Document:

exhibit10-4.htm

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Section B - Supplies or Services and Prices/Costs

 

	
ITEM

	
SUPPLIES / SERVICES

	
QTY / UNIT

	
UNIT PRICE

	
EXTENDED PRICE

	
0001

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	
[**] Doses

	
$[**]

	
$[**]

	  	
Funding in the amount of $125,009,128.00 was provided on the letter notice of award dated September 30, 2011.

	  	  	  
	
0001A

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0001B

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0001C

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0001D

	
BioThrax [**] product

[**] upon date of delivery

 [**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

 

Option 1 Additional Quantity Items:

 

	
0002

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	
[**] Doses

	
$[**]

	
$[**]

	
0002A

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0002B

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0002C

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0002D

	
BioThrax [**] product

[**] upon date of delivery

 [**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

 

Option 2 Additional Quantity Items:

 

	
0003

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	
[**] Doses

	
$[**]

	
$[**]

	
0003A

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0003B

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0003C

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0003D

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

 

Option 3 Additional Quantity Items:

 

	
0004

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	
[**] Doses

	
$[**]

	
$[**]

	
0004A

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0004B

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0004C

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0004D

	
BioThrax [**] product

[**] upon date of delivery

 [**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

 

Option 4 Additional Quantity Items:

 

	
0005

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	
[**]Doses

	
$[**]

	
$[**]

	
0005A

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0005B

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0005C

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

	
0005D

	
BioThrax [**] product

[**] upon date of delivery

[**]

To be delivered in accordance with the delivery schedule below

	  	
$[**]

	
$[**]

 

B.1 Alternate CLINS

 

[**].

 

 

TOTAL DOSES TO BE DELIVERED                                                                                    44,750,000

 

TOTAL VALUE AT [**] PRODUCT                                                                                     $[**]

 

TOTAL VALUE AT [**] PRODUCT                                                                                     $1,253,167,500.00

 

B.2  Option for Increased Quantity – Separately Priced Line Items

 

The Government may require the delivery of the numbered line items, identified in the Schedule above as option items, in incremental quantities 

	
a) 

	
From a minimum order of [**] doses per order, and at the price stated in the Schedule above, up to the maximum quantity identified for each numbered line item. Each option line item may be exercised more than once, until the cumulative number of doses to be delivered under each option is delivered. The total doses ordered hereunder shall not exceed 44,750,000 doses over the 5 year period of performance, unless changed by formal modification to the contract. Each CLIN, including the alternate CLINs (with the same number and a lettered suffix) collectively function as one option. [**].

	
b)  

	
[**].

	
c)  

	
The Contracting Officer may exercise the option by written notice to the Contractor.  The Contractor will be notified in writing, by letter or email, at least one (1) business day before the option to acquire more product is exercised.  After that written notification, a funded, unilateral modification will be issued to actually exercise the option and order the doses.

 

B.3 Use of product by the US Government

 

To the extent that third parties contact DSNS to obtain doses of BioThrax®, DSNS will notify such third parties that Emergent sells AVA on the commercial market.

 

B.4 Price Protections.

 

Should the Government be unable to pick up product within [**] days of a scheduled delivery date while Emergent is ready, able and willing to deliver released lots of BioThrax, on the scheduled delivery date, the pricing for such lots shall be based on the remaining expiry dating as of the scheduled delivery date.  This does not apply if the shipment is rescheduled at the Contractor’s request.  Further, this does not apply if there are unresolved issues with the quality, safety, and/or efficacy of the delivered product.

 

Section C – Statement of Work

 

C.1 Vaccine Production and cGMP Compliance:

 

	
a)  

	
The Contractor shall manufacture BioThraxâ in accordance with current Good Manufacturing Practices (cGMP) guidelines.  The Contractor shall manufacture 44,750,000 doses of Final Drug Product (FDP) in 5 mL, ten dose vials in accordance with the targeted delivery schedule from October 1, 2011 – September 30, 2016.

	
b)  

	
BioThrax® shall be delivered on any business day, except Federal holidays, within the scheduled month in accordance with the targeted delivery schedule.  Contractor shall notify the Government promptly upon becoming aware of any deviations from the targeted delivery schedule.  All changes to the targeted delivery schedule must be approved by the Contracting Officer and/or the Contracting Officer’s Representative (COR).

	
c)  

	
Quantities for each scheduled delivery shall be of a specific quantity.

	
d)  

	
The Contractor shall perform all requisite assays and release tests, including but not limited to potency, identity, and stability testing in accordance with the FDA approved Biologic License Application (BLA-License Number 1755, STN 103821, and any approved change).

	
e)  

	
All BioThraxâ delivered under this contract shall be labeled with an expiration date consistent with its current product license at the time of manufacture.

	
f)  

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

	
g)  

	
The Contractor shall report to the Government material correspondence from the FDA regarding the quality, safety, or efficacy of BioThrax®.

	
h)  

	
The Contractor shall provide the Government with access to and/or provide copies of the following documents: (1) Form 483s form FDA inspections of Contractor’s Lansing facility, (2) Establishment Inspection Reports (EIRs) from FDA inspections of Contractor’s Lansing facility; (3) Warning Letters relating to BioThrax®; and Contractor’s Annual Safety Report to FDA regarding BioThrax®.  These documents will be provided to the Contracting Officer within [**] business days of receipt.

	
i)  

	
The Government shall be notified of any issues with the safety and efficacy of BioThrax® and/or manufacturing or quality of the FDA-licensed production lines at the Contractor’s Lansing facility within [**] business days of the determination of potential to be reported to FDA.

	
j)  

	
The Government shall have the option to conduct quarterly inspections of the Contractor’s Lansing facility.  Such inspections shall be performed by the COR or the COR’s  designee(s).

	
k)  

	
If the contractor should obtain FDA approval for the manufacture and production of BioThrax® having [**] while under this contract, the Government will accept delivery of those doses with the longer shelf life in addition to doses with a shorter shelf life.  Contractor may invoice only for those doses actually delivered under contract in accordance with Section B.

	
l)  

	
The product shall be delivered in accordance with cGMP (current Good Manufacturing Practices).

	
m)  

	
At least [**] business days prior to the product being ready for pick up by the SNS, the Contractor shall provide to the Contracting Officer and Contracting Officer’s Representative (COR):

	
a.  

	
The date the product will be ready for loading on the truck(s) scheduled by the SNS

	
b.  

	
Physical address of the product pick up location (facility name, address, point of contact name and telephone number)

	
c.  

	
Certificate(s) of Analysis

	
d.  

	
FDA Lot Release(s)

	
e.  

	
Number of pallets, vials, and doses to be loaded

	
n)  

	
At least [**] hours before each scheduled pick up by the SNS, Contractor shall provide the following to the Contracting Officer and COR:

	
a.  

	
Packing Slip

	
b.  

	
Actual number of pallets, vials and doses to be loaded

	
c.  

	
Diagram of product shipment pallet (how many vials per box, per pallet)

	
o)  

	
Within [**] business days after delivery, the Government shall provide the Contractor the SNS destination location(s) for the lot(s) delivered.

	
p)  

	
Within [**] hours after the product has been picked up by the SNS, the Contractor shall provide to the Contracting Officer and COR:

	
a.  

	
The remaining ambient exposure time letter disclosing accumulated ambient temperature exposure until the point that SNS (or SNS-designated personnel) assumed responsibility for temperature control, per Section E.3, for each lot from the Contractor’s Quality Department.  The letter should indicate that the product was manufactured and released in accordance with cGMP and has met all acceptance criteria to allow for Government distribution.

	
q)  

	
Funds provided shall be paid on a price per doses basis only on those products delivered to the SNS under contract.

	
r)  

	
Under the CLINs of this contract the products shall have an [**] product.  The Contractor shall target [**] of the total [**] remaining when the Government takes delivery of the product.  If [**] dated product is approved by the FDA, the product shall have an [**].  The Contractor shall target [**] of the total [**] remaining when the Government takes delivery of the product.  In the event that product with lower than targeted [**] should be delivered, product with an [**] greater than or equal to [**] shall be deemed [**] product.  A product with an [**] greater than or equal to [**] shall be deemed [**] product. A product with an [**] greater than or equal to [**] shall be deemed [**] product.  [**] when the Government takes delivery of the product according to the pricing table and Section B.1in Section B.

C.2 Delivery Schedule:

	
CLIN (includes alternate CLINS)

	
Delivery Period

	
# of Doses

	
0001

	
October 1, 2011 to September 30, 2012

	
[**]

	
0002

	
October 1, 2012 to September 30, 2013

	
[**]

	
0003

	
October 1, 2013 to September 30, 2014

	
[**]

	
0004

	
October 1, 2014 to September 30, 2015

	
[**]

	
0005

	
October 1, 2015 to September 30, 2016

	
[**]

The number under quantity shows the number of doses per year that the Contractor anticipates delivering during the period shown.    Should the projected number of doses not be delivered in a specific period, the Contractor shall adjust the delivery schedule to make up for deficiencies in prior deliveries.  Further, the Contractor may accelerate deliveries within each CLIN or into a subsequent CLIN, if production capacity permits such delivery and the CLIN is funded to a level to pay for the accelerated delivery.  Accelerated delivery is subject to approval by the COR.  Ultimately, the Contractor shall deliver a total of 44,750,000 doses by September 30, 2016.

C.3 Audits/Site Visits:

 

	
a)  

	
Pre-award Site Visit:  The Government reserves the right to conduct a pre-award site visit of the manufacturing plant.

 

	
b)  

	
Site Visits/Audits:  The Government shall perform annual site visits/security audits as deemed necessary by the Government throughout the period of performance of the contract.

 

	
c)  

	
Quality:  The Government may visit the Lansing site for purposes of assessing quality on an annual basis or as deemed necessary by the Government throughout the period of performance of the contract.

 

	
d)  

	
The contractor shall facilitate cGMP site-visit or inspection as requested by FDA/CBER at the time of production of product lots destined for the SNS.

 

	
e)  

	
Quality Management System (QMS):   Contractor shall submit evidence of its QMS to the Contracting Officer within 90 days after contract award.

 

	
f)  

	
Notice:  The Government shall provide 2 weeks advance notice prior 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.

 

	
g)  

	
All audits shall be conducted between normal business hours i.e. 8 a.m. through 4 p.m., Monday through Friday.

 

C.4 Meetings and Reports:

 

	
a)  

	
The contractor shall participate in a quarterly meeting (teleconference and/or face-to-face) to discuss performance under the contract.  These meetings should provide status updates and discuss on-going manufacturing, clinical, regulatory, and shipment issues as applicable.  These meetings shall be coordinated by the COR and/or Contracting Officer

 

	
b)  

	
Risk Mitigation Plan:  The plan should identify manufacturing, quality, regulatory, and shipment risks and countermeasures to mitigate these risks.  This report should be updated annually or as deemed necessary by the USG.

 

	
c)  

	
Additional reporting requirements:

 

	
1.  

	
Contractor shall notify DSNS in its quarterly reports if Contractor undertakes post-marketing commitments for Phase 4 studies in the event of emergency use authorization.

 

	
2.  

	
Contractor shall provide DSNS with drafts of supplements to its BLA for BioThrax® that are material to the manufactured product and to the contract.

 

Section D – Packaging and Marking

 

D.1 Method of Delivery

Unless otherwise specified by the Contracting Officer, delivery of the items other than BioThrax® to be furnished to the Government under this contract (including invoices) shall be made by first class mail, overnight carrier or e-mail.

D.2 Packaging

Packaging shall be consistent with the FDA approved labeling and packaging for this product at the time of manufacture.

 

Section E - Inspection and Acceptance

 

	
FAR SOURCE

	
TITLE AND DATE

	
52.246-1

	
Contractor Inspection Requirements (Apr 1984)

	
52.246-2

	
Inspection of Supplies – Fixed Price (Aug 1996)

	
52.246-16

	
Responsibility for Supplies (Apr 1984)

E.1  Inspection and Acceptance (Apr 2009)

E.1.1  Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative.

 

E.1.2 The Contractor shall only tender for acceptance those items that conform to the requirements of this contract.  The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance.  The Government may require repair or replacement of nonconforming supplies or re-performance of nonconforming services at no increase in contract price.  The Government must exercise its post-acceptance rights:

 

	
  

	
(1) Within a reasonable time after the defect was discovered or should have been discovered; and

 

	
  

	
(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

 

(End of Clause)

E.2 Contractor Inspection Requirements

The Contractor is responsible for performing or having performed all inspections and tests necessary to substantiate that the supplies or services furnished under this contract conform to contract requirements, including any applicable technical requirements for specified manufacturers’ parts.  This clause takes precedence over any Government inspection and testing required in the contract’s specifications, except for specialized inspections or tests specified to be performed solely by the Government.

