DNA sample means any material that has come from a human body and consists of or includes human cells;
Reference biological product means the single biological product licensed pursuant to 42 U.S.C.
Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.
Samples mean representative physical examples of materials, equipment or workmanship, used to confirm compliance with requirements and/or to establish standards for use in execution of the Work.
Regulatory Information Service means a service approved by the London Stock Exchange for the distribution to the public of announcements; and
Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.
Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).
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.
Grab sample means an individual sample collected in less than 15 minutes in conjunction with an instantaneous flow measurement.
Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.
Finished Product means a cannabis product in its final form to be sold at a retail premises.
Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.
Study Data shall have the meaning set forth in Section 8.1.
Annual Net Sales means, with respect to any Calendar Year, the aggregate amount of the Net Sales for such Calendar Year.
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.
Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;
Manufacturing Site means a location where a manufacturing
Study means the investigation to be conducted in accordance with the Protocol.
Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).
API means American Petroleum Institute.
Bid sample means a sample to be furnished by a bidder to show the characteristics of the item offered in the bid.
Recyclable Materials means materials that are separated from mixed municipal solid waste for the purpose of recycling or composting, including paper, glass, plastics, metals, automobile oil, batteries, source-separated compostable materials, and sole source food waste streams that are managed through biodegradative processes. Refuse-derived fuel or other material that is destroyed by incineration is not a recyclable material. (Minn. Stat. § 115A.03, Subd. 25a)
non-audit services means services other than audit services;
Investigational Medicinal Product means the study drug or control material as defined in the Protocol.
cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;
Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.