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Delaware
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001-38193
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46-4744124
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(State or other jurisdiction of
incorporation)
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(Commission File Number
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(IRS Employer
Identification No.)
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201 Santa Monica Boulevard, Suite 500
Santa Monica, CA
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90401
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(Address of Principal Executive Offices)
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(Zip Code)
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(310) 598 5410
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Registrant’s telephone number, including area code
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(Former name or former address if changed since last report,)
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a.
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The total estimated cost of the base period of the contract excluding fee is
[***].
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b.
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The total fixed fee for the base period of performance is
[***].
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c.
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The total estimated cost of the base period of the contract, CLIN 0001, represented by the sum of the total estimated cost plus fixed fee is
[***].
The government will not be responsible for any Contractor-incurred costs that exceed this amount unless a modification to the contract is signed by the Contracting Officer which expressly increases this amount.
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d.
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The Contractor shall maintain records of all contract costs and such records shall be subject to FAR 52.215-2 (Oct 2010), Audit and Records-Negotiation, and Health and Human Services Acquisition Regulation (HHSAR) 352.242-74, Final Decisions on Audit Findings, incorporated by reference into this contract in SECTION I.
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CLIN
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Estimated Period of Performance
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Supplies/Services
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Total Estimated Cost
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Fixed Fee
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Total Estimated Cost Plus Fixed Fee
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0001
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09/19/2018- 9/30/2019
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Clinical - Human Use Characteristics
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[***]
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[***]
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[***]
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CLIN
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Option
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Est. Period of Performance
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Supplies/ Services
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Total Estimated Cost
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Fixed Fee
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Total Estimated Cost Plus Fixed Fee
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0002
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1
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10/01/2019 - 12/20/2021
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CMC Registration Batch Manufacture
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[***]
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[***]
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[***]
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0003
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2
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11/29/2019 - 12/29/2020
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Regulatory NDA
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[***]
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[***]
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[***]
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a.
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Items Unallowable Unless Otherwise Provided
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1.
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Acquisition, by purchase or lease, of any interest in real property;
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2.
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Special rearrangement or alteration of facilities;
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3.
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Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);
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4.
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Travel to attend general scientific meetings, subject to limitation under Article B.4.b.1;
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5.
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Foreign travel;
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6.
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Subcontractor and/or Consultant costs;
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7.
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Patient care costs;
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8.
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Accountable government property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items” regardless of acquisition value (Section J, Attachment 6).
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9.
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Printing Costs (as defined in the government Printing and Binding Regulations).
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10.
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Light Refreshment and Meal Expenditures are not authorized.
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11.
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Costs for meeting room or conference space used for face to face meetings with United States government (USG) staff in the performance of this contract at Government or Contractor facilities are not authorized.
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b.
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Travel Costs
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1.
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Total expenditures for all travel (transportation, lodging, subsistence, and incidental expenses) incurred by the Prime Contractor in direct performance of this contract during the base period shall not exceed
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2.
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The Contactor shall invoice and be reimbursed for all travel costs in accordance with FAR
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3.
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Requests for foreign travel must be submitted at least four weeks in advance and shall contain the following:
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(iii)
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contract purpose to be served by the travel;
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a.
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Subcontracts
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1.
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Is of the cost-reimbursement type or Time-and-Materials (T&M) for any amount;
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2.
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Is Fixed-Price and exceeds $150,000 or 5% of the total estimated cost of the Contract.
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b.
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Security
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c.
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Confidential Treatment of Sensitive Information
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d.
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Sharing of contract deliverables within United States Government (USG)
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e.
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Approval of Protocols
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f.
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Rights in Data
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a.
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Kickoff Meeting
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b.
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Quarterly and Ad-Hoc Meetings
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c.
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Face-to-Face Project Review Meetings
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a.
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Site Visits and Inspections
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•
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If issues are identified during the audit, the Contractor shall submit a report to the CO and COR within five (5) business days detailing the finding and corrective action(s) of the audit.
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•
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COR and CO will review the report and provide a response to the Contractor within ten (10) business days.
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•
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Once corrective action is completed, the Contractor will provide a final report to the CO and COR.
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CLIN
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Option
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Est. Period of Performance
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Supplies/ Services
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2
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1
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10/01/2019 - 12/20/2021
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CMC Batch Manufacturing
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3
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2
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11/29/2019 - 12/29/2020
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Regulatory NDA
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a.
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Summary of Contract Deliverables
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Technical Reports
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Item
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Deliverable
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Description
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Deliverable Schedule
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1
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Bi- weekly Teleconference and Meeting Minutes
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The Contractor shall prepare minutes of all “Project Meetings and “Project Meeting Conference Calls” as defined in Article C. of this contract. In preparation for the monthly calls, briefing materials, including the agenda and documents and information to be discussed will be prepared as needed.
