Typology of Legal/Contractual Terms for Biodiversity Specimens

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Permits and Contracts and Terms for Biological Specimens › Typology of Legal/Contractual Terms for Biodiversity Specimens


Typology of Legal/Contractual Terms

Information visible to future users of collection specimens for T3.3 Information for IT specialists intending to implement the vocabulary in an IT system
Catchphrase List different document contents, i.e. specific actions that may be subject to a permit or loan options for indicating legal background (explanation ¹) Does it refer to a specific action in the past (e.g. prior to adding material to a collection), or does it refer to using the specimen in the future? quality statement? Y/n under national (or supranational, e.g. EU) legislation (N)
not subject to national/supranat. legislation
required by contracts/deeds under civil law, e.g. a loan agreement, permission from (land)owner
(D)
refers to individually granted permission?
comment ¹
(D)
refers to individually assigned obligation (duty or restriction)?
comment ¹
(D)
refers to individually assigned prohibition
comment ¹
(L)
refers to permission in written law
(L)
refers to obligation (duty or restriction) in written law
(L)
refers to prohibition in written law
info not processed information on official permissions, obligations or prohibitions for this specimen is available, but has not been digitally processed yet not specified neither not specified not specified not specified not specified not specified not specified not specified not specified n/a
no ties Neither for collecting this specimen in the past, nor for future working/using/exhibiting (with) this specimen any official permission was/is necessary, nor do official obligations or prohibitions exist regarding working/using/exhibiting. Institutional loan conditions may apply. N both n n/a n/a n/a n/a n/a n/a Y n/a
permission & free further use Neither for collecting this specimen in the past, nor for future working/using/exhibiting (with) this specimen any official permission was/is necessary, nor do official obligations or prohibitions exist regarding working/using/exhibiting. Institutional loan conditions may apply. not specified
D
L
N
LN
both n possible n/a n/a possible n/a n/a possible n/a
free further use + reporting Already existing official permissions refer to the past only (e.g. collecting) and no official permissions are necessary for further use, but reporting obligations apply. No prohibitions. Institutional loan conditions may apply. not specified
D
L
C
both n possible possible n/a possible possible n/a n/a possible
OK: exhibition Exhibiting this specimen and use for educational purposes is officially permitted without further obligations. Institutional loan conditions may apply. not specified
D
L
N
LN
refers to future n possible n/a n/a possible n/a n/a possible n/a
obligations: exhibition Exhibiting this specimen and use for educational purposes is permitted but specific obligations apply. Institutional loan conditions may apply. not specified
D
L
CD
refers to future n possible possible n/a possible possible n/a n/a possible
NO exhibition exhibiting this specimen is officially prohibited D
L
CD
refers to future n n/a n/a possible n/a n/a possible n/a possible
OK: taxonomy taxonomic work with this specimen is permitted without further legal obligations (non-taxonomic work may not be covered, e.g. genetic analysis beyond taxonomy, and institutional obligations e.g. on destructive sampling may apply) not specified
D
L
N
LN
refers to future n possible n/a n/a possible n/a n/a possible n/a
obligations: taxonomy Using this specimen for taxonomy is permitted, but specific legal obligations apply. Institutional loan conditions may apply. not specified
D
L
refers to future n possible possible n/a possible possible n/a n/a n/a
OK: physical analysis Using this specimen for physical analysis, such as morphology or anatomy, is legally permitted. Institutional loan conditions, e.g. on dissecting the specimen, may be present. not specified
D
L
N
LN
refers to future n possible n/a n/a possible n/a n/a possible n/a
