Draft Statement of Work - 75N98026Q00996.pdf

DRAFT STATEMENT OF WORK (SOW)

1.0 TITLE

Quantifying Prediction Error in Two-time Scale Competing Risk Models

2.0 BACKGROUND

The Surveillance Research Program (SRP) of the National Cancer Institute (NCI) supports various cancer surveillance programs, including the Surveillance, Epidemiology, and End Results (SEER) Program. SEER consists of population-based registries covering nearly 50% of the US population. To highlight the cancer burden in the United States (US), SRP reports annually on incidence, survival, treatment, and mortality trends using SEER registry data. Such reports are widely disseminated, garnering attention in the medical literature and the wider public.

Survival information has often been presented as net survival. Net survival measures the probability of dying of cancer in the absence of non-cancer death and has utility as a cancer control measure. However, net survival is less useful for cancer patients and clinicians as patients are at risk of dying of non-cancer causes. Survival measures that can account for competing risks such as other-cause death are valuable for clinical decision-making. For example, patients with multiple comorbidities may have an elevated risk of non-cancer death, thereby justifying not pursuing aggressive cancer treatment. Cumulative probabilities of cancer death, non-cancer death, and the probability of survival are of interest when calculating statistics that account for competing causes of death.

SRP has invested in the development of methods to better utilize SEER data and estimate competing risks survival models. The ultimate goal is to develop tools that provide clinically relevant survival information to physicians and individual patients. Statistical methods that can produce more accurate measures of the risks of cancer and non-cancer death are of high interest to SRP.

Standard competing risks analysis models cause-specific hazard functions from diagnosis for both cancer and non-cancer death via the proportional hazards model in continuous time, as described in Cheng, Fine, and Wei (Biometrics, 1999). Later, Lee et al (2017, Biostatistics) modeled cancer mortality on the time since diagnosis scale and other-cause mortality on the age time scale. Other-cause mortality was modeled on the age scale as this is a more natural scale to model the risk of non-cancer death. Lee et al (2019, Statistics in Medicine) extended the two time scale, continuous-time method to discrete time and proposed a flexible and computationally convenient framework. In the prior work by Lee et al (2017, Biostatistics; 2019, Statistics in Medicine), as patients become “at risk” only after diagnosis, the other-cause death model accounted for left truncation at the diagnosis age. In a prior contract, the contractor extended the discrete-time methods of Lee et al (2019, Statistics in Medicine) to continuous time using parametric models. Continuous time offers a computationally simpler and more straight-forward framework than discrete time. Moreover, most risk calculators and clinical nomograms are presented in continuous time. To improve the value of continuous-time competing risks models, additional enhancements are needed.

One enhancement is to develop measures of predictive accuracy and prediction error for competing risks models on two time scales. Predictive accuracy is the ability of the model to produce individual predictions that are close to the observed values. Prediction can be quantified for each cause and overall, both at specific time points and averaged across all times.

Work in this area has been limited, and most prior work focused on estimating prediction error for a single cause at a particular time point. Methods to produce an overall estimate of prediction error that accounts for multiple competing risks have not been widely disseminated.

Quantifying prediction error is important as it provides a measure of assurance in model predictions. As SRP is interested in developing risk prediction tools for the general public, including predictive accuracy measures in such tools is necessary to provide users with an idea of the reliability of the predictions that are produced.

2.1 OBJECTIVE

The purpose of this contract is to extend methods for risk prediction for continuous-time competing risks survival models on two-time scales. Competing risks models may be parametric or semi-parametric. The contract aims to explore measures to summarize prediction error. The innovation of this contract is to develop measures to assess how well the competing risks models can predict the risk of cancer and other-cause death. SRP expects that the methods proposed in this contract will be used in reports or web-based tools to contextualize the probabilities of dying of cancer, dying of other causes, and surviving that will be useful for clinical decision making.

3.0 SCOPE

This contract will extend risk prediction methods for a continuous-time competing risks model using two time scales: age for non-cancer (other-cause) death and time since diagnosis for cancer death. For the competing risks models, the Contractor shall implement both semiparametric and parametric models. With parametric models, the Gompertz, piecewise Gompertz, or flexible parametric baseline hazard will be used by the Government and Contractor for other-cause mortality modeling. To quantify prediction error, the Government and Contractor will explore time-dependent and overall measures based on a simple Brier score. In addition, both parties will develop cause-specific and overall predictive accuracy measures. The deliverables from this work will be an outline of the methodology, a draft manuscript to be submitted to a statistical journal, and all software developed to implement this approach.