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Contractor shall provide teleconference agenda and related materials twenty-four (24) hours in advance of the call.
Contractor provides meeting minutes to COR within five (5) business days of the meeting. COR reviews, comments, and approves minutes within 15 business days of receipt.
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2
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Monthly Technical Progress Report and Invoice
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Monthly Progress report shall address the progress occurring over the corresponding period of time. See below, ARTICLE F.2.(b), “Detailed Description of Select Contract Deliverables,” for detailed instructions. Additionally, submission of the Monthly Technical Progress Report will contain the invoice for actual costs incurred during the previous month that work was performed under the contract. The costs incurred in the invoice will be justified in a summary report contained within the Monthly Technical Progress Report.
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The 15
th
calendar day of each month following the first full month of the contract award. The Monthly Progress Report will not be required in months when an Annual or Final Technical Progress Report is due.
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3
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Annual Progress Report
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Annual Progress report shall address the progress occurring over the corresponding period of time. See below, Article F.2.(b), “Detailed Description of Select Contract Deliverables,” for detailed instruction.
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The 15
th
calendar day of the month following the end of each 12- month performance period. The Monthly Progress Report will not be required in months when an Annual Progress report is due
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4
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In-Process Review (GO/NO GO
Decision Gate) Presentation
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In preparation for the IPR, the Contractor shall prepare a presentation demonstrating the technical progress made towards completion of the tasks under each work segment. The presentation shall demonstrate the status or completion of the milestones and deliverables as specified under Section F.
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The presentation must be submitted to the CO/COR thirty
(30) business days prior to the IPR IPR for BARDA review and comment. Subsequently, a revised/final presentation will be required ten (10) business days prior to the IPR.
The CO will provide a written response within ten (10) business days on the decision to exercise or not exercise an option.
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13
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FDA/Regulatory Agency Submissions
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BARDA shall provide comment within five (5) business days after receipt. BARDA reserves the right to request more than 5 business days for review of any regulatory submission that is of significant length.
The Contractor shall inform BARDA of the anticipated submission length so BARDA can make a determination if more than 5 business days will be needed to complete its review of the document.
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14
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Supplemental Technical Documents
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Upon request. Contractor shall provide CO and COR with deliverables from the following contract funded activities: Process Development Reports; Stability Assay Reports; Assay Qualification Plan/Report; Assay Validation Plan/Report; Assay Technology Transfer Report; Batch Records; pertinent Contractor/
Subcontractor Standard Operating Procedures (SOPs); Master Production Records; Certificate of Analysis; Clinical Studies Data or Reports. The CO and COR reserve the right to request within the PoP a nonproprietary technical document for distribution within the USG.
Contractor shall provide technical document within 5 business days of CO or COR request.
Contractor can request additional time on an as-needed basis.
*If corrective action is recommended, the Contractor must address, in writing, concerns raised by BARDA.
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15
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Invention Report
Annual Utilization Report
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Due on or before the 30
th
of the month following each 12-month period of performance.
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16
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Final Invention Report
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Due on or before the completion date of the contract.
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17
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Kickoff Meeting
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Within thirty (30) calendar days of contract award.
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b.
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Detailed Description of Select Contract Deliverables
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1.
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Monthly Progress Report
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2.
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Annual Progress Reporting Requirement
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3.
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Summary of Salient Results
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4.
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Audit Reports
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5.
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Copies of FDA/Regulatory Agency Correspondence and Meeting Summaries
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•
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Within five business days of any formal meeting with the FDA or other regulatory agency, the contractor shall forward the initial draft minutes to BARDA. The contractor shall forward final draft minutes when available.
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•
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Within five business days of any informal meeting with the FDA or other regulatory agency, the contractor shall forward the final draft minutes to BARDA.
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•
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The contractor shall forward the dates and times of any meeting with the FDA and other regulatory agencies to BARDA and make arrangements for appropriate BARDA staff to attend the meetings.
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•
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The contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the contractor prior to the contractor’s submission to the FDA.
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•
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The contractor shall forward pertinent contractor Standard Operating Procedures (SOPs) upon request from Project Officer/Contracting Officer.
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•
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The contractor shall provide upon request animal study and/or other technology packages developed under this contract. Packages shall include complete protocols and critical reagents for animal models developed and/or improved with contract funding.
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•
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The contractor shall provide upon request raw data and/or specific analysis of data generated with USG funds.
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6.
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Other Reports/Deliverables
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•
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Government Rights in Data and Inventions
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•
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Institutional Biosafety Approval
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•
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Experimental Protocols
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7.
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Data
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i.
