09172018_Mandrake_2.0_RFP_Document.docx

U.S. Department of State Pharmaceutical Countermeasures

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Overview

The U.S. Department of State (“DOS”, “State”, or “the Department”), Bureau of Medical Services (MED), Directorate of Operational Medicine (MED/DMD/OM) has an immediate need to partner with a highly qualified contractor to produce various pharmaceutical countermeasures for all Department posts worldwide.

B.2 Type of Contract

a) This is an indefinite-delivery, indefinite-quantity (IDIQ) contract, as defined in Federal Acquisition Regulation (FAR) 16.504 (Indefinite-Quantity Contracts) for non-commercial items.

b) Supplies and/or services to be procured will be identified at the delivery or task order level.

c) The contract type(s) for an individual order will be one or a combination identified in FAR Part 16 (Types of Contracts), depending on one or more of the factors identified in FAR 16.104 (Factors in Selecting Contract Types).

d) ‘X’ in CLIN Identifier = Contract Year (e.g., ‘0’ = Base Period; ‘1’ = Option Year 1, etc.)

e) Firm-fixed-price (see FAR 16.202) = Payment at negotiated firm-fixed-price. Negotiated firm-fixed-price includes direct labor costs, direct non-labor costs, applicable indirect costs, and profit.

f) Firm-fixed-unit-price (FFUP) = Payment at negotiated firm-fixed-unit-price. Negotiated FFUP includes all direct costs, applicable indirect costs, and profit.

g) Cost Type (see FAR 16.302) = Payment at allowable actual incurred costs and applicable indirect costs. Payment of fee or profit is prohibited. Applicable indirect costs are calculated by multiplying negotiated applicable provisional billing indirect cost rates by actual incurred materials/other direct costs.

h) The Contracting Officer is the only person authorized to issue orders under this contract.

B.3 MINIMUM AND MAXIMUM contract QUANTITIES

a) The Government shall meet the contract minimum of $15,000 (inclusive of all direct costs, indirect costs, and profit/fee) through the issuance of order(s) within the contract’s period of performance.

b) The maximum quantity for the contract’s period of performance, including any extension(s), shall be any quantity or combination of supplies and services not exceeding $100,000,000 (inclusive of all direct costs, indirect costs, and profit/fee).

B.4 PRICING TABLES

BASE PERIOD DISCOUNT PRICING SCHEDULE

The pricing discount tiers identified herein are cumulative per contract period of performance. For example, if the Department places a delivery order with the Contractor for 750,001 Autoinjectors (Atropine 2mg; Obidoxime 220mg) on Day 1 of the base period of performance, all CLIN 0001 units will be at the Tier 5 discounted unit price. All subsequent orders during the 60-month base period of performance will also be at the Tier 5 discounted unit price. Upon completion of each period of performance, the pricing discount tiers start over.

Tables to be completed at time of award.

Tier 2: 125,001 - 250,000

Tier 3: 250,001 - 500,000

Tier 4: 500,001 - 750,000

Tier 5: 750,001 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

OPTION YEAR 1

Tier 2: 25,001 – 50,000

Tier 3: 50,001 – 100,000

Tier 4: 100,001 – 125,000

Tier 5: 125,001 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

OPTION YEAR 2

Tier 2: 25,001 – 50,000

Tier 3: 50,001 – 100,000

Tier 4: 100,001 – 125,000

Tier 5: 125,001 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

OPTION YEAR 3

Tier 2: 25,001 – 50,000

Tier 3: 50,001 – 100,000

Tier 4: 100,001 – 125,000

Tier 5: 125,001 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

OPTION YEAR 4

Tier 2: 25,001 – 50,000

Tier 3: 50,001 – 100,000

Tier 4: 100,001 – 125,000

Tier 5: 125,001 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

OPTION YEAR 5

Tier 2: 25,001 – 50,000

Tier 3: 50,001 – 100,000

Tier 4: 100,001 – 125,000

Tier 5: 125,001 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

Tier 2: 1,251 - 2,500

Tier 3: 2,501 - 5,000

Tier 4: 5,001 - 7,500

Tier 5: 7,501 and above

B.5 NOT-TO-EXCEED (NTE) PROFIT PERCENTAGES

a) In order to avoid the cost-plus-a-percentage-of-cost system of contracting [see FAR 16.102(c)], this section applies only prior to task order performance or prior to any task order modification performance. Thus, the percentages negotiated herein (or discounts to such percentages) shall be applied only to proposed/estimated costs and never to actual incurred costs.

b) This section applies when profit is an applicable element (e.g., under fixed-price, labor-hour, and time portion of time-and-materials arrangements) and when:

1. proposing and negotiating new cost elements (e.g., new labor categories and other direct costs) in the contract or task order; and/or

2. changes (i.e., additions and/or deletions) in negotiated contract or task order pricing occur.

c) Examples of this section’s applicability are when proposing and negotiating:

1. fully-loaded hourly labor rates for labor categories not already identified in the contract or task order;

2. fixed-price task orders;

3. fixed-price line items in a task order; and/or

4. equitable adjustments under fixed-price task orders or line items in a task order.

d) The following are the negotiated NTE profit percentage(s):

Base Period: To be inserted at award Option Year 1:

Option Year 2:

Option Year 3:

Option Year 4:

Option Year 5:

Six-Month Option to Extend (see FAR 52.217-8):

B.6 NOT-TO-EXCEED (NTE) FEE PERCENTAGES

a) In order to avoid the cost-plus-a-percentage-of-cost system of contracting [see FAR 16.102(c)], this section applies only prior to task order performance or prior to any task order modification performance. Thus, the percentages negotiated herein (or discounts to such percentages) shall be applied only to proposed/estimated costs and never to actual incurred costs.

b) This section applies when fee is an applicable element and when:

1. proposing and negotiating cost elements already identified in the contract (e.g., existing labor categories and other direct costs);

2. proposing and negotiating new cost elements (e.g., new labor categories and other direct costs) in a task order; and/or

3. changes (i.e., additions and/or deletions) in negotiated task order pricing occur.

c) Examples of this section’s applicability are when proposing and negotiating:

1. cost-plus-fixed-fee and cost-plus-award-fee task orders;

2. cost-plus-fixed-fee and cost-plus-award-fee line items in a task order; and/or

3. equitable adjustments under cost-plus-fixed-fee and cost-plus-award-fee task orders or line items in a task order.

Note: For cost-plus-award-fee task orders or line items in a task order, the percentages negotiated herein (or discounts to such percentages) shall apply to the proposed award fee, not the base fee. The base fee shall be $0.00.

d) The following are the negotiated NTE fee percentage(s):

Base Period: To be inserted at award Option Year 1:

Option Year 2:

Option Year 3:

Option Year 4:

Option Year 5:

Six-Month Option to Extend (see FAR 52.217-8):

B.7 FIXED FEE

a) This section applies to cost-plus-fixed-fee task orders or cost-plus-fixed-fee line items in a task order.

b) If, pursuant to FAR 16.306(a) (Cost-Plus-Fixed-Fee Contracts), changes in the work to be performed under the task order or cost-plus-fixed-fee line item(s) occur [pursuant to FAR 52.243-2 (Changes – Cost-Reimbursement)], the Government and Contractor will adjust the negotiated fixed fee by multiplying the fee percentage used for the task order to the sum of the new estimated direct costs and applicable indirect costs.

c) The negotiated fixed fee for each performance period will be paid in monthly installments by dividing the negotiated fixed fee for the performance period by the number of months in the performance period, minus the applicable withholding of a fixed fee reserve pursuant to FAR 52.216-8(b) (Fixed Fee).

d) However, full monthly payment is contingent upon the Contractor meeting the acceptable quality levels, measurable performance standards, or otherwise minimum task order requirements for the invoice period [reference FAR 16.306(d)(1) (Cost-Plus-Fixed-Fee Contracts)].

e) If the Contractor has not met the acceptable quality levels, measurable performance standards, or otherwise minimum task order requirements for the invoice period, the Contractor will receive a pro-rata share of the monthly amount of the negotiated fixed fee for the month’s requirements to which the Contractor has met the acceptable quality levels, measurable performance standards, or otherwise minimum task order requirements for the invoice period.

f) Any withheld fixed fee resulting from the Contractor not meeting the acceptable quality levels, measurable performance standards, or otherwise minimum task order requirements for the invoice period will be released to the Contractor when the Contractor completes the requirement(s). Commencement of such completion is predicated on the Government requiring the Contractor to perform the services again in conformity with task order requirements. FAR 52.246-5 (Inspection of Services – Cost-Reimbursement) provides additional information.

g) The Contracting Officer is the ultimate Government authority in determining whether the Contractor has met the acceptable quality levels, measurable performance standards, or otherwise minimum task order requirements for the invoice period. Prior to making his determination, the Contracting Officer will consider input from the Contracting Officer’s Representative.

h) “Total fixed fee,” as defined in FAR 52.216-8(b) (Fixed Fee), means “the fixed fee cumulative of all performance periods in the task order.”

i) The task order will identify the total fixed fee, and the Contractor will be responsible for subtracting the appropriate amount on each invoice. The appropriate amount is the withheld amount (15% of the total fixed fee or $100,000, whichever is less) divided by the number of months in the task order period of performance, including option periods [reference FAR 52.216-8(b) (Fixed Fee)].

