Distribution Services: Frequently Asked Questions

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General questions about MTAs

 

Who is the Authorized Official who signs the MTA and IURAL document?

The Authorized Official is someone who is legally authorized to bind your institution. Typically, this individual can be found in your technology transfer office (or the equivalent) of your institution. This individual must review the MTA and IURAL before the Principal Investigator signs.

 

I do not have a technology transfer office. Who should sign as the Authorized Official?

Please check thoroughly to make sure your institution does not have a technology transfer/commercialization office. You could consult the head of your department or your President’s office to see who might sign this type of agreement for your institution. It is important that whoever signs has legal authorization to do so.

 

What is the Harvard Agreement number at the top of the MTA documents?

You do not need to complete this number. This is for Harvard’s internal tracking purposes. We assign your agreement a number after we receive the partially executed copy.

 

Could we execute the MTA paperwork as PDFs via email correspondence?

Yes, if your institution is a non-profit entity and if your institution allows it. If your institution requires original signatures on documents (and will not accept PDFs) please send two (2) signed copies to:

 

Office Of Technology Development

Harvard University

Holyoke 727E

1350 Massachusetts Avenue

Cambridge, MA 02138

Attn: material transfer coordinator

 

Questions about ESCRO approval

 

My request is only for iPS cell lines. Do I need to submit ESCRO documentation?

If you have only requested iPS cell lines then you do not need to submit ESCRO documentation because there will be a section on your MTA that includes the following language:

 

Recipient affirms that: (check the box that applies)

  • Investigator has obtained ESCRO (or equivalent) approval for the proposed use of the Material, or
  • Under Recipient’s policies, no ESCRO (or equivalent) approval is required for the proposed use of the Material.

Select the appropriate box on the MTA. Even though you have requested iPS cell lines, it is Harvard policy that before we can ship iPS cell lines, your institutional official must affirm in the MTA that either your work with the requested lines has received approval from your institution’s Stem Cell Research Committee (or equivalent ethical review committee), or that no such approval is required at your institution. This is because the 2010 NAS Guidelines for Human Embryonic Stem Cell Research require approval by an ethics committee for certain kinds of work with iPS cell lines. Please note that the institutional official in your technology transfer office will need to consult such ethical oversight committee(s) in order to complete the appropriate box in this section of MTA.

 

Questions about the status of my cell line request

 

I placed a request months ago but have not yet received my cells.

You can check the status of your request by logging into the Divvly website, where you placed your request. If you have questions about using the Divvly website, please contact them directly (info@divvly.com).

 

Note that we cannot ship cell lines until the MTA is fully executed and we have received adequate documentation of ESCRO approval. Please refer to the complete Process Description; if you still have questions about the status of your order, please email etomczyk@fas.harvard.edu.

 

I am a friend or collaborator or close colleague of the researcher who derived the line that I am requesting. Do I still need to do all of this paperwork?

Yes. All requests for stem cell lines must follow the process outlined on this website to ensure that we comply with all of the relevant laws, guidelines and third party rights involved in derivation and distribution of this material.

 

Questions about the cell lines

 

Are the hES cell lines that I am interested in eligible for NIH funding?

Some, but not all, of the HUES lines are eligible for NIH funding. Some of the lines have restrictions on how they may be used with NIH funding. Please refer to the NIH Human Embryonic Stem Cell Registry.

 

I can’t find the line I am looking for in your catalog, but I know it was derived by an HSCI investigator. Where is it?

As we are able to deposit lines with our distribution partners, some lines may no longer be available from us. If you cannot find the line you are looking for in our catalog, feel free to email etomczyk@fas.harvard.edu.

 

Questions about requesting HUES lines

 

Which MTA documents do I need to complete to receive HUES cells?

  1. Material Transfer Agreement (MTA) is a form approved by WiCell, Inc. under a memorandum of understanding permitting the transfer of materials that are or may be covered by claims in U.S. Patent 5,843,780, U.S. Patent 6,200,806, U.S. Patent Application 09/522,030 and corresponding U.S. or foreign patent rights. The MTA must be signed by an authorized person on behalf of the institution, as well as by the principal investigator. This agreement is not negotiable.
  2. Institutional Undertaking Regarding Applicable Law, which confirms that no applicable laws, regulations or contracts will be violated by the transfer or use of the HUES cells. This must be signed by an authorized person on behalf of the institution, as well as by the principal investigator.
  3. Verification Statement, required only for institutions outside the U.S., which provides a verification by legal counsel that no applicable foreign laws or regulations will be violated by the transfer or intended use of the HUES cells. This must be signed by legal counsel for the foreign institution.

I am requesting the HUES lines, but I am not the Principal Investigator of my lab. Can I sign the MTA and IURAL?

No. Please have the Principal Investigator of your lab sign the MTA on your behalf.

 

Can the Authorized Official sign the Verification Statement?

NO. The Verification Statement must be signed by a legal counsel (lawyer) who can verify that no applicable foreign laws or regulations will be violated by the transfer or intended use of the HUES cells. This individual should not be your authorized official.

 

Are the MTA documents for HUES lines negotiable?

Rarely. We will not accept substantive changes to these documents. Because our MTA is approved by WiCell, Inc./WARF, Harvard and the Howard Hughes Medical Institute can only make minor adjustments that do not conflict with our agreement with WiCell, Inc./ WARF.

 

I have recently acquired a new position at another institution and would like to take the HUES lines with me. Do I need to execute a new MTA?

Yes. A new MTA is needed if the lines will be transferred to another institution.

 

I have been working with the HUES lines in another Principal Investigator’s lab and have recently become a Principal Investigator of my own lab. Do I need to execute a new MTA?

Yes. Each Principal Investigator should have his/her own MTA paperwork to be using the HUES lines.

 

I would like to obtain HUES lines from a colleague and will not need the lines to be shipped from Harvard. Can I do so?

Yes. Please provide us with the name of the Principal Investigator and his/her institution from which you will be receiving the lines. You will still need to complete an MTA with Harvard, but we will modify the MTA to acknowledge the circumstance.

 

I need replacement vials of a HUES line. I have completed an MTA in the past; do I need a new MTA?

Probably not, but we will check your previous MTA to make sure it is not significantly outdated.

 

I am from a for-profit entity. Are there any extra steps I need to take to obtain HUES lines?

Yes. Please verify that you have a license in place with WiCell Inc./WARF. You will need this before you can complete the MTA documents.

 

Questions about invoicing and payment

 

I paid my bill a while ago but my status has not been updated to payment received, why not?

Harvard is so large that sometimes if the address or department name is not exactly right, then the payment could be sitting in the wrong department. Contact etomczyk@fas.harvard.edu for assistance.