Revised Section F-3-2-10.pdf

RFP-12-100-SOL-00016

Amendment 004 – Attachment 4

F.3.2.10. Deliverable Schedule Below is a summary of deliverables, reporting procedures and the deliverable schedule.

# Type of

Deliverable Frequency/ time periods

Description of Deliverable Reporting Procedures

Quantity/ Form

1. Project Meeting Every month or as amended by the Contracting Officer (CO) and the Contracting Officer’s Representative

(COR)

The Contractor shall participate in Project Meetings (teleconferences) every month with HHS to discuss performance on the contract. The Contractor shall prepare a proposed agenda and shall record, maintain and provide draft-meeting minutes to the COR for approval. The COR will approve the draft version and distribute the final version to the CO and Contractor.

• Contractor provides agenda 48hrs in advance of meeting to the COR and CO

• COR approves (with CO concurrence) and distributes agenda

• Contractor provides meeting minutes within 3 business days of the meeting

• COR reviews, comments and approves minutes

1 Electronic Copy to COR and

CO

2. Progress Reports – Monthly, Quarterly and Annual Report/ Meeting

Monthly Reports:

Monthly reports are due on the 20th of each month, except on months when Quarterly/Annual Technical Progress Reports are due

Quarterly Report/Meeting:

Contractor provides Quarterly Status Report five business days prior to meeting;

Contractor provides meeting minutes within 3 business days of the meeting

Annual Meeting:

Contractor provides Annual Report deliverables five business days prior to the annual meeting.

The annual report should also include information from

The Progress Reports shall address the items listed below and cross-reference to the subtasks within each milestone, and Scope of Work (SOW).

An Executive Summary in MS PowerPoint (.ppt) format, highlighting the progress, issues, and relevant activities. The Executive Summary should be limited to 2-3 pages and highlight critical issues for that reporting period.

The Monthly, Quarterly, and Annual Progress Report shall address each of the items below.

• 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 any differences between the two, and the corrective steps.

• The reports shall also include a three-month rolling forecast of key planned activities.

• Estimated and Actual Expenses:

This report shall also contain a narrative statement or in table form as to whether there is any discrepancy at this time between the % of work completed and the cumulative costs incurred to date. This section of the report

Monthly Reports:

• Contractor provides Monthly Report deliverables on the 20th of each month.

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

Quarterly Report/Meeting:

• This report is an expanded version of the Monthly Report

• Contractor shall prepare itinerary for the quarterly site visits with COR concurrence

• Contractor provides agenda to the COR and CO 48hr in advance of meeting

• COR approves (with CO concurrence) and distributes agenda

• COR reviews, comments and approves minutes Annual Report/Meeting:

• A draft report including .ppt slides should be provided 5

1 Electronic Copy to COR and

CO

1 hard copy to the CO with original signature

# Type of

Deliverable Frequency/ time periods

Description of Deliverable Reporting Procedures

Quantity/ Form the annual meeting due 15 business days after the meeting.

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.

business days prior to the meeting.

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

• COR approves (with CO concurrence) and distributes agenda

• COR approves (with CO concurrence) all meeting material

• Contractor provides meeting minutes within 2 business days of meeting

• COR reviews, comments and approves minutes

• Contractor provides a FINAL annual report within 15 business days after the conclusion of the annual meeting. CO approves and accepts the FINAL Annual Report

3. Incident Report Within 24 or 48 hrs of activity or incident

The Contractor shall communicate and document all critical programmatic concerns, risks or potential risks with the COR and any other designee within 48 hours. The Contractor shall communicate via email or telephone.

In addition, 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 and/or written communication.

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

• Written communication with HHS COR 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

1 Electronic Copy COR and CO

Frequency/ time periods

Description of Deliverable Reporting Procedures

Quantity/ Form

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

4. Draft and Final Report

Draft copy received 75 calendar days before and Final shall be submitted on or before the completion date of the POP

A draft of Final 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 Report incorporating the feedback received from HHS 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 Final Report 75 calendar days before the end of the POP and the Final Report shall be submitted on or before the completion date of the POP

• COR provides edits and additional feedback, which Contractor will incorporate into the Final Report

• CO approves and accepts the Final Report.

