Transferred Regulatory Materials definition

Transferred Regulatory Materials has the meaning set forth in Section 3.3(a)(iv).
Transferred Regulatory Materials has the meaning set forth in Section 2.1(a).
Transferred Regulatory Materials means all U.S. and foreign regulatory applications, submissions and approvals (including all INDs and Drug Approval Applications and foreign counterparts thereof), and all Regulatory Approvals for TGFb Molecules, and all correspondence with the FDA and other Regulatory Agencies relating to the TGFb Molecules or any of the foregoing regulatory applications, submission and approvals, that, in each case, are in the possession of or Controlled by, or held by Respondents or any of their Affiliates as of the Effective Date, whether generated, filed or held by or for Respondents or any of their Affiliates or licensees. aaa.

Examples of Transferred Regulatory Materials in a sentence

  • Until such transfer and assignment is complete, MabCare shall maintain the Transferred Regulatory Materials in good standing.

  • Without limiting the foregoing, MabCare shall initiate the transfer and assignment of such Transferred Regulatory Materials [*].


More Definitions of Transferred Regulatory Materials

Transferred Regulatory Materials has the meaning set forth in Section 3.3(a)(iv). “Transferred Third Party Agreements” means those Third Party Agreements that are primarily related to Binimetinib. “Transferred Trademarks” means those trademarks and trademark applications, and any resulting trademark registrations, related to the marks set forth on Schedule 1.1(d), including all goodwill arising therefrom. “Transition Agreement” means the transition services agreement to be executed and delivered by Array and Novartis on the Effective Date, substantially in the form mutually agreed upon by the Parties. “Transition Committee” or “TC” has the meaning set forth in Section 3.10(a). “Upfront Payment” has the meaning set forth in Section 5.4(a). Section 1.2

Related to Transferred Regulatory Materials

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • Technical Information means technical data or computer software, as those terms are defined in the clause at DFARS 252.227-7013, Rights in Technical Data-Non Commercial Items, regardless of whether or not the clause is incorporated in this solicitation or contract. Examples of technical information include research and engineering data, engineering drawings, and associated lists, specifications, standards, process sheets, manuals, technical reports, technical orders, catalog-item identifications, data sets, studies and analyses and related information, and computer software executable code and source code.