B.8 PERIOD OF PERFORMANCE

This contract is comprised of a five-year (60-month) base period plus five, one-year (12-month) option periods.

Base Period: To be inserted at award Option Year 1:

Option Year 2:

Option Year 3:

Option Year 4:

Option Year 5:

Six-Month Option to Extend (see FAR 52.217-8):

SECTION C – STATEMENT OF WORK

C.1 PURPOSE

The U.S. Department of State (“DOS”, “State”, or “the Department”), Bureau of Medical Services (MED), Directorate of Operational Medicine (MED/DMD/OM) has an immediate need to partner with a highly qualified contractor to produce various medical countermeasures (including, but not limited to, medication autoinjectors) for all Department posts worldwide.

C.2 BACKGROUND

a) MED/DMD/OM executes the Department’s Operational Medicine Program: planning, developing, resourcing, and executing medical contingency plans to enhance the security of U.S. diplomats and other Chief of Mission personnel engaged in high-risk environments worldwide. The Operational Medicine program identifies existing and emerging medical risks and provides senior Department leaders with flexible response options to mitigate these risks. One of the Directorate’s most important responsibilities is to respond to critical threats to Department diplomatic missions overseas. These responses must be appropriate, and of equal importance, timely. Therefore, the Government must equip itself with the tools that best enable its response to be safe, accurate, and fast.

b) Chemical nerve agent exposure has immediate health effects on exposed individuals. Treatment of exposure to agents such as organophosphorus nerve agents having cholinergic activities requires the use of specifically designed medical countermeasures. Delays in administration or application of medical countermeasures may result in long term adverse health impacts.

c) Exposure to biological and chemical weapons can be the result of accidental or intentional release. Such events may occur where advanced medical intervention is impractical or will result in significant security risk. Immediate response to exposed individuals requires extremely rapid administration of medical countermeasures to treat individuals. Medical intervention that requires drawing the antidote from a single or multi dose package into a syringe and then administering that antidote will be too time intensive or beyond the capability of exposed individuals or responders. In order to assure that immediate lifesaving measures may be taken upon exposure, medication filled autoinjectors and other novel delivery devices may be employed by either exposed individuals or first responders is required.

d) Threats posed by countries and non-state actors possessing chemical and biological weapons will continue through the next decade. Currently, there are seven countries and several non-state violent extremist groups that have known chemical weapons programs. To mitigate this risk, the MED/DMD/OM has established and maintains medical countermeasures (MCM) for the highest risk chemical and biological agents. MED/DMD/OM’s chemical/biological protection program stockpiles MCM at each overseas post. A key component of the MCM program is an autoinjector unit which delivers life-saving antidote rapidly to exposed victims of a nerve agent attack. Unfortunately, as detailed below, the ability of MED to maintain these stockpiles has been placed at risk by failure of previous sole source providers of autoinjector medical countermeasures to maintain adequate production capacity. It is vital to rapidly establish a stable supply chain of autoinjector medical countermeasures to maintain the safety of deployed Department employees.

e) The Department requires medical countermeasures that deliver select drugs at various dosages to carry out programs designed to protect against and mitigate the effects of individuals exposed to weapons of mass destruction. The Department has undertaken efforts to identify additional manufacturers both within and outside the United States to secure the supply chain further for this critical component of hazard mitigation planning. The purpose of this Contract is to establish a long-term, reliable, and resilient supply chain for medical countermeasures described in specific Contract Line Item Numbers (CLINs) at different dosage levels and ultimately encourage increased production and availability of these products.

f) MED/DMD/OM is currently (FY2018) replenishing its existing stock of drug autoinjectors worldwide. These autoinjectors (Atropine 2mg; Obidoxime 220mg) will require replacement as their expiration date is reached.