1 Electronic Copy to COR and

CO

1 hard copy of the Final Report to the CO with original signature

5. In Process Review/Presentation

In Process Reviews (IPRs) may be conducted at the discretion of the USG to discuss the progression of the contract.

Contractor shall provide a presentation following a prescribed template provided by HHS prior to the IPR

• Contractor shall provide an update on progress and provide the draft presentation 10 days prior to the

IPR

• After reviewing, the CO will provide a written response

1 Electronic Copy to COR and

CO

6. Standard Operating Procedures

As requested by COR and/or CO

Contractor shall provide Standard Operating Procedures (SOPs) to HHS for review, as they are completed and updated

• Contractor shall submit the SOPs in the form requested by the COR and CO within 15 calendar days of request

1 Electronic Copy to COR and

CO

7. HHS Audit Ad Hoc The Contractor shall accommodate for periodic or ad hoc site visits by HHS.

If HHS, 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 CO and COR.

• If HHS, 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 the CO and COR within 10 business days.

• The CO will provide a written response to the Contractor.

• Once corrective action, approved by

1 Electronic Copy to

Frequency/ time periods

Description of Deliverable Reporting Procedures

Quantity/ Form the CO, is completed, the Contractor will provide a final report to HHS

8. Press Releases 5 business days prior to release

The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases

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

• 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 CO and COR concurrently or no later than one (1) calendar day of its submission.

1 Electronic Copy to

PROJECT BIOSHIELD SPECIFIC DELIVERABLES

Frequency/ time periods

Description of Deliverable Reporting Procedures

Quantity/ Form

1. Availability to the USG of a Medical Countermeasure

Per the Quality Agreement

Availability to the USG of the Medical Countermeasure and that the product complies with cGMP Compliance. The total acquisition over the contract period shall be a minimum of TBD unit doses of product.

The Contractor shall provide documentation for the availability of the initial TBD doses in the VMI and documentation of all subsequent additional deliveries

• Contractor shall provide (30) days of advance notice and receive a Contracting Officer Authorization letter prior to availability to the

CDC/SNS.

• After receiving the request BARDA/ CDC will review.

• If approved the CO will provide a written Contract Officer Authorization (COA) Letter to the Contractor. This COA provides authorization to the Contractor to deliver to the SNS

1 Electronic Copy to COR and CO

EVMS DELIVERABLES

# Type of Deliverable Frequency/ time periods

Description of Deliverable Reporting Procedures

Quantity/ Form

1 Performance Measurement Baseline Review (PMBR)

Within 90 days of contract award

The PMBR Report shall address each of the items listed below and be cross-referenced to the WBS, SOW, IMS, Risk Mitigation Matrix and product approval strategy.

1. Contractor provides baseline proposal and PowerPoint brief

2. Responsibility Assignment Matrix

3. A description of the work scope through control account Work Authorization Documents (WADs) and/or WBS Dictionary down to the control account level

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.

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

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

• COR approves (with CO concurrence) and distributes agenda

• COR approves (with CO concurrence) all meeting material

• Contractor provides minutes within 2 business days of the meeting

• COR 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

Electronic Copy to

2. Risk Management Plan 90 days following contract award and updated quarterly (additional submissions as requested by CO or

COR)

The Contractor will provide a Risk Management Plan that outlines the impacts of each risk in relation to the cost, schedule and performance objectives. The Risk Management Plan will include risk mitigation strategies.

Each risk mitigation strategy will capture how the corrective action will reduce impacts on cost, schedule and performance.

• Contractor shall provide a Risk Management Plan 90 days following contract award and update on the 20th of each Quarter in their Quarterly or Annual 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 20 business days of Contractor’s receipt of this list of concerns.

