Common use of CLINICAL AND NON-CLINICAL TERMS OF AWARD Clause in Contracts

CLINICAL AND NON-CLINICAL TERMS OF AWARD. BARDA has a responsibility to obtain documentation concerning mechanisms and procedures that are in place to protect the safety of participants and animals in BARDA funded clinical trials and non-clinical studies. Therefore, the Contractor shall develop a protocol for each clinical trial and non-clinical study funded under this contract and submit all such protocols and protocol amendments to the Contracting Officer’s Representative (COR) for evaluation and comment. Approval by the COR is required before work under a protocol may begin. The COR comments will be forwarded to the Contractor within [**] business days. The Contractor must address, in writing, all concerns (e.g. study design, safety, regulatory, ethical, and conflict of interest) noted by the COR. If the draft protocols are to be submitted to the FDA, BARDA review shall occur before submission, pursuant to the terms set forth by ARTICLE F.2 of this contract. The Contractor shall consider revising their protocols to address the COR’s concerns and recommendations prior to FDA submission. The Contractor must provide the CO and the COR with a copy of FDA submissions, within the time frame set forth by ARTICLE F.2 of this contract. Execution of clinical and non-clinical studies requires written authorization from the Government. The USG will provide written authorization to the Contractor upon either 1) receiving documentation in which all COR comments have been satisfactorily addressed; or 2) receiving documentation that the FDA has reviewed and commented on the protocol. The Government shall have rights to all protocols, data resulting from execution of these protocols, and final reports funded by BARDA under this contract, as set forth in the FAR clauses referenced in PART II of this contract. The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form (e.g. redacted and /or abridged as necessary as reasonably determined by the Contractor) to ensure the Government has the ability to review and distribute the deliverables as the Government deems necessary. Important information regarding performing human subject research is available at xxxx://xxx0.xxxxx.xxx.xxx/healthscience/clinicalstudies/. Any updates to technical reports are to be addressed in the Monthly and Annual Progress Reports. The Contractor shall advise the Contracting Officer’s Representative or designee in writing and via electronic communication in a timely manner of any issues potentially affecting contract performance.

CLINICAL AND NON-CLINICAL TERMS OF AWARD. BARDA has a responsibility to obtain documentation concerning mechanisms and procedures that are in place to protect the safety of participants and animals in BARDA funded clinical trials and non-clinical studies. Therefore, the Contractor shall develop a protocol for each clinical trial and non-clinical study funded under this contract and submit all such protocols and protocol amendments to the Contracting Officer’s Representative (COR) for evaluation and comment. Approval by the COR is required before work under a protocol may begin. The COR comments will be forwarded to the Contractor within [**] business days*]. The Contractor must address, in writing, all concerns (e.g. study design, safety, regulatory, ethical, and conflict of interest) noted by the COR. If the draft protocols are to be submitted to the FDA, BARDA the COR review shall occur before submission, pursuant to the terms set forth by ARTICLE Article F.2 of this contract. The Contractor shall consider revising revise their protocols to address the CORBARDA’s concerns and recommendations prior to FDA submission. The Contractor must provide the CO and the COR BARDA with a copy of FDA submissions, within the time frame set forth by ARTICLE Article F.2 of this contract. Execution of clinical and non-clinical studies requires written authorization from the Government. The USG Government will provide written authorization to the Contractor upon either 1) receiving documentation in which all COR comments have been satisfactorily addressed; or 2) receiving documentation that the FDA has reviewed and commented on the protocol. For purposes of this contract, “Execution” or “Start” of a clinical study shall mean enrollment of the first subject or patient. The Government shall have unlimited rights to all protocols, data resulting from execution of these protocols, and final reports funded by BARDA XXXXX under this contract, as set forth in the FAR clauses referenced in PART II of this contract. The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form (e.g. redacted and /or abridged as necessary as reasonably determined by the Contractor) to ensure the Government has the ability to review and distribute the deliverables as the Government deems necessary. Important information regarding performing human subject research is available at xxxx://xxx0.xxxxx.xxx.xxx/healthscience/clinicalstudies/. xxxxx://xxx.xxxxx.xxx.xxx/research/clinical-research. Any updates to technical reports are to be addressed in the Monthly and Annual Progress Reports. The Contractor shall advise the Contracting Officer’s Representative or designee in writing and via electronic communication in a timely manner of any issues potentially affecting contract performance.

CLINICAL AND NON-CLINICAL TERMS OF AWARD. BARDA has a responsibility to obtain documentation concerning mechanisms and procedures that are in place to protect the safety of participants and animals in BARDA funded clinical trials and non-clinical studies. Therefore, the Contractor shall develop a protocol for each clinical trial and non-clinical study funded under this contract and submit all such protocols and protocol amendments to the Contracting Officer’s Representative (COR) for evaluation and comment. Approval by the COR is required before work under a protocol may begin. The COR comments will be forwarded to the Contractor within [**] business days*]. The Contractor must address, in writing, all concerns (e.g. study design, safety, regulatory, ethical, and conflict of interest) noted by the COR. If the draft protocols are to be submitted to the FDA, BARDA the COR review shall occur before submission, pursuant to the terms set forth by ARTICLE Section F.2 of this contract. The Contractor shall consider revising revise their protocols to address the CORBARDA’s concerns and recommendations prior to FDA submission. The Contractor must provide the CO and the COR BARDA with a copy of FDA submissions, within the time frame set forth by ARTICLE Section F.2 of this contract. Execution of clinical and non-clinical studies requires written authorization from the Government. The USG Government will provide written authorization to the Contractor upon either 1) receiving documentation in which all COR comments have been satisfactorily addressed; or 2) receiving documentation that the FDA has reviewed and commented on the protocol. For purposes of this contract, “Execution” or “Start” of a clinical study shall mean enrollment of the first subject or patient. The Government shall have unlimited rights to all protocols, data resulting from execution of these protocols, and final reports funded by BARDA XXXXX under this contract, as set forth in the FAR clauses referenced in PART II of this contract. The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form (e.g. redacted and /or abridged as necessary as reasonably determined by the Contractor) to ensure the Government has the ability to review and distribute the deliverables as the Government deems necessary. Important information regarding performing human subject research is available at xxxx://xxx0.xxxxx.xxx.xxx/healthscience/clinicalstudies/. xxxxx://xxx.xxxxx.xxx.xxx/research/clinical-research. Any updates to technical reports are to be addressed in the Monthly and Annual Progress Reports. The Contractor shall advise the Contracting Officer’s Representative or designee in writing and via electronic communication in a timely manner of any issues potentially affecting contract performance.

