U.S. Army Space & Missile Defense Command and PharmAthene, Inc. Development and Licensure Contract for Bioscavenger Increment II
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This contract is between the U.S. Army Space & Missile Defense Command and PharmAthene, Inc. for the development and licensure of a recombinant drug candidate known as Bioscavenger Increment II. PharmAthene will provide research, development, and related services as outlined in their proposal, with a total contract value of $34,744,063. The agreement specifies delivery, payment, and administrative terms, and is effective as of September 22, 2006. Key obligations include meeting performance milestones and adhering to the contract schedule and requirements.
EX-10.20 10 e602624_ex10-20.txt Exhibit 10.20 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION (THE "SEC") PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT WITH RESPECT TO THE OMITTED PORTIONS. OMITTED PORTIONS ARE INDICATED BY [***]. - ------------------------------------------------------------------------------------------------------------------------------------
Page 2 of 21 Section A - Solicitation/Contract Form CONTINUATION OF FORM 26 Award is hereby made for the PharmAthene proposal dated 17 July 2006 and negotiation memorandum dated 23 August 2006 for the Development and Licensure of Bioscavanger Increment II (recombinant drug candidate). The PharmAthene proposal is incorporated into contract number W9113M-06-C-0189 with the following revisions: 1. This contract is awarded excluding CLIN 0006. 2. The negotiation memorandum dated 23 August 2006 requests the Government accept CLIN 0002 as submitted by the contractor in the amount of $[***]. The Government accepts this request. 3. Per the negotiation memorandum dated 23 August 2006 regarding CLIN 0005, the contractor understands and agrees that there shall be no progress payments. Instructions for invoicing are located in Section G - Contract Administration of this contract. 4. CLIN 0005 - The Government will accept TED increments of [***]. The contractor may invoice for the increments upon Government acceptance. - ---------- *** Portions of this page have been omitted pursuant to a Request for Confidential Treatment filed separately with the SEC. Page 3 of 21 Section B - Supplies or Services and Prices SPECIAL NOTICE B.1. During the Product Development and Licensure Application effort, the contractor may manufacture some number of doses of product, which will obviate the need to procure the entire initial stockpile requirement when the Food and Drug Administration approves the Licensure Application. Knowing that the number of doses, the Production Option will require the completion in which event the option CLIN 0005 would be renegotiated prior to being exercised. If exercised, the only remaining stockpile requirement, which may be less than 90,000 TED, and in some cases may be none. The successful offeror's dated proposal will be inserted into CLIN 0003, if exercised by the Government.
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- ---------- *** Portions of this page have been omitted pursuant to a Request for Confidential Treatment filed separately with the SEC. Page 7 of 21 Section C - Descriptions and Specifications STATEMENT OF WORK The contractor's proposal dated 17 July 2006 and revised budget dated 23 August 2006 is incorporated (excluding all efforts associated with CLIN 0006) in its entirety and herein by reference. Page 8 of 21 Section D - Packaging and Marking SECTION D PACKAGING AND SHIPPING: D.1. All product packaging and shipping shall be in strict accordance with FDA license product requirements. In addition, the contractor shall use approved shipping validation procedures. Page 9 of 21 Section E - Inspection and Acceptance INSPECTION AND ACCEPTANCE TERMS Supplies/services will be inspected/accepted at: CLIN INSPECT AT INSPECTED BY ACCEPT AT ACCEPT BY 0001 Origin Government Origin Government 0002 Origin Government Origin Government 0003 Origin Government Origin Government 0004 Origin Government Origin Government 0005 Origin Government Origin Government CLAUSES INCORPORATED BY REFERENCE
