B08-Solicitation-W81XWH-19-R-0032.docx

W81XWH19R0032

Section A - Solicitation/Contract Form

GENERAL INFORMATION

Project Title: Analgesic Ketamine

This is a Research & Development (R&D) requirement.

The Government anticipates that any resulting award from this Request for Proposal (RFP) will be a Cost Plus Fixed Fee contract.

North American Industry Classification System (NAICS) Code: 541715

Points of Contact (POCs): The primary point of contact (POC) for this solicitation is Jamie Diggs, Contract Specialist, jamie.l.diggs.civ@mail.mil. All inquiries regarding this requirement must be submitted via electronic mail (e-mail) to the Contract Specialist.

Solicitation Questions: Questions concerning this solicitation shall be submitted in writing to the POC via e-mail no later than 29 May 2019 at 9:00 AM Eastern Time. The e-mail must have a subject title of “W81XWH-19-R-0032 Solicitation Questions”. Any questions submitted after this date and time will not be accepted or answered. Answers to Contractor submitted questions will be provided to all Offerors through a solicitation amendment. Telephone inquiries will NOT be accepted at any time.

Proposal Submission: Proposals shall only be electronically submitted to the primary POC via e-mail. The e-mail must have a subject title of “W81XWH-19-R-0032 Proposal Submission”. The Offeror is responsible for verifying receipt by the POC. One electronic copy shall be submitted for each proposal volume. Each proposal volume should be a separate attachment.

Proposal Due Date: No later than 21 June 2019 at 9:00 AM Eastern Time. Any proposals received after this date and time may not be considered for evaluation. Offerors’ proposals shall remain open for a minimum of 120 days from the date of submission.

Alternate Proposals: Only one proposal from each Offeror will be evaluated by the Government.

The Government anticipates that this solicitation will result in one contract award.

This invitation to submit a proposal does not assure that a contract will be awarded.

The Offeror’s proposal will be incorporated by reference into a resulting contract. The Offeror’s Statement of Work (SOW) will be incorporated in full text into any resulting contract.

Section B - Supplies or Services and Prices

Analgesic Ketamine Development

CPFF

The creation of a new Ketamine Label indication for analgesic use added to existing FDA Approved Ketamine Anesthetic product. Analgesic ketamine will be designed and developed in accordance with product specifications listed in SOO to include an FDA approved individually packaged, intramuscular analgesic ketamine dose and delivery device that meets or exceeds the requirements of the SOO.

FOB: Destination

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

CPFF

Emergency Use Authorization package prepared for submission to the FDA for approval of emergency use.

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

CPFF

Production and shipment of licensed analgesic ketamine vials supplying up to 112,500 doses (Initial Operational Capacity – IOC). This quantity would be divided into three sub-options up to 37,500 doses per order/shipment.

ESTIMATED COST

FIXED FEE

TOTAL EST COST + FEE

ODC

COST

ESTIMATED COST

CMR

FFP

NET AMT

CDRL A0001

CDRL A0001

NET AMT

CDRL A0002

CDRL A0002

NET AMT

Section C - Descriptions and Specifications

STATEMENT OF OBJECTIVES

1.0 PURPOSE

The mission of the U.S. Army Medical Research and Materiel Command (USAMRMC) is to “Responsively and responsibly create, develop, deliver, and sustain medical capabilities for the Warfighter”. Accordingly, it is the mission of the U.S. Army Medical Materiel Development Activity (USAMMDA) Pharmaceutical Systems Program Management Office (PSPMO) to develop and deliver vaccines, drugs, diagnostics, and hemorrhage control and resuscitation products to protect, treat, and sustain the health, readiness, and lethality of our U.S. Service Members.

Battlefield pain management is a key focus for the Department of Defense (DoD), which must improve the delivery of pain relief at, or as close as possible to, the point of injury in both space and time. The alleviation of pain caused by a traumatic battlefield injury significantly improves the potential for Soldier survival, favorable functional outcomes, and is an essential element of patient care in any situation. The currently licensed and available acute pain management item for the combat medic is intramuscular morphine sulfate. This drug and means of administration are no longer the accepted standard of care and have been found in multiple cases of treatment of severe wounds to be ineffective. Additionally, opioids have serious side effects, including respiratory and cardiovascular suppression, as well as, the risk of addiction and abuse.

