MATERIAL TRANSFER AGREEMENT
FOR THE TRANSFER OF MATERIALS FROM NCRAD
Whereas the National Cell Repository for Alzheimer’s Disease (NCRAD), whose address is
Department of Molecular and Medical Genetics, Indiana University, 975 West Walnut Street, IB
130, Indianapolis, IN 46202-5251, was established by the National Institute on Aging (NIA) of
the National Institutes of Health (NIH), an agency of the Public Health Service (PHS) and the
U.S. Department of Health & Human Services (HHS), to help address the public health needs for
continued research concerning Alzheimer’s Disease and related neurological diseases and aging;
Whereas NCRAD, located at Indiana University, an educational institution organized under the
laws of the State of Indiana, whose address is Research and Sponsored Programs, 620 Union
Drive, Room 618, Indianapolis, IN 46202-5167, will receive coded blood samples, tissue, cell
lines and/or DNA from humans and associated phenotypic data submitted by public and private
sector investigators (“Provider”);
Whereas NCRAD will distribute coded cell lines and DNA from humans and associated
phenotypic data to qualified investigators for the development of genetic data and whereas
National Institute on Aging Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS) at
Washington University, along with other NIA approved sites have been designated by NIA for
the deposit of all genetic data developed by Recipient using the materials and/or data provided
by NCRAD; and
Whereas Recipient (as defined in Appendix C), contingent upon being found to be a qualified
investigator as determined by the NIA-designated Cell Bank Advisory Committee (CBAC),
desires to obtain from NCRAD coded cell lines and/or DNA from humans and associated
phenotypic data and accompanying documentation and updates;
WHEREAS, Associated Phenotypic Data is defined as deidentified data on family structure, age,
sex, vital status, psychopathology, diagnosis, and other clinically relevant associated phenotypic
information, stripped of all personal identifiers and thus unlinkable to the individuals from whom
they were obtained;
WHEREAS, Genetic Data is defined as de-identified data derived from genotyping, mutation
analysis, single nucleotide polymorphisms (SNPs) and other genetic analyses of Biomaterials
and Associated Phenotypic Data conducted by Submitters and other scientists, stripped of all
personal identifiers and thus unlinkable to the individuals from whom they were obtained;
Therefore, Recipient and NCRAD enter into the following agreement governing the transfer and
use of such coded cell lines and DNA from humans and Associated Phenotypic Data, as well as
any resultant Genetic Data.
In response to Recipient’s request for the Research Material (defined as the specific coded cell
line(s) and DNA from humans and Associated Phenotypic Data requested by Recipient,
including the biological samples, their progeny, and/or derivatives thereof) as listed in Appendix
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C, the Recipient and the institution employing and/or affiliated with the Recipient, which has the
authority to approve or disprove legal agreements on behalf of the Recipient (“Recipient
Institution”) must agree to the following before the Recipient receives the Research Material.
1. The control and distribution of the above Research Material is the responsibility of
NCRAD and is made available as a service to qualified individuals in the research
community to further research in Alzheimer’s Disease and related neurological diseases
and aging.
2. THIS RESEARCH MATERIAL MAY NOT BE USED IN EXPERIMENTS
INVOLVING HUMAN SUBJECTS. The Recipient agrees to comply with all Federal
rules and regulations applicable to the use and handling of the Research Material.
3. Non-profit and for-profit Recipients will use this Research Material for non-commercial
research purposes solely in connection with the following project described specifically
in Appendix C (“Research Project”). NCRAD and Recipient agree that subsequent
transfers of Research Materials from NCRAD to Recipient will be made using the
ADDENDUM TO THE MATERIAL TRANSFER AGREEMENT FOR THE
TRANSFER OF MATERIALS FROM NCRAD, attached hereto as Appendix E. This
Addendum document will be signed by the Recipient Scientist and a NCRAD
representative.
This Research Material represents a significant investment on the part of the Provider and
the NIA. Information received from NCRAD including coded biological samples, their
derivatives, and accompanying coded phenotypic data may only be used exclusively by
the Recipient and/or those individuals under his/her supervision in connection with the
Research Project as described above.
4. The Research Material will not be further distributed by the Recipient to others without
NCRAD’s written consent. The Recipient shall refer any request for the Research
Material to NCRAD. Investigators using Research Material from NCRAD shall share
Genetic Data derived from the Research Project by placing these Data and Associated
Phenotypic Data either in the NIAGADS or another NIA approved site or both.