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Contract Management Report (CMR)
|
•
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Contractor shall provide CMR as part of the Monthly Progress Report (this requirement begins only as set forth in the Contract Milestones & Related Deliverables table)
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•
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Contractor shall provide top level or key changes in baseline cost as a result of anticipated cost savings or risks
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•
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In accordance with FAR 52.215-2, Audit and Records-Negotiation (Oct 2010), the USG may request, on a monthly or ad hoc basis that the Contractor provide raw data at a reporting level or lower level as ASPR deems necessary.
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•
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Contractor must address, in writing, all concerns raised by the USG.
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•
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Reporting will commence after the CMR system has been implemented but no later than six (6) months after start of base period.
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ii.
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Integrated Master Plan (IMP)
|
•
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Contractor shall provide the draft IMP within 180 days of contract award with final due 8 months after award and updated monthly as part of the Monthly Progress Report
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•
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Contractor must address, in writing, all concerns raised by the USG.
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iii.
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Performance Measurement Baseline Review (PMBR)
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•
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Contractor provides baseline proposal
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•
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Responsibility Assignment Matrix
|
•
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A description of the work scope through control account Work Authorization Documents and/or WBS Dictionary down to the agreed upon control account level.
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•
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Template for work packages
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•
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Integrated Master Schedule (IMS) with the inclusion of agreed major milestones and control account plans for all control accounts
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•
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Baseline revision documentation and program log(s) risk management plan
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•
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PMBR is due within one year of contract award
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•
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Contractor shall provide baseline proposal .ppt briefing 10 business days prior to meeting
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•
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Contractor provides agenda to COR 2 business days in advance of meeting
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•
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COR approves (with CO concurrence) and distributes agenda
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•
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COR approves (with CO concurrence) all meeting material
|
•
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Contactor provides minutes with 2 business days of the meeting
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•
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COR reviews and approves (with CO concurrence) minutes
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•
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ASPR will review documentation and provide written comments and questions to Contractor
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•
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Contractor shall address BARDA’s comments and resubmit PMBR report for BARDA approval within 10 business days.
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iv.
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Risk Management Plan
|
▪
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Due within 180 days of contract award
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▪
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Contractor provides updated Risk Management Plan in Monthly Progress Report
|
▪
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ASPR shall provide Contractor with a written list of concerns in response plan submitted
|
▪
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Contractor must address, in writing, all concerns raised by ASPR within 20 business days of Contractor’s receipt of ASPR’s concerns.
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v.
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Requirement for Notification of Deviation and Mitigation Strategy
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1)
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The Contracting Officer (CO) is the only individual who can legally commit the USG to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.
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2)
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The Contracting Officer is the only person with the authority to act as agent of the USG under this contract. Only the Contracting Officer has authority to (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor of any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract.
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3)
|
No information other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the US government, other otherwise, shall be considered grounds for deviation from any stipulation of this contract.
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4)
|
The USG may unilaterally change the CO or CS designation
|
1)
|
Recommending to the Contracting Officer changes in requirements;
|
2)
|
Assisting the Contracting Officer in interpreting the statement of work and any other technical performance requirements;
|
3)
|
Performing technical evaluation as required;
|
4)
|
Performing technical inspections and acceptances required by this contract; and
|
5)
|
Assisting in the resolution of technical problems encountered during performance. The USG may unilaterally change the COR designation.
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Name
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Title
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David O’Toole
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Chief Financial Officer
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Carina Caulfield
|
Director of Program Management
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Juan Wooten Contracting Officer HHS/ASPR/CMA
330 Independence Ave., S.W., Room G640
Washington, DC 20201 Email:
juan.wooten@hhs.gov
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Kristen Herring Contracting Officer Representative HHS/ASPR/BARDA
330 Independence Ave., S.W., Room G640 Washington, DC 20201 Email: kristen.herring@hhs.gov
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PSC_Invoices@psc.hhs.gov
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a.
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Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests and Contract Financial Reporting.
|
b.
|
Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the USG.
|
c.
|
The Contractor agrees to immediately notify the CO in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the estimated costs for the base period or any option period(s) (See estimated costs under Articles B.2) and the reasons for the variance. These requirements are in addition to the specified requirements of FAR Clause 52.232-20, Limitation of Cost that is incorporated by reference under Article I.1 which states;
|
(b)
|
The Contractor shall notify the Contracting Officer in writing whenever it has reason to believe that—
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d.
|
The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.
|
e.
|
An electronic copy of the payment request shall be uploaded into the designated eRoom (as defined in SECTION F.3 ELECTRONIC SUBMISSION) and an e-mail notification of the upload will be provided to the CO and COR.
|
f.
|
All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt Payment (Jul 2013).
