Product Authorization definition

Product Authorization 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 Credit Party 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.
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Product Authorization means any Permit or Registration for a Sternal Product issued by a Governmental Authority where (a) such Permit or Registration is not directly and legally assignable or otherwise transferable by Seller to Buyer, and (b) obtaining an equivalent Permit or Registration requires Buyer to apply for, qualify for, and obtain its own Permit or Registration for the Sternal Product.
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Product Authorization means a Permit that is applicable to any Product or Product Candidate for the manufacturing, import, export, distribution, use, promotion or sale of veterinary medicinal products (small molecules, biological entities and vaccines), pesticides, biocides, nutritionals, crop pesticides, vaccines, biologics and other veterinary products, including medical devices, in the Aqua Health Field for one or more indications (if applicable) or that is otherwise applicable to any Product or Product Candidate in a country or other regulatory jurisdiction, including approval of New Animal Drug Applications (as such term is defined in the United States Food, Drug and Cosmetic Act) or any corresponding foreign application, including, with respect to the European Union, the approval of a marketing authorization application filed with the European Medicines Agency pursuant to the centralized approval procedure or with the applicable Government Authority of a country in the European Economic Area with respect to the decentralized procedure or mutual recognition or any other national approvals.
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Examples of Product Authorization in a sentence

  • No Obligor has received any notices or other correspondence from the FDA or any other Regulatory Authority requiring the termination or suspension of any clinical, preclinical, safety or other studies or tests used to support regulatory clearance of, or any Product Authorization or Regulatory Approval for, any Product.

  • No Obligor has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Product Authorization or Regulatory Approval, including that any of the Products is misbranded or adulterated as defined in the FD&C Act or the rules and regulations promulgated thereunder.

  • No Obligor has received any notices or other correspondence from the FDA, Health Canada, or any other Regulatory Authority requiring the termination or suspension of any clinical, preclinical, safety or other studies or tests used to support regulatory clearance of, or any Product Authorization or Regulatory Approval for, any Product.

  • Products shall be repackaged only into containers having a rated capacity of greater than fifty-five (55) U.S. gallons, unless authorization for Small Volume Repackaging is provided for the specific Product on the TENKOZ Product Authorization Notice.

  • No Obligor has received any notices or other correspondence from the FDA or any other Regulatory Authority requiring the termination or suspension of any clinical, preclinical, safety or other studies or tests used to support regulatory clearance of, or any Product Authorization or other Regulatory Approval for, any Product.

  • No Obligor nor any of its Subsidiaries has received any notices or other correspondence from the FDA or any such other Regulatory Authority requiring the termination or suspension of any clinical, preclinical, safety or other studies or tests used to support regulatory clearance of, or any Product Authorization or Regulatory Approval for, any Product or any Product Development and Commercialization Activities.

  • When you select File > Software License, the Product Authorization screen will be displayed.

  • Without limiting the foregoing sentence, without the payment of applicable Maintenance fees consistent with the Contract Price List, the State may not change authorized hardware, add additional users, change operating systems, acquire additional Product Authorization Codes or license additional software products for use with such Software.

  • No Loan Party nor any of their respective Subsidiaries has received any notices or other correspondence from the FDA or any other Regulatory Authority requiring the termination or suspension of any clinical, preclinical, safety or other studies or tests used to support regulatory clearance of, or any Product Authorization or Regulatory Approval for, any Product.

  • Microsoft agrees to maintain a written record of individual employees that actually accessed the StarSight Product Authorization Codes or StarSight Protocols, and shall provide such information to StarSight upon request.


More Definitions of Product Authorization

Product Authorization means any and all approvals, licenses, notifications, registrations, clearances or authorizations or other permits of any governmental authority necessary for the testing, manufacture, development, distribution, use, storage, import, export, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction, including without limitation registration and listing, new drug applications, any related orphan drug exclusivity designation and approval, any related new chemical entity designation and approval, and similar applications.
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Product Authorization means a Permit that is necessary for the manufacturing, import, export, distribution, use, promotion or sale of veterinary medicinal products (small molecules, biological entities and vaccines), pesticides, biocides, nutritionals, crop pesticides, vaccines, biologics and other veterinary products, including medical devices, in the Animal Health Field for one or more indications (if applicable) or that is otherwise applicable to any Business Product in a country or other regulatory jurisdiction, including approval of New Animal Drug Applications (as such term is defined in the United States Food, Drug and Cosmetic Act) or any corresponding foreign application, including, with respect to the European Union, the approval of a marketing authorization application filed with the European Medicines Agency pursuant to the centralized approval procedure or with the applicable Government Entity of a country in the European Economic Area with respect to the decentralized procedure or mutual recognition or any other national approvals.
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Related to Product Authorization

  • 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.

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Product Approval(s) 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.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.