Scale-Up definition

Scale-Up means activities that are reasonably required to advance a candidate process for producing a Target Cannabinoid from laboratory scale through Pilot Scale as contemplated by the applicable TDP.

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Scale-Up means the scale-up of a CATALYST into pilot-plant and commercial scale, starting with the CATALYST RECIPE.

Scale-Up means, with respect to the Product and a designated Manufacturing facility, the process of developing a reliable and practical method of manufacturing the Product in such designated manufacturing facility to effectuate the orderly transition from laboratory production of the Product to routine full-scale production of the Product in such designated facility in quantities necessary for commercial sale. Without limitation, Scale-Up includes (a) installation, evaluation and validation of the necessary equipment, (b) establishment, evaluation, validation and finalization of the necessary production and process controls, (c) demonstration of the ability to produce a batch size of * of the proposed commercial production batch for the Product at such facility, (d) demonstration of compliance with all other applicable laws, regulations and good manufacturing practices, (e) production of GMP bio-batches for pivotal clinical trials, and (f) transposition to routine full scale production.

Examples of Scale-Up in a sentence

• Isconova will at all times during the Research Term maintain the necessary financial and human resources to complete the activities of Isconova set forth in the Development and Scale-Up Plan.

• Isconova undertakes to work diligently and shall use Commercially Reasonable Efforts to perform activities under the Development and Scale-Up Plan in accordance with the timeline set forth in the Development and Scale-Up Plan.

• The Adjuvant Specifications may be amended from time to time in accordance with this Agreement and the timelines in the Development and Scale-Up Plan.

• Genocea and Isconova will collaborate during the Research Term to conduct research to assist in the identification, evaluation and Development of vaccine product candidates containing both the Licensed Adjuvant and one or more Genocea Antigens pursuant to the Research and Phase 1 Supply Plan and the Development and Scale-Up Plan.

• The Research Funding shall be used solely for the performance of activities under the Research and Phase 1 Supply Plan and the Development and Scale-Up Plan and, for the avoidance of doubt, solely to fund Development and research activities for human (and not veterinary) applications in accordance with such Research and Phase 1 Supply Plan and Development and Scale-Up Plan.

• The Scale-Up Trigger is intended to ensure that sufficient operating data is obtained to de-risk the scale-up of the Licensed Process.

• Isconova undertakes to work diligently and shall use Commercially Reasonable Efforts to perform activities under the Development and Scale-Up Plan in accordance with the timelines set forth in the Development and Scale-Up Plan.

• The Parties shall establish a joint steering committee (“JSC”) that will be responsible for overseeing the activities under the Development and Scale-Up Plan, the Research and Phase 1 Supply Plan and any results of pre-clinical activities and Clinical Trials conducted pursuant to this Agreement.

• Each Party shall maintain scientific records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which shall fully and properly reflect all work done and results achieved in the performance of the Research and Phase 1 Supply Plan and the Development and Scale-Up Plan by such Party.

• Each Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy (or request the other Party to copy) all records of the other Party maintained in connection with the work done and results achieved in the performance of the Research and Phase 1 Supply Plan and Development and Scale-Up Plan, but solely to the extent access to such records is necessary for a Party to exercise its rights under this Agreement.

More Definitions of Scale-Up

Scale-Up has the meaning specified in Section 2.5;

Scale-Up will mean the process of converting a laboratory-developed method or procedure into a method, procedure, or protocol useful for manufacturing a commercial product, taking into account variables such as, but not limited to, efficiency, yield, cost, safety, reproducibility, and stability.

Scale-Up means Scale Up Accounting Ltd, its successors and assigns, together with the duly authorised servants, agents, associates or contractors of Scale Up Accounting Ltd.

Scale-Up. . In practice, this means that rare nucleation events leading to diffraction-quality crystals may be less likely to be observed in smaller drops. The stochastic nature of nucleation, and its depen- dence on drop volume, should not be confused with the size (volume) of any eventual crystals, which will also be governed by drop size; more specifically, the latter will be governed by the amount of material available for inclusion in the growing crystals.

Scale-Up means an option that allows Customer to add capacity to the Performance Level of any environment during the Term of the applicable Order Form to match Customer’s demand.

Scale-Up means, with respect to a Licensed Product, that such Licensed Product has been successfully produced by or on behalf of ▇▇▇▇▇▇▇ or its Affiliates in a [***] that is at least [***] in volume.