PRODUCT SAFETY

Lentiviral Product Safety
Level Information

This Lentiviral Product Safety Level Information constitutes Product
Documentation according to clause 1 of the Product Terms and Conditions.
It is applicable to the following Dharmacon lentiviral products (“Products”):•••••••••

SMARTvector™ shRNAs
SMARTchoice™ shRNAs
SMARTchoice™ Inducible shRNAs
SMARTchoice™ shMIMIC™ miRNA
SMARTchoice™ Inducible
shMIMIC™ miRNA
GIPZ™ shRNAs
TRIPZ™ shRNAs
Precision LentiORFs
Edit-R™ Lentiviral sgRNAs• Edit-R™ Lentiviral sgRNA pooledlibraries• Edit-R™ Lentiviral All-in-one
sgRNAs• Edit-R™ Lentiviral Cas9
• CRIRPRmod™ Lentiviral dCas9• CRISPRmod™ Lentiviral sgRNAs

The Products are solely for internal research use (as set forth in theProduct Terms and Conditions) in laboratories where the containment
measures stated below and in applicable laws and regulations are met.
Products may not be used for diagnostic, therapeutic or other commercial
purposes and may not to be administered to humans for any purposeor to animals for therapeutic purposes. The Products are replicationincompetent, self-inactivating (SIN) and non-pathogenic (do not cause
infectious human disease).
Any investigator who purchases Dharmacon lentiviral products is
responsible for consulting with their institution’s health and biosafety
personnel for specific guidelines on the handling of lentiviral
vector particles. Furthermore, each investigator is fully responsible
for obtaining the required permissions for research using and theacceptance of replication-incompetent SIN lentiviral vectors andreplication-defective lentiviral particles into their local jurisdiction
and institution.
For questions concerning the design or production of the products,
please contact:
Horizon Discovery | Dharmacon Technical Support
Tel: 800-235-9880 (Option 2) Or 303-604-9499 (Option 2)
Fax: 1-800-292-6088 Or 303-604-9680
Email: technical@horizondiscovery.com

horizondiscovery.com

In the US
For US guidance on containment for lentiviral vectors, please refer to theRecombinant DNA Advisory Committee (RAC) guidelines for research withlentiviral vectors: https://osp.od.nih.gov/wp-content/uploads/2014/01/
Lenti_Containment_Guidance_0.pdf.
The U.S. Department of Health and Human Services Centers for Disease
Control and Prevention and National Institutes of Health, Biosafety in
Microbiological and Biomedical Laboratories (BMBL), Fifth Edition, Dec
2009 downloadable here: https://www.cdc.gov/biosafety/publications/index.htm.
In the EU
For the EU directives, please consult the following:
1. Council Directive 2009/41/EC of the European Parliament and of theCouncil of 6 May 2009 on the contained use of genetically modifiedmicro-organisms. (revised version Directive of 90/219/EEC of the EuropeanParliament and of the Council of 23 April 1990 on the contained use ofgenetically modified micro-organisms, amended by Council Directive
98/81/EC of 26 October 1998); and2. Council Directive 2001/18/EC of the European Parliament and of theCouncil of 12 March 2001 on the deliberate release into the environment ofgenetically modified organisms and repealing Council Directive 90/220/EEC.
In Germany
Required Containment Measures
The containment requirements as stated in the German Genetic Safety
Ordinance (Gentechnik-Sicherheitsverordnung) of Safety Level 2* orhigher have been assigned to the handling of the above-mentioned
lentiviral vector particles. Please note that a higher Security Level might
be required if the lentiviral vector particles are used for genetic engineering
operations with other products which require a higher Security Level.

Safety Level 2: activities of low risk for human health and the environmentby the state of scientific knowledge (Stand der Wissenschaft).
For the German regulations, please consult the following:
1. German Genetic Engineering Act (Gentechnikgesetz - GenTG); and2. Genetic Engineering Safety Ordinance (GentechnikSicherheitsverordnung - GenTSV).

Label Licenses
The shRNA and gene expression Products, use and applications, arecovered by pending and issued patents. Certain Label licenses govern theuse of the products, these can be found at https://horizondiscovery.com/-/
media/Files/Horizon/legal/dharmacon-licensing-statements.pdf. It is each
Buyer’s responsibility to determine which intellectual property rights heldby third parties may restrict the use of Products for a particular application.
Please review the Label Licenses governing all use of the shRNA and gene
expression Products. https://horizondiscovery.com/-/media/Files/Horizon/
legal/horizon-discovery-product-terms-conditions.pdf

To find the contact information in your country for your technology of interest, please visit us at
horizondiscovery.com/contact-us
Horizon Discovery, 8100 Cambridge Research Park, Waterbeach, Cambridge, CB25 9TL, United Kingdom©2020 The Horizon logo and other trademarks are the property of Horizon Discovery Limited, unless otherwise stated. DHARMACON, CRISPRMOD, EDIT-R, GIPZ, SMARTCHOICE,SMARTVECTOR, AND TRIPZ are trademarks of Dharmacon Inc.

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