Revised Section B-3.pdf

RFP-12-100-SOL-00016

Amendment 004 – Attachment 3

B.3. OPTION PRICES

The final contract will contain the price/cost provisions for Options agreed upon by the Government and the Offeror.

Below is a list of possible Optional CLINs; the final contract will contain Optional CLINs agreed upon by the Government and the Offeror:

Optional

CLIN #

Cost Type

Description of Option Item(s) -or- Option Service(s)

Quantity (Units)

Unit Price

Total Price of Option

0002 FFP Acquire and USG access to additional G & GM-CSF products as described in

SECTION C.4.

TBD TBD TBD

0003 FFP Inventory management as described in

SECTION C.5.

TBD TBD TBD

0004 FFP *Distribution and Shipping of products (VMI) in a declared emergency as described in SECTION C.6. (FOB Destination)

TBD TBD TBD

FFP Prepare product stored as VMI for pick up by the USG as described in SECTION C.7. (FOB Origin)

TBD TBD TBD

* For purposes of proposing shipping prices, the Offeror shall use a uniform cost assumption of shipping from its manufacturing/storage facility to a destination approximately 2400 miles away.

Optional

CLIN #

Cost Type

Description of Option Item(s) -or- Option Service(s)

Estimated Cost

Fixed Fee

Total Estimated Cost Plus Fixed Fee

CPFF

Advanced Development of an elected cytokine for studies leading to an FDA licensure for the indication of mitigation of neutropenia arising from exposure to ionizing radiation

TBD TBD TBD

B.3.1. Firm Fixed Price Options

B.3.1.1. Option to purchase additional product (CLIN 0002)

The USG may exercise this optional CLIN to purchase additional product.

The Offeror shall submit a plan and schedule for additional drug product manufacture and control at large-scale production and under cGMP compliance to provide access to up to 2.79 million doses.

The plan shall provide unit dose prices for additional doses so that the USG has the option of ordering additional doses in increments of 1000 doses. Offeror shall propose volume discounts of G or GM-CSF products as described in SECTION C in increments of 100,000 unit doses up to 2.79M unit doses. Additional product purchases shall be initiated by exercising an option for incremental purchase(s) of product at the price(s) negotiated at contract award.

The current requirement is up to 2.79M doses, inclusive of CLIN 0001 and CLIN 0002. CLIN 0001 is the minimum requirement of this contract which equals $500,000; CLIN 0002 provides for any additional purchase of product in excess of $500,000.

B.3.1.2. Option to purchase additional VMI (CLIN 0003)

The USG may exercise this optional CLIN to purchase VMI for additional storage of product in monthly increments.

B.3.1.3. Option to purchase distribution and shipping of product upon a declared emergency

(CLIN 0004)

The USG may exercise this optional CLIN for a requested number of doses to be delivered to the location of the emergency as requested by the Contracting Officer in the Notification of Release of Product for each shipment (see SECTION C.5.3.).

B.3.1.4. Option to prepare product stored as VMI for pick up by the USG (CLIN 0005)

The USG may exercise this optional CLIN for a requested number of doses to be picked up by the USG from the VMI as requested by the Contracting Officer, or by an individual designated by the Contracting Officer, in the Notification of Release of Product for each shipment.

a. Unless the Government exercises its option pursuant to the option clause referenced in SECTION

I.3. Additional Contract Clauses, this contract consists only of the base award.

b. The Government may, by unilateral contract modification, require the Contractor to perform the Option(s) listed in the table below. Pursuant to FAR 52.217-7 Option for Increased Quantity – Separately Priced Line Item, if the Government exercises this/these option(s), notice will be given 30 days before exercising the Option. The fixed price of this contract will be increased as set forth in paragraph c., below.

c. Upon the delivery and acceptance of the [Option Item/Option Items/Option Service/Option

Services] identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth below:

B.3.2. Cost Reimbursement Options

B.3.2.1. Option to fund advanced development (CLIN 0006)

The USG may fund the advanced development of an elected cytokine for studies leading to FDA licensure for the indication of mitigation of neutropenia arising from exposure to ionizing radiation.

The Offeror shall provide the USG, under an agreed upon level of funding (Cost Reimbursement) with a compendium of studies which may provide sufficient evidence of efficacy and safety to allow for the USG to place the product under consideration for potential use in a declared emergency under Emergency Use Authorization (EUA; see guidance documents at FDA web site).

The following will be included in the contract for any Cost Reimbursement options:

a. The estimated cost of the Optional CLIN of this contract is $ .

b. The fixed fee for the Optional CLIN of this contract is $ . [For completion contracts: The fixed fee shall be paid in installments based on the percentage of completion of work, as determined by the Contracting Officer. / For level of effort contracts: The fixed fee shall be paid in direct ratio to the level of effort expended; that is, the percent of fee paid shall be equal to the percent of total effort expended.] Payment shall be subject to the withholding provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the General Clause Listing in Part II, SECTION I.1. of this contract.

c. The total estimated amount of the contract, represented by the sum of the estimated cost plus the fixed fee for the Optional CLIN is $ .

d. If the Government exercises its option pursuant to the OPTION PROVISION in SECTION H of this contract, the Government's total estimated contract amount represented by the sum of the estimated cost plus the fixed fee will be increased as follows:

Estimated Cost ($) Fixed Fee ($) Estimated Cost

Plus Fixed Fee ($) Base Period Option (s):

Total [Base Period and Option(s)]

e. Payments will be made from the following Line Items as follows:

Line

Item No.

Cost Type

Option/Increment Description Line Item Period of

Performance

Funded Amount