Pre-Commercial Lots definition

Pre-Commercial Lots means the API as manufactured for the purpose of conducting human clinical studies as well as for pre-commercial work such as experimental, demonstration and stability lots.
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Examples of Pre-Commercial Lots in a sentence

  • As set forth in Schedule B, DPC shall be responsible for performance of the manufacturing process of the Pre-Commercial Lots.

  • DPC and NovaCardia shall agree on the schedule for manufacture and delivery of API and Pre-Commercial Lots.

  • The District and school telephone numbers are:Administrative Office & Student Services 708-614-45006611 West 171st Street Tinley Park, IL 60477 www.district146.orgCentral Middle School 708-614-451018146 S.

  • DPC shall provide its facilities, personnel and equipment for the manufacturing, testing and validation, where required, of the Pre-Commercial Lots.

  • DPC shall perform: (i) development and validation of all API analytical methods set forth on Schedule A hereto, (ii) Materials USP/NF monograph testing, and (iii) all analytical and microbiological testing for API and for release of Pre-Commercial Lots.

  • DPC shall be responsible for the testing and release of the Pre-Commercial Lots.

  • The following points include those that would be directly relevant for INTREC, i.e. specifically for the training of INDEPTH scientists.

  • If a third party asserts that a patent or other right owned by it is infringed by the manufacture of Pre-Commercial Lots by ***Confidential Treatment Requested DPC pursuant to this Agreement, the party first obtaining knowledge of such a claim shall immediately provide the other party notice of such claim and the related facts in reasonable detail.

  • If a third party asserts that a patent or other right owned by it is infringed by the manufacture of Pre-Commercial Lots by DPC pursuant to this Agreement, the party first obtaining knowledge of such a claim shall immediately provide the other party notice of such claim and the related facts in reasonable detail.

Related to Pre-Commercial Lots

  • pre-commercial procurement means the procurement of research and development services involving risk-benefit sharing under market conditions, and competitive development in phases, where there is a clear separation of the research and development services procured from the deployment of commercial volumes of end-products;

  • commercial fishing means to take, harvest, hold, transport, or off-load marine species for sale or intended sale (R.I. Gen. Laws § 20-1-3).

  • Medical cannabis card means the same as that term is defined in Section 26-61a-102.

  • Pre-commissioning means the testing, checking, and any other required activity that may be specified in the Technical Requirements that are to be carried out by the Supplier in preparation for Commissioning of the System as provided in GCC Clause 26 (Installation).

  • Cannabis processing facility means a person that:

  • Commercial driver s license" means:

  • Cannabis product means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

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

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

  • Investment product means a financial instrument (within the meaning of Article 4(1)(15) of MiFID II) or a structured deposit (within the meaning of Article 4(1)(43) of MiFID II).

  • Commercial property means property formerly or currently used primarily for business, retail, governmental or professional purposes.

  • Agricultural product means the products listed in Annex I to the Treaty, except fishery and aquaculture products listed in Annex I to Regulation (EU) No 1379/2013 of the European Parliament and of the Council of 11 December 2013;

  • Medical marijuana concentrate means a specific subset of Medical Marijuana that was produced by extracting Cannabinoids from Medical Marijuana. Categories of Medical Marijuana Concentrate include Water-Based Medical Marijuana Concentrate, Food-Based Medical Marijuana Concentrate, Solvent-Based Medical Marijuana Concentrate, and Heat/Pressure- Based Medical Marijuana Concentrate.

  • Commencement of Commercial Production means the first occurrence of Commercial Production in an Area.

  • Commercial Product means any such product as defined in FAR 2.101.

  • 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.

  • Manufactured home park means any tract of land upon which three or more manufactured or mobile homes used for habitation are parked, either free of charge or for revenue purposes, and includes any roadway, building, structure, vehicle, or enclosure used or intended for use as a part of the facilities of the park. "Manufactured home park" does not include any of the following:

  • Commercial vehicle means a motor vehicle, trailer, or semitrailer used or

  • Existing Manufactured Home Park or Manufactured Home Subdivision means a manufactured home park or subdivision for which the construction of facilities for servicing the lots on which the manufactured homes are to be affixed (including, at a minimum, the installation of utilities, the construction of streets, and either final site grading or the pouring of concrete pads) was completed before the initial effective date of the floodplain management regulations adopted by the community.

  • Cannabis retailer means any licensed person or entity that purchases or otherwise obtains usable cannabis from cannabis cultivators and cannabis items from cannabis manufacturers or cannabis wholesalers, and sells these to consumers from a retail store, and may use a cannabis delivery service or a certified cannabis handler for the off-premises delivery of cannabis items and related supplies to consumers. A cannabis retailer shall also accept consumer purchases to be fulfilled from its retail store that are presented by a cannabis delivery service which will be delivered by the cannabis delivery service to that consumer.

  • Commercial project means any project, including, but not

  • Tobacco products means cigars, cigarettes, cheroots, stogies, periques, granulated, plug cut, crimp cut, ready rubbed, and other smoking tobacco, snuff, snuff flour, moist snuff, cavendish, ping and twist tobacco, fine-cut and other chewing tobaccos, shorts, refuse scraps, clippings, cuttings and sweepings of tobacco, and other kinds and forms of tobacco, prepared in such manner as to be suitable for chewing or smoking in a pipe or otherwise, or both for chewing and smoking.

  • Cannabis testing facility means an entity registered by

  • Commercial Production means the operation of the Property or any portion thereof as a producing mine and the production of mineral products therefrom (excluding bulk sampling, pilot plant or test operations);

  • Agricultural production means the commercial production of food or fiber.