Non-Clinical Data/ Materials Distribution Agreement

Transcription

1 Non-Clinical Data/ Materials Distribution Agreement The undersigned parties hereby enter into this Non-Clinical Data/ Materials Distribution Agreement as of the date specified on the final page hereof. PRELIMINARY STATEMENT With support from the National Institutes of Health (NIH), Denver Health Medical Center has sponsored the collection of blood and tissue samples. The NIH and the researchers it supports recognize their responsibility to the public in general, and to the scientific community in particular, to encourage as rapid scientific progress as possible using this resource, subject to appropriate terms and conditions. To take full advantage of such resources and maximize their research value, it is important that data collected with public funds be made available, on appropriate terms and conditions, to the largest number of investigators in a timely manner. The participating investigators have made a substantial long-term contribution in establishing and maintaining the blood and tissue samples, experimental protocols and methodologies. Denver Health Medical Center and the Surgery Department seek to encourage appropriate collaborative relationships between investigators, and to ensure that the contribution of the participating investigators is appropriately acknowledged. The NIH and Denver Health Medical Center further seek to promote the development of valuable discoveries and inventions beneficial to the public health based upon use of this repository of valuable materials and data. DEFINITIONS For the purposes of this agreement, Non-Clinical Data refers to data collected and recorded in experimental studies as well as standard operating procedures and methodologies conducted pursuant to the Surgery Department at Denver Health Medical Center s protocol. Biological Materials refers to blood and tissue samples and the products thereof including extracted RNA and DNA, collected and prepared in the performance of the protocol. RECIPIENT, an Investigator within the UCD Trauma Center Grant Investigator at UCD wishing to collaborate with the Trauma Center Investigator at a not-for-profit institution outside UCD Investigator at a for-profit institution

2 ( Recipient ) requests access to Non-Clinical Data and/or Biological Materials at its sole risk and at no expense to the Surgery Department at Denver Health Medical Center or the NIH. The Surgery Department at Denver Health is willing to grant said access under the following terms and conditions; AGREED TERMS AND CONDITIONS It is mutually agreed as follows: 1. Biological Materials. The Surgery Department at Denver Health agrees to provide Recipient with Biological Materials described below for use by the Recipient s Principal Investigator (named below). These Biological Materials are described as follows: Biological Materials shall only be used to conduct the research project entitled under the direct supervision of the Principal Investigator and may not be transferred to any other party. 2. Non-Transferability. This Distribution Agreement is non-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 an execution of a new Data Sharing Agreement in which the new Principal Investigator and/or new Research Project are designated. 3. Publication. Prompt publication of the results of the Research Project is encouraged. Recipient agrees to provide Dr. Jeffrey L. Johnson at Denver Health Medical Center, 777 Bannock Street, MC 0206, Denver, Colorado 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. Electronic submission is preferred at Jeff.Johnson@dhha.org 4. Transfer of Raw Data. Recipient agrees to deliver raw data for all tests completed on biological samples to the trauma primes research program, c/o Dr. Jeffrey Johnson, above. These data will be stored in the MOF Database in the Denver Health secure data center. 5. Acknowledgements. Recipient agrees to acknowledge the contribution of the Surgery Department at Denver Health in any and all oral and written presentations, disclosures, and publications resulting from any and all analyses of shared Non-Clinical Data and Biological Materials. 5.1 Collaborations/Acknowledgments. If the research project involves collaboration with the co-investigators, then Recipient will acknowledge said

