CSS_NIHDA201800016.pdf

COMBINED SYNOPSIS / SOLICITATION

COMPETITIVE

Title: Medicinal Chemistry Consultant Support Services

(i) 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; proposals are being requested at this time and an additional written solicitation will NOT be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items.

(ii) The solicitation number is NIHDA201800016 and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures;

FAR Subpart 13.5— Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-96, dated November 6, 2017. The resultant contract will include all applicable clauses in effect through this date.

(iv) The intended procurement is classified under NAICS code 541690 -- Other Scientific and Technical Consulting Services with a Size Standard of $15 Million.

(v) The National Institutes of Health (NIH) is the nation's leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people's health and save lives.

The NIH Blueprint for Neuroscience Research, a consortium of 8 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services are provided without cost to the PI through NIH contracts.

(vi) Purpose and Objectives: The purpose of this requirement is to procure up to three (3) consultants to provide technical recommendations to the NIH Blueprint Neurotherapeutics Network drug discovery and development program in the area of Medicinal Chemistry.

Project Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

The Contractor shall provide this support while serving on NIH BPN Lead Development Teams. Lead Development Teams (LDT) meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time.

The Contractor is expected to provide support services in a collaborative way. Lead Development Teams the Contractor is assigned to may work on a number of projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages.

The Contractor shall provide consulting support services to the NIH Blueprint Neurotherapeutics Network in the area of Medicinal Chemistry

Medicinal chemistry consultants will be expected to provide senior-level medicinal chemistry expertise and contribute feedback and guidance on projects to the NIH and to LDT members through conference calls and by email.

The role of the medicinal chemistry consultant may include but is not limited to the following responsibilities and tasks:

• Offer input on project milestones, target product profiles, and testing funnels

• Provide feedback on chemical structures and processes proposed by a chemistry service contractor for each round of SAR

• Evaluate SAR data on a weekly or biweekly basis.

• Medicinal chemistry consultant may be asked to evaluate the potential tractability

(including surrounding IP space) of a chemical structure for medicinal chemistry. Specific consulting responsibilities will depend on the expertise of the individual consultant and the needs of individual projects.

• In partnership with other consultants, contractors, and the NIH staff, advise, strategically plan, and manage medicinal chemistry programs to facilitate exploratory chemistry, hit-to-lead, lead optimization, IND enabling, and clinical studies.

• Serve as the medicinal chemistry expert in order to identify potential drug discovery and development challenges and suggest strategies to address these challenges.

• Collaborate on design of investigative studies in support of NIH drug discovery and development projects.

• Accompany NIH staff or visit, at BPN staff request, Contract Research Organizations

[CRO] under contract to BPN. Inspect facilities and discuss appropriateness of CRO proposed methodology. Submit trip reports to BPN staff.

• Facilitate Lead Development Team discussions via telephone and email regarding assigned drug medicinal chemistry.

Contract Deliverables:

a. Annual and Final Reports - The Contractor shall provide the COR and CO an annual report and final report of all tasks and subtasks completed, outcomes of each, timelines within which they were accomplished, any challenges encountered and how they were resolved, lessons learned, and, a summary of customer feedback, where applicable. Monthly invoices should include details of work done during the month. The annual report may be a compilation or summary of those details.

The Contractor shall submit a draft report four (4) weeks prior to the end of the year in a format approved by COR. The COR will have ten (10) business days to provide the comments to the contractor. The Contractor shall revise and resubmit the final document within three (3) business days. Additionally, the Contractor shall prepare and submit a final report that includes all tasks/activities for the duration of the Contract. The Contractor shall submit a draft final report within four (4) weeks prior to the contract end period, in a format approved by the COR. The COR will have ten (10) business days to provide the Contractor any comments/edits. The contractor shall revise and submit final document within three (3) business days of receipt of comments.

b. Contractor Non-Disclosure Agreement (NDA)- Each Contractor (and/or any subcontractor) employee having access to non-public government information under this contract shall complete the NIH non-disclosure agreement https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf , as applicable. A copy of each signed and witnessed NDA shall be submitted to the Contracting Officer (CO) and/or CO Representative (COR) prior to performing any work under this acquisition.

c. Vulnerability Scanning Reports The Contractor shall report the results of the required monthly special vulnerability scans no later than 10 days following the end of each reporting period. If required monthly, this report may be included as part of the Technical Progress Report. Otherwise, this report shall be submitted under a separate cover on monthly basis.

d. Service Contract Reporting Per FAR Clause 52.204-14 Contractors shall submit via SAM an annual report on October 31st encompassing the previous year from 1 October through 30 September.

