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1 76

NIH-OD-OLAO-OA-(PLS)-2019 11/15/2018 draft

DRAFT.-RFP.PATENT-LEGAL-SERVICES#NIH-OD-OLAO-OA-(PLS)-2019 - Page 1 of 76

Draf t

RFP Number : NIH-OD-OLAO-OA-(PLS)-2019

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. NAICS CODE AND SIZE STANDARD

b. TYPE OF CONTRACT AND NUMBER OF AWARDS

c. COMMITMENT OF PUBLIC FUNDS

d. COMMUNICATIONS PRIOR TO CONTRACT AWARD

e. RELEASE OF INFORMATION

f. PREPARATION COSTS

g. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Evaluation of Proposals

4. Potential Award Without Discussions

5. Use of the Metric System of Measurement

6. Privacy Act - Treatment of Proposal Information

7. Selection of Offerors

8. Past Performance Information

9. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Small Business Subcontracting Plan

4. Mentor Protege Program, HHSAR 352.219-70

DRAFT.-RFP.PATENT-LEGAL-SERVICES#NIH-OD-OLAO-OA-(PLS)-2019 - Page 2 of 76

5. HUBZone Small Business Concerns

6. Other Administrative Data

7. Qualifications of the Offeror

8. Subcontractors

9. Proposer's Annual Financial Report

10. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. TECHNICAL EVALUATION FACTORS

3. PAST PERFORMANCE FACTOR

DRAFT.-RFP.PATENT-LEGAL-SERVICES#NIH-OD-OLAO-OA-(PLS)-2019 - Page 3 of 76

PART I - THE SCHEDULE

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The National Institutes of Health (NIH) is seeking law firms to provide patent-related legal services in the areas of Biotechnology, Chemistry, Mechanical Engineering, and Software. Technology Transfer is the infrastructure within the NIH that is responsible for facilitating the transfer of knowledge, discoveries and technologies out to the rest of the world in a manner that gives benefit to the public health, recognizes a return on the Nation's investment in biomedical research, and complies with the relevant statutes, regulations and policies. Through certain aspects of its Technology Transfer enterprise, the Federal Government strives where appropriate to transfer federally owned or originated technology to the private sector for commercial development and to researchers for the continued advancement of science and the NIH's mission. It is the Public Health Service's policy to coordinate its technology transfer activities among and within its Agencies consistent with its mission and responsibilities pursuant to the Federal Technology Transfer Act of 1986, as amended.

The Secretary of the Department of HHS has designated the NIH as the lead agency for technology transfer and intellectual property (IP) matters for HHS including the patenting and licensing of Government inventions and discoveries.

NIH expects to file about 200-300 patent applications each year. NIH's current active patent prosecution docket is more than two thousand and five hundred (2,500) cases. Inventions for which NIH seeks patent protection are generally biological or medical in nature. In response to this solicitation, separate contracts will be awarded in Four (4) Technology Categories for which patent-related legal services are required: Biotechnology, Chemistry, Medical Engineering, and Software. NIH anticipates awarding multiple contracts: approximately nine (9) contracts for Biotechnology, seven (7) contracts for Chemistry, four (4) contracts for Medical Engineering, and two (2) contracts for Software. The Government has established a small business reserve of 1 to 2 additional awards for capable small business law firms. This would be contingent on receiving a technically acceptable proposal from capable small business law firms.

These Indefinite Delivery/Indefinite Quantity (IDIQ) master contracts for patent-legal services will enable the National Institutes of Health (NIH) to issue task orders for patent-legal services in the areas of biotechnology, chemistry, mechanical engineering and software for the Offices of Technology Transfer at NIH, the Centers for Disease Control and Prevention, and other Department of Health and Human Services (HHS) Operating Divisions (OPDIVS).

