CONTRACT

Exhibit 10.53

 

ADB Contract Number: N01-AI-50004

 

OMB Approval 2700-0042    

 

 

 

 

 

 

 

 

 

Contract No. HHSN266200500004C

 

DETAILED TABLE OF CONTRACT CONTENTS

 

 

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Contract No. HHSN266200500004C

 

 

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Contract No. HHSN266200500004C

 

SECTION B—SUPPLIES OR SERVICES AND PRICES/COSTS

 

ARTICLE B.1. BRIEF DESCRIPTION OF SERVICES

 

This acquisition is being issued for services to develop and manufacture cGMP bulk drug substance for up to three human or human compatible mAbs with potency demonstrated in a standardized mouse protection bioassay for botulinum neurotoxins A1 and A2.

 

ARTICLE B.2. PRICES

 

a.	The total fixed price of this contract is $ 15,000,000.00 .

 

b.

Upon delivery and acceptance of the items and/or services specified in SECTION F, ARTICLE F.2. and described in SECTION C, the Government shall make progress payments monthly, upon submission of proper invoices or vouchers, the prices stipulated in this contract for work delivered or rendered and accepted, less 10 percent of the total amount of the payment. If satisfactory progress is achieved and upon completion of the contract, the Government shall release all withheld funds to the contractor.

 

MILESTONE PAYMENT SCHEDULE

 

 

ARTICLE B.3. ADVANCE UNDERSTANDINGS

 

Other provisions of this contract notwithstanding, approval of the following items within the limits set forth is hereby granted without further authorization from the Contracting Officer.

 

a.	cGMP Audit

 

A Pre-award site visit and cGMP audit was carried out at XOMA facilities on February 3-4, 2005 and recommendations were made by the auditors. Progress on these recommendations must be tracked in the monthly reports and through frequent formal communication with NIAID Project Officer.

 

NIAID will require additional audits and inspections of Prime Contractor and Subcontractor’s facilities and documents throughout the performance period of the contract.

 

b.	Written plan, timeline, Gantt Chart

 

XOMA is expected to provide a written plan, timeline, Gantt chart or other means of documenting all development activities that would designate the individual studies, outline (i.e. in a paragraph or two) how these studies would be

 

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conducted (e.g. a few paragraphs to describe the specifics for the study such as the number of replicates, conditions, numbers of samples, test to be conducted, etc.). The first written plan should be provided within two weeks of contract award and cover the first three months of activities. Subsequent plans should be provided quarterly, and two weeks in advance of initiation of activities outlined in the plan. Modifications to plans should be discussed with NIAID prior to changes. These plans should allow NIAID to be prospectively involved in the development of the product to better ensure that the resulting process will be robust, transferable, and meet long term FDA scrutiny. Specifically it is required that Analytical Development Reports, Process Development Reports, Validation Protocols and Qualification Reports will be included as part of the final report, and the Technical Transfer Packages. Critical reagents and/or reagent production procedures are also required as part of the Technical Transfer Package. In addition, the Batch Production Records are expected to contain sufficient detail to allow for technical transfer of the manufacturing process, either as part of the Batch Production Record itself or as an appendix to the Batch Production Record.

 

c.	Subcontract – SRI International

 

A firm fixed-price type subcontract with SRI International at a fixed price of $934,051 for an eighteen month period of performance March 7, 2005 to September 6, 2006. A copy of the signed, approved subcontract must be provided to the Contracting Officer within 30 calendar days after the effective date of the contract . The subcontractor may not begin performance until the subcontracting agreement has been executed by both parties.

 

d.	Contract Number Designation

 

On all correspondence submitted under this contract, the contractor agrees to clearly identify the two contract numbers that appear on the face page of the contract as follows:

 

Contract No. HHSN266200500004C

ADB Contract No. N01-AI-50004

 

[End of Section B]

 

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Contract No. HHSN266200500004C

 

SECTION C—DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

 

ARTICLE C.1. STATEMENT OF WORK

 

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work, SECTION J, ATTACHMENT 1, dated March 8, 2005, attached hereto and made a part of this contract.

 

ARTICLE C.2. REPORTING REQUIREMENTS

 

a.	Technical Reports

 

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE F.2. DELIVERIES of this contract:

 

1. Monthly Technical Progress Reports

 

The Contractor shall submit a Monthly Technical Report that shall include the following specific information:

 

a)

Cover page that lists the contract number and title, the period of performance being reported, the contractor’s name and address, the author(s), and the date of submission;

 

b)

An introduction covering the purpose and scope of the contract effort;

 

c)

Detail, document, and summarize the results of work completed and cost incurred during the period covered in relation to proposed effort and budget.

 

These reports shall be in sufficient detail to explain comprehensively the results achieved. The description shall include pertinent data and/or conclusions resulting from analysis and scientific evaluation of data accumulated to date under the project. Also to be included is a summary of the work proposed for the next reporting period.

