20181231_PM_01.50_-_Attachments.1-13.RFP_No._NIH-OD-OLAO-OA-(PLS)-2019.pdf

Statement of Work

Patent Legal Services National Institutes of Health

Technology Transfer Centers RFP No. NIH-OD-OLAO-OA-(PLS)-2019

December 27, 2018

This Statement of Work (SOW) sets forth the requirements for patent legal services to be used by the National Institutes of Health, an agency of the United States Government under the Department of Health and Human Services.

Attachment 1 RFP No. NIH-OD-OLAO-OA-(PLS)-2019

TABLE OF CONTENTS

I. INTRODUCTION/OVERVIEW

II. CATEGORIES OF TECHNOLOGY SERVICES AND OTHER TASK AREAS

III. REQUIREMENTS FOR PATENT LEGAL SERVICES

IV. DELIVERABLES

V. LABOR MIX

VI. TRANSITION CASES

Attachment 1

I. INTRODUCTION/OVERVIEW

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.

BACKGROUND

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 support both extramural and intramural programs. Pursuant to the Federal Technology Transfer Act (FTTA) of 1986, 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. 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.

SCOPE

The NIH currently contracts for patent-related legal services, which will expire in 2019. The patent-related legal services solicited will service the needs in pursuing patent protection for some inventions and may also include ancillary intellectual property related services for NIH and CDC.

OBJECTIVES

The objective is to obtain the support of highly qualified law firms to provide a full-range of patent-legal services to the Offices of Technology Transfer at the NIH and CDC in the areas of Biotechnology, chemistry, Mechanical Engineering, and Software.

Attachment 1

II. CATEGORIES OF TECHNOLOGY SERVICES AND OTHER TASK AREAS

The following are the four (4) categories of technology prosecution that contractors shall perform, upon request, during the course of the contract:

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.

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

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..

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 shall 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 perform an initial conflict-of-interest determination for each matter. Contractors will follow specific instructions provided by NIH for individual activities, which are described in exemplary detail below.

Patent Search Services: The Contractor shall provide patent search services to include, without limitation:

Prepare draft claim sets, including broad claims used to perform the initial patentability search or distinguish the invention from any potential prior art found.

Attachment 1 RFP No. NIH-OD-OLAO-OA-(PLS)-2019 https://www.uspto.gov/web/offices/pac/mpep/index.html

Perform patent search and evaluation of relevant business, scientific and patent publications and indicate to NIH the documents of potential relevance.

Searches may include a review of specified databases, such as world patent databases (e.g. Google Patent Thomson BIOSIS or DERWENT WPI) and small molecule databases (e.g. Beilstein).

Conduct infringement and validity searches, and

Conduct necessary and appropriate research of applicable patent law, other legal research and preparation of legal memoranda to present the foregoing evaluations.

Opinions: The Contractor shall provide comprehensive and complete analysis of NIH’s invention in view of other prior art. Analysis should result in a detailed patentability opinion for the NIH Technology Categories. Representative activities related to Patent Opinions include but are not limited to the following:

Patentability opinions;

Clearance opinions;

Validity opinions;

Invalidity opinions;

Infringement opinions;

Non-infringement opinions;

Inventorship opinions (on a claim-by-claim basis); and

Freedom to operate opinions.

Inventorship Analyses: Upon request, Contractors shall conduct an inventorship analysis under which the contributions of all purported co-inventors are analyzed in view of their contribution(s) to a claim as filed or any hypothetical claims for the invention generally, if a patent application does not yet exist. Interviews with individual purported inventors should be conducted as needed, with approval of the NIH Technical Representative. NIH will be the final arbiter of inventorship should disputes between purported inventors arise.

