SAIC FREDERICK SOLICITATION, OFFER AND AWARDNonSolicitation Agreement |
|
|
You are currently viewing: This NonSolicitation Agreement involves
VICAL INC. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here. |
|
|
|
|
*** Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2
SAIC FREDERICK Solicitation, Offer and Award
1. Maryland Sales and Use Tax Direct Pay Permit No. 3
2. Subcontract No. 23XS003
3. Solicitation No. S03-003
4. o Sealed Bid (IFB) ý Negotiated (RFP)
5. Date Issued 4/01/03
6. Requisition/Purchase No. DD1069
7. Issued By: Address Offer To:
SAIC-Frederick, Inc.
8. Delivery Date: Specified in resulting Delivery Orders
8A. Place of Delivery: N/A
8B. ¨ FOB Destination ý FOB Origin
NOTE: In sealed bid solicitation “offer” and “offeror” mean “bid” and “bidder” .
SOLICITATION
9. To be timely sealed offers in original and copies must be received at the room specified in Item 7 by local time . Envelopes shall be marked to show solicitation number and time. (hour) (date)
10. FOR INFORMATIONCALL:
A. NAME Jean LaPadula B. Telephone No. (Include area code) (NO COLLECT CALLS) (301) 644-2045
OFFER/SUBCONTRACT CONSISTS OF:
B. Supplies or Services and Prices/Costs C. Description/Specs./Statement of Work H. Special Contract Requirements
Part III - List Of Documents, Exhibits and Other Attachments
Part IV - Representations and Instructions
K. Representations, Certifications and Other Statements of Offerors
SCHEDULE
12. In compliance with the above, if this offer is accepted within calendar days (60 calendar days unless a different period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item in accordance with the terms of the offer. Note: Sealed bids providing less than calendar days for acceptance will be considered non-responsive and rejected.
14. ACKNOWLEDGMENT OF AMENDMENTS
The offeror acknowledges receipt of amendments to the solicitation for offerors and related documents numbered and dated:
15A. Name and Address of Offeror
Vical, Inc.
15B. Telephone No. (Include Area Code): 858-646-1100
15C. ¨ Check if remittance address is different from above. Enter such address in schedule.
16. Name and Title of Person Authorized to Sign Offer (Type or print)
Vijay B. Samant
17. Signature
18. Offer Date April 4, 2003
AWARD (On this form or by other written notice)
19. Accepted As To Items Numbered:
20. IDIQ – Minimum obligation is [ …***… ]
21. Accounting Data:
22. Submit Invoices to Address, Item 7, Attn.: Accounts Payable (3 copies unless other specified)
23. Name/Title of Person Authorized to Sign – SAIC Dennis Dougherty Manager, Research Contracts
24. Signature of Person Authorized to Sign – SAIC
28. Award Date
5/6/03
PART I
SECTION A - SOLICITATION, OFFER AND AWARD FORM
1
TABLE OF CONTRACT CONTENTS
2
SECTION B - SUPPLIES OR SERVICES AND PRICES/COST
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
A. SAIC Frederick, Inc. (hereafter “SAIC” or “Government”) under its Operations and Technical Support (OTS) contract with the National Cancer Institute – Frederick (“NCI”) requests Vical, Inc. (“Contractor”) to produce DNA plasmids on a delivery order basis for the Vaccine Research Center (VRC).
B. This is an Indefinite Delivery/Indefinite Quantity Contract for the supplies or services specified in Section C, Description/Specifications/Statement of Work. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract. Work shall proceed upon the issuance of a Delivery Order issued by the SAIC Contracting Officer. The Delivery Order issued shall be on a fixed price basis. Payment shall be made at the unit contract price(s) established for the initial period of performance and each option period specified in Article B.2. The period of performance is for (1) year after date of award with four (4) additional one-year option years to be unilaterally exercised by the Government. The total duration of this contract shall be for five years if all option years are exercised.
