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Australian Export Controls and the Life Sciences

A guide to understanding export control laws regarding the physical export, intangible supply, publication or brokering of life sciences related goods, software or technology

Annex 2: Definitions used in this Guide

Basic scientific research” means experimental or theoretical work undertaken principally to acquire new knowledge of the fundamental principles of phenomena or observable facts, not primarily directed towards a specific practical aim or objective.

Development” is related to all stages prior to serial production, such as: design, design research, design analyses, design concepts, assembly and testing of prototypes, pilot production schemes, design data, process of transforming design data into a product, configuration design, integration design, layouts.

In the public domain”, as it applies herein, means “technology” or “software” which has been made available without restrictions upon its further dissemination (copyright restrictions do not remove “technology” or “software” from being “in the public domain”).

Isolated live cultures” includes live cultures in dormant form and in dried preparations.

Microorganisms” means bacteria, viruses, mycoplasma, rickettsia, chlamydiae or fungi, whether natural, enhanced or modified, either in the form of isolated live cultures or as material including living material which has been deliberately inoculated or contaminated with such cultures.

Object code” means an equipment executable form of a convenient expression of one or more processes (“source code” (source language)) which has been converted by a programming system.

Person” (relevant to Australia) means:

  1. the Commonwealth, a State or a Territory or an authority of the Commonwealth, a State or a Territory; or
  2. an individual who is an Australian citizen; or
  3. an individual who is, within the meaning of the Migration Act 1958, the holder of a permanent visa; or
  4. a body corporate incorporated by or under a law of the Commonwealth or of a State or Territory.

Production” means all production phases, such as: construction, production engineering, manufacture, integration, assembly (mounting), inspection, testing, and quality assurance.

Required”, as applied to “technology”, refers to only that portion of “technology” which is peculiarly responsible for achieving or extending the controlled performance levels, characteristics or functions.  Such “required” “technology” may be shared by different goods.

Software” means a collection of one or more “programs” or ‘microprograms’ fixed in any tangible medium of expression. [Note: ‘Microprogram’ means a sequence of elementary instructions, maintained in a special storage, the execution of which is initiated by the introduction of its reference instruction into an instruction register.]

Technology” means specific information necessary for the “development”, “production” or “use” of a product. This information takes the form of ‘technical data’ or ‘technical assistance’.  Controlled “technology” for the Dual-Use List is defined in the General Technology Note and in the Dual-Use List.  Controlled “technology” for the
Munitions List is specified in ML22.
 
Note 1:   ‘Technical assistance’ may take forms such as instruction, skills, training, working knowledge and consulting services and may involve the transfer of ‘technical data’.
Note 2:    ‘Technical data’ may take forms such as blueprints, plans, diagrams, models, formulae, tables, engineering designs and specifications, manuals and instructions written or recorded on other media or devices such as disk, tape, read only memories.

Toxins” means toxins in the form of deliberately isolated preparations or mixtures, no matter how produced, other than toxins present as contaminants of other materials such as pathological specimens, crops, foodstuffs or seed stocks of “microorganisms”.

Use” means operation, installation (including on-site installation), maintenance (checking), repair, overhaul and refurbishing.

Vaccine” is a medicinal product in a pharmaceutical formulation licensed by, or having marketing or clinical trial authorisation from, the regulatory authorities of either the country of manufacture or of use, which is intended to stimulate a protective immunological response in humans or animals in order to prevent disease in those to whom or to which it is administered.

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