NIAGADS along with other NIA approved sites will make these Genetic Data and
Associated Phenotypic Data available to qualified investigators in the scientific
community for secondary analysis in accordance with standards established by the NIA.
The Recipient agrees to provide such genetic data as soon as possible, but no later than
upon acceptance of a subset of data for publication or public disclosure of a submitted
patent application, whichever is earlier.
5. The Recipient will acknowledge the contribution of NCRAD, all institutions contributing
to NCRAD, and the NIA in any and all oral and written presentations, disclosures, and
publications resulting from any and all analyses of the Research Material, as well as any
data received from NCRAD. The following language should be used, “Samples from the
National Cell Repository for Alzheimer’s Disease (NCRAD), which receives government
support under a cooperative agreement grant (U24 AG21886) awarded by the National
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Institute on Aging (NIA), were used in this study. We thank contributors, including the
Alzheimer’s Disease Centers who collected samples used in this study, as well as patients
and their families, whose help and participation made this work possible.”
6. Any Research Material delivered pursuant to this Agreement is understood to be
experimental in nature and may have hazardous properties. All cultured animal and
human tissue cells have the potential for carrying viruses, latent viral genomes, and other
infectious agents in a non-apparent state. By accepting this Research Material, the
undersigned Recipient assumes full responsibility for the safe and appropriate handling of
the Research Material. THE PROVIDER OF THE RESEARCH MATERIAL TO
NCRAD, NCRAD, AND INDIANA UNIVERSITY MAKE NO REPRESENTATIONS
AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR
IMPLIED INCLUDING, BUT NOT LIMITED TO MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE
RESEARCH MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT,
TRADEMARK, OR OTHER PROPRIETARY RIGHTS. Unless prohibited by law,
Recipient assumes all liability for claims for damages against it by third parties which
may arise from Recipient’s use, storage or disposal of the Research Material except that,
to the extent permitted by law.
7. The Recipient agrees to use the Research Material in compliance with all applicable
statutes, rules, and regulations.
8. The Recipient agrees that neither the Research Material nor accompanying data will be
used either alone or in conjunction with any other information, in any effort whatsoever
to establish the individual identities of any subjects from which the Research Material
was derived.
9. NCRAD may terminate this agreement if the Recipient is in default of any of the terms
specified herein and if the deficit has not been remedied within thirty (30) days after the
date of written notice by NCRAD of such deficit. Upon termination of the specific
research project, the Recipient agrees to destroy all unused Research Material, including
accompanying Phenotypic and clinical Data and Genetic Data generated from Recipient’s
use of the Research Material, and Recipient shall provide NCRAD with written
certification of their destruction, unless permission to retain Research Material and data is
specifically provided in writing by NCRAD to the Recipient.
10. Subjects from whom Research Material has been derived and provided to NCRAD may
decide to withdraw consent for use of the Research Material. In this event, the Provider
of such Research Material for which consent was obtained shall notify NCRAD that
consent has been withdrawn and that the applicable sample(s) should be destroyed.
NCRAD will then notify all Recipients of the Research Material and Associated
Phenotypic Data for which consent has been withdrawn and request that the recipients
destroy the samples if not already destroyed. Recipient shall destroy the Research
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Material and the Associated Phenotypic Data which was provided, and shall provide
NCRAD with certification stating that the Research Material had been destroyed.
11. With the exception below, the Research Material is provided at no cost, or with an
optional transmittal fee solely to reimburse NCRAD for its preparation and distribution
costs. A fee for requests of large numbers of samples may be applied.
12. The Recipient, Recipient Institution, NCRAD, and Indiana University must sign both
copies of this agreement and return one signed copy to NCRAD. NCRAD will then send
the Research Material to Recipient.
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RECIPIENT INFORMATION and AUTHORIZED SIGNATURE
Name & Title of Authorized Official:
__________________________
Signature of Authorized Official
_________
Date
Certification of Recipient: I have read and understood the conditions outlined in this Agreement and I
agree to abide by them in the receipt and use of the Research Material and accompanying data.
