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Technology Transfer Issues When Research Staff Leaves NINDS
 
For Investigators
 
Material Transfer Agreement (MTA) - A variety from which to choose
 

A primary goal of research is to attain the widest possible circulation of research knowledge and material in order to maintain a cycle of continual learning. To that end, the NIH has developed multiple methods for transferring materials between research entities, whether federal or academia, with a minimal amount of documentation. However, realistically, there are just as many various competitive, legal, and regulatory interests influencing your research options. Those influencing interests require definition of such factors, not exclusive list by any means, such as use, liability, and profit. Therefore, the day of no paperwork or even little paperwork is rare.

The vast majority of academic and commercial institutes will now require some type of agreement prior to sending you material. You should ask if an agreement is required, it can save you possible headaches later and possibly your fellow researchers job. If they say no agreement is necessary, enjoy it- it won’t happen often!!!

Take heart however, for the underlying design of Material Transfer Agreement (MTA) and Simple Letter of Agreement (SLA) is to be succinct, specific, and easy. While an MTA is not mandated, the use of such a simple process makes good sense in the administration of a lab. The terms included in any agreement vary between providers, and significant differences in structure exist between providers from an academic and commercial entity, but in general, an MTA and SLA will address at a minimum, the following:

  • Identification of the provider and recipient
  • Identification of the material and the volume of material
  • Definition of the research, how the material will and will not be used. The use of the material can be broad or narrow, depending on what the scientists involved have agreed upon. By documenting the intended use in writing, the chances of a misunderstanding between the scientists as to what research will be conducted are reduced.
  • Maintenance of confidentiality of background or supporting data or information, if any
    term of agreement and disposal of material at end of agreement MTAs specify that the receiving scientist may not transfer the materials to another scientist without authorization from the providing scientist. This allows the providing scientist some assurance that he will be informed if the material is transferred to another laboratory.
  • Indemnification and warranties. MTAs are agreements between institutions, therefore any liability incurred in using or disposing of the materials is the responsibility of the institutions and not the scientists sending or receiving the material.
  • Issues of discovery or invention from the use of the material.
  • Conformance to applicable statutes, regulations, and NINDS and NIH policy.
  • When materials are transported from the NIH campus, since they are federal property, one should have either a property pass or a MTA to avoid complications which could arise from accusation of mishandling of federal property.

The UBMTA ( Uniform Biological Material) transfer Agreement is an agreement born out of a desire to streamline the transfer of materials for research. Amongst those organizations catering to such a philosophy, regardless of classification, any organization can be signatory to this agreement as administered by the Association of University Technology Managers (AUTM). The use of the UBMTA is not mandatory, so in instances that special circumstances prevail, a signatory is not bound to the use of only this agreement but can opt for any agreement of their choice.

A Consortium or Repository MTA may have many of the same clauses of a standard MTA, but generally will include a special section dealing with “ background rights” to those materials being deposited or being requested from the repository. Generally, the consortiums and repositories have agreements for those contributing materials and a separate agreement for those requesting materials

Software Transfer Agreements (STA) are still being revised, simply due to the complex underlying legal issues surrounding software development and protections. The Office of General Counsel has approved software transfer agreements as utilized by some of the ICs of the NIH, and within the near future the PHS Technology Transfer Policy Board will adopt a version that can be utilized as a Standard.

 
Processing an Agreement for the Transfer Material :
 

An important part of many of your labs is attaining and distributing materials, compounds, or software from colleagues’ labs. We want to make the process of using any form of the Material Transfer Agreement (MTA) efficient in assisting you to get materials into and out of your lab. A few hints to getting this done quickly is:

  • Use your NINDS TTO services to send and receive the agreements – get them involved early
  • Your lab chiefs must be the requestor for the material (NEW)
  • Someone from the NINDS TTO must review the agreement before taking it for signature

To initiate this process, you have three options:
go on the website http://ott.od.nih.gov/forms_model_agreements to attain the form which you can fill out the information, send it electronically to the NINDS TTO for review. After review, the NINDS TTO will have you download and print out in duplicate, sign where appropriate as the investigator, get the lab or section chief to sign, then send to NINDS TTO via campus mail. The NINDS TTO will get the appropriate NINDS signature, then overnight the duplicates to the recipient for their signature. NINDS TTO will follow up with the firm to get signature in a timely manner.
Or
you can contact your NINDS TTO office and we will send to you an electronic copy of the Word form for the appropriate agreement for your situation. You can fill it in electronically, email it back to one of the NINDS TTO staff, who will review and approve it, send it back via email so you can print it out, in duplicate, sign it as requesting researcher, have your lab chief sign it, then send it back to the NINDS TTO who will get the NINDS signatory to execute it. The NINDS TTO will overnight the duplicates to the recipient for their signature and follow up with the firm to get signature. Once it is returned to NINDS TTO, we will notify you that the material can be shipped
Or
You can send the email or fax that you got from the fellow researcher requesting the material, and forward it to the NINDS TTO including your name, your lab chief’s name, your address, phone and email and a brief description and amount of material you plan to send. We will contact the recipient if necessary, fill in all information, send you the completed form electronically. You print it out in duplicate, sign it as researcher, have your lab chief sign it, then return it to NINDS TTO which will overnight the duplicates to the recipient for their signature and follow up with the firm to get signature. When the NINDS TTO receives a fully executed copy back into our office, we will send you a copy of the fully executed agreement for your files. At that time, you can ship out the materials.

Processing an Agreement for non-NINDS Entities :

Your NINDS TTO must review all outside agreements. Unfortunately, simply because the title of the agreement is Material Transfer Agreement does not mean that it says the same as the NIH form. An MTA is a good management practice because it helps to prevent misunderstanding and avoid commitment to non allowed liabilities. We find quite often, universities and research institutes include articles to which we cannot agree due to statutes or NIH policy. If you are requesting material from a commercial firm, quite often their agreement is listed as a Material Transfer Agreement, but many times it will have terms we can have only in our MCRADA or Clinical Trial Agreement.
For those agreements that are and should be MTAs, once the NINDS TTO has reviewed the agreement, if no changes are required, the TTO will route the agreement for appropriate signatures. If changes are required, the NINDS TTO personnel will notify you that some terms are not acceptable and then contact the provider’s appropriate personnel and negotiate appropriate terms. The signature routing includes the NINDS investigator sent duplicate copies with a routing sheet for signature, the signature of the lab chief, and the signature of the authorized NINDS signatory (NEW) who will send both copies back to the NINDS TTO. NINDS TTO personnel will send the duplicates to the provider of the material and follow up with them to attain their signatures and get one fully executed copy back for NINDS files.

Note: When staff are leaving your lab’s employment, they must fill out an MTA for materials which they are taking with them. They can do this as individuals, or they can have the new employer sign ( the latter is generally the preferable ).
When materials are transported from the NIH campus, since they are federal property, one should have either a property pass or a MTA to avoid complications which could arise from accusation of mishandling of federal property.

 

 
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