RFQ 75F40122Q00001 Patent Legal Services.pdf

Solicitation Number: 75F40122Q00001

Title: Patent Legal Services

Food and Drug Administration (FDA)

Office of Operations

Office of the Commissioner

Request for Quote #: 75F40122Q00001

Table of Contents

PART I SOLICITATION information

1. DESCRIPTION

2. NOTICE OF COMBINED SYNOPSIS/SOLICITATION

3. NOTICE OF FAC

4. CONTRACT TYPE AND MINIMUM/MAXIMUM AMOUNTS

Pricing Schedule

PART 2 - Requirements:

1. Background

2. Objective

3. Scope of Work

4. Task areas

4.1. Patent Legal Services

4.1.1. Patent Search Services

4.1.2. Patent Opinions

4.1.3. Patent Prosecution Services

4.1.4. Patent Litigation

4.1.5. Petitions

4.1.6. Ancillary Patent Services

4.1.7. Fee Payment Services

4.1.8. Infringement and Interference Services

4.1.9. Post Grant Proceedings

4.1.10. Transition Activities

4.1.10.1. Initial Transition of patent work in to Contractor

4.1.10.2. Transition of patent work in to Contractor

4.1.10.3. Transition of patent work out to other law firms

4.2. Project Management

5. ORDERING PROCEDURES

PART 3 FAR and HHSAR CLAUSES

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—

Commercial Products and Commercial Services. (Nov 2021)

52.212-1 Instructions to Offerors—Commercial Products and Commercial Services. (Nov 2021)

PART 4 FDA INFORMATION:

1. Place Of Performance

2. Period Of Performance

3. Agency Task Order Ombudsman

4. Points Of Contact

5. Contracting Officer’s Authority

6. Contracting Officer’s Representative

7. Government Furnished Property

8. Travel Administration

9. Security

10. Organizational Conflict Of Interest

11. Non-Personal Services

12. Personnel Security Clearance Requirements

13. 508 Standard Requirements

14. Inspection And Acceptance

15. Contractor Performance Evaluations

16. Observance Of Federal Holidays

17. Reporting Matters Involving Fraud, Waste And Abuse

18. General Invoicing Instructions

19. FDA 3398 – Access to Non-Public Information

20. Briefings

21. Security and Privacy Language for Information and Information Technology Procurements

22. Contractor Security Requirements

PART 5 – Solicitation Provisions And QUOTE Instructions

PART 6 – EVALUATION

Basis of Award and Evaluation Criteria

Attachments

PART I SOLICITATION INFORMATION

1. DESCRIPTION

This contract is to acquire Patent Legal Services that support the entire patent life cycle and provide protection for FDA-owned intellectual property across FDA’s Technologies. Patent Legal Services acquired under this contract consist of pre-grant prosecution activities such as patent search services, patent opinions, patent prosecution services, patent litigation, petitions, ancillary patent services and patent fee payment services for both domestic and foreign patent filings. FDA also requires legal services that support contested proceedings and Post-grant activities such as proceedings conducted by the Patent Trial and

Appeal Board, Ex-Parte, Inter-Partes Review, covered business method reviews, post-grant review, interference, and licensing consultation. Such post grant services also include reissue, reexamination and interference activities and opposition activities conducted before foreign patent offices.

2. NOTICE OF COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. This is a request for quotations (RFQ) for commercial items in accordance with (IAW) the procedures of FAR Part 12 – Acquisition of Commercial Items, and FAR Part 13.5.

This requirement is being solicited for unrestricted competition, and the Government contemplates a single award, hybrid Labor Hour/Firm-Fixed Price, IDIQ contract will result from this solicitation. The associated North American Industrial Classification System (NAICS) code for this procurement is 541110 Offices of Lawyers. Its associated Small Business Size Standard is $11 Million. The PSC Code is R418 – Support Professional: Legal.

3. NOTICE OF FAC

This solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular 2022-01 dated 12-06-2021. The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) Number/Effective Date: 2022-01 dated 12-06-2021.

FAR provisions and clauses referenced in this RFQ can be found on the following website:

www.acquisition.gov. HHSAR provisions and clauses referenced in this RFQ can be found on the following website: www.acquisition.gov/hhsar.

4. CONTRACT TYPE AND MINIMUM/MAXIMUM AMOUNTS

Contract Type

The Government anticipates one Indefinite Delivery-Indefinite Quantity (IDIQ) type contract, with a https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%2012_6.html#wp1088488 http://www.acquisition.gov/ http://www.acquisition.gov/hhsar

Performance Period of five (5) years, a ceiling of $5,000,000 and a guaranteed minimum of $500.00, which is being funded in this Base IDIQ Award. Task Order types may include Time And Materials, Labor Hour, Or Firm Fixed Price. Task Order will be issued by the Contracting Officer to the Contractor.