C. Independently, and not as an agent of the Government, the Contractor shall furnish services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government under the terms of this Indefinite Delivery/Indefinite Quantity Contract, as needed to produce DNA plasmids, or to otherwise perform the Statement of Work (SOW) specified in Section C herein.
ARTICLE B.2. PRICES/COSTS
Delivery Orders will be placed utilizing the following pricing for each corresponding year of performance:
001 – 100-Liter Small-Scale Production
Note: The Contractor is responsible for vialing, labeling, and packaging of material produced with the 100-Liter manufacturing train. All vials [ …***… ] will be filled up to a concentration of [ …***… ] / mL and to a volume of [ …***… ] unless otherwise specified in resulting Delivery Orders. The maximum number of vials to be filled by the Contractor cannot exceed [ …***… ] per two fermentation runs.
002 – 500-Liter Large-Scale Production
Note: The Contractor is not responsible for formulating, vialing, labeling, or packaging material produced with the 500-Liter manufacturing train.
3
003 – Preparation of Master Cell Bank
Note: Government is responsible for costs associated with the procurement of adventitious agent testing and DNA sequencing.
004 – Document Preparation and Shipping
005 – Stability Testing
Note: The following costs are not included in the fixed prices listed in Line Items 001-005: 1. Sequencing of new plasmids; 2. Post-bulk expression testing; 3. Adventitious agent testing of Master Cell Bank; and 4. DNA sequencing of Master Cell Bank.
General Assumptions: 1. Plasmid size is no larger than 10,000 base pairs
ARTICLE B.3. ITEMS TO BE FURNISHED TO THE CONTRACTOR
A. The Government will provide the Contractor with equipment consisting of a 500-Liter manufacturing train (Article G.3.B) . The equipment is Government property and shall be used for this project only and shall not be used subsequently by the Contractor for any for-profit or non-for-profit venture without explicit written permission of SAIC-Frederick, Inc. Following the receipt of authorization to use the equipment, the Contractor may use the equipment for the approved dates for a fee (Note: fee is a percentage of purchase price calculated in accordance with FAR 52.245-9 (c)(i)). The Government will evaluate in good faith specific requests made by Contractor for waiver of the rental fee on a case-by-case basis. The Government shall not unreasonably deny requests from the Contractor for commercial use of the equipment.
In addition to providing equipment, the Government will pay to install and validate the equipment in the Contractor’s facility. Contractor is responsible for all costs related to facility improvements, including but not limited to upsizing utilities, and proper maintenance and repair of the equipment. Contractor shall provide equipment maintenance records to the Government on an annual basis for all Government-
4
owned equipment.
At contract termination, the Government and the Contractor will mutually select and pay for an independent appraiser to appraise the current fair market value(1) of the equipment which appraisal shall assess only the fair market value of the equipment excluding the facilities and any facility improvements. The government and Contractor will negotiate a fair and reasonable price for the equipment based on the appraised value.
B. The Government shall provide the Contractor plasmids suitably developed (i.e. reasonably optimized for growth, plasmid yield and plasmid stability) for clinical trial production (as identified in resulting Delivery Orders). All materials and products, provided by the Government shall be used for this project only and shall not be used subsequently by the Contractor for any for-profit or not-for-profit venture without explicit written permission of SAIC-Frederick, Inc. Following contract completion, the DNA plasmids should be returned or disposed of as directed by the COTR.
C. In the event items are not furnished by the date specified, the Delivery Order will be modified, as necessary, to accommodate the delay (FAR 52.242-17, Government Delay of Work, April 1984).
D. The Contractor is responsible for the Contractor’s loss or damage of Government furnished equipment, tools and supplies.
(1) Definition of fair market value: “The price a willing and knowledgeable buyer would pay to a willing and knowledgeable seller, both free from mistake or coercion, without regard to increases or decreases attributable to the project for which the property is being acquired.” Source: GAO; "Principles of Federal Appropriations Law;" Second Addition; Volume IV; March 2001.