Electronic Copy to COR and

3. Integrated Master Schedule The 20th of The Contractor will provide • Contractor shall 1 each month

Integrated Master Schedule (IMS) with monthly status updates to reflect changes in schedule, performance, and critical path.

Contractor will include BARDA Portfolio Management Milestones in their IMS and provide monthly updates within their IMS.

provide an IMS on the 20th of each month in their Project Status Reports

• IMS 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 within 10 business days of Contractor’s receipt of this list of concerns.

Electronic Copy (PDF and Microsoft Project Schedule (.mmp) format to COR and

CO

4. EVM / Contract Performance Report

The 20th day of the month after each calendar month

Contractor will provide a monthly Contract Performance Report (CPR) Format 1 at an agreed upon reporting level using the BARDA provided WBS and a Variance Analysis Report (Format 5).

The supplemental monthly CAP report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled (BCWS)), earned value (budgeted cost of work performed (BCWP)) and actual costs of work performed (ACWP) as captured in Contractor’s EVM systems. The Contractor shall provide a rational in the package of its use of % complete as EVMS methodology or identity if any other EVMS methodology is being used.

Contractor will provide an .xml export of the EVM data monthly for loading onto Deltek Winsight EVM analysis tool.

• Contractor shall provide a CPR and Variance Analysis Report on the 20th day of the month after the end of each Month.

• Contractor shall provide any changes in baseline cost as a result of anticipated cost savings or risks.

• Contractor shall provide a PDF of deliverables or in a format as directed by COR. BARDA may request, on a monthly 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

Electronic Copy to COR and

CO

5. Deviation Request TBD Process for changing study protocols and/or the IMS activities as base lined at the PMBR.

• Contractor shall submit a Deviation Request as soon as the Contractor has sufficient data to support the need for a change from the approved study protocols, IMS and/or

PBMR

• The BARDA CO will review and provide a written

Electronic Copy to 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 or mutual a re-baseline is conducted.

ADVANCED DEVELOPMENT DELIVERABLES

# Type of Deliverable Frequency/ time periods Description of Deliverable Reporting Procedures Quantity/

Form 1 Approval Strategy Within 90 days of contract award and updated as part of the quarterly report (if strategy changes)

Contractor shall provide a 2-3 page summary of the FDA approval strategy for all indications supported by this contract to include all clinical and non-clinical studies

• 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

1 Electronic Copy to COR and CO for each FDA review of the Strategy

2 Study Protocols At least 60 calendar days prior to study start and 50 days prior to FDA Submission

Contractor shall provide Pre- Clinical/Non-Clinical/ Clinical Trial Protocols prior to a study start for a BARDA review and approval and prior to FDA submission

• Detailed protocols for each study proposed are to be provided for review that sufficiently defines the animal model and therapies to be evaluated in each study cohort.

• If corrective action is required, the Contractor must address in writing all study design, safety, regulatory, ethical, and conflict of interest concerns raised by BARDA to the satisfaction of BARDA before study execution.

• Contractor shall not proceed with any study protocol until the CO gives approval.

1 Electronic Copy to COR and CO for each stage of a technical study

3 Draft and Final Study Reports

A Draft Study Report Template - 30 days after the start of

A Draft Study Report Template shall be for each study. The template will have all sections, tables and proposed figures as empty templates and shall be

• Contractor shall provide the Draft Study Report Templates, Draft Study Reports and

1 Electronic Copy to COR and CO for each study;

each study.

Draft Study Reports- 30 days after the last executable action of the study.

based upon the technical report deliverables and objectives.

A Draft Study Report shall be provided 30 days after the end of life phase of any animal study or 30 days after the last executable action required of the study (i.e.

histopathology interpretations)

A Final Study Report shall be provided for all studies and delivered 60 days after the last actionable activity (i.e. insertion of the histopathology report).

Final Study Reports to BARDA for review and comment.

• COR provides edits and additional feedback, which Contractor will incorporate into the Final Study Report.

