Novo Nordisk Compound Sharing

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Novo Nordisk Compound Sharing

Your information

Please insert the requested information below to ensure that we have the correct information to allow for a compound shipment to arrive at your lab. The information you enter will also be used for the Novo Nordisk Compound Sharing agreement (containing the information provided in the order form, the compound request and the terms and conditions described below), which will be sent to you by e-mail if your request is approved.

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Personal information

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E-mail address*

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E-mail address of receiver*

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Additional information

Will your study include in vivo experiments?*

Will your study include use of human biosamples?*

TERMS AND CONDITIONS

These are the terms and conditions for Novo Nordisk A/S (“Novo”) providing you the selected Compounds. By accepting these terms and conditions, Novo and you are entering into an agreement covering the transfer and use of the Compounds (the “Agreement”), subject to you receiving final email notification that Novo has accepted your request.

The Compounds provided to you under this Agreement will be used solely by you and your team for the Study Purpose (as described in your Compound request form). Except to the extent necessary to carry out the Study Purpose, you shall not analyse, modify, synthesise or create derivatives of any of the Compounds provided under this Agreement. You agree not to sell or distribute the Compounds to any third party.

You agree to use the Compounds in compliance with any and all applicable laws and regulations. You shall not administer the Compounds to humans under any circumstances.

You are free to publish the data and study results obtained from the use of the Compounds. You shall acknowledge Novo and the Novo Nordisk Compound Sharing in any publication publishing such data and study results. Please use the following format:

“NNCXXXX-XXXX was provided by Novo Nordisk Compound Sharing”

This Agreement shall not be interpreted as granting you any right or license under any intellectual property, now or hereafter owned or controlled by Novo. Any intellectual property generated by you carrying out the Study Purpose will belong to you.

This Agreement will become effective on the date you receive final email notification that Novo has accepted your request and will remain effective until the completion of the study. Novo may terminate this Agreement in case of your material breach of the Agreement. All terms that are intended to survive termination, will survive, including but not limited to the Compounds only being used for the Study Purpose and you acknowledging Novo and the Novo Nordisk Compound Sharing in any publication.

You cannot assign this Agreement to a third party without the prior written consent of Novo. Novo will have the right at any time to assign or transfer any or all of its rights and obligations under this Agreement to any of its affiliates.

You acknowledge that the Compounds are provided “as is” and without any representation or warranty, express or implied, as to the accuracy or completeness of the Compounds, including, without limitation, any implied warranty of merchantability or fitness for a particular purpose, or any warranty that the use of the Compounds will not infringe or violate any patent or other proprietary rights of any third party. Acceptance of receipt of the Compounds will constitute acceptance by you of liability for any damages or injuries resulting from your use of the Compounds.

You and Novo each hereby agrees to hold harmless and indemnify the other party against any and all losses and/or liabilities resulting from such party’s breach of this Agreement and/or unauthorised use and/or disclosure of the Compounds. 

THIS AGREEMENT SHALL BE GOVERNED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF DENMARK TO THE EXCLUSION OF ANY RULE THAT WOULD REFER THE SUBJECT MATTER TO ANOTHER FORUM. YOU AND NOVO AGREE TO THE EXCLUSIVE JURISDICTION OF THE DANISH COURTS.

 

NOVO NORDISK PRINCIPLES ON THE USE OF ANIMALS

When performing in vivo experiments, you must adhere to the following principles:

- All activities involving animals must be conducted strictly in accordance with present legislation.

- Animals will be used only where no available and acceptable alternatives exist.

- Alternatives to animal experiments must be used whenever possible.

- Transgenic animals may be used for testing and experiments when this model is justified.

- Animals bred specifically for experimental purposes must be used unless special conditions are in evidence.

- Housing, husbandry and transportation of animals must as a minimum comply with internationally approved standards.

- Housing conditions must take into consideration the special needs for the animal species in question.

- Housing, husbandry and care of animals must be undertaken by personnel having received adequate and relevant education. The level of education must be documented.

- Health control should be supervised by a veterinary officer experienced in regard to laboratory animals.

- Transportation of animals must be as lenient as possible, taking into consideration the special needs for the animal species in question.

- All precautions must be taken to reduce suffering and distress.