5
SECTION C - DESCRIPTION/SPECIFICATION/STATEMENT OF WORK
ARTICLE C.1. STATEMENT OF WORK
A. Background
The Vaccine Research Center (VRC) has an on-going need for DNA plasmids to support clinical trials of different vaccine products. The purpose of this contract is to enable the VRC to quickly fulfill requirements for DNA plasmids through the issuance of Delivery Orders.
B. Scope
The scope of this contract is the cGMP production of DNA plasmids for use in Phase I or Phase II human clinical trials for the specified disease targets (see below). Production of plasmids at the 100 liter scale shall include production, formulation in saline, vialing, labeling, packaging and storage of product. Production of plasmids at the 500 liter scale shall include only the production of bulk product.
The Contractor shall manufacture DNA plasmids for the following disease targets for the base year and all option years:
[…***…]
The Contractor shall manufacture DNA plasmids for the following disease targets during the base year of this contract (written agreement from the Contractor is required for the manufacture of these plasmids for each option year):
[ …***… ]
C. Tasks
The Contractor shall manufacture products as specified in resulting Delivery Orders. The Contractor will develop and produce specified amounts (defined in resulting delivery orders) of clinical grade lots (cGMP) of DNA plasmids in suitable packaging and purity for clinical human vaccine trials. In addition, the Contractor shall provide storage required for stability testing of the plasmids. Stability testing shall be performed in accordance with cGMP guidelines and all of the relevant Points to Consider at the Contractor’s facility for a maximum of two (2) years following each production or at the first time point following last clinical use.
6
1. The Contractor shall complete the following tasks to produce the specified vaccine products as directed by the COTR:
a. Where applicable, obtain starting materials from product inventor/supplier. Complete a material transfer agreement, if needed.
b. As applicable and as requested by the Government, prepare a Master Cell Bank including the preparation of approximately 50 glycerol stock tubes, to be stored in liquid nitrogen. The Contractor will manage the administration of adventitious agent testing and DNA sequencing of the Master Cell Bank. Costs associated with the procurement of adventitious agent testing and DNA sequencing shall be borne by the Government.
c. Develop detailed production plan and timeline for manufacture of lots of candidate vaccine products.
d. Where applicable, purchase or otherwise acquire products and materials necessary for production of stated vaccine product.
e. Produce vaccine product in a form suitable for use in human clinical studies. These products shall be prepared under cGMP conditions (Article C.1.3).
f. Prepare vaccine product for shipment as specified in Article D.1.
g. The Contractor shall provide notification of all deviations, Out of Specifications (OOS), and failure investigations to the COTR (Article G.1.B) and Program Manager (Article G.1.C) within 5 business days.
2. The Contractor shall provide the necessary facilities, equipment and resources including:
a. Provide facilities and equipment suitable for cGMP production of vaccine product. All equipment and room identification must be traceable to batch records.
b. Maintain and operate controlled storage of samples at appropriate temperatures with appropriate monitoring for failure (Room temperature through -70°C. Liquid nitrogen storage may be required for some products.)
c. If necessary, receive, store and manipulate biohazardous materials (Biosafety Level 1 Containment) and maintain their viability in facilities, which provide aseptic and/or sterile conditions as appropriate.
d. If necessary, provide protective garments, equipment and sufficient monitoring to assure safe handling of potentially hazardous materials, employed by Contractor, for the safety and protection of workers.
e. Conduct work under the contract in accordance with all applicable and current Federal, state, and local laws, codes, ordinances and regulations, as well as all PHS Safety and Health provisions.
7
3. Other than Potency Testing, the Contractor shall perform or manage as applicable the subcontracting of vaccine lot characterization tests.