US service members need modernized pain management solutions. Their confidence in military medical care enables them to fulfill the mission, which often puts them in harm’s way, with the assurance that all assets from the combat medic to the Role 4 hospital are ready to treat them if injured. Without additional U.S. Food and Drug Administration (FDA) approved analgesics, DoD runs the risk of failing to meet this warfighter expectation on the battlefield at the point of injury and through transport to, and at, the early roles of care. This gap threatens soldier readiness and must be addressed by this development effort.

2.0 BACKGROUND

Ketamine was licensed in 1970 as an anesthetic for intravenous or intramuscular administration. Its analgesic properties have long-been recognized, both alone, and more commonly in combination with other analgesics. Established effects of ketamine, beyond the primary analgesic effect, make it particularly valuable for battlefield pain management. It has hypnotic (sedative/sleep-producing) and amnesic effects coupled with a lack of impact on airway reflexes, respiratory function, and sympathomimetic cardiovascular effects (increased arterial pressure and heart rate). Additionally, ketamine appears to minimize early wind-up and suppress central sensitization with acute pain, reduce the likelihood of N-Methyl-D-aspartic acid (NMDA) receptor mediated neuroplasticity, and limit or prevent opioid hyperalgesia. Preliminary evidence suggests utility in the treatment of drug resistant depression and post-traumatic stress disorder (PTSD) with a potential benefit of preventing or reducing PTSD.

The therapeutic profile of ketamine is quite favorable, but like all pharmaceuticals has side effects and limitations to use. Sub-dissociative intravenous (IV) dosing is typically described as up to 0.5 mg/kg, with a dose range of 0.1-0.3 mg/kg IV being slightly more typical. Common side effects are dysphoria, nausea, and dizziness, which are typically short-lived and self-limiting. Emergence reactions are a notable concern, but are typically associated with doses higher than this analgesic range. Historic contraindications for use in cases of increased intracranial and intraocular pressure still remain as concerns, but have limited scientific evidence to support maintaining these contraindication particularly in controlled clinical settings and multimodal analgesia. Moderate evidence supports the contraindications of ketamine usage in those with a history of schizophrenia, current psychosis, or pregnancy.

3.0 PROGRAM OBJECTIVES

In accordance with our mission, the USAMRMC’s objective is to develop, achieve FDA approval, and field a ketamine analgesic that can be used by U.S. Service Members. Ultimately, the developed analgesic ketamine must be FDA-approved and must achieve (at minimum) all “threshold” requirements documented in Appendix A. Preferably, the analgesic ketamine should be developed to the “objective” specifications wherever possible; while keeping the importance of rapid delivery/fielding and cost in mind. Incremental development strategies that depict rapid development and fielding at or above threshold requirements should be described whenever possible. Once FDA approved, analgesic ketamine will be used from Role 1 (combat medic) through Role 3 (combat support hospital) outside the continental United States (OCONUS).

a. It is anticipated that the Offeror’s activities will include, but are not limited to, the following: Design and develop, analgesic ketamine that meets or exceeds the requirements in Appendix A.

b. Provide all manner of necessary services to achieve requirements; minimizing the level of government involvement to the greatest extent possible. Government will be available to consult on technical requirements and trade space.

c. Leverage existing capabilities and data as a current FDA licensed manufacturer of ketamine to expedite development and save cost.

d. Serve as the Regulatory Sponsor, in accordance with 21 Code of Federal Regulations (CFR) 312 subpart D, throughout the effort, develop and maintain a documented regulatory strategy, target product profile, and develop all required regulatory submissions and perform all necessary FDA interactions/correspondence. A key factor in this role is the determination of a sound regulatory strategy to achieve the Government’s requirements.

e. Conduct all development activities in compliance with FDA (to include human subject protection regulations), International Council for Harmonisation, current Good Manufacturing Processes, and local, regional, and other applicable regulations; as necessary in order to achieve Government requirements.