Patent Application Preparation and Filing: Contractors shall assign a case to the appropriate members of their personnel approved to work on the contract and shall work in close coordination with NIH Technical Representatives. The Contractor shall undertake appropriate actions to accomplish the requested task. These actions may

Attachment 1 include analyzing the EIR and any relevant background literature or publications and supporting data or figures concurrently submitted to produce a draft set of claims to be sent to NIH for review and comment; analyzing patent eligibility issues in view of controlling case law; and analyzing impact of any prior disclosures of the invention on patentability in view of U.S. and foreign laws. After initial review and discussions with the NIH Technical Representative and at least one inventor, the Contractor may be asked to provide a patentability opinion. The Contractor shall draft a patent application, prepare figures, illustrations or drawings (as required), source code listings (as required), sequence listings (as required), and claims according to Patent Office requirements.

Claims and specification details will be discussed with the inventors and NIH Technical Representative.

Contractors shall contact the inventor(s) and NIH Technical Representative prior to starting to draft of a patent application and discuss strategy and clarify any substantive issues relating to understanding the invention and the scope of optimal protection.

Deadlines for providing patent application drafts will be specified in the TORFQ and can be adjusted ad hoc as befits each case after discussions and with the approval of the NIH Technical Representative.

The number of claims and claim scope shall be discussed with the NIH Technical Representative and inventor prior to drafting. Contractor should take care in drafting claims of interest to NIH, and pursuant to NIH patent policy, intended to incentivize licensing for the purposes of product development and commercialization.

Figures, illustrations, chemical structures, sequence and source code listings, may be prepared either in-house or using subcontractors as is typical in patent prosecution practice. The Contractor shall be responsible for the accuracy and quality of any work product produced by its subcontractor.

All relevant priority documents or parent filing information shall be included in the specification of the patent application, as necessary.

Upon approval of a final draft by the NIH Technical Representative, the Contractor shall file applications in accordance with electronic filing systems, where available, unless otherwise preapproved by the NIH Technical Representative.

Subsequent filings claiming priority to previous filings may, if appropriate, include any updates provided from the inventor. NIH Technical Representative will discuss issues of new matter with the Contractor should updates from inventors necessitate new filing strategies.

Declarations, Powers of Attorney, and Assignments (including those for third-party co-owners): Contractors shall be responsible for preparing various legal

Attachment 1 documents related to perfecting patent rights and required by Patent Offices. Contractors shall contact the inventors, NIH Technical Representative and other required persons as instructed to coordinate the preparation, execution and filing of these documents.

Patent Prosecution: Contractor shall report correspondence from Patent Offices to NIH electronically. NIH will issue new Task Orders or sets of instructions under existing Task Orders to Contractors for responding to Patent Office notices or actions.

Contractors may be instructed to request Examiner interviews for all

BIOTECHNOLOGY and CHEMISTRY cases that are identified by the NIH Technical Representatives or COR to have significant prior art issues or which have a high probability of obtaining a first action allowance before issuance of the first office action, and preferably within six (6) months of filing a non-provisional patent application or entering the national stage of prosecution in the US.

Contractors shall respond to Patent Office actions or notices by the shortened statutory time periods prescribed under the law to minimize NIH patent prosecution costs and, where applicable, to minimize the reduction of accumulated patent term adjustment. Extensions of time and possible fees associated with responses to Patent Office actions or notices shall be arranged with the NIH Technical Representative in advance. After a Task Order or corresponding set of instructions is issued, extensions of time must be agreed to with the NIH Technical Representative at least ten (10) business days prior to the due date of the action, otherwise the Contractor will bear the cost of the extension.

If (1) a Task Ordering Official or a NIH Technical Representative has not responded to the firm’s request to take an extension of time, (2) the extension of time is necessary to avoid abandonment of the patent application, and (3) it is within three business days of the non-extendable statutory deadline to file a response, the firm is authorized to take the extension of time and to file documents necessary to avoid loss of NIH’s intellectual property rights at minimal expense to NIH. Such documents include, depending on the status of prosecution, filing a continuation application, a Notice of Appeal, or a Request for Continued Examination.

NIH Technical Representatives will have at least ten (10) business days prior to the deadline to review and approve responses to office actions or notices for any action due. Any extensions of time not approved at least ten (10) business days prior to the due date of a response shall be incurred at the expense of the Contractor.