Technical direction may be provided by the task order COR in accordance with information below.

Pricing Terms

Labor Rates quoted for each task order issued against the resulting IDIQ contract shall be in accordance with the quoted labor categories and fixed labor rates. If a task order’s stated period of performance must be extended as a result of Government delay, the Contractor shall request that the most current labor rates be used to price the work effort during the extended period. However, in no event shall the Contractor perform, or be paid for any work which exceeds the stated price or not-to-exceed dollar amount of a task order. Reference: FAR 52.232-7 (AUG 2012) for Time and Materials and Labor Hour Contract Type.

For Firm Fixed Price (FFP) task orders issued under this contract, the applicable FFP for a task order shall be based on a combination of the quoted level of effort, fixed labor rate for labor mix quoted and other direct costs (ODCs). The total FFP is the amount agreed upon by the Government and the Contractor at the time the task order is issued.

Each Labor-Hour or Time-and-Materials task order will contain a ceiling price.

FDA is the only agency authorized to place task orders against this IDIQ contract.

All task orders issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any task order.

This IDIQ contract will have an ordering period of five (5) years from the effective date of the contract. Each task order issued under this contract will specify:

• (i) Date of order.

• (ii) Contract number and order number.

• (iii) For supplies and services, contract line item number (CLIN) and description, quantity, and unit price.

• (iv) Specific tasks to be performed.

• (v) Specific deliverables and deliverable due dates.

• (vi) Task Order Contracting Officer Representative (COR), if different from the IDIQ COR.

• (vii) Delivery or performance schedule.

• (viii) Place of delivery or performance (including consignee).

• (ix) Any applicable packaging, packing, and shipping instructions.

• (x) Accounting and appropriation data.

• (xi) Method of payment and payment office, to include invoicing instructions, if not specified in the contract.

PRICING SCHEDULE

Patent Legal Services PRICING SCHEDULE SOLICITATION #: 75F40122Q00001

Base Ordering Period LABOR CATEGORY - CLIN DESCRIPTION ESTIMATED HOURS HOURLY RATE Base

Partner 75

4002 Senior Associate 150

4003 Junior Associate 150

4004 Senior Patent Agent 150

4005 Patent Agent 175

4006 Technical Advisor 120

Paralegal 50

4008 Project Manager 50

Subtotal

Reimbursable Fees

4009 Patent Office Fees 4010 Patent Annuities and Maintenance Fees 4011 Document Transmission Expense 4012 Foreign Associate Fees

Subtotal Grand total

Ordering Period 1

Partner 75

4002 Senior Associate 150

4003 Junior Associate 150

4004 Senior Patent Agent 150

4005 Patent Agent 175

4006 Technical Advisor 120

Paralegal 50

4008 Project Manager 50

Reimbursable Fees

4009 Patent Office Fees 4010 Patent Annuities and Maintenance Fees 4011 Document Transmission Expense 4012 Foreign Associate Fees

Ordering Period 2

Partner 75

4002 Senior Associate 150

4003 Junior Associate 150

4004 Senior Patent Agent 150

4005 Patent Agent 175

4006 Technical Advisor 120

Paralegal 50

4008 Project Manager 50

Subtotal

Reimbursable Fees

4009 Patent Office Fees 4010 Patent Annuities and Maintenance Fees 4011 Document Transmission Expense 4012 Foreign Associate Fees

Ordering Period 3

Partner 75

4002 Senior Associate 150

4003 Junior Associate 150

4004 Senior Patent Agent 150

4005 Patent Agent 175

4006 Technical Advisor 120

Paralegal 50

4008 Project Manager 50

Subtotal

Reimbursable Fees

4009 Patent Office Fees 4010 Patent Annuities and Maintenance Fees 4011 Document Transmission Expense 4012 Foreign Associate Fees

Ordering Period 4

Partner 75

4002 Senior Associate 150

4003 Junior Associate 150

4004 Senior Patent Agent 150

4005 Patent Agent 175

4006 Technical Advisor 120

Paralegal 50

4008 Project Manager 50

Subtotal

Reimbursable Fees

4009 Patent Office Fees 4010 Patent Annuities and Maintenance Fees 4011 Document Transmission Expense

4012 Foreign Associate Fees

PART 2 - REQUIREMENTS :

Statement of Work

1. BACKGROUND

The mission of the U.S. Food and Drug Administration (FDA) is to protect and promote the public health by assuring the safety, efficacy, and security of food, drugs, medical devices, radiation-emitting products, vaccines, blood & biologics, animal & veterinary products and cosmetics. Since 2009, the FDA has also been responsible for regulating the manufacture, marketing, and distribution of tobacco products. To achieve the mission, it is vital to support and advance FDA’s scientific knowledge through research, so that FDA’s regulatory mission is met through application of the highest caliber of science. FDA research is primarily conducted in seven Centers within the agency and the Office of Regulatory Affairs (ORA). The Center for Food Safety and Nutrition (CFSAN), Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluations and Research (CDER), Center for Veterinary Medicine (CVM), Center for Tobacco Products (CTP) and the National Center for Toxicological Research (NCTR) comprise the FDA Centers.