(See paragraph XI for complete FAR Clause. In the past, they have submitted details of work done with every invoice. It is hard to figure out what else they can report on. Also, if they are tasked to look at a particular problem, they do send in written reports. So, is this needed?

Level of Effort: The estimated level of effort for this requirement is one (1) contractor employee on a part-time basis for each of the, up to, three (3) anticipiated contract https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf awards.

The required level of effort varies depending on the quantity and complexity of BPN projects at any given time. Accordingly, a minimum and maximum level of effort is anticipated. A minimum of 50 hours and a maximum of 800 hours of support is required annually. Hours above the annual minimum shall be exercised in increments of Option

(a) – 20 hours, Option (b) – 50 hours, or Option (c) - 100 hours if needed, or any combination thereof, using FAR Clause 52.217-7 Option for Increased Quantity- Separately Priced Line Item.

Government Furnished Information/Property: No Government furnished property shall be provided. Project related data will be provided to the Contractor for performance of work efforts. All data provided to the Contractor must be treated as confidential and not be disclosed to any third party.

Project data will be collected and stored by NINDS. NINDS will provide data as needed to the consultant each time it requests service. The consultant may store data up to 12 months after initially receiving it, after that time the consultant should either delete the data files and sanitize the computer using NIST SP 800-88 (current revision) or if information is still needed contact the COR for permission to store data longer.

Key Personnel: The Contractor employee providing services for this effort shall be considered Key personnel. Key Personnel requirements are as follows:

General requirements

• Consultants must have extensive experience in managing or being a senior leader in drug discovery projects in the biopharmaceutical industry. Experience with drug discovery for nervous system conditions is preferred.

• Consultants must be able to work in a cross-functional team environment and manage competing priorities.

• Consultants must have strong interpersonal skills, an attention to detail, excellent organizational, writing, communication, presentation, and documentation skills as well as computer and software literacy.

• Consultants must have experience working with multi-disciplinary teams at a senior level in the biopharmaceutical industry, especially teams with members from outside organizations and members at various management levels.

Education and work experience requirements

• An advanced degree in chemistry or medicinal chemistry is required.

• Minimum of 15 years of medicinal chemistry experience

• Experience in executing and managing drug development tasks, particularly for nervous system conditions.

• A track record of advancing projects into drug development. Measures of success include patents, Investigational New Drug (IND) applications, publications, and drugs brought to market.

• Previous experiences in identifying and anticipating problems early in a project, overcoming technical difficulties, and making strategic decisions that make wise use of limited resources (including terminating projects that appear unlikely to succeed) will be considered as signs of a strong track record in drug development.

• Expertise leading chemistry efforts performed by contract research organizations, and managing drug project portfolios.

The proposed Key Personnel will become subject to the provisions of Health and Human Services Acquisition Regulation (HHSAR) Clause HHSAR 352.237-75 Key Personnel as follows:

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.

Travel (Option Item): The consultant may be required to travel within the contiguous United States to provide the services described in this statement of work. Travel reimbursement will be provided for such required travel.

All travel arrangements must be made in accordance with Federal Travel Regulations and must be approved by the Contracting Officer and authorized by the Contracting Officer’s Representative prior to being finalized or invoiced. Contracting Officer approved and Contracting Officer’s Representative-authorized travel shall not exceed $1,500.00 annually.

Please note that travel time may not be billed to the Government. Please see the Federal Travel Regulation for allowable travel expenses, such as fares, rental fees, mileage payments and other expenses related to transportation per FTR §30110.2.

Information Systems Security: The Contractor must ensure that any computer system used in the course of this contract shall include the following features:

1. Any computer used in relation to this contract must be patched with most updated IT

Security Patches.