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g.
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Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget
|
a.
|
Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or percentage of effort), and amount claimed.
|
b.
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Fringe Benefits - Cite rate and amount
|
c.
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Overhead - Cite rate and amount
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d.
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Materials & Supplies - Include detailed breakdown when total amount is over $1,000.
|
e.
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Travel - Identify travelers, dates, destination, purpose of trip, and total breaking out amounts for transportation (plane, car etc.), lodging, M&IE. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.
|
f.
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Consultant Fees - Identify individuals, amounts and activities. Cite appropriate COA
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g.
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Subcontracts - Attach subcontractor invoice(s). Cite appropriate COA
|
h.
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Equipment - Cite authorization and amount. Cite appropriate COA
|
i.
|
Other Direct Costs - Include detailed breakdown when total amount is over $1,000.
|
j.
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G&A - Cite rate and amount.
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k.
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Total Cost
|
l.
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Fee
|
m.
|
Total Cost Plus Fixed Fee
|
Opiant Pharmaceuticals
|
||
|
|
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Rate Type
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Rate
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Allocation Base
|
Fringe Benefits
|
18.00%
|
Total salaries and wages
|
Overhead/G&A
|
0.0%
|
Total direct costs
|
1)
|
The USG shall reimburse the Contractor those costs determined by the Contracting Officer to be allowable (hereinafter referred to as allowable cost) in accordance with FAR 52.216-7, Allowable Cost and Payment and FAR Subpart 31.2. Examples of allowable costs include, but are not limited to, the following:
|
a)
|
All direct materials and supplies that are used in the performing of the work provided for under the contract, including those purchased for subcontracts and purchase orders.
|
b)
|
All direct labor, including supervisory, that is properly chargeable directly to the contract, plus fringe benefits.
|
c)
|
All other items of cost budgeted for and accepted in the negotiation of this basic contract or modifications thereto.
|
d)
|
Travel costs including per diem or actual subsistence for personnel while in an actual travel status in direct performance of the work and services required under this contract subject to the restrictions under Article B.4. b. and the following:
|
i.
|
Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make necessary connections) and must comply with the Fly America Act (49 U.S.C. 40118).
|
ii.
|
Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent.
|
iii.
|
Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).
|
iv.
|
Travel via privately owned automobile shall be reimbursed at not more than the current General Services Administration (GSA) FTR established mileage rate.
|
1.
|
Contractor Performance Evaluations
|
2.
|
Electronic Access to Contractor Performance Evaluations
|
1.
|
Non-Clinical Terms of Award
|
a.
|
Safety and Monitoring Issues
|
i.
|
PHS Policy on Humane Care and use of Laboratory Animals
|
•
|
All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.
|
•
|
All material changes in IACUC policies and procedures, identified by version number, date, and all required signatories (if applicable).
|
•
|
Termination or temporary suspension of the study(ies) for regulatory issues.
|
•
|
Termination or temporary suspension of the protocol.
|
•
|
Any change that is made in the specific IACUC approval for the indicated study(ies).
|
•
|
Any other problems or issues that could affect the scientific integrity of the study(ies), i.e., fraud, misrepresentation, misappropriation of funds, etc.
|
b.
|
BARDA Review Process before Non-Clinical study Execution Begins
|
•
|
IACUC approved (signed) non-clinical research protocol identified by version number, date, or both, including details of study design, euthanasia criteria, proposed interventions, and exclusion criteria.
|
•
|
For non-pivotal mouse studies, the Contractor will provide an annual animal care and use protocol.
|
•
|
Documentation of IACUC approval, including OLAW federal wide number, IACUC registration number, and IACUC name.
|
•
|
Contractor should reduce the number of animals required for a study using power of statistics.
|
•
|
Plans for the management of side effects, rules for interventions and euthanasia criteria.
|
•
|
Procedures for assessing and collecting safety data were appropriate.
|
•
|
If a study is contracted through Contract Research Organizations (CROs), work orders and service agreements the Contractor shall assure an integrated safety documentation plan is in place for the study site, pharmacy service records on the dosing material to be used and excipients, and laboratory services (including histopathology).
|
•
|
Documentation that the Contractor and all required staff responsible for the conduct of the research have received training in the protection and handling of animals, or that the CRO has the required documentation.
|
•
|
Purchasing of animals and/or other supplies for non-clinical studies funded in part or in whole by BARDA requires written approval by the Contracting Officer in accordance with the contract. The Contractor must have the ability to return/re-sell animals, at purchase price, to distributor or a third part, in the event that the Contracting Officer Authorization is not granted.
|
•
|
Provide justification for whether studies require good laboratory practice (GLP) conditions.
