Attach 01 SOW_ID04200024 23 Nov 2020_.pdf

General Services Administration Federal Acquisition Services

77 Forsyth Street, SW Atlanta, GA 30303

STATEMENT OF WORK (SOW)

TACTICAL COMBAT CASUALTY CARE (TCCC)

RFP Attachment 1

ID04200024

1.0 INTRODUCTION

The Program Manager (PM), SOF Survival, Support & Equipment Systems (PM SOF SSES) is responsible for the procurement, training and sustainment of operationally tested, approved and fielded materiel solutions in support of the United States Special Operations Command (USSOCOM) Tactical Combat Casualty Care (TCCC) Casualty Evacuation (CASEVAC) Program of Record (PoR). The TCCC CASEVAC program objective is to preserve the force and facilitate its reconstitution by reducing preventable battlefield deaths and minimizing effects from injuries.

SOF TCCC CASEVAC Kits are designed using a Sets, Kits and Outfits (SKO) approach consisting of sets/kits organized according to field functionality (extraction, mobility, transport, and sustainment). Each kit is further broken down into individual modules that are, again, grouped according to sub‐functionality.

Depending on factors such as type of mission, environment, available modes of transportation, etc., SOF personnel are able to select specific modules and/or kits to optimize medical support for the anticipated mission conditions. Unlike conventional‐service medical kits, SOF TCCC CASEVAC kits are set apart by providing robust and turn‐key patient access, rescue, and treatment capabilities.

The program requirements include performance metrics (functionality, weight, interoperability, etc.), as well as use with SOF standard and non‐standard equipment; including various mobility platforms for air, ground, and sea movement. It also includes the requirements for kitting, delivery, training, training media development, and documentation such as Material Data Safety Sheets (MSDS) and Contractor Data Requirements List (CDRL’s). This will also outline Spiral Development requirements, continued product improvement/change requirements which will be priced at the Delivery Order/Task order level after contract award.

2.0 SCOPE

This Statement of Work (SOW) defines the requirement for the acquisition of TCCC CASEVAC Sets, New Equipment Training Courses (NET), individual sustainment parts, and Material Support. The Contractor shall provide all material, services and necessary support documentation needed to complete the requirements of this SOW. The deliverables shall meet their respective performance requirements as specified in the contract, this SOW and corresponding attachments.

3.0 APPLICABLE DOCUMENTS

The following documents are applicable, at their latest revision, to this SOW and attached appendices to the extent herein. In the event of conflict between the applicable documents listed below and this SOW, the SOW shall take precedent

3.1 Military Standards

3.1.1 Military Standard (MIL‐STD) 810H, Department of Defense (DOD) Test Method

Standard for Environmental Engineering Considerations and Laboratory Tests.

3.1.2 MIL‐STD‐147E (W/ CHANGE‐1), DEPARTMENT OF DEFENSE STANDARD PRACTICE:

PALLETIZED UNIT LOADS (23‐DEC‐2013)., This standard establishes the methods, materials, and techniques to be employed in the formation of bonded palletized unit loads of military supplies, which are adaptable to unit loading. MIL‐STD‐130, Identification Marking of U.S. Military Property, MIL‐STD‐129R military marking for shipment and storage.

3.2 Government Documents

3.2.1 Tactical Combat Casualty Care Guidelines 2018 (online)

3.2.2 Army Regulation (AR) 70‐62, Airworthiness of United States (U.S.) Army Aircraft

Systems

3.2.3 Military Edition, Pre‐Hospital Trauma Life Support Version 6E

3.2.4 National Fire Protection Association (NFPA) standard 2020

3.2.5 National Fire Protection Association (NFAP) 1006 – Standard for Technical Rescue

Personnel Professional Qualifications

3.2.6 Union Internationale des Associations d' Alpinisme (UIAA) or European Committee for Standardization (CEN) climbing certifications of complicity http://safety.theuiaa.org/front/index public.php

3.2.7 Food and Drug Administration (FDA) approved for medical use certification (Devices@FDA.gov)

3.2.8 International Civil Aviation Organization (ICAO) Technical Instructions for the Safe Transport of Dangerous Goods by Air