2. Any Contractor computer used in relation this contract must have virus protection loaded and running with definition files that are updated on at least a daily basis.

3. Hard drives and portable media used for this contract must be encrypted using the

FIPS 140-2 standard.

4. Contractors are required to take NIH Security and Privacy Training annually http://irtsectraining.nih.gov/

5. Contractor are required to sign the NIH non-disclosure agreement http://irtsectraining.nih.gov/NIH_Non-Disclosure_Agreement.pdf

6. Contractors are required to report any lost or stolen NIH data to the NINDS ISSO within one hour of knowing of the lost or theft even if the data is on a Contractor furnished computer.

7. Contractors are required to adhere to the NIH IT rules of behavior which can be found at https://ocio.nih.gov/InfoSecurity/training/Pages/nihitrob.aspx

8. Any computers used in reference to this contract must be assessed for vulnerabilities.

9. Any computers used in reference to this contract must be backed up on an external hard drive which is password protected.

10. Any computers used in reference to this contract must have auditing enabled such that if an incident occurred then that event could be reconstructed.

11. Any computers that are used in reference to this contract must employ at a minimum user name and password authentication or if possible two factor authentication.

12. Any computer used in relation to this contract must be password protected. All Password must meet the NIH standard such that users must choose passwords that have at least eight characters and at least three of the following types of characters:

a. capital letters

b. lower case letters

c. numeric characters

d. special characters (!@#$%^&*()_+|~-=\`{}[]:";'<>?,./)

Data Rights: The National Institute of Neurological Disorders and Stroke shall have unlimited rights to and ownership of all deliverables provided under this procurement including reports, analyses, recommendations and all other deliverables. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” shall be incorporated into any resulting award by reference.

Intellectual property: As an exception to the data rights clause above, should a consultant contribute to the creation of new intellectual property, he or she may be named as an inventor according to U.S. or prevailing patent law. In such cases, the consultant must complete negotiations with the pertinent principal investigator’s institution regarding assignment of rights and royalties distribution prior to advising on nay activities. The consultant must provide copies of any and all intellectual property agreements made related to this effort for this requirement to NINDS COR.

Section 508 Compliance:

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CRF part 1194), require that Federal agencies electronic and information technology is accessible to people with disabilities.. The Federal Acquisition Regulations (FAR)Final Rule for Section 508 (EIT Accessibility) can be found at www.section508.gov and at the Access Board’s Web site at https://www.access-board.gov/508.htm . The contractor must state that they will comply with the requiremetns of Section 508 or cite a justifiable reason for an exception.

Non-Personal Service Statement: Contract employee performing services will be controlled, directed and supervised at all times by management personnel of the contractor. Actions of contractor employees may not be interpreted or implemented in any manner that results in any contractor employee creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal employees, providing direct personal services to any Federal employee or otherwise violating the prohibitions set forth in Parts 7.5 and 37.1 of the Federal Acquisition Regulations (FAR).

Collaboration Requirements: It is required that all contractors involved with the NIH community work collaboratively with federal staff and other contractors towards the NIH mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required.

Confidentiality of Information: Confidential Information means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization. Confidential Information or records shall not be disclosed by the Contractor without written authorization from the Contracting Officer.

Whenever the Contractor is uncertain with regard to the confidentiality of or a property interest in information under this contract, the Contractor should consult with the Contracting Officer prior to any release, disclosure, dissemination, or publication.

Contract Type: Up to three (3) Firm Fixed Price Contract(s) with Options to Extend the Term of the Contract as well as Options to Increase the Quantiy is contemplated.

Invoicing shall be on a NET30 basis and payment shall be made via Electronic Funds Transfer (EFT)

Response Format: Responses to this solicitation must include clear and convincing evidence of the offeror's capability of fulfilling the requirement as it relates to the technical evaluation criteria. The offeror must submit 1) a technical response and

2) a separate price quotation.

The technical response should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to thirty (30) single sided pages.

