National Institutes of Health, Patent-Legal Services

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February 28, 2019
Please carefully read the attached document titled:
"RFP Clarifications/Other Information/Reminders/Changes for RFP NIH-OD-OLAO-OA (PLS)-2019" dated February 27, 2019.
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Firms may submit a proposal regardless of submitting a Letter of Intent.
The Letter of Intent is not binding. The purpose of the Letter is solely to assist NIH in planning for an efficient proposal review process..

Modification No. 01 to RFP NIH-OD-OLAO-OA-(PLS)-2019:
Extends proposal due date to March 12, 2019;
Provides responses to questions and corrections/changes to solicitation;
Announces pre-proposal conference call and related logistics.
PLEASE SEE ATTACHED SF-30 FOR MORE DETAILS. ALSO ATTACHED IS THE Q & A DOCUMENT..

Contracting Office Address: Department of Health and Human Services (DHHS), National Institutes of Health (NIH), Office of Logistics and Acquisition Operations (OLAO), Office of Acquisitions (OA), Research and Development (R & D) Section, 6011 Executive Blvd., Rockville, MD 20852.
ATTENTION: The Contracting Officer listed on this notice is the only government official to contact with regards to this requirement.

Solicitation Notice: Pursuant to FAR 5.102 -- Availability of Solicitations
You are invited to submit a proposal(s) in response to RFP # NIH-OD-OLAO-OA-(PLS)-2019 for Patent-Legal Services. This solicitation is full and open to ALL capable business concerns in the U.S. The North American Industry Classification System (NAICS) code for this acquisition is 541110 - Office of Lawyers.

In response to this solicitation, the Government intends to award four (4) master ID/IQ contracts for patent level services; one (1) for Biotechnology; one (1) for Chemistry; one (1) for Mechanical Engineering, and; one (1) for Software. Capable law firms (contractors) selected to provide patent-legal services under any of the four technology categories and via this solicitation, will compete for task order awards under the designated category or categories. The Government intends to select approximately nine (9) capable law firms in the area of Biotechnology; approximately seven (7) capable law firms in the area of Chemistry; approximately four (4) capable law firms in the area of Mechanical Engineering, and; approximately two (2) capable law firms in the area of Software to compete for task order awards within the designated technology category.

The NIH Patent Legal Services contracts are awarded to a Contractor, not to a specific partner or other individual. Contracts, and therefore the NIH as a client, are NOT portable business and cannot be assigned or transferred to a new Contractor due to decisions of personnel to leave an existing Contractor.
DEADLINES:
Questions and comments regarding this solicitation shall be sent via email to louis.kuta@nih.gov no later than 1:00 P.M., EST. ON WEDNESDAY, JANUARY 16, 2019.

Letters of Intent shall be submitted via email to louis.kuta@nih.gov no later than 4:00 P.M., EST. ON WEDNESDAY, JANUARY 30, 2019.

Proposals shall be submitted electronically via the Electronic Proposal Submission (eCPS) website at https://ecps.nih.gov no later than 4:00 P.M., EST. ON FRIDAY, MARCH 1, 2019.
Introduction and Background:

The National Institutes of Health (NIH) is an agency of the United States Government under the Department of Health and Human. NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to improve human health, extend life, and reduce illness and disability. The NIH comprises twenty-seven (27) separate Institutes and Centers that have intramural research programs.

Pursuant to the Federal Technology Transfer Act (FTTA), the NIH established a significant technology transfer program that includes the management, patenting, and licensing of inventions with commercial potential originating from research conducted at said intramural research programs. The patent-related legal services NIH's needs in pursuing patent protection for some such inventions and may also include ancillary intellectual property related services. Generally and as applicable to the proposed contract, NIH's day-to-day technology transfer operations are divided into nine (9) centers housed within the National Cancer Institute; National Center for Advancing Transitional Science; National Heart, Lung and Blood Institute; National Human Genome Research Institute; National Institute of Allergy and Infectious Diseases; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Mental Health, and the National Institute of Neurological Disorders and Stroke. The current nine centers conduct technology transfer operations for the Institute or Center which houses them as well as acting as service centers for other NIH Institutes or Centers that do not have in-house technology transfer operations.

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.

The following are the Four (4) Technology Categories:

1. BIOTECHNOLOGY: may include, for example, biochemistry, molecular biology, nanotechnology as it effects 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 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.
Contractors performing tasks to fulfill patent-related services requirements will comply, as required, with U.S. law under Title 35 of the United States Code, Volume 37 of the Code of Federal Regulations, and per the instructions set forth in the Manual of Patent Examining Procedure (https://www.uspto.gov/web/offices/pac/mpep/index.html), and law of any country or territory where patent protection is sought by themselves or through a foreign associate subcontractor. Contractors shall also perform an initial conflict-of-interest determination for each matter. Contractors shall follow specific instructions provided by NIH for individual activities, which are described in exemplary detail below. Finally, Contractors shall be authorized to begin work on any given activity (1) only after receipt of a signed Task Order corresponding to a given activity, or (2) only after receipt of specific instructions linked to an appropriate existing Task Order.