Every year, FDA researchers generate new technologies with the potential to improve public health. Pursuant to the Federal Technology Transfer Act (FTTA), FDA’s Technology Transfer Program (FDAT2) translates these inventions into practical application. FDAT2 educates FDA employees regarding their obligation to disclose federal inventions and their rights as federal employee inventors. FDAT2 evaluates these inventions, secures patent protection when appropriate, and seeks partners to further product development by fostering cooperative research activities through Cooperative Research and Development Agreements (CRADAs) and by licensing FDA technologies.

FDAT2 is responsible for the protection of FDA intellectual property (IP) developed by FDA scientists. The intellectual property generated by the FDA centers generally falls within several technology areas (FDA Technologies) that deal with the safety, efficacy, manufacture and security of:

1) food supply, nutrition and dietary supplements;

2) drugs and biological therapeutics;

3) medical devices and radiation emitting products;

4) biologics including regulated products such as allergenics, blood and blood products, cellular & gene therapy products, tissue and tissue products, vaccines and xenotransplantion;

5) animal and veterinary drugs and products;

6) tobacco products and

7) cosmetics.

FDA Technologies also include diagnostics and methods for the detection of pathogens, chemical agents and toxins, biomarker identification, bio-imaging, nanotechnology, software and personalized medicine.

FDA research within the above FDA Technologies can lead to a discovery or new technology that results in multiple independent and/or distinct inventions. The FDA currently holds over six hundred active patents and patent applications and files 10 applications for new inventions per year on average.

Historically, approximately two-thirds of provisional patent application filings go on to Patent

Cooperation Treaty (PCT) stage and approximately one-half of those cases enter national phase. The most common national phase filings occur in the United States, Europe, Australia, Canada, Japan, and

China.

These patent applications are prosecuted in the United States within a variety of United States Patent and Trademark Office (USPTO) Technology Centers. The majority of FDA’s patent prosecution work has been handled within USPTO Technology Center 1600. This contract will address the prosecution of patent applications for FDA Technologies that may fall within all of the USPTO Technology Centers listed below:

• 1600 Biochemistry and Chemistry

• 1700 Chemical and Material Engineering

• 2100 Computer Architecture, Software, and Information Security

• 2600 Communications

• 2800 Semiconductor, Electrical and Optical Systems and components

• 3600 Transportation, Construction, Electronic commerce, Agriculture, National Security and

License & Review

• 3700 Mechanical Engineering, Manufacturing, Products

2. OBJECTIVE

The objective of this contract is to acquire Patent Legal Services that support the entire patent life cycle and provide protection for FDA-owned intellectual property across FDA’s Technologies. Patent Legal

Services acquired under this contract consist of pre-grant prosecution activities such as patent search services, patent opinions, patent prosecution services, patent litigation, petitions , ancillary patent services and patent fee payment services for both domestic and foreign patent filings. FDA also requires legal services that support contested proceedings and Post-grant activities such as proceedings conducted by the Patent Trial and Appeal Board, Ex-Parte, Inter-Partes Review, covered business method reviews, post-grant review, interference, and licensing consultation. Such post grant services also include reissue, reexamination and interference activities and opposition activities conducted before foreign patent offices.

3. SCOPE OF WORK

This Indefinite Delivery Indefinite Quantity (IDIQ) contract provides for Patent Legal services in the area of intellectual property. The Patent Legal Services related to intellectual property protection required under this IDIQ include:

• Patent Search Services

• Patent Opinions

• Patent Prosecution Services

• Patent Litigation Service

• Petitions

• Ancillary Patent Services

• Fee Payment services

• Infringement and Interference Services

• Post Grant Proceedings

• Transition Activities

The Contractor shall provide all personnel, services, supplies and methodology necessary to meet the requirements of this IDIQ. The specific services provided to the Government under this IDIQ will be accomplished on an individual Task Order basis.

4. TASK AREAS

4.1. PATENT LEGAL SERVICES

The Contractor shall provide the following patent legal services to FDA:

4.1.1. PATENT SEARCH SERVICES

The Contractor shall provide patent search services. Representative activities include but are not limited to:

• Perform patent search and evaluation of relevant business, scientific and patent publications and indicate the relevant portions of the relevant documents; Searches may include a review of specified databases, such as world patent databases, using specified search tools (e.g. DERWENT WPI) and small molecule databases (e.g. Beilstein).