4.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

The Contractor shall accomplish the following objectives:

4.1 Develop Methodology for Prediction Accuracy for Competing Risks Models on Two

Time Scales

The Contractor shall develop methodology to summarize cause-specific and overall prediction error for competing risks models fit on two time scales. Other-cause mortality will be modeled on the age scale and cancer mortality will be modeled on the time since diagnosis scale. The competing risks model for each cause may be parametric or semiparametric.

4.1.1 Develop predictive accuracy measures for competing risks

The first objective (Ob1) is to develop predictive accuracy measures for continuous-time competing risk models on two time scales. Task 1.1 of Ob1 is to fit the two-time scales continuous time models. Task 1.2 for Ob1 is to define cause-specific and overall prediction error based on the continuous time models fit in Task 1.1. Task 1.3 for Ob1 is to study the numerical and statistical properties of the measures developed in Task 1.2. Numerical comparisons will use artificially generated data and real datasets.

4.2 Develop Software for Calculating Prediction Error Measures

The Contractor shall develop reproducible software programs to calculate the prediction error measures developed in Objective 4.1. The program will be implemented by the Government and Contractor in standard statistical software programs, such as SAS, R, or Stata. The program will allow users to calculate the prediction error for a competing risks model on two time scales.

The program may also include functions to generate visualizations based on the data or model output. The program may depend on standard functions available in the chosen software program, functions available through libraries, or original code.

4.2.1 Develop reproducible software program in statistical software:

The second objective (Ob2) is to provide software implementing the prediction error calculations developed in Ob1. Task 2.1 for Ob2 is to produce a reproducible software program or function to implement the proposed methodology. Prediction error measures will be implemented in standard statistical software (R, SAS) and will allow users to fit competing risks models on two time scales, obtain risk predictions, and derive the cause-specific and overall prediction error. The program will include functions to generate data visualizations and model output. The program will use standard functions available through pre-existing libraries where possible, and original code where standard functions are not available.

4.3 Summarize Research Findings in a Technical Report

The Contractor shall summarize the methodology and results in a research report that is suitable for publication in a statistical or medical research journal. The Contractor should outline the novelty and utility of the methods developed in this contract. The report will include both theoretical details of the methodology and a real-data illustration using a cancer-related data set.

4.3.1 Generate manuscript summarizing major findings :

The third objective (Ob3) is to generate the probabilities of dying of cancer, dying of other causes, and surviving that will be useful for clinical decision making, along with associated prediction errors. Task 3.1 for Ob3 is to draft a manuscript describing the proposed predictive accuracy measures for continuous time risk predictions and the numerical results, both simulated and based on real data sets. Task 3.2 for Ob3 will be to draft a manuscript outlining the statistical software implemented from Ob2. These drafts will be disseminated in peer-reviewed journals.

5.0 TYPE OF ORDER

This is a firm fixed price purchase order.

6.0 PERIOD OF PERFORMANCE

The period of performance shall be:

Base Period: 12 months from the date of award.

Option Period One: 12 months following the Base Period.

7.0 PLACE OF PERFORMANCE

The work shall be performed at the Contractor’s facility.

8.0 NON-GOVERNMENT INFORMATION/DOCUMENTS

The Contractor may develop the program to calculate prediction error measures in a standard statistical software program such as R, SAS, or Stata. Depending on which software program the Contractor chooses, they may implement their methods as a set of functions in a sole program, a library or package, or a macro function. If the Contractor would like to submit the programs to a wider audience (e.g., an R package), the program must adhere to all standards set forth by CRAN (https://cran.r-project.org/submit.html).

https://cran.r-project.org/submit.html

9.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

All written deliverables shall be sent electronically to the NCI Technical Point of Contact (TPOC), TBD at award, in appropriate formats (including but not limited BAM, CRAM, VCF, Excel, DOC, CSV, PDF, PNG, etc.) unless approved by the TPOC in accordance with the deliverable schedule below. The TPOC shall review the contents of all draft deliverables. If no comments or requests for revisions are provided to the Contractor within 30 business days, the deliverables shall be considered acceptable. If revisions are required, NCI shall respond to the Contractor within five

(5) business days of receiving the deliverable, specifying the required changes/revisions. Final copies of approved drafts shall be delivered to the NCI TPOC within five (5) business days after receipt of the Government’s comments.