At various steps during the manufacture of a vaccine the product must be characterized. Prior to use of a vaccine in clinical studies the manufactured vaccine will need to undergo final lot release testing. As described in the regulations for General Biological Product Standards (21 CFR 610) the following tests must be performed for each lot of vaccine.
a. Test for Potency. A test for potency (21 CFR 610.10) will evaluate in an in vitro or in vivo test the specific ability of the vaccine to effect a given response, such as an immune response in mice, which should be supportive of the efficacy of the vaccine in humans. In the case of DNA vaccines potency may be evidenced by the production of the pertinent antigen in a transfected cell line. This test will be performed by and at the Vaccine Research Center, NIAID, NIH.
b. Test for General Safety. The general safety test (21 CFR 610.11) must be performed in mice and guinea pigs on each lot of vaccine to detect extraneous toxic contaminants potentially introduced during manufacture.
c. Test for Sterility. A test for sterility (21 CFR 610.12) must be performed as described in the regulations.
d. Test for Purity. A test for purity (21 CFR 610.13) must be performed on each lot to ensure that the product is free from extraneous material except for that which is unavoidable due to the manufacturing process. In addition, the test for purity includes an evaluation of residual ethanol and the presence of pyrogenic substances in the product as necessary.
e. Test for Identity. The test for identity (21 CFR 601.14) is generally a physical or chemical test performed to establish the identity of the material in the final container.
f. Test for Quantity. A measure of the amount of material present is imperative for calculating the dilution of the bulk material required for the final container fill.
g. For materials produced at the 100 liter scale, perform stability testing at 3, 6, 9, 12, 18 and 24 months post-fill, or at the first time point following last clinical use. The Government shall inform Contractor of the specific stability tests (ex: gel electrophoresis, HPLC analysis for conformers, pH as appropriate) requested 60 days prior to initiation of such tests. Contractor will not be responsible for developing or administering expression / potency assays.
4. Contractor shall provide the following information to the VRC to aid in applicable regulatory submissions for products produced under this contract:
a. IND/BMF cross-reference authorization
b. CMC documentation for finished product
c. Quality Assurance review / certificates of analysis
8
5. Participate in discussions with the FDA during pre-IND and IND meetings.
6. Meet with the COTR at periodic intervals, to be scheduled after contract award.
7. Retain all records, samples, histopathological slides, etc. as indicated and as applicable under GLP and cGMP guidelines and make them available.
ARTICLE C.2. DELIVERABLES
A. The Contractor shall provide the following deliverables at each of the designated milestones:
B. The Contractor shall provide the following deliverables following completion of the final milestone:
9
• Clinical grade lots (cGMP) of DNA plasmids in suitable packaging and purity for clinical human vaccine trials in amount specified in Delivery Orders. • IND/BMF cross-reference authorization • CMC documentation for finished product • Quality assurance review / certificates of analysis • Certificate of conformance (see Attachment A for template)
10
ARTICLE C.3. GUARANTEED MINIMUM AMOUNTS
A. The Contractor shall deliver the following minimum quantity of bulk material for processing weeks purchased at either the 100-Liter or 500-Liter scale based on the table below:
Example: 1) Contractor completes two fermentation runs and produces [ …***… ] grams of cell paste. 2) Using the above table, multiply [ …***… ] by [ …***… ] = [ …***… ] . Contractor will deliver a minimum of [ …***… ] mg of bulk plasmid DNA.
B. In addition, Contractor shall also perform a minimum of two fermentation runs per “block” of processing time purchased at the 100 liter scale, and a minimum of one fermentation run per “block” of processing time purchased at the 500 liter scale. Contractor shall also achieve a minimum cell paste of [ …***… ] grams per fermentor at the 100 liter scale, and [ …***… ] grams of cell paste per fermentor at the 500 liter scale.
11
SECTION D - PACKAGING AND SHIPMENT
ARTICLE D.1. PACKAGING AND SHIPMENT
Contractor shall prepare all materials for shipment in accordance with applicable International Air Transport Association (IATA) guidelines.
All deliverables shall be shipped F.O.B. – Origin
ARTICLE D.2. RELEASE OF MATERIALS
The Contractor shall submit the Certificate of Analysis and other appropriate documentation to SAIC-Frederick, Inc. following completion of the production of plasmids. The SAIC-Frederick, Inc. COTR will be responsible for review and acceptance of the documentation and materials. Prior to release of any materials produced by Contractor, the Government shall review applicable batch records at the Contractor’s facility. Upon acceptance of materials, the Government shall send written verification of its acceptance of materials. Prior to final release of materials for shipment, the Government shall send written notification. The Contractor shall not release materials for shipment prior to receiving written authorization from the SAIC-Frederick, Inc. Contracting Officer. Following approval, SAIC-Frederick, Inc. will coordinate and pay for the shipment of materials.