• Infringement and validity searches;

• Evaluate complex patent law matters on various topics including inventorship;

• Conduct necessary and appropriate patent law and other legal research and prepare legal memoranda to present the foregoing evaluations;

• Prepare draft claim sets, including broad claims used to perform the initial patentability search as well as more narrow claims that distinguish the invention from any potential prior art found.

4.1.2. PATENT OPINIONS

The Contractor shall provide comprehensive and complete analysis of FDA’s invention in light of other prior art, FDA’s existing patent portfolio, and new published technologies. Analys is should result in detailed patent opinion for the FDA Technology Areas. Representative activities related to Patent Opinions include but are not limited to the following:

• Patentability opinions

• Clearance opinions

• Validity opinions

• Invalidity opinions

• Infringement opinions

• Non-infringement opinions

• Inventorship opinions

• Freedom to operate opinions

• License or transactional agreement (material transfer agreements, research collaboration or cooperative research and development agreements) opinions

4.1.3. PATENT PROSECUTION SERVICES

The Contractor shall perform all necessary services as required by applicable law in connection with the preparation, filing and prosecution of patent applications filed in the United States

Patent and Trademark Office (USPTO), as well as Patent Cooperation Treaty (PCT) applications and national stage applications filed in foreign patent offices. This may be accomplished through foreign law firm associates. The preparation and filing of provisional or utility patent applications and any foreign patent applications shall be based on invention disclosures in light of known prior art and any contemplated prosecution strategy.

FDA will have a reasonable time to review and provide substantive comments before the deadlines and before patent fees such as extension for response fees may need to be paid.

Representative patent prosecution services include but are not limited to the following:

• Perform analyses and provide advice on patentability under applicable US and foreign law;

• Evaluate inventorship;

• Prepare and file provisional or utility patent applications, including Continuing, Divisional and Continuation-in-part applications, based on invention disclosures, taken in view of prior art and contemplated prosecution strategy;

• Develop prosecution and claim strategies that ensure claims directed to various aspects of the invention including its likely commercial embodiments, such that the most commercially valuable patent results;

• Prepare and timely file required prosecution information such as Information Disclosure

Statements, filing of responses, filing declarations, affidavits, and notices of appeals;

• Prepare and file informal and formal drawings, including: (1) preparation of informal or formal drawing for United States Patent and Trademark Office (USPTO), Patent Cooperation Treaty (PCT), and foreign patent applications; and (2) deliver the drawings to FDA, USPTO, or foreign patent authority;

• Prepare and file amino acid and/or nucleic acid sequences;

• Arrange for timely deposit of organisms, cell lines and other biological materials that may be necessary to satisfy the requirements of 35 USC 112, the Budapest Treaty and foreign laws;

• Prepare and file Inventor declarations, Powers of Attorney, assignments of worldwide patent rights by employee and non-employee inventors to the US Government;

• Conduct interviews, in-person or by telephone with USPTO or foreign patent office examiners;

• Confer with inventors , inventors and FDA staff as may be appropriate to ensure the maximum protection of FDA intellectual property;

• Review and respond to all Office Actions (domestic and foreign) in consultation with FDA and the inventors as needed;

• Oral arguments before the USPTO Board of Patent appeals and Interferences;

• Prepare and file interference related papers, notices correspondence and other required documents;

• Support prosecution work in compliance with USPTO or other foreign patent office electronic filling regulations;

• Coordinate the filing, prosecution and maintenance of foreign patent properties with associate foreign counsel;

• Provide substantive review, and support on behalf of FDA on patent matters involving cases owned or co-owned by the Government but for which the primary case work is handled by a third party such as a licensee or co-owner;

• Transfer patent prosecution activities for a case by providing to another contract firm all case files and records, including work papers, draft documents, notes, etc., should the case be reassigned by FDA;

The Contractor shall file all required responses to US and foreign patent office actions within foreign filing deadlines or shortened US statutory periods such that patent fees such as those associated with extension for response or patent revival are avoided. This may be accomplished through foreign law firm associates. It is the responsibility of the Contractor to avoid missing filing deadlines; consequently payment of any patent fees such as extension of response time or patent revival fees are the responsibility of the Contractor, unless otherwise directed by Contracting Officer or COR.

