5.  Non-transferability.  This Distribution Agreement is not transferable.  Recipient agrees that substantive changes made to the Research Project described above, and/or appointment by Recipient of another Principal Investigator to complete the Research Project, require execution of a new Distribution Agreement in which the new Principal Investigator and/or new Research Project are designated.

6.  Publication.  Prompt publication of the results of the Research Project is encouraged.  Recipient agrees to provide to the HyperGEN a copy of any abstract ten (10) days in advance of submission for publication and any manuscript thirty (30) days in advance of submission for publication, in order to permit review and comment, and ensure compliance with the confidentiality requirements of this Agreement.

7.  Acknowledgments.  Recipient agrees to acknowledge the contribution of HyperGEN investigators in any and all oral and written presentations, disclosures, and publications resulting from any and all analyses of Clinical Data and Biological Materials.

    7.1  Collaborations/Acknowledgments.  If the Research Project involves a collaboration with HyperGEN co-investigators (see paragraph 4 above), then Recipients will acknowledge HyperGEN co-investigators as co-authors, as appropriate, on any publication.  In addition, the Recipient will use the first acknowledgment printed below.

    7.2  Other Studies/Acknowledgments.  If the Research Project does not involve a collaboration with HyperGEN co-investigators (see paragraph 4 above), then the manuscripts, upon submission pursuant to paragraph 6 above, will be reviewed by HyperGEN investigators for scientific content and consistency of data interpretation with previous HyperGEN publications.  If Recipient agrees to incorporate significant comments from the review, Recipient will use the acknowledgment printed below. 

"The HyperGEN is supported by the National Heart, Lung, and Blood Institute (NHLBI).  This manuscript has been reviewed by HyperGEN investigators for scientific content and consistency of data interpretation with previous HyperGEN publications and significant comments have been incorporated prior to submission for publication." 

If Recipient does not agree to incorporate significant comments from the review, Recipient will use the acknowledgment:

"The HyperGEN is supported by the National Heart, Lung, and Blood Institute (NHLBI).  This manuscript was not prepared in collaboration with investigators of the HyperGEN and does not necessarily reflect the opinions or views of the HyperGEN, the NHLBI, or the universities participating in the HyperGEN."

    7.3  Acknowledgments/Genetic Analysis Data.  If Genetic Analysis Data are received, the Recipient agrees to acknowledge the contribution of HyperGEN investigators and/or the investigator(s) who derived such data in any and all oral and written presentations, disclosures, and publications resulting from any and all analyses of such Genetic Analysis Data.

8.  Non-Identification.  Recipient agrees that Biological Material and Clinical Data 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 Clinical Data or Biological Materials were obtained.

9.  Use Limited to Research Project.  Recipient agrees that Clinical Data and Biological Material, its 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 Research Project.

10.  Use in Human Experimentation Prohibited.  Recipient agrees that Biological Material, its progeny, and unmodified or modified derivatives thereof will not be used in human experimentation of any kind.

11.  Compliance with Subjects' Informed Consent.  Recipient agrees that the Clinical Data and Biological Material, its progeny, and unmodified or modified derivatives thereof will not be used for any purpose contrary to the subjects' applicable signed informed consent document(s).  It is the responsibility of the Recipient's Principal Investigator to consult with the HyperGEN investigators to ascertain, specifically and in detail, the terms and conditions of applicable HyperGEN informed consent documents.

12.  No Distribution, Avoidance of Waste, Return of Materials.  Recipient agrees to retain control over Clinical Data, Genetic Analysis Data, and Biological Material, its progeny, and unmodified or modified derivatives thereof, and further agrees not to transfer Clinical Data, Genetic Analysis Data or Biological Material, its progeny, and unmodified or modified derivatives thereof, with or without charge, to any other entity or any individual.  Recipient agrees, in handling the Biological Materials, to make reasonable efforts to avoid contamination or waste of the samples.  When the Research Project is completed, or three (3) years have elapsed from the effective date of this Distribution Agreement, whichever occurs first, the Clinical Data, Genetic Analysis Data, and Biological Material will be either returned to the HyperGEN, or disposed of as mutually agreed upon by HyperGEN investigators and Recipient, unless an extension of this Agreement is obtained.