__________________________
_________
Recipient Signature
Date
NCRAD INFORMATION and AUTHORIZED SIGNATURE
Name & Title of NCRAD Representative:
__________________________
Signature of NCRAD Representative
Name & Title of Authorized Official:
__________________________
Signature of Authorized Official
_________
Date
Janice C. Froehlich
Interim Vice Chancellor for Research
Indiana University
_________
Date
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APPENDIX C
RESEARCH MATERIAL TO BE PROVIDED BY NCRAD TO RECIPIENT
Date:
Recipient Name:
Phone:
Fax:
E-mail address:
Recipient Institution:
Address:
Recipient’s address for receipt of the Research Material(s):
Please list the Research Material(s) being requested from NCRAD (using specific identifiers for
each Research Material) (attach separate page(s) as necessary):
Please discuss the non-commercial research to be conducted by Recipient (“Research Project”)
using the Research Material(s) listed above from NCRAD (attach separate page(s) as necessary):
Please specify the specific Genetic Data that will be sought in the Research Project (attach
separate page(s) as necessary):
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APPENDIX E
ADDENDUM TO THE MATERIAL TRANSFER AGREEMENT
FOR THE TRANSFER OF MATERIALS FROM NCRAD
Whereas the National Cell Repository for Alzheimer’s Disease (NCRAD), whose address is
Department of Molecular and Medical Genetics, Indiana University, 975 West Walnut Street, IB
130, Indianapolis, IN 46202-5251, was established by the National Institute on Aging (NIA) of
the National Institutes of Health (NIH), an agency of the Public Health Service (PHS) and the
U.S. Department of Health & Human Services (HHS), to help address the public health needs for
continued research concerning Alzheimer’s Disease and related neurological diseases and aging;
Whereas Indiana University, an educational institution organized under the laws of the State of
Indiana, whose address is Research and Sponsored Programs, 620 Union Drive, Room 618,
Indianapolis, IN 46202-5167, on behalf of NCRAD, has entered into a Material Transfer
Agreement with Recipient (as defined below), fully signed on
, to provide blood, brain
tissue, cell lines, and/or DNA and associated phenotypic data (“Research Material”) to Recipient
from NCRAD, which were provided to NCRAD by Alzheimer Disease Centers, individual
investigators, and medical personnel;
Whereas NCRAD will distribute coded cell lines and DNA from humans and associated
phenotypic data to qualified investigators for the development of genetic data and whereas the
National Institute on Aging Genetics of Alzheimer’s Disease Data Storage Site (NIAGADS)
along with other NIA approved sites have been designated by NIA for the deposit of all genetic
data developed by Recipient using the materials and/or data provided by NCRAD; and
Whereas Recipient desires to obtain additional coded cell lines and/or DNA from humans and
associated phenotypic data and accompanying documentation and updates from NCRAD for
furthering research;
WHEREAS, Associated Phenotypic Data is defined as deidentified data on family structure, age,
sex, vital status, psychopathology, diagnosis, and other clinically relevant associated phenotypic
information, stripped of all personal identifiers and thus unlinkable to the individuals from whom
they were obtained;
WHEREAS, Genetic Data is defined as de-identified data derived from genotyping, mutation
analysis, single nucleotide polymorphisms (SNPs) and other genetic analyses of Biomaterials
and Associated Phenotypic Data conducted by Submitters and other scientists, stripped of all
personal identifiers and thus unlinkable to the individuals from whom they were obtained;
Therefore, Recipient wishes to obtain the following additional materials (using specific
identifiers for each material) to be included in the definition of “Research Material” as specified
above and in the original Agreement (attach separate page(s) as necessary):
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Please discuss the non-commercial research to be conducted by Recipient (“Research Project”)
using the Research Material(s) listed above from NCRAD (attach separate page(s) as necessary):
Please specify the specific Genetic Data that will be sought in the Research Project (attach
separate page(s) as necessary):
RECIPIENT INFORMATION and SIGNATURE
Recipient Name:
Phone:
Fax:
E-mail address:
Recipient Institution:
Address:
Certification of Recipient: I have read and understood the conditions outlined in this Agreement and I
agree to abide by them in the receipt and use of the Research Material and accompanying data.
__________________________
Recipient Signature
_________
Date
NCRAD INFORMATION and SIGNATURE
Name & Title of NCRAD Representative: Tatiana Foroud, Ph.D
__________________________
Signature of NCRAD Representative
_________
Date
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