3.2.9 International Maritime Dangerous Goods Code (IMDG)

3.2.10 Code of Federal Regulations (CFR), Titles 29, 40 and 49

3.2.11 Joint Service Regulation AFJMAN24‐204/TM38‐250/NAVSUPPUB 505/MCO

P4030.19/DLAM 4145.23 (for military air shipments)

4.0 REQUIREMENTS

The Contractor shall provide all products and tasked events as delineated in this SOW. The contractor shall provide all materials, personnel, and facilities necessary to manufacture and deliver the types and quantities of the products that shall be required in future delivery orders.

4.1 TCCC CASUALTY EVACUATION (CASEVAC) SETS EQUIPMENT AND KIT ASSEMBLY

The TCCC CASEVAC Set includes four component kits: Casualty Extraction Kit, Casualty Mobility Kit, Casualty Transportation Kit and Casualty Sustainment Kit. All Sets shall be available in Multicam and Coyote, patterns as specified in the delivery order. The Contractor1 shall deliver TCCC equipment2 in accordance with the provided List of Materials (LOM), engineering diagrams (wire schematics) and applicable Government guidance. The kits will be packaged/delivered in IAW the operationally tested, approved, and fielded configurations as illustrated by the engineering diagrams and LOM. In addition, each kit and/or module shall contain reference materials to include a digital copy and hard version copy of the current LOM, manuals, and engineering diagrams and NET training video. Delivery quantities shall be as specified in the Delivery Order (DO) and delivery dates shall be in accordance with the delivery section of the contract/order.

1 Contractor as referenced in this document is the Prime Integrator 2 Equipment as referenced in this SOW means CASEVAC Set, Kits, Modules and individual items.

The Contractor shall provide all facilities for inventory, staging, assembly, and kitting of TCCC sets.

Facilities shall be secured and maintained in accordance with best commercial practices for personnel access and facility integrity. The organization being inspected/assessed positions information system components within the facility to minimize the opportunity for unauthorized access specific to the location of the information system as documented in PE‐1, CCI 00904.

4.1.1 CASEVAC EXTRACTION KIT

The Contractor shall provide the Casualty Extraction Kit which includes three modules: Casualty Extraction Module 1 (E‐1), Casualty Extraction Module 2 (E‐2), and Casualty Extraction Module 3 (E‐3).

4.1.2 CASEVAC MOBILITY KIT

The Contractor shall provide the Casualty Mobility Kit which includes two modules: Casualty Mobility Module 1 (M‐1), and Casualty Mobility Module 2 (M‐2).

4.1.3 CASEVAC TRANSPORTATION KIT

The Contractor shall provide the Casualty Transportation Kit which includes six Modules:

Casualty Transport Module 1 (T‐1), Casualty Transport Module 2 (T‐2), Casualty Transport Module 3 (T‐3), Casualty Transport Module 4 (T‐4), Casualty Transport Module 5 (T‐5), and Casualty Transport Module 6 (T‐6).

4.1.4 CASEVAC SUSTAINMENT KIT

The Contractor shall provide the Casualty Sustainment Kit which includes two Modules:

Casualty Sustainment Module 1 (S‐1), and Casualty Sustainment Module 2 (S‐2).

4.1.5 INDIVIDUAL EQUIPMENT SUSTAINMENT

The Contractor shall provide individual sustainment items in accordance with delivery orders. The items will be identified in an attachment to the Delivery Order (DO). The DOs will be derived of items contained within the CASEVAC List of Materials (LOM).