A. Technical response http://www.section508.gov/ https://www.access-board.gov/508.htm

Respondents must provide clear and convincing documentation of their capability of providing the services specified in this notice. In addition to a detailed CV, respondents are requested to provide document discussing at a minimum, the following (please see Evaluation Criteria for further guidance):

• Key personnel professional experience in drug discovery and development

• Key personnel education and certification

• Key personnel collaborative team experience

• Past performance details for at least two (2) references with knowledge of the respondent’s relevant skills and experience in the areas outlined in the Statement of Work:

Name of organization Brief description of offeror’s responsibilities Point of contact name, title, telephone number and email address.

• The respondent must also provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HubZone, etc., pursuant to the applicable NAICS code and any other information that may be helpful in developing or finalizing the acquisition requirements.

• Finally, respondents are also encouraged to provide a general overview of the respondent’s opinions about the difficulty and/or feasibility of the potential requirement, and any other information regarding innovative ideas or concepts that may be applicable.

B. Price quotation

The price quotation must include an hourly rate as well as extended pricing for the full level of effort of each contract period. Options for increased quantity must also be detailed, as in the example below. A travel opt ion for not-to-exceed $1,500 should be included for each year of the contract. A summary of the whole contract price should all options be exercised must also be included.

Example for Base Period Pricing:

Base Period:

Hourly Rate - $XX/hour x 50 Hours - $XXX

Base Period Options for Increased Quantity:

Hourly Rate -- $XX/hour for Options -

Option A- 20 Hours - $XXX Option B- 50 Hours - $XXX Option C- 100 Hours - $XXX

Travel (Option Item) – NTE $1,500.

Total Minimum - $XXX Total Maximum - $XXX

Contractors must provide their Company Name, Dun & Bradstreet Number (DUNS), Taxpayer Identification Number (TIN), Business Size, Physical Address, and Point of

Contact Information in their responses. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov."

(vii) Period of Performance: The required period of performance is a one-year base period from February 28, 2018 through February 27, 2019 and four (4) subsequent one-year option periods.

Place of Performance: The primary place of performance shall be Contractor site.

Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities or facilities of selected principal investigators on an as needed basis.

(viii) The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items (Jan 2017), applies to this acquisition.

(ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Items (Oct 2014), applies to this acquisition.

(a) The Government will award a contracts resulting from this solicitation to the responsible offerors whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

EVALUATION CRITERIA

The Government will award a contract resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below:

Factor 1: Key Personnel Professional Experience in Drug Discovery and Development

Key personnel proposed shall be evaluated for length and breadth of demonstrated leadership experience in drug discovery and development projects related to medicinal chemistry.

Leadership experience in executing and managing drug discovery and development tasks, particularly for nervous system conditions, shall be evaluated. Broad experience across the entire drug discovery and development process from discovery to clinical trials shall be considered favorably.

Key personnel professional experience shall also be evaluated for preparation of successful investigational new drug applications, as well as publications, patents, and work on drugs brought to market. In addition, experience showing use of expertise to identify or anticipate problems early, overcome technical or regulatory difficulties, distill complex situations, or demonstrate strong risk-assessment ability to make wise use of limited resources shall be considered favorably.

Finally, key personnel professional experience shall be evaluated for efforts involving compliance and familiarity with regulatory procedures and guidelines relevant to small molecule drug discovery development, especially for nervous system indications.

http://www.sam.gov/

Factor 2: Key Personnel Education & Qualifications

Key personnel proposed shall be evaluated for conformance to the key personnel qualifications identified in the statement of work as well as for additional education and certifications related to the statement of work requirements. Advanced education and board certifications, as well as other evidence of advanced expertise applicable to drug medicinal chemistry shall be considered favorably.

Factor 3: Key Personnel Collaborative Team Experience

Key personnel proposed shall be evaluated for length and breadth of experience collaborating with multi- disciplinary teams, especially teams with members from outside organizations and members at various management levels. Experiences such as team leadership, consulting, or service on strategic and advisory boards shall be considered favorably.