C.3 SCOPE

a) The Contractor shall provide various medical countermeasure configurations (e.g., medication autoinjectors) containing chemicals, drugs and dosages defined by the Department, with the flexibility to adapt those medical countermeasures, order additional medical countermeasures, or develop new countermeasures as the need arises. Throughout the life of the contract the Contractor shall maintain the capability to manufacture and deliver (at a minimum) the following medical countermeasures:

1. Autoinjector, atropine 2mg with Obidoxime 220mg an oxime

2. Autoinjector (Scopolamine 0.3 mg; Atropine 2 mg; 1,1'-Methylenebis[4-[(hydroxyimino)methyl]-pyridinium] (MMB4) dimethanesulfonate (DMS) (MMB4) 600 mg))

3. Autoinjector (Atropine 2 mg)

4. Autoinjector (Ketamine 25 mg)

5. Autoinjector (Morphine 10 mg)

6. Autoinjector (Midazolam 10 mg)

7. Autoinjector (Naloxone 10 mg)

8. Skin Decontamination Lotion (Packaged as a disposable dispensing wipes)

9. Skin Decontamination Lotion (Packaged as a clear liquid in 4oz dispensing bottle)

10. Skin Decontamination Lotion (bulk packaging (no more than 32oz per bottle))

11. Countermeasure training devices (not containing drug solution)

C.3.1 PERFORMANCE SPECIFICATIONS

a) The Contractor shall establish and maintain a reliable supply chain for drug filled autoinjectors and other medical countermeasures as defined by the Department. This manufacturing action shall include the required device and its filled contents in the dosage prescribed by the Department.

b) Should there be an unexpected disruption in the supply chain for the required medication filled autoinjectors or other countermeasure, the Contractor shall notify the COR within one (1) business day. The Contractor shall be responsible for identifying and proposing to the COR and Contracting Officer equivalent substitutions, and is at all times responsible for delivery of products meeting specifications set forth in the delivery order at the negotiated price specified in Section B and in each delivery order.

c) The drug filled autoinjectors shall have a shelf life, based on the date of expiration of the drug or any component, documented stability testing and the actual date of delivery of the product, not less than forty-eight (48) months from the actual date of delivery to the Government. Outer packaging of the components shall not be damaged or in any way altered in a manner that would reasonably be expected to result in a shortened service life of the product.

d) All products delivered under this contract shall be labeled with an expiration date consistent with its current product license at the time of manufacture. Marking or secondary packaging shall not reduce the readability of the drug label.

e) The Contractor shall provide primary and secondary points of contact that shall be available 24 hours per day, seven days per week to be notified in case of a public health emergency.

f) The Contractor shall report to the COR and CO, material correspondence from all regulatory and monitoring sources (e.g., the European Commission, the U.S. Food and Drug Administration, or other national regulatory body) regarding the quality, safety, or efficacy of products acquired under this contract.

g) The Contractor shall notify the COR of any issues with the safety and efficacy of required products and/or manufacturing or quality production lines at the Contractor’s facilities within two (2) business days of cognizance and/or notice from a regulatory body or organization.

h) The Government shall have the option to conduct quarterly inspections of the Contractor’s or subcontractor’s facilities. Such inspections shall be performed by the COR or Government Technical Monitor (GTM).

i) The Contractor will notify the Department at least 30 days prior of estimated shipment of product, and shall schedule delivery in strict compliance with the delivery schedule provided at the time of the delivery order award.

j) The Contractor will notify the Government at least seven (7) calendar days prior to the Required Delivery Date if there will be a delay in the shipment of product. Failure to recognize and report delays in delivery at least seven calendar days in advance of the Required Delivery Date may result in unrecoverable costs by the Government and result in an equitable price reduction (reference FAR Clause 52.246-2 Inspection of Supplies – Fixed-Price).

C.3.1.1 Production Quality and Compliance

a) All goods produced under this contract shall meet current Good Manufacturing Practice (cGMP) guidelines as defined in Code of Federal Regulations Title 21 (21 CFR) or applicable host nation oversight regulations. The Contractor is responsible for ensuring:

1. Production facilities are certified by the cognizant legal and regulatory oversight authority for the production of pharmaceuticals.

2. Autoinjectors and other countermeasures are inspected and pass objective quality control inspections in accordance with the Contractor’s approved Quality Management Plan.

3. Autoinjectors shall have a minimum remaining shelf life of 48 months at the time of delivery.

4. Autoinjectors and other countermeasures are packaged to protect the device from physical damage without interfering with the visibility of the contents, the lot number, or the expiration date.

C.3.1.2 Medication Filled Autoinjectors

a) Medication filled autoinjectors shall be produced in strict compliance with U.S. law and regulation or, if manufactured outside of the US, in compliance with the regional or local regulatory oversight authority, and shall bear quality certification by a regional or local guidance or authority (3rd Party Quality Assurance testing authority, where required) prior to delivery to the Government.

b) Autoinjector (Atropine 2mg; Obidoxime 220 mg) CLIN X001: The Contractor may manufacture and deliver an autoinjector with 2mg atropine and 220 mg obidoxime to ensure the fast delivery of the specified medication during a chemical attack. The autoinjector shall have a distinctive label, to include lot number and expiration date. The autoinjector shall also have a distinctive color to differentiate it from other autoinjectors.