Anticipated Period of Performance: Pursuant to FAR Subpart 6.1-Full and Open Competition, the Government intends to compete and award four (4) HHS-wide Indefinite Delivery/Indefinite Quantity (IDIQ) contract; one (1) in each Technology Categories in the Fall of 2019. The anticipated period of performance will be a minimum base period of one (1) year and the possibility of a maximum of nine (9) option years. Firm-fixed price, Firm-fixed price with equitable adjustment, or time-and-materials/labor task orders may be issued to support NIH and the Centers for Disease Control and Prevention (CDC).

Information Submission Instructions:

1. There is a limit of ten (10) questions per potential offeror.
a. Focus on the technical aspects of the RFP.
2. There will be an opportunity to ask additional questions as part of a pre-proposal
conference. An amendment will be posted with the date and time.
a. Be sure to include a valid Point of Contact when submitting questions and
comments to Mr. Kuta.
3. Questions and comments shall be submitted to the Contracting Officer in writing. In
order to control communications with potential Offerors and ensure fairness, NO
VERBAL RESPONSES TO QUESTIONS OR COMMENTS WILL BE PROVIDED.
a. List the questions and comments (1-10)
b. Font: Times New Roman
c. Font Size: 12
4. Questions and comments shall be submitted in writing and sent electronically to Mr.
Louis Kuta, Senior Contracting Officer, at Louis.Kuta@nih.gov, in either MS Word or
Adobe Portable Document Format (PDF), on or before 1:00 p.m., Eastern, on
Wednesday, January 16, 2019. All responses must be received by the specified
due date and time to be considered.

Disclaimer and Important Notices: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any law firm responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the law firm's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the questions received, additional notices may be published in Federal Business Opportunities.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

.

Contracting Office Address: Department of Health and Human Services (DHHS), National Institutes of Health (NIH), Office of Logistics and Acquisition Operations (OLAO), Office of Acquisitions (OA), Research and Development (R & D) Section, 6011 Executive Blvd., Rockville, MD 20852.
ATTENTION: The Contracting Officer listed on this notice is the only government official to contact with regards to this requirement.

Solicitation Notice: Pursuant to FAR 5.102 -- Availability of Solicitations
You are invited to submit a proposal(s) in response to RFP # NIH-OD-OLAO-OA-(PLS)-2019 for Patent-Legal Services. This solicitation is full and open to ALL capable business concerns in the U.S. The North American Industry Classification System (NAICS) code for this acquisition is 541110 - Office of Lawyers.

In response to this solicitation, the Government intends to award four (4) master ID/IQ contracts for patent level services; one (1) for Biotechnology; one (1) for Chemistry; one (1) for Mechanical Engineering, and; one (1) for Software. Capable law firms (contractors) selected to provide patent-legal services under any of the four technology categories and via this solicitation, will compete for task order awards under the designated category or categories. The Government intends to select approximately nine (9) capable law firms in the area of Biotechnology; approximately seven (7) capable law firms in the area of Chemistry; approximately four (4) capable law firms in the area of Mechanical Engineering, and; approximately two (2) capable law firms in the area of Chemistry to compete for task order awards within the designated technology category.

The NIH Patent Legal Services contracts are awarded to a Contractor, not to a specific partner or other individual. Contracts, and therefore the NIH as a client, are NOT portable business and cannot be assigned or transferred to a new Contractor due to decisions of personnel to leave an existing Contractor.
DEADLINES:
Questions and comments regarding this solicitation shall be sent via email to louis.kuta@nih.gov no later than 1:00 P.M., EST. ON WEDNESDAY, JANUARY 16, 2019.

Letters of Intent shall be submitted via email to louis.kuta@nih.gov no later than 4:00 P.M., EST. ON WEDNESDAY, JANUARY 30, 2019.

Proposals shall be submitted electronically via the Electronic Proposal Submission (eCPS) website at https://ecps.nih.gov no later than 4:00 P.M., EST. ON FRIDAY, MARCH 1, 2019.
Introduction and Background:

The National Institutes of Health (NIH) is an agency of the United States Government under the Department of Health and Human. NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to improve human health, extend life, and reduce illness and disability. The NIH comprises twenty-seven (27) separate Institutes and Centers that have intramural research programs.