- Procedures for monitoring and evaluation of the well-being of the animals as well as treatment must be implemented.

If you are receiving NNC0100-0454 (insulin degludec), NNC0090-1170 (liraglutide) or NNC0113-0217 (semaglutide) for performing in vivo experiments, there is a process for handling and reporting of potentially serious and unexpected adverse findings which all personnel supporting the studies must follow.

This is to assure compliance with regulatory requirements. You will receive a list of ‘expected adverse findings’ which should not be reported. If there is a finding during your studies that is determined as potentially serious and unexpected, an email must immediately be sent to compoundsharing@novonordisk.com with a description of the finding. 

TERMS AND CONDITIONS

These are the terms and conditions for Novo Nordisk A/S (“Novo”) providing you the selected Compounds. By accepting these terms and conditions, Novo and you are entering into an agreement covering the transfer and use of the Compounds (the “Agreement”), subject to you receiving final email notification that Novo has accepted your request.

The Compounds provided to you under this Agreement will be used solely by you and your team for the Study Purpose (as described in your Compound request form). Except to the extent necessary to carry out the Study Purpose, you shall not analyse, modify, synthesise or create derivatives of any of the Compounds provided under this Agreement. You agree not to sell or distribute the Compounds to any third party.

You agree to use the Compounds in compliance with any and all applicable laws and regulations. You shall not administer the Compounds to humans under any circumstances.

You are free to publish the data and study results obtained from the use of the Compounds. You shall acknowledge Novo and the Novo Nordisk Compound Sharing in any publication publishing such data and study results. Please use the following format:

“NNCXXXX-XXXX was provided by Novo Nordisk Compound Sharing”

This Agreement shall not be interpreted as granting you any right or license under any intellectual property, now or hereafter owned or controlled by Novo. Any intellectual property generated by you carrying out the Study Purpose will belong to you.

This Agreement will become effective on the date you receive final email notification that Novo has accepted your request and will remain effective until the completion of the study. Novo may terminate this Agreement in case of your material breach of the Agreement. All terms that are intended to survive termination, will survive, including but not limited to the Compounds only being used for the Study Purpose and you acknowledging Novo and the Novo Nordisk Compound Sharing in any publication.

You cannot assign this Agreement to a third party without the prior written consent of Novo. Novo will have the right at any time to assign or transfer any or all of its rights and obligations under this Agreement to any of its affiliates.

You acknowledge that the Compounds are provided “as is” and without any representation or warranty, express or implied, as to the accuracy or completeness of the Compounds, including, without limitation, any implied warranty of merchantability or fitness for a particular purpose, or any warranty that the use of the Compounds will not infringe or violate any patent or other proprietary rights of any third party. Acceptance of receipt of the Compounds will constitute acceptance by you of liability for any damages or injuries resulting from your use of the Compounds.

You and Novo each hereby agrees to hold harmless and indemnify the other party against any and all losses and/or liabilities resulting from such party’s breach of this Agreement and/or unauthorised use and/or disclosure of the Compounds. 

THIS AGREEMENT SHALL BE GOVERNED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF DENMARK TO THE EXCLUSION OF ANY RULE THAT WOULD REFER THE SUBJECT MATTER TO ANOTHER FORUM. YOU AND NOVO AGREE TO THE EXCLUSIVE JURISDICTION OF THE DANISH COURTS.

TERMS AND CONDITIONS

These are the terms and conditions for Novo Nordisk A/S (“Novo”) providing you the selected Compounds. By accepting these terms and conditions, Novo and you are entering into an agreement covering the transfer and use of the Compounds (the “Agreement”), subject to you receiving final email notification that Novo has accepted your request.

The Compounds provided to you under this Agreement will be used solely by you and your team for the Study Purpose (as described in your Compound request form). Except to the extent necessary to carry out the Study Purpose, you shall not analyse, modify, synthesise or create derivatives of any of the Compounds provided under this Agreement. You agree not to sell or distribute the Compounds to any third party.

You agree to use the Compounds in compliance with any and all applicable laws and regulations. You shall not administer the Compounds to humans under any circumstances.

