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•        Contractor provides agenda 48hrs in advance of meeting to the PO

1 Electronic Copy to

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•        PO approves (with CO concurrence) and distributes agenda

•        Contractor provides meeting minutes within three business days of the meeting

•        PO reviews, comments and approves minutes

The Monthly/Quarterly Project/Annual Status Report shall address the items listed below and cross-referenced to the Work Breakdown Structure (WBS), Scope of Work (SOW), integrated Master Schedule (IMS), Integrated Baseline Review (IBR) report, Earned Value Management (EVM) Cost Performance Reports (CPR), and approval strategy.

1.      A Executive Summary in MS PowerPoint (.ppt) format, highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory. The Executive Summary should be limited to 2-3 pages and highlight critical issues for that reporting period. The Monthly, Quarterly, and Annual Technical Progress Report shall address each of the items below and be cross-referenced to the Critical Path. Integrated Master Schedule (IMS), EVM, WBS/Project Plan and the Risk Mitigation Plan.

2.      Progress in meeting contract milestones—broken out by subtasks within each milestone, overall project assessment, problems encountered and recommended solutions. The reports shall detail the planned progress and actual progress during the period covered, explaining occurrences of any differences between the two, and the corrective steps.

3.      Provide EVM CPR (quarterly) and Updated Risk Management Plan/Register (quarterly)

Monthly Reports:

•        Contractor provides Monthly Status Report deliverables on the 15th of each month via email/CD/e-room upload

•        PO and CO will review Monthly Reports with the Contractor and provide feedback

Quarterly Meeting:

•        Contractor provides Quarterly Status Report five business days prior to meeting. This report is an expanded version of the Monthly Status Report

•        Contractor shall identify itinerary for the quarterly site visits

•        Contractor provides agenda to the PO 48hr in advance of meeting

•        PO approves (with CO concurrence) and distributes agenda

•        Contractor provides meeting minutes within three business days of the meeting

•        PO reviews, comments and approves minutes

Annual Meeting:

•        Contractor provides Annual Project Status Report deliverables five business days prior to meeting. The annual

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4.      The reports shall also include a three-month roiling forecast of key planned activities, referencing the WBS/IPDP.

5.      A tracking log of progress on regulatory submissions with the FDA submission number, description of submission, date of submission, status of submission. and next steps shall he updated continuously upon submission for all Biodefense and Non-Biodefense activities supported in part or whole with BARDA funding

6.      Estimated and Actual Expenses: This report shall also have attached either: a) a tabular (excel file) Control Account Plan report generated from MPM; or b) an unofficial CPR Form I. This section of the report shall also contain estimates for the subcontractors’ expenses from the previous month if the subcontractor did not submit a bill in the previous month. Estimates shall be listed for each subcontractor. If the subcontractor(s) was not working or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors. This section should also include a summary of any cost savings identified by the contractor as part of the 5% cost savings initiative.

7.      Contractor shall identify the itinerary for the quarterly site visits (quarterly)

   report should also include information from the annual meeting due 15 business days after the meeting. A draft report including ..ppt slides should be provided 5 business days prior to the meeting.

•        Contractor shall ensure that the board of directors is available to meet with BARDA. BARDA reserves the right to meet with the Contractor’s board of directors once a year to discuss the contract

•        PO approves (with CO concurrence) and distributes agenda

•        PO approves (with CO concurrence) all meeting material

•        Contractor provides meeting minutes within three business days

•        PO reviews, comments and approves minutes

•        Contractor provides a FINAL annual report within 15 business days after the conclusion of the annual meeting. PO (with CO concurrence) reviews, comments and approves FINAL Annual Report

•        BARDA and Contractor shall participate in an in process review

The IBR Report shall address each of the items listed below and be cross-referenced to the WBS, SOW, IMS and approval strategy.

1.      Contractor provides baseline proposal and PowerPoint brief

2.      A description of the work scope through control account Work

•        Contractor provides baseline proposal, .ppt briefing, 10 business days prior to meeting

•        Contractor provides agenda to the PO 48hr in advance of meeting

•        PO approves (with CO

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         Authorization Documents (WADS)

3.      Template for Work Packages

4.      Integrated Master Schedule (IMS) with the inclusion of agreed major milestones and control account plans (CAP) for all control accounts

5.      Baseline revision documentation and program logs (s) risk register.

         concurrence) and distributes agenda

•        PO approves (with CO concurrence) all meeting material

•        Contractor provides minutes within 48hr of the meeting

•        PO reviews and approves minutes

•        BARDA will review documentation and provide written comments and questions to Contractor

•        Contractor shall address BARDA’s comments and resubmit IBR for BARDA approval within 10 business days

Integrated Master Plan (aka Integrated Product Development Plan) including WBS, critical path milestones and Earned Value Management Plan

Contractor has the option to combine details from the IMP with the WBS Dictionary (#6) in a single document, updated quarterly. Details include: milestones matched to planned EVM measurements; completion criteria; success criteria: assignments of responsible lead personnel for milestones, or for oversight of subcontractor effort required to meet milestones; and dependencies that cross reference to the Risk Management Plan

•        Contractor shall provide all the Integrated Master Plan deliverables 30 days following contract award, and thereafter on the 15th of each month. Deliverable should he included in the Quarterly or Annual Project Status Reports.

•        BARDA shall provide Contractor with a written list of concerns in response to Contractor’s submitted Integrated Master Plan, and the Contractor must address in writing all concerns raised by BARDA within twenty business days of Contractor’s receipt of this list of concerns.

Risk Management

Plan

•        Contractor shall provide a Risk Management Plan 90 days following contract award and update on the 15th of each Quarter in their Quarterly or Annual

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   Project Status Reports

•        BARDA shall provide Contractor with a written list of concerns in response to Contractor’s submitted Risk Management Plan, and the Contractor must address in writing all concerns raised by BARDA within twenty business days of Contractor’s receipt of this list of concerns.

•        Contractor shall provide an Integrated Master Schedule on the 15th of each quarter in their quarterly or annual Project Status Reports

•        Integrated Master Schedule shall be in both PDF and Microsoft Project Form

•        BARDA shall provide Contractor with a written list of concerns in response to Contractor’s submitted IMS, and the Contractor must address in writing all concerns raised by BARDA within twenty business days of Contractor’s receipt of this list of concerns.

1 Electronic Copy (PDF and Microsoft

Project Schedule (.mmp) format to PO and CO

Contractor shall provide a CPR and Variance Analysis Report on the 30th day of the month after the end of each calendar quarter in their Quarterly or Annual Project Status Reports Contractor shall provide and changes in baseline cost as a result of anticipated cost savings or risks

•        Contractor shall provide a PDF of deliverables. BARDA may request, on

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   a quarterly or ad hoc basis that the Contractor provide raw data. BARDA may request additional data at a reporting level or at lower levels, as BARDA deems necessary

•        The Contractor must address in writing all concerns raised by BARDA staff to the satisfaction of BARDA

The Contractor shall communicate and document all critical programmatic concerns, risks or potential risks with BARDA within 48 hours. The Contractor shall communicate via email or telephone.

The Contractor shall report to the government any activity or incident that is in violation of established security standards or indicates the loss or theft of government products within 24 hrs of activity or incident. The Contractor shall communicate via email, oral or written communication.

•        Email, Letter to CO Telephone (w/ written follow-up)

•        Written communication with BARDA PO and CO within 48 hrs of Contractor identifying a project risk or potential risk and 24 hrs for Security activities or incident

•        Additional updates within 48 hrs of additional developments, additional information and/or understanding

•        Contractor shall submit within 5 business days a Corrective Action Plan (if necessary) to address any potential security issues

•        If corrective action is required, the Contractor must address concerns raised by BARDA

•        Contractor shall address BARDA’s concerns in writing within 5 business days

•        Contractor shall submit a Deviation Request as soon as the Contractor has sufficient data to support the need for a change from the

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approved study protocols and/or Integrated Master Plan

•        The BARDA CO will review and provide a written response to the Deviation Request.

•        Contractor shall address BARDA’s comments and resubmit the deviation request that addresses BARDA’s comments within 5 business days

•        Contractor shall not proceed with the deviation until BARDA gives its approval

A draft of Final Technical Progress Report containing a summation of the work performed and the results obtained for the entire contract period of performance. The draft report shall be duly marked as ‘Draft’.

The Final Technical Progress Report incorporating the feedback received from BARDA and containing a summation of the work performed and the results obtained for the entire contract period of performance. This final report shall detail, document and summarize the results of the entire contract. This report shall be in sufficient detail to fully describe the progress achieved under all milestones. The final report shall be duly marked as ‘Final’.

•        Contractor shall provide a draft report 20 business days and final 10 business days before completion of the contract period

•        PO provides edits and additional feedback, which Contractor will incorporate into the Final Technical Progress Report

•        The Contractor shall submit one (1) copy of a comprehensive final report to the CO and two (2) copies (one electronically on a CD) to the PO

•        Contractor shall provide a Product Transition Strategy to support transition of the product(s) 90 days prior to end of the (base/option) POP as an addendum to that Quarter’s Quarterly Project Status Report.

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•        Contractor shall provide an update to technical progress made towards completion of the Decision Gate and provide the presentation, 10 business days prior to the Decision Gate Review

•        Contractor shall submit written justification of progress towards satisfying Decision Gate criteria

•        After reviewing, the BARDA PO and CO will provide a written response

•        Contractor shall submit the Standard Operating Procedures (SOPs) in the form requested by the PO and CO within 15 calendar days of request

•        Contractor will submit proposed clinical and non-clinical strategy to support approval

•        If corrective action is required, the Contractor must address concerns raised by BARDA

Contractor steal I provide Pre- Clinical/Non-Clinical/Clinical Trial Protocols to BARDA for evaluation, prior to FDA submission

(The CO and PO reserves the right to request within the period of performance a non-proprietary Study Protocol for distribution within the United States Government(USG))

•        Contractor will submit proposed protocols to BARDA at least 10 business days prior to FDA submission. If corrective action is required, the Contractor must address in writing all safety, regulatory, ethical, and conflict of interest concerns raised by BARDA to the satisfaction of BARDA before study execution

•        After receiving the corrected documentation,

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that satisfies BARDA the CO will provide a written Contract Officer Authorization (COA) Letter to the Contractor. This COA provides authorization to the Contractor to execute the specific clinical study funded in part or in whole by BARDA

•        Contractor shall not proceed with any study protocol until BARDA gives its approval

•        Final FDA submissions shall be submitted to BARDA concurrently or no later than one calendar day after its submission to CDER

Contractor shall provide Draft and Final Pre-Clinical/Non-Clinical/Clinical Study Reports to BARDA for review and edits within 30 (draft) or 60 (final) calendar days after completion of analysis of Pre-Clinical/Non-Clinical/ Clinical data and 15 business days prior to submission to FDA

Alternatively, clinical draft study reports may be submitted 40 business days, and final reports submitted within 75 business days after database lock, provided submission to BARDA is still at least 15 days prior to FDA submission (“Alternative Schedule”)

(The CO and PO reserves the right to request within the period of performance a non-proprietary Study Report for distribution within the USG)

•        Contractor shall provide Draft and Final Pre- Clinical/Non-Clinical/ Clinical Study Reports to BARDA within 30 (draft) or 60 (final) calendar days after completion of each report. Clinical study reports may be provided via the Alternative Schedule.

•        Contractor will submit proposed Pre- Clinical/Non-Clinical/ Clinical Study Report to BARDA at least 15 business days prior to FDA Submission

•        If corrective action is required. The Contractor must address in writing all concerns raised by BARDA to the satisfaction of BARDA before FDA Submission

•        Contractor shall not proceed with any study report until BARDA

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gives its approval

•        Final FDA submissions shall be provided to BARDA concurrently or no later than 1 calendar day of its submission to CDER

Contractor shall provide Manufacturing Campaign Reports to BARDA for review and edits prior to submission to FDA

(The CO and PO reserve the right to request within the period of performance a non-proprietary Manufacturing Campaign Reports for distribution within the USG)

•        Contractor will submit proposed Analysis Reports and Manufacturing Campaign Reports to BARDA at least 15 business days prior to FDA Submission.

•        If corrective action is required, the Contractor must address in writing all concerns raised by BARDA to the satisfaction of BARDA before FDA Submission

•        Contractor shall not proceed with any FDA submission until BARDA gives its approval

•        Final FDA submissions shall be submitted to BARDA concurrently or no later than one (1) calendar day after its submission to CDER

•        Contractor must notify BARDA of an upcoming meeting with the FDA within 24 hours of scheduling the meeting with the FDA and no later than 10 business days prior to the scheduled meeting

•        Contractor provides FDA correspondence and meeting minutes within three (3) calendar days of the meeting or correspondence

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The Contractor shall provide BARDA the opportunity to review and comment upon all draft regulatory documents before submission to the FDA. Contractors shall provide BARDA with an electronic copy of the final FDA submission. All documents shall be duly marked as either ‘Draft’ or ‘Final’.

The Contractor must address in writing all concerns raised by BARDA to the satisfaction of BARDA before FDA submission.

•        Contractor will submit proposed FDA Meeting Briefing Packets to BARDA at least 15 business days prior to FDA submission

•        If corrective action is required, the Contractor must address in writing all concerns raised by BARDA staff to the satisfaction of BARDA before FDA submission

•        Final FDA submissions shall be submitted to BARDA concurrently or no later than one (1) calendar day of its submission to CDER

•        The Contractor shall notify the PO and CO within 24 hours of all FDA arrivals to conduct site visits/audits by any regulatory agency

•        Contractor provides QA Audit Reports within 15 calendar days of the audit

•        The Contractor shall also provide copies of any FDA audit report received from subcontractors that occur as a result of this contract or for this product within three (3) calendar days of receiving correspondence from the FDA and/or third party.

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•        The Contractor shall inform the PO and CO 10 days in advance of upcoming audits/site visits of subcontractors

•        The Contractor shall notify the PO and CO within 5 business days of report completion

•        If BARDA, the Contractor or other parties identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions and provide a report to BARDA within 10 business days.

•        The PO and CO will review the deliverable and provide a response to the Contractor.

•        Once corrective action, approved by the CO, is completed, the Contractor will provide a final report to BARDA

•        Contractor provides deliverables within 15 calendar days of the completion of activities

•        If additional time is required, Contractor shall request additional

For Final Documents:

1 Electronic Copy to

PO and CO

Records, Certificate of Analysis

(The CO and PO reserves the right to request within the period of performance a non-proprietary Technical Documents for distribution within the USG)

time from BARDA on a per deliverable basis

•        If corrective action is required, the Contractor must address in writing concerns raised by BARDA

•        Contractor will submit proposed FDA Technical Documents to BARDA at least 15 business days prior to FDA submission

•        If corrective action is required the Contractor must address in writing all concerns raised by BARDA to the satisfaction of BARDA before FDA Submission

•        Contractor shall provide Animal Model or other Technology Transfer Package within 10 business days of request by CO/PO

•        Contractor shall provide Raw Data or Data Analysis within 20 business days of request by CO/PO

•        Contractor must submit samples of therapeutics within 20 business days of request by CO/PO.

•        The Contractor will be advised by the CO how samples are to be packaged and where samples are to be shipped.

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•        Contractor must submit all manuscript or scientific meeting abstract to PO and CO within 20 business days for manuscripts and 10 business days for abstracts

•        The CO will respond with written comments within 10 business days for manuscripts and 5 business days for abstracts.

•        If corrective action is required, the Contractor must address in writing all concerns raised by BARDA to the satisfaction of BARDA before Submission.

•        Any Final submissions shall be submitted to BARDA concurrently or no later than one (1) calendar day of its submission

•        The Contractor shall ensure that the CO has received and approved an advanced copy of any press release to this contract not less than 5 business days prior to the issuance of the press release

•        If corrective action is required, the Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases

•        Any final submissions shall be submitted to BARDA concurrently or no later than one (1) calendar day of its

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