|
•
|
Provide justification for whether studies will be classified as non- pivotal or pivotal studies.
|
c.
|
References
|
a.
|
Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through
|
b.
|
The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.
|
c.
|
The Contractor agrees that the care, use and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.
|
d.
|
If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with approved Assurances.
|
a.
|
Confidential information, as used in this article, means information or data of a personal nature about an individual or proprietary information or data submitted by or pertaining to an institution or organization.
|
b.
|
The Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the USG will furnish to the Contractor or that the Contractor is expected to generate which is confidential and providing further that the government is not entitled to unlimited rights to that information pursuant to FAR 52.227-14. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.
|
c.
|
If it is established elsewhere in this contract that information to be utilized under this contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.
|
d.
|
Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.
|
e.
|
Whenever the Contractor is uncertain with regard to the proper handling of material under the contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.
|
f.
|
The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.
|
A.
|
Publication and Publicity
|
(1)
|
the percentage and dollar amounts of the total program or project costs financed with Federal money and;
|
(2)
|
the percentage and dollar amount of the total costs financed by nongovernmental sources
|
B.
|
Press Releases
|
1)
|
Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the USG. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at
http://www.gpoaccess.gov/cfr/index.html
|
2)
|
The Project Officer is hereby designated as the official who is responsible for monitoring contractor compliance with the Privacy Act.
|
3)
|
The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System of Records number 09-25-0200. This document may be obtained at the following link:
http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm
|
•
|
Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications
|
•
|
Contractor shall notify the COR and CO within 5 business days of report completion.
|
•
|
If issues are identified during the audit, Contractor shall submit a report to the CO and COR detailing the finding and corrective action(s) within 10 business days of the audit.
|
•
|
COR and CO will review the report and provide a response to the Contractor with 10 business days.
|
•
|
Once corrective action is completed, the Contractor will provide a final report to the CO and COR.
|
•
|
Within 48 hours of activity or incident or within 24 hours 24 hours for a security related activity or incident, Contractor must notify BARDA.
|
•
|
Additional updates due to COR and CO within 48 hours of additional developments.
|
•
|
Contractor shall submit within 5 business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues.
|
(1)
|
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
|
FAR
CLAUSE
|
DATE
|
CLAUSE TITLE
|
52.202-1
|
Nov 2013
|
Definitions
|
52.203-3
|
Apr 1984
|
Gratuities
|
52.203-5
|
May 2014
|
Covenant Against Contingent Fees
|
52.203-6
|
Sep 2006
|
Restrictions on Subcontractor Sales to the government
|
52.203-7
|
May 2014
|
Anti-Kickback Procedures
|
52.203-8
|
May 2014
|
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
|
52.203-10
|
May 2014
|
Price or Fee Adjustment for Illegal or Improper Activity
|
52.203-12
|
Oct 2010
|
Limitation on Payments to Influence Certain Federal Transactions
|
52.203-13
|
Apr 2010
|
Contractor Code of Business Ethics and Conduct
|
52.203-17
|
April 2014
|
Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower rights
|
52.204-4
|
May 2011
|
Printed or Copied Double-Sided on Recycled Paper
|
52.204-7
|
Jul 2013
|
System for Award Management
|
52.204-10
|
Jul 2013
|
Reporting Executive Compensation and First-Tier Subcontract Awards
|
52.204-13
|
Jul 2013