The Contractor shall store complete bulk and finished materials for a maximum of three months.
12
SECTION E - INSPECTION AND ACCEPTANCE
ARTICLE E.1. INSPECTION AND ACCEPTANCE
A. The acceptance criteria (i.e, expression test and pass/fail assays) for each plasmid shall be defined and documented in the Materials Ordering Form. The acceptance criteria for all materials shall be mutually agreed upon in writing prior to the issuance of the first Delivery Order.
B. The Contracting Officer or a duly authorized representative will perform the evaluation of the research services and acceptance of deliverables provided.
C. For the purpose of this Article, the SAIC Contracting Officer’s Technical Representative (COTR) is the authorized technical representative of the Contracting Officer, unless specified otherwise in an individual Delivery Order.
D. This contract incorporates the following 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 http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
ARTICLE E.2. cGMP INSPECTION REQUIREMENTS
A. Review of Material Production Records. The Contractor shall have established procedures for regularly assessing a contract manufacturing facility’s compliance with the applicable product and establishment standards. This may include, but is not limited to, review of all batch records and manufacturing deviations and defects, and periodic audits. Contract facilities engaged in the manufacture of a biological product are responsible for compliance with applicable provisions of the FD&C Act and will be subject to FDA inspection as provided for inspection 351(c) of the PHS Act and section 704(a) of the FD&C Act. The Contractor shall ensure that all owned and contract facilities are ready for inspection by SAIC-Frederick, Inc. and Government staff. Upon 15 business days advance written notice, the Contractor shall permit appropriately skilled representatives of SAIC-Frederick, Inc. or the Government, at SAIC-Frederick, Inc.’s expense, to have access, as necessary, during the Contractor’s normal business hours to inspect Contractor’s records as may be reasonably necessary to verify that the product manufactured by the Contractor are in accordance with Good Manufacturing Practices (GMP) and conform to the specifications outlined in this contract
B. Routine cGMP Audits. Upon 60 days advance written notice from SAIC-Frederick, Inc. or Government staff (other than FDA personnel), and not more than once per calendar year, (other than for cause) the Contractor shall permit appropriately skilled representatives of SAIC-Frederick, Inc. or the Government, at SAIC-Frederick, Inc.’s expense, to have access during the Contractor’s normal business hours to inspect Contractor’s records and facilities as may be reasonably necessary to verify that the production facilities and Standard Operating Processes (SOPs) used by the Contractor are in accordance
13
with Good Manufacturing Practices (GMP) and conform to the specifications outlined in this contract.
C. SAIC-Frederick, Inc. and the Government shall treat all information subject to review under this Article E.2. in strict confidence and shall cause its consultants who review such information to be bound by confidentiality agreements. The Contractor shall provide written documentation to the SAIC-Frederick, Inc. COTR and Sponsor of any FDA citation of a deviation from cGMP to allow evaluation of its impact on the purity, potency, and safety of the product.
D. Examples of documents available for audit include:
1. Documents listing raw materials, vendors, lot numbers, vendors’ Certificate of Analysis, and internal release documentation (information required to trace starting materials to batch records) 2. A transaction history of all filled product inventories detailing the quantity of starting material used; quantity produced, sampled, and rejected; and final quantity placed in inventory and all subsequent distributions. 3. Environmental Monitoring (EM) data trends for production areas, including EM and personnel monitoring performed during aseptic operations. Data required to trace equipment and room identification to batch records. 4. Documentation demonstrating proper storage of process intermediaries and final product. 5. Chain of custody documentation for receipt and QA release of material including full reconciliation of material from release forward. 6. Batch Records
14
SECTION F - DELIVERIES OR PERFORMANCE
ARTICLE F.1. PERIOD OF PERFORMANCE
A. The initial period of performance of this contract shall be for twelve (12) months from the date of contract award. The Contracting Officer may extend the period of performance by exercising one or more of the four priced twelve (12) months option years in accordance with paragraph B below. The total duration of the contract shall not exceed five (5) years if all options are exercised.
