Commercial Scale definition

Commercial Scale means the scale of a chemical or biological process for the Manufacture of a Product in sufficient quantities to support the projected supply requirements for the marketed Product as of the First Commercial Sale of such Product. Commercial Scale, as it relates to a Product, shall, as appropriate, be further defined in the applicable Product Work Plan.

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Commercial Scale means with respect to a particular Commercial Farnesene Strain, the use of such Strain to reproducibly produce farnesene of commercially quality in commercial quantities and at commercially reasonable cost, as shown by production of [*].

Commercial Scale means the same as defined in section

Examples of Commercial Scale in a sentence

• Increases in Yield must be evidenced by the average Yield of the [ * ] Batches of Drug Substance (or, if the Yield for one Batch differs by at least [ * ] percentage points from the average Yield of the other [ * ] Batches, the average Yield of such [ * ] Batches and the next Batch at Commercial Scale that complies with the warranties in Section 8.1(a)) at or in excess of [ * ] Yield (as so adjusted).

• If Onyx determines that the Suite has insufficient capacity for the manufacture of Drug Substance at Commercial Scale, in light of Onyx and any Onyx Partner's needs for ONYX-015 product, and Onyx desires that XOMA supply such additional needs, it will so notify XOMA, and the Parties will negotiate in good faith to attempt to reach an agreement, the purpose of which would be for XOMA to manufacture Drug Substance to fulfill Onyx's needs for additional Drug Substance.

• In accordance with the Work Plan and as quickly as reasonably practicable, XOMA will scale up the manufacturing scale for Drug Substance to Commercial Scale, including, without limitation, performing process development work to improve the manufacturing process for Drug Substance that is transferred to XOMA pursuant to Section 4.1, increasing of the Drug Substance Yield, and addressing FDA expectations for quality (i.e., purity and potency).

• Increases in Yield must be evidenced by the average Yield of the [*] Batches of Drug Substance (or, if the Yield for one Batch differs by at least [*] percentage points from the average Yield of the other [*] Batches, the average Yield of such [*] Batches and the next Batch at Commercial Scale that complies with the warranties in Section 8.1(a)) at or in excess of [*] Yield (as so adjusted).

• Unless otherwise agreed to by the parties in writing, a Long Term License Agreement shall be executed within ninety (90) days after the completion of the Commercial Scale Trials.

More Definitions of Commercial Scale

Commercial Scale means the manufacturing of Batches in conformance with all Applicable Laws and on a scale suitable for commercial manufacturing and supply as further described in the Manufacturing Process after scale-up by SKYEPHARMA pursuant to Article 3 of this Agreement.

Commercial Scale means the [*]L nominal volume fermentation bioreactor production scale for the ONYX-015 manufacturing process that will result from scale-up work during the Development Phase, as it may be modified pursuant to Section 4.2(c).

Commercial Scale means the operation of the Cascade Process in the Production Facility at a batch size sufficient to permit the processing of 200,000 litres of Raw Material on a 12 month basis;

Commercial Scale means the [ * ]L nominal volume fermentation bioreactor production scale for the ONYX-015 manufacturing process that will result from scale-up work during the Development Phase, as it may be modified pursuant to Section 4.2(c).

Commercial Scale means with respect to a particular Commercial Farnesene Strain, the use of such Strain to reproducibly produce farnesene of commercially quality in commercial quantities and at commercially reasonable cost, as shown by production of [*]

Commercial Scale means with respect to a particular Commercial Farnesene Strain, the use of such Strain to reproducibly produce

Commercial Scale means, with respect to an