c) Autoinjector (Scopolamine 0.3 mg; Atropine 2 mg; 1,1'-Methylenebis[4-[(hydroxyimino)methyl]-pyridinium] (MMB4) dimethanesulfonate (DMS) (MMB4) 600 mg)): The Contractor may be required to develop the specified autoinjector to include 0.3 mg of scopolamine, 2 mg of atropine and 600 mg of MMB4 for use by the Government. The autoinjector shall have a distinctive label to include lot number and expiration date. The autoinjector shall also have a distinctive color to differentiate it from other autoinjectors.

d) Autoinjector (Atropine 2 mg): The Contractor may be required to develop the specified autoinjector to include 2 mg of atropine for use by the Government. The autoinjector shall have a distinctive label to include lot number and expiration date. The autoinjector shall also have a distinctive color to differentiate it from other autoinjectors.

e) Autoinjector (Ketamine 25 mg): The Contractor may be required to develop the specified autoinjector to include 25 mg of ketamine for use by the Government. The autoinjector shall have a distinctive label to include lot number and expiration date. The autoinjector shall also have a distinctive color to differentiate it from other autoinjectors.

f) Autoinjector (Morphine 10 mg): The Contractor may be required to develop the specified autoinjector to include 10 mg of morphine for use by the Government. The autoinjector shall have a distinctive label to include lot number and expiration date. The autoinjector shall also have a distinctive color to differentiate it from other autoinjectors.

g) Autoinjector (Naloxone 10 mg): The Contractor may be required to develop the specified autoinjector to include 10 mg of naloxone for use by the Government. The autoinjector shall have a distinctive label to include lot number and expiration date. The autoinjector shall also have a distinctive color to differentiate it from other autoinjectors.

h) Skin Decontamination Lotion (Packaged as a disposable dispensing wipes): The contractor may be required to develop a decontamination lotion to include .1722 g/ml dekon 139 active ingredient, packaged as a disposable wipe in a dispensable container. The container shall have a distinctive label to include lot number and expiration date.

i) Skin Decontamination Lotion (Packaged as a clear liquid in 4oz dispensing bottle): The contractor may be required to develop a decontamination lotion to include .1722 g/ml dekon 139 active ingredient, packaged as a clear liquid in a dispensable (pump) container. The container shall have a distinctive label to include lot number and expiration date.

j) Skin Decontamination Lotion (bulk packaging (no more than 32oz per bottle)): The contractor may be required to develop a decontamination lotion to include .1722 g/ml dekon 139 active ingredient, in bulk packaging not to exceed a 32oz container. The container shall have a distinctive label to include lot number and expiration date.

k) Medical countermeasures shall be shipped to a location determined by the Government in strict compliance with the delivery schedule set forth at the delivery order level. Only complete orders shall be accepted. Delays in delivery and details of partial shipment of the delivery shall be negotiated with the CO and COR, with a decision regarding a revised delivery plan and consideration of an equitable price reduction or other consideration.

l) Packaging and Marking shall be negotiated at time of contract award, but shall not vary significantly from that required by the cognizant regulatory agencies with oversight of the pharmaceutical production process. Outer packaging of the components shall not be damaged or in any way altered in a manner that would reasonably be expected to result in a shortened service life of the product. If the Government determines that modified packaging is needed, a bilateral modification will be issued.

C.3.1.3 Training Device Autoinjectors

a) The Contractor shall manufacture and deliver training devices that can be used to demonstrate the proper use of the Contractor’s unique autoinjector utilization.

b) The training devices shall not be filled with either a drug, liquid, or a needle; instead, the training device is used to practice the removal of safety packaging devices (i.e., exterior carrying case or safety caps over activation device or button) and to feel the tactile and audio feedback the device provides when activated (i.e., replication of the sound the autoinjector makes when the needle is extended from the device and any ‘popping or kickback’ motion the device makes when the activation device or button is pushed).

c) The training device shall be marked in such a way that is easily identified as a training device with either a different external color or non-removable marking or sticker. The marking shall contain the wording “Training Device, Contains No Active Agent or Needle” in bold, red type face that is easily identified as such.

C.3.2 ORDERING AND DELIVERY

a) The Department and Contractor shall negotiate delivery location and schedule prior to issuance of any Delivery Order.

b) The Government shall review annual production requirement forecasts with the Contractor during a scheduled conference in the fourth quarter of each fiscal year.

c) The Government shall negotiate delivery schedules for unforecasted requirements at the time of the delivery order. The required delivery date for unforecasted requirements of existing countermeasure products shall be within 90 calendar days of award unless otherwise agreed to by the Government in advance.

d) The Contractor shall maintain temperature control and physical security of products through the production and transportation process until delivered to the receiving point designated by the Government.

e) The Contractor shall ensure that, following production and prior to delivery, products are stored in a physically secure and climate controlled location.

f) The Contractor shall ensure that during storage and transportation, products are protected from physical damage through proper external packaging and handling.

