Policies

Athna Biotech, Inc.’s activity involves collaborations with academic institutes and industrial partners. The policies for establishment of consortium or contract are as follows:

1. An intent of consortium and contractual agreement will be submitted to the President and Vice President of the company for review and approval.

2. A formal written agreement with consortium participant(s) that addresses the negotiated arrangements to meet the scientific, administrative, financial, and reporting requirements of the project and grant funding agencies, including those necessary to ensure compliance with all applicable federal regulations and policies. This agreement must include the following:

• Identification of the individual who will serve as the consortium principal investigator or project director (PD/PI) and other individuals responsible for the research and administrative activities of the project at each consortium participant along with their roles and responsibilities.

• The consortium agreement must address the specific aspects to these individuals holding the PD/PI role in the other organizations, including the requirement for the prime institution to secure and retain all PD/PI signatures for all applications, progress reports, and post-award prior approval requests. Further, such signatures must be made available to the company management, funding agency or other authorized officers, such as Federal officials from National Institutes of Health (NIH), upon request.

• Procedures for directing and monitoring the research effort and activities.

• Procedures to be followed in reimbursing each consortium participant for his/her effort, including dollar ceiling, method and schedule of reimbursement, type of supporting documentation required, procedures for review and approval of expenditures of grant funds at each organization and timing of applicable reporting requirements. This includes provisions on access to core facilities and resources and whether access will be provided as a fee-for-service.

• Policies to be followed in such areas as travel reimbursement and salaries and fringe benefits (the policies of the consortium participant may be used as long as they meet the requirements of funding agencies, such as NIH).

• Document whether there is a Financial Conflict of Interest (FCOI) that applies to the subrecipient's Investigators and organizations. If the subrecipient's Investigators must comply with the subrecipient's FCOI policy, the subrecipient shall certify as part of the written agreement that its policy complies with the 2011 revised FCOI regulation (42 CFR 50 Subpart F). If the subrecipient cannot provide such certification, the agreement shall state that subrecipient Investigators are subject to the FCOI policy of the awardee Institution for disclosing significant Financial Interests directly related to the contractual work from Athna Biotech, Inc. The written agreement shall specify time period(s) for the subrecipient to report all identified FCOI to the awardee Institution. Such time period(s) shall be sufficient to enable the awardee Institution to provide timely FCOI reports, as necessary, to the PHS as required by the regulation.

• Include all proposed performance sites of the consortium research activities.

o A provision addressing ownership and disposition of data produced under the consortium agreement. This includes whether cell lines, samples or other resources will be freely available to other investigators in the scientific community or will be provided to particular investigators only.

o If a subcontract for the NIH grant will be set up, the NIH data sharing and inventions and patent policy, including a requirement to report inventions to the company, applicable to each consortium participant and its employees in order to ensure that the rights of the parties to the consortium agreement are protected and that the recipient can fulfill its responsibilities to NIH.

o Expectations for authorship and co-authorship on publications.

o Provisions regarding property (other than intellectual property), program income, publications, reporting, and audit necessary for the recipient to fulfill its obligations to the funding agency.

o Compliance with requirements for a DUNS number and subrecipient reporting under FFATA.

o Incorporation of applicable public policy requirements and provisions indicating the intent of each consortium participant to comply, including submission of applicable assurances and certifications.

3. The names and position of the authorized representative of the organization as well as the contact information.

4. The agreement will be signed by the PI and the authorized person of the organization.

5. Consortium funds will be managed by the financial manager or administrator of the company, including receiving invoices from the contracting organization, obtaining approval signature from the authorized signatory officials of Athna Biotech, Inc., and making payments.

6. All invoices and related documents will be archived. Amounts and dates of invoices and payments will be recorded in the corresponding financial statement for each research project. 

The expenses and remaining balances will be checked monthly by the President and Vice President of Athna Biotech, Inc.

7. The PI of each research project and the Chief Scientific Officer (CSO) of the Athna Biotech, Inc. are responsible for ensuring that all subcontract sites engaging in human subjects research have an appropriate Office for Human Research Protections (OHRP)-approved assurance and Institutional Review Board (IRB) approval of the research consistent with 45 CFR 46 (see Guidance on Engagement of Institutions in Human Subjects Research), and for complying with funding agency prior approval requirements.

8. The PI of each research project and the CSO of the Athna Biotech, Inc. are responsible to ensure that all animal welfare requirements that apply to consortium participants and subprojects and that all sites engaged in research involving the use of live vertebrate animals have an approved Animal Welfare Assurance and that the activity has valid Institutional Animal Care and Use Committee (IACUC) approval.

9. The PI of each research project and the financial manager or administrator of Athna Biotech, Inc. will ensure and the subcontract organizations following the funding agency’s policy on Allowable and Unallowable, and the use of an approved federally recognized and acceptable indirect cost rate between the subcontract organizations and the Federal Government.

10. The PI of each research project is responsible for obtaining NIH awarding institute or center approval for any actions to be undertaken by consortium participants that require prior approval.

11. The PI and the Vice President of Athna Biotech, Inc. must require consortium participants to comply with the requirements of 45 CFR 75 Subpart F or 45 CFR Parts 75.501(h) through 75.501(k), as applicable, for audit of NIH grant funds expended by consortium participants.

12. The PI and the Vice President of Athna Biotech, Inc. will be responsible to ensure the consortium organizations have completed the research activities in the agreement and submit the progress report.