NIAAA/COGA DATA AND BIOMATERIALS

DISTRIBUTION AGREEMENT-- WAVE I and WAVE II


WHEREAS, the national Institute on Alcohol Abuse and Alcoholism ("NIAAA") pursuant to its public health mission to identify and characterize the genetic basis of alcohol-related disorders supports research projects in which there is collection by scientific investigators and their relatives;

WHEREAS, anonymous blood samples obtained from Wave I and/or Wave II subjects, collected by Submitters, stripped of all personal identifiers and thus unlinkable to the individuals from whom they were obtained are used for the production of immortalized cell lines and extraction of DNA (cell lines and DNA samples are collectively known as "Biomaterials");

WHEREAS, anonymous data on family structure, age, sex, vital statistics, psychopathology, diagnosis, and other clinically relevant information ("Clinical Data") obtained from Wave I and/or Wave II subjects have been collected by Submitters, stripped of all personal identifiers and thus are unlinkable to the individuals from whom the data were collected;

WHEREAS, anonymous data on individual biochemistry, brain electrical responses, and psychological test performances ("Research Data") obtained from Wave I and/or Wave II subjects have been collected by Submitters, stripped of all personal identifiers and thus are unlinkable to the individuals from whom the data were collected;

WHEREAS, anonymous data derived from genotyping, mutation analysis, and other genetic analyses of Biomaterials, Clinical Data, and Research Data ("Genetic Analysis Data") obtained from Wave I and/or Wave II subjects, conducted by Submitters and other scientist, have been stripped of all personal identifiers and thus are unlinkable to the individual from whom the data were collected;

WHEREAS, NIAAA will coordinate the sharing of Biomaterials, Clinical Data, Research Data, and Genetic Analysis Data obtained from Wave I and/or Wave II subjects, on alcohol-related disorders that are owned by the Research Foundation of the State University of New York ("SUNY") and are to be distributed for analysis to qualified scientific investigators conducting research specifically on the genetic basis of these and related disorders;

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Receiving Institution ("Recipient")

desires to use Biomaterials, Clinical Data, Research Data, or Genetic Analysis Data at its sole risk and at no expense to NIAAA or SUNY.

NOW THEREFORE, it is mutually agreed as follows:

  1. SUNY, through the Collaborative Study on the Genetics of Alcoholism (COGA) cell repository ("Cell Repository"), agrees to transfer to the Recipient Biomaterials collected from Wave I and/or Wave II subjects, and/or SUNY, through COGA data centers ("Centers") of Washington University at St. Louis and SUNY, agrees to transfer Clinical Data, Research Data, and/or Genetic Analysis Data, for use only by Recipient's principal investigator ("Principal Investigator") to conduct research on

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    Recipient will submit to NIAAA a signed and dated Distribution Agreement for each study for which Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, or Genetic Analysis Data are requested.

  2. Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, or Genetic Analysis Data that are received from COGA will be used by Principal Investigator only in connection with a specific research project ("Research Project") for which Principal Investigator has sole responsibility and which is explicitly described in information provided to NIAAA.
     
  3. This Distribution Agreement is not transferable to another Recipient or to another facility that is not under the control of Recipient. Principal Investigator cannot transfer the Research Project to a different institution unless NIAAA and SUNY agree to a new Distribution Agreement with that institution. Recipient cannot appoint a new Principal Investigator, conduct the Research Project at a different facility under Recipient's control, or make other substantive changes including changes in the research protocol, unless NIAAA and SUNY agree to an appropriate amendment of the Distribution Agreement.
     
  4. Recipient agrees to retain control over Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, and Genetic Analysis Data received from COGA and further agrees not to provide them, with or without charge, to any other entity or any individual other than Principal Investigator.
     
  5. COGA, through the Centers, agrees to provide Principal Investigator with documentation for all Wave I and/or Wave II data sent.
     
  6. If requested, COGA, through the Centers, agrees to provide Principal Investigator with periodic updates of Wave I and/or Wave II Clinical Data, including updates of family structure as determined from laboratory analysis of DNA samples, if available.
     
  7. If Wave I and/or Wave II--Genetic Analysis Data are requested, SUNY, through the Centers, agrees to provide Principal Investigator with periodic updates of Genetic Analysis Data, if available, including the names and addresses of the scientist who generated such Genetic Analysis Data.
     
  8. Biomaterials are provided at a cost of $35 per 50 micrograms of DNA and $75 per lymphoblastoid cell line. These fees are subject to change following written notification from NIAAA. Recipient agrees to pay any and all fees to the COGA Cell Repository before shipment is made.
     