Page 10 of 21 Section F - Deliveries or Performance CONTRACT DATA REQUIREMENT LIST Contract Data Requirements List The following deliverables apply to both SOOs. F.1. Reports F.1.1. Contractor's Status Report. CDRL Sequence No. A00l & C001, DD Form 1423. This report shall be submitted monthly and shall contain a summary description of the progress and accomplishments of the contract; problem areas and proposed action to resolve the problems; and funds status. F.1.2. Earned Value Report: Contract Performance Report. CDRL Sequence No. B001, DD Form 1423. This report shall be submitted monthly and shall contain a Contract Performance Report (CPR), DJ-MGMT-81466 (DD Form 2734. The CPR shall at a minimum contain Formats 1, 3, and 5. Format 5 is a monthly Variance Analysis Report for cost, schedule, and at-completion variance deviations from agreed-to thresholds. These reports shall be integrated with the Contract Work Breakdown Structure (CWBS), DI-MGMT-81334A, and the Integrated Master Schedule (IMS), DI-MGMT-81650 (below). F.1.3. Contract Funds Status Report. CDRL Sequence No. A002 & C002, DD Form 1423. The Contract Funds Status Report (CFSR), DI-MGMT-81468 (DD Form 1568) shall be submitted monthly. F.1.4. Contract Work Breakdown Structure. CDRL Sequence No. A003 & C003, DD Form 1423. The Contract Work Breakdown Structure (CWBS), D1-MGMT-81334A, and the CWBS dictionary shall be updated quarterly. F.1.5. Integrated Master Schedule. CDRL Sequence No. A004 & C004, DD Form 1423. The Integrated Master Schedule, Dl-MGMT-81650, shall be updated monthly. F.1.6. Pre-Milestone B Data Package. CDRL Sequence No. A005, DD Form 1423. This data package shall be submitted after the Phase I clinical trial and shall contain information necessary to conduct the downselection process. These data shall include, but are not necessarily limited to, preclinical toxicology studies and Phase 1 clinical data and pharmacokinetic data and chemistry, manufacturing and control data, including product shelf life and projected production costs for doses. F.1.7 Regulatory Submission File. CDRL Sequence No. A006 & C005, DD Form 1423. This data package shall contain copies of IND submissions, annual reports, NDA submissions and other communications with the FDA. The data package shall also contain all FDA-initiated correspondence, to include meeting minutes, requests for additional information, etc. The Government expects that it shall be included in all discussions with the FDA. The preferred format for these regulatory documents is electronic. F.1.8. Letter of Cross-reference. CDRL Sequence No. A007, DD form 1423. The Contractor shall prepare for the Government a Letter of Cross-reference to the Sponsor's IND or Drug Master File that Government shall use to prepare an Emergency Use Authorization submission to submit to the FDA. F.2. Optional F.2.1. Technical Data Package. CDRL Sequence No. D001, DD Form 1423. Technical Data Package to include all necessary documentation to assist in technical transfer as determined by the Government. F.2.2. Initial Operational Capability Doses. CDRL Sequence No. E001, DD Form 1423. The production and post-approval/licensure delivery of 90,000 doses of the product. Page 11 of 21 DELIVERY INFORMATION- SHIP IN PLACE CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS UIC 0001 31-MAR-2009 PHARMATHENE, INC. 175 ADMIRAL COCHRANE DRIVE SUITE 101 ANNAPOLIS MD ###-###-#### FOB: Origin 0002 31-JUL-2019 (SAME AS PREVIOUS LOCATION) FOB: Origin 0003 31-JUL-2015 (SAME AS PREVIOUS LOCATION) FOB: Origin 0004 31-JUL-2019 1 (SAME AS PREVIOUS LOCATION) FOB: Origin 0005 31-JUL-2019 1 (SAME AS PREVIOUS LOCATION) FOB: Origin CLAUSES INCORPORATED BY REFERENCE 52.242-15 Alt I Stop-Work Order (Aug 1989)- Alternate I APR 1984 52.242-17 Government Delay Of Work APR 1984 52.247-29 F.O.B. Origin FEB 2006 Page 12 of 21 Section G - Contract Administration Data CONTRACT ADMINISTRATION DATA G.1 INVOICING The contractor shall submit bi-weekly vouchers using the Standard Form 1034 for CLINs 0001, 0002 and 0003 (if exercised). Vouchers shall be sent electronically via Wide Area Work Flow (WAWF) and cc: ***@*** and ***@***. The contractor shall submit DD250 forms for payment related to FFP CLINs 0004 and 0005 (if options are unilaterally exercised by the Government). The cognizant Defense Finance and Accounting Office for this contract is identified on the SF 26, Block 12 of this contract. The Contracting Officer's Representative (COR) and contact information is as follows: Dr. Mary Alice Woody 64 Thomas Johnson Drive Frederick MD 21702 Phone ###-###-#### Email: ***@*** ACCOUNTING AND APPROPRIATION DATA AA: 9760400260165Y5YCM406038BP000255Y12YMBSW90GXK62140117YMBS12044008 AMOUNT: $[***] CIN 000000000000000000000000000000: $[***] CLAUSES INCORPORATED BY FULL TEXT ###-###-#### CONTRACTING OFFICER'S REPRESENTATIVE (DEC 1991) (a) "Definition. Contracting officer's representative" means an individual designated in accordance with subsection 201.602-2 of the Defense Federal Acquisition Regulation Supplement and authorized in writing by the contracting officer to perform specific technical or administrative functions. (b) If the Contracting Officer designates a contracting officer's representative (COR), the Contractor will receive a copy of the written designation. It will specify the extent of the COR's authority to act on behalf of the contracting officer. The COR is not authorized to make any commitments or changes that will affect price, quality, quantity, delivery, or any other term or condition of the contract. (End of clause) - ---------- *** Portions of this page have been omitted pursuant to a Request for Confidential Treatment filed separately with the SEC. Page 13 of 21 Section H - Special Contract Requirements SPECIAL REQUIREMENTS H.1 Downselection Process at Milestone B The downselection process will focus on 1) technical data, as delineated below; 2) contractor performance; and 3) an affordability analysis. The safety of the product is of the utmost importance, followed by other technical considerations and contractor performance. If two products cannot be distinguished by product safety, technical considerations, and contractor performance, then an affordability analysis will be performed to determine which of two products has the lowest validated life cycle cost. The downselection determination will be by expert judgment, possibly from an outside contractor hired on for the specific purpose, based on evaluation of the data provided. Pre-Milestone B Data package will include the following. 1. Technical data a. Acute toxicology study and Phase 1 clinical trial outcomes, to determine relative safety and tolerability of the product and risks in proceeding to approval or licensure b. Pharmacokinetic properties of product in animals and humans c. Chemistry, Manufacturing, and Control data to allow assessment of risks for scale-up to meet the production option requirements and for process validation 2. Contractor performance a. Adherence to contract cost and schedule b. Problem-solving and strategies for effective interaction with the Food and Drug Administration 3. Economy of product a. Costs to complete development through approval or licensure b. Projected costs of producing doses needed c. Support needed to effectively field the product MITS will determine whether sufficient expertise exists in-house or select an outside contractor (independent of the contractors developing products) to perform the evaluation of the Pre-Milestone B Data Package. The contractor or contractors that are developing candidate Increment II products will prepare and submit the data package(s) by March 31, 2009. If a contractor should be delayed in completion of the Phase 1 clinical trial, MITS will examine the causes of the delay and decide if and for how long to postpone the downselection. Extensions are not automatically granted and might not be granted if poor contractor performance is determined to be a significant cause. Data packages will be reviewed independently and confidentially. MITS' decision will be final. H.2 Insurance/Indemnification Offerors shall seek commercial insurance coverage for contract performance as required. When seeking adequate insurance coverage and the cost of coverage is considered prohibitive, offerors may submit an application for relief under the Support Anti-terrorism in accordance with Fostering Effective Technologies Act of 2002 (Safety Act), Public Law 107-296, administered by the Department of Homeland Security. Applications may be sought at www.safetyact.gov. Application forms are also available by mail addressing to the Department of Homeland Security, ATTN: Safety Act, 245 Murray Land, Building 410, Washington, DC 20528. H.3 Electronic Data Interchange The contractor shall use a seamless Electronic Data Interchange (EDI) with the Government to facilitate electronic mail and scheduling, as well as to provide electronic access to, and updates of all CDRLS (DD 1423s). Page 14 of 21 Section I - Contract Clauses CLAUSES INCORPORATED BY REFERENCE
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CLAUSES INCORPORATED BY FULL TEXT 52.216-10 INCENTIVE FEE (MAR 1997) (a) General. The Government shall pay the Contractor for performing this contract a fee determined as provided in this contract. (b) Target cost and target fee. The target cost and target fee specified in the Schedule are subject to adjustment if the contract is modified in accordance with paragraph (d) below. (1) "Target cost," as used in this contract, means the estimated cost of this contract as initially negotiated, adjusted in accordance with paragraph (d) below. (2) "Target fee," as used in this contract, means the fee initially negotiated on the assumption that this contract would be performed for a cost equal to the estimated cost initially negotiated, adjusted in accordance with paragraph (d) below. (c) Withholding of payment. Normally, the Government shall pay the fee to the Contractor as specified in the Schedule. However, when the Contracting Officer considers that performance or cost indicates that the Contractor will not achieve target, the Government shall pay on the basis of an appropriate lesser fee. When the Contractor demonstrates that performance or cost clearly indicates that the Contractor will earn a fee significantly above the target fee, the Government may, at the sole discretion of the Contracting Officer, pay on the basis of an appropriate higher fee. After payment of 85 percent of the applicable fee, the Contracting Officer may withhold further payment of fee until a reserve is set aside in an amount that the Contracting Officer considers necessary to protect the Government's interest. This reserve shall not exceed 15 percent of the applicable fee or $100,000, whichever is less. The Contracting Officer shall release 75 percent of all fee withholds under this contract after receipt of the certified final indirect cost rate proposal covering the year of physical completion of this contract, provided the Contractor has satisfied all other contract terms and conditions, including the submission of the final patent and royalty reports, and is not delinquent in submitting final vouchers on prior years' settlements. The Contracting Officer may release up to 90 percent of the fee withholds under this contract based on the Contractor's past performance related to the submission and settlement of final indirect cost rate proposals. (d) Equitable adjustments. When the work under this contract is increased or decreased by a modification to this contract or when any equitable adjustment in the target cost is authorized under any other clause, equitable adjustments in the target cost, target fee, minimum fee, and maximum fee, as appropriate, shall be stated in a supplemental agreement to this contract. (e) Fee payable. (1) The fee payable under this contract shall be the target fee increased by 15 cents for every dollar that the total allowable cost is less than the target cost or decreased by 15 cents for every dollar that the total allowable cost exceeds the target cost. For CLIN 0001 in no event shall the fee be greater than 15 percent or less than 10 percent of the target costs. For CLIN 0002 in no event shall the fee be greater than 15 percent or less than 0 percent of the target costs. For CLIN 0003 in no event shall the fee be greater than 15 percent or less than 4.6 percent of the target costs. (2) The fee shall be subject to adjustment, to the extent provided in paragraph (d) above, and within the minimum and maximum fee limitations in subparagraph (1) above, when the total allowable cost is increased or decreased as a consequence of (i) payments made under assignments or (ii) claims excepted from the release as required by paragraph (h)(2) of the Allowable Cost and Payment clause. Page 17 of 21 (3) If this contract is terminated in its entirety, the portion of the target fee payable shall not be subject to an increase or decrease as provided in this paragraph. The termination shall be accomplished in accordance with other applicable clauses of this contract. (4) For the purpose of fee adjustment, "total allowable cost" shall not include allowable costs arising out of-- (i) Any of the causes covered by the Excusable Delays clause to the extent that they are beyond the control and without the fault or negligence of the Contractor or any subcontractor; (ii) The taking effect, after negotiating the target cost, of a statute, court decision, written ruling, or regulation that results in the Contractor's being required to pay or bear the burden of any tax or duty or rate increase in a tax or duty; (iii) Any direct cost attributed to the Contractor's involvement in litigation as required by the Contracting Officer pursuant to a clause of this contract, including furnishing evidence and information requested pursuant to the Notice and Assistance Regarding Patent and Copyright Infringement clause; (iv) The purchase and maintenance of additional insurance not in the target cost and required by the Contracting Officer, or claims for reimbursement for liabilities to third persons pursuant to the Insurance Liability to Third Persons clause; (v) Any claim, loss, or damage resulting from a risk for which the Contractor has been relieved of liability by the Government Property clause; or (vi) Any claim, loss, or damage resulting from a risk defined in the contract as unusually hazardous or as a nuclear risk and against which the Government has expressly agreed to indemnify the Contractor. (5) All other allowable costs are included in "total allowable cost" for fee adjustment in accordance with this paragraph (e), unless otherwise specifically provided in this contract. (f) Contract modification, The total allowable cost and the adjusted fee determined as provided in this clause shall be evidenced by a modification to this contract signed by the Contractor and Contracting Officer. (g) Inconsistencies. In the event of any language inconsistencies between this clause and provisioning documents or Government options under this contract, compensation for spare parts or other supplies and services ordered under such documents shall be determined in accordance with this clause. (End of clause) 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 sixty (60) days. 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) 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: http://acquisition.gov/far/index.html (End of clause) Page 18 of 21 52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984) (a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause. (b) The use in this solicitation or contract of any Defense Federal Acquisition Regulation (48 CFR Chapter 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation. (End of clause) 252 ###-###-#### Transportation of Supplies by Sea (MAY 2002) (a) Definitions. As used in this clause-- (1) "Components" means articles, materials, and supplies incorporated directly into end products at any level of manufacture, fabrication, or assembly by the Contractor or any subcontractor. (2) "Department of Defense" (DoD) means the Army, Navy, Air Force, Marine Corps, and defense agencies. (3) "Foreign flag vessel" means any vessel that is not a U.S.-flag vessel. (4) "Ocean transportation" means any transportation aboard a ship, vessel, boat, barge, or ferry through international waters. (5) "Subcontractor" means a supplier, materialman, distributor, or vendor at any level below the prime contractor whose contractual obligation to perform results from, or is conditioned upon, award of the prime contract and who is performing any part of the work or other requirement of the prime contract. (6) "Supplies" means all property, except land and interests in land, that is clearly identifiable for eventual use by or owned by the DoD at the time of transportation by sea. (i) An item is clearly identifiable for eventual use by the DoD if, for example, the contract documentation contains a reference to a DoD contract number or a military destination. (ii) "Supplies" includes (but is not limited to) public works; buildings and facilities; ships, floating equipment and vessels of every character, type, and description, with parts, subassemblies, accessories, and equipment; machine tools; material; equipment; stores of all kinds; end items; construction materials; and components of the foregoing. (7) "U.S.-flag vessel" means a vessel of the United States or belonging to the United States, including any vessel registered or having national status under the laws of the United States. (b)(l) The Contractor shall use U.S.-flag vessels when transporting any supplies by sea under this contract. (2) A subcontractor transporting supplies by sea under this contract shall use U.S.-flag vessels if-- (i) This contract is a construction contract; or (ii) The supplies being transported are-- (A) Noncommercial items; or (B) Commercial items that-- Page 19 of 21 (1) The Contractor is reselling or distributing to the Government without adding value (generally, the Contractor does not add value to items that it contracts for f.o.b. destination shipment); (2) Are shipped in direct support of U.S. military contingency operations, exercises, or forces deployed in humanitarian or peacekeeping operations; or (3) Are commissary or exchange cargoes transported outside of the Defense Transportation System in accordance with 10 U.S.C. 2643. (c) The Contractor and its subcontractors may request that the Contracting Officer authorize shipment in foreign-flag vessels, or designate available U.S.-flag vessels, if the Contractor or a subcontractor believes that-- (1) U.S.-flag vessels are not available for timely shipment; (2) The freight charges are inordinately excessive or unreasonable; or (3) Freight charges are higher than charges to private persons for transportation of like goods. (d) The Contractor must submit any request for use of other than U.S.-flag vessels in writing to the Contracting Officer at least 45 days prior to the sailing date necessary to meet its delivery schedules. The Contracting Officer will process requests submitted after such date(s) as expeditiously as possible, but the Contracting Officer's failure to grant approvals to meet the shipper's sailing date will not of itself constitute a compensable delay under this or any other clause of this contract. Requests shall contain at a minimum-- (l) Type, weight, and cube of cargo; (2) Required shipping date; (3) Special handling and discharge requirements; (4) Loading and discharge points; (5) Name of shipper and consignee; (6) Prime contract number; and (7) A documented description of efforts made to secure U.S.-flag vessels, including points of contact (with names and telephone numbers) with at least two U.S.-flag carriers contacted. Copies of telephone notes, telegraphic and facsimile message or letters will be sufficient for this purpose. (e) The Contractor shall, within 30 days after each shipment covered by this clause, provide the Contracting Officer and the Maritime Administration, Office of Cargo Preference, U.S. Department of Transportation, 400 Seventh Street SW., Washington, DC 20590, one copy of the rated on board vessel operating carrier's ocean bill of lading, which shall contain the following information: (1) Prime contract number; (2) Name of vessel; (3) Vessel flag of registry; (4) Date of loading; (5) Port of loading; Page 20 of 21 (6) Port of final discharge; (7) Description of commodity; (8) Gross weight in pounds and cubic feet if available; (9) Total ocean freight in U.S. dollars; and (10) Name of the steamship company. (f) The Contractor shall provide with its final invoice under this contract a representation that to the best of its knowledge and belief-- (1) No ocean transportation was used in the performance of this contract; (2) Ocean transportation was used and only U.S.-flag vessels were used for all ocean shipments under the contract; (3) Ocean transportation was used, and the Contractor had the written consent of the Contracting Officer for all non-U.S.-flag ocean transportation; or (4) Ocean transportation was used and some or all of the shipments were made on non-U.S.-flag vessels without the written consent of the Contracting Officer. The Contractor shall describe these shipments in the following format: ITEM DESCRIPTION CONTRACT LINE ITEMS QUANTITY - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- - -------------------------------------------------------------------------------- TOTAL -------------------------------------------------------------------------- (g) If the final invoice does not include the required representation, the Government will reject and return it to the Contractor as an improper invoice for the purposes of the Prompt Payment clause of this contract. In the event there has been unauthorized use of non-U.S.-flag vessels in the performance of this contract, the Contracting Officer is entitled to equitably adjust the contract, based on the unauthorized use. (h) In the award of subcontracts for the types of supplies described in paragraph (b)(2) of this clause, the Contractor shall flow down the requirements of this clause as follows: (1) The Contractor shall insert the substance of this clause, including this paragraph (h), in subcontracts that exceed the simplified acquisition threshold in part 2 of the Federal Acquisition Regulation. (2) The Contractor shall insert the substance of paragraphs (a) through (e) of this clause, and this paragraph (h), in subcontracts that are at or below the simplified acquisition threshold in part 2 of the Federal Acquisition Regulation. (End of clause) Page 21 of 21 Section J - List of Documents, Exhibits and Other Attachments SECTION J LIST OF ATTACHEMENTS: - -------------------------------------------------------------------------------- Exhibit Number Description No. of Pages - -------------------------------------------------------------------------------- 1 Contract Data Requirements List DD Forms 1423 14 and continuation pages. - -------------------------------------------------------------------------------- 2 Disclosure of Lobbying Activities 2 - --------------------------------------------------------------------------------