B. Execution of option years will be based upon actual Contractor performance.
FAR 52.217-9 Option to Extend the Term of the Contract (Mar 1989)
The Government may extend the term of this contract by written notice to the Contractor within thirty (30) days provided, that the Government shall give the Contractor a preliminary written notice of its intent to extend at least sixty (60) days before the contract expires. The preliminary notice does not commit the Government to an extension.
If the Government exercises this option, the extended contract shall be considered to include this option provision.
The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.
C. If SAIC Frederick exercises its option(s) pursuant to Article F.1, paragraph B, the period of performance will be increased as listed below:
15
ARTICLE F.2. PLACE OF PERFORMANCE
The principle place of performance shall be at the Contractor’s facility.
ARTICLE F.3. GOVERNMENT DELAY OF WORK
This contract incorporates the following 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 http://www.arnet.gov/far/.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
ARTICLE F.4. INDEFINITE DELIVERY/INDEFINITE QUANTITY CONTRACT (IDIQ)
A. This is an indefinite delivery/indefinite quantity contract for the supplies or services specified and effective for the period stated in the Schedule and any option periods. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract. Work shall proceed upon the issuance of a Delivery Order issued by the SAIC Contracting Officer. Payment shall be made at the unit contract price(s) established in Article B.2.
B. Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the contract as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”
C. Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue Delivery Orders requiring delivery to multiple destinations.
D. Any Delivery Order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the Delivery Order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that Order to the same extent as if the Order were completed during the contract’s effective period; provided , that the Contractor shall not be required to make any deliveries under this contract after 90 days beyond the ordering period.
16
SECTION G - CONTRACT ADMINISTRATION DATA
ARTICLE G.1. CONTRACT REPRESENTATIVES
A. The following individual is designated as SAIC-Frederick’s Contracting Officer and is authorized to conduct business, negotiate award and modifications.
Mr. Dennis Dougherty SAIC-Frederick, Inc. NCI-FCRDC, P.O. Box B, Building 244 Frederick, Maryland 21702—1201 Phone: 301-846-1087 Fax: 301-846-5414 E-mail: ddougherty@mail.ncifcrf.gov
B. The following individual is designated as SAIC-Frederick’s Contracting Officer’s Technical Representative (COTR) and is authorized to provide technical guidance and otherwise represent the Government as stated herein:
Dr. John W. Madsen Vaccine Clinical Materials Program SAIC-Frederick, Inc. NCI Frederick 92 Thomas Johnson Drive, Suite 250 Frederick, MD 21702-1201 Phone: 301-644-2089 Fax: 301-694-9467 E-mail: madsenj@ncifcrf.gov
1. The Contracting Officer’s Technical Representative is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.
2. The Contracting Officer is the only person with the authority to act as an agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the Statement of Work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.
17
C. The following individual is designated as the VRC Project Manager (PM) and is authorized to provide technical guidance:
Dr. Phillip Gomez Vaccine Research Center NIAID/NIH Building 40, Room 5502 Bethesda, MD 20892 Phone: 301-594-8485 Fax: 301-480-2788 Email: pgomez@mail.nih.gov
D. The following individual has been designated as SAIC’s-Frederick’s Contract Specialist for purposes of administering, processing and handling contractual documentation:
Ms. Annette Bishop SAIC Frederick NCI-FCRDC, P.O. Box B Frederick, Maryland 21702—1201 Phone: 301-644-2039 Fax: 301-644-2027 E-mail: abishop@mail.ncifcrf.gov
E. The following individuals are representatives designated by Vical, Incorporated:
18
ARTICLE G.2. INVOICE SUBMISSION
A. Invoices shall be prepared and submitted as follows:
1. An original to the following designated payment office:
NCI-Frederick Cancer Research & Development Center SAIC Frederick Accounts Payable Department, Building 244 P. O. Box B - West 7th Street Frederick, Maryland 21702-1201