Optional Tasks

f. Conduct all manner of activities necessary to provide anesthetic ketamine under Emergency Use Authorization.

g. Design, develop, manufacture, and serve as the Regulatory Sponsor for an individually packaged intramuscular analgesic ketamine dose and delivery device (pre-filled syringe, auto-injector, or functionally equivalent device), that meets or exceeds the requirements in Appendix A.

h. Low Rate Initial Production (LRIP): Production and shipment of licensed analgesic ketamine vials supplying up to 112,500 doses (Initial Operational Capacity – IOC). This quantity would be divided into three sub-options up to 37,500 doses per order/shipment.

4.0 LOGISTICS OBJECTIVES

4.1. This contract is for activities to achieve FDA approval for intramuscular analgesic ketamine. The contractor should submit a Statement of Work (SOW) in response to this Statement of Objectives (SOO).

4.2 The Contractor(s) shall develop the solution in accordance with (IAW) all applicable State laws, Federal laws, DoD regulations, and US Army regulations. The Government does not intend to provide equipment or facilities. The Government will not provide the Contractor with Government network access, building access badges, or common access cards during the duration of the contract.

4.3 The Contractor shall conduct monthly IPT meetings Joint Government/Project Integrated Product Team (IPT) Meeting Participation and Minutes (Deliverable 1). Participation jointly with the Government and record meeting minutes. The meeting shall focus on areas of the effort requiring input from the government and critical path items towards achieving contract objectives. Minutes will be circulated among all IPT members prior to the subsequent IPT meeting, after which the minutes will be finalized with a final copy sent to the COR.

4.4 The contractor shall submit Monthly Task Status Report (Deliverable 2). The report for this requirement to the COR that highlights major events in the reporting period. The report shall include details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, and any problems/issues encountered. The contractor shall require and incorporate input from subcontractors where there are critical or significant tasks related to the contract. Critical or significant tasks shall be defined by mutual agreement between the Government and contractor.

4.5 The contractor shall submit an Integrated Master Schedule (IMS) (Deliverable 3). The IMS shall be structured to correlate with the Contractor’s SOW. The IMS shall contain planned events and milestones, accomplishments, and activities from contract award to the completion of the contract.

4.6 The contractor shall create a Regulatory Strategy and Target Product Profile (TPP) (Deliverable 4) following the FDA “Guidance for Industry and Review Staff Target Product Profile – A Strategic Development Process Tool.” A Regulatory strategy detailing engagement with and licensure by FDA for both the base effort and Optional Task (f) should also be described. This should include details of IND filing path(s) and all regulatory actions necessary to achieve FDA approval.

4.7 The contractor shall provide a Spend Plan (Deliverable 5) which details how the Offeror expects to incur and invoice for costs against the contract. The Spend Plan shall detail costs to be incurred monthly by fiscal year (1 October – 30 September) and by contract year, starting with the first month of the contract period of performance. The Spend Plan total shall match with the total costs proposed for the entire contract in the Cost/Pricing Sheet. The contractor shall report actual progress against the Spend Plan in the Monthly Task Status Report.

4.8 The contractor shall provide a Market Sustainment Plan (Deliverable 6) which details how the Offeror will sustain the production and availability (sales) of product to Department of Defense (DoD) long-term, for the expected life-cycle of analgesic ketamine (FY40). The sustainment plan should detail both DoD and civilian markets and positioning of analgesic ketamine in the overall company product portfolio. The Market Sustainment Plan should include the base effort as well as Optional Task (f).

4.9 The contractor shall provide a Risk Management Plan (RMP) (Deliverable 7) and subsequent semiannual reports (or more if needed/unexpected risk emerges) documenting comprehensive and sound risk management with project risks routinely assessed, tracked, and mitigated. Issues and questions from the RMP shall be discussed with the COR. The RMP shall be structured to correlate with the critical path and milestone achievement.

4.10 The contractor shall establish a Quality Management Plan (QMP) / Subcontractor Management Plan (SMP) (Deliverable 8) with the Government that outlines roles and responsibilities of the Quality components of each organization, and the Quality standards to which the contractor will adhere. This Agreement will include timeframes for receipt of contract deliverables in accordance with the deliverables table.