(End of Clause)

E.3 Temperature Control and Monitoring

 

E.3.1  FOB Origin Deliveries:  The Contractor shall be responsible for maintaining product temperature control until the product leaves Contractor’s validated [**]°C storage facility for loading onto the carrier designated by the Government.  The Contractor shall provide the Government with an ambient exposure letter that covers the time until the product leaves the Contractor’s validated [**]°C storage facility.  Upon transfer of the product to the Government, the responsibility for temperature control shall transfer to the Government as well as the responsibility for logging ambient exposure time (temperatures between [**]°C).  The Government shall provide and place TempTale(s) on each pallet of product while the product is inside the Contractor’s validated [**]°C storage facility.  The Contractor shall be responsible for placing the product onto the truck(s) of the Government -designated carrier.  The Government should be allowed access to the pallets at least one hour prior to the loading of the pallets to place the TempTale(s) on the pallets.  The Government’s acceptance of the aforementioned responsibility applies only to temperature control and does not indicate its acceptance of the lot(s).

 

E.3.2  FOB Destination Deliveries:  The Contractor shall be responsible for maintaining product temperature control until the point that SNS personnel (or SNS-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 DSNS 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 SNS 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 SNS as well as the responsibility for logging ambient exposure time (temperatures between [**]°C). TempTale(s) will continue recording ambient temperature until the lot(s) is(are) stored in SNS' 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).

 

E.4 DSNS Quality Control Unit (QCU) Acceptance Procedure for BioThrax (AVA)

At the time the product is picked up by DSNS personnel or delivered to a designated DSNS delivery location all AVA product will be placed into DSNS Quarantine pending receipt of the required lot distribution documentation and the remaining ambient exposure time letter from the Contractor.   The Contractor shall supply the Government:

	
a.  

	
Notification of practices that may impact DSNS shipping procedures, if applicable

 

	
b.  

	
All items outlined in Section F.3.

 

E.4.1 Acceptance Process and Timeframe (FOB Origin Delivery)

 

	
1)  

	
Contractor shall deliver to the Government,  via e-mail or facsimile:

 

	
a)  

	
All required documentation outlined in Sections F.3.2

 

	
b)  

	
Notification of the date and time that the product was delivered (Picked Up by the Government or Delivered In Place).

 

	
2)  

	
Acceptance Timeframe:  The Government shall have [**] full business days, after receipt of all documentation required per Section E.4.1.1), to establish that the requirements of Section E.5 have been satisfied and provide Contractor notice that SNS accepts the lot(s).

 

	
a)  

	
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. 

 

	
b)  

	
For the avoidance of doubt, DSNS shall provide the Contractor with a written acceptance or refusal of BioThrax® lot(s) no later than 5:00PM on the [**] business day after receipt of the documentation.

 

E.4.2 Acceptance Process and Timeframe (FOB Destination Delivery only)

Contractor shall have the option to ship product for delivery to the SNS, at no additional cost to the Government, up to [**] times per calendar year.  COR consent for Contractor delivery under this option is required.  It is anticipated that  consent for delivery will not be unreasonably withheld, conditioned or delayed by the Government, and it is recognized that the Government requires time to make arrangments for planned deliveries.  In the event that delivery under this option can’t be worked out between the COR and the Contractor, or is denied, the COR must coordinate the issue with the Contracting Officer (CO).  The Contractor can appeal a significant delay or denial with the CO and DSNS management and have an appeal addressed at least in a preliminary manner, within [**] business days.

 

	
1)  

	
The Contractor shall request consent from the COR for Contractor delivery under this option at least [**] days prior to the planned delivery time so that arrangements can be made to accept delivery.  If possible, the Contracting Officer shall provide Contractor with the SNS location and point of contact information for the delivery [**] days prior to delivery to the SNS.

 

	
2)  

	
At least [**] hours prior to delivery to the SNS, Contractor shall provide to the Government:

 

	
a)  

	
Certificate(s) of Analysis

 

	
b)  

	
FDA Lot Releases

 

	
c)  

	
Number of pallets, vials and doses to be delivered

 

	
d)  

	
Name of Security Representative who will be accompanying the delivery

 

	
e)  

	
Estimated Time of Arrival for the delivery at the SNS location

 

	
3)  

	
With each shipment, contractor will provide:

 

	
a)  

	
Bill of Lading

 

	
b)  

	
Packing Slip

 

	
c)  

	
Shipping Directives

 

	
d)  

	
Contractor’s shipping instructions for Drivers

 

	
e)  

	
Identification Number for truck(s)

 

	
f)  

	
Diagram of product shipment pallet (how many vials per box, per pallet and positioning in truck(s) )

 

	
4)  

	
Within [**] business days after delivery, Contractor shall provide to the Contracting Officer:

 

	
a)  

	
Confirmation from the Contractor’s Quality Department that the product remained within the acceptable temperature ranges during shipping.

 

	
b)  

	
The remaining ambient exposure time for each lot from the Contractor’s Quality Department.

 

	
c)  

	
Post-Transit product delivery checklist

 

	
5)  

	
Acceptance Timeframe:  Following the receipt of the lot distribution documentation in Section E.4.2 parts 1 through 4 (“Documentation”) from the Contractor, DSNS will have a maximum of [**] business days to provide written notification to Contractor of acceptance or refusal of the delivered BioThrax lot(s).  Contractor shall provide DSNS the Documentation via email or facsimile. If the Documentation is sent by the Contractor and received by DSNS prior to 9:00AM on a given business day, the tolling of the [**] allotted business days set forth in the acceptance timeframe shall begin on that business day.  If the Documentation is sent by Contractor and received by DSNS  after 9:00AM on a given business day, the tolling of the [**] business days set forth in the acceptance timeframe will begin on the next business day.

 

	
a)  

	
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. 

 

	
b)  

	
For the avoidance of doubt, DSNS shall provide the Contractor with a written acceptance or refusal of BioThrax® lot(s) no later than 5:00PM on the [**] business day after receipt of the documentation.

 

E.5 DSNS QCU Release for BioThrax (AVA)

The DSNS QCU recommends that the temperature acceptance range for AVA, using the temperature monitoring device accuracy of [**]°C, would be [**]°C to [**]°C.  This temperature is consistent with licensed label specifications ([**]°C to [**]°C) and takes into account Emergent rounding practices (memo dated 8/12/09)  , and the accuracy of the temperature monitoring device (TempTale Bio).   

TempTale device alarms will be set for shipments to alert for possible temperature deviations for further evaluation.  DSNS QCU will review the temperature data for SNS internal processes.  As a clarification and guide for SNS, the table below outlines temperature limits acceptable during the period that Contractor is responsible for maintaining product temperature control and the resulting actions under each scenario.  This table is based on the TempTale with an accuracy of [**]°C. If any of the following changes occur while the Government is responsible for temperature monitoring and control, DSNS QCU will seek guidance from the Contractor:

	
Temperature Range

	
Action

	
< [**]°C

	
· AVA Pallet will be placed into DSNS quarantine pending further disposition

	
[**]°C

	
 

· Acceptable for use by the SNS

 

	
[**]°C

	
· AVA Pallet will be placed into DSNS quarantine

· Release of product by QCU will be pending quality disposition investigation, and remaining ambient exposure for the lot

	
>[**]°C

	
· AVA Pallet will be placed into DSNS quarantine pending further disposition

 

Temperature deviations during shipping are the responsibility of the Government for FOB Origin deliveries and the responsibility of Emergent for FOB Destination deliveries.  Deviations during shipping shall not delay the Government’s acceptance of the lots when FOB Origin and shall be evaluated and fully documented by the Party responsible for temperature control and monitoring in accordance with standard procedures.  When deliveries are FOB Destination, deviations during shipment shall delay the Government’s acceptance.  Contractor shall include an Event Description and Contractor's Product Impact Assessment in the Contractor's Certification Letter, per Section E.4.2.4), for each lot impacted by such deviations.  Contractor shall state in the Certification Letter that, "A Full Deviation Report, including root cause analysis and corrective and preventative actions will be submitted to the Government within [**] business days of report completion."  The Party responsible for temperature control and monitoring is also responsible for root cause analysis and defining appropriate corrective and preventative actions.  

 

Section F - Deliveries or Performance

 

	
FAR SOURCE

	
TITLE AND DATE

	
52.211-17

	
Delivery of Excess Quantities (Sept 1989)

	
52.242-15

	
Stop-Work Order (Aug 1989)

	
52.242-15 Alternate I

	
Stop-Work Order - Alternate I (Apr 1984)

	
52.242-17

	
Government Delay of Work (Apr 1984)

	
52.247-30

	
FOB Origin, Contractor’s Facility (Feb 2006)

 

F.1 Period of Performance

 

The period of performance of this contract shall be five (5) years, from September 30, 2011 through September 29, 2016.

 

F.2 Product Delivery

 

F.2.1  Product Pick Up by SNS (FOB Origin Deliveries)

 

	
a)  

	
The delivery of BioThrax® product shall be F.O.B Origin at the Contractor designated pick up location.

 

	
b)  

	
The place of product pick up by the SNS will be provided by the Contractor to the Contracting Officer and COR at least [**] business days prior to scheduled pick up.

 

	
c)  

	
Contractor may provide a Delivery-In-Place service, fulfilling the requirements of a F.O.B Origin delivery by meeting the following requirements:

 

	
a.  

	
Contractor shall store lot(s) to be delivered in a validated [**]°C storage facility at no additional cost to the Government for pick-up at the next scheduled delivery or [**] days after the Delivery-In-Place acceptance date, (as scheduled by the SNS), whichever comes first.

 

	
b.  

	
Contractor shall submit all lot documentation as required under Section F.3.2 below for the lot(s) to be delivered.

 

	
i.  

	
Pre-notification deadlines under Section F.3.2 shall not apply for Delivery-In-Place services.

 

	
ii.  

	
Once Contractor has provided these documents, the Government’s evaluation of these documents will be completed in accordance with Section E.4.1 above.

 

	
c.  

	
Contractor maintains responsibility for temperature control until lot(s) leave the validated [**]°C storage facility per Section E.3 above.

 

	
d.  

	
Contractor maintains responsibility for physical integrity of lot(s) until they are placed onto the SNS designated carrier per Section E.3 above.

 

F.2.2  Product Delivery by Emergent (FOB Destination deliveries)

 

	
a)  

	
If agreed to by the COR and/or CO in accordance with clause E.4.2, the delivery of BioThrax® product shall be F.O.B Destination at the SNS designated delivery location.

 

	
b)  

	
The place of product delivery to the SNS will be provided by the Contracting Officer to the Contractor at least [**] days prior to scheduled pick up.

 

	
c)  

	
Contractor shall ensure lot(s) are delivered via a validated [**]°C carrier at no additional cost to the Government.

 

	
d)  

	
Each BioThrax lot will be shipped to the SNS with [**] temperature monitoring devices TempTale(s) assigned for the purpose of recording ambient temperatures during shipment until the point of delivery.  The temperatures recorded by the TempTale(s) will be the only temperatures analyzed to determine whether each BioThrax lot was shipped within the FDA approved temperature range. 

 

	
e)  

	
Contractor shall submit all lot documentation as required under Section F.3.2 below for the lot(s) to be delivered.

 

	
a.  

	
SNS evaluation of these documents will be completed in accordance with Section E.4.2 above.

 

F.3 Deliverables

 

F.3.1 Product Schedule

 

	
CLIN

	
Delivery Period

	
# of Doses

	
0001

	
October 1, 2011 to September 30, 2012

	
[**]

	
0002

	
October 1, 2012 to September 30, 2013

	
[**]

	
0003

	
October 1, 2013 to September 30, 2014

	
[**]

	
0004

	
October 1, 2014 to September 30, 2015

	
[**]

	
0005

	
October 1, 2015 to September 30, 2016

	
[**]

At the time of issuance of this contract document, formalizing the letter notice of award 200-2011-M-41852 dated September 30, 2011, [**]..

F.3.2 Delivery Documentation

For product delivered FOB Destination, the Contractor shall deliver the documentation as outlined in Section E.4.2, items 2), 3) and 4), within the timeframes specified therein, to the Contracting Officer and COR.

For product delivered FOB Origin, the Contractor shall deliver, within the specified timeframes, the following documents to the Contracting Officer and COR:

.

	
a.  

	
At least [**] business days prior to each product pick up by the SNS, the Contractor shall provide to the Contracting Officer and COR:

	
i.  

	
The delivery date:

	
i.  

	
For FOB Origin deliveries, shall be the date the product will be ready for loading on the truck(s) scheduled by the SNS

	
ii.  

	
For FOB Destination deliveries, shall be the date the product will arrive at the SNS designated delivery location

	
ii.  

	
Physical address of the product pick up location (facility name, address, point of contact name and telephone number)

	
iii.  

	
Certificate(s) of Analysis

	
iv.  

	
FDA Lot Release(s)

	
v.  

	
Forecasted number of 40”x48” pallets, number of vials, and doses to be loaded

	
b.  

	
At least [**] hours before each scheduled pick up by the SNS the Contractor shall provide the following to the Contracting Officer and COR:

	
i.  

	
Packing Slip

	
ii.  

	
Actual number of pallets, vials and doses to be loaded

	
iii.  