4.2 NEW EQUIPMENT TRAINING (NET)

The Contractor shall conduct a 4 day NET course at Government owned facilities and/or Contractor provided Government‐approved training sites/facilities (see the NET Appendix spreadsheet, RFP attachment 02, for existing Government approved locations, if applicable, contractor may propose additional training sites for Government consideration) utilizing Government Furnished Equipment (GFE) to deliver the Government‐approved training curriculum. This training shall provide the instruction necessary for students to properly employ all kits and/or modules contained in the CASEVAC Set, identifying details for the proper and safe operation, along with basic steps to perform operator level maintenance. Contractor shall be responsible for moving, storing, and supporting all Government Furnished Equipment (GFE) utilized during training course delivery, regardless of venue (See RFP attachment 03 for NET training outline). Contractor shall tailor NET curriculum to meet all tasks, conditions, and standards provided by the Government (see RFP attachment 02) for each respective NET course (7, 14, 21, and 28 students).

Upon completion of the course, students shall be provided a Certificate of Completion identifying that he or she has completed all required training/milestones IAW the Government‐approved training curriculum. In the event that a student is identified as unsuccessful in completing a requisite task(s), remedial training shall be provided to ensure the student may progress with his or her peers.

Offeror shall provide a minimum of one (1) third‐party training venue to conduct NET when government‐sponsored locations are not available. Third‐party venues shall be capable of facilitating the entire NET curriculum and meet all training requirements identified within this statement of work.

Attributes of acceptable venues shall include, but are not limited to:

• Covered areas/shelters in the event of inclement weather

• Areas to facilitate lunch breaks during training – ideally out of the elements

• Restroom facilities

• Basic infrastructure (electricity, desks, chairs, etc.) to facilitate classroom‐based blocks of instruction such as PowerPoint presentation, Exams, etc.

• Ranges/venues large enough to facilitate training of up to 28 students and associated cadre; utilizing acceptable student to instructor ratios (7:1, at a minimum).

• Multistory structure(s) (building or rope tower) capable of facilitating up to 28 students, concurrently, within minimum student to instructor ratio requirements.

• Areas suitable for vehicle breaching/extrication without posing additional risks to students or property

• Geographically located within a reasonable distance to commercial lodging facilities.

4.3 PRODUCTION

The Contractor shall provide production kits as required subsequent to Government‐ issued Delivery Orders (DO). The production kits will be assembled IAW this SOW, and the Government‐approved configuration data (LOM and Engineering Drawings/Wire Schematics).

4.4 PROGRAM AND DATA MANAGEMENT

The Contractor shall establish and maintain program management practices throughout the Period of Performance (PoP). Documentation shall be readily available to Government representatives during planned visits.

The contractor shall be 9001:2015 certified. ISO 9001 sets out the criteria for a quality management system which focuses on principles including customer focus, motivation and implication of top management, and process approach/continuous improvement;

ISO 9001:2015 demonstrates an organization's ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.

Additionally, the Project Management Institute’s Project Management Body of Knowledge (PMBOK) Sixth Edition shall be referenced as additional standards by which the TCCC contract shall be fulfilled. Offerors must clearly and thoroughly describe in their technical response, their approach to using, at a minimum, these two industry standards (ISO, PMBOK). Where an offeror has a similar, corresponding, but different set of minimum standards than those cited above, the offeror will be expected to cross‐ reference or otherwise map how their own standards meet the same level of detail and scope of review as the industry standards cited herein (e.g., ISO, PMBOK) Failure to do provide this cross‐referencing of standards in the offeror’s proposal will be deemed as being non‐responsive to this solicitation for purposes of evaluation of the offeror’s proposal.

Contractor’s shall implement data management procedures for the preparation, quality control, administration, and delivery of data required by the Contractor Data Requirements List (CDRL). Contractor’s shall maintain data status and delivery schedules for all CDRL items as well as maintain a current listing of all non‐CDRL data generated in performance of the contact in a Data Accession List (DAL) (CDRL A010). In addition to maintaining the DAL, the contractor shall deliver the DAL in digital format upon Government request. All documentation and other data generated in performance of this program will be made available to the Government. Contractor shall provide a central POC for Data Management who will ensure contract data compliance with the data requirements of the contract.

