Regulatory Materials

Regulatory Materials. Regulatory applications, submissions, notifications, communications, correspondence, registrations, drug approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, manufacture, market, sell or otherwise Commercialize the Product in a particular country or jurisdiction.

Regulatory Materials. Means regulatory applications, submissions, notifications, registrations, Regulatory Approvals and/or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Pursue Approval, manufacture, or Market and Distribute the Product in a particular country or regulatory jurisdiction.

Regulatory Materials. Any and all regulatory submissions, applications, regulatory reports, safety reports, registrations, filings, approvals and associated Drug Master File(s), label(s), labeling, package insert(s) and packaging and associated correspondence required to Develop, Manufacture, market, sell and import Products in the Territory, including without limitation the materials, information and data generated by Epirus and/or its representative or designee for the purpose of obtaining Regulatory Approvals in... India pursuant to Section 3.1(a) View More

Regulatory Materials. Means any regulatory application, submission, notification, communication, correspondence, registrations, approvals and other filings made to or received from a Regulatory Authority relating to any Licensed Product, including, without limitation, INADs, INDs clinical trial applications, NADAs, NDAs and any other marketing authorizations.