	
Diagram of product shipment pallet (how many vials per box, per pallet)

	
c.  

	
Within [**] hours after the product has been picked up by the Government, the Contract shall provide to the Contracting Officer and COR the remaining ambient exposure time letter disclosing temperature control until the point that SNS (or SNS-designated personnel) assumed responsibility for temperature control, per Section E.3, for each lot from the Contractor’s Quality Department.  The letter should indicate that the product was manufactured and released in accordance with cGMP and has met all acceptance criteria to allow for government distribution.

 

F.3.3 Periodic Reports

	
a.  

	
The Contractor shall participate in a quarterly meeting (teleconference and/or face-to-face) to discuss performance under the contract.  These meetings should provide status updates and discuss on-going manufacturing, clinical, regulatory, and shipment issues as applicable.  These meetings shall be coordinated by the COR and/or Contracting Officer.

 

	
b.  

	
Risk Mitigation Plan:  The risk mitigation plan should identify manufacturing, quality, regulatory, and shipment risks and countermeasures to mitigate these risks.  This plan should be updated annually or as deemed necessary by the Government .

 

	
c.  

	
Additional reporting requirements:

 

	
1.  

	
Contractor will notify DSNS in its quarterly reports if Contractor undertakes post-marketing commitments for Phase 4 studies in the event of emergency use authorization.

 

	
2.  

	
Contractor will provide DSNS with drafts of supplements to its BLA for BioThrax® that are material to the manufactured product and to the contract.

 

F.4 Excusable Delay

 

The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God, or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers.  Furthermore, the Contractor will not be in default under this contract if it is unable to deliver AVA doses in accordance with any delivery schedule because of the action or inaction of the FDA, except the extent that such action or inaction is a direct consequence of the negligence or fault of the Contractor.  Additionally, the Contractor will not be in default of this contract in the event that deliveries are delayed as a result of another Government agency placing an order for AVA doses that is determined to have priority over this contract under the Defense Priority Allocation System or as a result of allocating up to 10 lots of BioThrax® to improvement programs, including fill/finish and manufacturing process improvements.  The Contractor shall notify the Contracting Officer in writing within [**] business days after the excusable delay is recognized, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

Section G - Contract Administration Data

G.1 Electronic Subcontracting Reporting System (eSRS) (Dec 2005)

G.1.1 The Contractor shall register with the Electronic Subcontracts Reporting System (eSRS) for the submission of its Individual Subcontract Report (SF 294) and the Annual Summary Reports (SF 295).  Before registering in eSRS, the Contractor information must be correct in Central Contractor Registration database.  The eSRS is a world wide web-based application available at: http://www.esrs.gov.  The eSRS website provides training and instruction for data submission.

(End of Clause)

G.2 Invoice Submission

 

(a) The Contractor shall submit the original contract invoice/voucher to the CDC Finance Management Office (FMO) to the following email address:  fmoapinv@cdc.gov

 

	
  

	
(b)   The contractor shall simultaneously submit an invoice/voucher via email to the cognizant contracting officer at cnp9@cdc.gov and to the cognizant CDC Contracting Officer’s Representatives at gtv4@cdc.gov and bmk7@cdc.gov.

(c)  In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Financial Management Office is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(d)  The Contractor shall include (as a minimum) the following information on each invoice:

(1)  Contractor’s Name & Address

(2)  Contractor’s Tax Identification Number (TIN)

(3)  Purchase Order/Contract Number and Task Order Number, if Appropriate

(4)  Invoice Number

(5)  Invoice Date

	
(6)  

	
Contract Line Item Number and Description of Item

(7)  Quantity

(8)  Unit Price & Extended Amount for each line item

	
(9)  

	
Shipping and Payment Terms

	
(10)  

	
 Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c) (1).

	
(13)  

	
DUNS + 4 Number

G.3 Contracting Officer (Jul 1999)

G.3.1 The Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds.  No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract.

G.3.2 No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

(End of Clause)

G.4 Project Officer/Contracting Officer’s Representative

G.4.1 Performance of the work here under shall be subject to the technical directions of the designated Project Officer/Contracting Officer’s Representative (COR) for this contract.

G.4.2 As used herein, technical directions are directions to the Contractor which fill in details, suggest possible lines of inquiry, or otherwise complete the general scope of work set forth herein.  These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof.  In the event that the Contractor feels that full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer in a letter separate of any required report(s) within [**] weeks of the date of receipt of the technical direction and no action shall be taken pursuant to the direction.  If the Contractor fails to provide the required notification within the said [**] week period that any technical direction exceeds the scope of the contract, then it shall be deemed for purposes of this contract that the technical direction was within the scope.  No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

G.4.3 The Government Project Officer/COR is not authorized to change any of the terms and conditions of this contract.  Changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

G.4.4 The Government will provide the Contractor with a copy of the delegation memorandum for the Project Officer/COR.  Any changes in Project Officer’s/COR delegation will be made by the Contracting Officer in writing with a copy being furnished to the Contractor.

(End of Clause)

G.5 Payment by Electronic Funds Transfer (Dec 2005)

G.5.1 The Government shall use electronic funds transfer to the maximum extent possible when making payments under this contract.  FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration, in Section I, requires the Contractor to designate in writing a financial institution for receipt of electronic funds transfer payments.

G.5.2 In addition to Central Contractor Registration, the Contractor shall make the designation by submitting the form titled “ACH Contractor/Miscellaneous Payment Enrollment Form” to the address indicated below.  The form may be obtained by contacting the CDC Financial Management Office at (404) 498-4050.

G.5.3   In cases where the Contractor has previously provided such designation, i.e., pursuant to a prior contract/order, and been enrolled in the program, the form is not required unless the designated financial institution has changed.

G.5.4 The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, to the following address:

The Centers for Disease Control and Prevention

Financial Management Office (FMO)

P.O. Box 15580

Atlanta, GA  30333

Or – Fax copy to:  404-638-5342

 

G.6 Notification of Utilization

G.7 Contract Communications/Correspondence (Jul 1999)

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number from Page 1 of the contract.

(End of Clause)

 

Section H - Special Contract Requirements

H.1  Privacy Act Applicability (Apr 2000)

H.1.1  Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government.  The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act.  A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&tpl=/ecfrbrowse/Title45/45cfr5b_main_02.tpl

H.1.2   The Project Officer/COR is hereby designated as the official who is responsible for monitoring Contractor compliance with the Privacy Act.

H.1.3 The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act system notice.

NOTE: Clinical trials cannot be initiated until the System Notice has been published and the Contracting Officer notifies the contractor.

(End of Clause)

H.2 Non-Disclosure Agreement for Contractor and Contractor Employees (Mar 2006)

H.2.1 Contractor’s employees shall sign Contractor’s non-disclosure agreement (NDA) per Exhibit 1 below..

H.2.2 During the contract performance period, the Contractor is responsible for ensuring that all additional or replacement Contractor’s employees, meeting criteria per H.2.1 above, sign a NDA and it is made available upon demand to the Contracting Officer and the Project Officer/COR.

H.2.3 The Contractor shall prepare and maintain a current list of employees working under NDAs provided with specific access to Sensitive But Unclassified Information as designated by the DSNS and submit to the Contracting Officer upon request during the contract period of performance.  The list should, at a minimum, include: contract number, employee’s name, position, date of hire and NDA requirement.

H.2.4  NDA methodology described above is preliminary at the time of issuance of this contract document, formalizing the letter notice of award 200-2011-M-41852 dated September 30, 2011.  The Contractor and the Government will further discuss the NDA requirement by June 30, 2012 and will incorporate a revised version of clause H.2 via modification by July 31, 2012.  The Government and the Contractor agree that the goal is to protect the Government’s interests and information, and provide adequate protection of the Government’s Sensitive But Unclassified (SBU) information, while not placing an undue administrative burden on the Contractor.  Not all Contractor employees will be required to sign NDAs.  Contractor employees with a need to know Government SBU information must sign an NDA.  The Contractor must provide an initial list and annual updates to the Government listing the individual Contractor employees who are subject to and have signed NDAs applicable to this contract.

 

H.3 Laboratory License Requirements (May 1998)

 

 

H.4 Disposition of Information

 

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the Project Officer/COR, which approval shall not be unreasonably withheld, conditioned, or delayed; provided, however, that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity for submission to any securities exchange on which the Contractor’s (or parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers, acquisitions, or other business transactions.

 

H.5 Identification and Disposition of Data

 

 

H.6  Manufacturing Standards

 

The Current Good Manufacturing Practice Regulation (cGMP) (21 CFR Parts 210-211) will be the standard to be applied for manufacturing, processing and packaging of this product.

 

If at any time during the life of the contract, the Contractor fails to comply with the cGMP in the manufacturing, processing and packing of this product and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure) as identified by CBER and CDER, the contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure.  If the contractor fails to take such material failure is identified to cure such material failure.  If the contractor fails to take such an action within the thirty (30) calendar day period, then the contract may be terminated.

 

H.7 Prohibition on Contractor Involvement with Terrorist Activities

 

 

H.8 Liability Protection under the PREP Act

 

 

The Public Readiness & Emergency Preparedness Act (PREP Act), Pub. L. 109-148, Division C, 119 Stat. 2818 to 2832, amended the Public Health Service Act, 42, U.S.C. 243 et seq., to provide targeted liability protections.  The Government agrees that the medical countermeasure delivered by the Contractor under this contract will be administered in humans, in accordance with the declaration under the PREP Act issued by the Secretary of the Department of Health and Human Services on October 1, 2008 pursuant to section 319F-3(b) of the Public Health Service Act, 42, U.S.C 247-d-6d.  The declaration provides targeted liability protections for anthrax countermeasures based on a credible risk that the threat of exposure to Bacillus anthracis and the resulting disease constitutes a public health emergency.

 

Section I - Contract Clauses

 

Section I-1 - Clauses Incorporated By Reference

 

	
FAR Ref

	
Date

	
Title

	
52.203-3

	
Apr-84

	
Gratuities

	
52.204-4

	
May-11

	
Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

	
52.227-1

	
Dec-07

	
Authorization and Consent

	
52.227-2

	
Dec-07

	
Notice and Assistance Regarding Patent and Copyright Infringement

	
52.229-3

	
Apr-03

	
Federal, State, and Local Taxes

	
52.232-11

	
Apr-84

	
Extras

	
52.232-18

	
Apr-84

	
Availability of Funds

	
52.223-3

	
Jan-97

	
Hazardous Material Identification and Material Safety Data.

	
52.233-4

	
Oct-04

	
Applicable Law for Breach of Contract Claim

	
52.242-13

	
Jul-95

	
Bankruptcy

	
52.243-1

	
Aug-87

	
Changes - Fixed-Price

	
52.244-5

	
Dec-96

	
Competition in Subcontracting

	
52.245-1

	
Aug-10

	
Government Property

	
52.245-9

	
Aug-10

	
Uses and Charges

	
52.247-30

	
Feb-06

	
F.O.B. Origin, Contractor’s Facility

	
52.247-34

	
Nov-91

	
F.O.B. Destination

	
52.249-2

	
May-04

	
Termination for the Convenience of the Government (Fixed-Price)

	
52.249-8

	
Apr-84

	
Default (Fixed-Price Supply and Service)(Over the Simplified Acquisition Threshold)

	
352.201-70

	
Jan-06

	
Paperwork Reduction Act

	
352.202-1

	
Jan-06

	
Definitions

	
352.203-70

	
Jan-06

	
Anti-Lobbying (Over Simplified Acquisition Threshold)

	
352.222-70

	
Jan-10

	
Contractor Cooperation in Equal Employment Opportunity Investigations

	
352.223-70

	
Jan-06

	
Safety and Health

	
352.227-70

	
Jan-06

	
Publications and Publicity

	
352.231-71

	
Jan-01

	
Pricing of Adjustments

	
352.242-73

	
Jan-06

	
Withholding of Contract Payments

	
352.270-4

	
Jan-06

	
Protection of Human Subjects

	
352.270-5

	
Jan-06

	
Care of Laboratory Animals

Section I-2 - Clauses Incorporated In Full Text

 

I.2.1 52.212.-4 Contract Terms and Conditions—Commercial Items (June 2010)

 

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

 

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

 

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item

 

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

 

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

 

(d) Disputes. This contract is subject to the Contract Disputes Act of 1978, as amended (41 U.S.C. 601-613). Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

 

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

 

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

 

(g) Invoice.

 

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include— (i) Name and address of the Contractor;

 

(ii) Invoice date and number;

 

(iii) Contract number, contract line item number and, if applicable, the order number;

 

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

 

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

 

(vi) Terms of any discount for prompt payment offered;

 

(vii) Name and address of official to whom payment is to be sent;

 

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

 

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

 

(x) Electronic funds transfer (EFT) banking information.

 

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

 

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration, or 52.232-34, Payment by Electronic Funds Transfer—Other Than Central Contractor Registration), or applicable agency procedures.

 

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

 

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR Part 1315.

 

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

 

(i) Payment.—

 

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

 

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR Part 1315.