You are free to publish the data and study results obtained from the use of the Compounds. You shall acknowledge Novo and the Novo Nordisk Compound Sharing in any publication publishing such data and study results. Please use the following format:

“NNCXXXX-XXXX was provided by Novo Nordisk Compound Sharing”

This Agreement shall not be interpreted as granting you any right or license under any intellectual property, now or hereafter owned or controlled by Novo. Any intellectual property generated by you carrying out the Study Purpose will belong to you.

This Agreement will become effective on the date you receive final email notification that Novo has accepted your request and will remain effective until the completion of the study. Novo may terminate this Agreement in case of your material breach of the Agreement. All terms that are intended to survive termination, will survive, including but not limited to the Compounds only being used for the Study Purpose and you acknowledging Novo and the Novo Nordisk Compound Sharing in any publication.

You cannot assign this Agreement to a third party without the prior written consent of Novo. Novo will have the right at any time to assign or transfer any or all of its rights and obligations under this Agreement to any of its affiliates.

You acknowledge that the Compounds are provided “as is” and without any representation or warranty, express or implied, as to the accuracy or completeness of the Compounds, including, without limitation, any implied warranty of merchantability or fitness for a particular purpose, or any warranty that the use of the Compounds will not infringe or violate any patent or other proprietary rights of any third party. Acceptance of receipt of the Compounds will constitute acceptance by you of liability for any damages or injuries resulting from your use of the Compounds.

You and Novo each hereby agrees to hold harmless and indemnify the other party against any and all losses and/or liabilities resulting from such party’s breach of this Agreement and/or unauthorised use and/or disclosure of the Compounds.

THIS AGREEMENT SHALL BE GOVERNED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF DENMARK TO THE EXCLUSION OF ANY RULE THAT WOULD REFER THE SUBJECT MATTER TO ANOTHER FORUM. YOU AND NOVO AGREE TO THE EXCLUSIVE JURISDICTION OF THE DANISH COURTS.

 

HUMAN BIOSAMPLES AND INFORMED CONSENT

Definitions. The terms used below shall have the following meaning.

Biosamples” means any and all human biological materials or derivatives, including without limitation, tissue, tissue derivatives, blood, blood derivative, primary cells, biofluids, tissue microarrays and isolated cells. Biosamples does not include materials of a human design derived by synthetic or biomanufacturing (e.g., antibodies, hormones, cDNA, cell lines).

Donor” means the person from whom a Biosample is collected.

Personal Data” means any personal information relating to a Biosample processed by Recipient as a result of, or in connection with, carrying out its obligations hereunder, that relates to an identifiable natural person such as name, initials, dates of birth, social security number, address, CV information, etc.

Informed Consent” means the consent for the collection, storage and use of Biosample(s) from the Donor (or such other person as may be entitled) that is given in accordance with applicable laws and exercising that degree of skill, care, diligence, prudence and foresight which would be reasonably expected from a skilled and experienced clinical services company.  In the event that such Informed Consent cannot be obtained from a Donor due to disability/incapacity of that individual, Informed Consent must be obtained from an individual who is legally authorised to give such consent on behalf of the incapacitated Donor.

You represent and warrant that (i) in regard to the collection, storage, handling, transport and testing of Biosamples, you have and will comply with all applicable laws and regulations and (ii) it is properly licensed and registered with all applicable regulatory bodies to perform your obligations under this Agreement in connection with the use of the Biosamples. You agree to comply with the applicable laws and regulations relating to the privacy and confidentiality of patient health information.

You will not send any Personal Data to Novo.

You acknowledge that it is your sole responsibility to, and represent and warrant to Novo that you will, prior to the collection and use of any Biosamples, obtain Informed Consent for the collection and use of the Biosamples to perform the Study Purpose. The Informed Consent form must appropriately state the risks of obtaining the Biosample and any conflicts of interest of you. Notwithstanding the foregoing, in lieu of Informed Consent, you may receive authorisation to make use of the Biosamples in accordance with this Agreement from a competent body under applicable law (e.g., IRB or ethics committee (or equivalent) waiver of consent). You will obtain all other relevant consents and approvals necessary or desirable to enable use of the Biosamples in accordance with the terms of this Agreement.