5.0 PERFORMANCE

5.1 Delivery Schedule

The Government estimates that all activities from pre-IND to FDA approval will take no more than six years to complete (post award). If an option for a single dose device is awarded, up to an additional three years could be necessary to achieve licensure of the delivery device.

5.2 Place of Performance

The Offeror is to determine the place of performance in its Technical Proposal.

6.0 DELIVERABLES

NOTE: For this requirement “deliver” means that the USAMMA COR is in receipt of the deliverable.

6.1 The SOW should include:

Table 1. Deliverables

Deliverable 2

Deliverable 3

Deliverable 4

(CDRL A001)

Deliverable

* NLT = No Later Than

7.0 CONTRACT DATA REQUIREMENTS LIST

7.1 The contractor shall create a Regulatory Strategy and Target Product Profile (TPP) IAW DI-TCSP-82040 (Deliverable 4, CDRL A0001) following the FDA “Guidance for Industry and Review Staff Target Product Profile – A Strategic Development Process Tool.” A Regulatory strategy detailing engagement with and licensure by FDA for both the base effort and Optional Task (f) should also be described. This should include details of IND filing path(s) and all regulatory actions necessary to achieve FDA approval.

7.2 The contractor shall prepare and maintain current Technical Data Package (TDP)(Deliverable 9), CDRL A0002) in an electronic database that includes all necessary documentation and technical data, protocols and reports collected and prepared during the development effort funded by the Government. The contractor shall allow Government password protected access to TDP database. The TDP shall include all necessary documentation and data for the Government, or its designee, to continue the development or production of the product. The Contractor shall assist in the technical transfer as determined by the Government. The TDP shall be transferred to the Government immediately if at any time the Contractor defaults and fails to remedy said default before or after approval, or within three (3) months of FDA licensure or NLT 7 calendar days after Government request.

Table 2. Contract Data Requirements List (CDRL)

8.0 DELIVERABLES SCHEDULES

Table 3. Contracting Term Abbreviations

8.1 Delivery Address

All deliverables shall be delivered to the USAMMA COR designated in the COR appointment letter.

8.2 Method of Delivery

Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS Word, MS Excel, MS PowerPoint, MS Project, or MS Access format), unless otherwise specified by the USAMMA COR. Electronic submission shall be made via email, unless otherwise agreed to by the USAMMA COR. The contractor shall make sure of commercial best practices in the packing and shipment of packages.

Appendix A: Analgesic Ketamine Requirements

Shelf Life:

Storage Conditions and Stability

storage at 20-25°C > 3 years storage at minus 20-45°C

* KPP = Key Performance Parameter

9.0 TRAVEL & OTHER DIRECT COSTS (ODCS)

ODCs shall be billed on a cost reimbursable basis. ODCs are defined as purchase price of materials or services plus applicable indirect costs and tax (if applicable), fee will not be paid on ODCs or travel.

Contractor will be authorized travel expenses consistent with the substantive provision of the Joint Travel Regulation (JTR) and the limitation of funds specified in the contract. All travel requires Government prior approval/authorization by the USAMMA COR.

Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. Contractor shall submit travel requests with estimated costs to the COR NLT fifteen (15) calendar days prior to travel. Travel costs shall be incurred and billed in accordance with FAR Part 31 for up to 3 Contractor employees for each prototype demonstration event held at Fort Detrick, Maryland. Costs for these expenses will be reviewed, certified and approved by the USAMMA COR. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area results in reasonable charges to the government. The Government will not pay for business class or first-class travel. Lodging and meals shall be reimbursed in accordance with regulations defined in FAR Part 31.