  9. A Recipient who proposes to use Wave I and/or Wave II--Biomaterials in the Research Project described in this agreement must request those Biomaterials no later than four (4) months from the date on which Clinical Data and Genetic Analysis data are sent to the Recipient by the Centers. If Biomaterials are not requested within that time period, the proposed Research Project will be deemed terminated. At that time, Recipient will notify NIAAA and SUNY and provide written certification that any and all Wave I and/or Wave II--Biomaterials, Clinical Data Research Data, and Genetic Analysis Data were destroyed by Recipient, unless Recipient obtain NIAAA's and SUNY's agreement to an extension of the agreement. Any such extension must be in writing and in accordance with the terms and conditions under which SUNY is distributing data and Biomaterials at that time.
     
  10. Recipient agrees to provide COGA, through the Centers, with any and all Wave I and/or Wave II--Genetic Analysis Data derived from Clinical Data, Research Data, and Biomaterials received under the conditions of this Distribution Agreement. Recipient will provide to the Centers such Genetic Analysis Data twelve (12) months after receipt of Biomaterials of upon publication of research in which such data were analyzed, whichever comes first, and annually thereafter upon the anniversary of this date. This will continue until the Research Project is completed. NIAAA and SUNY, through the COGA Centers, may at any time distribute these Genetic Analysis Data to qualified scientific investigators, subject to any patents or pending patent applications of Recipient. Recipient will provide Wave I and/or Wave II--Genetic Analysis Data, indexed by subject's ID number, in the electronic format specified by the Centers. When genotyping has been conducted, DNA marker names and allele sizes in base pairs and corresponding frequencies, relative distances in Megabases and in Centimorgan, marker heterozygosity, and the source of information used to determine map location, will also be provided. Recipient also agrees to subunit to the Centers all Wave I and/or Wave II data relevant to the establishment of family structure as determined from laboratory analysis, at the time such determinations are made. Recipient also agrees to send to NIAAA annual Progress Reports on work accomplished using the COGA data and/or Cell Repository, and once per year thereafter, until the conclusion of the Research Project.
     
  11. Principal Investigator will acknowledge the contributions of the Collaborative Study on the Genetics of Alcoholism, supported by NIH Grants U10AA08401 and U10AA08403 (NIAAA), in any and all analyses of Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, or Genetic Analysis Data. Similarly, Principal Investigator will acknowledge the contributions, if used, of any and all scientists who have provided genotyping data to the Wave I and/or Wave II--Genetic Analysis Data. Principal Investigator will provide to NIAAA a list of all such presentations, disclosures, and publications.
     
  12. When the Research Project is completed, Recipient must notify NIAAA and SUNY and provide written certification of the destruction of Wave I and/or Wave II Biomaterials, Clinical Data, Research Data, or Genetic Analysis Data received from Cell Repository and Centers in accordance with all applicable laws and/or accepted safety procedures. The Research Project shall be deemed completed for purposes of this agreement three (3) years after the effective date of this agreement, unless Recipient obtains NIAAA's and SUNY's agreement to an extension of the agreement. Any such extension must be in writing and in accordance with the terms and conditions under which COGA is distributing data and biomaterals at that time.
     
  13. Recipient agrees that Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, or Genetic Analysis Data received from the Cell Repository and Centers will not be used, either alone or in conjunction with any other information, in any effort whatsoever to establish the individual identities of any of the subjects from whom Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, or Genetic Analysis Data were obtained.
     
  14. Recipient agrees that Wave I and/or Wave II--Biomaterials, their progeny, and unmodified or modified derivatives thereof will not be used in any experiments or procedures that are not disclosed and approved as part of the Distribution Agreement, as required by this Agreement, and will not be used in human experimentation of any kind.
     
  15. NO WARRANTIES, EXPRESSED OR IMPLIED, ARE OFFERED AS TO THE MERCHANTABILIGY OR FITNESS FOR ANY PURPOSE OF THE WAVE I AND/OR WAVE II-- BIOMATERIALS, CLINICAL DATA, RESEARCH DATA, AND GENETIC ANALYSIS DATA PROVIDED BY THE CELL REPOSITORY AND CENTERS TO RECIPIENT UNDER THIS AGREEMENT, OR THAT THE WAVE I AND/OR WAVE II--BIOMATERIALS, CLINICAL DATA, RESEARCH DATA, AND GENETIC ANALYSIS DATA MAY BE EXPLOITED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY OR PROPRIETARY RIGHTS OF ANY THIRD PARTIES.
     
  16. The United States Government and SUNY, or its subcontractors, are not responsible for the accuracy of Wave I and/or Wave II--Clinical Data, Research Data, or Genetic Analysis Data, provided by Submitters and other Recipients, which are distributed by the COGA Centers.
     