You represent and warrant to Novo that the Donors of the Biosamples are not paid for providing Informed Consent or Biosamples.  You may reimburse Donor for out-of-pocket costs, loss of earnings, or other reasonable costs in connection with donating. 

For the purposes of ensuring compliance with the representations, warranties and obligations under this Agreement, you will keep accurate and detailed books, accounts, and records on all business activity conducted pursuant to this Agreement. Novo may at any time request access to relevant consent forms, participation information etc. (either templates or redacted copies) in order to ensure compliance.

TERMS AND CONDITIONS

These are the terms and conditions for Novo Nordisk A/S (“Novo”) providing you the selected Compounds. By accepting these terms and conditions, Novo and you are entering into an agreement covering the transfer and use of the Compounds (the “Agreement”), subject to you receiving final email notification that Novo has accepted your request.

The Compounds provided to you under this Agreement will be used solely by you and your team for the Study Purpose (as described in your Compound request form). Except to the extent necessary to carry out the Study Purpose, you shall not analyse, modify, synthesise or create derivatives of any of the Compounds provided under this Agreement. You agree not to sell or distribute the Compounds to any third party.

You agree to use the Compounds in compliance with any and all applicable laws and regulations. You shall not administer the Compounds to humans under any circumstances.

You are free to publish the data and study results obtained from the use of the Compounds. You shall acknowledge Novo and the Novo Nordisk Compound Sharing in any publication publishing such data and study results. Please use the following format:

“NNCXXXX-XXXX was provided by Novo Nordisk Compound Sharing”

This Agreement shall not be interpreted as granting you any right or license under any intellectual property, now or hereafter owned or controlled by Novo. Any intellectual property generated by you carrying out the Study Purpose will belong to you.

This Agreement will become effective on the date you receive final email notification that Novo has accepted your request and will remain effective until the completion of the study. Novo may terminate this Agreement in case of your material breach of the Agreement. All terms that are intended to survive termination, will survive, including but not limited to the Compounds only being used for the Study Purpose and you acknowledging Novo and the Novo Nordisk Compound Sharing in any publication.

You cannot assign this Agreement to a third party without the prior written consent of Novo. Novo will have the right at any time to assign or transfer any or all of its rights and obligations under this Agreement to any of its affiliates.

You acknowledge that the Compounds are provided “as is” and without any representation or warranty, express or implied, as to the accuracy or completeness of the Compounds, including, without limitation, any implied warranty of merchantability or fitness for a particular purpose, or any warranty that the use of the Compounds will not infringe or violate any patent or other proprietary rights of any third party. Acceptance of receipt of the Compounds will constitute acceptance by you of liability for any damages or injuries resulting from your use of the Compounds.

You and Novo each hereby agrees to hold harmless and indemnify the other party against any and all losses and/or liabilities resulting from such party’s breach of this Agreement and/or unauthorised use and/or disclosure of the Compounds. 

THIS AGREEMENT SHALL BE GOVERNED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF DENMARK TO THE EXCLUSION OF ANY RULE THAT WOULD REFER THE SUBJECT MATTER TO ANOTHER FORUM. YOU AND NOVO AGREE TO THE EXCLUSIVE JURISDICTION OF THE DANISH COURTS.

 

NOVO NORDISK PRINCIPLES ON THE USE OF ANIMALS

When performing in vivo experiments, you must adhere to the following principles:

- All activities involving animals must be conducted strictly in accordance with present legislation.

- Animals will be used only where no available and acceptable alternatives exist.

- Alternatives to animal experiments must be used whenever possible.

- Transgenic animals may be used for testing and experiments when this model is justified.

- Animals bred specifically for experimental purposes must be used unless special conditions are in evidence.

- Housing, husbandry and transportation of animals must as a minimum comply with internationally approved standards.

- Housing conditions must take into consideration the special needs for the animal species in question.

- Housing, husbandry and care of animals must be undertaken by personnel having received adequate and relevant education. The level of education must be documented.

- Health control should be supervised by a veterinary officer experienced in regard to laboratory animals.

- Transportation of animals must be as lenient as possible, taking into consideration the special needs for the animal species in question.

- All precautions must be taken to reduce suffering and distress.

- Procedures for monitoring and evaluation of the well-being of the animals as well as treatment must be implemented.