4.4.1 SCHEDULE

The Contractor shall maintain an accurate schedule of program events and recommended program schedules, including review and evaluation techniques, which provide for the earliest delivery schedule while at the same time satisfying all requirements in a cost‐effective manner. The program schedule shall include all significant events. A Program Planning Milestone Chart shall depict major tasks and events from start to completion of the contract. The Contractor shall provide a monthly status report (MSR) that illustrates the overall health of the program. The Contractor shall notify the Government in writing of any anticipated or projected work stoppages or delays that will impact schedules. All Kits, Modules and LOM items shall be delivered within 120 days after DO award.

4.4.2 ASSIGNMENT OF RESPONSIBILITY AND AUTHORITY

The Contractor shall identify the organizational elements responsible for the conduct of the activities delineated in this SOW. Responsibilities shall be assigned and clear lines of authority defined for determining and controlling the resources necessary to satisfy each element of this SOW. The following billets shall be considered key personnel. The Contractor shall appoint, in writing, all persons filling key personnel billets. The Contractor shall notify the Government of any key personnel changes made during the period of performance within five days. This does not imply each billet has to be a separate individual. Roles outlined within this statement of work may be fulfilled individually, or coupled with another set of duties (i.e. Program Manager may fulfill Configuration Management duties as an additional role).

4.4.3 PROGRAM MANAGER (PM)

The Contractor shall designate a PM who shall possess sufficient corporate authority to manage, direct, execute, and control all elements of the contract. The PM shall serve as the primary point of contact between the Contractor and the Government and be responsible for the coordination of all Contractor activities related to the contract.

4.4.3.1 LOGISTICS MANAGER (LM)

The Contractor shall designate a Logistics Manager who possesses a sufficient authority to manage, direct, execute, and control all logistical elements and support aspects of the contract.

4.4.3.2 CONFIGURATION MANAGER (CM)

The Contractor shall designate a CM representative to serve as primary point of contact

(POC) to the Government for all CM matters and be responsible for any sub‐ contractor CM efforts.

4.4.3.3 DATA MANAGER (DM)

The Contractor shall provide a central POC for data management who will ensure contract data compliance with the requirements of the contract.

4.4.3.4 TRAINING CADRE

Given the high‐level of technical expertise necessary to successfully deliver the required, Government‐approved training curriculum, the Contractor shall employ qualified personnel as training cadre. Specifically, the Contractor shall provide trainers that meet the following qualifications:

● 3 years of experience providing military and/or non‐military tactical rescue.

● In absence of the above, 1 year of experience delivering the current, approved SOF CASEVAC NET Curriculum and/or delivering similar training as part of government program/contract.

4.4.4 TECHNICAL DATA AND REPORTS

Unless otherwise specified, the Contractor shall prepare technical data and reports and submit them in the format and scope specified in Contract Data Requirements List (CDRLs) identified in paragraphs within this SOW

4.4.5 OPERATIONS SECURITY (OPSEC) REVIEW

All data and documentation generated under this contract will be subject to OPSEC review. The Contractor shall consider its data OPSEC sensitive and shall notify the Senior Contracting Officer (SCO) of any request for data from any other agency or entity. Prior to public release, all data delivered must undergo Government review and approval if the Distribution Statement is selected as “A” per DFARS clause 252.204‐ 7012, Safeguarding Covered Defense Information and Cyber Incident Reporting. Any document with a Distribution Statement other than A will not be released.

4.5 MEETINGS

The Contractor shall plan, host, attend, coordinate, support, and conduct all meetings, formal reviews, conferences, and audits (hereinafter called "reviews"). The reviews may be conducted at Government, Contractor or Commercial facilities. Reviews requiring demonstration and/or examination of equipment shall primarily be conducted at the Contractor‐coordinated facility. All such reviews shall be included in the program schedule and may be held concurrently with the Government’s approval.

The Government reserves the right to cancel any review or require a review to be scheduled at critical points during the period of performance.

4.5.1 POST AWARD CONFERENCE (PAC)

The Contractor shall host a PAC at the Contractor's facility fifteen days after Contract Award. During the PAC, the Contractor will present the status of technical and other specialty areas, demonstrate their management procedures, provide progress assessments and establish schedule dates for near term critical meetings/actions/reviews to the Government. The Contractor shall present management, key personnel, and program implementation processes.