 

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

 

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

 

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

 

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

 

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

 

(B) Affected contract number and delivery order number, if applicable;

 

(C) Affected contract line item or subline item, if applicable; and

 

(D) Contractor point of contact.

 

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

 

(6) Interest.

 

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in Section 611 of the Contract Disputes Act of 1978 (Public Law 95-563), which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

 

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

 

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

 

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

 

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

 

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

 

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

 

(v) Amounts shall be due at the earliest of the following dates:

 

(A) The date fixed under this contract.

 

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

 

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

 

(A) The date on which the designated office receives payment from the Contractor;

 

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

 

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

 

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

 

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

 

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

 

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

 

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

 

(l) Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

 

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

 

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

 

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

 

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

 

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

 

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. 3701, et seq., Contract Work Hours and Safety Standards Act; 41 U.S.C. 51-58, Anti-Kickback Act of 1986; 41 U.S.C. 265 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. 423 relating to procurement integrity.

 

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

 

(1) The schedule of supplies/services.

 

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, and Compliance with Laws Unique to Government Contracts paragraphs of this clause.

 

(3) The clause at 52.212-5.

 

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

 

(5) Solicitation provisions if this is a solicitation.

 

(6) Other paragraphs of this clause.

 

(7) The Standard Form 1449.

 

(8) Other documents, exhibits, and attachments.

 

(9) The specification.

 

(t) Central Contractor Registration (CCR).

 

(1) Unless exempted by an addendum to this contract, the Contractor is responsible during performance and through final payment of any contract for the accuracy and completeness of the data within the CCR database, and for any liability resulting from the Government’s reliance on inaccurate or incomplete data. To remain registered in the CCR database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the CCR database to ensure it is current, accurate and complete. Updating information in the CCR does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

 

(2)(i) If a Contractor has legally changed its business name, “doing business as” name, or division name (whichever is shown on the contract), or has transferred the assets used in performing the contract, but has not completed the necessary requirements regarding novation and change-of-name agreements in FAR Subpart 42.12, the Contractor shall provide the responsible Contracting Officer a minimum of one business day’s written notification of its intention to (A) change the name in the CCR database; (B) comply with the requirements of Subpart 42.12; and (C) agree in writing to the timeline and procedures specified by the responsible Contracting Officer.

 

The Contractor must provide with the notification sufficient documentation to support the legally changed name.

 

(ii) If the Contractor fails to comply with the requirements of paragraph (t)(2)(i) of this clause, or fails to perform the agreement at paragraph (t)(2)(i)(C) of this clause, and, in the absence of a properly executed novation or change-of-name agreement, the CCR information that shows the Contractor to be other than the Contractor indicated in the contract will be considered to be incorrect information within the meaning of the “Suspension of Payment” paragraph of the electronic funds transfer (EFT) clause of this contract.

 

(3) The Contractor shall not change the name or address for EFT payments or manual payments, as appropriate, in the CCR record to reflect an assignee for the purpose of assignment of claims (see Subpart 32.8, Assignment of Claims). Assignees shall be separately registered in the CCR database. Information provided to the Contractor’s CCR record that indicates payments, including those made by EFT, to an ultimate recipient other than that Contractor will be considered to be incorrect information within the meaning of the “Suspension of payment” paragraph of the EFT clause of this contract.

 

(4) Offerors and Contractors may obtain information on registration and annual confirmation requirements via the internet at http://www.ccr.gov or by calling 1-888-227-2423 or 269-961-5757.

 

I.2.2 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Items (Nov 2011)

 

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

 

(1) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

 

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

 

(2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

 

(3) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Pub. L. 108-77, 108-78).

 

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

 

[Contracting Officer check as appropriate.]

 

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402).

 

 

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

 

 

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

 

 

X__ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2010) (Pub. L. 109-282) (31 U.S.C. 6101 note).

 

 

__ (5) 52.204-11, American Recovery and Reinvestment Act—Reporting Requirements (Jul 2010) (Pub. L. 111-5).

 

 

_X_ (6) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Dec 2010) (31 U.S.C. 6101 note).

 

 

__ (7) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

 

 

__ (8) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

 

 

__ (9) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

 

 

__ (10) [Reserved]

 

 

__ (11)(i)  52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

 

 

__ (ii) Alternate I (Nov 2011).

 

 

__ (iii) Alternate II (Nov 2011).

 

 

__ (12)(i)  52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

 

 

__ (ii) Alternate I (Oct 1995) of 52.219-7.

 

 

__ (iii) Alternate II (Mar 2004) of 52.219-7.

 

 

_X_ (13) 52.219-8, Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)).

 

 

_X_ (14)(i)  52.219-9, Small Business Subcontracting Plan (Jan 2011) (15 U.S.C. 637(d)(4)).

 

 

__ (ii) Alternate I (Oct 2001) of 52.219-9.

 

 

__ (iii) Alternate II (Oct 2001) of 52.219-9.

 

 

__ (iv) Alternate III (Jul 2010) of 52.219-9.

 

 

__ (15) 52.219-13, Notice of Set-Aside of Orders (Nov 2011)(15 U.S.C. 644(r)).

 

 

__ (16) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C. 637(a)(14)).

 

 

_X_ (17) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

 

 

__ (18)(i)  52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

 

 

__ (ii) Alternate I (June 2003) of 52.219-23.

 

 

__ (19) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Dec 2010) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

 

 

__ (20) 52.219-26, Small Disadvantaged Business Participation Program— Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

 

 

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C. 657 f).

 

 

__ (22)  52.219-28, Post Award Small Business Program Rerepresentation (Apr 2009) (15 U.S.C. 632(a)(2)).

 

 

__ (23) 52.219-29 Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business Concerns (Nov 2011).

 

 

__ (24) 52.219-30 Notice of Set-Aside for Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Nov 2011).

 

 

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

 

 

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jul 2010) (E.O. 13126).

 

 

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

 

 

_X_ (28) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

 

 

_X_ (29) 52.222-35, Equal Opportunity for Veterans (Sep 2010)(38 U.S.C. 4212).

 

 

_X_ (30) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

 

 

_X_ (31) 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212).

 

 

_X_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

 

 

_X_ (33) 52.222-54, Employment Eligibility Verification (Jan 2009). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

 

 

__ (34)(i)  52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

 

 

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

 

 

__ (35) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

 

 

__ (36)(i)  52.223-16, IEEE 1680 Standard for the Environmental Assessment of Personal Computer Products (Dec 2007) (E.O. 13423).

 

 

__ (ii) Alternate I (Dec 2007) of 52.223-16.

 

 

_X_ (37) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) (E.O. 13513).

 

 

_X_ (38) 52.225-1, Buy American Act—Supplies (Feb 2009) (41 U.S.C. 10a-10d).

 

 

__ (39)(i)  52.225-3, Buy American Act—Free Trade Agreements—Israeli Trade Act (June 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, and 110-138).

 

 

__ (ii) Alternate I (Jan 2004) of 52.225-3.

 

 

__ (iii) Alternate II (Jan 2004) of 52.225-3.

 

 

__ (40) 52.225-5, Trade Agreements (Nov 2011) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

 

 

_X_ (41) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

 

 

__ (42) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

 

 

__ (43) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

 

 

__ (44) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

 

 

__ (45) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

 

 

_X_ (46) 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332).

 

 

__ (47) 52.232-34, Payment by Electronic Funds Transfer—Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332).

 

 

__ (48) 52.232-36, Payment by Third Party (Feb 2010) (31 U.S.C. 3332).

 

 

__ (49) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

 

 

__ (50)(i)  52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

 

 

__ (ii) Alternate I (Apr 2003) of 52.247-64.

 

 

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

 

 

[Contracting Officer check as appropriate.]

 

 

__ (1) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

 

 

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 1989) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

 

 

__ (3) 52.222-43, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Multiple Year and Option Contracts) (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

 

 

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Act—Price Adjustment (Sep 2009) (29 U.S.C. 206 and 41 U.S.C. 351, et seq.).

 

 

__ (5) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (Nov 2007) (41 351, et seq.).

 

 

__ (6) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services—Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

 

 

__ (7) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247).

 

 

__ (8) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

 

 

(d)  Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

 

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

 

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

 

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

 

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

 

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)).

 

(ii) 52.219-8, Utilization of Small Business Concerns (Dec 2010) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

 

(iii) [Reserved]

 

(iv) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

 

(v) 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212).

 

(vi) 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793).

 

(vii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

 

(viii) 52.222-41, Service Contract Act of 1965 (Nov 2007) (41 U.S.C. 351, et seq.).

 

(ix) 52.222-50, Combating Trafficking in Persons (Feb 2009) (22 U.S.C. 7104(g)).

 

___Alternate I (Aug 2007) of 52.222-50 (22 U.S.C. 7104(g)).

 

 

(x) 52.222-51, Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (Nov 2007) (41 U.S.C. 351, et seq.).

 

(xi) 52.222-53, Exemption from Application of the Service Contract Act to Contracts for Certain Services-Requirements (Feb 2009) (41 U.S.C. 351, et seq.).

 

(xii) 52.222-54, Employment Eligibility Verification (Jan 2009).

 

(xiii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Mar 2009) (Pub. L. 110-247). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

 

(xiv) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

 

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

 

I.2.3 52.217-6 Option for Increased Quantity. (Mar 1989)

 

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within any time during the period of performance Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

 

(End of clause)

 

I.2.4 52.217-7 Option for Increased Quantity—Separately Priced Line Item. (Mar 1989)

 

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within any time during the period of performance. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

 

(End of clause)

 

I.2.5 52.217-9 Option to Extend the Term of the Contract (Mar 2000)

 

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

 

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

 

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 66 months.

 

(End of clause)

 

Section J - List of Attachments

 

 

[Note to SEC for confidential treatment review:  Exhibit 4 was not attached to the agreement by the parties.]

 

 

	
  

	
Section K - Representations, Certifications, and Other Statements of Offerors

 

Online Representations and Certification Application (ORCA) (Dec 2005)

 

 

	
(a)  

	
All Contractors are required to complete electronic annual representations and certifications at http://orca.bpn.gov in conjunction with registration in the Central Contractor Registration (CCR) database per FAR 4.1102 and FAR 4.1201.  Certifications in ORCA are required prior to the submission of contract proposals.

	
  

	
(b)

	
Contractors shall update the representations and certifications submitted to ORCA as necessary, but at least annually, to ensure they are kept current, accurate, and complete.  All Contractors with current contracts shall notify the Contracting Officer in writing when changes are made to ORCA.   The representations and certifications are effective until one year from date of submission or update to ORCA.

(End of Clause)

SUMMARY OF RELATED ACTIVITIES

The following specific information must be provided by the offeror pertaining to the Project Director, Principal Investigator, and each of any other proposed key professional individuals designated for performance under any resulting contract.

 

	
a.

	
Identify the total amount of all presently active federal contracts/cooperative agreements/grants and commercial agreements citing the committed levels of effort for those projects for each of the key individuals* in this proposal.

 

	
  

	
Professional’s Name and Title/Position:

 

	
Identifying Number

	
Agency

	
Total Effort Committed

	  	  	  
	  	  	  
	  	  	  
	  	  	  

*If an individual has no obligation(s), so state.

 

	
b.

	
Provide the total number of outstanding proposals, exclusive of the instant proposal, having been submitted by your organization, not presently accepted but in an anticipatory stage, which will commit levels of effort by the proposed professional individuals*.

 

	
  

	
Professional’s Name and Title/Position:

 

	
Identifying Number

	
Agency

	
Total Effort Committed

	  	  	  
	  	  	  
	  	  	  
	  	  	  

*If no commitment of effort is intended, so state.

 

	
C.

	
Provide a statement of the level of effort to be dedicated to any resultant contract awarded to your organization for those individuals designated and cited in this proposal.

 

	
Name

	
Title/Position

	
Total Proposed Effort

	  	  	  
	  	  	  
	  	  	  
	  	  	  

 

 

Protection of Human Subjects

Assurance Identification/IRB Certification/Declaration of Exemption

(Common Rule)

	
Policy. Research activities involving human subjects may not be conducted or supported by the Departments and Agencies adopting the Common Rule (56FR28003, June 18, 1991) unless the activities are exempt from or approved in accordance with the Common Rule. See section 101(b) of the Common Rule for exemptions. Institutions submitting applications or proposals for support must submit certification of appropriate Institutional Review Board (IRB) review and approval to the Department or Agency in accordance with the Common Rule.

	
Institutions must have an assurance of compliance that applies to the research to be conducted and should submit certification of IRB review and approval with each application or proposal unless otherwise advised by the Department or Agency.

	
1. Request Type

 ORIGINAL

 CONTINUATION

 EXEMPTION

	
2. Type of Mechanism

 GRANT                       CONTRACT FELLOWSHIP

 COOPERATIVE AGREEMENT

 OTHER

	
3. Name of Federal Department or Agency and, if known, Application or Proposal Identification No.

	
4. Title of Application or Activity

	
5. Name of Principal Investigator, Program Director, Fellow, or Other

6. Assurance Status of this Project (Respond to one of the following)

 This Assurance, on file with Department of Health and Human Services, covers this activity:

Assurance Identification No. ___________________, the expiration date ________________ IRB Registration No. _________________

 This Assurance, on file with (agency/dept) _______________________________________________________________ covers this activity.