OK: genetic & biochemical Utilizing this specimen for any kind of research and development on its genetic and/or biochemical composition is officially permitted without further obligations. Institutional loan conditions, e.g. on destructive esampling, may be present. not specified
D
L
N
LN
refers to future n possible n/a n/a possible n/a n/a possible n/a
obligations: genetic & biochemical Utilizing this specimen for research and development on its genetic and/or biochemical composition is officially permitted with specific obligations (e.g. new PIC/MAT in certain situations). Institutional loan conditions may apply. not specified
D
L
refers to future n possible possible n/a possible possible n/a n/a n/a
reporting: genetic & biochemical Utilizing this specimen for research and development on its genetic and/or biochemical composition is officially permitted with reporting duties. Institutional loan conditions may apply. not specified
D
L
refers to future n possible possible n/a possible possible n/a n/a n/a
NO genetic & biochemical utilizing this specimen for research and development on it's genetic and/or biochemical composition is prohibited
D
L
refers to future n n/a n/a possible n/a n/a possible n/a n/a
benefit-sharing-NP Utilizing this specimen for research and development on its genetic and/or biochemical composition is officially permitted with benefit-sharing duties from countries that are Party to the Nagoya Protocol (NP). Institutional loan conditions may apply. not specified
D
L
refers to future n possible possible n/a possible possible n/a n/a n/a
benefit-sharing-CBD Utilizing this specimen/genetic resource is officially permitted with benefit-sharing duties from countries that are Party to the Convention on Biological Diversity (CBD), but not to the Nagoya Protocol. Institutional loan conditions may apply. not specified
D
L
refers to future n possible possible n/a possible possible n/a n/a n/a
benefit-sharing-ITPGRFA Using this specimen for research, breeding and training for food and agriculture is permitted with duties and restrictons from the ITPGRFA (International Treaty for Plant Genetic Resources for Food and Agriculture). Institutional loan conditions may apply. not specified
D
L
refers to future n possible possible n/a possible possible n/a n/a n/a
OK: TK-utilisation Utilizing traditional knowledge (sensu Nagoya Protocol) associated with genetic resources is officially permitted without further legal obligations in research and development on the genetic and/or biochemical properties. Additionally, institutional obligations may apply. not specified
D
L
N
LN
refers to future n possible n/a n/a possible n/a n/a n/a n/a
obligations: TK utilization Utilizing this specimen's associated traditional knowledge (sensu Nagoya Protocol) in research and development on the genetic and/or biochemical composition is permitted, but specific legal obligations apply. Institutional loan conditions may apply. not specified
D
L
refers to future n possible possible n/a possible possible n/a n/a n/a
OK: living organism research Living organism research such as germination trials or experiments, moisture relationship testing and diagnostic characterization is officially permitted without further obligations on research and development on the genetic and/or biochemical properties. Additionally, institutional obligations may apply. not specified
D
L
N
LN
refers to future n possible n/a n/a possible n/a n/a n/a n/a
obligations: living organism research Living organism research such as germination trials or experiments, moisture relationship testing and diagnostic characterization (everything about living organisms) is officially permitted with specific obligations. Additionally, institutional obligations may apply. not specified
D
L
refers to future n possible possible n/a possible possible n/a n/a n/a
NO living organism research Living organism research such as germination trials or experiments, moisture relationship testing and diagnostic characterization (everything about living organisms) is prohibited
D
L
refers to future n n/a n/a possible n/a n/a possible n/a n/a
OK: 3rd party Official permission to transfer the object to third parties. Institutional loan obligations may apply not specified
D
L
N
LN

