Product Approvals definition

Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

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

Product Approvals means, in respect of a Seller, all permits, licences, certificates, registrations or other authorisations or consents issued by any Governmental Entity to that Seller or one of its Affiliates with respect to its Products or the use, research, development, marketing, distribution or sale thereof, including the Marketing Authorisations;

Examples of Product Approvals in a sentence

• The State shall recertify its clearance patterns at least every five years.

• Subject to Section 6.3(b), from and after the date hereof, the Parties will cooperate in connection with the transfer of the transferable Product Approvals and Permits to Purchaser as of the Closing Date and the obtaining by Purchaser of new Product Approvals and Permits to the extent a Product Approval or Permit is not transferable.

• Each party shall promptly notify the other and provide to the other a copy or transcription, if available, of any communication from any Regulatory Authority relating to Company Product, the marketing thereof, or any related matter (including copies of all Product Approvals) and shall keep the other party reasonably apprised of regulatory interactions and similar activities with governmental authorities and international bodies in connection with Company Product anywhere in the Territory.

• Prior to the Closing Date, the Parties will agree upon procedures to ensure a smooth transition from the Company to Purchaser of all of the activities required to be undertaken by the holder of the Product Approvals and Permits, including adverse experience reporting, quarterly and annual reports to the FDA, handling and tracking of complaints, sample tracking, and communication with health care professionals and customers.

• Included are our Quality Declaration, Functionality Requirements, Vendor Report Cards, Supplier Corrective Action Requests, Hazardous Substance compliance, Certification and Power Product Approvals, FCC Requirements and Power Supply Requirements, as well as forms for Intent to Modify/Discontinue.

More Definitions of Product Approvals

Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product

Product Approvals means all permits, licences, certificates, clearances, registrations or other authorisations or consents issued by any Governmental Entity to the Seller or one of its Affiliates with respect to the Products or the Product Expansions, or the manufacture, use, research, development, marketing, distribution or sale thereof, including the Marketing Authorisations;

Product Approvals means the Regulatory Approvals for each Product, together with all supporting documents, submissions, correspondence, reports, pre-clinical studies and clinical studies relating to such Regulatory Approvals (including, without limitation, documentation of pharmacovigilance, good clinical practice, good laboratory practice and good manufacturing practice).

Product Approvals means all Permits (including approvals of NDAs and ANDAs, pricing and third party reimbursement approvals and labeling approvals) legally required for the development, testing (including the conducting of clinical trials), manufacturing, processing, distribution, importation, marketing, storage, labeling, packaging, promotion, sale, offer for sale or use of any Products.

Product Approvals means any approvals, licenses, registrations or authorizations 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 Licensed Products in a regulatory jurisdiction in the Territory, including but not limited to those listed on Appendix A, attached hereto and incorporated herein by reference, and all correspondence, filings, and documents related thereto.

Product Approvals means, 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 has the meaning set forth in Section 9.1.