The Contractor shall bring unelected or withdrawn subject matter to the attention of the lead inventor and the NIH Technical Representative and advise on the availability of rights in said unelected subject matter in view of the

Attachment 1 prosecution history. The Contractor shall provide their opinion on the value of pursuing said unelected subject matter or for argument for rejoinder.

Contractors will advise the NIH Technical Representative of the option to file reissue applications within three (3) months of the deadline. Per the legally required duty of disclosure, the NIH or the Contractor shall advise the other anytime information is identified that should be brought to the attention of a Patent Office in an Information Disclosure Statement or foreign equivalent thereof.

Patent Maintenance. Contractor shall pay and manage maintenance/annuity-related fees for patent applications and issued patents in foreign countries. as instructed if necessary. Note, the NIH may have a contract with a separate maintenance fee management company for tracking and paying maintenance fees and annuities. Either way, the Contractor shall forward any correspondence related to maintenance or annuity to the NIH.

Attachment 1

III. REQUIREMENTS FOR PATENT LEGAL SERVICES

Patent legal services for each technology category identified in this statement of work may include but not be limited to:

Patentability searches and opinions, Advice on patent filing and prosecution strategies, Inventorship determinations, Claim interpretation, validity analyses, infringement analyses, and freedom-to-operate analyses, Patent application drafting, preparation, and filing worldwide:

U.S. provisional patent applications, International Applications under the Patent Cooperation Treaty

(PCT),

National stage applications (countries will be specified),

i) Validation and translation, U.S. non-provisional patent applications and/or foreign patent applications, including national applications in countries that are not signatories to the Patent Cooperation Treaty, Divisional applications, Continuation applications, and

Continuation-in-part applications.

Patent Prosecution (worldwide):

Obtaining and recording declaration signatures from inventors and assignees, Obtaining and recording assignments from inventors with notarization as required, Obtaining and recording foreign and U.S. powers of attorney from NIH Technical Representatives (TBD) as designated by each IC, Preparing and filing information disclosure statements, Preparing and filing responses to notices and communications, Preparing and filing responses to restriction requirements and unity of invention objections, Preparing and filing responses to office actions, Preparing and filing petitions, Preparing and filing appeals, Preparing and filing responses to PCT correspondence and notices, Payment of maintenance, annuity and issue fees, when requested, and related correspondence, Post allowance reviews, including patent term adjustments, Correction of issued patents, and

Tracking maintenance fees for the payment of maintenance fees.

Contentious proceedings (worldwide): From time-to-time, the NIH either initiates or finds itself a party to contentious proceedings which include litigious matters. It is understood that some of the actions listed hereunder are new to U.S. patent practice as of the Leahy–Smith America Invents Act of 2011 (AIA).

Matters handled before the appropriate bodies within the patent offices, including the Patent Trial and Appeal Board (PTAB) under pre-AIA and under current patent law, the America Invents Act (AIA), non-limiting examples of such matters and their foreign equivalents, as applicable, including:

inter partes reviews, post-grant reviews, and covered business method patent reviews, derivation proceedings, appeals from adverse Examiner decisions in patent applications and reexamination proceedings, interferences, their successor embodiments, and

Oppositions (worldwide), Protests, Ex parte reexaminations, and

Litigation support.

As an agency of the United States Government NIH is subject to the jurisdiction of Federal Courts, per Article III of the United States Constitution, wherein NIH might appeal of adverse decisions of PTAB or otherwise be a party to a litigation to which such Courts have subject matter jurisdiction and/or personal jurisdiction over the Government. Appeals matters from the PTAB will be handled through the Department of Justice as appellate review of such decisions are the subject matter jurisdiction of the U.S. Court of Appeals for the Federal Circuit and the United States Supreme Court.

As a requirement of this contract, Contractors may be asked to

Attachment 1 provide litigation support for such proceedings and coordinate with the Department of Justice. Contractors may be required to provide litigation support services that may include opinion work, fact gathering and discovery when the U.S. Government is a party to a litigation in a Court that has jurisdiction over it.