|
System for Award Management Maintenance
|
52.209-6
|
Aug 2013
|
Protecting the government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment
|
52.209-9
|
Jul 2013
|
Updates of Publicly Available Information Regarding Responsibility Matters
|
52.210-1
|
Apr 2011
|
Market Research
|
52.215-2
|
Oct 2010
|
Audit and Records – Negotiation
|
52.215-8
|
Oct 1997
|
Order of Precedence - Uniform Contract Format
|
52.215-10
|
Aug 2011
|
Price Reduction for Defective Certified Cost or Pricing Data
|
52.215-12
|
Oct 2010
|
Subcontractor Certified Cost or Pricing Data
|
52.215-15
|
Oct 2010
|
Pension Adjustments and Asset Reversions
|
52.215-17
|
Oct 1997
|
Facilities Capital Cost of Money
|
52.215-18
|
Jul 2005
|
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions
|
52.215-19
|
Oct 1997
|
Notification of Ownership Changes
|
52.215-21
|
Oct 2010
|
Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data – Modifications
|
52.215-23
|
Oct 2009
|
Limitations on Pass-Through Charges
|
52.216-7
|
Jun 2013
|
Allowable Cost and Payment
|
52.216-8
|
Jun 2011
|
Fixed Fee
|
52.217-8
|
Nov 1999
|
Option to Extend Services
|
52.219-8
|
Oct 2014
|
Utilization of Small Business Concerns
|
52.222-2
|
Jul 1990
|
Payment for Overtime Premiums
|
52.222-3
|
Jun 2003
|
Convict Labor
|
52.222-21
|
Apr 2015
|
Prohibition of Segregated Facilities
|
52.222-26
|
Apr 2015
|
Equal Opportunity
|
52.222-35
|
Jul 2014
|
Equal Opportunity for Veterans
|
52.222-36
|
Jul 2014
|
Equal Opportunities for Workers with Disabilities
|
52.222-37
|
Jul 2014
|
Employment Reports on Veterans
|
52.222-40
|
Dec 2010
|
Notification of Employee Rights Under the National Labor Relations Act
|
52.222-50
|
Mar 2015
|
Combating Trafficking in Persons
|
52.222-54
|
Aug 2013
|
Employment Eligibility Verification
|
52.223-6
|
May 2001
|
Drug-Free Workplace
|
52.223-18
|
Aug 2011
|
Encouraging Contractor Policies to Ban Text Messaging While Driving
|
52.224-1
|
April 1984
|
Privacy Act Notification
|
52.224-2
|
April 1984
|
Privacy Act
|
52.225-13
|
Jun 2008
|
Restrictions on Certain Foreign Purchases
|
52.227-1
|
Dec 2007
|
Authorization and Consent, Alternate I
|
52.227-2
|
Dec 2007
|
Notice and Assistance Regarding Patent and Copyright Infringement
|
52.227-3
|
April 1984
|
Patent Indemnity
|
52.227-11
|
May 2014
|
Patent Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.)
|
52.227-14
|
May 2014
|
Rights in Data – General, Alt II
|
52.227-16
|
Jun 1987
|
Additional Data Requirements
|
52.232-9
|
Apr 1984
|
Limitation on Withholding of Payments
|
52.232-17
|
May 2014
|
Interest
|
52.232-20
|
Apr 1984
|
Limitation of Cost
|
52.232-23
|
May 2014
|
Assignment of Claims
|
52.232-25
|
Jun 2013
|
Prompt Payment Alternate I (Feb 2002)
|
52.232-33
|
Jul 2013
|
Payment by Electronic Funds Transfer--System for Award Management
|
52.233-1
|
May 2014
|
Disputes
|
52.233-3
|
Aug 1996
|
Protest After Award, Alternate I (June 1985)
|
52.233-4
|
Oct 2004
|
Applicable Law for Breach of Contract Claim
|
52.242-1
|
Apr 1984
|
Notice of Intent to Disallow Costs
|
52.242-3
|
May 2014
|
Penalties for Unallowable Costs
|
2.242-4
|
Jan 1997
|
Certification of Final Indirect Costs
|
52.242-13
|
Jul 1995
|
Bankruptcy
|
52.243-2
|
Aug 1987
|
Changes - Cost Reimbursement, Alternate V (Apr 1984)
|
52.244-2
|
Oct 2010
|
Subcontracts, Alternate I (Jun 2007)
|
52.244-5
|
Dec 1996
|
Competition in Subcontracting
|
52.244-6
|
Apr 2015
|
Subcontracts for Commercial Items
|
52.245-1
|
Apr 2012
|
Government Property
|
52.245-9
|
Apr 2012
|
Use and Charges
|
52.246-9
|
Apr 1984
|
Inspection of Research and Development (Short Form)
|
52.246-23
|
Feb 1997
|
Limitation of Liability
|
|
|
|
52.246-25
|
Feb 1997
|
Limitation of Liability – Services
|
52.247-63
|
Jun 2003
|
Preference for U.S.-Flag Air Carriers
|
52.247-67
|
Feb 2006
|
Submission of Transportation Documents for Audit
|
52.249-6
|
May 2004
|
Termination (Cost-Reimbursement)
|
52-249-14
|
Apr 1984
|
Excusable Delays
|
52.251-1
|
Apr 2012
|
Government Supply Sources
|
52.253-1
|
Jan 1991
|
Computer Generated Forms
|
(2)
|
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:
|
HHSAR
CLAUSE NO.