Patent-legal services provided to the Government under any contract awarded as a result of this Request for Proposal (RFP) are done via the Task Order mechanism. Task orders will be issued following FAR 16.505 Ordering procedures. These task orders may be firm-fixed-price (FAR 16.202), fixed-price with economic price adjustment (FAR 16.203), time-and-materials, Labor-Hour (FAR 16.601), or a combination of firm-fixed-price and time-and-materials (hybrid). Services provided to the Government must be invoiced to the Government at the completion of the Task Order or as described on each individual Task Order. An offeror must be able to adapt their billing system to accommodate the Task Order-based system used by the Government to procure patent-legal services under any contract awarded in response to this RFP.

DRAFT.-RFP.PATENT-LEGAL-SERVICES#NIH-OD-OLAO-OA-(PLS)-2019 - Page 4 of 76

Patent-legal services provided to the Government under any contract awarded as a result of this RFP will be comprehensive in nature. Offerors shall provide a level of service equivalent to that of "In-House" patent counsel responsible for managing and carrying out all patent prosecution activities both domestic and foreign.

ARTICLE B.2. CATEGORIES OF TECHNOLOGY

The following are the four (4) categories of technology prosecution that contractors shall perform, upon request, during the course of the contract. Offerors may submit proposals for one or more of the categories of contract activities listed below. A separate proposal is required for each type of contract activity that an offeror wishes to be considered for (i.e., an offeror qualified to perform Biotechnology related patent prosecution and Mechanical Engineering, shall submit two proposals, each one focused on the particular type of contract activity).

1. BIOTECHNOLOGY: may include, for example, biochemistry, molecular biology, nanotechnology as it affects biological systems, diagnostics, therapeutics, cell biology, genetics/genomics/epigenetics, proteomics, recombinant technology, gene editing, anatomy and physiology, immunology, and vaccines.

2. CHEMISTRY: may include, for example, organic small molecules, inorganic molecules, analytics, nanotechnology, conjugation, formulations, processes and pharmaceutical formulations and compounding, and imaging agents.

3. MECHANICAL ENGINEERING: may include, for example, laboratory research instrumentation, clinical/surgical devices, systems, machines, microscopy, optics, medical devices, microfluidics, nanodevices, occupational safety devices, environmental sensors, mining equipment, and electrical devices.

4. SOFTWARE: may include, for example, bioinformatics, health information technology, cloud computing and data processing, database technology, systems integration, algorithms as they relate to data processing, imaging technology, image processing, artificial intelligence, and machine/iterative learning.

ARTICLE B.3. PRICES/COSTS

1. The final contract will contain the price provisions agreed upon by the Government and the Offeror. Offerors shall submit prices based on the Technology Area of their expertise according to the Section B Pricing Table. The hourly rates and annual ceiling priced proposed in the BUSINESS PROPOSAL are fixed contract terms and may not be exceeded without the written authorization of the NIH Contracting Officer.

2. Offerors' prices shall be FULLY-burdened labor rates for each year for a period of ten (10) years. Fully-burdened labor rates include all direct, indirect, general and administrative costs, fringe, benefits, and profit associated with providing required skill. (Offerors shall provide rates for each of the labor categories for ALL years). The Congressional Budget Office released the Economic Projections in April 2018. Offerors may allow an inflationary increase per year that not exceed more than 1% of the given year's CPI. For information on the 5-year Budget Projections, go to https://www.cbo.gov/about/products/budget-economic-data#3 .

The prices set forth in this ARTICLE shall cover the contract period of five (5) years.

3. This is a Multiple Award Indefinite Delivery/Indefinite Quantity (IDIQ) contract as contemplated by FAR 16.504.

The Contractor shall be paid by the Government in an amount as listed below:

• Biotechnology - not less than a total of $500 (minimum) nor more than a total of $386,000,000 (maximum) for successful performance of this contract.

• Chemistry - not less than a total of $500 (minimum) nor more than a total of $115,000,000 (maximum) for successful performance of this contract.