Factor 4: Past Performance

The Contractor shall provide at least two (2) past performance references with knowledge of the contractor's relevant skills and experience related to the requirements outlined in this Statement of Work. References shall include the following information:

• Name of Organization

• Brief Description of Contractor's Responsibilities

• Point of Contact Name, Title, and Telephone Number

Past Performance will be evaluated for demonstrated performance of the offeror on current and past contracts relevant to the current requirement as well as customer satisfaction in reference to the following:

• Interpersonal skills

• Attention to detail

• Computer and software literacy

• Writing, Communication, and Presentation Skills

EVALUATION METHOD

Technical proposals will be evaluated using a summary adjectival rating in accordance with the following scale:

Excellent

A combination of following factors is likely to result in excellent performance as a medicinal chemistry consultant.

• Over 10 years’ experience leading medicinal chemistry team’s small molecule drug discovery efforts as demonstrated by holding a senior level position.

• 15 years’ participation in small molecule medicinal chemistry teams throughout the drug discovery and development process.

• Preparation and submission of medicinal chemistry components of INDs for 5+ drug candidates.

• 3+ years providing medicinal chemistry consulting to small companies and academics.

• PhD degree in chemistry or medicinal chemistry with adequate post-doctoral preparation and at least 15+ years Medicinal Chemistry experience in the pharmaceutical industry.

OR

MS degree in chemistry or medicinal chemistry with more than 20 years hands-on medicinal chemistry experience in the pharmaceutical industry. [MS degree + 6 years’ work experience can be equated to a PhD with limited post-doctoral experience].

Engaging the offeror as medicinal chemistry consultant represents a benefit to the BPN program.

Good

A combination of following factors is likely to result in good performance as a medicinal chemistry consultant.

• 10 years’ experience leading medicinal chemistry team’s small molecule drug discovery efforts as demonstrated by holding a senior level position.

• 15 years’ participation in small molecule medicinal chemistry teams throughout the drug discovery and development process.

• Preparation and submission of medicinal chemistry components of INDs for several drug candidates.

• 1+ years providing medicinal chemistry consulting to small companies and academics.

• PhD degree in chemistry or medicinal chemistry with adequate post-doctoral preparation and at least 15+ years medicinal chemistry experience in the pharmaceutical industry.

OR

MS degree in chemistry or medicinal chemistry with 20 years hands-on medicinal chemistry experience in the pharmaceutical industry. [MS degree + 6 years’ work experience can be equated to a PhD with limited post-doctoral experience].

Engaging the offeror as medicinal chemistry consultant represents no risk to the BPN program.

Acceptable

A combination of following factors is likely to result in acceptable performance as a medicinal chemistry consultant.

• 5 years’ experience leading medicinal chemistry team’s small molecule drug discovery efforts as demonstrated by holding a senior level position.

• 10 years’ participation in small molecule medicinal chemistry teams throughout the drug discovery and development process

• Preparation and submission of medicinal chemistry components of INDs for several drug candidates.

• PhD degree in chemistry or medicinal chemistry with adequate post-doctoral preparation and at least 10+ years medicinal chemistry experience in the pharmaceutical industry.

OR

MS degree in chemistry or medicinal chemistry with 15 years hands-on medicinal chemistry experience in the pharmaceutical industry. [MS degree + 6 years’ work experience can be equated to a PhD with limited post-doctoral experience].

Engaging the offeror as medicinal chemistry consultant represents a neutral risk to the BPN program.

Marginal

A combination of following factors is likely to result in marginal performance as a medicinal chemistry consultant.

• Limited experience leading small molecule drug development medicinal chemistry team through the whole drug development process.

• Limited experience leading a drug discovery and development medicinal chemistry team through drug development process.

• Limited experience in team preparation and submission of medicinal chemistry components of INDs.

• PhD degree in chemistry or medicinal chemistry without adequate post-doctoral preparation or medicinal chemistry pharmaceutical industry experience.

OR

MS degree in chemistry or pharmaceutical sciences without adequate hands-on experience in pharmaceutical industry. [MS degree + 6 years’ work experience can be equated to a PhD with limited post-doctoral experience].

Engaging the offeror as medicinal chemistry consultant represents a degree of risk to the BPN program.

Unacceptable

A combination of the following factors is likely to result in unsatisfactory performance as a medicinal chemistry consultant.

• Lack of graduate degree in chemistry or medicinal chemistry.

• Lack of or limited hands-on participation in a drug discovery and development medicinal chemistry team throughout the drug development process.

• Lack of or limited experience leading small molecule drug development medicinal chemistry team through the whole drug development process.

• Lack of or limited experience in preparation and submission of medicinal chemistry components of INDs.

Engaging the offeror as medicinal chemistry consultant represents a very high degree of risk to the BPN program.

(b) Options. Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The

Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(x) The Offerors shall include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications—Commercial Items (Nov 2017), with its offer.

This requirement may be met by completion of the provision in the System of Award Amanagement and so indicate in their offer.

(xi) FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items (Jan 2017), with ADDENDUM applies to this acquisition.

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 (including, when applicable, Human Subjects Testing requirements). 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.

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

Name Title

OPTION PROVISION

Unless the Government exercises its option pursuant to the Option Clause set forth in the contract, the contract will consist only of the Base Period of the Statement of Work as defined . Pursuant to FAR Clause 52.217-7, Option for Increased Quantity- Separately Priced Line Item and FAR Clause 52.217-9, Option to Extend the Term of the Contract the Government may, by unilateral contract modification, require the Contractor to perform additional options set forth in the Statement of Work. If the Government exercises any of these options, notice must be given at least 10 days prior to execution of said option, and the price of the contract will be increased as set forth in the OPTION PRICES SECTION of the contract.

52.217-7 Option for Increased Quantity—Separately Priced Line Item (Mar 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 10 days prior to execution of said option. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of clause)

52.217-9 -- Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 10 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least _10__ days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years.

(End of clause)

52.242-15 Stop-Work Order (Aug 1989)

(a) The Contracting Officer may, at any time, by written order to the Contractor, require the Contractor to stop all, or any part, of the work called for by this contract for a period of 90 days after the order is delivered to the Contractor, and for any further period to which the parties may agree. The order shall be specifically identified as a stop-work order issued under this clause. Upon receipt of the order, the Contractor shall immediately comply with its terms and take all reasonable steps to minimize the incurrence of costs allocable to the work covered by the order during the period of work stoppage. Within a period of 90 days after a stop-work is delivered to the Contractor, or within any extension of that period to which the parties shall have agreed, the Contracting Officer shall either—

(1) Cancel the stop-work order; or

(2) Terminate the work covered by the order as provided in the Default, or the Termination for Convenience of the Government, clause of this contract.

(b) If a stop-work order issued under this clause is canceled or the period of the order or any extension thereof expires, the Contractor shall resume work. The Contracting Officer shall make an equitable adjustment in the delivery schedule or contract price, or both, and the contract shall be modified, in writing, accordingly, if—

(1) The stop-work order results in an increase in the time required for, or in the Contractor’s cost properly allocable to, the performance of any part of this contract; and

(2) The Contractor asserts its right to the adjustment within 30 days after the end of the period of work stoppage; provided, that, if the Contracting Officer decides the facts justify the action, the Contracting Officer may receive and act upon the claim submitted at any time before final payment under this contract.

(c) If a stop-work order is not canceled and the work covered by the order is terminated for the convenience of the Government, the Contracting Officer shall allow reasonable costs resulting from the stop-work order in arriving at the termination settlement.

(d) If a stop-work order is not canceled and the work covered by the order is terminated for default, the Contracting Officer shall allow, by equitable adjustment or otherwise, reasonable costs resulting from the stop-work order.

(End of clause)

INFORMATION SECURITY AND/OR PHYSICAL ACCESS SECURITY

A. Baseline Security Requirements

1. Applicability- The requirements herein apply whether the entire contract or order

(hereafter "contract"), or portion thereof, includes either or both of the following:

a. Access (Physical or Logical) to Government Information: A Contractor (and/or any subcontractor) employee will have or will be given the ability to have, routine physical (entry) or logical (electronic) access to government information.

b. Operate a Federal System Containing Information: A Contractor (and/or any subcontractor)will operate a federal system and information technology containing data that supports the HHS mission. In addition to the Federal Acquisition Regulation (FAR) Subpart 2.1 definition of "information technology" (IT), the term as used in this section includes computers, ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for security and surveillance), peripheral equipment designed to be controlled by the central processing unit of a computer, software, firmware and similar procedures, services (including support services), and related resources.

2. Safeguarding Information and Information Systems- In accordance with the Federal Information Processing Standards Publication (FIPS)199, Standards for Security Categorization of Federal Information and Information Systems, the Contractor (and/or any subcontractor) shall:

a. Protect government information and information systems in order to ensure:

• Confidentiality , which means preserving authorized restrictions on access and disclosure, based on the security terms found in this contract, including means for protecting personal privacy and proprietary information;

• Integrity , which means guarding against improper information modification or destruction, and ensuring information non-repudiation and authenticity; and

• Availability , which means ensuring timely and reliable access to and use of information.

b. Provide security for any Contractor systems, and information contained therein, connected to an HHS network or operated by the Contractor on behalf of HHS regardless of location. In addition, if new or unanticipated threats or hazards are discovered by either the agency or contractor, or if existing safeguards have ceased to function, the discoverer shall immediately, within one (1) hour or less , bring the situation to the attention of the other party.

c. Adopt and implement the policies, procedures, controls, and standards required by the HHS Information Security Program to ensure the confidentiality, integrity, and availability of government information and government information systems for which the Contractor is responsible under this contract or to which the Contractor may otherwise have access under this contract. Obtain the HHS Information Security Program security requirements, outlined in the HHS Information Security and Privacy Policy (IS2P), by contacting the CO/COR or emailing fisma@hhs.gov .

d. Comply with the Privacy Act requirements.

3. Information Security Categorization- In accordance with FIPS 199 and National Institute of Standards and Technology (NIST) Special Publication (SP) 800-60, Volume II: Appendices to Guide for Mapping Types of Information and Information Systems to Security Categories, Contractor Non-Disclosure Agreement and based on information provided by the ISSO, CISO, or other security representative, the risk level for each Security Objective and the Overall Risk Level, which is the highest watermark of the three factors (Confidentiality, Integrity, and Availability) of the information or information system are the following:

Confidentiality: [ ] Low [ X ] Moderate [ ] High Availability: [ ] Low [ X ] Moderate [ ] High

Integrity [ ] Low [ X ] Moderate [ ] High Overall Risk Level: [ ] Low [ X ] Moderate [ ] High\

Based on information provided by the ISSO, Privacy Office, system/data owner, or other security or privacy representative, it has been determined that this solicitation/contract involves:

[X ] No PII [ ] Yes PII

4. Controlled Unclassified Information (CUI)- CUI is defined as "information that laws, regulations, or Government-wide policies require to have safeguarding or dissemination controls, excluding classified information." The Contractor (and/or any subcontractor) must comply with Executive Order 13556, Controlled Unclassified Information, (implemented at 3 CFR, part 2002) when handling CUI. 32 C.F.R. 2002.4(aa) As implemented the term "handling" refers to "…any use of CUI, including but not limited to marking, safeguarding, transporting, disseminating, re-using, and disposing of the information." 81 Fed. Reg. 63323. All sensitive information that has been identified as CUI by a regulation or statute, handled by this solicitation/contract, shall be:

mailto:fisma@hhs.gov

a. Marked appropriately;

b. Disclosed to authorized personnel on a Need-To-Know basis;

c. Protected in accordance with NIST SP 800-53, Security and Privacy Controls for Federal

Information Systems and Organizations applicable baseline if handled by a Contractor system operated on behalf of the agency, or NIST SP 800-171, Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations if handled by internal Contractor system; and

d. Returned to HHS control, destroyed when no longer needed, or held until otherwise directed. Destruction of information and/or data shall be accomplished in accordance with NIST SP 800-88, Guidelines for Media Sanitization.

5. Protection of Sensitive Information- For security purposes, information is or may be sensitive because it requires security to protect its confidentiality, integrity, and/or availability. The Contractor (and/or any subcontractor) shall protect all government information that is or may be sensitive in accordance with OMB Memorandum M-06-16, Protection of Sensitive Agency Information by securing it with a FIPS 140-2 validated solution.