C.3.3 AUDITS/SITE VISITS

a) Site Visit/Audits: The Contractor shall allow the Government access to all production and storage locations involved in the production, testing, storage, and distribution of products procured under this contract, including those of their subcontractors and agents, as deemed necessary throughout the period of performance of the contract.

b) Notice: The Department shall provide 30 days advance notice to the Contractor of all site visits and audits. The notice will include a statement concerning the intended scope of the audit and a list of the required documents or access to personnel.

c) All visits and audits shall be conducted during the Contractor’s normal business hours.

C.4 PROGRAM MANAGEMENT AND REPORTING

The Contractor shall provide comprehensive program management, including quality control, oversight, risk mitigation, and communication. The Contractor shall:

a) Obtain the necessary licenses and permits to manufacture and deliver the product to the Government, as required by applicable laws and regulations.

b) Wherever applicable at the delivery order level, obtain all necessary host country licenses, visas, and permits, and satisfy all required taxes and fees, necessary to operate within the place of performance. Satisfaction of tax liabilities is the responsibility of the Contractor.

c) Participate in meetings with the Government as requested to discuss performance under the contract. These meetings shall provide status updates and discuss ongoing manufacturing, clinical, regulatory, and shipment issues as applicable. These meetings shall be coordinated by the COR.

C.4.1 CUSTOMER SERVICE AND SUPPORT

The Contractor is expected to maintain a customer-focused approach to the work, ensuring a high level of customer satisfaction while operating within the terms and conditions of the contract. The Contractor shall:

a) Return phone calls and emails from the CO, COR, or GTM within one business day. Calls placed by the Contractor in which the intended Government official cannot be reached shall be followed immediately by an email

b) Meet the contractual requirements for timeliness, quality, and cost efficiency.

c) Establish and implement quality control procedures by proactively identifying risks, issues, and problems, and implementing plans for mitigation, whether under Contractor or DOS control.

d) Refer issues and problems immediately to the CO, COR, or appropriate GTM as applicable.

C.4.2 MEETINGS

a) The Contractor shall attend a post-award orientation / “kick-off” meeting with the CO and the COR not later than three (3) business days after the date of award or a mutually acceptable date. At the direction of the Government, this may be conducted as a teleconference. The purpose of the meeting is to review the final technical and contracting objectives of the statement of work and review the Contractor's project plan.

b) The Contractor shall attend an annual meeting, scheduled at the convenience of the Government and typically in the fourth quarter of each fiscal year (October-September) to review past performance and develop forecasts for the upcoming year’s production requirements.

c) The Contractor shall participate in a quarterly meeting with the Department to discuss performance under the contract. These meetings shall provide status updates and discuss on-going acquisition, manufacturing, clinical, regulatory, and shipment issues as applicable. These meetings shall be coordinated by the COR.

C.4.3 REPORTS AND DELIVERABLES

a) The reliability and predictability of services provided under this contract weigh very heavily in the judgment of the program's success and the Contractor’s performance. The Government fully expects that medical countermeasures shall be assembled and shipped according to the terms of this contract and the subsequent delivery orders, regardless of challenges faced by the Contractor in meeting agreed upon performance metrics. Reports are expected to be delivered in a complete and professional manner, on time, in the correct format, and to the correct recipients. Failure to meet defined performance standards shall cause serious harm to the Government, including its failure to mitigate a life safety issue in our highest threat posts. As such, failure to deliver medication filled autoinjectors as scheduled may force the Government to purchase similar materials outside the contract in order to meet mission requirements, and shall serve, in part, as an equitable price reduction, as determined by the CO.

b) Contractor shall provide all Department requested documents pertaining to operations under this contract and not otherwise considered to be proprietary by the Contractor. Certain deliverables shall be based upon the specifics of the task and/or delivery order.

c) Quality Management System (QMS): The Contractor shall provide QMS reports related to products procured under this contract quarterly following the first delivery of product.

d) Risk Mitigation Plan (RMP): The Contractor shall provide an update to that plan on an annual basis and within five business days of request by the Government.

e) A monthly report shall be generated by the Contractor on the first business day of a calendar month, and delivered electronically to the COR no later than close of business on the second business day of the calendar month. Each standard report format shall be determined by the COR, and communicated to the Contractor no later than seven (7) calendar days prior to the next standard report due date. Standard report formats will be negotiated at time of Contract Award. Format changes may be requested by the COR throughout the period of performance as required.