• Mechanical Engineering - not less than a total of $500 (minimum) nor more than a total of $17,000,000 (maximum) for successful performance of this contract.

• Software - not less than a total of $500 (minimum) nor more than a total of $17,000,000 (maximum) for successful performance of this contract.

DRAFT.-RFP.PATENT-LEGAL-SERVICES#NIH-OD-OLAO-OA-(PLS)-2019 - Page 5 of 76

Draf https://www.cbo.gov/about/products/budget-economic-data#3

4. The Government will compete and award Task Orders based on the work described in the attached Statement of Work (SOW). See Section C of this contract. The anticipated type of Task Orders will be Firm-Fixed Price, Time-and-Materials, Labor Hour, or Hybrid type. Each Task Order will stand alone and will be issued in accordance with FAR16.505(a)(b). Task Orders for services will be issued in accordance with standard ordering procedures for Patent-Legal Services. An example of current ordering procedures is attached.

5. The labor rate in effect at the time the Task Order is issued applies until the work is completed. Should a contractor's actual year standard billing rate for their best customers be lower than the rate listed on the contract, the lower rate must be used. In such a case the contractor is to provide the Contracting Officer's Representative and the Contracting Officer a notice of any change in the final billing rate as they are established no more than 30 days after they become effective.

6. The contractor activities under this contract are subject to audit by the Government, its agents, or other organizations of the Federal Government. such audits shall be undertaken at the cost of the Government.

However, should the audit report find that charges to the Government exceed the amount that should properly have been charged, the contractor shall pay the Government the difference between the amount paid and the proper amount billed, and pay the cost of the audit.

ARTICLE B.4. TASK ORDER AWARDS AGAINST AN OPDIV-WIDE IDIQ

Pursuant to FAR 16.504(a)(4)(vi), any duly warranted federal government Contracting Officer (as that term is defined in FAR 2.1) in good standing with the appropriate contracting authority is authorized to award task orders under this contract. For purposes of this contract, these individuals are referred to as Contracting Officers. Task orders may be multi-year or include options as defined in FAR Part 17 and agency-specific FAR Part 17 supplements. Refer to Section F. Task Order Period of Performance.

The task ordering period for any IDIQ contract awarded in response to this RFP will be for an initial 12-month period of performance commencing on the date of award, and ten (10) Option periods of performance. See Section F.

In order to continue past the initial 12-month period of performance, the contractor shall earn a satisfactory or above performance rating for each 12-month period of performance. See Ramp Off and Ramp On procedures under Section H.

ARTICLE B.5. PRICES

For the purposes of this RFP, the offeror's proposed labor rates, as shown in the BUSINESS PROPOSAL represents the best price for a given labor category based on the type of technology(s) the offeror is pursuing.

ARTICLE B.6. OPTION PRICING TABLE

1. Unless the Government exercises its option pursuant to the option clause referenced in ARTICLE I.3.

ADDITIONAL CONTRACT CLAUSES, this contract consists only of the Base Period specified in the Statement of Work as defined in SECTIONS C and F, for the price set forth in ARTICLE B.2. of this contract.

2. Pursuant to set forth in ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES of this contract, the Government may, by unilateral contract modification, require the Contractor to perform the Option Period(s) specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises this/these option(s), notice must be given before the expiration date of the contract. Specific information regarding the time frame for this notice is set forth in the OPTION PROVISION Article in SECTION H of this contract. The fixed price of this contract will be increased as set forth in paragraph c., below.

3. Upon the delivery and acceptance of the described in SECTION C of the contract and identified in the schedule of charges below, the Government shall pay the Contractor the unit price(s) set forth below.

4. Offerors shall complete a table for ten (10) 12-month periods of performance for proposals submitted for each category. An Excel workbook is included in the RFP.

DRAFT.-RFP.PATENT-LEGAL-SERVICES#NIH-OD-OLAO-OA-(PLS)-2019 - Page 6 of 76

5. If Offerors are unable to propose the minimum labor categories listed below, Offerors may propose an alternative labor mix.