6. Confidentiality and Nondisclosure of Information- Any information provided to the contractor (and/or any subcontractor) by HHS or collected by the contractor on behalf of HHS shall be used only for the purpose of carrying out the provisions of this contract and shall not be disclosed or made known in any manner to any persons except as may be necessary in the performance of the contract. The Contractor assumes responsibility for protection of the confidentiality of Government records and shall ensure that all work performed by its employees and subcontractors shall be under the supervision of the Contractor. Each Contractor employee or any of its subcontractors to whom any HHS records may be made available or disclosed shall be notified in writing by the Contractor that information disclosed to such employee or subcontractor can be used only for that purpose and to the extent authorized herein.

The confidentiality, integrity, and availability of such information shall be protected in accordance with HHS and NIH policies. Unauthorized disclosure of information will be subject to the HHS/NIH sanction policies and/or governed by the following laws and regulations:

a. 18 U.S.C. 641 (Criminal Code: Public Money, Property or Records);

b. 18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information); and

c. 44 U.S.C. Chapter 35, Subchapter I (Paperwork Reduction Act).

Each employee, including subcontractors, having access to non-public Department information under this acquisition shall complete the "Commitment to Protect Non-Public Information - Contractor Employee Agreement" located at:

https://ocio.nih.gov/aboutus/publicinfosecurity/acquisition/Documents/Nondisclosure.pdf . A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the Project Officer/COR prior to performing any work under this acquisition.

7. Internet Protocol Version 6 (IPv6)- All procurements using Internet Protocol shall comply with OMB Memorandum M-05-22, Transition Planning for Internet Protocol Version 6 (IPv6).

8. Government Websites- All new and existing public-facing government websites must be securely configured with Hypertext Transfer Protocol Secure (HTTPS) using the most recent version of Transport Layer Security (TLS). In addition, HTTPS shall enable HTTP Strict Transport Security (HSTS) to instruct compliant browsers to assume HTTPS at all times to reduce the number of insecure redirects and protect against attacks that attempt to downgrade connections to plain HTTP. For internal-facing websites, the HTTPS is not required, but it is highly recommended.

9. Contract Documentation- The Contractor shall use provided templates, policies, forms and other agency documents provided by the Contracting Officer and the Contracting Officer's Representative to comply with contract deliverables as appropriate.

10. Vulnerability Management - Use SCAP-compliant automated tools for authenticated scans to scan information system(s) and detect any security vulnerabilities in all assets (computers, servers, routers, Web applications, databases, operating systems, etc.) that store and process government information. Contractors shall actively manage system vulnerabilities using automated tools and technologies where practicable and in accordance with HHS policy. Automated tools shall be compliant with NIST-specified SCAP standards for vulnerability identification and management. The contractor shall maintain a capability to provide security vulnerability scanning information for 100% of IT assets using SCAP-compliant automated tools and report to the agency at least within 30 days of the contract award.

11. Standard for Encryption- The Contractor (and/or any subcontractor) shall:

a. Comply with the HHS Standard for Encryption of Computing Devices and Information to prevent unauthorized access to government information.

b. Encrypt all sensitive federal data and information (i.e., PII, protected health information [PHI], proprietary information, etc.) in transit (i.e., email, network connections, etc.) and at rest (i.e., servers, storage devices, mobile devices, backup media, etc.) with FIPS 140-2 validated encryption solution.

c. Secure all devices (i.e.: desktops, laptops, mobile devices, etc.) that store and process government information and ensure devices meet HHS and NIH-specific encryption standard requirements. Maintain a complete and current inventory of all laptop computers, desktop computers, and other mobile devices and portable media that store or process sensitive government information (including PII).

d. Verify that the encryption solutions in use have been validated under the Cryptographic Module Validation Program to confirm compliance with FIPS 140-2. The Contractor shall provide a written copy of the validation documentation to the Contracting Officer and the Contracting Officer's Technical Representative within 15 days of the validation .

e. Use the Key Management system on the HHS personal identification verification (PIV) card or establish and use a key recovery mechanism to ensure the ability for authorized personnel to encrypt/decrypt information and recover encryption keys. Encryption keys shall be provided to the COR upon request and at the conclusion of the contract.

12. Contractor…