f) The Contractor shall provide a production schedule for each delivery order within five (5) business days of delivery order award.

g) The Contractor shall provide, with each delivery order, an electronic spreadsheet in Microsoft Excel (.xls) format that details the product, the lot number, the date of production, and the expiration date.

h) The Contractor shall provide a quarterly program report to the COR. The quarterly program report shall be in Microsoft Excel (.xls) format, and include the following information (at a minimum):

1. Reporting period

2. List of delivery orders issued under the contract, including date of award for the delivery order, the RDD, any amendment to the RDD issued by the Government, the actual delivery date, and product by lot number and quantity.

3. A declining balance sheet that identifies initial and subsequent contract funding, the value and time of issuance and payment for each invoice segregated by sub-CLIN, and the balance of remaining funds available on the contract.

C.5 OTHER REQUIREMENTS

C.5.1 DATA COMPONENTS AND REPORTING

a) All data, databases, formatted reports, and answers to specific requests for information shall become the property of the Government, and shall be developed, transmitted, and maintained in a manner acceptable to the COR.

b) Unless otherwise specified, data shall be exportable to Microsoft Excel format, and responses to requests for data shall be transmitted in Microsoft Excel format, organized and labeled in a manner that is easily understood and formatted to print on standard letter paper unless otherwise specified by the COR.

c) Written reports and responses to requests for information shall be transmitted by the Contractor to the Government in (*.pdf) format unless otherwise specified by the COR.

C.5.2 SECURITY REQUIREMENTS

a) All information associated with this requirement and contract shall be considered Sensitive but Unclassified (SBU), and shall not be disclosed without the expressed written permission of the Contracting Officer’s Representative.

b) The physical security for the production and storage of pharmaceutical products shall provide adequate security against pre-delivery losses or thefts and shall be in compliance with cognizant regional and local legal and regulatory oversight authority for the production of pharmaceuticals and associated delivery devices.

C.5.3 SAFEGUARDING OF INFORMATION

a) The Contractor, including subcontractors, shall exercise the utmost discretion in regard to all matters relating to their duties and functions. They shall not communicate to any person any information known to them by reason of their performance of services under this contract which has not been made public, without written authorization from the COR.

b) All documents and records (including photographs) generated during the performance of work under this contract, excluding Contractor proprietary work product and Contractor’s receipt of official certification and/or authorization of special mission or other equipment or processes, shall be for the sole use of and become the exclusive property of the Department. Furthermore, no information, article, book, pamphlet, recording, broadcast, speech, television appearance, film or photograph concerning any aspect of work performed under this contract shall be published or disseminated through any form of media (including the internet) without the prior written authorization of the COR.

c) The Contractor agrees that any violation of the certifications or restrictions of the conditions of nondisclosure shall constitute a material and substantial violation of the terms, conditions and provisions of the contract and that the Department may, in addition to any other remedy available, terminate this contract for default.

d) These obligations do not cease upon the expiration or termination of this contract. The Contractor shall include the substance of this provision in all contracts of employment and in all subcontracts hereunder.

C.5.4 RESTRICTED DISTRIBUTION OF DOCUMENTS

a) The Contractor, including its sub-Contractors, may be provided access to documents deemed “Sensitive” by the Department. Access to these documents, which must be appropriately labeled or marked as “sensitive,” shall be limited to members of the contract team on a need to know basis. The Department may limit the number of hard copies and prohibit electronic copies of such “Sensitive” documents. These documents shall be used on this contract only and shall not be used on any other contract or given or sold to another company, person(s) or entity.

b) The Contractor, including its sub-Contractors shall exercise the utmost discretion in regard to all matters relating to all Department documents. They shall not communicate to any person any information known to them because of their access to the Department documents. These documents are for use on this contract and are the exclusive property of the Department except as provided for elsewhere herein. Furthermore, no information, article, book, pamphlet, recording, broadcast, speech, television appearance, film or photograph concerning any aspect of these documents shall be copied, reproduced, published or disseminated through any media or the internet.

C.5.6 NOTIFICATION OF CONFIDENTIALITY

Notwithstanding any other provision or term of this agreement, it shall be the responsibility of the party seeking confidentiality as to any item of information, documents or things to notify the other party in advance and in writing as to same. Additionally, no restrictions shall apply to routine information or documents, or to information or documents provided to employees, agents and Contractors which are reasonably needed for the performance of duties.

C.6 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

This Quality Assurance Surveillance Plan (QASP) provides a systematic method of evaluating the services the Contractor is required to provide under contract.

