Scale-up Batches definition

Scale-up Batches means each and every Batch of the Products Manufactured by Sicor pursuant to Section 2.3 hereof.

Examples of Scale-up Batches in a sentence

  • Before the [****] of each Clinical Scale-up Batch, which is allocated to SciClone, is fully utilized, RESprotect agrees to supply SciClone or any Sublicensee of SciClone (“Sublicensee”) with additional quantities of Licensed Product and after the shares of the Clinical Scale-up Batches are allocated, RESprotect agrees to supply SciClone or any Sublicensee with quantities of Licensed Product in accordance with orders received from SciClone or its Sublicensee.

  • If it becomes apparent to either party hereto at any time during the performance of the scale-up activities, the production of the Scale-up Batches and/or the GMP-related Activities that it will not be possible to carry out such activities for scientific reasons or as a result of Force Majeure (as described in Article 11 below), the parties shall permit [***] business days for discussion to resolve, if possible, the scientific issue or Force Majeure issue giving rise to the problem.

Related to Scale-up Batches

  • 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.

  • 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.

  • 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.

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • 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.

  • Anti-Static Product means a product that is labeled to eliminate, prevent, or inhibit the accumulation of static electricity. “Anti-Static Product” does not include “Electronic Cleaner,” “Floor Polish or Wax,” “Floor Coating,” and products that meet the definition of “Aerosol Coating Product” or “Architectural Coating.”

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

  • 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.

  • Small quantity generator means a generator who generates less than 1000 kg of hazardous waste in a calendar month.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

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

  • Defective Product has the meaning set forth in Section 5.2.

  • Process unit means the equipment assembled and connected by pipes and ducts to process raw materials and to manufacture either a final or intermediate product used in the onsite production of other products. The process unit also includes the purification of recovered byproducts.

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

  • Reference biological product means the single biological product licensed pursuant to 42 U.S.C.

  • Generator Forced Outage means an immediate reduction in output or capacity or removal from service, in whole or in part, of a generating unit by reason of an Emergency or threatened Emergency, unanticipated failure, or other cause beyond the control of the owner or operator of the facility, as specified in the relevant portions of the PJM Manuals. A reduction in output or removal from service of a generating unit in response to changes in market conditions shall not constitute a Generator Forced Outage.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Manufacturing Process means any process for—

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • medium voltage means the set of nominal voltage levels that lie above low voltage and below high voltage in the range of 1 kV to 44 kV;

  • Plasma arc incinerator means any enclosed device using a high intensity electrical discharge or arc as a source of heat followed by an afterburner using controlled flame combustion and which is not listed as an industrial furnace.

  • API means the American Petroleum Institute.

  • Service Specification means and include detailed description, statements to technical data, performance characteristics, and standards (Indian as well as) as applicable and as specified in the Contract as well as those specifications relating to Industry standards and codes applicable to the performance of the work, work performance quality and the specifications affecting the works or any additional specification required to be produced by the DCO to meet the design criteria.

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

  • Service Switching Point (SSP) is a telephone central office switch equipped with a Signaling System 7 (SS7) interface.