2. A copy of the invoice should be sent via mail or facsimile to Annette Bishop (see Article G.1.D)
B. Inquiries regarding payment of invoices should be directed to the attention of Annette Bishop (see Article G.1.D).
C. An invoice is a written request for payment under the contract for items delivered, services rendered, or milestones achieved. In order to be proper, an invoice must include, as applicable, the following:
(1) Invoice date (note: date of Contractor’s invoice shall not be earlier than delivery/service date (2) Contractor’s name (3) Contract number (including Delivery Order number , if applicable) (4) Description of items or services, quantity, contract unit of measure, contract unit price, and extended total (5) Payment terms and any trade discounts or allowances (6) Wiring instructions for which the payment is to be made; and (7) Name, title, phone number, and mailing address of person to be notified in event of a defective invoice.
E. The Contractor may invoice SAIC-Frederick, Inc. following the successful completion of milestones listed in Article C.2. The completion of the last milestone is defined as the earlier of shipment or 60 days following completion of vialing (100-Liter scale), or bulk material (500-Liter scale). The Contractor may invoice for master cell bank preparation, document preparation and shipping preparation, and stability testing after services are provided.
F. SAIC shall pay the Contractor, upon the submission of proper invoices or vouchers, the prices stipulated in this contract for products/services rendered and accepted, less any deductions provided in this contract.
G. A proper invoice will be deemed to have been received, when it is received by the office designated in the contract, or Delivery Order issued hereunder, for receipts of invoices and acceptance of the items delivered or services rendered has occurred.
19
H. Payment shall be considered made on the date on which a check for such payment is dated. If the Contractor opts to receive electronic funds transfer (EFT), payment shall be considered made on the date of the transfer.
ARTICLE G.3 GOVERNMENT PROPERTY
A. The parties agree that no non-expendable property or equipment will be acquired or furnished under this contract, unless prior written authorization is obtained from the Contracting Officer.
B. The following equipment/documentation will be provided by the Government:
[ …***… ]
ARTICLE G.4. ORDERING
A. Any services to be furnished under this contract shall be ordered by the issuance of a Delivery Order (See Attachment C for example) by the SAIC-Frederick, Inc. Contracting Officer. Such Delivery Orders may be issued commencing with the date of the contract award through the contract expiration date (ordering period). Prior to the placement of a Delivery Order, the Contractor shall provide detailed comparison data that will demonstrate to the Government the suitability of the 500-L process given
20
previous 100-L performance.
B. All Delivery Orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order and this contract, the contract shall control.
C. The Government shall place Delivery Orders a minimum of six (6) months in advance of the anticipated manufacturing start date. Delivery Orders may be issued via facsimile, email, or the mail by the SAIC-Frederick, Inc. Contracting Officer. If mailed, a Delivery Order is considered “issued” when SAIC deposits the order in the mail. The Contractor will notify the Contract Administrator (See ARTICLE G.1.D.) within 10 business days that the Order has been received and work shall begin in accordance with the order.
D. The Government shall submit rolling utilization forecasts (see Attachment E for example) to the Contractor a minimum of one year in advance of the anticipated manufacturing start date. The utilization forecast shall project all weeks of processing time requested for each manufacturing campaign that is anticipated to start during the one year utilization forecast period. The rolling forecast will be provided monthly throughout the term of this Agreement and will show production demand on a weekly basis for the next twelve months. The first rolling forecast is due upon award of this contract.
E. Nine months prior to the anticipated start date of work requiring the 500-Liter manufacturing train, the Government shall issue a Reservation Order (see Attachment B for example) reserving the necessary manufacturing weeks. The Reservation Order will have a fixed dollar amount equivalent to [ …***… ] of the price of the reserved manufacturing weeks (in accordance with Article B.2). In the event t | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
AGREEMENTS / CONTRACTS
CLAUSES
| Get Email Updates |