If you are receiving NNC0100-0454 (insulin degludec), NNC0090-1170 (liraglutide) or NNC0113-0217 (semaglutide) for performing in vivo experiments, there is a process for handling and reporting of potentially serious and unexpected adverse findings which all personnel supporting the studies must follow.

This is to assure compliance with regulatory requirements. You will receive a list of ‘expected adverse findings’ which should not be reported. If there is a finding during your studies that is determined as potentially serious and unexpected, an email must immediately be sent to compoundsharing@novonordisk.com with a description of the finding. 

 

HUMAN BIOSAMPLES AND INFORMED CONSENT

Definitions. The terms used below shall have the following meaning.

Biosamples” means any and all human biological materials or derivatives, including without limitation, tissue, tissue derivatives, blood, blood derivative, primary cells, biofluids, tissue microarrays and isolated cells. Biosamples does not include materials of a human design derived by synthetic or biomanufacturing (e.g., antibodies, hormones, cDNA, cell lines).

Donor” means the person from whom a Biosample is collected.

Personal Data” means any personal information relating to a Biosample processed by Recipient as a result of, or in connection with, carrying out its obligations hereunder, that relates to an identifiable natural person such as name, initials, dates of birth, social security number, address, CV information, etc.

Informed Consent” means the consent for the collection, storage and use of Biosample(s) from the Donor (or such other person as may be entitled) that is given in accordance with applicable laws and exercising that degree of skill, care, diligence, prudence and foresight which would be reasonably expected from a skilled and experienced clinical services company.  In the event that such Informed Consent cannot be obtained from a Donor due to disability/incapacity of that individual, Informed Consent must be obtained from an individual who is legally authorised to give such consent on behalf of the incapacitated Donor.

You represent and warrant that (i) in regard to the collection, storage, handling, transport and testing of Biosamples, you have and will comply with all applicable laws and regulations and (ii) it is properly licensed and registered with all applicable regulatory bodies to perform your obligations under this Agreement in connection with the use of the Biosamples. You agree to comply with the applicable laws and regulations relating to the privacy and confidentiality of patient health information.

You will not send any Personal Data to Novo.

You acknowledge that it is your sole responsibility to, and represent and warrant to Novo that you will, prior to the collection and use of any Biosamples, obtain Informed Consent for the collection and use of the Biosamples to perform the Study Purpose. The Informed Consent form must appropriately state the risks of obtaining the Biosample and any conflicts of interest of you. Notwithstanding the foregoing, in lieu of Informed Consent, you may receive authorisation to make use of the Biosamples in accordance with this Agreement from a competent body under applicable law (e.g., IRB or ethics committee (or equivalent) waiver of consent). You will obtain all other relevant consents and approvals necessary or desirable to enable use of the Biosamples in accordance with the terms of this Agreement.

You represent and warrant to Novo that the Donors of the Biosamples are not paid for providing Informed Consent or Biosamples.  You may reimburse Donor for out-of-pocket costs, loss of earnings, or other reasonable costs in connection with donating. 

For the purposes of ensuring compliance with the representations, warranties and obligations under this Agreement, you will keep accurate and detailed books, accounts, and records on all business activity conducted pursuant to this Agreement. Novo may at any time request access to relevant consent forms, participation information etc. (either templates or redacted copies) in order to ensure compliance.   

Novo Nordisk A/S, CVR no. 24256790, Novo Allé, 2880 Bagsvaerd, Denmark is responsible for processing your personal data as part of the Novo Nordisk Compound Sharing website (the “Website”). Novo Nordisk will collect and process personal data about you for the legitimate interest of Novo Nordisk to expand external access to and interest in Novo Nordisk’s compounds, to explore potential new disease understanding and the ongoing activities in the scientific community and to send you Compound Sharing Updates.

As a data subject, you have the right to access your personal data, you may at any time object to the processing, and/or request to have your information corrected. If you have any complaints about Novo Nordisk’s processing of your personal data, you may contact the Danish Data Protection Agency.

Please visit Novo Nordisk’s privacy notice for further information about Novo Nordisk’s collection and processing of your personal data.

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Novo Nordisk Compound Sharing

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Novo Nordisk Compound Sharing

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