|
DATE
|
TITLE
|
352.201-70
|
Jan 2006
|
Paperwork Reduction Act
|
352.202-1
|
Jan 2006
|
Definitions, with Alternate paragraph (h)
|
352.203-70
|
Mar 2012
|
Anti-Lobbying
|
352.216-70
|
Jan 2006
|
Additional Cost Principles
|
352.222-70
|
Jan 2010
|
Contractor Cooperation in Equal Employment Opportunity Investigations
|
352.223-70
|
Jan 2006
|
Safety and Health
|
352.224-70
|
Jan 2006
|
Privacy Act
|
352.227-70
|
Jan 2006
|
Publications and Publicity
|
352.228-7
|
Dec 1991
|
Insurance - Liability to Third Persons
|
352.231-70
|
Aug 2012
|
Salary Rate Limitation
|
352.233-71
|
Jan 2006
|
Litigation and Claims
|
352.242-70
|
Jan 2006
|
Key Personnel
|
352.242-73
|
Jan 2006
|
Withholding of Contract Payments
|
352.242-74
|
Apr 1984
|
Final Decisions on Audit Findings
|
352.270-4
|
Jan 2006
|
Protection of Human Subjects
|
a.
|
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
|
(b)
|
(1) The North American Industry Classification System (NAICS) code for this acquisition is
325413
.
|
(c)
|
Representations
.
|
(1)
|
The offeror represents as part of its offer that it [X] is, [ ] is not a small business concern.
|
(2)
|
The offeror represents as part of its offer that it [ ] is, [X] is not, a small disadvantaged business concern as defined in 13 CFR 124.1002.
|
(3)
|
The offeror represents as part of its offer that it [ ] is, [X] is not a woman-owned small business concern.
|
(3)
|
For long-term contracts--
|
1.
|
Statement of Work, dated September 19, 2018 (6 pages).
|
2.
|
Gantt Chart (1 page)
|
3.
|
Milestones/Deliverables and Technical Deliverables (1 page)
|
4.
|
Invoice/Financing Request Instructions and Contract Financial Reporting Instructions for Cost-Reimbursement Type Contracts (5 pages).
|
Mstn #
|
GO/NO GO Contract Milestones
|
Go Criteria
|
No-Go Criteria
|
Deliverable
|
SOW/WBS #
|
CLIN initiated by Milestone Success
|
CLIN 0001
|
Completion of human factors and usability studies
|
Successful demonstration of ease of use of the intranasal device
|
Unable to demonstrate ease of use of the intranasal device
|
Study protocol and final study report
|
1.2.1
|
Required to initiate
CLIN 0002
|
Completion of dose formulation and clinical batch manufacture in NIDA grant
|
Successful identification of dose formulation, device and process requirements to use in the intranasal device
|
Unable to identity of a dose formulation, device and/or process requirements to use in the intranasal device
|
Final study report
|
N/A
|
Required to initiate CLIN 0002
|
|
CLIN 0002
|
Completion of manufacture and stability of registration batch material
|
Successful manufacture of material and demonstration of at least twelve month stability in accordance with ICH requirements
|
Unable to manufacture the material and/or demonstrate twelve month stability in accordance with ICH requirements
|
Batch and stability report
|
2.2.1
2.2.2
|
Required to initiate CLIN 0003
|
Completion of nonclinical and clinical studies from NIDA grant
|
Acceptable toxicity issues and achievement of pilot study PK results in a larger pivotal study
|
Unacceptable toxicity issues and/or unable to repeat pilot study PK results in a larger clinical study
|
Final study reports
|
N/A
|
Required to initiate CLIN 0003
|
|
CLIN 0003
|
Preparation of the NDA
|
Successful completion of the NDA for FDA filing
|
Unable to complete the NDA for FDA filing
|
NDA data package
|
3.2.1
|
N/A
|
Filing the NDA with the FDA
|
Successful approval of the NDA by the FDA
|
Rejection of the NDA by the FDA
|
NDA approval
|
3.2.2
|
N/A
|
(a)
|
Interim Invoice/Contract Financing Request:
These are interim payment requests submitted during the contract performance period.
|
(b)
|
Completion Invoice:
The completion invoice shall be submitted promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and it completes all performance provisions.
|
(c)
|
Final Invoice:
A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions).
|
(a)
|
Designated Billing Office Name and Address:
Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section B and F of the Contract Schedule.
|
(b)
|
Contractor's Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number:
Show the Contractor's name and address exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of the
|
(c)
|
Invoice/Financing Request Number:
Insert the appropriate serial number of the payment request.
|
(d)
|
Date Invoice/Financing Request Prepared:
Insert the date the payment request is prepared.
|
(e)
|
Contract Number and Order Number (if applicable):
Insert the contract number and order number (if applicable).
|
(f)
|
Effective Date:
Insert the effective date of the contract or if billing under an order, the effective date of the order.
|
(g)
|
Total Estimated Cost of Contract/Order:
Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated cost of the order, exclusive of fixed-fee.
|
(h)
|
Total Fixed-Fee:
Insert the total fixed-fee (where applicable).
|
(i)
|
Two-Way/Three-Way Match:
Identify payment to be made using a three-way match.