Contractors with a primary specialization in patent prosecution may handle or may be asked by NIH to handle such contentious proceedings or litigation support matters. Offerors with excellent skills in patent prosecution, but who may not have experience in contentious proceedings are strongly encouraged to apply for the contract since NIH deems the requirement for Contentious Proceedings to be ancillary to the primary requirements of the contract and would occur on an ad hoc basis.

Patent licensing consultation:

contractual legal issues and interpretation (formation, performance, termination, remedies, liquidation, penalties and enforcement), license valuation, and market analysis.

Services rendered under this requirement shall be used in conjunction with advice received from NIH’s Office of the General Counsel.

NIH does not require Contractors to represent the U.S. Government in infringement or invalidity litigation. All matters involving the enforcement of patent rights in which U.S.

Government has title are handled internally or by the United States Department of Justice unless otherwise specified by U.S. law. However, Contractors may be required to provide litigation support services that may include opinion work, fact gathering, due diligence investigations, and discovery when the U.S. Government is a party to a litigation.

Contractors and their foreign associate subcontractors shall have relevant secured computer systems and procedures in place to enable electronically filing all required correspondence with Patent Offices including electronic signatures, throughout the duration of this contract. Contractors shall have practices for updating software required to affect such electronic filings. Paper correspondence is only to be used when U.S. or foreign jurisdictions provide Letters Patent or required documents with original ink signatures. Contractors and their foreign associate subcontractors shall demonstrate proficiency using modern word processing and portable document format software, and specifically Microsoft Word and Adobe Acrobat, in ways that generate documents that are easily navigable and searchable.

Resources to Facilitate Electronic Communications and Filing: Contractor shall use automation and electronic filing means and describe the uses of the same portals in their Technical Approach and Capability in meeting client demands, maintaining quality control, facilitating communications, minimizing expenses, and maintaining confidentiality. Contractors shall also provide explanations regarding redundancies and safeguards to address such things as confidentiality and emergency provisions (e.g., electronic outages, data breaches).

IV. DELIVERABLES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work 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:

Master Contract Deliverables:

Item 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 1

(7) Annual Technical Report 1

(8) List of Government Furnished Property

(9) Annual 508 Compliance Report 1

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 is a breakdown of common deliverables:

Task Order Deliverables:

Document No. of Copies Deliverable Due

Annuity/Maintenance Fees Two (2) copies Quarterly

Papers filed in the U.S. or foreign patent office

Varies (refer to Project Officer)

Within five (5) business days of filing

Attachment 1 RFP No. NIH-OD-OLAO-OA-(PLS)-2019

TBD

Include w/Technical Proposal See Attachment#10 Transferring Cases

Annually and/or upon request

30 days prior to employee's start date

Annually Annually

Annually

Annually

Annually

(10) Small Business Subcontracting Reports

See Article H.4. Subcontracting Provisions

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

Varies (refer to Project Officer)

Within five (5) business days of their receipt

Final Draft of patent application or official communication from a Patent Office

Varies (refer to Project Officer)

Two (2) weeks in advance of intended filing date

V. LABOR MIX

Personnel designated as “attorneys” within the Labor Mix are required to maintain a valid license, be current on their CLE requirement (if applicable), and requisite training, to practice law in accordance with the requirements of the bar associations in the state, district, commonwealth, territory or possession in which they practice and before the United States Patent and Trademark Office (USPTO). Contractors employing foreign attorneys, will ensure similar requirements commensurate in scope with the appropriate licensing body in each country for the practice of patent law.

Contractors shall provide certificates of good standing from the state bars of the state(s) in which their proposed Personnel practice for all Personnel who are attorneys and from the USPTO for all Personnel who are attorneys or patent agents.