4.1.4. PATENT LITIGATION

Contractor shall provide services on a variety of patent litigation and pre-litigation matters related to FDA’s patent portfolio. Representative activities include, but are not limited to the following:

• Analyze the patent(s) and prosecution history;

• Conduct infringement analysis (including taking additional measures to buttress infringement claims);

• Conduct validity analysis (including taking measures to correct validity challenges);

• Conduct fact discovery;

• Assist in claim construction hearing;

• Provide counseling on potential counterclaims including declaratory judgment, strategic business objectives and alternatives, and market position;

• Provide reviews of competitor’s issued patents and pending applications for strategic alternatives and design-around opportunities;

• Provide litigation related services.

• Conduct Pre-trial and trial activities.

4.1.5. PETITIONS

The Contractor shall provide expert petition work for identified specialized matters before the USPTO office of Petitions. Representative activities include petitions, requests, and any related inquiries regarding the filing of patent applications, revival of abandoned applications, reinstatement of expired patents, withdrawal of patent applications form issue, small entity entitlement, review of previous decisions of Technology Centers, suspensions of regulations and questions not specifically provided for by regulations.

4.1.6. ANCILLARY PATENT SERVICES

The Contractor shall provide ancillary patent services. Ancillary patent services include but are not limited to the following:

• Obtain copies of patents, file histories, assignment records, as requested;

• Obtain signatures of inventors and/or designated authorities on legal papers and deliver to the USPTO and/or foreign patent offices, under very tight time constraints;

• File requests for corrections to patents;

• Secure all copies and translations of cited art and drawing to the extent required by the patent authority;

• Provide courier service to deliver papers to and from inventors and between FDA and the USPTO and/or foreign patent authorities;

• Provide translation services for foreign patent filings.

• Proactively inform the designated COR and COR designee of any issues, problems and recommendations related to patent prosecution activities that should be addressed in order for the overall effective accomplishment of task order goals.

4.1.7. FEE PAYMENT SERVICES

The Contractor shall provide the necessary services to monitor and pay in a timely fashion all required patent fees, including filing fees, maintenance or annuity fees for both domestic and foreign patent all patent filings. Contractor shall also assume responsibility for the monitoring and payment of patent fees including maintenance or annuity fees for FDA’s current patent docket.

4.1.8. INFRINGEMENT AND INTERFERENCE SERVICES

The Contractor shall evaluate complex patent law matters on validity and infringement. The Contractor shall provide litigation related support; handle interference proceedings, and provide, infringement related support and services.

4.1.9. POST GRANT PROCEEDINGS

The Contractor shall provide support with post grant proceedings such as proceedings conducted by the Patent Trial and Appeal Board, Ex-Parte and Inter-Partes Review, covered business method reviews, post-grant review, interference, contested proceedings and licensing consultation. Such services also include reissue, reexamination and interference activities and opposition activities conducted before foreign patent offices.

4.1.10. TRANSITION ACTIVITIES

The FDA currently has approximately 250 active and over 200 pending patent U.S. and foreign applications. Responsibility for prosecution of these patent applications will be transitioned to the Contractor under this contract. Responsibility for the monitoring and payment of maintenance and annuity fees for these patents will also be transitioned to the Contractor under this contract.

Additionally, FDA anticipates that transitioning work out to other law firms may be needed if conflict of interest situations arise during the performance of the contract, where the situations can be mitigated through transitioning the work out.

4.1.10.1. INITIAL TRANSITION OF PATENT WORK IN TO CONTRACTOR

The Contractor shall be required to assume responsibility for patent prosecution and related activities for FDA cases that are currently handled by the current contractor.

4.1.10.2. TRANSITION OF PATENT WORK IN TO CONTRACTOR

The Contractor may also be required to transfer cases in during the contract period of performance when FDA needs to assume the management of a patent case previously handled by a co-inventor’s law firm.

4.1.10.3. TRANSITION OF PATENT WORK OUT TO OTHER LAW FIRMS

The Contractor may be required to transfer responsibility for a particular application or family of applications to a new contractor. Such transfer of responsibility may occur when an organizational conflict arises that requires the transition of one or more cases to a new firm, or when responsibility for prosecution is transferred to a co-inventor or licensee’s law firm or at the expiration or termination of this contract.

At the expiration or termination of this contract the Contractor shall provide FDA with a listing of all FDA cases that were handled by the Contractor during the life of the contract.

Attachment G—Portfolio Transition Table—is provided showing the minimum data required in the listing of FDA cases. The listing of all FDA cases will be provided by the Contractor 90 days prior to the expiration date of the contract and [90 days prior to the termination date for the contract]. The FDA will review the listing and decide which cases the Contractor shall transfer to the law firm selected under the next contract. All files related to FDA patent related work are considered Government Property and shall be returned to FDA or transferred to a new contractor as directed by FDA.

4.2. PROJECT MANAGEMENT

The Contractor shall provide project management to establish control, management, monitoring, and notification mechanisms to ensure that task activities stay on track and important milestones are met.

