of any Regulatory Authority necessary for the development (including the conduct of clinical trials), manufacture, distribution, marketing, promotion, offer for sale, use, import, reimbursement, export or sale of a Subject Product in the Field in a regulatory jurisdiction in the Territory, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each NDA or foreign equivalent, including the IND, NDA and supplemental new drug applications (sNDAs), or foreign equivalents in the Territory.

Regulatory Dossier means the technical, medical and scientific registrations, authorizations and approvals (including approvals of NDAs, supplements and amendments, pre- and post- approvals, pricing and Third Party reimbursement approvals, and labeling approvals) of any Regulatory Authority necessary for the Development (including the conduct of clinical trials), Manufacture, Commercialization (including distribution, marketing, promotion, offer for sale, use, import, reimbursement, export or sale) of a product in a regulatory jurisdiction, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each NDA, including all Regulatory Materials and drug master file(s) (if any).

Regulatory Dossier means a dossier which contains all the relevant information relating to a drug which is required by the EMEA or by the FDA, as the case may be; such dossier will normally contain information about the chemistry, formulation, manufacture, toxicology, pharmacology, pharmacokinetics and clinical studies related to a drug;

Regulatory Dossier means all regulatory documents and filings registered with a Drug Regulatory Authority for a Marketing Authorisation containing the administrative, safety, efficacy, quality, non-clinical and clinical data and CMC data for the Drug Product as it may change from time to time;

Regulatory Dossier means a dossier and all formal responses and submissions to any questions or issues raised by a Regulatory Authority in response to such a Regulatory Dossier once submitted which contains all the relevant information relating to a drug which is required by a Regulatory Authority as the case may be. Such a dossier will normally contain information about the chemistry, formulation, manufacture, toxicology, pharmacology, pharmacokinetics and clinical studies related to a drug;

Regulatory Dossier means all regulatory documents and filings registered with a Regulatory Authority for a Marketing Authorisation containing the administrative, safety, efficacy, quality, non‐clinical and clinical data and CMC data for the Product as it may change from time to time.