 

The first report shall be submitted on or before April 22 ^nd , 2005 . Thereafter, reports shall be due on or before the 20 ^th of the month following each monthly reporting period.

 

2. Milestone Reports

 

A milestone report will be provided after the completion of each Milestone unless otherwise agreed by the Principal Investigator and the Project Officer. Milestone reports and monthly reports may be combined if agreed by the Project Officer. These reports shall be due on or before the 15 ^th day after completion of each milestone.

 

3. Final Report

 

The contractor shall submit an original and one (1) copy of the Final Report that details, documents, and summarizes the results of the entire contract work for the period covered. This report shall be in sufficient detail to explain comprehensively the results achieved. This Final Report shall be submitted on or before the completion date of the contract.

 

b.	Reports Distribution

 

Copies of the technical reports shall be submitted to the Project Officer and Contracting Officer in accordance with ARTICLE F.2. DELIVERIES. If the Contractor is unable to deliver the reports specified hereunder within the period of performance because of unforeseen difficulties, notwithstanding the exercise of good faith and diligent efforts in performance of the work, the Contractor shall give the Contracting Officer immediate written notice of anticipated delays, stating the reasons and providing the revised delivery date. The revised submission date is subject to the approval of the Project Officer and Contracting Officer.

 

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ARTICLE C.3. INVENTION REPORTING REQUIREMENT

 

All reports and documentation required by [FAR Clause 52.227-11/FAR Clause 52.227-11 (Deviation)/FAR Clause 52.227-13] including, but not limited to, the invention disclosure report, the confirmatory license, and the government support certification, shall be directed to the Extramural Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive, Room 1040 A, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

 

The final invention statement (see FAR 27.303(a)(2)(ii)) shall be submitted on the expiration date of the contract to the following address:

 

Liem T. Nguyen

Contract Specialist

National Institutes of Health

National Institute of Allergy and Infectious Diseases, DEA, CMP

6700B Rockledge Drive, Room 3214

Bethesda, Maryland 20892-7612

 

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

 

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed “Interagency Edison,” an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov) , or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

 

[End of Section C]

 

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SECTION D—PACKAGING, MARKING AND SHIPPING

 

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

 

[End of Section D]

 

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Contract No. HHSN266200500004C

 

SECTION E—INSPECTION AND ACCEPTANCE

 

a.	The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

 

b.	For the purpose of this SECTION, the Project Officer identified in ARTICLE G.1. is the authorized representative of the Contracting Officer.

 

c.	Inspection and acceptance will be performed at NIH, NIAID, DMID, 6610 Rockledge Drive, Room 4011, Bethesda, Maryland 20892.

 

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

 

d.	This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

 

FAR Clause 52.246-4, INSPECTION OF SERVICES—FIXED PRICE (AUGUST 1996).

 

[End of Section E]

 

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SECTION F—DELIVERIES OR PERFORMANCE

 

ARTICLE F.1. PERIOD OF PERFORMANCE

 

The period of performance of this contract shall be from the date of award for a total period of 549 calendar days.

 

ARTICLE F.2. DELIVERIES

 

a.

Satisfactory performance of this contract shall be deemed to occur upon performance of the work described in Article C.1. and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the items specified in the Delivery Schedule which are described in SECTION C of this contract.

 

The items specified below as described in SECTION C, ARTICLE C.2. will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. DESTINATION, WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of the contract:

 

 

b.	The above items shall be addressed and delivered to the address/addressee listed below:

 

Project Officer

Division of Microbiology and Infectious Diseases

NIAID, NIH, DHHS

6610 Rockledge Drive, Room 4011

BETHESDA MD 20892-6604

 

Contracting Officer

CMP, DEA, NIAID, NIH, DHHS

Room 3214

6700B Rockledge Drive, MSC 7612

Bethesda, MD 20892-7612

 

c.	Unless otherwise specified, deliveries shall be made to the Delivery Point specified above Mondays through Fridays (excluding Federal Holidays) between the hours of 8:30 a.m. and 5:30 p.m. EST only. Supplies or services scheduled for delivery on a Federal holiday shall be made the following day.

 

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ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

 

This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.arnet.gov/far/.

 

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

 

52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).

 

[End of Section F]

 

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SECTION G—CONTRACT ADMINISTRATION DATA

 

ARTICLE G.1. PROJECT OFFICER

 

The following Project Officer will represent the Government for the purpose of this contract:

 

Katherine A. Taylor, Ph.D.

Division of Microbiology and Infectious Diseases

NIAID, NIH, DHHS

6610 Rockledge Drive, Room 4011

MSC 6604

Bethesda, Maryland 20892-6604

Phone: 301-451-5068

Email: kataylor@niaid.nih.gov

 

The Project Officer 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.

 

The Contracting Officer is the only person with authority to act as 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.

 

The Government may unilaterally change its Project Officer designation.

 

ARTICLE G.2. KEY PERSONNEL

 

Pursuant to the Key Personnel clause incorporated in Section I of this contract, the following individual is considered to be essential to th