Performance Objective

Performance Standard

PWS Para

Performance Threshold

Autoinjectors are inspected and pass objective quality control inspections in accordance with the approved Quality Management Plan (QMP).

Autoinjectors shall have a minimum remaining shelf life of 48 months at the time of delivery.

Autoinjectors are packaged to protect the device from physical damage without interfering with the visibility of the contents, the lot number, or the expiration date.

C.3.1.1(a)

C.3.1.1(b)

C.3.3.1(c)

C.3.3.1(d)

100% compliance with all production, quality, and packaging standards.

100% of test sample passes quality control testing prior to release of any specific lot.

100% of delivered products shall have a minimum of 48 months remaining in their shelf life.

100% of delivered products pass external inspection of packaging.

100% of random sample pass detailed inspection at the time of delivery.

The Contractor shall ensure that following production, and prior to delivery, products are stored in a physically secure and climate controlled location.

The Contractor shall ensure that during storage and transportation, products are protected from physical damage through proper external packaging and handling.

C.3.2(d)

C.3.2(e)

C.3.2(f) 100% of the product will be stored in physically secure and climate controlled location.

100% of the transported products are maintained within manufacturer’s recommended temperature limits and will be reflected in a temperature log provided to the USG at time of delivery.

100% of delivered products pass external inspection of packaging.

100% of random sample pass detailed inspection at the time of delivery.

The Contractor, and not the Department, is responsible for management and quality control actions to meet the terms of the contract. The Government retains the right to inspect deliveries to ensure compliance with contract standards prior to acceptance of a delivery.

SECTION D – PACKAGING AND MARKING

D.1 MARKING OF REPORTS

All reports delivered by the Contractor to the Government under this contract shall prominently show on the cover of the report:

a) Name and address of the Contractor;

b) Contract and task or delivery order number(s);

c) Date of report; and

d) Program office(s) (e.g., Directorate of Operational Medicine)

The Contractor shall not include any company watermarking or statement that would prevent the Government from utilizing or circulating the information contained in the report. If there are issues with the potential proprietary nature of the information, it shall be brought to the attention of the Contracting Officer’s Representative for resolution.

Reports shall be submitted electronically to the contract administration personnel identified in Section G.1.

D.2 SHIPPING INSTRUCTIONS

Supplies shall be packed for shipment in a manner that will ensure acceptance by common carriers and safe delivery at destination. Packaging shall be consistent with the prevailing rules and regulations in both the Contractor’s host nation as well as in the receiving country’

D.2.1 Delivery Process and Timeframe

All supplies shall be delivered to the destination specified in the delivery order at the Contractor’s expense. The Government shall not be liable for any delivery, storage, demurrage or other charges involved before the actual delivery (or “constructive placement” as defined in carrier tariffs), of the products to the destination, unless such charges are caused by an act or order of the Government acting in its contractual capacity.

a) Contractor shall deliver to the Government, via email:

1. All required documentation outlined for delivery of product, including data detailed in C.3.2 and copies of all permits, licenses, and certifications related to the quality, stability, and safety of the specific delivery.

2. Notification of the date and time that the product is to be delivered.

b) Acceptance Timeframe: The Government will have five full business days, after receipt of all documentation required to establish that the requirements have been satisfied and provide Contractor notice that Government accepts the lot(s).

1. For purposes of this acceptance timeframe, business days are defined as 9:00AM to 5:00PM Eastern Time, Monday through Friday, excluding U.S. Government Holidays.

2. For the avoidance of doubt, the Government will provide the Contractor with a written acceptance or refusal of lot(s) no later than 5:00PM on the fifth (5th) business day after receipt of products and documentation.

D.2.2 Temperature Control and Monitoring

The Contractor shall be responsible for maintaining product temperature control until the point that Government personnel (or Government-designated personnel) open the truck door(s) at the delivery location. The time the truck door(s) is (are) opened will be documented according to the Government Receiving procedure as well as on the Contractor’s controlled receiving log. The time recorded on the Contractor’s controlled receiving log will be verified and annotated by the Government personnel and used as the official time for the opening of the truck door(s). At this time, the responsibility for temperature control will transfer to Government as well as the responsibility for logging ambient exposure time (temperatures between 15-25°C). Temperature monitoring devices will continue recording ambient temperature until the lot(s) is (are) stored in the Government’s storage facility. The Government’s acceptance of the aforementioned responsibility applies only to temperature control and does not indicate its acceptance of the lot(s).

D.2.3 Packaging

The Contractor will be responsible for packaging the products ordered under this contract in accordance with the instructions provided at the delivery order level.

D.3 LATE DELIVERY