CLINICAL AND NON-CLINICAL TERMS OF AWARD. BARDA has a responsibility to obtain documentation concerning mechanisms and procedures that are in place to protect the safety of participants and animals in BARDA funded clinical trials and non-clinical studies. Therefore, the Contractor shall develop a protocol for each clinical trial and non-clinical study funded under this contract and submit all such protocols and protocol amendments to the Contracting Officer’s Representative (COR) for evaluation and comment. Approval by the COR is required before work under a protocol may begin. The COR comments will be forwarded to the Contractor within [**] ten (10) business days. The Contractor must address, in writing, all concerns (e.g. study design, safety, regulatory, ethical, and conflict of interest) noted by the COR. If the draft protocols are to be submitted to the FDA, BARDA the COR review shall occur before submission, pursuant to the terms set forth by ARTICLE Section F.2 of this contract. The Contractor shall consider revising revise their protocols to address the CORBARDA’s concerns and recommendations prior to FDA submission. The Contractor must provide the CO and the COR BARDA with a copy of FDA submissions, within the time frame set forth by ARTICLE Section F.2 of this contract. Execution of clinical and non-clinical studies requires written authorization from the Government. The USG Government will provide written authorization to the Contractor upon either 1) receiving documentation in which all COR comments have been satisfactorily addressed; or 2) receiving documentation that the FDA has reviewed and commented on the protocol. The Government shall have unlimited rights to all protocols, data resulting from execution of these protocols, and final reports funded by BARDA XXXXX under this contract, as set forth in the FAR clauses referenced in PART II of this contract. The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form (e.g. redacted and /or abridged as necessary as reasonably determined by the Contractor) to ensure the Government has the ability to review and distribute the deliverables as the Government deems necessary. Important information regarding performing human subject research is available at xxxx://xxx0.xxxxx.xxx.xxx/healthscience/clinicalstudies/. xxxxx://xxx.xxxxx.xxx.xxx/research/clinical- research. Any updates to technical reports are to be addressed in the Monthly and Annual Progress Reports. The Contractor shall advise the Contracting Officer’s Representative or designee in writing and via electronic communication in a timely manner of any issues potentially affecting contract performance.

CLINICAL AND NON-CLINICAL TERMS OF AWARD. BARDA has a responsibility to obtain documentation concerning mechanisms and procedures that are in place to protect the safety of participants and animals in BARDA funded clinical trials and non-clinical studies. Therefore, the Contractor shall develop a protocol for each clinical trial and non-clinical study funded under this contract and submit all such protocols and protocol amendments to the Contracting Officer’s Representative (COR) for COR evaluation and comment. Approval by the COR is required before work under a protocol may begin. The COR comments will be forwarded to the Contractor within [**] ten (10) business days. The Contractor must address, in writing, all concerns (e.g. study design, safety, regulatory, ethical, and conflict of interest) noted by the COR. If the draft protocols are to be submitted to the FDA, BARDA review shall occur before submission, pursuant to the terms set forth by ARTICLE F.2 of this contract. The Contractor shall consider revising their protocols to address the CORBARDA’s concerns and recommendations prior to FDA submission. The Contractor must provide the CO and the COR BARDA with a copy of FDA submissions, within the time frame set forth by ARTICLE F.2 of this contract. Execution of clinical and non-clinical studies requires written authorization from the Government. The USG will provide written authorization to the Contractor upon either 1) receiving documentation in which all COR comments have been satisfactorily addressed; or 2) receiving documentation that the FDA has reviewed and commented on the protocol. The Government shall have unlimited rights to all protocols, data resulting from execution of these protocols, and final reports funded by BARDA BXXXX under this contract, as set forth in the FAR clauses referenced in PART II of this contract. The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form (e.g. redacted and /or abridged as necessary as reasonably determined by the Contractor) to ensure the Government has the ability to review and distribute the deliverables as the Government deems necessary. Important information regarding performing human subject research is available at xxxx://xxx0.xxxxx.xxx.xxx/healthscience/clinicalstudies/. hxxx://xxx0.xxxxx.xxx.xxx/xxxxxxxxxxxxx/clinicalstudies/. Any updates to technical reports are to be addressed in the Monthly and Annual Progress Reports. The Contractor shall advise the Contracting Officer’s Representative or designee in writing Portions of this Exhibit, indicated by the mark “[***],” were omitted and via electronic communication in a timely manner have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of any issues potentially affecting contract performancethe Securities Exchange Act of 1934, as amended.