Pilot Batch definition

Pilot Batch means a Batch of Product designated as a pilot Batch which shall not comply with cGMP and is not required to meet the Specifications.

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Pilot Batch means a Batch of Product designated as a pilot batch which shall not comply with cGMP and is not required to meet the Specifications.

Pilot Batch means a batch of Product Manufactured during the Development Program at a volume sufficient for process development, stability testing and related quality testing reasonably required by the Development Program, using excipients reasonably anticipated to be clinically safe and made available in containers suitable for the purpose under the Development Program, but which batch does not need to comply with cGMP or cGLP.

Examples of Pilot Batch in a sentence

• Subject to Clause 2, if such tests show that the Product does not comply with the Testing Summary (in respect of product from a Pilot Batch after the Initial Phase) or the Specification (in respect of cGMP Product), Customer shall give Lonza written notice thereof within sixty (60) days from the date of Delivery and shall return such Product to Lonza’s premises for further testing.

• Any Pilot Batch made after the Initial Phase shall be tested and released against a certificate of testing which will relate to such Testing Summary.

• Signed for and on behalf of /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇ LONZA SALES ▇▇ ▇▇▇▇▇▇ Gander Senior Legal Counsel TITLE /s/ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ KEY ACCOUNT MANAGER TITLE Signed for and on behalf of /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ KOLLTAN PHARMACEUTICALS, INC President & CEO TITLE Dated 30th March 2012 Re: Schedule 2 Stage 10 - Development Pilot Batch (non-cGMP) at [**] Scale Schedule 3 Price and Payment THIS AMENDMENT No. 4 is made the 13th day of December 2013.

• In the event that Customer provides written notice of cancellation to Lonza at any time of one or more Pilot Batch(es) [***] or less prior to the Commencement Date for such Pilot Batch, then [***] of the Batch Price of each such Pilot Batch cancelled is payable as a Cancellation Fee.

• Customer shall pay to Lonza the applicable Price for all Pilot Batches after the Initial Phase which comply with the Testing Summary, provided always that if such a Pilot Batch does not comply with the Testing Summary, and the reason for such noncompliance is for a scientific or technical reason or any other reason beyond Lonza’s reasonable control, then Customer shall still be obliged to pay the applicable Price for such Pilot Batches.

• Cosmetics will be provided with a sample of this Pilot Batch accompanied by a document called Cosmetic pilot batch approval by customer (Schedule IV) to be signed and returned to AMI by Cosmetics, to indicate, if appropriate, Cosmetics' approval with respect to the physical characteristics of the Product.

• The Parties acknowledge that, because the production equipment used in AMI's manufacturing facility is not of the same scale as that used for the Pilot Batch, the Product, as reflected in the Pilot Batch, may have minor differences in appearance and texture compared to the final manufactured Product.

• If Customer provides a Cancellation Notice of any Pilot Batch less than or equal to […***…] prior to the Commencement Date of such Pilot Batch or at any time after, then a Cancellation Fee of […***…] percent […***…] of the Batch Price of each such Pilot Batch cancelled is payable.

• AMI's Quality Control Department will comprehensively check the Pilot Batch against the signed-off laboratory sample before dispatch.

• AMI will produce a preliminary batch of the Product (a "Pilot Batch") in order to confirm the satisfactory character thereof.

More Definitions of Pilot Batch

Pilot Batch means the small scale volume of the Product which is produced as a result of the operation of the Process (but not in accordance with cGMP);

Pilot Batch means first twenty Project Gram Panchayats in which implementation of the Project commenced in April 2001;

Pilot Batch means a batch of approximately 50,000 doses of a product made on pilot size production equipment at Biovail’s manufacturing facility on which in vitro studies or pilot bio studies may be performed.

Pilot Batch means a Batch produced from a Run that is completed through the [*] bioreactor, and which is subsequently harvested [*] and purified at the laboratory scale using an appropriate small scale laboratory model of the Manufacturing Process. For a Batch to be considered a Pilot Batch the Batch must be completed [*] and provide sufficient quantities of samples to enable the Parties to complete analytical testing [*]. A Pilot Batch may be processed through the final purification step at the laboratory scale.