Regulatory Filings

Regulatory Filings. As to any Performance Period, filings submitted to an Approval Authority with respect to a Product for which the Company is pursuing Product Approval

Regulatory Filings. Regulatory applications, submissions, notifications, registrations, Regulatory Authorizations, or other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to research, Develop, manufacture, market, sell or otherwise commercialize Licensee Products in a particular country or jurisdiction

Regulatory Filings. Shall mean a pre-market approval application and/or any other filings or dossier as may be required by REGULATORY AUTHORITIES to obtain or maintain REGULATORY APPROVALS for sale, use or marketing of any PRODUCT.

Regulatory Filings. Means any filing under the Act in the United States, or a corresponding filing required in other countries of the Territory, in which AVANIR, or its sublicensee, is seeking Applicable Permits, including any NDA.

Regulatory Filings. Means, with respect to a compound or a product, any submission to a Regulatory Authority of any appropriate regulatory application with respect to such compound or product, including any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto. For the avoidance of doubt, Regulatory Filings shall include any IND, NDA or MAA or the corresponding application in any other country or group of countries with respect to such products.

Regulatory Filings. Means, for any country, those applications, filings, dossiers and the like submitted to a Regulatory Authority for the purpose of obtaining an approval from such Regulatory Authority to perform a clinical study that is subject to this Agreement in such country.

Regulatory Filings. Collectively, all INDs for the Product, the DMF, any application for Marketing Approval, Marketing Approvals and other filings, such as annual reports, required by any Regulatory Authority in any country in the Territory.

Regulatory Filings. Means, with respect to the Drug Substance or Product, any submission to the FDA of any appropriate regulatory application, and shall include any IND or NDA.

Regulatory Filings. Means, with respect to a particular country or regulatory jurisdiction, any and all applications for, notifications or other submissions made to or with a Regulatory Authority that is necessary or reasonably desirable to develop, test, use, make, transport, store or commercialize a particular product or service in such country or regulatory jurisdiction, whether made before or after receipt of approval, clearance or other authorization in such country or regulatory jurisdiction, including all... amendments and supplements thereto. View More

Regulatory Filings. Any written application, submission, notice or other filing made to an applicable Regulatory Authority in the Territory: (a) seeking approval for the commercial manufacture, use, storage, import, export, transport, distribution, marketing or sale of a Product, including, without limitation, any Marketing Authorization Approval; or (b) that is required to be filed with the applicable Regulatory Authority before beginning clinical testing of a Product in human subjects, including, without... limitation, any successor application or procedure, non-U.S. equivalents to any of the foregoing and all supplements and amendments that may be filed with respect to any of the foregoing. View More