Common use of CHANGES/PROBLEMS Clause in Contracts

CHANGES/PROBLEMS. [Optional/Mandatory] The PI is reminded that the grantee is required to obtain prior written approval from the Contracting Officer whenever there are significant changes in the project or its direction. Requests for prior written approval must be submitted to the Contracting Officer (submission via Fedconnect is acceptable). If not previously reported in writing, provide the following additional information, if applicable: • Changes in approach and reasons for change. • Actual or anticipated problems or delays and actions or plans to resolve them. • Changes that have a significant impact on expenditures. • Significant changes in use or care of animals, human subjects, and/or biohazards. INSTRUCTIONS - Changes/Problems Changes in approach and reasons for change Describe any changes in approach during the reporting period and reasons for these changes. Remember that significant changes in objectives and scope require prior approval of the agency. Actual or anticipated problems or delays and actions or plans to resolve them Describe problems or delays encountered during the reporting period and actions or plans to resolve them. Changes that have a significant impact on expenditures Describe changes during the reporting period that may have a significant impact on expenditures, for example, delays in hiring staff or favorable developments that enable meeting objectives at less cost than anticipated. Significant changes in use or care of human subjects, vertebrate animals, and/or Biohazards Describe significant deviations, unexpected outcomes, or changes in approved protocols for the use or care of human subjects, vertebrate animals, and/or biohazards during the reporting period. If required, were these changes approved by the applicable institution committee and reported to the agency? Also specify the applicable Institutional Review Board/Institutional Animal Care and Use Committee approval dates. Change of primary performance site location from that originally proposed Identify any change to the primary performance site location identified in the proposal, as originally submitted.

CHANGES/PROBLEMS. [Optional/Mandatory] The PI is reminded that the grantee is required to obtain prior written approval from the Contracting Officer whenever there are significant changes in the project or its direction. Requests for prior written approval must be submitted to the Contracting Officer (submission via Fedconnect is acceptable). If not previously reported in writing, provide the following additional information, if applicable: • · Changes in approach and reasons for change. • · Actual or anticipated problems or delays and actions or plans to resolve them. • · Changes that have a significant impact on expenditures. • · Significant changes in use or care of animals, human subjects, and/or biohazards. INSTRUCTIONS - Changes/Problems Changes in approach and reasons for change Describe any changes in approach during the reporting period and reasons for these changes. Remember that significant changes in objectives and scope require prior approval of the agency. Actual or anticipated problems or delays and actions or plans to resolve them Describe problems or delays encountered during the reporting period and actions or plans to resolve them. [ * ] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Changes that have a significant impact on expenditures Describe changes during the reporting period that may have a significant impact on expenditures, for example, delays in hiring staff or favorable developments that enable meeting objectives at less cost than anticipated. Significant changes in use or care of human subjects, vertebrate animals, and/or Biohazards Describe significant deviations, unexpected outcomes, or changes in approved protocols for the use or care of human subjects, vertebrate animals, and/or biohazards during the reporting period. If required, were these changes approved by the applicable institution committee and reported to the agency? Also specify the applicable Institutional Review Board/Institutional Animal Care and Use Committee approval dates. Change of primary performance site location from that originally proposed Identify any change to the primary performance site location identified in the proposal, as originally submitted.

CHANGES/PROBLEMS. [Optional/Mandatory] Mandatory The PI is reminded that the grantee is required to obtain prior written approval from the Contracting Officer whenever there are significant changes in the project or its direction. Requests for prior written approval must be submitted to the Contracting Officer (submission via Fedconnect is acceptable). If not previously reported in writing, provide the following additional information, if applicable: • · Changes in approach and reasons for change. • · Actual or anticipated problems or delays and actions or plans to resolve them. • · Changes that have a significant impact on expenditures. • · Significant changes in use or care of animals, human subjects, and/or biohazards. INSTRUCTIONS - Changes/Problems Changes in approach and reasons for change Describe any changes in approach during the reporting period and reasons for these changes. Remember that significant changes in objectives and scope require prior approval of the agency. Actual or anticipated problems or delays and actions or plans to resolve them Describe problems or delays encountered during the reporting period and actions or plans to resolve them. Changes that have a significant impact on expenditures Describe changes during the reporting period that may have a significant impact on expenditures, for example, delays in hiring staff or favorable developments that enable meeting objectives at less cost than anticipated. Significant changes in use or care of human subjects, vertebrate animals, and/or Biohazards Describe significant deviations, unexpected outcomes, or changes in approved protocols for the use or care of human subjects, vertebrate animals, and/or biohazards during the reporting period. If required, were these changes approved by the applicable institution committee and reported to the agency? Also specify the applicable Institutional Review Board/Institutional Animal Care and Use Committee approval dates. Change of primary performance site location from that originally proposed Identify any change to the primary performance site location identified in the proposal, as originally submitted.