3 investigators as co-authors, as appropriate, on any publication. The Recipient will use first acknowledgment printed below. 5.2 Other Studies/Acknowledgments. If the research project does not involve collaboration with the co-investigators, then the manuscripts, upon submission pursuant to paragraph 3 above, will be reviewed by the Surgery Department at Denver Health for scientific content and consistency of data interpretation with previous publications. If Recipient agrees to incorporate significant comments from the review, Recipient will use the acknowledgement printed below. The Trauma Primes Cells Research Program is conducted and supported by the National Institutes of Health (NIH) in collaboration with the Surgery Department at Denver Health Medical Center and the University of Colorado Denver. This manuscript has been reviewed by the Surgery Department at Denver Health and the University of Colorado Denver for scientific content and consistency of data interpretation with previous Program publications and significant comments have been incorporated prior to submission for publication. If Recipient does not agree to incorporate significant comments for review, Recipient will use the acknowledgment: The Trauma Primes Cells Research Program is conducted and supported by the National Institutes of Health (NIH) in collaboration with the Surgery Department at Denver Health Medical Center and the University of Colorado Denver. This manuscript was not prepared in collaboration with investigators of the Program, and does not necessarily reflect the opinions or views of the Research Program, the Department of Surgery at Denver Health, or the Department of Surgery at the University of Colorado Denver 6. 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. 7. No Distribution, Avoidance of Waste, Return of Materials. Recipient agrees to retain control over Non-Clinical Data and Biological Material, its progeny, and unmodified or modified derivatives thereof, and further agrees not to transfer Non-Clinical Data or Biological Material, its progeny, and unmodified or modified derivatives thereof, with or without charge, to any other entity or individual. Recipient agrees, in handling 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 Biological Material will be either returned to the Surgery Department at Denver Health Medical Center, or disposed of as mutually agreed upon by the Surgery Department at Denver

4 Health Medical Center and the Recipient, unless an extension of this Agreement is obtained. 8. Costs/No Warranties. Costs for blood or tissue sample distribution will be borne by the Recipient requesting the material. Costs are subject to change following written notification from the Surgery Department at Denver Health Medical Center. NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO THE MERCHANTABILITY OR FITNESS FOR ANY PURPOSE OF THE BIOLOGICAL MATERIALS OR STANDARD OPERATING PROCEDURES TO RECIPIENT UNDER THIS AGREEMENT, OR THAT THE BIOLOGICAL MATERIALS OR STANDARD OPERATING PROCEDURES MAY BE EXPLOITED WITHOUT INFRINGING THE INTELLECTUAL PROPERTY, PROPRIETARY RIGHTS OR OTHER RIGHTS OF ANY PARTIES. 9. 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. 10. Non-Endorsement, Indemnification. Recipient agrees not to claim, infer, or imply Governmental or Denver Health Medical Center endorsement of the Research Project, the entity, or personnel conducting the research project or any resulting commercial product(s) except as described in paragraph 4. To the extent permitted by law, Recipient agrees to indemnify the United States Government, the Department of Surgery at Denver Health Medical Center, and all other investigator(s) and the agents and employees of each of them for all liabilities, demands, damages, expenses, and losses arising out of Recipient s use for any purpose of Non-Clinical Data or Biological Material, its byproducts, or modified or unmodified derivatives. 10. Amendments. Amendments to this Data Sharing Agreement must be made in writing and signed by authorized representatives of both parties. 11. Termination. The Surgery Department at Denver Health Medical Center, in consultation with the NIH, may terminate this Distribution Agreement if Recipient is in default of any condition of this Agreement and such default has not been remedied within 30 days after the date of written notice by the Surgery Department at Denver Health Medical Center of such default. Upon termination of this Distribution Agreement, Recipient agrees to return all unused Biological Materials and Non-Clinical Data to the Surgery Department at Denver Health Medical Center. 12. Disqualification, Enforcement. Failure to comply with any of the terms specified herein may result in disqualification of Recipient from receiving additional Non-Clinical Data, Biological Materials, and/or Standard Operating Procedures. The United States

5 Government and/or the Surgery Department at Denver Health Medical Center 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 both. Proceedings may be initiated against the violating party, legal representatives, and assigns, for a restraining injunction, compensatory and punitive damages, mandamus, and/or any other proceeding in law or equity, including obtaining 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. 13. Accurate Representations. Recipient expressly certifies that the contents of any statements made or reflected in this document are truthful and accurate. This Data Sharing Agreement is entered into as of: RECIPIENT (effective date) Name of Recipient: Name of Recipient Entity: Name and Title of Recipient s Authorized Representative: Authorized Representative s Address: Authorized Representative s Telephone Number: Signature and Date of Recipient s Authorized Representative: Date: PRINCIPAL INVESTIGATOR Principal Investigator s Name and Title: Principal Investigator s Surface Mail Address: Principal Investigator s Address: Principal Investigator s Telephone Number: Principal Investigator s Fax Number: Signature and Date of Principal Investigator: Date: