Regulatory Submissions definition
Regulatory Submissions means any filing, application, or submission with any Regulatory Authority in support of the Development, Manufacture, Commercialization, or other Exploitation of a pharmaceutical or biologic product (including to obtain, support, or maintain Regulatory Approval from that Regulatory Authority), and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences, or discussions with the relevant Regulatory Authority. Regulatory Submissions include all INDs, ▇▇▇▇, and other applications for Regulatory Approval and their equivalents.
Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.
Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.
Examples of Regulatory Submissions in a sentence
Subject to the terms and conditions of this Agreement, Odyssey will have the sole responsibility to: (a) prepare and submit to applicable Regulatory Authorities all Regulatory Submissions, including NDAs and INDs, for Licensed Compounds and Licensed Products in the Territory and (b) obtain and maintain all Regulatory Approvals for Licensed Compounds and Licensed Products in the Territory.
Pending transfer of such Regulatory Submissions, Regulatory Approvals, and Pricing Approvals, upon the Opt-Out Date, the Opt-Out Party hereby grants to the Continuing Party a right of reference to all such Regulatory Submissions, Regulatory Approvals, and Pricing Approvals, upon the Opt-Out Date for purposes of obtaining Regulatory Approval for the Licensed Compounds and Licensed Products.
More Definitions of Regulatory Submissions
Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Collaboration Product in the Field in a particular country, whether obtained before or after a Regulatory Approval in the country. Regulatory Submissions include, without limitation, investigational new drug applications and NDAs, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Collaboration Product in a particular country.
Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Product in the Field in a particular country, whether obtained before or after Regulatory Approval in the country. Regulatory Submissions include, without limitation, investigational new drug applications and NDAs, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Product in a particular country.
Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including INDs, Regulatory Approvals and Regulatory Approval Applications, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to the Licensed Product.
Regulatory Submissions means all Regulatory Materials submitted to a Regulatory Authority in support of the Development, Manufacture or Commercialization of a pharmaceutical or biological product.
Regulatory Submissions means all applications, notifications, and submissions made to a Regulatory Authority (including any attachment or supplement thereto) to obtain Regulatory Approval in connection with the development, manufacture or commercialization of the Product, and all Information contained therein (but excludes IceCure Information, IceCure Patents, and Inventions).
Regulatory Submissions means all applications, filings, dossiers and the like submitted to the FDA and associated with NDA #205488, including any internal records, minutes or informal communications (e-mails and letters) related to discussions with the FDA, as set forth on Schedule 1.121.
Regulatory Submissions has the meaning set forth in Section 2.5.