Define: Pilot Batch

How is Pilot Batch defined in a legal contract?

• Pilot Batch means a set of product labeled as a pilot batch, not required to comply with Good Manufacturing Practice (cGMP) rules or meet specific requirements. Seen in 11 SEC Filings.
• Pilot Batch means a set of product produced during the development program in sufficient quantity for process development, stability testing and related quality testing as required by the Development Program, but not required to comply with cGMP or Good Laboratory Practice (cGLP). Seen in 3 SEC Filings.
• Pilot Batch means a small scale volume of the product produced as a result of the process, but not in compliance with cGMP. Seen in 3 SEC Filings.
• Pilot Batch means sets labelled as pilot batches of either drug substance or drug product, that are not obliged to comply with cGMP or meet certain specifications. Seen in 1 SEC Filing.
• Pilot Batch means a produced set of product that comes from a run that is completed through the [clause] bioreactor, and is then harvested and purified at the laboratory scale using an appropriate small-scale laboratory model of the manufacturing process. To be considered a Pilot Batch, the set must be completed, and must provide sufficient quantities of samples to enable the parties to complete analytical testing. Seen in 1 SEC Filing.

Please note that an effort has been made to simplify the definitions without altering their intent or meaning.

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 pilot batch' yourself to verify these results. We are always keen to point people to source documents.

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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.

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Genie Definition 1

Pilot Batch means a set of produced product at small scale not complying with Good Manufacturing Practice, for process development and testing.

Relevant Contract Types

• Manufacturing Agreement
• Supply Agreement
• Product Development Agreement

Relevant Circumstances

• Establishing manufacturing process
• Initiating supply chains
• Conducting process development testing
• Negotiating product development

Relevant Sectors

• Pharmaceuticals
• Chemicals
• Manufacturing

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Genie Definition 2

Pilot Batch means a processed product that is finalized and analyzed at the laboratory scale, using suitable small-scale lab model.

Relevant Contract Types

• Research and Development Agreement
• Manufacturing Agreement
• Testing Agreement

Relevant Circumstances

• Finalizing product for lab-scale testing
• Complying with analytical testing requirements
• Conducting research and development

Relevant Sectors

• Pharmaceuticals
• Biotechnology
• Food and Beverage

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