The TPOC for this order is:

(TBD)

All deliverables shall be sent electronically per the following deliverable schedule:

DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT

REQUIREMENTS DUE DATE

Base Period

Base Period Objective 4.1

Methodology for quantifying cause-specific and overall prediction error for competing risks model on two-time scales.

11 months after award

Base Period Objective 4.2

Programs for implementation of the proposed methodology.

Option Period One

Option Period One Objective 4.2

Programs for implementation of the proposed methodology.

Option Period One Objective 4.3

Manuscript draft on the proposed methodology with a real-data application.

10.0 INSPECTION AND ACCEPTANCE CRITERIA

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this contract is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI TPOC, TBD, who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below, shall be the responsibility of the Contractor.

Products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. §

1194.1 & Apps. A, C & D, and available at https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards- and-guidelines.

Per Section 508 and as mandated under HHS Policy for Section 508 Compliance and Accessibility of Information and Communications Technology (ICT) (07/2020) all documents or electronic files provided to the NIH NCI under contract must be conformant with Section 508 standards and accessible to persons with disabilities. Conformance shall be confirmed by use of material provided at HHS OS Factsheets & Reference Guides and verified through the use of the HHS Checklist Documents (WCAG 2.0 Refresh); in addition, contractors and vendors are encouraged to make use of the instructional materials and checklists at GSA Section 508.gov’s Create Accessible Digital Products.

11.0 PAYMENT

Payment shall be made every six months upon delivery, inspection and acceptance by the Government. Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the attached payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the

Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract

Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.

* NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

B. The Contractor shall submit invoices to the Department of Treasury’s Invoice

Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following TPOC:

(TBD)

II. Invoice Payment

A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (Mar 2023)

(a)

(1) In accordance with 31 U.S.C. 3903 and 10 U.S.C. 3801, within 15 days after receipt of accelerated payments from the Government, the Contractor shall make accelerated payments https://www.ipp.gov/ to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

(2) The Contractor agrees to make such payments to its small business subcontractors without any further consideration from or fees charged to the subcontractor.

(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of clause)

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

12.0 PURCHASE ORDER CLAUSES

FAR 52.227-14 Rights in Data-General (MAY 2014)

As prescribed in 27.409(b)(1), insert the following clause with any appropriate alternates:

Rights in Data-General (May 2014)

(a) Definitions. As used in this clause-

Computer database or "database means" a collection of recorded information in a form capable of, and for the purpose of, being stored in, processed, and operated on by a computer. The term does not include computer software.

Computer software-

(1) Means (i) Computer programs that comprise a series of instructions, rules, routines, or statements, regardless of the media in which recorded, that allow or cause a computer to perform a specific operation or series of operations; and

(ii) Recorded information comprising source code listings, design details, algorithms, processes, flow charts, formulas, and related material that would enable the computer program to be produced, created, or compiled.

(2) Does not include computer databases or computer software documentation.

Computer software documentation means owner’s manuals, user’s manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software.

Data means recorded information, regardless of form or the media on which it may be recorded. The term includes technical data and computer software. The term does not include information incidental to contract administration, such as financial, administrative, cost or pricing, or management information.

Form, fit, and function data means data relating to items, components, or processes that are sufficient to enable physical and functional interchangeability, and data identifying source, size, configuration, mating and attachment characteristics, functional characteristics, and performance requirements. For computer software it means data identifying source, functional characteristics, and performance requirements but specifically excludes the source code, algorithms, processes, formulas, and flow charts of the software.

Limited rights means the rights of the Government in limited rights data as set forth in the Limited Rights Notice of paragraph (g)(3) if included in this clause.

Limited rights data means data, other than computer software, that embody trade secrets or are commercial or financial and confidential or privileged, to the extent that such data pertain to items, components, or processes developed at private expense, including minor modifications.

Restricted computer software means computer software developed at private expense and that is a trade secret, is commercial or financial and confidential or privileged, or is copyrighted computer software, including minor modifications of the computer software.

Restricted rights, as used in this clause, means the rights of the Government in restricted computer software, as set forth in a Restricted Rights Notice of paragraph (g) if included in this clause, or as otherwise may be provided in a collateral agreement incorporated in and made part of this contract, including minor modifications of such computer software.

