Commercial Batch definition

Commercial Batch means a Batch produced by SAFC under cGMP conditions after Company has obtained Regulatory Approval for Sale (as defined herein) of its Drug Product.
Commercial Batch or "Commercial Lot" means a Batch or Lot produced from a Commercial Run.
Commercial Batch means a Batch produced from a Commercial Run.

Examples of Commercial Batch in a sentence

  • This Agreement commences with the Effective Date and terminates one year after the expiration of the last Commercial Batch or through completion of any ongoing stability studies, whichever is later.

  • Commercial Batch Prices: Risperidone Powder Filled Syringes 90mg $[***] Risperidone Powder Filled Syringes 120mg $[***] [***].

  • For each Commercial Batch, the “Delivery Date” shall be the date established by the applicable Firm Order and accompanying Tercica purchase order, by which date such Batch will have completed Quality Review and Approval and be made available for pick-up by the Designated Carrier, unless the Parties agree in writing on an alternative delivery date.

  • The techniques of data collection used in this research are following many steps.

  • Unless and until such technology transfer failure is resolved, Lonza shall fulfill its Commercial Batch manufacturing obligations under this Agreement using the Porrino Facility under the Supply Terms of the 2014 Agreement.

  • For Triesence, the Product NDA shall not be transferred from Novartis to the Purchaser until the prevailing supply chain interruptions impacting that Product have been resolved to Novartis’ reasonable satisfaction and the Triesence Commercial Batch Release has occurred.

  • The CO2 compressors are always prototypes and they seem to be well optimized.

  • The minimum price per batch of • Commercial Batch Prices are effective on 1 January 2008, and are $[**] shall apply in accordance effective through 31 December 2009.

  • The reader is advised to consider the appendix for a brief introduction into the biological terminology.The course of information processing in brain regions depends on the propa- gation of synaptic potentials - which are averaged postsynaptic potentials - along the subnetworks of these regions.


More Definitions of Commercial Batch

Commercial Batch means a BATCH intended for clinical use or market supply.
Commercial Batch or "Commercial Lot" means a Batch or Lot produced from a

Related to Commercial Batch

  • Commercial Item means a commercial item as defined in FAR 2.101.

  • Commercial Launch means the initial First Commercial Sale of a Product in the Territory.

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • Commercial applicator means a person who, by contract or for hire, engages in the

  • Commercial Sale means the sale of Product (as indicated by shipment of Product) to an unaffiliated third-party of the Licensee, or of its sublicensee or distribution partner, such as a wholesaler, managed care organization, hospital or pharmacy and shall exclude (i) any transfer of Product by Licensee to its sublicensee, distribution partner or Affiliate and (ii) any distribution of Product for use in research, development, pre-clinical and clinical trials.

  • Commercial use request means a re- quest from or on behalf of one who seeks information for a use or purpose that furthers the commercial, trade, or profit interests of the requester or the person on whose behalf the request is made.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Commercial Service means water service provided by the water utility that the customer uses in the promotion of a business or business product that is a source of revenue or income to the customer or others using the premises.

  • commercial air transport means an aircraft operation involving the transport of passengers, cargo, or mail for remuneration or hire.

  • Commercial unit means such a unit of goods as by commercial usage is a single whole for purposes of lease and division of which materially impairs its character or value on the market or in use. A commercial unit may be a single article, as a machine, or a set of articles, as a suite of furniture or a line of machinery, or a quantity, as a gross or carload, or any other unit treated in use or in the relevant market as a single whole.

  • Harvest batch means a specifically identified quantity of dried flower or trim, leaves, and other cannabis plant matter that is uniform in strain, harvested at the same time, and, if applicable, cultivated using the same pesticides and other agricultural chemicals, and harvested at the same time.

  • Process Gas means gas used for which alternate fuels, other than another gaseous fuel, are not technically feasible such as in applications requiring precise temperature controls and precise flame characteristics.

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

  • Procurement Process means the process commenced by the issuing of this Invitation and concluding upon the award of a contract (or other outcome as determined by Tetra Tech International Development) or upon the earlier termination of the process

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Process weight means the total weight of all materials introduced into any source operation. Solid fuels charged will be considered as part of the process weight, but liquid and gaseous fuels and combustion air will not.

  • Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.

  • Commercial driver s license" means:

  • Batch Record means the production record pertaining to a Batch.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Commercial vessel means any vessel not owned and operated by the United States military or the United States Coast Guard.