13.  Recipient's Resulting Genetic Analysis Data to be Provided to HyperGEN Investigators.  Recipient agrees to provide the HyperGEN with a report every twelve (12) months during the term of this Agreement containing Genetic Analysis Data derived by Recipient, in the performance of the Research Project.  Such report will cover all Genetic Analysis Data derived by Recipient up to six (6) months before the reporting date.  Recipient agrees that the HyperGEN may distribute these data to qualified scientific investigators requesting access through established NHLBI procedures and completing a signed Distribution Agreement comparable to this Agreement.  Recipient will provide Genetic Analysis Data, indexed by genotyping ID number in the precise electronic format specified by HyperGEN.  When genotyping has been conducted, DNA marker names and allele sizes in numbers of base pairs will be provided for each individual subject as indexed by HyperGEN subject ID number; descriptive information about each typed marker that includes marker name, allele sizes in numbers of base pairs and corresponding frequencies, relative distances in Megabases and in Centimorgans, marker heterozygosity, and the source of information used to determine map location will also be provided.  Recipient also agrees to submit all data relevant to the establishment of paternity at the time such determinations are made.

14.  Costs/No Warranties.  Actual costs for DNA or other biological material distribution (processing and shipping) up to $100 will be borne by the HyperGEN Study Central Laboratory at no cost to the Recipient. Actual costs greater than $100 (anticipated in the case of special specimen  processing requests; agreed upon in advance by the Central Laboratory and Recipient in consultation with NHLBI; and specified in this agreement) will be invoiced to the Recipient by

the HyperGEN Study Central Laboratory.  Costs are subject to change following written notification from the HyperGEN Study.  NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO THE MERCHANTABILITY OR FITNESS FOR ANY PURPOSE OF THE BIOLOGICAL MATERIALS, GENETIC ANALYSIS DATA, AND DATA PROVIDED TO  RECIPIENT UNDER THIS AGREEMENT,  OR THAT THE BIOLOGICAL MATERIALS, GENETIC ANALYSIS DATA, OR DATA MAY BE EXPLOITED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY OR PROPRIETARY RIGHTS OF ANY THIRD PARTIES

15.  Recipient's Responsibility for Handling Biological Materials.  Recipient acknowledges that Biological Material has the potential for carrying viruses, latent viral genomes, and other infectious agents in an unapparent state.  The Recipient agrees to treat Biological Material as if it were not free of contamination, and that Biological Material will be handled by trained persons

under laboratory conditions that afford adequate biohazard containment.  By accepting Biological Material, Recipient assumes full responsibility for its safe and appropriate handling.

16.  Non-Endorsement, Indemnification.  Recipient agrees not to claim, infer, or imply Governmental endorsement of the Research Project, the entity, or personnel conducting the Research Project or any resulting commercial product(s) except as described in paragraph 7.  To the extent permitted by law, Recipient agrees to hold the HyperGEN, the United States Government, and all other investigator(s) who generated Genetic Analysis Data, and the agents and employees of each of them, harmless and to defend and indemnify all such parties for all liabilities, demands, damages, expenses, and losses arising out of Recipient's use for any purpose of Clinical Data, Genetic Analysis Data, and Biological Material, its byproducts, or modified or unmodified derivatives.

17.  Accuracy of Data.  Recipient agrees that the HyperGEN, the United States Government, and the other investigator(s) who generated Genetic Analysis Data, are not responsible for the accuracy of Genetic Analysis Data provided by other Recipients.  The HyperGEN and the United States Government are not responsible for the accuracy of Clinical Data or Biological Materials provided.

 18.  Recipient's Compliance with IRB Requirements.  Recipient acknowledges that the conditions for use of these Clinical Data and Biological Material have been approved by the Recipient's Institutional Review Board (IRB) in accordance with Department of Health and Human Services regulations at 45 CFR Part 46.  Recipient agrees to comply fully with all such conditions and with the subjects' informed consent documents, on record with the HyperGEN.  It is intended that the Recipient's agreements herein shall inure to the benefit of the research subjects, as well as to the parties to this agreement.  Recipient agrees to report promptly to the HyperGEN any proposed change in the research project and any unanticipated problems involving risks to subjects or others. Recipient remains subject to applicable State and local laws and regulations and institutional policies which provide additional protections for human subjects.

19.  Conflict of Interest.  The Recipient agrees to promptly disclose direct and indirect conflicts of interest, such as affiliation(s) with any organization with an explicit or indirect financial interest in the subject matter of the proposed research employing Clinical Data or Biologic Materials from the HyperGEN.  Examples of such affiliations are employment consultancies, expert testimony, honoraria, stock, or retainers that may affect the work being considered.

20.  Amendments.  Amendments to this Distribution Agreement must be made in writing and signed by authorized representatives of both parties.

21.  Termination.  The HyperGEN may terminate this Distribution Agreement if Recipient is in default of any condition of this Distribution Agreement and such default has not been remedied within 30 days after the date of written notice by the HyperGEN of such default.  Upon termination of this Distribution Agreement, Recipient agrees to return all unused Biological Materials and Clinical Data to the HyperGEN.

22.  Disqualification, Enforcement.  Failure to comply with any of the terms specified herein may result in disqualification of Recipient from receiving additional Clinical Data, Biological Materials, and/or Genetic Analysis Data.  The HyperGEN shall have the right to institute and prosecute any proceeding at law or in equity against the Recipient for violating or threatening to violate the confidentiality requirements of this agreement, the limitations on the use of the data or materials provided, or both.  Proceedings may be initiated against the violating party, its legal representatives, and assigns, for a restraining injunction, compensatory and punitive damages, mandamus, and/or any other proceeding in law or equity, including obtaining the proceeds from any intellectual property or other rights that are derived in whole or in part from the breach of the confidentiality requirements or use limitations of this agreement.  In addition, Recipient acknowledges and agrees that a breach or threatened breach of the confidentiality requirements or use limitations of this agreement may subject Recipient to legal action on the part of HyperGEN participants and their families, or the universities participating in the HyperGEN.

23.  Accurate Representations.  Recipient expressly certifies that the contents of any statements made or reflected in this document are truthful and accurate.

24.  Prior Distribution Agreements.  The following two paragraphs apply only to Recipients that have entered into a previous Distribution Agreement:

    24.1.  Execution of this Distribution Agreement is contingent upon Recipient's compliance with all terms and conditions of existing Distribution Agreements with NHLBI, excluding the requirements stated in paragraph 4 of the previous Distribution Agreement.

    24.2.  If Recipient has executed a previous Distribution Agreement, Recipient agrees to provide the HyperGEN with a report every twelve (12) months during the term of such prior Distribution Agreement containing Genetic Analysis Data derived by Recipient from any Clinical Data and Biological Materials previously received from the HyperGEN.  Such report will cover all Genetic Analysis Data derived by Recipient up to six (6) months before the reporting date.  Recipient agrees that the HyperGEN may distribute these data to qualified scientific investigators requesting access through established NHLBI procedures and completing a signed Distribution Agreement comparable to this Agreement.  If the effective date of such previous Distribution Agreement was more than twelve (12) months before the time of the current request for Clinical Data and Biological Materials, and Recipient has not provided to the HyperGEN Genetic Analysis Data derived from any Clinical Data and Biological Materials previously received from the HyperGEN, Recipient agrees that provision to the HyperGEN of such Genetic Analysis Data is a precondition for consideration of the current Distribution Agreement.

This Distribution Agreement is entered into as of:

___________________________ (effective date)

RECIPIENT:

Name of Recipient Entity:

Name and Title of Recipient's Authorized Representative:

Signature and Date of Recipient's Authorized Representative:

PRINCIPAL INVESTIGATOR:

Principal Investigator's Name and Title:

Principal Investigator's Surface Mail Address:

Principal Investigator's E-Mail Address:

Principal Investigator's Telephone Number:

Principal Investigator's Fax Number:

Signature and Date: Principal Investigator:

HyperGEN:

Name and Title of HyperGEN’s Authorized Representative:

Signature and Date of HyperGEN’s Authorized Representative:

TRUSTEES OF [                     ] UNIVERSITY:

Name and Title of [                   ] University’s Authorized Representative:

Signature and Date of [                       ] University’s Authorized Representative:

Signature and Date of Authorized NHLBI Representative (only for distribution of biologic specimens)