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

  • 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.

  • 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.

  • Manual Filling Pricing Tables Commercial Batch Prices for the manual filling are set forth below.

  • Commercial Batch Prices: Product Product Strength Price per batch ($) Risperidone Powder Filled Syringes 90mg $[***] Risperidone Powder Filled Syringes 120mg $[***] [***].

  • Pricing Tables Commercial Batch Prices: Product Product Strength Price per batch ($) Risperidone Powder Filled Syringes 90mg $[***] Risperidone Powder Filled Syringes 120mg $[***] Minimum Annual Revenue Commitment lndivior will pay Patheon a minimum annual revenue of $[***] for each calendar year during the Product Term (the "Minimum Annual Revenue Commitment").

  • N/A Responsibility Comment Hospira Cempra [*] [*] [*] [*] [*] [*] [*] Table VII Commercial Batch Production Req.

  • 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.

  • APRICUS will provide to PEDIATRX up to 500 bottles of Granisol from the Commercial Batch for PEDIATRX to replace that product whose shelf-life will expire currently with distributors and wholesalers.

  • Assist in operator training during production of a Biologically Active Commercial Batch, provided that LICENSEE shall pay or reimburse LICENSOR, as applicable, for any out-of-pocket costs incurred in providing such services, including travel, hotel and meals.

  • Exhibit B PRICING Commercial Compounding/Filling: $[*****] per batch Commercial Inspection/Packaging: $[*****] per batch Total Commercial Batch pricing: $[*****] per batch [*****] Confidential materials omitted and filed separately with the Securities and Exchange Commission.


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 on a country-by-country basis, the first sale of a Product to a Third Party following Regulatory Approval of the Product in such country.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Commercial applicator means any person, unless exempted in I(4) hereunder, whether or not the person is a private applicator with respect to some uses, who:

  • Commercial Bank means a bank, defined as a scheduled bank under section 2(e) of the Reserve Bank of India Act, 1934.

  • Commercial Sale means for a given product and country the sale for value of that product by a Party (or, as the case may be, by an Affiliate or permitted sublicensee of a Party), to a Third Party after regulatory approval (if necessary) has been obtained for such product in such country.

  • 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 service to Customers engaged primarily in the sale of goods or services including institutions and local, sate and federal government agencies for uses other than those involving manufacturing or electric power generation.

  • 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 altemate 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 Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • 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 or “MBR” shall mean, with respect to each Presentation of Clinical Product or Commercial Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. The MBR shall be developed and maintained in Xxxxxx’x standard format by Baxter, using Celator’s master formula and technical support.

  • 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 product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

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