Hard copy of final report to

4 Draft and Final Technical Progress Reports

Draft 75 calendar days before and Final shall be submitted on or before the completion date of the

POP

A Draft Final Technical Progress Report is required to summarize 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'.

• The Draft Technical Progress report will be submitted to BARDA for Review and comment.

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

1 Electronic Copy to COR and

CO

Hard copy of final report to

5 GO/NO GO Decision Gate Presentation

Event Driven Review following completion of a pre-defined stage of product development and prior to initiation of a new stage.

The presentation will be provided no later than 10 business days prior to the Decision Gate/IPR Review

Contractor shall submit written justification of progress towards satisfying GO/NO GO Decision Gate criteria.

Contractor shall provide a presentation following a prescribed template provided by BARDA prior to the Decision Gate Review or In Process Review (IPR) for the Advanced Development Deliverables.

• Contractor shall provide an update to technical progress made towards completion of the GO/NO GO Decision Gate and provide the presentation, 10 business days prior to the Decision Gate Review

• After reviewing, the CO will provide a written response

1 Electronic Copy to

FDA Meeting Notification No later than

10 business days prior to the scheduled meeting

The Contractor shall forward the dates and times of any meeting with the FDA to BARDA and arrange for appropriate BARDA staff to attend the FDA meetings. BARDA staff shall minimally include up to a maximum of four people (COR, CO, and up to two (2) Subject Matter Experts (SME(s)).

• 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

1 Electronic Copy to COR and

CO

7 FDA Correspondence and Meeting Minutes

Within five

(5) calendar days of receipt.

The Contractor shall forward initial Contractor and CDER-issued draft minutes and final minutes of any meeting with the FDA to BARDA. All documents shall be duly marked as either 'Draft' or 'Final'.

• Contractor provides FDA correspondence and meeting minutes to BARDA for review.

1 Electronic Copy to

8 FDA Submissions Draft- At least 15 business days prior to submission to FDA 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 provide BARDA the opportunity to review and allow for incorporation of comments 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 any FDA submission.

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

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

BARDA.

1 Electronic Copy to

9 FDA Audits Within 10 business days of a scheduled audit or within 24 hours of an ad hoc site visits or audits if the FDA did not provide advanced notification

The Contractor shall notify the COR and CO within 24 hours of FDA's arrival to conduct site visits/audits by any regulatory agency. In the event of an FDA inspection of a study facility which occurs as a result of this contract that has the reasonable potential to impact the performance of this contract, the Contractor shall provide BARDA with an exact copy (non-redacted of the FDA Form 483, and the Establishment Inspection Report (EIR). The Contractor shall provide the COR and CO copies of the plan for addressing areas of non-conformance to FDA regulations for GLP or GCP guidelines as identified in the audit report within 10 business days, status updates during the plans execution, and a copy of all final responses to the FDA. The Contractor shall also provide non-redacted copies of any FDA

• The Contractor shall notify the COR and CO Within 10 business days of a scheduled audit or within 24 hours of an ad hoc site visits/audits if the FDA did not provide advanced notification.

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 subcontractor that occur as a result of this contract or for this product within three (3) calendar days of receiving correspondence from

1 Electronic Copy to 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. The Contractor shall make arrangements for a BARDA representative(s) to be present during the final debrief by the regulatory inspector.

the FDA and/or third party.

10 QA Audit Reports 5 business days of report completion

The Contractor shall inform the COR and CO in advance of upcoming audits/site visits of subcontractors as part of the weekly communications, including goals and agenda.

BARDA reserves the right to participate in the audit. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, details addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution

• The Contractor shall inform the COR and CO 15 days in advance of upcoming audits/site visits of subcontractors

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

1 Electronic Copy to

11 BARDA Audit Ad Hoc The Contractor shall accommodate for periodic or ad hoc site visits by BARDA. 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.

• A document that captures the issues and identifies potential solutions shall be provided to BARDA within 10 business days after the ad hoc site visit.

• The COR and CO will review the deliverable report and provide a response for any corrective action(s) to the Contractor.

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

1 Electronic Copy to