Technical data means recorded information (regardless of the form or method of the recording) of a scientific or technical nature (including computer databases and computer software documentation). This term does not include computer software or financial, administrative, cost or pricing, or management data or other information incidental to contract administration.

The term includes recorded information of a scientific or technical nature that is included in computer databases (See 41 U.S.C. 116).

Unlimited rights means the rights of the Government to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly, in any manner and for any purpose, and to have or permit others to do so.

(b) Allocation of rights. (1) Except as provided in paragraph (c) of this clause, the Government shall have unlimited rights in-

(i) Data first produced in the performance of this contract;

(ii) Form, fit, and function data delivered under this contract;

(iii) Data delivered under this contract (except for restricted computer software) that constitute manuals or instructional and training material for installation, operation, or routine maintenance and repair of items, components, or processes delivered or furnished for use under this contract; and

(iv) All other data delivered under this contract unless provided otherwise for limited rights data or restricted computer software in accordance with paragraph (g) of this clause.

(2) The Contractor shall have the right to-

(i) Assert copyright in data first produced in the performance of this contract to the extent provided in paragraph (c)(1) of this clause;

(ii) Use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, unless provided otherwise in paragraph (d) of this clause;

(iii) Substantiate the use of, add, or correct limited rights, restricted rights, or copyright notices and to take other appropriate action, in accordance with paragraphs (e) and (f) of this clause;

and

(iv) Protect from unauthorized disclosure and use those data that are limited rights data or restricted computer software to the extent provided in paragraph (g) of this clause.

(c) Copyright- (1) Data first produced in the performance of this contract. (i) Unless provided otherwise in paragraph (d) of this clause, the Contractor may, without prior approval of the Contracting Officer, assert copyright in scientific and technical articles based on or containing data first produced in the performance of this contract and published in academic, technical or professional journals, symposia proceedings, or similar works. The prior, express written permission of the Contracting Officer is required to assert copyright in all other data first produced in the performance of this contract.

(ii) When authorized to assert copyright to the data, the Contractor shall affix the applicable copyright notices of 17 U.S.C. 401 or 402, and an acknowledgment of Government sponsorship (including contract number).

(iii) For data other than computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in such copyrighted data to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly by or on behalf of the Government. For computer software, the Contractor grants to the Government, and others acting on its behalf, a paid-up, nonexclusive, irrevocable, worldwide license in such copyrighted computer software to reproduce, prepare derivative works, and perform publicly and display publicly (but not to distribute copies to the public) by or on behalf of the Government.

(2) Data not first produced in the performance of this contract. The Contractor shall not, without the prior written permission of the Contracting Officer, incorporate in data delivered under this contract any data not first produced in the performance of this contract unless the Contractor-

(i) Identifies the data; and

(ii) Grants to the Government, or acquires on its behalf, a license of the same scope as set forth in paragraph (c)(1) of this clause or, if such data are restricted computer software, the Government shall acquire a copyright license as set forth in paragraph (g)(4) of this clause (if included in this contract) or as otherwise provided in a collateral agreement incorporated in or made part of this contract.

(3) Removal of copyright notices. The Government will not remove any authorized copyright notices placed on data pursuant to this paragraph (c), and will include such notices on all reproductions of the data.

(d) Release, publication, and use of data. The Contractor shall have the right to use, release to others, reproduce, distribute, or publish any data first produced or specifically used by the Contractor in the performance of this contract, except-

(1) As prohibited by Federal law or regulation (e.g., export control or national security laws or regulations);

(2) As expressly set forth in this contract; or

(3) If the Contractor receives or is given access to data necessary for the performance of this contract that contain restrictive markings, the Contractor shall treat the data in accordance with such markings unless specifically authorized otherwise in writing by the Contracting Officer.

(e) Unauthorized marking of data. (1) Notwithstanding any other provisions of this contract concerning inspection or acceptance, if any data delivered under this contract are marked with the notices specified in paragraph (g)(3) or (g) (4) if included in this clause, and use of the notices is not authorized by this clause, or if the data bears any other restrictive or limiting markings not authorized by this contract, the Contracting Officer may at any time either return the data to the Contractor, or cancel or ignore the markings. However, pursuant to 41 U.S.C.