Assurance No. ________________, the expiration date _____________ IRB Registration/Identification No. ____________ (if applicable)

	
  

	
 No assurance has been filed for this institution. This institution declares that it will provide an Assurance and Certification of IRB review and approval upon request.

	
  

	
 Exemption Status: Human subjects are involved, but this activity qualifies for exemption under Section 101(b), paragraph _____.

7. Certification of IRB Review (Respond to one of the following IF you have an Assurance on file)

 This activity has been reviewed and approved by the IRB in accordance with the Common Rule and any other governing regulations.

	
  

	
by:   Full IRB Review on (date of IRB meeting) ______________ or  Expedited Review on (date)

	
  

	
 If less than one year approval, provide expiration date ______________________

	
  

	
 This activity contains multiple projects, some of which have not been reviewed. The IRB has granted approval on condition that all projects covered by the Common Rule will be reviewed and approved before they are initiated and that appropriate further certification will be submitted.

 

8. Comments

 

  

	
9. The official signing below certifies that the information provided above is correct and that, as required, future reviews will be performed until study closure and certification will be provided.

	
10. Name and Address of Institution

	
11. Phone No. (with area code)

 

	
12. Fax No. (with area code)

 

	
13. Email:

 

	
14. Name of Official

 

	
15. Title

 

	
16. Signature

 

	
Date

Authorized for Local Reproduction                                                                                                           Sponsored by HHS

Instructions for Protection of Human Subjects Assurance identification/

 

IRB Certification/Declaration of Exemption Form

 

Box 1:                      Check Request Type: Original (New Award), Continuation, or Exemption (Do Not Use)

 

	
Box 2:

	
Check Type of Award Mechanism: Grant, Contract, Cooperative Agreement, Fellowship, Other

 

Box 3::                      Insert National Institute of Justice as Name of Federal Department or Agency

 

Box 4:                      List Title of Application

 

Box 5:                      List Name as requested

 

Box 6:                      For Assurance Status of this Project, four options for response are provided:

 

Option 1) Assurance on file with HHS and IRB has approved.  (NOTE: The Federalwide Assurance number, expiration date, and IRB registration number must be provided here.  The Certification of IRB review and approval must also be provided.)

 

Option 2) Assurance on file with another Federal agency or department and IRB has approved.  (NOTE: The Assurance number, expiration date, and IRB registration number must be provided here.  The Certification of IRB review and approval must also be provided.)

 

Option 3) No Assurance has been filed.  The institution declares that it will provide and Assurance and Certification of IRB review and approval upon request.

 

All applicants should check the third option unless the applicant has already submitted this research application to and received approval or exemption from an IRB with an Assurance on file.

 

Option 4) Exemption Status: Use this option only if one of the exemptions listed in the regulation applies.  Your IRB approval of exemption memo must be provided, or you may apply for an exemption from NIJ.  See Exemption Request Information.

 

	
Box 7:

	
For Certification of IRB Review, if an Assurance is on file (that is, if Option 1 or 2 was selected in Box 6), two options for response are provided.

 

Option 1) Select this option if IRB approval was provided for this project, provide the date and indicate whether the approval was the result of a Full or Expedited IRB Review.

 

Option 2) Select this option if this project has not yet received IRB certification.

 

Box 8:                      Comments: If applicable, indicate that “This project will not involve human subjects.”

 

Box 10-17:  Complete as indicated.  The signing official must be a representative of the applicant institution, i.e., Director, Office of Sponsored Research or Chair, IRB.

 

 

DISCLOSURE OF LOBBYING ACTIVITIES

Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352

(See reverse for public burden disclosure.)

	
1. Type of Federal Action:

a. contract

b. grant

c. cooperative agreement

d. loan

e. loan guarantee

f. loan insurance

	
2. Status of Federal Action:

a. bid/offer/application

b. initial award

c. post-award

	
3. Report Type:

a. initial filing

b. material change

For Material Change Only:

year ________ quarter ________

date of last report _____________

	
4. Name and Address of Reporting Entity:

 Prime                               Subawardee

Tier _______, if known:

 

 

 

 

 

Congressional District, if known: 4c

	
5. If Reporting Entity in No. 4 is a Subawardee, Enter Name and Address of Prime:

 

 

 

 

 

 

Congressional District, if known:

	
6. Federal Department/Agency:

	
7. Federal Program Name/Description:

 

 

 

CFDA Number, if applicable: _____________

 

	
8. Federal Action Number, if known:

 

	
9. Award Amount, if known:

$

 

	
10. a. Name and Address of Lobbying Registrant

(if individual, last name, first name, MI):

 

 

 

 

 

 

 

	
b. Individuals Performing Services (including address if different from No. 10a)

(last name, first name, MI):

	
11.Information requested through this form is authorized by title 31 U.S.C. section 1352.  This disclosure of lobbying activities is a material representation of fact upon which reliance was placed by the tier above when this transaction was made or entered into.  This disclosure is required pursuant to 31 U.S.C. 1352.  This information will be available for public inspection.  Any person who fails to file the required disclosure shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.

	
 

 

Signature:

 

Print Name:

 

Title:

 

Telephone No.: Date:

	
Federal Use Only:

	
Authorized for Local Reproduction

Standard Form LLL (Rev. 7-97)

INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES

 

This disclosure form shall be completed by the reporting entity, whether subawardee or prime Federal recipient, at the initiation or receipt of a covered Federal action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352.  The filing of a form is required for each payment or agreement to make payment to any lobbying entity for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with a covered Federal action.  Complete all items that apply for both the initial filing and material change report.  Refer to the implementing guidance published by the Office of Management and Budget for additional information.

 

	
  

	
1.

	
Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.

 

	
  

	
2.

	
Identify the status of the covered Federal action.

 

	
  

	
3.

	
Identify the appropriate classification of this report.  If this is a followup report caused by a material change to the information previously reported, enter the year and quarter in which the change occurred.  Enter the date of the last previously submitted report by this reporting entity for this covered Federal action.

 

	
  

	
4.

	
Enter the full name, address, city, State and zip code of the reporting entity.  Include Congressional District, if known.  Check the appropriate classification of the reporting entity that designates if it is, or expects to be, a prime or subaward recipient.  Identify the tier of the subawardee, e.g., the first subawardee of the prime is the 1st tier.  Subawards include but are not limited to subcontracts, subgrants and contract awards under grants.

 

	
  

	
5.

	
If the organization filing the report in item 4 checks “Subawardee,” then enter the full name, address, city, State and zip code of the prime Federal recipient.  Include Congressional District, if known.

 

	
  

	
6.

	
Enter the name of the Federal agency making the award or loan commitment.  Include at least one organizational level below agency name, if known.  For example, Department of Transportation, United States Coast Guard.

 

	
  

	
7.

	
Enter the Federal program name or description for the covered Federal action (item 1).  If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for grants, cooperative agreements, loans, and loan commitments.

 

	
  

	
8.

	
Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number; Invitation for Bid (IFB) number; grant announcement number; the contract, grant, or loan award number; the application/proposal control number assigned by the Federal agency).  Include prefixes, e.g., “RFP-DE-90-001.”

 

	
  

	
9.

	
For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime entity identified in item 4 or 5.

 

	
  

	
10.

	
(a)

	
Enter the full name, address, city, State and zip code of the lobbying registered under the Lobbying

 

	
  

	
Act of 1995 engaged by the reporting entity identified in item 4 to influence the covered Federal

 

	
  

	
action.

 

	
  

	
(b)

	
Enter the full names of the individual(s) performing services, and include full address if different

 

	
  

	
from 10(a).  Enter Last Name, First Name, and Middle Initial (MI).

 

	
  

	
11.

	
The certifying official shall sign and date the form, print his/her name, title, and telephone number.

 

 

ACH VENDOR/MISCELLANEOUS PAYMENT

 

ENROLLMENT FORM

 

This form is used for Automated Clearing House (ACH) payments with an addendum record that contains

 

payment-related information processed through the Vendor Express Program.

 

	
PRIVACY ACT STATEMENT

	
The following information is provided to comply with the Privacy Act of 1974 (P.L. 93-579).  All information collected on this form is required under the provisions of 31 U.S.C. 3322 and 31 CFR 210.  This information will be used by the Treasury Department to transmit payment data, by electronic means to vendor’s financial institution.  Failure to provide the requested information may delay or prevent the receipt of payments.

	
AGENCY INFORMATION

	
FEDERAL PROGRAM AGENCY

Centers for Disease Control & Prevention

	
AGENCY IDENTIFIER:

CDC

	
AGENCY LOCATION CODE (ALC):

7509-0421

	
ACH FORMAT:

 CCD+                       CTX            CTP

	
ADDRESS

P. O. Box 15580, MS D06

	
 

Atlanta, GA 30333

	
CONTACT PERSON:

Customer Service

	
TELEPHONE NUMBER:

(404) 718-8100

	
ADDITIONAL INFORMATION

FAX: (404) 638-5342

	
PAYEE/COMPANY INFORMATION

	
PAYEE/COMPANY NAME:

 

	
SSN or TAXPAYER ID NO.

 

	
ADDRESS:

 

	
DUNS+4 NUMBER

 

	
CITY

 

	
STATE

 

	
ZIP

 

	
CONTACT PERSON/NAME:

 

	
TELEPHONE NUMBER:

 

	
FINANCIAL INSTITUTION INFORMATION

	
FINANCIAL INSTITUTION NAME:

 

	
ADDRESS (OR BRANCH):

 

	
CITY:

 

	
STATE:

 

	
ZIP:

 

	
NINE-DIGIT ROUTING TRANSIT NUMBER:

       

	
DEPOSITOR ACCOUNT NUMBER:

 

	
TYPE OF ACCOUNT:

 CHECKING                                            SAVINGS

	
ACH COORDINATOR NAME OR AUTHORIZED OFFICIAL AT FINANCIAL INSTITUTION (NOT REQUIRED):

 

	
TELEPHONE NUMBER:

 

	
CDC 0.4433 (E), CDC Adobe Acrobat 9.0, S508 Electronic Version, January 2009

SMALL BUSINESS SUBCONTRACTING PLAN

 

	
DATE OF PLAN: _____________

	
CONTRACTOR:                                                                                                                                       

	
ADDRESS:                         

  

	
DUN & BRADSTREET NUMBER:                                                                                                                                        

	
SOLICITATION OR CONTRACT NUMBER:                                                                                                                                        

	
ITEM/SERVICE (Description):                                                                                                                                        

 

	
TOTAL CONTRACT AMOUNT:$_______________________________

Total contract or Base-Year, if options

$_____________                                $_________________                                     $______________                                   $_____________

Option #1                              Option #2                                     Option #3                                   Option #4

(if applicable)                              (if applicable)                                     (if applicable)                                   (if applicable)

 

	
TOTAL MODIFICATION AMOUNT, IF APPLICABLE $                                                                                                                                        

	
TOTAL TASK ORDER AMOUNT, IF APPLICABLE     $                                                                                                                                        

	
PERIOD OF CONTRACT PERFORMANCE (Month, Day & Year):                                                                                                                                        

The following outline meets the minimum requirements of section 8(d) of the Small Business Act, as amended, and implemented by Federal Acquisition Regulations (FAR) Subpart 19.7.  While this outline has been designed to be consistent with statutory and regulatory requirements, other formats of a subcontracting plan may be acceptable.  It is not intended to replace any existing corporate plan that is more extensive.  Failure to include the essential information of FAR Subpart 19.7 may be cause for either a delay in acceptance or the rejection of a bid or offer when a subcontracting plan is required.  “SUBCONTRACT,” as used in this clause, means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime contractor or subcontractor calling for supplies or services required for performance of the contract or subcontract.

 

If assistance is needed to locate small business sources, contact the Office of Small and Disadvantaged Business Utilization (OSDBU) at 202.690.7300 or the OPDIV Small Business Specialist at _____________.  Sources may also be obtained from the Central Contractor Registration’s (CCR) web site at http://www.ccr.gov.

 

For this procurement, HHS expects all proposed subcontracting plans to contain the following goals at a minimum:  34% for Small Business; 6.4% for Small Disadvantaged Business; 5.0% for Women-Owned Small Business; 3.0% for HUBZone Small Business; and 3.0% for Veteran-Owned Small Business and Service-Disabled Veteran-Owned Small Business.  These goals shall be expressed as percentages of the total estimated subcontracting dollars.  The offeror is required to include an explanation for a category that has zero as a goal.

 

NOTE TO CONTRACTORS:  Please provide your CCR number with your Dunn & Bradstreet number.

 

1.           Type of Plan (check one)

 

	
  

	
[  ]

	
Individual plan (all elements developed specifically for this contract and applicable for the full term of this contract).

 

	
  

	
[  ]

	
Master plan (goals developed for this contract) all other elements standardized and approved by a lead agency Federal Official; must be renewed every three years and contractor must provide copy of lead agency approval.

 

	
  

	
[  ]

	
Commercial products/service plan This plan is used when the contract sells products and services customarily used for non-government purposes.  Plan/goals are negotiated with the initial agency on a company-wide basis rather than for individual contracts.  The plan is effective only during the year approved.  The contractor must provide a copy of the initial agency approval, and must submit an annual SF-295 to HHS with a breakout of subcontracting prorated for HHS (with an OPDIV breakdown, if possible).

 

2.           Goals

 

State separate dollar and percentage goals for Small Business (SB), Small Disadvantaged Business (SDB), Woman-owned Small Business (WOSB), Historically Underutilized Business Zone (HUBZone) Small Business, Veteran-owned Small Business (VOSB), Service-Disabled Veteran-owned Small Business (SDVOSB) and “Other than small business” (Other) as subcontractors, for the base year and each option year, as specified in FAR 19.704.  (Break out and append option year goals, if the contract contains option years or project annual subcontracting base and goals under commercial plans.)

 

	
  

	
a.

	
Total estimated dollar value of ALL planned subcontracting, i.e., with ALL types of concerns under this contract is $_______________________ (b + h = a) (Base Year)

 

	
FY-_____(1st Option)

$________&_____%

	
FY-_____(2nd Option)

$________&_____%

	
FY-_____(3rd Option)

$________&_____%

	
FY-_____(4th Option)

$________&_____%)

	
  

	
b.

	
Total estimated dollar value and percent of planned subcontracting with SMALL BUSINESSES (including SDB, WOSB, HUBZone, VOSB, and SDVOSB):

 

	
  

	
(% of “a”)  $____________ and _____% (Base Year)

 

	
FY-_____(1st Option)

$________&_____%

	
FY-_____(2nd Option)

$________&_____%

	
FY-_____(3rd Option)

$________&_____%

	
FY-_____(4th Option)

$________&_____%)

	
  

	
c.

	
Total estimated dollar and percent of planned subcontracting with SMALL DISADVANTAGED BUSINESSES:  (% of “a”)  $____________ and _____% (Base Year)

 

	
FY-_____(1st Option)

$________&_____%

	
FY-_____(2nd Option)

$________&_____%

	
FY-_____(3rd Option)

$________&_____%

	
FY-_____(4th Option)

$________&_____%)

	
  

	
d.

	
Total estimated dollar and percent of planned subcontracting with WOMEN-OWNED SMALL BUSINESSES: (% of “a”)  $____________ and _____% (Base Year)

 

	
FY-_____(1st Option)

$________&_____%

	
FY-_____(2nd Option)

$________&_____%

	
FY-_____(3rd Option)

$________&_____%

	
FY-_____(4th Option)

$________&_____%)

	
  

	
e.

	
Total estimated dollar and percent of planned subcontracting with HUBZone SMALL BUSINESSES:

 

	
  

	
(% of “a”)  $____________ and _____% (Base Year)

 

	
FY-_____(1st Option)

$________&_____%

	
FY-_____(2nd Option)

$________&_____%

	
FY-_____(3rd Option)

$________&_____%

	
FY-_____(4th Option)

$________&_____%)

	
  

	
f.

	
Total estimated dollar and percent of planned subcontracting with VETERAN SMALL BUSINESSES:

 

	
  

	
(% of “a”)  $____________ and _____% (Base Year)

 

	
FY-_____(1st Option)

$________&_____%

	
FY-_____(2nd Option)

$________&_____%

	
FY-_____(3rd Option)

$________&_____%

	
FY-_____(4th Option)

$________&_____%)

	
  

	
g.

	
Total estimated dollar and percent of planned subcontracting with SERVICE-DISABLED VETERAN  SMALL BUSINESSES:

 

	
  

	
(% of “a”)  $____________ and _____% (Base Year)

 

	
FY-_____(1st Option)

$________&_____%

	
FY-_____(2nd Option)

$________&_____%

	
FY-_____(3rd Option)

$________&_____%

	
FY-_____(4th Option)

$________&_____%)

	
  

	
h.

	
Total estimated dollar and percent of planned subcontracting with “OTHER THAN SMALL BUSINESSES”:

 

	
  

	
(% of “a”)  $____________ and _____% (Base Year)

 

	
FY-_____(1st Option)

$________&_____%

	
FY-_____(2nd Option)

$________&_____%

	
FY-_____(3rd Option)

$________&_____%

	
FY-_____(4th Option)

$________&_____%)

Notes:

 

	
  

	
1.

	
Federal Prime contract goals

 

	
  

	
SB equals 30.32%; SDB equals 11.12%; HUBZone equals 3.03%, WOSB equals 5.05% and SDVOSB equals 3%, VOSB equals 3% and can serve as objectives for subcontracting goal development.

 

	
  

	
2.

	
SDB, WOSB, HUBZone, SDVOSB and VOSB goals are subsets of SB and should be counted and reported in multiple categories, as appropriate.

 

	
  

	
3.

	
If any contract has more than four options, please attach additional sheets showing dollar amounts and percentages.

 

	
  

	
i.

	
Provide a description of ALL the products and/or services to be subcontracted under this contract, and indicate the size and type of business supplying them (check all that apply).

 

	
Product/Service

	
Other

	
SB

	
SDB

	
WOSB

	
HUBZoneSB

	
VOSB

	
SDVOSB

	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  

	
  

	
j.

	
Provide a description of the method used to develop the subcontracting goals for SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB concerns.  Address efforts made to ensure that maximum practicable subcontracting opportunities have been made available for those concerns and explain the method used to identify potential sources for solicitation purposes.  Explain the method and state the quantitative basis (in dollars) used to establish the percentage goals.  Also, explain how the areas to be subcontracted to SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB concerns were determined, how the capabilities of these concerns were considered for subcontract opportunities and how such data comports with the cost proposal.  Identify any source lists or other resources used in the determination process.  (Attach additional sheets, if necessary.)

 

	
  

	
k.

	
Indirect costs have [   ] have not [   ] been included in the dollar and percentage subcontracting goals above (check one).

 

	
  

	
l.

	
If indirect costs have been included, explain the method used to determine the proportionate share of such costs to be allocated as subcontracts to SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB concerns.

 

3.           Program Administrator:

 

NAME/TITLE:

 

ADDRESS:

 

TELEPHONE/E-MAIL:

 

Duties:  Does the individual named above have general overall responsibility for the company’s subcontracting program, i.e., developing, preparing, and executing subcontracting plans and monitoring performance relative to the requirements of those subcontracting plans and perform the following duties:

 

[   ] yes [   ] no                                                                                                                                 

 

(If NO is checked, please indicate who in the company performs those duties, or indicate why the duties are not performed in your company.)

 

	
  

	
a.

	
Develops and promotes company-wide policy initiatives that demonstrate the company’s support for awarding contracts and subcontracts to SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB concerns; and assures that these concerns are included on the source lists for solicitations for products and services they are capable of providing; [   ] yes [   ] no

 

	
  

	
b.

	
Develops and maintains bidder source lists of SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB concerns from all possible sources; [   ] yes [   ] no

 

	
  

	
c.

	
Ensures periodic rotation of potential subcontractors on bidder’s lists; [   ] yes [   ] no

 

	
  

	
d.

	
Ensures that SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB businesses are included on the bidders’ list for every subcontract solicitation for products and services that they are capable of providing; [   ] yes [   ] no

 

	
  

	
e.

	
Ensures that Requests for Proposals (RFPs) are designed to permit the maximum practicable participation of SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB concerns; [   ] yes [   ] no

 

	
  

	
f.

	
Reviews subcontract solicitations to remove statements, clauses, etc., which might tend to restrict or prohibit SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB participation; [   ] yes [   ] no

 

	
  

	
g.

	
Accesses various sources for the identification of SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB concerns to include the Central Contractor Registration’s (CCR) web site at (http://www.ccr.gov), the National Minority Purchasing Council Vendor Information Service, the Office of Minority Business Data Center in the Department of Commerce, local small business and minority associations, contact with local chambers of commerce and Federal agencies’ Small Business Offices; [   ] yes [   ] no

 

	
  

	
h.

	
Establishes and maintains contract and subcontract award records; [   ] yes [   ] no

 

	
  

	
i.

	
Participates in Business Opportunity Workshops, Minority Business Enterprise Seminars, Trade Fairs, Procurement Conferences, etc; [   ] yes [   ] no

 

	
  

	
j.

	
Ensures that SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB concerns are made aware of subcontracting opportunities and assisting concerns in preparing responsive bids to the company; [   ] yes [   ] no

 

	
  

	
k.

	
Conducts or arranges for the conduct of training for purchasing personnel regarding the intent and impact of Section 8(d) of the Small Business Act, as amended; [   ] yes [   ] no

 

	
  

	
l.

	
Monitors the company’s subcontracting program performance and makes any adjustments necessary to achieve the subcontract plan goals; [   ] yes [   ] no

 

	
  

	
m.

	
Prepares and submits timely, required subcontract reports; [   ] yes [   ] no

 

	
  

	
n.

	
Coordinates the company’s activities during the conduct of compliance reviews by Federal agencies; [   ] yes [   ] no; and

 

	
  

	
o.

	
Other duties:

	 

 

4.           Equitable Opportunity

 

Describe efforts the offeror will make to ensure that SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB concerns will have an equitable opportunity to compete for subcontracts.  These efforts include, but are not limited to, the following activities:

 

	
  

	
a.

	
Outreach efforts to obtain sources:

 

	
  

	
1.

	
Contacting minority and small business trade associations; 2) contacting business development organizations and local chambers of commerce; 3) attending SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB procurement conferences and trade fairs; 4) requesting sources from the Central Contractor Registration’s (CCR) web site at (hhtp://www.ccr.gov) and other SBA and Federal agency resources.  Contractors may also conduct market surveys to identify new sources, to include, assessing the NIH e-Portals in Commerce, (e-PIC), (http://epic.od.nih.gov/).  The NIH e-Portals in Commerce is not a mandatory source and may be used at the offeror’s discretion.

 

	
  

	
b.

	
Internal efforts to guide and encourage purchasing personnel:

 

	
  

	
1.

	
Conducting workshops, seminars, and training programs;

 

	
  

	
2.

	
Establishing, maintaining, and utilizing SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB source lists, guides, and other data for soliciting subcontractors; and

 

	
  

	
3.

	
Monitoring activities to evaluate compliance with the subcontracting plan.

 

	
  

	
c.

	
Additional efforts:

 

5.           Flow Down Clause

 

The contractor agrees to include the provisions under FAR 52.219-8, “Utilization of Small Business Concerns,” in all acquisitions exceeding the simplified acquisition threshold that offers further subcontracting opportunities.  All subcontractors, except small business concerns, that receive subcontracts in excess of $500,000 ($1,000,000 for construction) must adopt and comply with a plan similar to the plan required by FAR 52.219-9, “Small Business Subcontracting Plan.”  (Flow down is not applicable for commercial items/services as described in 52.212-5(e) and 52.244-6(c).)

 

6.           Reporting and Cooperation

 

The contractor gives assurance of (1) cooperation in any studies or surveys that may be required; (2) submission of periodic reports which show compliance with the subcontracting plan; (3) submission of Standard Form (SF) 294, “Subcontracting Report for Individual Contracts,” and attendant Optional Form 312, SDB Participation Report, if applicable, (required only for contracts containing the clause 52.219-25) and SF 295, “Summary Subcontract Report,” in accordance with the instructions on the forms; and (4) ensuring that subcontractors agree to submit Standard Forms 294 and 295.

 

	
Reporting Period

	
Report Due

	
Due Date

	
Oct 1 – Mar 3

	
SF-294

	
4/30

	
Apr 1 – Sept 30

	
SF-294

	
10/30

	
Oct 1 – Sept 30

	
SF-295

	
10/30

	
Contract Completion

	
OF-312

	
30 days after completion

Special instructions for commercial plan:  SF-295 Report is due on 10/30 each year for the previous fiscal year ending 9/30.

 

	
  

	
a.

	
Submit SF-294 to cognizant Awarding Contracting Officer.

 

	
  

	
b.

	
Submit Optional Form 312, (OF-312), if applicable, to cognizant Awarding Contracting Officer.

 

	
  

	
c.

	
Submit SF-295 to cognizant Awarding Contracting Officer and to the:

 

Office of Small and Disadvantaged Business Utilization

 

Department of Health and Human Services

 

200 Independence Avenue, SW

 

Humphrey H. Building, Room 517-D

 

Washington, D.C. 20201

 

	
  

	
d.

	
Submit “information” copy of the SF-295 and the SF-294 upon request to the SBA Commercial Market Representative (CMR); visit the SBA at http://www.sba.gov/gc and click on assistance directory to locate your nearest CMR.

 

7.           Record keeping

 

In accordance with FAR 19.704(a)(11), the following is a recitation of the types of records the contractor will maintain to demonstrate the procedures adopted to comply with the requirements and goals in the subcontracting plan.  These records will include, but not be limited to, the following:

 

	
  

	
a.

	
SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB source lists, guides and other data identifying such vendors;

 

	
  

	
b.

	
Organizations contacted in an attempt to locate SB, SDB, WOSB, HUBZone, VOSB, and SDVOSB sources;

 

	
  

	
c.

	
On a contract-by-contract basis, records on all subcontract solicitations over $100,000, which indicate for each solicitation (1) whether SB, SDB, WOSB, HUBZone, VOSB, and/or SDVOSB concerns were solicited, if not, why not and the reasons solicited concerns did not receive subcontract awards.

 

	
  

	
d.

	
Records to support other outreach efforts, e.g., contacts with minority and small business trade associations, attendance at small and minority business procurement conferences and trade fairs;

 

	
  

	
e.

	
Records to support internal guidance and encouragement provided to buyers through (1) workshops, seminars, training programs, incentive awards; and (2) monitoring performance to evaluate compliance with the program and requirements; and

 

	
  

	
f.

	
On a contract-by-contract basis, records to support subcontract award data including the name, address, and business type and size of each subcontractor.  (This item is not required on a contract-by-contract basis for company or division-wide commercial plans.)

 

	
  

	
g.

	
Other records to support your compliance with the subcontracting plan:  (Please describe)

 

 

8.           Timely Payments to Subcontractors

 

FAR 19.702 requires your company to establish and use procedures to ensure the timely payment of amounts due pursuant to the terms of your subcontracts with small business concerns, small disadvantaged small business concerns, women-owned small business concerns, HUBZone small business concerns, veteran-owned small business concerns, and service-disabled veteran-owned small business concerns.

 

9.           Description of Good Faith Effort

 

Maximum practicable utilization of small, small disadvantaged, women-owned, HUBZone, veteran-owned, and service-disabled veteran-owned small business concerns as subcontractors in Government contracts is a matter of national interest with both social and economic benefits.  When a contractor fails to make a good faith effort to comply with a subcontracting plan, these objectives are not achieved, and 15 U.S.C. 637(d)(4)(F) directs that liquidated damages shall be paid by the contractor.  In order to demonstrate your compliance with a good faith effort to achieve the small, small disadvantaged, women-owned, HUBZone, veteran-owned, and service-disabled veteran-owned small business subcontracting goals, outline the steps your company plans to take.  These steps will be negotiated with the contracting officer prior to approval of the plan.

 

SIGNATURE PAGE

Signatures Required:

This subcontracting plan was submitted by:

Signature:                              

Typed Name:                              

Title:                              

Date:                              

This plan was reviewed by:

Signature:                              

Typed Name:                              

Title:                              

Date:                              

This plan was reviewed by:

Signature:                              

Typed Name:                              

Title:                              

Date:                              

This plan was reviewed by:

Signature:                              

Typed Name:                              

Title:                              

Date:                              

And is Accepted By:

Signature:                              

Typed Name:                              

Title:                              

Date:exhibit10-5.htm

Exhibit 10.5

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Asterisks denote omissions.

CONSULTING AGREEMENT

This Consulting Agreement (“Agreement”), effective as of September 6, 2011 (“Effective Date”), is made by and between Emergent BioSolutions Inc. (“Emergent”), with a principal office at 2273 Research Blvd. Suite 400 Rockville, MD 20850, and Robert Kramer (“Consultant”), with a principal office at 6872 Oleander Lane Portage, MI 49024.  Emergent and Consultant are hereinafter referred to individually as “Party” or collectively as the “Parties”.  The Parties hereby agree as follows:

1. Services; Work Orders.  Consultant agrees to perform certain services (“Services”) for Emergent as mutually agreed from time to time in a fully-executed statement of work (each, a “Work Order”). The initial Work Order is attached hereto as Exhibit A.  Each Work Order shall identify the Services to be performed, the person(s) providing Services, applicable milestones and deliverables, and the fees and total maximum compensation.  If Consultant is requested or required to perform work beyond the Services necessarily contemplated by or specifically set forth in an applicable Work Order, any such additional work and an appropriate adjustment to amounts payable shall be negotiated in good faith and mutually agreed upon in writing prior to the performance thereof.  If any Affiliate of Emergent enters into a Work Order with Consultant, for purposes of such Work Order and this Agreement “Emergent” shall mean and refer to such Affiliate, and “Parties” shall mean and refer to such Affiliate and Consultant.  “Affiliate” shall mean any direct or indirect, current or future subsidiary of a Party, or any other entity controlled by, under common control with, or which controls such Party.  “Control” shall mean direct or indirect possession of at least fifty percent (50%) of another entity’s voting equity (or other comparable interest for a non-corporation), or the power to direct or cause the direction of the management or policies of such entity whether through ownership of securities, by contract or otherwise.  Unless otherwise explicitly noted in a Work Order, this Agreement supersedes any provision of any Work Order or other document that is inconsistent with this Agreement.

2. Federally-funded Services.  In the event that Emergent uses a Federal grant or contract as the source of funding for any Services, Emergent shall notify Consultant and may require, as a condition of such grant or contract and for continued eligibility for such federal funding, that the Parties comply with additional contract provisions, including certain clauses of the Federal Acquisitions Regulation, agency supplements, policy directives or other terms and conditions (“Flowdown Provisions”).  Emergent shall have the right to include applicable Flowdown Provisions in the relevant Work Order, and Consultant shall comply with such Flowdown Provisions.  If Flowdown Provisions require Emergent to submit detailed and certified cost or pricing data for Consultant’s performance of Services, Consultant shall promptly provide and certify such non-proprietary data as is reasonably required to permit Emergent to comply with the Flowdown Provisions.  Consultant shall also provide any other cost or pricing data as is required for Consultant to comply with the Flowdown Provisions.  Notwithstanding any indemnification provision(s) of this Agreement to the contrary, unless otherwise specified in the applicable Work Order, Consultant shall indemnify and hold harmless Emergent for any cost or price reduction effected by the Federal Government, to the extent caused by (a) certified cost or pricing data submitted by Consultant or its permitted subcontractors that is not accurate, current or complete as certified by Consultant, or (b) the failure of Consultant or its permitted subcontractors to disclose and consistently follow applicable cost accounting practices and standards or otherwise comply with the Flowdown Provisions (including any regulations promulgated by the Cost Accounting Standards Board).

3. Performance Standards.  Services shall be provided in accordance with the terms of this Agreement, specific requirements of the Work Order, and best industry standards applicable thereto.  Consultant shall (a) provide the facilities and supplies necessary to perform Services unless otherwise specified in an applicable Work Order, (b) report to the authorized contact(s) identified in the applicable Work Order or such other person(s) as Emergent or its Affiliates may designate from time to time in writing, (c) provide Emergent with deliverables and reports described in the applicable Work Order or such other reports as Emergent or its Affiliates may from time to time request, and (d) not subcontract with or otherwise engage or consult any third party to provide Services or any part thereof without Emergent’s prior written consent.

4. Payment.  Emergent shall compensate Consultant for Services rendered based on invoices submitted by Consultant under the applicable Work Order and in accordance with the terms of this Agreement.  All invoices shall reference the Emergent Accounting Codes designated in the applicable Work Order.  Invoices shall be payable within twenty (20) days of receipt by Emergent.  To protect against the possibility that the internal Revenue Service may deem Consultant’s relationship with Emergent to be that of an “employee,” Emergent will withhold and timely remit on behalf of Consultant federal and state income taxes at the applicable statutory rates. Consultant acknowledges that notwithstanding the withholding of taxes, Consultant is and remains an independent service provider. Consultant shall be fully responsible for payment of any other taxes or payment which may be due and owing by Consultant as the result of fees or amounts paid to it by Emergent under this Agreement, and Consultant shall indemnify and hold harmless Emergent from and against any such tax or payment. Payment of an invoice, net of applicable income taxes, shall be in full compensation for the corresponding Services performed unless expressly otherwise agreed in writing by the Parties.  Consultant shall not receive employee benefits (such as paid vacation, sick leave or any insurance benefits) from Emergent even if Consultant is physically situated at Emergent’s offices.

5. Expenses.  Emergent shall pay for or reimburse Consultant for out-of-pocket expenses reasonably incurred in the performance of Services in addition to the compensation detailed in the applicable Work Order.  Consultant shall submit monthly invoices detailing expenses incurred during the immediately preceding month by appropriate category and shall provide supporting documentation as is acceptable to Emergent in its reasonable discretion.  Expenses shall not be marked up.  All travel must be in accordance with the Emergent Corporate Travel, Food and Lodging Policy, a copy of which will be provided separately to Consultant.  This Agreement relates to the provision of Services only. In the event Consultant deems it necessary to purchase equipment, goods, software or other tangible or intangible property for which it will seek reimbursement from Emergent, no such purchase shall be made and Emergent shall not be responsible for reimbursement to Consultant unless Consultant has received Emergent’s express, prior written authorization.

6. Confidential Information.  Consultant acknowledges that this Agreement creates a confidential relationship between the Parties, and that, in order to perform the Services, Consultant or its members, principals, directors, shareholders, officers, employees, agents, affiliates and advisors (collectively, “Representatives”) may need to have access to certain commercially valuable, proprietary, and non-public information that Emergent considers to be Confidential Information.  “Confidential Information” means any and all written, oral, electronic, graphic or other information relating directly or indirectly to Emergent or the business, products, markets, customers, suppliers, condition (financial or otherwise), operations, assets, liabilities, results of operations, cash flows or prospects of Emergent that is delivered, disclosed or furnished by or on behalf of Emergent to Consultant or its Representatives, whether before, on or after the Effective Date hereof, or which Consultant or its Representatives otherwise learns or obtains, through observation or through analysis of such information, and shall also be deemed to include all notes, analyses, compilations, studies, forecasts, interpretations or other documents prepared by Consultant or its Representatives to the extent such material contains, reflects or is directly based upon, in whole or in part, such information.  Confidential Information may include, without limitation, technical information, business plans, identification or characterization of biological or other materials, results and/or design of experiments or preclinical or clinical testing, know-how, trade secrets, methods, methodologies, designs, specifications, clinical protocols, data, inventions, improvements, intellectual properties, devices, processes, procedures, financial analysis, accounting policies and procedures, employee staffing, employee compensation and benefits, manuals and marketing and advertising strategies disclosed directly or indirectly by Emergent to Consultant (whether prepared by Emergent, its advisors or otherwise). The existence, terms and conditions of this Agreement shall also be considered Confidential Information. Consultant agrees to keep confidential and not, without the prior written consent of Emergent, publish, disclose to any third party or use (except for purposes of performance under this Agreement) any Confidential Information. The obligations of this paragraph do not pertain to information which is generally known or hereafter becomes generally known to the public through no fault of Consultant or which is disclosed by Consultant with the written approval of Emergent.  Consultant shall return all Confidential Information to Emergent upon completion of the corresponding Services hereunder or upon Emergent’s request.  Consultant shall be entitled to disclose Confidential Information as required by applicable law, regulation or court order only to the extent necessary to comply therewith; provided, however, Consultant shall, if reasonably practicable, provide Emergent an opportunity to seek to prevent disclosure of, or to obtain a protective order for, such Confidential Information by giving advance written notice of such required disclosure; provided further, that Consultant shall make such required disclosures in consultation with Emergent and shall cooperate with Emergent in connection with efforts to obtain any protective order or other remedy.

7. Ownership of Work. Consultant shall promptly disclose to Emergent in writing all data, information, documents, materials and inventions relating to or arising out of Services, and agrees that all right, title, and interest in and to the foregoing shall belong to and be the property of Emergent.  Consultant hereby assigns all its rights in the foregoing to Emergent and agrees, without further payment by Emergent, to make any further assignments and execute all documents necessary to effect Emergent's title thereto in all countries of the world.  All documents and materials prepared by Consultant in the performance of Services constitute works-for-hire and shall belong to and be the exclusive property of Emergent, and shall be surrendered by Consultant to Emergent upon request.

8. Independent Contractor.  With respect to the subject matter hereof, the Parties are and remain independent contractors.  This Agreement shall not be deemed to create an employer/employee relationship, joint venture, partnership, association, or agency between the Parties.  Consultant is not authorized to incur or create any obligation (express or implied) on behalf of Emergent or to bind Emergent in any manner whatsoever.

9. Term; Termination.  This Agreement is effective as of the Effective Date and shall continue in effect for 18 months thereafter or until the Agreement otherwise terminates under this Section (“Term”); provided, however, that in the event that any Work Order or amendment thereto is then pending, the Term shall be automatically extended until the Services to be provided thereunder are completed.  This Agreement (or any Work Order, as applicable) shall terminate upon the expiration of the Term or the first to occur of (a) the date Emergent provides Consultant with written notice (setting out with particularity) that this Agreement is being terminated for “cause” where Consultant:  (i) commits any act of embezzlement, theft or fraud against Emergent; (ii) is convicted of a felony or any crime involving moral turpitude, whether or not related to Services; (iii) commits any act of gross negligence or willful misconduct; or (iv) breaches the representations, warranties or covenants contained in this Agreement; or (b) the date either Party terminates the Agreement for convenience on not less than thirty (30) days’ prior written notice.  Upon termination of this Agreement, Emergent shall have no further liability other than for payment in accordance with the terms of this Agreement for Services provided prior to the termination date.  If this Agreement is terminated by Emergent under the foregoing subsection (a)(iv), in the event that Consultant materially breaches the representations, warranties or covenants contained in Sections 10(a), 10(d), and 11, in  addition to any other rights or remedies available at law or in equity, Consultant will surrender any claim for payment under the Agreement and will refund any payments received under this Agreement.  The provisions of Sections 4 – 7, 9, 11 – 15, 16 (only for the applicable period following termination or expiration) and 17 shall survive the expiration or termination of this Agreement for any reason.

10. Representations and Warranties. In addition to any other representations and warranties set forth in this Agreement, Consultant represents and warrants that Consultant:  (a) will perform Services in a competent, diligent and workmanlike manner consistent with the expected industry standards of professional conduct; (b) has not ever been debarred, and any Consultant representative who provides any portion of the Services has not been debarred, pursuant to the United States Food, Drug and Cosmetic Act, or been excluded from any federal health care program (including Medicare or Medicaid), and Consultant will notify Emergent immediately if any of the foregoing occurs; (c) will perform Services for Emergent and has been advised of the restrictions and obligations set forth in this Agreement, including without limitation, the requirements of confidentiality, compliance with laws and non-solicitation; (d) has full power to enter into and fully perform this Agreement and has the full and unrestricted right to disclose to Emergent any information Consultant makes available to Emergent under this Agreement; and (e) in the event Consultant is employed by a third party, Consultant has verified that the Services do not present a conflict with Consultant’s primary employment and that Consultant has the right and authority to enter into this Agreement and to comply with the requirements of Section 7 (Ownership of Work).

11. Compliance with Laws.  Consultant shall perform its duties and responsibilities hereunder in accordance with the highest standards of ethical business conduct and not engage in any acts or activities that are illegal or that may adversely affect or reflect upon the business, integrity or goodwill of Emergent.  Consultant shall take no action that it believes might cause (or be construed as causing) Emergent to be in violation of international, federal, state or local laws or regulations, or Emergent’s policies and procedures.  Consultant further agrees, to the extent applicable to performance of the Services, to abide by the Emergent BioSolutions Code of Conduct and Business Ethics policy as posted from time to time on the company’s website.  Without limiting the generality of the foregoing, Consultant represents, warrants and agrees that Consultant will: (a) comply with all applicable laws, rules and regulations, including those governing employment practices (including employee recruiting and hiring), anti-bribery, anti-corruption and anti-gratuities laws or other similar laws; (b) comply with Emergent stated policies and procedures generally applicable to parties operating at Emergent’s offices, including those governing safety, health, harassment, and discrimination; (c) prohibit its staff or any representatives from involvement with the payment or giving of anything of value, either directly or indirectly, to an official of any government, political party or official thereof, any candidate for foreign political office, or any official of an international organization, for the purpose of influencing an act or decision in its official capacity, or inducing that official to use influence with any government, to assist Emergent in obtaining or retaining business for or with, or directing business to, any person, or for obtaining an improper advantage; and (d) certify in writing, at such times as may be requested by Emergent, that Consultant and its Representatives understand, have complied with and are in compliance with the foregoing.  Consultant will immediately advise Emergent if Consultant should learn of or have reason to believe that there has been a violation of any of the foregoing undertakings.

12. Export Control Restrictions.  Each Party acknowledges that, in the course of exchanging Confidential Information, it may desire to have access to certain information about the production and/or development of materials that is subject to export controls by the U.S. Department of Commerce and requires a specific license from that agency before such technology can be transferred outside the United States or disclosed in the United States to nationals of other countries (unless such individuals have been granted U.S. citizenship, permanent residence, or asylee status) (“Controlled Technology”).  Each Party agrees that Controlled Technology will not be transferred or “released” (as that term is defined in Title 15 CFR Sect. 734.2(b)(3)) to the other Party unless and until the disclosing Party notifies the prospective receiving Party that such information constitutes Controlled Technology and the prospective receiving Party agrees in writing to receive such Controlled Technology, and that any such ultimate disclosure or “release” shall be provided under a license or as may be otherwise authorized by the laws of the United States.

13. Indemnification.  Consultant shall hold harmless and indemnify Emergent, its employees, agents and representatives, from and against any and all suits, demands, losses, damages, judgments, claims, costs (including reasonable attorneys’ fees and costs) or other liabilities (including claims for personal injury or death) to the extent arising from or relating to the performance of Services under this Agreement, or the negligence, acts or omissions of Consultant or any of Consultant’s Representatives.

14. Dispute Resolution.  All disputes or claims arising hereunder that cannot be resolved by the Parties shall be submitted to non-binding mediation for a period of thirty (30) days, which may be extended by written agreement of the Parties.  If such dispute is not resolved through mediation or otherwise within the specified period, either Party may pursue remedies available to it at law or in equity, subject to the terms of this Agreement.

15. Non-Solicitation.  Consultant agrees that, during the Term and for a period of twelve (12) consecutive months after termination of the Agreement, Consultant will not knowingly (i) directly induce or attempt to induce or otherwise counsel, advise, solicit or encourage any employee to leave the employ of Emergent or accept employment with Consultant or any other person or entity, except for employees of Emergent that are being managed out an employment relationship with Emergent with the assistance of human resources, (ii) directly induce or attempt to induce or otherwise counsel, advise, solicit or encourage any person who at the time of such inducement, counseling, advice, solicitation or encouragement had left the employ of Emergent within the previous six (6) months to accept employment with any person or entity besides Emergent, except for employees of Emergent that are being managed out an employment relationship with Emergent with the assistance of human resources, or (iii) solicit, interfere with, or endeavor to cause any customer, client, or business partner of Emergent to cease or reduce its relationship with Emergent or induce or attempt to induce any such customer, client, or business partner to breach any agreement that such customer, client, or business partner may have with Emergent.

16. Restriction on Insider Trading.  Emergent BioSolutions Inc. is a publicly traded company on the New York Stock Exchange.  Consultant acknowledges the existence of laws and regulations prohibiting “insider trading,” including the purchase or sale of securities of a company while in the possession of material information that has not been generally disclosed in the marketplace.  Consultant acknowledges and agrees that it may have access to certain material nonpublic information of Emergent BioSolutions Inc. or its Affiliates as a result of the Services, and covenants and agrees that it will not engage in insider trading or disclose such information to any third parties.

17. Force Majeure.  Neither Party shall be liable for delay or failure in the performance of any of its obligations under this Agreement if and to the extent such delay or failure is due to circumstances beyond the reasonable control of such Party, including but not limited to fires, floods, explosions, accidents, acts of God, war, riot, strike, lockout or other concerted acts of workers, acts of government and shortages of materials. The Party claiming force majeure shall use its commercially reasonable efforts to eliminate or prevent the cause so as to continue performing its obligations under this Agreement.  During such time that the event of force majeure causes such a delay or failure of performance, this Agreement and the Parties’ obligations and responsibilities under it shall be deemed suspended until the event of force majeure ceases.

18. Miscellaneous Provisions.

(a) Non-Waiver.  No delay by or omission of any Party in exercising any right, power, privilege, or remedy shall impair such right, power, privilege, or remedy or be construed as a waiver thereof.

(b) Remedies.  The rights and remedies provided in this Agreement are cumulative and are not exclusive of other rights or remedies provided by law.

 

(c) Notices.  Any notice hereunder shall be given by first class mail, express mail, or facsimile (followed by confirmation), addressed to the Parties at the addresses given in the preamble of this Agreement, or to such other address as a Party may later designate in writing to the other Party.  Notice of any legal action, claim or other legal matter given by Consultant to Emergent shall be directed to Emergent’s General Counsel at 2273 Research Boulevard, Rockville, Maryland, USA 20850.

(d) Use of Name.  Neither Party shall use the name, tradename or trademark of the other Party in a press release, advertising, publicity or promotional activity without the prior written consent of the other Party.

(e) Severability.  In the event that any section or any part of a section of this Agreement should be declared void, invalid, or unenforceable by any court of law, for any reason, such a determination shall not render void, invalid, or unenforceable any other section or any part of any other section of this Agreement and the remainder of this Agreement shall remain in full force and effect.

(f) Headings.  Headings and titles of parts and sections are for convenience only and have no interpretative significance.

(g) Assignability.  This Agreement may not be assigned by Consultant without Emergent’s prior, express written consent.  Emergent may, without Consultant’s written consent, assign and transfer this Agreement to any Affiliate, in which event Consultant agrees to continue to perform the duties and obligations according to the terms hereof to or for such assignee or transferee of this Agreement.

(h) Amendments.  No modification or amendment to this Agreement or any Work Order shall be effected by or result from the receipt, acceptance, signing or acknowledgement of any purchase order, quotation, invoice, shipping document or other business form containing terms or conditions different from those set forth in this Agreement or any Work Order, and all such additional terms and conditions are hereby specifically rejected by both Parties.

(i) Governing Law and Jurisdiction.  This Agreement and its interpretation shall be governed by the laws of Maryland without reference to its conflict of law or choice of law provisions.  Any action commenced by a Party to enforce the terms of this Agreement must be brought in the courts of the jurisdiction where the Services were primarily delivered hereunder, and the Parties hereby irrevocably consent to the jurisdiction and venue of such courts to enforce the terms of this Agreement.  The Parties expressly waive any right that they have or may have to a jury trial of any dispute arising out of or in any way related to this Agreement, or any breach thereof.

(j) Integration; Counterparts; Signatures.  This Agreement and any Work Orders (including any corresponding Exhibits), constitute the entire agreement of the Parties, supersede all prior discussions, negotiations and understandings verbal and written, if any, and may only be amended or modified by a written agreement signed by both Parties.  In the event of a conflict between the terms of this Agreement and the terms of any Work Order, Exhibit or attachment hereto, proposal, quotation or any Consultant documentation, the terms of this Agreement shall prevail.  This Agreement may be signed in multiple identical copies, each of which shall be deemed to be an original copy, and each facsimile or electronic copy shall constitute a legally binding, enforceable document.  Electronic signatures shall not be an acceptable means of execution unless both Parties have agreed in writing to the format and standard of such signature.

(k) Advice of Counsel.  EACH PARTY ACKNOWLEDGES THAT, IN EXECUTING THIS AGREEMENT, SUCH PARTY HAS HAD THE OPPORTUNITY TO SEEK THE ADVICE OF INDEPENDENT LEGAL COUNSEL, AND HAS READ AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT. THIS AGREEMENT SHALL NOT BE CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION HEREOF.

  

  

  

IN WITNESS WHEREOF, Emergent and Consultant have executed this Agreement to be effective as of the Effective Date.

Emergent BioSolutions Inc.                                                                                                Robert Kramer

By: /s/ Daniel J. Abdun-Nabi                                                                /s/ Robert Kramer 

Name: Daniel J. Abdun-Nabi                                                                           

Title: President                                                      

Date: September 9, 2011                                                                

  

  

  

Exhibit A

Work Order

This Work Order, effective as of September 6, 2011 (“Effective Date”), is made by and between Emergent BioSolutions Inc. (“Emergent”) and Robert Kramer (“Consultant”), and is a “Work Order” under the Consulting Agreement dated as of September 6, 2011, between Emergent and Consultant (“Agreement”).  Capitalized terms used but not defined herein shall have the meaning ascribed to such terms in the Agreement.

1.           Description of Services:

[**]

2.           Period of Performance:  Up to 18 months

3.           Person(s) providing Services: Robert Kramer

4.           Reports: Consultant shall provide the Emergent Representative with such reports as requested by Emergent from time to time.

5.           Fees and Maximum Compensation:

Fees:                      Monthly payment of $37,500

Maximum Compensation:  $450,000 per year.

Based upon your individual performance, along with the Corporations’ overall performance the company grant RSUs up to 20,000 shares, subject to Compensation Committee approval, at or near the completion of the twelfth month of the period of performance.

6.           Invoicing and Payment:  Invoices shall be sent to and payments made in accordance with the terms of the Agreement, and the following shall apply:

Manner/Location for Payments: First-class mail to Consultant business address

 

Accounting Codes (Must be noted on invoices for payment to be processed):

 

G/L No.:                      650881                                           Cost Center:                                           10045

 

Project Code (if applicable):

 

	
Emergent Address for Invoices:

	
Emergent BioSolutions Inc.

	
  

	
300 Professional Drive, Suite 250

	
  

	
Gaithersburg, Maryland  20879

	
  

	
Attn:  Accounts Payable

7.           Expenses:  Reimbursable in accordance with the terms of the Agreement.

8.           Contacts:                      Consultant Notices:  President & COO

Emergent Representative:  General Counsel

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