Representative activities include but are not limited to:

• Task Management Approach including responding to individual Task Orders Request for Quote and fulfilment of Task order deliverables

• Perform risk management, including conflict of interest risks, and implement conflict of interest and other risk mitigation strategies

• Communication and meeting management

• Personnel Staffing

• Plan, organize, secure, and manage resources with appropriate knowledge and skills

• Create all required status and financial reports and participate in progress reviews

• Develop and maintain project plans

• Track and manage cost

• Track and manage payment of patent fees and maintenance/annuity fees

• Proactively inform the designated COR and COR designee of any issues, problems and recommendations that shall be addressed in order for the overall effective accomplishment of task order goals.

Entrance Conference - Within two (2) weeks after contract award or as soon as is practical for FDA, the Contractor shall attend a one-day (8 hour) orientation for the entire FDA team and any administrative/billing personnel at FDA White Oak Campus, located in Silver Spring, Maryland , or via virtual meeting platform, as determined by FDA. The orientation shall be held to meet the FDAT2 staff and the FDA Contracting Officer as well as to review ordering, reporting, and billing procedures.

At the COR’s discretion the meeting may be held on a virtual platform.

5. ORDERING PROCEDURES

A. A request for task order quote (RFTOQ) will be issued via email to the Contractor IAW the procedures of FAR 16.505. The RFTOQ will clearly describe the services required and the anticipated task order type.

The Contractor will typically have five (5) – ten (10) calendar days to respond to any RFTOQ. At a minimum, the following required documents must be submitted with any quote in response to a RFTOQ:

• Technical quote

• Resume of key personnel identified in the RFTOQ

• Commitment letters for each identified key personnel posit ion, signed by the recommended candidate and the point of contact at the company that has the authority to offer employment

• Commitment letters must include the following information:

▪ Title of position

▪ Name of company

▪ Name of individual offered position

• Price quote

Task Order Transmission:

Task Orders will be issued by email or other means.

The Contractor is required to perform on any signed task order transmitted by any authorized means.

B. FDA Issuance of Task Orders/Technical Direction

a. Performance of the work under Task Orders issued shall be subject to the technical direction of the FDA Task Order Contracting Officer’s Representative (COR). The term “technical direction” is defined to include, without limitation, the following:

1) Communication to the contractor which directs or redirects the contract performance effort, shifts work emphasis between work areas or tasks, requires pursuit of certain lines of inquiry, fills in details or otherwise serves to accomplish the requirements in the Statement of Work.

2) Provide other direction as may be required to successfully achieve the objectives of the TO within the parameters established by the TO SOW.

3) Provision of information to the contractor which assists in the interpretation of drawings, specifications, or technical portions of the work descriptions.

4) Review and, where required by the contract and/or order, approval of technical reports, drawings, specifications, and technical information to be delivered by the contractor to the Government under the contract and task order.

b. The Contractor shall receive a copy of the written COR designation from the Contracting Officer. It will specify the extent of the COR's authority to act on behalf of the Contracting Officer.

c. Technical direction must be within the scope of work stated in the contract or task order. Neither the IDIQ COR nor the Task Order COR have the authority to, and may not issue any technical direction, which:

1) Constitutes an assignment of additional work outside the scope of work stated in the contract and task orders.

2) Constitutes a change as defined in the applicable contract clause entitled FAR 52.212-4(c)

Contract Terms and Conditions – Commercial Items.

3) In any manner causes an increase or decrease in the total estimated contract or task order cost or the time required for performance.

4) Changes any of the expressed terms, conditions, or specifications of the contract and task order.

5) Interferes with the Contractor’s right to perform the terms and conditions of the contract.

d. All technical direction shall be issued in writing by the Task Order COR. Technical direction to perform efforts under the TO SOW will be given by means of a Technical Direction Letter (TDL) issued in sequence with TDL numbering convention designated by Task Order COR. Each TDL shall establish the tasks to be accomplished under the TO SOW including performance milestones/metrics, deliverables, the effort to be expended for its performance, and the number of manhours, travel, direct material, and/or other direct costs which shall not be exceeded within limits established in the TO. The TDL shall identify the applicable TO Contract Line Item Number(s) (CLIN) under which the effort is to be performed for purposes of identifying the price of that individual effort. In no event shall the total number of labor hours and price issued under a series of TDLs exceed those labor hours and price set forth in section B of the specific Task Order for a particular CLIN. TDLs are not intended to replace informal direct communication or nondirective information between the contractor, the contractor's team members/subcontractors, and government personnel.

e. The contractor shall proceed promptly with the performance of technical direction duly issued by the COR in the manner prescribed by this article and within his/her authority under the provisions of this article. If, in the opinion of the contractor, any instructions or direction issued by the COR is within one of the COR unauthorized categories described above, the contractor shall not proceed and shall notify the Contracting Officer in writing within 5 working days after the receipt of any such instructions or direction and shall request the Contracting Officer to modify the order, accordingly. Upon receiving such notification from the contractor, the Contracting Officer will issue an appropriate modification or advise the contractor in writing that, in the Contracting Officer’s opinion, the technical direction is within the work of this contract or order. The contractor shall proceed immediately with the instructions or directions and shall be subject to the FAR clause FAR 52.233-1 “Disputes.”

f. At the discretion of the COR, FDA may cancel any TDL by written notification to the contractor.