4.5.2 INTEGRATED PRODUCT TEAMS (IPT) AND MEETINGS

IPTs shall be used throughout the period of performance (PoP) of this contract. These IPTs shall include participation from all relevant subject matter experts (SME) to include Government Program Office personnel, SOCOM component personnel/staff, and Contractor representatives. The IPT will be used as a forum for program reviews, design reviews, resolution of issues, and other contract‐related items. Formal IPT meetings will be held annually (at a minimum), and ad hoc IPT meetings will be conducted as needed via on‐site or via conference call/video conference. The Government and Contractor will jointly schedule the meetings and establish the agenda at least two working days before the IPT meeting.

4.6 CONFIGURATION MANAGEMENT

The Contractor shall establish and maintain an effective configuration management program throughout the contract period of performance (PoP). Contractor shall develop and maintain a Supplier’s Configuration Management Plan (SCMP) to control all aspects of the Configuration Management (CM) process. The SCMP will include event‐based criteria for assumption of control of the CM process following acceptance by the Government of documents, designs, or requirements (CDRL A009). The Contractor shall maintain a CM process for the control of all hardware configuration documentation, media, and parts representing or comprising the TCCC CASEVAC. The Contractor's CM process shall consist of configuration identification and control.

Consideration for interfacing with other acquisition requirements such as design review, assurance, and other program related disciplines shall be addressed. The Contractor shall designate a CM representative to serve as the primary point of contact to the Government for all CM matters.

4.6.1 CONFIGURATION REVIEWS

Configuration reviews will be conducted as needed in the event of updates to CASEVAC Set capabilities due to insertion of new technologies, obsolescence of items, spiral development, etc. The Contractor shall submit an Engineering Change Proposal (ECP) to summarize the configuration update in accordance with guidance provided by the Government (CDRL A006). Configuration reviews will be conducted as part of the IPT process/agenda, as applicable. The Government will have final approval of the production configuration.

4.6.2 PARTS MANAGEMENT PROGRAM

Contractor shall manage all parts and sub‐assemblies of the TCCC CASEVAC Program configuration to ensure optimal readiness and availability to meet program requirements and deliverables. This includes maintaining open lines of communication with sub‐contractors, suppliers, distributors, and/or manufacturers to ensure optimal availability. IAW the Contractor’s Parts Management Program, Contractor shall proactively identify obsolete items to remove/replace in order reduce the impact of CASEVAC Set/Kit/Module production. Upon identification of obsolete items, Contractor shall notify the Program Office within 10 days of their intended actions and tract the solution. Contractor shall submit a Diminishing Manufacturing Sources and Material Shortages (DMSMS) Management Plan. This plan establishes how the Contractor will implement identifying and managing the loss, or impending loss, of manufacturers’ or suppliers’ parts and/or material required for sustained operational availability of the program’s systems (CDRL A011).

4.6.3 BASELINE MANAGEMENT

The Contractor shall be responsible for maintaining the accuracy of the established baseline to ensure form, fit, function and interface. The Contractor shall establish definitive processes which identify how the baseline will be managed and maintained.

These processes shall be made available for Government review as required.

4.6.4 CONFIGURATION CONTROL

The Contractor shall implement configuration control methods and procedures to maintain the integrity and traceability of an established baseline. Changes to established baselines shall only be made after Government approval of ECPs and Request for Deviation (RFD). Sufficient supporting data to evaluate the proposed change, such as drawings, supplemental drawings, sketches, specifications, or manufacturer's data sheets, shall be submitted with ECPs and RFDs. Changes shall be identified to the affected assembly serial number, or if not part of an assembly, to the affected equipment serial number. The Contractor's configuration control process shall be available for Government review. The Contractor shall submit all ECPs, RFDs and Notification of Changes to Commercial Equipment in accordance with applicable CDRLs.