4703, the following procedures shall apply prior to canceling or ignoring the markings.

(i) The Contracting Officer will make written inquiry to the Contractor affording the Contractor 60 days from receipt of the inquiry to provide written justification to substantiate the propriety of the markings;

(ii) If the Contractor fails to respond or fails to provide written justification to substantiate the propriety of the markings within the 60-day period (or a longer time approved in writing by the Contracting Officer for good cause shown), the Government shall have the right to cancel or ignore the markings at any time after said period and the data will no longer be made subject to any disclosure prohibitions.

(iii) If the Contractor provides written justification to substantiate the propriety of the markings within the period set in paragraph (e)(1)(i) of this clause, the Contracting Officer will consider such written justification and determine whether or not the markings are to be cancelled or ignored. If the Contracting Officer determines that the markings are authorized, the Contractor will be so notified in writing. If the Contracting Officer determines, with concurrence of the head of the contracting activity, that the markings are not authorized, the Contracting Officer will furnish the Contractor a written determination, which determination will become the final agency decision regarding the appropriateness of the markings unless the Contractor files suit in a court of competent jurisdiction within 90 days of receipt of the Contracting Officer’s decision. The Government will continue to abide by the markings under this paragraph (e)(1)(iii) until final resolution of the matter either by the Contracting Officer’s determination becoming final (in which instance the Government will thereafter have the right to cancel or ignore the markings at any time and the data will no longer be made subject to any disclosure prohibitions), or by final disposition of the matter by court decision if suit is filed.

(2) The time limits in the procedures set forth in paragraph (e)(1) of this clause may be modified in accordance with agency regulations implementing the Freedom of Information Act ( 5 U.S.C.

552) if necessary to respond to a request thereunder.

(3) Except to the extent the Government’s action occurs as the result of final disposition of the matter by a court of competent jurisdiction, the Contractor is not precluded by paragraph (e) of the clause from bringing a claim, in accordance with the Disputes clause of this contract, that may arise as the result of the Government removing or ignoring authorized markings on data delivered under this contract.

(f) Omitted or incorrect markings. (1) Data delivered to the Government without any restrictive markings shall be deemed to have been furnished with unlimited rights. The Government is not liable for the disclosure, use, or reproduction of such data.

(2) If the unmarked data has not been disclosed without restriction outside the Government, the Contractor may request, within 6 months (or a longer time approved by the Contracting Officer in writing for good cause shown) after delivery of the data, permission to have authorized notices placed on the data at the Contractor’s expense. The Contracting Officer may agree to do so if the Contractor-

(i) Identifies the data to which the omitted notice is to be applied;

(ii) Demonstrates that the omission of the notice was inadvertent;

(iii) Establishes that the proposed notice is authorized; and

(iv) Acknowledges that the Government has no liability for the disclosure, use, or reproduction of any data made prior to the addition of the notice or resulting from the omission of the notice.

(3) If data has been marked with an incorrect notice, the Contracting Officer may-

(i) Permit correction of the notice at the Contractor’s expense if the Contractor identifies the data and demonstrates that the correct notice is authorized; or

(ii) Correct any incorrect notices.

(g) Protection of limited rights data and restricted computer software. (1) The Contractor may withhold from delivery qualifying limited rights data or restricted computer software that are not data identified in paragraphs (b)(1)(i), (ii), and (iii) of this clause. As a condition to this withholding, the Contractor shall-

(i) Identify the data being withheld; and

(ii) Furnish form, fit, and function data instead.

(2) Limited rights data that are formatted as a computer database for delivery to the Government shall be treated as limited rights data and not restricted computer software.

(3) [Reserved]

(h) Subcontracting. The Contractor shall obtain from its subcontractors all data and rights therein necessary to fulfill the Contractor’s obligations to the Government under this contract.

If a subcontractor refuses to accept terms affording the Government those rights, the Contractor shall promptly notify the Contracting Officer of the refusal and shall not proceed with the subcontract award without authorization in writing from the Contracting Officer.

(i) Relationship to patents or other rights. Nothing contained in this clause shall imply a license to the Government under any patent or be construed as affecting the scope of any license or other right otherwise granted to the Government.

(End of clause)

FAR 52.217-9 – OPTION TO EXTEND THE TERMS OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days of purchase order expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 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 42 months.

(End of clause)