The following sets forth the minimum qualifications required for a person proposed for the labor mix in any of the technology categories. CORs will approve any proposed changes to Contractor Personnel. The minimum qualifications for each labor category in the Personnel are:

Partner: A current equity or non-equity partner, shareholder, of counsel, or other senior staff member of the Contractor who is (1) a licensed attorney, (2) registered to practice before the USPTO, and (3) who has at least eight (8) years of cumulative patent prosecution experience as a licensed attorney and at least eight (8) years of cumulative experience as a registered practitioner before the

USPTO.

Senior Associate: A licensed attorney registered to practice before the USPTO with a minimum of six (6) years of cumulative experience in patent prosecution as an attorney or patent agent, including a minimum of four (4) years cumulative experience as a licensed attorney.

Junior Associate: A licensed attorney registered to practice before the USPTO with a minimum of three (3) years cumulative experience in patent prosecution either as an attorney or patent agent. No minimum requirement regarding number of years as licensed attorney.

Patent Agent: A person registered to practice before the USPTO as a patent agent and having a minimum of three (3) years of cumulative experience as a registered patent agent.

Case Manager/Paralegal: A person who has at least two (2) years of cumulative experience handling patent application prosecution formalities under the supervision of an attorney or patent agent.

Depending on the technology area each Offeror shall specify qualified Personnel who are able to meet a specific labor mix of experience. Failure to do so in response to the RFP will result in an Offeror’s proposal being Unacceptable. Note, this means not only specifying the correct labor mix but also ALL the qualifications and other materials that document the qualifications are met. The minimum required labor mix for each technology area is as follows:

Minimum labor mix for BIOTECHNOLOGY:

Two (2) Partners, One (1) Senior Associate, Four (4) Junior Associates or Patent Agents, and Two (2) Case Managers/Paralegals.

Minimum labor mix for CHEMISTRY:

Two (2) Partners, One (1) Senior Associate, Four (4) Junior Associates or Patent Agents, and Two (2) Case Managers/Paralegals.

Minimum labor mix for MECHANICAL ENGINEERING:

Two (2) Partners, One (1) Senior Associate, Three (3) Junior Associates or Patent Agents, and One (1) Case Manager/Paralegal.

Minimum labor mix for SOFTWARE:

One (1) Partner, One (1) Senior Associate or One (1) Patent Agent, and One (1) Case Managers/Paralegals.

State bar or the USPTO ethics rules governing attorney-client privilege and confidentiality will govern the relationship of NIH with a Contractor and any subcontractors under the supervision of the Contractor. The Contractor shall take into consideration the foreign rules and laws of confidentiality and privilege when communicating with foreign associate subcontractors. Personnel with a record of ethics violations may be discharged from the contract with NIH and the Contractor will be required to either provide a suitable replacement or terminate the contract. NIH reserves the right to terminate contracts at any time should it find violations of ethics rules, a pattern of lack of adherence to the terms of this contract, or pattern of negligent case management (e.g., unintentional loss of intellectual property rights), that are detrimental to its interests.

VI. TRANSITION CASES

“Outgoing Contractor” is a law firm that has had a contract for rendering patent-legal services with NIH from 2009-2019 but who has not been awarded a contract in 2019.

It is expected that all matters, where there are no open Task Orders, will be reviewed, docketed, and transferred (if appropriate) within thirty (30) days of award of the contract. For families of cases where there are open Task Orders, the transfer of responsibility for patent prosecution may be delayed until completion of the open Task Order or may occur piecemeal to accommodate situations where the NIH needs to authorize new tasks related to a family of cases.

All transitioned cases that exist in paper format shall be digitized by the receiving Contractor into searchable Microsoft Word format or Portable Document Format (PDF).

Contractors must take the steps necessary to affiliate with NIH Customer Number 005318 within sixty (60) days of being awarded the contract if one has not already been established.

Contractors shall provide a transition strategy for potentially an unknown number of cases for receipt from Outgoing Contractors, said transferred cases to be determined by the NIH Technical Representatives. The proposed strategy shall include any approaches that would facilitate transition with no interruption of service, data integrity, docketing of deadlines, and no loss of patent rights.