CD

refers to future possible n/a n/a possible n/a n/a possible possible
obligations: 3rd party legal or contractual duties and/or restrictions on third party transfer apply not specified
D
L
CD
refers to future n possible possible n/a possible possible n/a n/a possible
NO 3rd party transfer to 3rd parties is prohibited not specified
D
L
CD
refers to future n/a n/a possible n/a n/a possible n/a possible
any quality no quality statements (e.g. health certificates, ethical statement) necessary for this specimen not specified
D
L
N
LN
refers to past possible n/a n/a possible n/a n/a possible n/a
ethical research Ethical statement for a particular research project n/a both Y n/a n/a n/a n/a n/a n/a n/a n/a
PIC-exempt A certificate or other document issued by an authority confirms that no PIC (=Prior Informed Consent issued by e.g. a Competent National Authority) is necessary. Not always the document specifies whether the legal background for the exemption is a specific law or the fact that no legal regulation is present. The exemption may imply other elements of permits/contracts, such as “OK: genetic and biochemical” not specified
L
N
LN
refers to future n n/a n/a n/a possible n/a n/a possible n/a
MAT-exempt A certificate or other document issued by an authority confirms that no MAT (=Mutually Agreed Terms on Benefit-sharing) is necessary. Not always the document specifies whether the legal background for the exemption is a specific law or the fact that no legal regulation is present. The exemption may imply other elements of permits/contracts, such as “OK: genetic and biochemical” not specified
L
N
LN
refers to future n n/a n/a n/a possible n/a n/a possible n/a
pre-Act exemption A certificate or other document issued by an authority confirms that the material originates from a time prior to enacting a certain law, and therefore is exempt from that law's requirements. Not always the document specifies whether the legal background is a clause of that specific law or the fact that such old material is not legally regulated. not specified
L
N
LN
refers to future n n/a n/a n/a possible n/a n/a possible n/a
pre-listed exemption A certificate or other document issued by an authority confirms that the material originates from a time prior to it's listing in a certain law, and therefore is exempt from this law's requirements. Not always the document specifies whether the legal background is a clause of that specific law or the fact that such old material is not legally regulated. not specified
L
N
LN
refers to future n n/a n/a n/a possible n/a n/a possible n/a
not-protected exemption A certificate or other document issued by an authority confirms that an official collection permit is not required because no protected species are concerned. Not always the document specifies whether the legal background for the exemption is a specific law or the fact that no legal regulation is present. not specified
L
N
LN
in the past n n/a n/a n/a possible n/a n/a possible n/a
free of familiar pests Confirmation of non-hazardous health, phytosanitary, etc. status at a certain point of time. As such, this content has no legal background, it is solely based on an expert's technical knowledge. (nevertheless, conducting this quality assessment may be legally required). n/a in the past Y n/a n/a n/a n/a n/a n/a n/a n/a
free of biosecurity risks Confirmation that the material is free of biosecurity risks, such as viruses, bacteria, spores, invertebrate eggs, living stowaways at a certain point of time. As such, this content has no legal background, it is solely based on an expert's technical knowledge. (nevertheless, conducting such a quality assessment may be legally required). n/a in the past y n/a n/a n/a n/a n/a n/a n/a n/a
import approved Permission to bring physical material into country, based on a public administration's decision in a document addressed to a specific person or legal entity not specified

D

in the past n possible n/a n/a n/a n/a n/a n/a n/a
OK: collect material Permission to collect physical material not specified
D
L
N
LN