C. Financial reports Financial reports shall be submitted by the contractor with the invoices for time-and-materials and labor-hour Task Orders in accordance with the expenditure categories below:

• Labor hours and total labor charges for each skill level category for the current period and cumulative cost for the total contract to date.

• Accumulate total for all cost categories (i.e., labor, travel).

• Contract ceiling and percent expended to date.

• Estimate to complete.

• Travel – Include all direct costs to travel, including transportation subsistence and miscellaneous expenses. The following information shall be submitted: Name of traveler and purpose of trip; Place of departure, destination and return, including time and dates; and total cost of trip. The contractor will be reimbursed for travel expenditures incurred as a direct cost during performance of defined requirements stated in task orders in accordance with the appropriate limitations set forth in FAR 31.205-46. Nothing in this clause shall relieve a contractor’s responsibilities related to travel as defined in article 14.4.

6. Other Requirements

Other Quote Instructions:

The Offeror shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. If the Offeror submits documents that contain macros, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an Offeror to correct the document submission and the Government will not inform the Offeror that its submission is non-responsive prior to award. It is the Offeror’s responsibility to ensure that all electronic documents are submitted without the use of macros.

The following language will be included in the resultant BPA order award:

Be advised that the FDA does not accept documents which contain the use of macros. Document submissions required throughout the period of performance of this Order shall not have macro enabled functionality, and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.

PART 3 FAR AND HHSAR CLAUSES

a. FAR CLAUSES (by reference: https://www.acquisition.gov/

FAR CLAUSE #

TITLE

DATE

52.202-1 Definitions (JUN 2020)

52.204-13 System for Award Management

Maintenance.

(OCT 2018)

52.204-18 Commercial And Government

Entity Code Maintenance

(AUG 2020)

FAR 204-21 Basic Safeguarding of Covered

Contractor Information

Systems.

(JUN 2016)

FAR 52.204-24 Representation Regarding

Certain Telecommunications and Video Surveillance Services or Equipment.

(OCT 2020)

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance

Services or Equipment.

(AUG 2020

52.212-4 Contract Terms And

Conditions—Commercial Items

(OCT 2018)

52.212-4 Alt I Contract Terms And Conditions

– Commercial Items

(JAN 2017)

52.216-31 Time-and-Materials/Labor-Hour

Proposal Requirements-

Commercial Item Acquisition.

(FEB 2007)

52.227-14 RIGHTS IN DATA – GENERAL (MAY 2014)

52.232-7 PAYMENTS UNDER TIME-AND- (AUG 2012)

https://www.acquisition.gov/

MATERIALS AND LABOR-HOUR

CONTRACTS

52.232-40

PROVIDING ACCELERATED

PAYMENT TO SMALL

BUSINESS CONTRACTORS

(DEC 2013)

52.242-15

STOP - WORK ORDER (AUG 1989)

52.245-1

GOVERNMENT PROPERTY

(JAN 2017)

52.246-6 INSPECTION-TIME-AND-

MATERIAL AND LABOR-HOUR

(May 2001)

52.247-34

F.O.B DESTINATION (NOV 1991)

52.247-35 F.O.B DESTINATION, WITHIN

CONSIGNEE’S PREMISES

(APR 1984)

b. FAR Clauses in Full Text

FAR 52.204–26 Covered Telecommunications Equipment or Services-Representation (Oct 2020)

(a) Definitions. As used in this provision, "covered telecommunications equipment or services" and "reasonable inquiry" have the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for "covered telecommunications equipment or services".

(c) (1) Representation. The Offeror represents that it □ does, □ does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument.

(2) After conducting a reasonable inquiry for purposes of this representation, the offeror represents that it □ does, □ does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services.

(End of provision)

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders— Commercial Products and Commercial Services. (NOV 2021)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.sam.gov/ https://www.acquisition.gov/far/52.203-19#FAR_52_203_19

Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Nov 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and

108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting

Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial products and commercial services:

_x_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) (41 U.S.C. 4704 and 10 U.S.C. 2402).

_x_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) (41 U.S.C. 3509)).

