Genetic research often involves collaborations among several investigators of several laboratories that share materials toward a common goal. Also, as a result of new genomic technologies, data are often generated by multi-user core facilities. Many laboratories benefit from using common biological reference materials for research or clinical purposes. Thus, consistent with the mission to facilitate genetic research, the Repository will permit secondary distribution to accommodate certain situations if it can be established that protection of human subjects and quality control of the samples can be ensured. Secondary distribution, defined as the sharing of NIA Repository Sample(s) from the Repository with members of laboratories other than the Principal Investigator’s, is permitted only under certain clearly defined circumstances. Principal investigators who might wish to share NIA Repository Sample(s) with other investigators should read the information below very carefully and must contact Coriell before proceeding with a secondary distribution.

Permitted Uses:

1. Single purpose collaboration: Two or more investigators initiate a collaborative project that requires the use by each laboratory of the same NIA Repository Sample(s). One Principal Investigator obtains NIA Repository Sample(s) and explains in the Statement of Research Intent that the sample will be shared with specific, named collaborator(s) for a common research project. Secondary distribution to named collaborator(s) is permitted when the Statement of Research Intent is identical for all the named collaborator(s) and is consistent with this Assurance Form. Each collaborating investigator and his or her Institutional Official must sign and submit a copy of this Assurance Form.

2. Multi-user core facility: A core facility (for high-throughput genotyping, for example) purchases NIA Repository Sample(s) for use by the investigators within the facility to perform assays for investigators at his or her Institution or at a consortium of institutions. The Statement of Research Intent describes the range of studies that will be conducted using the NIA Repository Sample(s). In this situation, the use of these NIA Repository Sample(s) in the core facility may be permitted after the Coriell IRB assures that the use of these samples is consistent with the research subject’s informed consent. Since the NIA Repository Sample(s) will be used in the same facility by multiple investigators, quality can be ensured.

3. Distribution of aliquots of samples for use as reference materials: An Institution purchases a sample and describes in the Statement of Research Intent that the NIA Repository Sample(s) will be distributed for use as a reference material (for proficiency testing, for example). The Statement of Research Intent may not be able to specify the laboratories that will receive the materials. Prior approval by the Coriell IRB for this use Form 1401‐09 Rev C‐011711 NIA Assurance Page 4 of the NIA Repository is required. The Coriell IRB will decide this type of request on a case-by-case basis with the advice of the NIA Repository’s Project Officer. The NIA Repository Sample(s) that are distributed must be accompanied by a disclaimer of the Repository’s responsibility regarding safety and quality. Furthermore, residual NIA Repository Sample(s) must be returned to the Principal Investigator or destroyed.

4. Development of a Highly Unique Biological Resource: An Institution purchases a cell line from the Repository and develops it into a Highly Unique Resource that requires significant modification or specialized expertise to grow, characterize, and maintain (such as an induced pluripotent stem cell line). A Highly Unique Resource is substantially different from the original NIA Repository Sample obtained from the Repository. Simply modifying an NIA Repository Sample obtained from the Repository through the introduction of a gene (e.g., hTERT or green fluorescent protein) would not qualify as creating a Highly Unique Resource. The Principal Investigator may distribute aliquots of the Highly Unique Resource material by using an appropriate agreement between the Principal Investigator and/or the Principal Investigator’s Institution and the secondary institution receiving the Highly Unique Resource ("Secondary Recipient"). Often a material transfer agreement is used for transfers of research materials for this purpose. The agreement to transfer the Highly Unique Resource to a Secondary Recipient must include: (1) a statement naming the Highly Unique Resource as well as naming the Repository number of the cell line from which the Highly Unique Resource was derived; (2) a statement that the Secondary Recipient must acknowledge the Repository and the cell line numbers(s) in any publications or presentations based on the utilization of the NIA Repository Sample(s); (3) a statement prohibiting the use of the Highly Unique Resource for human experimentation or commercialization; and (4) a statement prohibiting sale of the Highly Unique Resource for profit; and (5) a statement that the Highly Unique Resource obtained from different sources will not have undergone the standard quality control of the Repository; (6) the requirement to submit a copy of the agreement to the NIA Repository.

The terms of the agreement between the investigator who developed the Highly Unique Resource and the Secondary Recipient who obtains the Highly Unique Resource must be executed by the Principal Investigator and an institutional official at the Principal Investigator’s Institution. A copy of such executed agreements must be submitted to the NIA Repository within 10 business days of the executive of the agreement. The NIA Repository Sample(s) may not be sold, leased, or licensed for commercial purposes but may be used for internal non-profit and for-profit research purposes. An institution that purchases the NIA Repository Sample(s) is encouraged to make available aliquots of the Highly Unique Resource derived from the NIA Repository Sample and appropriate protocols and training to the Repository for the Repository to expand, characterize, and distribute the unique resource through the Repository, should the Repository wish to do so. Form 1401‐09 Rev C‐011711 NIA Assurance Page 5

Prohibited Uses:

1. Multi-purpose use: An investigator working on a particular project submits a Statement of Research Intent describing that project and obtains NIA Repository Sample(s). At some time after obtaining the NIA Repository Sample(s), the Principal Investigator wishes to give a portion of the NIA Repository Sample(s) or a culture derived from the NIA Repository Sample(s) to an investigator who is working on another project. In this case, secondary distribution is prohibited because the use of the NIA Repository Sample(s) by the second investigator may not be consistent with this Assurance Form and the Statement of Research Intent. In addition, errors in cell culture technique and identification of cultures or DNA samples can occur and could compromise the Repository’s reputation.

2. The Secondary Distribution or sale of NIA Repository Sample(s) for any purpose not specified above is prohibited.