CD

in the past n possible n/a n/a possible n/a n/a possible possible
obligations: collect material Collecting physical material is permitted, but specific obligations apply not specified
D
L
CD
both (obligations may extend to the future) possible possible n/a possible possible n/a n/a possible
OK: sensitive information Permission to get and use sensitive information not specified
D
CD
both possible n/a n/a n/a n/a n/a n/a possible
export approved Official permission to export physical material from country, based on a public administration's decision in a document addressed to a specific person or legal entity not specified
D
in the past n possible n/a n/a n/a n/a n/a n/a n/a
holding approved Official permission to hold physical material that is subject to special national regulations because a government considered the specimen to be legally restricted (or even illegal) in one way or the other because of their properties. not specified
D
L
refers to future n possible n/a n/a possible n/a n/a n/a n/a
under CITES this specimen is subject to CITES regulations not specified
D
L
both possible possible n/a possible possible n/a n/a n/a
OK: move countrywide Permission to move physical material within a country (e.g. to another administrative division), based on a public administration's decision in a document addressed to a specific person or legal entity not specified
D
in the past n possible n/a n/a n/a n/a n/a n/a n/a
OK: setting free Permission to release living organisms into the wild, based on a public administration's decision in a document addressed to a specific person or legal entity not specified
D
in the past n possible n/a n/a n/a n/a n/a n/a n/a
OK: get ownership Transfer of ownership title to physical material not specified
D
in the past possible n/a n/a n/a n/a n/a n/a n/a
obligations: get ownership Transfer of ownership title to physical material with specific obligations not specified
D
both (obligations may extend to the future) possible possible n/a n/a n/a n/a n/a n/a
stewardship the object is transferred under terms of stewardship, the owner retains the title and obligations for including the object in the collection have been set not specified
D
both (obligations may extend to the future) possible possible n/a n/a n/a n/a n/a n/a
entering permitted permission to enter a certain location/area, based on a written decision addressed to a specific person or legal entity, or a verbal decision directed to a specific person who created a written record not specified
D
often in past n possible n/a n/a n/a n/a n/a n/a n/a
equipment permitted permission to use certain equipment for collecting specimens, based on a written decision addressed to a specific person or legal entity, or a verbal decision directed to a specific person who created a written record not specified
D
often in past n possible n/a n/a n/a n/a n/a n/a n/a
tagging permitted permission to tag animals, based on a written decision addressed to a specific person or legal entity, or a verbal decision directed to a specific person who created a written record not specified
D
often in past n possible n/a n/a n/a n/a n/a n/a n/a
mode(s) permitted specific methods or modes for collecting, hunting, fishing or otherwise taking objects from a place where objects occur in nature were permitted not specified
D
often in past possible n/a
BELOW WE LIST INDIVIDUAL OBLIGATIONS THAT MAY BE ADDED TO A MORE GENERAL ELEMENT FROM ABOVE SUCH AS
“obligations: genetic & biochemical”
required: for residents it is required to have temporary resident status not specified
D
often in past n n/a possible n/a n/a n/a n/a n/a n/a
required: visa it is required to have a temporary stay visa for researchers not specified
D
often in past n n/a possible n/a n/a n/a n/a n/a n/a
required: exit permit it is required to obtain an “exit permit” at the end of research not specified
D
often in past n n/a possible n/a n/a n/a n/a n/a n/a
required: teaching it is required to provide training for local staff or students not specified
D
often in past n n/a possible n/a n/a n/a n/a n/a n/a
required: report progress it is required to send regular progress reports not specified
D
n n/a possible n/a n/a n/a n/a n/a n/a
required: exit report it is required to deliver an interim report upon leaving the country not specified
D
often in past n n/a possible n/a n/a n/a n/a n/a n/a
required: cash it is required to deliver a security cash deposit not specified
D
often in past n n/a possible n/a n/a n/a n/a n/a n/a
required: payment upfront payment required for e.g. collecting not specified
D
often in past n n/a possible n/a n/a n/a n/a n/a n/a
required: send publication copies of publication must be sent not specified
D
CD
both n n/a possible n/a n/a n/a n/a n/a possible
required: inform public legal entity an authorised public legal entity must be informed about data that have been obtained from the specimen not specified
D
refers to future possible n/a n/a n/a n/a n/a n/a
required: send taxa names provide sample list to providing country not specified
D
often in past n n/a possible n/a n/a n/a n/a n/a n/a
required: provider uID use provider country's unique identifier not specified
D
both n n/a possible n/a n/a n/a n/a n/a n/a
required: holding location hold genetic resource in defined location only not specified
D
both n n/a possible n/a n/a n/a n/a n/a n/a
required: negotiate 3rd party transferring the specimen to a third party requires additional negotiations not specified
D
CD
refers to future n/a possible n/a n/a n/a n/a n/a possible
required: work abroad conduct work in provider country not specified
D
both n n/a possible n/a n/a n/a n/a n/a n/a
required: negotiate commercial using the specimen for commercial purposes requires additional negotiations not specified
D
CD
refers to future n/a possible n/a n/a n/a n/a n/a possible
required: non-commercial present permit requires uses to be non-commercial not specified
D
refers to future n n/a possible n/a n/a n/a n/a n/a n/a
required: no economic benefit only for research and development lacking economic benefits not specified
D
refers to future n n/a possible n/a n/a n/a n/a n/a n/a
required: IPR notification notify the provider country once intellectual property rights are granted based on research and development with this specimen, or when such rights are commercialised not specified
D
refers to future n/a possible n/a n/a n/a n/a n/a n/a
required: share sales a certain amount of the sales from a product based on research and development on this specimen must be shared not specified
D
refers to future n/a possible n/a n/a n/a n/a n/a n/a
required: method a certain methodology is required not specified
D
refers to future n n/a possible n/a n/a n/a n/a n/a n/a
required: single research only a specific research plan is allowed not specified
D
often in past n n/a possible n/a n/a n/a n/a n/a n/a
required: handle duplicates provisions for sample duplicates apply not specified
D
often in past n n/a possible n/a n/a n/a n/a n/a n/a
required: handle left-over provisions for left-over material apply not specified
D
both n n/a possible n/a n/a n/a n/a n/a n/a
required: return left-over at the end of the project all remaining genetic resources must be returned to the provider not specified
D
CD
refers to future n/a possible n/a n/a n/a n/a n/a possible
required: handle “DSI” provisions apply to “digital sequence information” originating from this specimen not specified
D
refers to future n n/a possible n/a n/a n/a n/a n/a n/a
BELOW WE LIST TYPICAL ELEMENTS OF LOAN AGREEMENTS
NO destructive sampling a loan is possible, but destructive sampling is not by any means acceptable CD refers to future n/a n/a n/a n/a n/a n/a n/a Y
destructive sampling restricted destructive sampling requires prior consultation with the lending institution and a separate permission CD refers to future n/a n/a n/a n/a n/a n/a n/a Y
dissecting restricted dissecting the specimen/material requires prior consultation with the lending institution CD refers to future n n/a n/a n/a n/a n/a n/a n/a Y
NO shipping cannot be shipped (transport outside the holding institution) CD refers to future n/a n/a n/a n/a n/a n/a n/a Y
preparation restricted transforming the (microscopic) specimen into a preparation requires prior consultation with the lending institution CD refers to future n/a n/a n/a n/a n/a n/a n/a Y
share images images that have been produced from the specimen must be shared with the lending institution CD refers to future n/a n/a n/a n/a n/a n/a n/a Y
NO microwave microwave treatment of the specimen is prohibited CD refers to future n/a n/a n/a n/a n/a n/a n/a Y
storage parameters the specimen must be stored under defined parameters and/or following specific procedures CD refers to future n/a n/a n/a n/a n/a n/a n/a Y
NO sampling borrowers must not take samples from the specimen on their own, they may ask the lending institution for providing a sample CD refers to future n/a n/a n/a n/a n/a n/a n/a Y
negotiate commercial use any commercial use of the specimen, of photographs of the specimen or of other elements created with the help of the specimen requires additional negotiations CD refers to future n/a n/a n/a n/a n/a n/a n/a Y
not available this specimen is temporarily not avaialble, e.g. because it is on loan or must be restored CD refers to future n/a n/a n/a n/a n/a n/a n/a Y

Explanations

¹ ) D — an individual document based on a public administration's decision (for a specific person or legal entity); L — written law; N — no legal provisions exist; LN — No individual document is necessary for e.g. the permission, but evidence is missing whether this is based on written law or missing legal provisions; CD — contract/deed (civil law)

Comments

¹ ) An individually granted permission/obligation/prohibition is based on a document issued to a specific person or legal entity, often after examination of a specific project; in contrast to permissions/obligations/prohibitions based on written law without individualised documents, the law however can be referenced. Neither is present where something is not subject to national/supranational (e.g. EU) legislation, which means that depending on the applicable legal system it is allowed (based the principle that everything is allowed unless expressly prohibited) or forbidden (principle that everything is prohibited unless expressly allowed)


Glossary

ABS Clearing House 
Global information portal (https://absch.cbd.int) developed under the Convention on Biological Diversity (CBD) and further elaborated in the Nagoya Protocol (NP) to make information available on national contacts (especially National Focal Points and Competent National Authorities), national legislation and other matters relevant to Access and Benefits Sharing and the Nagoya Protocol
Access to genetic resources or associated trad. knowledge 
The acquisition of genetic resources or associated traditional knowledge from the country that has sovereign right over those resources (providing country). Note that this term may be used differently by some countries or organisations. The EU Regulation defines access as ‘the acquisition of genetic resources or of traditional knowledge associated with genetic resources in a Party to the Nagoya Protocol’. Both the → Convention on Biological Diversity (CBD) and - in more detail - the → Nagoya Protocol (NP) contain provisions for granting access to genetic resources.
Access and Benefit-Sharing (ABS) 
A system based on public international law that outlines the way in which genetic resources or (where applicable) traditional knowledge associated with such resources is accessed and how the benefits that result from the utilisation of such resources and associated traditional knowledge are shared with the countries and/or indigenous peoples and local communities providing them.
Biodiversity Beyond National Jurisdiction (BBNJ) 
An international agreement, currently at the time of writing this glossary in 2022 under negotiation at the United Nations, on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction.
Bioprospecting 
The search for potentially valuable genetic data and biochemical compounds in biodiversity for the purpose of developing economically valuable products for different applications (e.g. pharmaceutical, cosmetic, agricultural). The UNDP defined bioprospection “Biodiversity prospecting or bioprospecting is the systematic search for biochemical and genetic information in nature in order to develop commercially-valuable products for pharmaceutical, agricultural, cosmetic and other applications. Bioprospecting activities must comply with the definition of utilization of genetic resources of the Nagoya Protocol or as stated in the national law or policy. The Nagoya Protocol applies to the utilization of genetic resources and their derivatives” (https://www1.​undp.org/​content/​dam/​sdfinance/​doc/​Bioprospecting%20_%20UNDP.pdf (archived 20220416), https://de.scribd.com/document/505930765/Bioprospecting-UNDP)
Convention on Biological Diversity (CBD) 
International agreement designed to promote three goals, the “conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources” (https://www.cbd.int/convention/text/). The agreement was adopted by the states that participated in the 1992 UN Conference on Environment and Development in Rio de Janeiro; it entered into force on 29 December 1993.
Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) 
International agreement designed to ensure that international trade in wild fauna and flora does not deteriorate the situation of endangered or strongly exploited species. CITES resulted from a resolution by the World Conservation Union (IUCN) in 1963; it entered into force on 01 July 1975.
Environmental sample 
A collected volume of water, soil, sediment, or any other material containing living our death organisms, or genetic material such as DNA.
Genetic resources (GR) 
Term identified in the → Convention on Biological Diversity (CBD) and refers to all “genetic material of actual or potential value”, thus encompasses “any material of plant, animal. microbial or other origin containing functional units of heredity” that is potentially valuable to humans. Genetic resources can be taken from the wild, domesticated or cultivated. They may be sourced from natural environments (in situ) or human-made collections (ex situ) (e.g. botanical gardens, gene banks, seed banks and microbial culture collections).
International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) 
Also referred to as the Plant Treaty or Seed Treaty. International agreement designed to promote the “conservation and sustainable use of plant genetic resources for food and agriculture and the fair and equitable sharing of the benefits arising out of their use, in harmony with the Convention on Biological Diversity, for sustainable agriculture and food security” (https://www.fao.org/3/i0510e/i0510e.pdf). It entered into force on 29 June 2004.
Mutually Agreed Terms (MAT) 
Mutually Agreed Terms (MAT) is a contract on benefit-sharing from the utilisation of genetic resources that has been mutually agreed between providers and users of genetic resources in the context of the Convention on Biological Diversity (CBD) including Nagoya Protocol (NP). See typology of Mutually Agreed Terms (MAT).
Nagoya Protocol (NP) 
Short for “The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization”. An international agreement related to the → Convention on Biological Diversity (CBD), which primarily aims at sharing the benefits arising from the utilisation of genetic resources in a fair and equitable way (https://www.cbd.int/abs/text/). It entered into force on 12 October 2014.
Pandemic Influenza Preparedness framework (PIP) 
International instrument that aims to “improve pandemic influenza preparedness and response” by improving and strengthening a system for the global sharing “of H5N1 and other influenza viruses with human pandemic potential and access to vaccines and sharing of other benefits” (https://apps.who.int/iris/rest/bitstreams/1351857/retrieve). It was negotiated by Member States of the World Health Organization (WHO) and entered into force on 24 May 2011.
Phytosanitary 
Scientific and regulatory frameworks relating to plant health, including the control of plant pests or pathogens.
Prior Informed Consent (PIC) 
A written permission, e.g. given by a government authority of a provider country to a user prior to and allowing access to genetic resources for their utilisation aso.; or for traditional knowledge (approval and involvement of indigenous peoples aso.); or it can also be the leading part of a combined document covering the contents of Mutually Agreed Terms (MAT) as well. See typology of Prior Informed Consent (PIC)
Reintroduction 
The intentional release of a species from captivity (e.g. zoo, botanical garden, seed bank) in an area inside its indigenous range from which it has disappeared.
Translocation 
The intentional movement of a species within its indigenous range to an area where it has disappeared.
Utilization of genetic resources 
To “conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology” (“biotechnology means any technological application that uses biological systems, living organisms, or derivatives thereof, to make or modify products or processes for specific use”) as defined in the → Nagoya Protocol (NP).