10. SUPPLEMENTAL INFORMATION

REGULATORY RIGHTS IN EVENT OF PRODUCT DEVELOPMENT FAILURES

This contract includes research with an investigational drug, biologic or medical device that is regulated by the U.S. Food and Drug Administration (FDA) and requires FDA pre-market approval or clearance before commercial marketing may begin. It is expected that this contract will result in the FDA clearance and commercialization of the Analgesic Ketamine. The Contractor is the sponsor of the Regulatory Application (an investigational new drug application (IND), investigational device exemption (IDE), new drug application (NDA), biologics license application (BLA), premarket approval application (PMA), or 510(k) pre-market notification filing (510(k)) or another regulatory filing submitted to FDA) that controls the research under this contract. As the sponsor of the Regulatory Application to FDA (as the terms “sponsor” and “applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C, or 814.20), the Contractor has certain standing before the FDA that entitles it to exclusive communications related to the Regulatory Application. This provision protects the return on research and development investment made by the Army Medical Research and Materiel Command (USAMRMC) in the event of certain regulatory product development failures related to the Technology.

The Contractor agrees to the following:

a. Contractor will, within three (3) business days of receipt, provide USAMRMC with all communications and summaries thereof, both formal and informal, to or from FDA regarding the Technology and ensure that USAMRMC representatives are given advance notice of and are invited to participate with at least two (2) representatives in any formal or informal sponsor meetings with the FDA;

intellectual property covered by section (b) above;

(ii) will survive the acquisition or merger of the Contractor by or with any third party;

(iii) will be included in any subcontracts relating to the development of the Technology;

(iv) will survive the expiration of this contract.

(End of Requirement)

ORGANIZATIONAL AND CONSULTANT CONFLICTS OF INTEREST (OCI)

The FAR Part 9.5 prescribes responsibilities, general rules, and procedures for identifying, evaluating, and resolving Organizational Conflict of Interest (OCI), provides examples to assist Contracting Officers in applying these rules and procedures to individual contracting situations; and implements section 8141 of the 1989 Department of Defense Appropriation Act. The two (2) underlying principles which the FAR seeks to avoid are preventing the existence of conflicting roles that might bias a Contractor's judgment and preventing unfair competitive advantage. An unfair competitive advantage exists where a Contractor competing for award of any Federal contract possesses --

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that Contractor in obtaining the contract.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

It is the Contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the Contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

Contractors shall sign a Non-Disclosure Agreement (Attachment XX) at the start of their performance on the contract.

If, under this contract, the Contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the Contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the Contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the Contractor shall not be permitted to furnish these items, either as a prime or subcontractor. The term of this prohibition shall endure for the entire period of this contract performance and for either two (2) years thereafter or the duration of the initial production contract whichever is longer. This rule shall not apply to Contractors who furnish specifications or data at Government request or to situations in which Contractors act as Government representatives to help Government agencies prepare, refine or coordinate specifications, provided this assistance is supervised and controlled by Government representatives.

If, under this contract, the Contractor will prepare or assist in preparing a work statement to be used in competitively acquiring a system or services, the Contractor shall not supply the system, its major components, or the service unless the Contractor is the sole source, the Contractor has participated in the development and design work, or more than one Contractor has been involved in preparing the work statement. The term of this prohibition shall endure for the length of this contract.

If, under this contract, the Contractor will provide technical evaluation of products or advisory and assistance services, the Contractor shall not provide such services if the services relate to the Contractor's own or a competitor's products or services unless proper safeguards are established to ensure objectivity.

If, under this contract, the Contractor gains access to proprietary or source selection information of other companies in performing advisory assistance services for the Government, the Contractor agrees to protect this information from unauthorized use or disclosure and to refrain from using the information for any purpose other than that for which it was furnished. A separate agreement shall be entered into between the Contractor and the company whose proprietary information is the subject of this restriction. A copy of this agreement shall be provided to the Contracting Officer.

The Contracting Officer has significant discretion as to the acceptability of any mitigation plan offered.

Contractors are encouraged to present their best strategy for mitigation of any potential OCI under this contract. Contractors shall submit a mitigation plan at the Contract level and update it as often as necessary throughout the life of the Contract.