4.6.5 REQUEST FOR VARIANCE (RFV)

The Contractor shall process RFVs if deliverables deviate from currently approved configuration documentation. Authorized variances are a temporary departure from the requirements and do not constitute a change in an approved baseline. Submission of recurring variances is discouraged and shall be minimized. Where it is determined that a change should be permanent, the Contractor shall process an ECP. MIL‐HDBK‐61 provides guidance concerning the classification of RFVs. At a minimum, the RFV shall contain the following information: (a) Date prepared; (b) Originator; (c) RFV Classification (critical, major, or minor); (d) Designation for variance (model/type, CAGE code, system designation, and variance number); (e) Class of variance; (f) Part Number affected; (g) Cost/Price data; (h) Effectivity; (i) Description of variance; (j) Need for variance; (k) Effect on delivery schedule; (l) Recommended corrective action; and (m) Alternatives evaluated (CDRL A012).

4.6.6 NOTIFICATION OF CHANGES TO COMMERCIAL EQUIPMENT

The Contractor shall submit notification to the Government when changes occur to COTS equipment/parts which affect the production sets/kits/modules. The Contractor shall submit a Change Notice (CN) to the Government implementing any Class II ECPs and the Government will approve/disapprove the class designation of the ECP as required.

4.6.7 PRE‐PLANNED PRODUCT IMPROVEMENT (P3I)/SPIRAL DEVELOPMENT (Pricing to be determined at DO/TO Level)

While the initial, Government‐approved list of materials (LOM) will be the baseline configuration for production of the TCCC‐CASEVAC sets, kits, and modules, the

Government is aware of the fact that technologies are constantly evolving. With that in mind, the Contractor shall provide technical data, designs, testing, and/or prototyping efforts identifying direct changes/enhancements to the TCCC CASEVAC performance, capability, and/or safety as opportunities for enhancement present themselves. Special interest to the Government would be in the areas of improved mobility and survivability of personnel through enhancements such as, but not limited to: reduction of weight/cube, enhanced medical capabilities, next‐generation technologies, etc.

4.7 QUALITY MANAGEMENT SYSTEM

The Contractor's quality management system shall ensure product conformation to contractual requirements. The Contractor shall have implemented, documented, and have previously demonstrated the ability to maintain the quality management system to be used on the contract. As noted earlier in this SOW (paragraph 4.4), ISO 9001:2015, and PMBOK shall be standards by which the TCCC contract shall be fulfilled. The Contractor shall make available all quality management documentation for the Government to review upon request.

4.8 ENVIRONMENT, SAFETY, AND OCCUPATIONAL HEALTH

The Contractor shall identify and evaluate environmental, safety, and health hazards, define risk levels, and establish a program that manages the probability and severity of all hazards associated with development, use, and disposal of the system in accordance with MIL‐STD‐882.

Residual risks will be evaluated by the Government in accordance with MIL‐STD‐882 and accepted as appropriate prior to exposing people, equipment, or the environment to known system related Environment, Safety, and Occupational Health (ESOH) risks. The Contractor must identify all explosive safety risks as such in the system safety documentation.

4.9 ITEM UNIQUE IDENTIFICATION (IUID)

4.9.1 IDENTIFYING IUID

Item Unique Identification marking requirements: End items for which the Government’s unit acquisition cost is $5,000 or more are to be marked and registered with the IUID registry in compliance with Defense Acquisition Regulation Supplement (DFARS) clause 252.211‐7003 and IAW MIL‐STD‐130. End items that may require an IUID shall be delivered for Government review/concurrence prior to marking any items.

4.9.2 MARKING IUID

All parts marking shall be in accordance with the current version of MIL‐STD‐130. The Contractor shall perform an engineering analysis required to determine the appropriate method for marking each item that requires Unique Item Identifiers. The Contractor shall ensure that the IUID marking location will be optimized for ease of scanning, and shall avoid applying IUID markings on curved or rounded surfaces. A 2‐D Data Matrix, ECC 200 compliant bar code (ISO/IEC 16022) shall be used to carry the IUID data elements. The Contractor shall include human readable information (HRI) of the 2D Data Matrix as part of the IUID mark where adequate space is available. Where nameplates/data plates are used, the IUID marking shall be applied to the upper left hand corner. The Contractor shall document the location and marking method on the deliverable engineering technical documentation (e.g., drawings).