  17. Recipient acknowledges that Wave I and/or Wave II--Biomaterials have the potential for carrying viruses, latent viral genomes, and other infectious agents in an inapparent state. Recipient agrees to treat Biomaterials received from the Cell Repository as if they were not free of contamination, and that Biomaterials will be handled by trained persons under laboratory conditions that afford adequate biohazard containment. By accepting Biomaterials from the Cell Repository, Recipient assumes full responsibility for their safe and appropriate handling.
  18. Recipient agrees not to claim, infer, or imply Governmental endorsement of the Research Project, the institution, or personnel conducting the Research Project or any resulting commercial product(s). To the extent permitted by law, Recipient agrees to hold the United States Government, SUNY, and subcontractors that operate the Cell Repository, Centers, Submitters, and other Recipients providing Genetic Analysis Data to the Centers harmless and to indemnify all such parties for all liabilities, demands, damages, expenses, and losses arising out of Recipient's use for any purpose of Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, and Genetic Analysis Data received from the Cell Repository or Centers.
  19. Recipient acknowledges that the collection of Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, and Genetic Analysis Data were approved by the Institutional Review Board (IRB) of the local collection sites, COGA Cell Repository and Centers in accordance with Department of Health and Human Services regulations at 45 CFR Part 46. Recipient agrees to report to NIAAA and COGA any unanticipated problems involving risks to subjects or others. Recipient remains subject to applicable State or local laws or regulations and institutional policies that provide additional protection for human subjects.
  20. Execution of this Distribution Agreement is contingent upon Recipient's compliance with all terms and conditions of any existing Distribution Agreement.
  21. If Recipient executed a Distribution Agreement more that twelve (12) months from the time of the current request for Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, and Genetic Analysis Data, and has not provided to COGA Genetic Analysis Data derived from any Biomaterials previously received from COGA, Recipient agrees to provide to NIAAA and SUNY, through the COGA Centers, resulting Genetic Analysis Data as a condition for execution of the current Distribution Agreement. If Recipient executed a Distribution Agreement within twelve (12) months from the time of the current request for Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, and Genetic Analysis Data, Recipient agrees to provide to NIAAA and SUNY, through the COGA Centers, any Genetic Analysis Data derived from such Biomaterials within twelve (12) months from the time that the Biomaterials were previously received, or upon publication of research in which such data were analyzed, whichever comes first.
  22. NIAAA may terminate this Distribution Agreement if Recipient is in default of any of the terms specified herein and if the deficit has not been remedied within 30 days after the date of written notice by NIAAA of such deficit. Upon termination of this Distribution Agreement. Recipient agrees to return all unused Wave I and/or Wave II--Biomaterials to the Cell Repository and Clinical Data, Research Data, and Genetic Analysis Data to the COGA Centers, or provide NIAAA with written certification of their destruction.
  23. Failure to comply with any of the terms specified herein may result in disqualification of the Recipient from receiving additional Wave I and/or Wave II--Biomaterials from the Cell Repository and Clinical Data, Research Data, and Genetic Analysis Data from NIAAA and SUNY, as provided by the COGA Centers.
  24. NIAAA reserves the right to distribute, through the COGA Cell Repository and Centers, any and all Wave I and/or Wave II--Biomaterials, Clinical Data, Research Data, and Genetic Analysis Data to others and to use it for its own purposes.
  25. Amendments to the Distribution Agreement must be made in writing and agreed to by all parties.
  26. Recipient expressly certifies that the contents of any statements made or reflected in this Distribution Agreement are truthful and accurate.
  27. This Distribution Agreement shall be construed in accordance with Federal law as applied by the Federal courts in the District of Columbia.

Name and Title, Receiving Institution's Principal Investigator

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      Mailing Address, Receiving Institution's Principal Investigator

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      Phone Number, Receiving Institution's Principal Investigator

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      Fax Number, Receiving Institution's Principal Investigator

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      E-mail, Receiving Institution's Principal Investigator

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Name and Title, Receiving Institution's Authorized Representative

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      Mailing address, Receiving Institution's Authorized Representative

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      Phone Number, Receiving Institution's Authorized Representative

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      Fax Number, Receiving Institution's Authorized Representative

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      E-mail, Receiving Institution's Authorized Representative

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DATED SIGNATURES

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Signature and Date, Receiving Institution's Principal Investigator

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Signature and Date, Receiving Institution's Authorized Representative

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Signature and Date, NIAAA's Authorized Representative

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Signature and Date, SUNY's Authorized Representative