_x_ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment

Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_x_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (5) [Reserved].

_x_ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_x_ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery

Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_x_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment. (Nov 2021) (31 U.S.C. 6101 note).

_x_ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility

Matters (Oct 2018) (41 U.S.C. 2313).

__ (10) [Reserved].

__ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Sep

2021) (15 U.S.C. 657a).

__ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business

Concerns (Sep 2021) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (13) [Reserved] __ (14)

(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-6.

__ (15)

(i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

__ (ii) Alternate I (Mar 2020) of 52.219-7.

_x_ (16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and

(3)).

_x_ (17) (i) 52.219-9, Small Business Subcontracting Plan (Nov 2021) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

https://www.acquisition.gov/far/52.204-23#FAR_52_204_23 https://www.acquisition.gov/far/52.204-25#FAR_52_204_25 https://www.acquisition.gov/far/52.209-10#FAR_52_209_10 https://www.acquisition.gov/far/52.233-3#FAR_52_233_3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.233-4#FAR_52_233_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-6#FAR_52_203_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-13#FAR_52_203_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.203-15#FAR_52_203_15 https://www.acquisition.gov/far/52.204-10#FAR_52_204_10 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.204-14#FAR_52_204_14 https://www.acquisition.gov/far/52.204-15#FAR_52_204_15 https://www.acquisition.gov/far/52.209-6#FAR_52_209_6 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title31-section6101&num=0&edition=prelim https://www.acquisition.gov/far/52.209-9#FAR_52_209_9 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title41-section2313&num=0&edition=prelim https://www.acquisition.gov/far/52.219-3#FAR_52_219_3 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section637a&num=0&edition=prelim https://www.acquisition.gov/far/52.219-4#FAR_52_219_4 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-6#FAR_52_219_6 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-7#FAR_52_219_7 https://www.acquisition.gov/far/52.219-8#FAR_52_219_8 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Jun 2020) of 52.219-9.

__ (v) Alternate IV (Sep 2021) of 52.219-9.

__ (18) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

__ (ii) Alternate I (Mar 2020) of 52.219-13.

__ (19) 52.219-14, Limitations on Subcontracting (Sep 2021) (15 U.S.C. 637s).

__ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep

2021) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Sep

2021) (15 U.S.C. 657f).

_x_ (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Sep

2021) (15 U.S.C. 632(a)(2)).

__ (ii) Alternate I (Mar 2020) of 52.219-28.

__ (23) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically

Disadvantaged Women-Owned Small Business Concerns (Sep 2021) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small

Business Concerns Eligible Under the Women-Owned Small Business Program (Sep 2021) (15 U.S.C. 637(m)).

__ (25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

__ (26) 52.219-33, Nonmanufacturer Rule (Sep 2021) (15U.S.C. 637(a)(17)).

_x_ (27) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_x_ (28) 52.222-19, Child Labor-Cooperation with Authorities and

Remedies (Jan2020) (E.O.13126).

_x_ (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_x_ (30) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

_x_ (31) (i) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).

__ (ii) Alternate I (Jul 2014) of 52.222-35.

_x_ (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

__ (ii) Alternate I (Jul 2014) of 52.222-36.

_x_ (33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

_x_ (34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec

2010) (E.O. 13496).

_x_ (35) (i) 52.222-50, Combating Trafficking in Persons (Nov 2021) (22 U.S.C. chapter 78 and

E.O. 13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

_x_ (36) 52.222-54, Employment Eligibility Verification (Nov 2021) . (Executive Order 12989).

(Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (37) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) ( 42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (Jun 2016) (E.O. 13693).

https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-9#FAR_52_219_9 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-13#FAR_52_219_13 https://www.acquisition.gov/far/52.219-14#FAR_52_219_14 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-16#FAR_52_219_16 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-27#FAR_52_219_27 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-28#FAR_52_219_28 https://www.acquisition.gov/far/52.219-29#FAR_52_219_29 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-30#FAR_52_219_30 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.acquisition.gov/far/52.219-32#FAR_52_219_32 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec644.htm https://www.acquisition.gov/far/52.219-33#FAR_52_219_33 https://www.govinfo.gov/content/pkg/USCODE-2018-title15/html/USCODE-2018-title15-chap14A-sec637.htm https://www.acquisition.gov/far/52.222-3#FAR_52_222_3 https://www.acquisition.gov/far/52.222-19#FAR_52_222_19 https://www.acquisition.gov/far/52.222-21#FAR_52_222_21 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-26#FAR_52_222_26 https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title38-section4212&num=0&edition=prelim https://www.acquisition.gov/far/52.222-35#FAR_52_222_35 https://www.acquisition.gov/far/52.222-36#FAR_52_222_36 http://uscode.house.