Product Approvals

Product Approvals. For any country in the Territory, those regulatory approvals required for importation, promotion, pricing, marketing and sale of a Product or Extended Product in such country.

Product Approvals. Any approvals, licenses, registrations, authorizations, or marketing clearance letters granted by, or applications therefor made to, any national, federal, state or local regulatory agency, department, bureau or other government entity within the Territory, including but not limited to the United States' Food & Drug Administration, necessary for the marketing, manufacture, use, storage, import, transport, or sale of Products in the Territory, and all correspondence, filings, and documents... related thereto. View More

Product Approvals. Means, those regulatory approvals required for manufacture, importation promotion, pricing, marketing and sale of the Product in any particular country.

Product Approvals. For any country or other jurisdiction in the Territory, those regulatory approvals required for importation, exportation, promotion, pricing, marketing and sale of the QSTM Products in such country or other jurisdiction for use in the Territory

Product Approvals. With respect to a Jurisdiction, all regulatory approvals required for importation, exportation, promotion, pricing, marketing and sale of any Product in such Jurisdiction

Product Approvals. Any approvals, licenses, registrations or authorizations granted by any national, federal, state or local regulatory agency, department, bureau or other government entity, including but not limited to the FDA, necessary for the development, clinical testing, marketing, manufacture, use, storage, import, transport, or sale of Products in any jurisdiction, any and all regulatory filings or submissions necessary to procure any of the foregoing, including, but not limited to, an investigational new... drug application ("IND"), an abbreviated new drug application ("ANDA"), a new drug application ("NDA"), or any other application acceptable to the FDA or equivalent foreign regulatory authority for the development, clinical testing, and/or marketing approval of a pharmaceutical or biological product, including any supplements or amendments thereto and any and all correspondence, filings, and documents related to any of the foregoing View More

Product Approvals. Means, for the United States, those regulatory approvals required for importation, promotion, pricing, marketing and sale of the Product in such country.