Manufacturing Development definition

Manufacturing Development means, with respect to a Collaboration Compound and/or Product, all activities related to the optimization of a commercial-grade Manufacturing process for the Manufacture of such Collaboration Compound and/or Product including, without limitation, test method development and stability testing, formulation, validation, productivity, trouble shooting and next generation formulation, process development, Manufacturing scale-up, development-stage Manufacturing, and quality assurance/quality control development .

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Manufacturing Development means all development activities which are directed to the Manufacturing of the Product, including, without limitation, [* * *].

Manufacturing Development means any of the following with respect to Bulk API or Finished Product: manufacturing process development and validation, process improvements, associated analytical development and validation and the manufacture and testing of clinical and stability or consistency lots (including process development, qualification, QA, and test batches).

Examples of Manufacturing Development in a sentence

• This Manufacturing Development and Scale-up Agreement (the “Agreement”) is made as of March 19, 2012 (the “Effective Date”), between Liquidia Technologies, Inc., a Delaware corporation (“Liquidia”) having its principal place of business at ▇▇▇▇▇ ▇▇▇, ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, Morrisville, NC 27560 and Chasm Technologies, Inc., a Massachusetts corporation (“Chasm”) with principal offices located at ▇▇ ▇▇▇▇▇ ▇▇, ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇.

• Manufacturing Development Activities shall not be set forth in the Development Plan.

• Licensee shall have sole responsibility for all Development (both Clinical Development and Manufacturing Development) and shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for Products in the Field and in the Territory.

• For purposes of clarity, Auxilium shall be solely responsible for one hundred percent (100%) of the costs incurred by Auxilium or its Affiliates associated with any Manufacturing Development Activities.

• Notwithstanding the foregoing, MacroGenics will continue to perform Manufacturing Development work as determined by the JMC with respect to the Licensed Compound following the Study Transition Date, and with respect to any such Manufacturing Development that relates [**] to the Licensed Compound, Incyte shall pay any and all such costs to the extent required pursuant to subsection (ii) below, and will retain final decision-making authority with respect to such Manufacturing Development.

More Definitions of Manufacturing Development

Manufacturing Development means any of the following with respect to the Compound or a Product: manufacturing process development, process improvements and any analytical development or validation associated with such development or improvements.

Manufacturing Development means, with respect to any API or Product, all activities related to the optimization of a commercial-grade Manufacturing process for the Manufacture of such API or Product including, test method development and stability testing, formulation, validation, productivity, trouble shooting and next generation formulation, process development, Manufacturing scale-up, strain improvements, development-stage Manufacturing, and quality assurance/quality control development.

Manufacturing Development means any of the following with respect to a Compound or Product: [***]

Manufacturing Development means any of the following with respect to a Compound or a Product: manufacturing process development and validation, process improvements, associated analytical development and validation and the manufacture and testing of stability or consistency lots (including process development, qualification, QA, and test batches).

Manufacturing Development all activities related to the optimization of a manufacturing process for the manufacture of Product (including Active Ingredients therefor), including but not limited to, test method development and stability testing, formulation, validation, productivity, troubleshooting and second generation formulation, process development, manufacturing scale-up, development stage manufacturing and quality assurance/quality control development.

Manufacturing Development means any of the following with respect to the Licensed Compound Bulk Drug Substance or Licensed Compound Drug Product, as applicable: manufacturing process development 244242908 v3 and validation, process improvements, formulation development, associated analytical development and validation and the manufacture and testing of stability and consistency lots (including process development, qualification, and test Batches).

Manufacturing Development has the meaning set forth in the Collaboration Agreement.