BIOTECHNOLOGY

LABOR

CATEGORIES

Year-1 Fully- Loaded Hourly Labor Rate

Year-2 Fully- Loaded Hourly Labor Rate

Year-3 Fully- Loaded Hourly Labor Rate

Year-4 Fully- Loaded Hourly Labor Rate

Year-5 Fully- Loaded Hourly Labor Rate

Year-6 Fully- Loaded Hourly Labor Rate

Year-7 Fully- Loaded Hourly Labor Rate

Year-8 Fully- Loaded Hourly Labor Rate

Year-9 Fully- Loaded Hourly Labor Rate

Year-10 Fully-

Loaded Hourly Labor Rate

Partner Partner Senior Associate Junior Associate Junior Associate Patent Agents Patent Agents Case Manager/ Paralegal Case Manager/ Paralegal

OTHER

EXPENSES*

SUBCONTRACTS**

CHEMISTRY

LABOR

CATEGORIES

Year-1 Fully- Loaded Hourly Labor Rate

Year-2 Fully- Loaded Hourly Labor Rate

Year-3 Fully- Loaded Hourly Labor Rate

Year-4 Fully- Loaded Hourly Labor Rate

Year-5 Fully- Loaded Hourly Labor Rate

Year-6 Fully- Loaded Hourly Labor Rate

Year-7 Fully- Loaded Hourly Labor Rate

Year-8 Fully- Loaded Hourly Labor Rate

Year-9 Fully- Loaded Hourly Labor Rate

Year-10 Fully-

Loaded Hourly Labor Rate

Partner Partner Senior Associate Junior Associate Junior Associate Patent Agents Patent Agents Case Manager/ Paralegal Case Manager/ Paralegal

OTHER

EXPENSES*

DRAFT.-RFP.PATENT-LEGAL-SERVICES#NIH-OD-OLAO-OA-(PLS)-2019 - Page 7 of 76

LABOR

CATEGORIES

Year-1 Fully- Loaded Hourly Labor Rate

Year-2 Fully- Loaded Hourly Labor Rate

Year-3 Fully- Loaded Hourly Labor Rate

Year-4 Fully- Loaded Hourly Labor Rate

Year-5 Fully- Loaded Hourly Labor Rate

Year-6 Fully- Loaded Hourly Labor Rate

Year-7 Fully- Loaded Hourly Labor Rate

Year-8 Fully- Loaded Hourly Labor Rate

Year-9 Fully- Loaded Hourly Labor Rate

Year-10 Fully-

Loaded Hourly Labor Rate

SUBCONTRACTS**

MECHANICAL ENGINEERING

LABOR

CATEGORIES

Year-1 Fully- Loaded Hourly Labor Rate

Year-2 Fully- Loaded Hourly Labor Rate

Year-3 Fully- Loaded Hourly Labor Rate

Year-4 Fully- Loaded Hourly Labor Rate

Year-5 Fully- Loaded Hourly Labor Rate

Year-6 Fully- Loaded Hourly Labor Rate

Year-7 Fully- Loaded Hourly Labor Rate

Year-8 Fully- Loaded Hourly Labor Rate

Year-9 Fully- Loaded Hourly Labor Rate

Year-10 Fully-

Loaded Hourly Labor Rate

Partner Partner Senior Associate Junior Associate Junior Associate Patent Agents Patent Agents Case Manager/ Paralegal Case Manager/ Paralegal

OTHER

EXPENSES*

SUBCONTRACTS**

SOFTWARE:

LABOR

CATEGORIES

Year-1 Fully- Loaded Hourly Labor Rate

Year-2 Fully- Loaded Hourly Labor Rate

Year-3 Fully- Loaded Hourly Labor Rate

Year-4 Fully- Loaded Hourly Labor Rate

Year-5 Fully- Loaded Hourly Labor Rate

Year-6 Fully- Loaded Hourly Labor Rate

Year-7 Fully- Loaded Hourly Labor Rate

Year-8 Fully- Loaded Hourly Labor Rate

Year-9 Fully- Loaded Hourly Labor Rate

Year-10 Fully-

Loaded Hourly Labor Rate

Partner Partner Senior Associate Junior Associate Junior Associate Patent Agents Patent Agents

DRAFT.-RFP.PATENT-LEGAL-SERVICES#NIH-OD-OLAO-OA-(PLS)-2019 - Page 8 of 76

LABOR

CATEGORIES

Year-1 Fully- Loaded Hourly Labor Rate

Year-2 Fully- Loaded Hourly Labor Rate

Year-3 Fully- Loaded Hourly Labor Rate

Year-4 Fully- Loaded Hourly Labor Rate

Year-5 Fully- Loaded Hourly Labor Rate

Year-6 Fully- Loaded Hourly Labor Rate

Year-7 Fully- Loaded Hourly Labor Rate

Year-8 Fully- Loaded Hourly Labor Rate

Year-9 Fully- Loaded Hourly Labor Rate

Year-10 Fully-

Loaded Hourly Labor Rate

Case Manager/ Paralegal Case Manager/ Paralegal

OTHER

EXPENSES*

SUBCONTRACTS**

* OTHER EXPENSES: All other costs, including filing fees, drawings, faxing, telephone, courier, other delivery, foreign agents, costs shall be billed at acquisition or production costs with no additional markup.

** SUBCONTRACTS: Subcontracting will require written approval from the Contracting Officer.

ARTICLE B.7. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., subcontracts) will be Task Order specific and included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

1. Subcontract Award of the subcontract shall not proceed without the prior written consent of the Contracting Officer upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract shall be provided to the Contracting Officer.

2. Non-Personal Services and Inherently Government Functions Pursuant to FAR 37.1, no personal services shall be performed under this contract. All work requirements shall flow only from the Contracting Officer's Representative (COR) to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

Pursuant to FAR 7.5, the Contractor shall not perform any inherently Governmental actions under this contract.

No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that they have no authority to in any way change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification has been issued by the Contracting Officer.

The Contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government's rights in any way under the other provisions of the contract, including those related to the Government's right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

3. Labor Categories

DRAFT.-RFP.PATENT-LEGAL-SERVICES#NIH-OD-OLAO-OA-(PLS)-2019 - Page 9 of 76

The labor categories represent the Government's best estimate of the kinds of personnel required for successful contract performance. The contractor is expected to map from the contract categories to the contractor own categories, for the purpose of matching resources to requirements.

4. Contractor Personnel The Contractor shall be responsible for maintaining satisfactory standards of employee competency, conduct, and integrity and shall be responsible for taking such disciplinary action with respect to his employees as may be necessary.

5. Supervision The Government shall not exercise any supervision or control over Contractor employees performing services under the contract. Such Contractor personnel shall be accountable solely to the Contractor who, in turn, shall be accountable to the Government.

The Contractor shall apply proper supervisory techniques and keep personnel informed of all changes and methods of operation. All work shall be performed in such a manner so that there is no interruption to, or interference with the NIH mission.

Contractor supervisors shall be available when the contract work is in progress, to receive notices, reports, or requests from the Contracting Officer's Representative (COR) or the Contracting Officer (CO). The Contractor shall furnish the COR updates and changes.

6. Confidential Treatment of Sensitive Information The Contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

7. Contract Number Designation On all correspondence submitted under this contract, the Contractor agrees to clearly identify the contract number that appears on the face page of the contract as follows:

Contract No. TBD

If it is related to a specific Task Order, including the Contract No. and the Task Order No.

DRAFT.-RFP.PATENT-LEGAL-SERVICES#NIH-OD-OLAO-OA-(PLS)-2019 - Page 10 of 76

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to 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, dated October 31, 2017 , attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award.