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements and review as necessary throughout the life of the contract. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all sub-Contractors, teaming partners or consultants prior to tasking any such party under this contract.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Performance Work Statement, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

(End of Requirement)

RESEARCH INVOLVING ANIMALS

READ FURTHER FOR DETAILS

All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP) Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. The ACURO must review and approve all animal use prior to the start of working with animals, including amendments to ongoing projects. PIs must submit the institutional animal use protocol, IACUC approval of that protocol, and a version of the animal use appendix titled, “Research Involving Animals.” Allow at least 2 to 3 months for ACURO regulatory review and approval processes for animal studies.

(End of Requirement)

USE OF TECHNICAL REFERENCE FACILITY

To the extent practical the Contractor shall utilize the technical reference facilities of the Defense Technical Information Center (DTIC) for the purpose of surveying existing knowledge and avoiding needless duplication of scientific and engineering effort and the expenditure thereby represented. The DTIC headquarters office is located at 8725 John J. Kingman Road, Fort Belvoir, VA 22060-6218. Information can also be obtained via the Internet at http://www.dtic.mil or via the toll-free number for the DTIC help desk, 1-800-225-3842. To the extent practical, all other sources, whether or not Government controlled, should be consulted for the same purpose.

(End of Requirement)

REPORTS, MANUSCRIPTS AND PUBLIC RELEASES

a. Contractors are encouraged to publish results of research supported by the US Army Medical Research and Materiel Command (USAMRMC) in appropriate media forum. Any publication, report or public release, which may create a statutory bar to the issuance of a patent on any subject invention, shall be coordinated with appropriate patent counsel.

b. Manuscripts intended for publication in any media shall be submitted to the KO and KO's Representative (COR), simultaneously with submission for publication. Review of such manuscripts is for comment to the Principal Investigator, not for approval or disapproval. Courtesy copies of the reprint shall be forwarded to the KO and COR, even though publication may be subsequent to the expiration of the contract

c. The Contractor shall notify the KO of planned news releases, planned publicity and advertising material concerning contract work, and planned presentations to scientific meetings, prior to public release. This is not intended to restrict dissemination of research information but to allow USAMRMC advance notice in order to adequately respond to inquiries.

d. Manuscripts, reports, public releases and abstracts, which appear in professional journals, media and programs, shall include the following statements:

e. Contractors are encouraged to publish results of research supported by the US Army Medical Research and Materiel Command (USAMRMC) in appropriate media forum. Any publication, report or public release, which may create a statutory bar to the issuance of a patent on any subject invention, shall be coordinated with appropriate patent counsel.

f. Manuscripts intended for publication in any media shall be submitted to the KO and KO's Representative (COR), simultaneously with submission for publication. Review of such manuscripts is for comment to the Principal Investigator, not for approval or disapproval. Courtesy copies of the reprint shall be forwarded to the KO and COR, even though publication may be subsequent to the expiration of the contract

g. The Contractor shall notify the KO of planned news releases, planned publicity and advertising material concerning contract work, and planned presentations to scientific meetings, prior to public release. This is not intended to restrict dissemination of research information but to allow USAMRMC advance notice in order to adequately respond to inquiries.

(End of Requirement)

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLAUSES INCORPORATED BY REFERENCE

Section F - Deliveries or Performance

DELIVERY INFORMATION

30-AUG-2025

FORT DETRICK-USAMMDA

1430 VETERANS DRIVE

FORT DETRICK MD 21702-9232

3016197860

W806YH

30-AUG-2025

W806YH

30-AUG-2025

USAMMDA - FORT DETRICK

1430 VETERANS DR.

FREDERICK MD 21702

W806YH

30-AUG-2025

W806YH

30-AUG-2025

W806YH

30-AUG-2025

W806YH

30-AUG-2025

USAMMDA - FORT DETRICK

1430 VETERANS DRIVE

FORT DETRICK MD 21702-9232

3016197860

W806YH

Section G - Contract Administration Data

CLAUSES INCORPORATED BY FULL TEXT

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)

(a) Definitions. As used in this clause—

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall—

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items—

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

(Contracting Officer: Insert either “Invoice 2in1” or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial item financing, submit a commercial item financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and receiving report in one step.]

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

(**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(g) WAWF point of contact.

TBD at time of award

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s WAWF point of contact.

TBD at time of award

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

(End of clause)

Section I - Contract Clauses