4.9.3 VALIDATING IUID

The Contractor shall register and validate all IUIDs with the DoD IUID Registry and shall ensure all item parent/child relationships are accurately recorded in the IUID Registry.

The Contractor shall ensure 2D Matrix are readable prior to delivery of equipment to the Government. The Contractor is responsible for all IUID marking and database loading utilizing the Procurement Integrated Enterprise Environment (PIEE), specifically, WAWF and IUID Marking Activity within WAWF when submitting invoices for payment.

The Contractor shall not deliver items without all approved items, subassemblies, components, and parts marked, registered, and properly tied to the TCCC parent.

Contractor is responsible for transferring IUID registration to Special Operations Forces Support Activity (SOFSA) upon upload within WAWF.

4.10 PUBLICATION PROGRAM

TCCC shall be supported by a multifaceted publications program. The Contractor shall deliver the following items (in both digital and/or hardcopy format as needed/requested):

Training Manuals (CDRL A002) Maintenance Manuals (CDRL A001, A002) List of Materials (CDRL A003, A005)

Engineering Diagrams (CDRL A003) Training Videos (CDRL A004)

4.10.1 COPYRIGHT RELEASE

The Contractor shall furnish unrestricted copyright releases for the operator’s manuals, engineering diagrams, list of materials, and all training materials. The Contractor shall ensure that the Government has the right to use, copy, and distribute the data files delivered under this contract, electronically and in hard copy as the Government deems necessary. For the manuals, when the Contractor uses commercial data which covers a subcontractor's component(s) or portion thereof, and the subcontractor's data contains copyrighted material, the Contractor shall be responsible for obtaining a copyright release from their subcontractor and furnishing such release to the Government. The copyright release shall be written for the Government’s use and shall not prohibit duplications, release, website publication, and such. The Government, at its discretion, will post the final Publications on the internet for the SOF user’s access. Final documentation submissions will not be accepted and shall be considered incomplete without the appropriate copyright release letters. The Government has unlimited rights to all data under this effort that are developed and funded by the Government.

4.10.2 DOCUMENTATION ACCURACY

The Contractor is responsible for the accuracy, completeness, and compatibility of each logistics product to the rest of the documentation developed under this effort. The Contractor shall perform a 100% review of the documents prior to submission to ensure that they meet contract requirements. The Contractor shall ensure that all manuals and training material are properly validated. The Contractor shall guarantee that procedures, training, and information provided under the CDRLs are accurate and safe for use. Upon updates to configuration, the contractor shall update all applicable documents within 10 days of approved configuration update.

4.11 GOVERNMENT LOGISTICS VALIDATION/VERIFICATION (V/V) OF MANUALS

The Government relies on complete, careful editing and review of all materials by the Contractor. If there are indications that the Contractor has performed incomplete or inadequate QA Reviews, insufficient Validation, or has changed the configuration without Government notification and approval, the Government may elect to reject or return products for rework and will perform additional reviews on the reworked products. Material determined to not meet requirements will be assessed to be “Unacceptable” and shall be the responsibility of the Contractor to correct the deficiency until it is determined to be “Acceptable.” The Contractor shall return Unacceptable deliverables within 72 hours.

4.12 SHIPPING AND HANDLING

Contractor shall ship Freight on Board (FOB): Destination, to the following address:

HQ USSOCOM SOFSA

5749 Briar Hill Rd. Bldg. 102 Lexington KY 40516

All items are to be delivered within 120 days after receipt of DO. The Contractor shall fulfill all applicable state and federal requirements in the handling, storage and shipment of pharmaceuticals in support of this contract. Further, the Contractor shall be fully insured, bonded, and licensed (if applicable) in support of the safe and legal handling of pharmaceutical components and associated materials of the TCCC sets. Proof or existing, or completed proposal of future capabilities for security, storage and insurance requirements will be submitted with proposals.