Regulatory Materials definition
Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.
Regulatory Materials means regulatory applications, submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, or Commercialize a Licensed Product in a particular country or jurisdiction.
Regulatory Materials means all regulatory submissions and filings or registrations, including any INDs, NDAs, certifications or approvals, made with or received from the FDA and all correspondence and material communications related thereto, together with all other reports or correspondence provided to or received from the FDA, in each case which primarily relate to the API or any Product.
Examples of Regulatory Materials in a sentence
To Sellers’ Knowledge, none of Sellers or any Affiliates, nor any of their respective owners, shareholders, partners, members, officers, directors, managers, employees or independent contractors, is under investigation by any Governmental Entity for a violation of any Information Privacy and Security Law with respect to the Programs, Clinical Data or the Regulatory Materials.
Sellers have made available to Purchaser true and complete copies of all Regulatory Materials and any other material governmental correspondence in the files of Sellers or their Affiliates (including copies of official notices, citations or decisions).
Neither Sellers nor any of their Affiliates has received any written communication alleging any violation of applicable Information Privacy and Security Laws pertaining to the privacy and security of protected health information within the Clinical Data or the Regulatory Materials.
More Definitions of Regulatory Materials
Regulatory Materials means the regulatory registrations, applications, authorizations and approvals (including approvals of MAAs, supplements and amendments, pre- and post-approvals, pricing and reimbursement approvals, and labeling approvals), Regulatory Approvals and other submissions made to or with any Regulatory Authority for research, development (including the conduct of Clinical Trials), manufacture, or commercialization of a pharmaceutical or diagnostic 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 MAA, including all Drug Master Files (if any), INDs and supplemental biologics license applications (sBLAs) and foreign equivalents of any of the foregoing.
Regulatory Materials means, with respect to each Product, all documentation, correspondence, submissions and notifications submitted to or received from a Regulatory Authority that are necessary or reasonably useful in order to Exploit such Product in the applicable field in the Territory. For the avoidance of doubt, Regulatory Materials shall include, with respect to each Product, all INDs, Regulatory Approval Applications, Regulatory Approvals, Pricing Approvals and amendments and supplements for any of the foregoing, as well as the contents of any minutes from meetings (whether in person or by audio conference or videoconference) with a Regulatory Authority.
Regulatory Materials means regulatory applications (including BLAs), submissions, notifications, registrations, and/or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, use, import, sell, offer to sell, register, market, manufacture, or otherwise commercialize the Licensed Product in the Field for the Territory, along with any documents related to Regulatory Approval issued by a Regulatory Authority for the Territory.
Regulatory Materials means the regulatory registrations, applications, authorizations and approvals (including approvals of BLAs, supplements and amendments, pre- and post-approvals, pricing and Third Party reimbursement approvals, and labeling approvals), Regulatory Approvals or other submissions made to or with any Regulatory Authority necessary for the research, Development (including the conduct of Clinical Trials), Manufacture, or Commercialization 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 BLA, including all Drug Master File(s) (if any), IND, CTA in the EU, MAA and supplemental new drug applications (sNDAs) or foreign equivalents of any of the foregoing.
Regulatory Materials means the regulatory registrations, applications, authorizations and approvals (including approvals of ▇▇▇▇, supplements and amendments, pre- and post-approvals, pricing and reimbursement approvals, and labeling approvals), Regulatory Approvals and other submissions made to or with any Regulatory Authority for research, development (including the conduct of Clinical Trials), manufacture, or commercialization of a pharmaceutical or diagnostic 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 MAA, including all Drug Master Files (if any), INDs and supplemental biologics license applications (sBLAs) and foreign equivalents of any of the foregoing.
Regulatory Materials means the regulatory applications, registrations, authorisations and approvals (including approvals of ▇▇▇▇, supplements and amendments, pre- and post-approvals, Pricing Approvals and labelling approvals), Regulatory Approvals and other submissions made to or with any Regulatory Authority, including drug master files, for Research, Development (including the conduct of Clinical Trials), Manufacture or Commercialisation of a pharmaceutical or biological 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, MAA, IND and foreign equivalents of any of the foregoing.
Regulatory Materials means the regulatory registrations, applications, Regulatory Approvals, and other submissions made to or with any Regulatory Authority in a regulatory jurisdiction, including approvals of INDs and NDAs.