Additional Reports required will be identified at the Task Order Level. For proposal preparation purposes only, it is estimated that only electronic version(s) of these reports will be required:

[ ] Monthly [X] Quarterly [ ] Semi-Annually [X] Annually [ ] Annually (with a requirement for a Draft Annual Report) [X] Final - Upon final completion of the contract [ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

b. Other Reports/Deliverables

HHS SECURITY AND PRIVACY LANGUAGE FOR INFORMATION AND IT PROCUREMENTS

1. Section 508 Annual Report

For each master IDIQ, the contractor shall submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at:

http://www.hhs.gov/web/508/contracting/technology/vendors.html under "Vendor Information and Documents."

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Draf http://www.hhs.gov/web/508/contracting/technology/vendors.html

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.

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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, Contracting Officer's Representative (COR) is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at: The location will be specified in each Task Order awarded.

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 52.242-17, Government Delay of Work (April 1984).

FAR Clause 52.246-4, Inspection of Services - Fixed Price (August 1996).

FAR Clause 52.246-6, Inspection Time-and Material and Labor Hour (May 2001).

Alternate I (April 1984) is not applicable to this contract.

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from August 1, 2019 through July 31, 2020.

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period Option Year 1 August 1, 2020 - July 31, 2021 Option Year 2 August 1, 2021 - July 31, 2022 Option Year 3 August 1, 2022 - July 31, 2023 Option Year 4 August 1, 2023 - July 31, 2024 Option Year 5 August 1, 2024 - July 31, 2025 Option Year 6 August 1, 2025 - July 31, 2026 Option Year 7 August 1, 2026 - July 31, 2027 Option Year 8 August 1, 2027 - July 31, 2028 Option Year 9 August 1, 2028 - July 31, 2029

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

a. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this master contract 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 this contract]:

Item Description Quantity Delivery Schedule

(1) Kick-off Meeting 1

(2) Transition Plan 1

(3) Staff Roster 1

(4) New Employee Notification 1

(5) System Security

Awareness Training

(6) Non-Disclosure Agreements

(7) Annual Technical Report 1

(8) List of Government

Furnished Property

(9) Annual 508 Compliance 1

b. The Government will issue individual Task Orders under a master contract for patent-legal services. Deliverables will be identified and listed under each Task Order. Below are examples of common deliverables:

Item Document No. of Copies Deliverable Due

(1) Annuity/Maintenance Fees One (1) copy Quarterly

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Item Document No. of Copies Deliverable Due

(2) Papers filed in the U.S. or foreign patent office Varies (refer to Contracting Officer's Representative)

Within five (5) business days of filing

(3) Official papers and attachments from the USPTO, other patent authorities, and foreign associate counsel

Varies (refer to Contracting Officer's Representative)

Within five (5) business days of their receipt

ARTICLE F.3. TIME OF DELIVERY

The products and services required under the contract shall be completed and delivered to the specific address contained in the individual Task Order within the specified time frame.

52.242-17, Government Delay of Work (April 1984).

ARTICLE F.4. TASK ORDER PERIOD OF PERFORMANCE

The period of performance for each task order placed under the contract will be specified in the individual task order.

Task order options, if included at initial issuance of the task order, may be exercised after the expiration date of the master contract. However, no task order (including task order options) may extend more than 60 months beyond the expiration date of the master contract.

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

[ To be specified prior to award.]

The COR 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 alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.

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 for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract. If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

Partner

Senior Associate

Junior Associate or Patent Agent

Case Manager/Paralegal

ARTICLE G.3. METHOD OF ORDERING

a. Task Orders are currently being place electronically. However, Task Orders issued under this contract may be placed by the Contracting Officer as follows:

[X] in writing

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[X] via telephone

[X] via facsimile (fax)

[X] via electronic mail (e-mail)

[X] Oral [Oral Orders will be confirmed in writing within days of issuance.