|
(j)
|
Office of Acquisitions:
Insert the name of the Office of Acquisitions, as identified in Section G of the Contract Schedule.
|
(k)
|
Central Point of Distribution:
Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.
|
(l)
|
Billing Period:
Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.
|
(m)
|
Amount Billed - Current Period:
Insert the amount claimed for the current billing period by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.
|
(n)
|
Amount Billed - Cumulative:
Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.
|
(o)
|
Direct Costs:
Insert the major cost elements. For each element, consider the application of the paragraph entitled "Costs Requiring Prior Approval" on page 1 of these instructions.
|
(2)
|
Direct Labor:
Include salaries and wages paid (or accrued) for direct performance of the contract.
|
(3)
|
Fringe Benefits:
List any fringe benefits applicable to direct labor and billed as a direct cost. Do not include in this category fringe benefits that are included in indirect costs.
|
(4)
|
Accountable Personal Property:
Include permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 or more, with a life expectancy of more than two years, and sensitive property regardless of cost (see the HHS
Contractor's Guide for Control of Government Property
). Show permanent research equipment separate from general purpose equipment.
|
-
|
item number for the specific piece of equipment listed in the Property Schedule, and
|
-
|
COA number, if the equipment is not covered by the Property Schedule.
|
(5)
|
Materials and Supplies:
Include equipment with unit costs of less than $1,000 or an expected service life of two years or less, and consumable material and supplies regardless of amount.
|
(6)
|
Premium Pay:
List remuneration in excess of the basic hourly rate.
|
(7)
|
Consultant Fee:
List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.
|
(8)
|
Travel:
Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.
|
(9)
|
Subcontract Costs:
List subcontractor(s) by name and amount billed. Cite applicable COA or notification.
|
(10)
|
Other:
List all other direct costs in total unless exceeding $1,000 in amount. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.
|
(p)
|
Cost of Money (COM):
Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed.
|
(q)
|
Indirect Costs:
Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.
|
(r)
|
Fixed-Fee:
Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract.
|
(s)
|
Total Amounts Claimed:
Insert the total amounts claimed for the current and cumulative periods.
|
(t)
|
Adjustments:
Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.
|
(u)
|
Grand Totals
|
(v)
|
Certification of Salary Rate Limitation:
If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request:
|
(w)
|
Signature
|
(a)
(b)
|
Designated Billing Office Name and Address:
DHHS/OS/ASPR/BARDA
Attn: Contracting Officer
330 Independence Ave., S.W. Room G644
Washington, D.C. 20201
Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number:
ABC CORPORATION
100 Main Street Anywhere, USA Zip Code
Name, Title, Phone Number, and E-mail Address of person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent.
VIN:
DUNS or DUNS+4:
|
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
|
Invoice/Financing Request No.: Date Invoice Prepared:
Contract No. and Order No. (if applicable):
Effective Date:
Total Estimated Cost of Contract/Order: Total Fixed-Fee (if applicable):
Two-Way Match: Three-Way Match:
Office of Acquisitions: Central Point of Distribution:
|
||||||
(l) This invoice/financing request represents reimbursable costs for the period from
to
|
|||||||||
Expenditure Category*
A
|
Cumulative Percentage of Effort/Hrs.
|
Amount Billed
|
Cost at Completion F
|
Contract Amount G
|
Variance H
|
||||
Negotiated B
|
Actual C
|
(m) Current D
|
(n) Cumulative E
|
||||||
(o) Direct Costs:
|
|
|
|
|
|
|
|
||
(1) Direct Labor
|
|
|
|
|
|
|
|
||
(2) Fringe Benefits
|
|
|
|
|
|
|
|
||
(3) Accountable Property
|
|
|
|
|
|
|
|
||
(4) Materials & Supplies
|
|
|
|
|
|
|
|
||
(5) Premium Pay
|
|
|
|
|
|
|
|
||
(6) Consultant Fees
|
|
|
|
|
|
|
|
||
(7) Travel
|
|
|
|
|
|
|
|
||
(8) Subcontracts
|
|
|
|
|
|
|
|
||
(9) Other
|
|
|
|
|
|
|
|
||
Total Direct Costs
|
|
|
|
|
|
|
|
||
(p) Cost of Money
|
|
|
|
|
|
|
|
||
(q) Indirect Costs
|
|
|
|
|
|
|
|
||
(r) Fixed Fee
|
|
|
|
|
|
|
|
||
(s) Total Amount Claimed
|
|
|
|
|
|
|
|
||
(t) Adjustments
|
|
|
|
|
|
|
|
||
(u) Grand Totals
|
|
|
|
|
|
|
|
||
I certify that all payments are for appropriate purposes and in accordance with the contract.
(Name of Official) (Title)
* Attach details as specified in the contract
|