Inactive Cases: These files are considered United States Government property. Files held by Outgoing Contractors having no patent application filed and no related applications, have been abandoned, lapsed, or expired and where there are no related applications pending or no issued patents; these files will be returned to NIH.

Transfer of Responsibility: During the term of a contract, the NIH Technical Representative has the right to decide whether the responsibility for patent prosecution of an application or application family continues to be carried out by a specific Contractor or if such responsibility will be transferred to another Contractor. If the NIH Technical Representative determines that the responsibility for patent prosecution should be transferred to another Contractor, the current Contractor will carry out the transfer instructions as specified by the NIH Technical Representative.

If the transition period (bulk or end of existing contract) commences in a time frame that leaves less than three (3) months before any existing contracts expire without possibility of a contract extension or in the event the contract is terminated Contractors must still comply with the transition procedures outlined herein. Any reasonable costs associated with the transition of cases

Attachment 1 after the expiration of the contracts will be billed to the NIH at rates in effect at the end of the contract.

VII. PERIOD OF PERFORMANCE

The period of performance will be up to 10 years.

VIII. GOVERNMENT FURNISHED PROPERTY

This section should identify any government-furnished property provided to the contractor. This includes all government-furnished property, such as government furnished material, equipment, or information. If the list of property is extensive, this section should identify where that list can be found.

Before offering to provide any property, make sure that it will be available when required, where required, and in the condition required by the contract. Failure to meet government furnished property requirements often lead to a contractor claim for an equitable adjustment to contract price, delivery, or other requirements. Specific requirements about providing government furnished property can be found in FAR 45, government property, and related agency policy.

IX. SECURITY REQUIREMENTS

This section should identify any unique security requirements associated with contract performance (when applicable). These requirements may include, but are not limited to, such items as: Special pass or identification requirements; Special security clearance requirements; or Special escort requirements.

Refer to - http://www.hhs.gov/asfr/ogapa/acquisition/policies/hspd12-contract-guide-102707.html

Attachment 1 RFP No. NIH-OD-OLAO-OA-(PLS)-2019 http://www.hhs.gov/asfr/ogapa/acquisition/policies/hspd12-contract-guide-102707.html

PROPOSAL INTENT RESPONSE FORM

RFP No:

RFP Title:

Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form by

Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

Choose one of the following Options:

Do intend to submit a proposal Do Not intend to submit a proposal

If you are not responding to this RFP, please provide your reason(s):

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

Attachment 2

10. a. Name and Address of Lobbying Registrant:

9. Award Amount, if known:

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Prefix * First Name Middle Name

Suffix

DISCLOSURE OF LOBBYING ACTIVITIES

Complete this form to disclose lobbying activities pursuant to 31 U.S.C.1352

Approved by OMB

4040-0013

1. * Type of Federal Action:

a. contract

b. grant

c. cooperative agreement

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f. loan insurance

2. * Status of Federal Action:

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3. * Report Type:

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Prime SubAwardee

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5. If Reporting Entity in No.4 is Subawardee, Enter Name and Address of Prime:

6. * Federal Department/Agency: 7. * Federal Program Name/Description:

CFDA Number, if applicable:

8. Federal Action Number, if known:

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Information requested through this form is authorized by title 31 U.S.C. section 1352. This disclosure of lobbying activities is a material representation of fact upon which reliance was placed by the tier above when the transaction was made or entered into. This disclosure is required pursuant to 31 U.S.C. 1352. This information will be reported to the Congress semi-annually and will be available for public inspection. Any person who fails to file the required disclosure shall be subject to a civil penalty of not less than $10,000 and not more than $100,000 for each such failure.

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Federal Use Only: Authorized for Local Reproduction Standard Form - LLL (Rev. 7-97)

NIH(RC)-2

Revised 7/2013

INVOICE INSTRUCTIONS FOR NIH FIXED-PRICE CONTRACTS, NIH(RC)-2

Format: Submit payment requests on Standard Form 1034, Public Voucher for Purchases and Services Other Than Personal, or the Contractor’s self-generated form provided it contains all of the information prescribed herein. DO NOT include a cover letter with the payment request.

