Define: Approval Application

How is Approval Application defined in a legal contract?

• Approval Application means a BLA, NDA or similar application for a product submitted to a Regulatory Authority to obtain marketing approval for a biological or pharmaceutical product in respective countries. Seen in 31 SEC Filings
• Approval Application means an application by a regulated entity seeking a permit, license, registration, certification, or other authorization. Seen in 11 SEC Filings
• Approval Application means any application required to obtain a Regulatory Approval, together with all required documents, data and information relating any product which is the subject of such application. Seen in 11 SEC Filings
• Approval Application means the submission to the relevant Governmental Authority of an appropriate application seeking any approval, registration, license or authorization required for the manufacture, development, commercialization, distribution, sale, storage or transport of the product in any territory. This includes, without limitation, a marketing authorization application, supplementary application or variation thereof, NDA, or any equivalent applications in any territory. Seen in 10 SEC Filings
• Approval Application means, with respect to a Licensed Product in a particular jurisdiction, an application for approval, license, registration, or authorization necessary for the Commercialization of such Licensed Product in such jurisdiction. Seen in 9 SEC Filings
• Approval Application means an application by a regulated entity under [applicable law or regulation] for a permit, permit modification, license, license amendment, or other authorization. Seen in 7 SEC Filings
• Approval Application means the appropriate applications, together with all required documents, data and information about a Licensed Compound or Product, required to obtain Regulatory Approval to use, import, market and/or sell a Licensed Compound or Product in a particular territory. Seen in 6 SEC Filings

Note: The Genie AI Legal Assistant pulled this data out of the SEC EDGAR Database of 500,000 records from the past 22 years of filings. We regularly update this page as new filings and definitions come in.

Search EDGAR for 'Definitions of approval application' yourself to verify these results. We are always keen to point people to source documents.

‍

Which definition should you use?

🤔 Our AI Legal Assistant has combined and improved the above descriptions to create market-standard 'Genie definitions' below, with guidance on which documents and which industry to use for each.

‍

Genie Definition 1

Approval Application means an application seeking any required approval, license, registration, certification, or authorization for a specific product or service.

Relevant Contract Types

• Product Licensing Agreement
• Software Development Agreement
• Consulting Agreement
• Manufacturing and Supply Agreement

Relevant Circumstances

• Introduction or modification of a product or service
• Seeking regulatory approval for a product or service
• Negotiating business deals or partnerships involving product or service exchange

Relevant Sectors

• Pharmaceuticals
• Technology
• Manufacturing

‍

Genie Definition 2

Approval Application means submission of documents, data, and other compulsory information about a product, necessary for obtaining Regulatory Approval.

Relevant Contract Types

• Non-Disclosure Agreement
• Joint Venture Agreement
• Vendor Agreement

Relevant Circumstances

• Seeking to introduce a new product or service to the market
• Applying for government or regulatory authorization for a product or service

Relevant Sectors

• Food and Beverage
• Energy
• Financial Services
• Healthcare

‍