[ ] Other Specify:

b. Only the Contracting Officer is authorized to issue orders and provide written confirmation of oral orders, if applicable, under the contract.

c. Current Task Order procedures are attached.

ARTICLE G.4. TASK ORDER PROCEDURES

a. General Information

Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE. No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

b. Requesting Task Order Quotations. The Contracting Officer or a designated individual may solicit responses to requirements from Contractors within a technical area covered by a task order requirement in writing. A Task Order Request for Quotation (TORFQ) will be prepared and issued for each task order requirement. Generally, the TORFQ will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained in this contract shall be incorporated in the TORFQ and the resultant Task Order. If conflicts exist between the contract clauses and the information outlined in the Task Order, the contract language takes precedence over the information in the Task Order. Contractors are not required to propose on all TORFQs.

Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit a proposal on or before the closing date and time established in the TORFQ. An election not to propose on a given TORFQ will not negatively affect or prohibit a Contractor from competing on future TORFQs.

However, it may affect the Contractor's eligibility for continuations or extensions of the resultant Task Order.

c. Competitive Ordering Process.

1. All Contractors within a technical area will receive e-mail notification advising of the availability of each proposed Task Order requirement. All proposed Task Orders will incorporate all terms of this contract unless otherwise specified in the proposed Task order.

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2. Contractors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order. Responses will not be considered a proposal as defined in FAR Part 15. However, the Contractor shall provide information sufficient for consideration in accordance with FAR Part 16. Each TORFQ will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated. Generally, the Contractor will be asked to demonstrate the following as appropriate:

• Understanding of the requirements;

• Experience and capability on similar tasks;

• Technical approach, methods and procedures for satisfying the requirements with a discussion of potential problems to be encountered and proposed solutions and/or risk mitigation strategies.

• Procedures for assuring quality of work, products, and deliverables;

• Plan for managing the Task Order, including meeting requirements and schedules, and performance measures (if applicable);

• Staffing plan with skill levels and level of effort for each individual proposed. Generally, resumes will be required for proposed personnel (if not previously submitted);

• References to evaluate past performance; and

• Cost/Price to perform the Task Order.

d. Evaluation and Award of Task Order Quotations

The Government will evaluate the Task Order Quotations against the requirements of the TORFQ. Specifically, the technical evaluation factors, cost/price, and any other factor specifically identified in the TORFQ will be used for evaluation of each proposal. In addition, the TORFQ will identify the basis for selecting a contractor for award.

Generally, technical factors will be significantly more important than cost or price However, each TORFQ will specify how the award decision will be made.

Upon completion of evaluations, the Contracting Officer will issue a Task Order to the Contractor whose proposal is most advantageous to the Government

The Contracting Officer will notify the Contractor(s) of the selection decision in writing.

e. Fair Opportunity

1. In accordance with FAR 16.505(b)(1)(i), each awardee will be given a fair opportunity to be considered for each order issued over $3,500 unless the following exception(s) apply:

I. The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

ii. Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

iii. The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

iv. It is necessary to place an order to satisfy a minimum guarantee.

2. All awardees will be given a fair opportunity to be considered in accordance with the FAR as follows:

I. For orders exceeding $3,500 up to the simplified acquisition threshold, in accordance with FAR16.505(b)(1) (ii);

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ii. For orders exceeding the simplified acquisition threshold up to $5.5 Million, in accordance with16.505(b)(1) (iii); and,

iii. For orders exceeding $5.5 Million, in accordance with FAR 16.505(b)(1)(iv).

3. Firm-Fixed Price Task Orders:

For Firm-Fixed Price (FFP) task orders, the contractor will multiply the quantity of each item or labor category required against the fixed rates listed in the pricing schedule under Article B.6. or as negotiated for the task, and the cumulative extended total of all items ordered will define the FFP for the task. Travel and other-direct-cost (ODC), if applicable, may be estimated for each task order. Any amount negotiated for travel and ODCs, will be added to the extended price of all ordered items to arrive at the total FFP for the task order. The CO must determine fair and reasonable pricing for all fixed-price task orders following FAR 15.4, Pricing.

