Design Change is a change in work and/or materials shown in the Schedule of Items and described in Plans or specifications that has been mutually agreed to in writing or ordered by Contracting Officer. Changes of a minor nature (such as adjustment in horizontal and vertical alignment, that do not exceed specified tolerance, necessary to maintain or balance earthwork quantities substantially as designed) and variation in quantities, as described in B5.251, shall not be considered Design Changes.
Proposed Change Order (PCO means a document that informs Contractor of a proposed change in the Work and appropriately describes or otherwise documents such change including Contractor’s response of pricing for the proposed change.
Alternative nicotine product means any vaping product, whether or not it includes nicotine, including electronic smoking devices, that can be ingested into the body by chewing, smoking, absorbing, dissolving, inhaling, or by any other means. ‘Alternative nicotine product’ does not include:
Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.
Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.
Minor Change means an amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited re-assessment of the properties or efficacy of the biocidal product or biocidal product family;
Manufacturing Process means any process for—
Functional Specifications means the descriptions of features and functions of the Application as expressly set forth in Quote.
Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:
Auricular acupuncture means the subcutaneous insertion of sterile, disposable acupuncture needles
Combination Products means any product containing both a pharmaceutically active agent or ingredient which constitutes a Licensed Product and one or more other pharmaceutically active agents or ingredients which do not constitute Licensed Products.
Investigational Medicinal Product means the study drug or control material as defined in the Protocol.
Biologically-based mental illness means schizophrenia, schizoaffective disorder, major depressive disorder, bipolar disorder, paranoia and other psychotic disorders, obsessive-compulsive disorder, and panic disorder, as these terms are defined in the most recent edition of the diagnostic and statistical manual of mental disorders published by the American Psychiatric Association.
Biological Material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;
complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.
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.
Customizations means those features, functions, interfaces or other aspects of the Contractor Customized Software that have been specifically developed or customized for District. Contractor Customized Software will include any and all bug fixes and other nonmaterial revisions to Contractor Customized Software, regardless of whether District has funded such bug fixes or other revisions.
Developed Technology means any Technology including, without limitation, any enhancements, substitutions or improvements to the Core Technology that is (a) discovered, developed or otherwise acquired by DURA pursuant to the terms of the Development Agreement or (b) otherwise acquired by or on behalf of Xxxxxx Corp. II during the term of the Development Agreement.
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;
Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.
Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.
Licensed Compounds means any EZH2 Compound(s) that is:
Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.
Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).
Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.
Third Party Components means software and interfaces, licensed by RIM from a third party for incorporation into a RIM software product, or for incorporation into firmware in the case of RIM hardware products, and distributed as an integral part of that RIM product under a RIM brand, but shall not include Third Party Software.