Product Authorizations definition

Product Authorizations means any and all approvals, licenses, notifications, registrations or authorizations of any Governmental Authority for the testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or commercialization of a Product in any country or jurisdiction, including, without limitation, registration and listing, INDs, NDAs and similar applications.

Product Authorizations means any and all approvals, including applicable supplements, amendments, pre- and post-approvals, clearances, licenses, notifications, registrations, certifications or authorizations of any Governmental Authority, any Standard Body necessary for the manufacture, development, distribution, use storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

Product Authorizations means any and all Governmental Approvals, whether U.S. or non-U.S. (including all applicable ANDAs, NDAs, BLAs, INDs, Product Standards, supplements, amendments, pre- and post- approvals, governmental price and reimbursement approvals and approvals of applications for regulatory exclusivity) of any Regulatory Authority, in each case, necessary to be held or maintained by, or for the benefit of, any Obligor or any of its Subsidiaries for the ownership, use or commercialization of any Product or for any Product Commercialization and Development Activities with respect thereto in any country or jurisdiction.

Examples of Product Authorizations in a sentence

• The Issuer shall, and as applicable, shall cause all Product Suppliers, to procure and maintain in full force and effect all Product Authorizations, Regulatory Permits and Intellectual Property rights from third parties it needs (other than those provided by Issuer and its Subsidiaries) in relation to the manufacture and/or supply of Products to Issuer and its Subsidiaries or their customers.

• To the knowledge of the Issuer, no Note Party or any of its Subsidiaries promotes, markets, communicates, implies, or otherwise indicates, or has promoted, marketed, communicated, implied, or otherwise indicated to any third party, including but not limited to healthcare providers, patients, and distributors, that Products can be used for intended uses that are not authorized by or that are outside the scope of the intended uses that are authorized by the Regulatory Permits and Product Authorizations.

• No person or entity other than the Company or any of the Company Subsidiaries owns or has any proprietary, financial or other interest (direct or indirect) in any of the Product Authorizations, licenses, permits, orders, approvals or registrations.

• Distributor shall keep Ligand informed, in writing, of the status of its applications for Product Authorizations on a regular basis, and in any event no less frequently than once every three months, and shall immediately notify Ligand in writing of any substantial change in the status of any Product Authorization or any substantive questions received from any Governmental Authority in respect of such Product Authorizations.

• Ligand warrants that all Products supplied hereunder shall (1) conform to the products specifications therefor, as published by Ligand from time to time consistent with the data contained in the Product Authorizations, and (2) have a shelf life of one year or more (or in the case of Ontak, nine months or more) from the date of shipment to Distributor.

More Definitions of Product Authorizations

Product Authorizations means any and all Governmental Approvals, including Regulatory Approvals, whether U.S. or non-U.S. (including all applicable ANDAs, NDAs, BLAs, INDs, Product Standards, supplements, amendments, pre- and post- approvals, governmental price and reimbursement approvals and approvals of applications for regulatory exclusivity) of any Regulatory Authority, in each case, necessary to be held or maintained by, or for the benefit of, any Obligor or any of its Subsidiaries for the ownership, use or commercialization of any Product or for any Product Commercialization and Development Activities with respect thereto in any country or jurisdiction.

Product Authorizations means any and all Regulatory Approvals (including all applicable Device Clearance Applications, supplements, amendments, governmental price and reimbursement approvals and approvals of applications for regulatory exclusivity), clearances, licenses, notifications, registrations, safety or quality specifications and standards, or any other authorizations of any applicable Regulatory Authority in each case necessary for the manufacturing, development, distribution, ownership, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of any Product or for any Product Development and Commercialization Activities with respect thereto in any country or jurisdiction, whether U.S. or non‑U.S.

Product Authorizations means any and all approvals, licenses, notifications, registrations or authorizations of any Governmental Authority for the testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or commercialization of a Product in any country or jurisdiction, including without limitation registration and listing, INDs, NDAs, ANDAs and similar applications.

Product Authorizations means any and all Regulatory Approvals (including all applicable IDEs, Device Clearance Applications, supplements, amendments, governmental price and reimbursement approvals and approvals of applications for regulatory exclusivity), clearances, licenses, notifications, registrations, safety or quality specifications and standards, or any other authorizations of any applicable Regulatory Authority in each case necessary for the manufacturing, development, distribution, ownership, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of any Product or for any Product Development and Commercialization Activities with respect thereto in any country or jurisdiction, whether United States or non‑United States.

Product Authorizations means any and all approvals (including pricing and reimbursement approvals), licenses, notifications, registrations or authorizations of any Governmental Authority necessary for the manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction, including without limitation registration and listing, IDEs, Device Approval Applications (including any supplements and amendments thereto) or similar applications, post-approval marketing authorizations (including any prerequisite manufacturing approval or authorization related thereto), labeling approvals, and technical, medical, and scientific licenses.

Product Authorizations any and all approvals (including pricing and reimbursement approvals), licenses, notifications, registrations or authorizations of any Governmental Authority necessary for the manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction, including without limitation registration and listing, IDEs, Device Approval Applications (including any supplements and amendments thereto) or similar applications, post- approval marketing authorizations (including any prerequisite manufacturing approval or authorization related thereto), labeling approvals, and technical, medical, and scientific licenses.

Product Authorizations means, with respect to any Product or any Product Commercialization and Development Activities, all applicable ANDAs, NDAs, BLAs, INDs and similar applications, approvals, clearances, registrations and authorizations of (or required by) any Regulatory Authority, whether U.S. or non-U.S.