4. Time-and-Materials/Labor Hours Task Orders:

For Time-and-Materials (T&M) task orders (including Labor Hour orders as defined by FAR 16.602), the contractor will multiply the quantity of hours required under each labor category against the fixed rates listed in their price schedule under Article B.6. The cumulative extended total of all labor categories ordered plus travel and ODCs will define the task order- ceiling price. The government will reimburse the contractor as provided under FAR 52.232-7, Payments under T&M and Labor-Hour Contracts (Aug 2012).

For informational purposes, specific procedures for issuing a Task Order for patent-legal services are attached to this RFP.

ARTICLE G.5. INVOICE SUBMISSION

a. Individual Task Orders will specify requirements for the preparation of vouchers and invoices.

b. Task Order will be Fixed-Price, Time-and-Materials, or a hybrid.

c. Example of invoicing instructions are attached.

ARTICLE G.6. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," which can be found at: http://oamp.od.nih.gov/sites/default/ files/appendix_q_hhs_contracting_guide.pdf.

ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a.Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared Annually starting one year after the initial award date.

Contractors will be evaluated on at least the following criteria:

1. Annually, Contractors will be evaluated based on at least the following criteria:

a) Quality of service-to include without limitation interaction with NIH staff, quality of responses to office actions, quality of claims written that cover NIH interests in protection inventions with public health focus, demonstration that the Contractor understands overall patent prosecution strategy, and adherence to the Task Order requirements and specific instructions,

b) Timeliness of performance-to include without limitation to timeliness of responses in patent prosecution as specified in the TORFQs, timeliness in view of statutory and shortened statutory

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Draf t http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf http://oamp.od.nih.gov/sites/default/files/appendix_q_hhs_contracting_guide.pdf periods, including justification and explanation why additional extensions of time to respond to office actions were necessary,

c) Cost Control, including accurate billing of work based on the contract labor mix, adherence to the invoicing details enumerated in Article G, and

d) Management of Key Personnel (quality control and time management of associates)

2. Each of the above criteria a)-d) will be scored on a 5-point scale: 5- Exceptional, 4- Very Good, 3- Satisfactory, 2- Marginal, 1-Unsatisfactory and 0- Complete failure to perform. NIH Technical Representatives will be invited to provide explanatory comments for each rating given. These comments will remain confidential within NIH.

3. For the first two years, Contractors will, on an ongoing basis, provide an electronic survey to NIH Technical Representatives within ten (10) days of filing of a U.S. provisional and PCT/non-provisional patent application and within ten (10) days of paying the issue fee for an application form comment on quality of performance.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b.Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov

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Draf http://www.cpars.gov

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

ARTICLE H.2. CERTIFICATION OF FILING AND PAYMENT OF TAXES

The contractor must be in compliance with Section 518 of the Consolidated Appropriations Act of FY 2014.

ARTICLE H.3. OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in SECTION I., the contract will consist only of the Base Period of the Statement of Work as defined in Sections C and F of the contract. Pursuant to FAR Clause 52.217-6, Option for Increased Quantity set forth in SECTION I. of this contract, the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work and also defined in Sections C and F of the contract. If the Government exercises this option, notice must be given at least 60 days prior to the expiration date of this contract, and the [ Use for Cost-Reimbursement Contracts:

estimated cost [plus fixed fee] of the contract will be increased as set forth in the ESTIMATED COST [PLUS FIXED FEE]/ Use for Fixed-Price Contracts: price of the contract will be increased as set forth in the OPTION PRICES] Article in SECTION B of this contract.

ARTICLE H.4. SUBCONTRACTING PROVISIONS

a. Small Business Subcontracting Plan

1. The Small Business Subcontracting Plan, dated To be determined is attached hereto and made a part of this contract.

2. The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or…