Number of Copies: Submit payment requests in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule.

Frequency: Submit payment requests upon delivery and acceptance of goods or services unless otherwise authorized by the Contracting Officer.

Currency: All NIH contracts are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.

Preparation and Itemization of the Payment Request: Prepare payment requests as follows:

Note: All information must be legible or the invoice will be considered improper and returned to the Contractor.

(a) Designated Billing Office Name and Address: Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

(b) Contractor's Name, Address, Point of Contact, TIN, and DUNS or DUNS+4 Number: Show the Contractor's name and address exactly as they appear in the contract. Any invoice identified as improper will be sent to this address. Also include the name, title, phone number, and e-mail address of the Point of Contact in case of questions. If the remittance name differs from the legal business name, both names must appear on the invoice. Provide the Contractor’s Federal Taxpayer Identification Number (TIN) and Data Universal Numbering System (DUNS) or DUNS+4 number. The DUNS number must identify the Contractor’s name and address exactly as stated in the contract, and as registered in the System for Acquisition Management (SAM) database.

When an approved assignment of claims has been executed, the Contractor shall provide the same information for the assignee as is required for the Contractor (i.e., name, address, point of contact, TIN, and DUNS number), with the remittance information clearly identified as such.

(c) Invoice/Voucher Number: Identify each payment request by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization. For example, if a contractor has already submitted invoice number 05 on one of its contracts or orders, it cannot use that same invoice number on any other contract or order.

Payment requests with duplicate invoice numbers will be considered improper and returned to the contractor.

The NIH does not prescribe a particular numbering format but suggests using a job or account

Attachment 4 number for each contract and order followed by a sequential invoice number (example:

8675309-05). Invoice numbers are limited to 30 characters. There are no restrictions on the use of special characters, such as colons, dashes, forward slashes, or parentheses.

If all or part of an invoice is suspended and the contractor chooses to reclaim those costs on a supplemental invoice, the contractor may use the same unique invoice number followed by an alpha character, such as “R” for revised (example: 8675309-05R).

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(e) Contract Number and Order Number (if applicable): Insert the contract number and order number (as applicable).

(f) Contract Title: Insert the contract title listed on the cover page of the contract and/or Section G of the Contract Schedule.

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(h) Total Fixed-Price of Contract/Order: Insert the total fixed-price of the contract/order.

(i) Two-Way/Three-Way Match: Identify whether payment is to be made using a two-way or three-way match. To determine required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.

(j) Office of Acquisitions: Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

(k) Central Point of Distribution: Identify the Central Point of Distribution, as specified in the Invoice Submission Instructions in Section G of the Contract Schedule.

(l) Billing Period: Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.

(m) Description of Supplies or Services: Provide a description of the supplies or services, by line item (if applicable), quantity, unit price (where appropriate), and total amount. The item description, unit of measure, and unit price must match those specified in the contract. For example, if the contract specifies 1 box of hypodermic needles (100/box) with a unit price of $50.00, then the invoice must state 1 box, hypodermic needles (100/box), $50.00, not 100 syringes at $0.50 each. Invoices that do not match the line item pricing in the contract will be considered improper and will be returned to the Contractor.

(n) Amount Billed - Current Period: Insert the amount claimed for the current billing period, including any adjustments, if applicable. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request.

(o) Amount Billed - Cumulative: Insert the cumulative amounts claimed to date, including any adjustments as applicable. If the Contract Schedule contains separately priced line items, Attachment 4 identify the contract line item(s) on the payment request.

(p) Freight or Delivery Charges: Identify all charges for freight or express shipments, other than f.o.b. destination, as a separate line item on the invoice. (If shipped by freight or express, and charges are more than $25, attach prepaid bill.)