Pursuant to the Federal Technology Transfer Act (FTTA), the NIH established a significant technology transfer program that includes the management, patenting, and licensing of inventions with commercial potential originating from research conducted at said intramural research programs. The patent-related legal services NIH's needs in pursuing patent protection for some such inventions and may also include ancillary intellectual property related services. Generally and as applicable to the proposed contract, NIH's day-to-day technology transfer operations are divided into nine (9) centers housed within the National Cancer Institute; National Center for Advancing Transitional Science; National Heart, Lung and Blood Institute; National Human Genome Research Institute; National Institute of Allergy and Infectious Diseases; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Mental Health, and the National Institute of Neurological Disorders and Stroke. The current nine centers conduct technology transfer operations for the Institute or Center which houses them as well as acting as service centers for other NIH Institutes or Centers that do not have in-house technology transfer operations.

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.

The following are the Four (4) Technology Categories:

1. BIOTECHNOLOGY: may include, for example, biochemistry, molecular biology, nanotechnology as it effects 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 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.
Contractors performing tasks to fulfill patent-related services requirements will comply, as required, with U.S. law under Title 35 of the United States Code, Volume 37 of the Code of Federal Regulations, and per the instructions set forth in the Manual of Patent Examining Procedure (https://www.uspto.gov/web/offices/pac/mpep/index.html), and law of any country or territory where patent protection is sought by themselves or through a foreign associate subcontractor. Contractors shall also perform an initial conflict-of-interest determination for each matter. Contractors shall follow specific instructions provided by NIH for individual activities, which are described in exemplary detail below. Finally, Contractors shall be authorized to begin work on any given activity (1) only after receipt of a signed Task Order corresponding to a given activity, or (2) only after receipt of specific instructions linked to an appropriate existing Task Order.

Anticipated Period of Performance: Pursuant to FAR Subpart 6.1-Full and Open Competition, the Government intends to compete and award four (4) HHS-wide Indefinite Delivery/Indefinite Quantity (IDIQ) contract; one (1) in each Technology Categories in the Fall of 2019. The anticipated period of performance will be a minimum base period of one (1) year and the possibility of a maximum of nine (9) option years. Firm-fixed price, Firm-fixed price with equitable adjustment, or time-and-materials/labor task orders may be issued to support NIH and the Centers for Disease Control and Prevention (CDC).

Information Submission Instructions:

1. There is a limit of ten (10) questions per potential offeror.
a. Focus on the technical aspects of the RFP.
2. There will be an opportunity to ask additional questions as part of a pre-proposal
conference. An amendment will be posted with the date and time.
a. Be sure to include a valid Point of Contact when submitting questions and
comments to Mr. Kuta.
3. Questions and comments shall be submitted to the Contracting Officer in writing. In
order to control communications with potential Offerors and ensure fairness, NO
VERBAL RESPONSES TO QUESTIONS OR COMMENTS WILL BE PROVIDED.
a. List the questions and comments (1-10)
b. Font: Times New Roman
c. Font Size: 12
4. Questions and comments shall be submitted in writing and sent electronically to Mr.
Louis Kuta, Senior Contracting Officer, at Louis.Kuta@nih.gov, in either MS Word or
Adobe Portable Document Format (PDF), on or before 1:00 p.m., Eastern, on
Wednesday, January 16, 2019. All responses must be received by the specified
due date and time to be considered.

Disclaimer and Important Notices: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any law firm responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the law firm's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the questions received, additional notices may be published in Federal Business Opportunities.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

.

Contracting Office Address: Department of Health and Human Services (DHHS), National Institutes of Health (NIH), Office of Logistics and Acquisition Operations (OLAO), Office of Acquisitions (OA), Research and Development (R & D) Section, 6011 Executive Blvd., Rockville, MD 20852.
ATTENTION: The Contracting Officer listed on this notice is the only government official to contact with regards to this requirement.

Pre-solicitation Notice: Pursuant to FAR 5.205(c)-Special Notices,
This Pre-solicitation Notice with a DRAFT Request for Proposal is a request for comments and questions. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to advise you of the upcoming requirement for patent-legal services and to obtain comments and questions with regards to the attached DRAFT Request for Proposal.
Upon submitting your comments and questions, please provide the following:
1. Whether you are a small business, HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses.
2. Size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition.
Your comments and questions to this special notice will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization (law firm) that is not considered a small business under NAICS code 541110-Office of Lawyers should not submit a response to this notice.

Introduction and Background:

The National Institutes of Health (NIH) is an agency of the United States Government under the Department of Health and Human. NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to improve human health, extend life, and reduce illness and disability. The NIH comprises twenty-seven (27) separate Institutes and Centers that have intramural research programs.

