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 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.
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.
Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.
Examples of Regulatory Submissions in a sentence
Xxxxx will lead and have control over preparing and submitting all Regulatory Submissions related to the Licensed Products for the Indication in the Field of Use, including all XXXx, provided, however, that Gemma shall provide Passage (or at Passage’s written request, Penn) with copies of all such applications prior to submission, to the extent such submission includes any Confidential Information of Passage.
Gemma will own any and all Regulatory Materials, Regulatory Submissions (including INDs), and Regulatory Approvals related to the Licensed Products for the Indication in the Field of Use, which will be held in the name of Gemma or its designees.
On a Licensed Product-by-Licensed Product basis, following the occurrence of the various milestones set forth in Exhibit C hereto (collectively, the “Regulatory Transfer Milestone”), Passage shall and does hereby assign to Gemma all Regulatory Materials and Regulatory Submissions Controlled by Passage as of the Effective Date specific to such Licensed Product and set forth in Exhibit C hereto.
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 Product in the Field in one or more of the countries in the Territory, whether obtained before or after a Regulatory Approval in such countries. Regulatory Submissions include, without limitation, investigational new drug applications and new drug applications, 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 jurisdiction.
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 all applications, approvals, licenses, notifications, registrations, submissions and authorizations made to a Regulatory Authority in connection with the development, manufacture or commercialization of a medical device product, including any marketing and reimbursements.
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 all applications, notifications, and submissions made to a Regulatory Authority (including any attachment or supplement thereto) to obtain Regulatory Approval in connection with the commercialization of the Product, and all Information contained therein.
Regulatory Submissions means all applications (including all INDs and drug approval applications), filings, dossiers, reports and other information and data submitted to a Regulatory Authority for the purpose of obtaining and maintaining Regulatory Approval;
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.