(q) Government Property: If the contract authorizes the purchase of any item of Government Property (e.g., equipment), the invoice must list each item for which reimbursement is requested. Include reference to the following (as applicable):

- item number for the specific piece of equipment listed in the Property Schedule, and

- Contracting Officer Authorization (COA) Number, if the equipment is not covered by the

Property Schedule.

Attachment 4

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS

Updated through FAC 2005-95

Last updated: 01/2017

This SECTION is made up of nine parts as follows:

1. Annual Representations and Certifications, FAR 52.204-8

2. Commercial and Government Entity Code Reporting, FAR 52.204-16

3. Predecessor of Offeror, FAR 52.204-20

4. Information Regarding Responsibility Matters, FAR 52.209-7

5. Cost Accounting Standards

6. Certification Regarding Trafficking in Persons Compliance Plan

7. Certification Regarding Environmental Tobacco Smoke

8. Certification of Institutional on Financial Conflicts of Interest

9. Disaster or Emergency Area Representation

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

1. ANNUAL REPRESENTATIONS AND CERTIFICATIONS (JAN 2017), FAR Provision 52.204-8

(a)(1) The North American Industry Classification System (NAICS) code for this acquisition is ____________ [insert NAICS code].

(2) The small business size standard is ____________ [insert size standard].

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b)(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7 is not included in this solicitation, and the offeror is currently registered in the System for Award Management (SAM), and has completed the Representations and Certifications section of SAM electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certification in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

[_] (i) Paragraph (d) applies.

[_] (ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c)(1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

Attachment 5

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.203-18, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements—Representation. This provision applies to all solicitations.

(iv) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(v) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(vi) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations—Representation.

(vii) 52.209-5; Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(viii) 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law. This provision applies to all solicitations.

(ix) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(x) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(xi) 52.219-1, Small Business Program Representations (Basic & Alternate I). This provision applies to solicitations when the contract will be performed in the United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by DoD, NASA, or the Coast Guard.

(xii) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United States or its outlying areas.

(xiii) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xiv) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xv) 52.222-38, Compliance with Veterans' Employment Reporting Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

Attachment 5

(xvi) 52.222-57, Representation Regarding Compliance with Labor Laws (Executive Order 13673).

This provision applies to solicitations expected to exceed $50 million which are issued from October 25, 2016 through April 24, 2017, and solicitations expected to exceed $500,000, which are issued after April 24, 2017.

Note to paragraph (c)(1)(xvi): By a court order issued on October 24, 2016, 52.222-57 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, DoD, GSA, and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(xvii) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased Products Under Service and Construction Contracts.

(xviii) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA- designated items.

(xix) 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals— Representation. This provision applies to solicitations that include the clause at 52.204-7.

(xx) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xxi) 52.225-4, Buy American--Free Trade Agreements--Israeli Trade Act Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225- 3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $77,533, the provision with its Alternate II applies.

(D) If the acquisition value is $79,507 or more but is less than $100,000, the provision with its Alternate III applies.

(xxii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

(xxiii) 52.225-20, Prohibition on Conducting Restricted Business Operations in Sudan--Certification.

This provision applies to all solicitations.

(xxiv) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certification. This provision applies to all solicitations.

(xxv) 52.226-2, Historically Black College or University and Minority Institution Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following representations or certifications are applicable as indicated by the Contracting Officer:

[Contracting Officer check as appropriate.] ___ (i) 52.204-17, Ownership or Control of Offeror.

___ (ii) 52.204-20, Predecessor of Offeror.

Attachment 5

___ (iii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed End Products.

___ (iv) 52.222-48, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Certification.

___ (v) 52.222-52 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Certification.

___ (vi) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered Material Content for EPA-Designated Products (Alternate I only).

___ (vii) 52.227-6, Royalty Information.

___ (A) Basic.

___ (B) Alternate I.

___ (viii) 52.227-15, Representation of Limited Rights Data and Restricted Computer Software.

(d) The offeror has completed the annual representations and certifications electronically via the SAM Web site accessed through https://www.acquisition.gov .