Pursuant to the Federal Technology Transfer Act (FTTA), the NIH established a significant technology transfer program that includes the management, patenting, and licensing of inventions with commercial potential originating from research conducted at said intramural research programs. The patent-related legal services NIH's needs in pursuing patent protection for some such inventions and may also include ancillary intellectual property related services. Generally and as applicable to the proposed contract, NIH's day-to-day technology transfer operations are divided into nine (9) centers housed within the National Cancer Institute; National Center for Advancing Transitional Science; National Heart, Lung and Blood Institute; National Human Genome Research Institute; National Institute of Allergy and Infectious Diseases; National Institute of Dental and Craniofacial Research; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Mental Health, and the National Institute of Neurological Disorders and Stroke. The current nine centers conduct technology transfer operations for the Institute or Center which houses them as well as acting as service centers for other NIH Institutes or Centers that do not have in-house technology transfer operations.

The awarded contracts will be centralized, and Contractors will perform patent legal services for all nine centers. One or more of these centers also conducts technology transfer operations on behalf of other U.S. Government agencies (e.g., the Centers for Disease Control and Prevention) who delegate such authority thereto and any awarded contracts will require Contractors to also service these agencies. The contracts will be awarded by NIH OLAO as a central resource. Each of the technology transfer centers will issue Task Orders with some or all the awarded Contractors. Thus, Contractors may perform patent services for several NIH Institutes.

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: up to Nine (9) contracts for Biotechnology, up to Seven (7) contracts for Chemistry, up to Four (4) contracts for Medical Engineering, and up to Two (2) contracts for Software. Contractors awardees will be asked to shall perform the high-quality patent related services in these technology categories.

The NIH Patent Legal Services contracts are awarded to a Contractor, not to a specific partner or other individual. Contracts, and therefore the NIH as a client, are generally NOT portable business and cannot be assigned or transferred to a new Contractor due to decisions of personnel to leave an existing Contractor.
The following are the Four (4) Technology Categories:
1. BIOTECHNOLOGY: may include, for example, biochemistry, molecular biology, nanotechnology as it effects 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 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.
Contractors performing tasks to fulfill patent-related services requirements will comply, as required, with U.S. law under Title 35 of the United States Code, Volume 37 of the Code of Federal Regulations, and per the instructions set forth in the Manual of Patent Examining Procedure (https://www.uspto.gov/web/offices/pac/mpep/index.html), and law of any country or territory where patent protection is sought by themselves or through a foreign associate subcontractor. Contractors shall also perform an initial conflict-of-interest determination for each matter. Contractors shall follow specific instructions provided by NIH for individual activities, which are described in exemplary detail below. Finally, Contractors shall be authorized to begin work on any given activity (1) only after receipt of a signed Task Order corresponding to a given activity, or (2) only after receipt of specific instructions linked to an appropriate existing Task Order.

Anticipated Period of Performance: Pursuant to FAR Subpart 6.1-Full and Open Competition, the Government intends to compete and award four (4) HHS-wide Indefinite Delivery/Indefinite Quantity (IDIQ) contract; one (1) in each Technology Categories in the Fall of 2019. The anticipated period of performance will be a minimum base period of one (1) year and the possibility of a maximum of nine (9) option years. Firm-fixed price or time-and-materials task order will be issued to support NIH and the Centers for Disease Control and Prevention (CDC).

Information Submission Instructions:

1. There is a limit of ten (10) questions per potential offeror.
a. Focus on the technical aspects of the draft RFP.
2. There will be an opportunity to ask additional questions either in writing or as part of a pre-solicitation conference. A notification will be posted after this one expires.
a. Be sure to include a valid Point of Contact when submitting questions and
comments to Mr. Kuta.
3. Questions and comments shall be submitted to the Contracting Officer in writing. In order to control communications with potential Offerors and ensure fairness, NO VERBAL RESPONSES TO QUESTIONS OR COMMENTS WILL BE PROVIDED.
a. List the questions and comments (1-10)
b. Font: Times New Roman
c. Font Size: 12
4. Questions and comments shall be submitted in writing and sent electronically to Mr. Louis Kuta, Senior Contracting Officer, at Louis.Kuta@nih.gov and a copy to Ms. Shirlene Smith, Contract Specialist, at Shirlene.Smith@nih.gov , in either MS Word or Adobe Portable Document Format (PDF), on or before 10:00 a.m. Eastern on November 30, 2018. All responses must be received by the specified due date and time to be considered.

Disclaimer and Important Notices: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any law firm responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the law firm's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After review of the questions received, additional notices may be published in Federal Business Opportunities.

Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

.