Exhibit 10.2

 

Portions of this document have been redacted pursuant to a Request for
Confidential Treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
Redacted portions are indicated with the notation “*”.

 

 

 

 

 [tex10-2pg2.jpg]

 

 

 

  

Contract Number: HHSN261201400048C

 

CONTRACT TABLE OF CONTENTS

 

  Page     PART I - THE SCHEDULE 5         SECCTION B - SUPPLIES OR SERVICES AND
PRICES/COSTS 5         ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES 5
  ARTICLE B.2. ESTIMATED COST AND FIXED FEE 5   ARTICLE B.3. ADVANCE
UNDERSTANDINGS 5   ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS 8        
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 9         ARTICLE C.1.
STATEMENT OF WORK 9   ARTICLE C.2. REPORTING REQUIREMENTS 9   ARTICLE C.3.
INVENTION REPORTING REQUIREMENT 12         SECTION D - PACKAGING, MARKING AND
SHIPPING 13         SECTION E - INSPECTION AND ACCEPTANCE 13         SECTION F -
DELIVERIES OR PERFORMANCE 13         ARTICLE F.1. PERIOD OF PERFORMANCE 13  
ARTICLE F.2. DELIVERIES 14   ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR
52.252-2 (FEBRUARY 1998) 15         SECTION G - CONTRACT ADMINISTRATION DATA 16
        ARTICLE G.1. CONTRACTING OFFICER’S REPRESENTATIVE (COR) 16   ARTICLE
G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006) 16   ARTICLE G.3. INVOICE
SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT FINANCIAL REPORT 17   ARTICLE
G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR
52.232-40 (December 2013) 19   ARTICLE G.5. INDIRECT COST RATES 20   ARTICLE
G.6. GOVERNMENT PROPERTY 20   ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR
PERFORMANCE 21         SECTION H - SPECIAL CONTRACT REQUIREMENTS 21

 

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Contract Number: HHSN261201400048C

 

  ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)
21   ARTICLE H.2. HUMAN SUBJECTS 22   ARTICLE H.3. RESTRICTION ON USE OF HUMAN
SUBJECTS, HHSAR 352.270-6 (January 2006) 22   ARTICLE H.4. REQUIRED EDUCATION IN
THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS 23   ARTICLE H.5. HUMAN MATERIALS
23   ARTICLE H.6. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE) 23   ARTICLE
H.7. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING
FROM NIH-FUNDED RESEARCH 24   ARTICLE H.8. NEEDLE DISTRIBUTION 24   ARTICLE H.9.
ACKNOWLEDGEMENT OF FEDERAL FUNDING 24   ARTICLE H.10. RESTRICTION ON ABORTIONS
25   ARTICLE H.11. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH 25  
ARTICLE H.12. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION 25  
ARTICLE H.15. LIMITATIONS ON SUBCONTRACTING - SBIR 25   ARTICLE H.16. ELECTRONIC
AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR 352.239-73(b) (January 2010) 25
  ARTICLE H.17. CONFIDENTIALITY OF INFORMATION 26   ARTICLE H.18. INSTITUTIONAL
RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST - PHASE II
27   ARTICLE H.19. PUBLICATION AND PUBLICITY 30   ARTICLE H.20. REPORTING
MATTERS INVOLVING FRAUD, WASTE AND ABUSE 30   ARTICLE H.21. YEAR 2000 COMPLIANCE
30       PART II - CONTRACT CLAUSES 31         SECTION I - CONTRACT CLAUSES 31  
    PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS 36        
SECTION J - LIST OF ATTACHMENTS 36       1. Statement of Work 36       2.
Invoice/Financing Request and Contract Financial Reporting Instructions for NIH
Cost- Reimbursement Type Contracts, NIH(RC)-4 36       3. Disclosure of Lobbying
Activities, SF-LLL 36       4. Government Property - Schedule 36      

 

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Contract Number: HHSN261201400048C

 

5. Report of Government Owned, Contractor Held Property 36       PART IV -
REPRESENTATIONS AND INSTRUCTIONS 37         SECTION K - REPRESENTATIONS AND
CERTIFICATIONS 37       1. Annual Representations and Certifications 37       2.
Annual Representations and Certifications, FAR Clause 52.204-8 37       3. Human
Subjects Assurance Identification Number 37

 

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Contract Number: HHSN261201400048C

 

PART I - THE SCHEDULE

 

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

 

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

 

This contract will (1) development a prototype analytical system incorporating
Enumeral’s technology, including automation, software and data analysis and (2)
test prototypes on clinical samples in collaborating academic laboratories to
demonstrate clinical utility and advantages over analytical current techniques.

 

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

 

a.           The estimated cost of this contract is $952,349.

 

b.           The fixed fee for this contract is $47,618. The fixed fee shall be
paid in installments based on the percentage of completion of work, as
determined by the Contracting Officer, and subject to the withholding provisions
of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in the
General Clause Listing in Part II, ARTICLE I.1. of this contract.

 

c.           The total estimated amount of the contract, represented by the sum
of the estimated cost plus the fixed fee, is $999,967.

 

ARTICLE B.3. ADVANCE UNDERSTANDINGS

 

Other provisions of this contract notwithstanding, approval of the following
items within the limits set forth is hereby granted without further
authorization from the Contracting Officer.

 

a.           Establishment of Indirect Cost Rate

 

Fringe benefits costs are funded at a rate of 17% in an amount not to exceed
$28,755 and General and Administrative (G&A) costs are funded at a rate of 40%
in an amount not to exceed $272,099; however, the Contractor shall not bill or
be reimbursed for indirect costs until such time as an indirect cost proposal
has been submitted to the cognizant office responsible for negotiating the
indirect cost rates, unless a temporary billing rate(s) has been included
herein. Unless otherwise specified below, the indirect cost rate proposal shall
be submitted no later than three (3) months after the date of contract award.

 

The Contractor may bill fringe benefits at a temporary billing rate of 17% of
direct labor and may bill G&A at a temporary billing rate of 40% total direct
costs; until such time as indirect costs have been established, provided, that
the Contractor’s indirect cost proposal is submitted to the cognizant office
responsible for negotiating indirect costs no later than December 16, 2014. If
the indirect cost proposal is not submitted within this time frame, any
temporary indirect costs billed after this due date will be suspended until such
time as the indirect cost proposal is submitted.

 

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Contract Number: HHSN261201400048C

 

The Government is not obligated to pay any additional amount should the final
indirect cost rates exceed the above ceiling. In the event that the final
indirect cost rates are less than these ceilings rates, the Government’s
obligation shall be reduced to conform to the lower rate.

 

The Contractor shall complete all work in accordance with the Statement of Work,
terms and conditions of this contract.

 

b.           Subcontract

 

A cost-reimbursement type subcontract with * for the installation and work with
the prototype system and optimization of the process from the standpoint of
end-users for an amount not to exceed $71,778 for the period 9/16/14-9/15/16. A
copy of the signed, executed subcontract shall be provided to the Contracting
Officer prior to performing work under this contract.

 

A cost-reimbursement type subcontract with * for their participation in the
evaluation of the prototype for an amount not to exceed $71,465 for the period
9/16/14-9/15/16. A copy of the signed, executed subcontract shall be provided to
the Contracting Officer prior to performing work under this contract.

 

c.           Contractor/Subcontractor Travel

 

Expenditures for travel (transportation, lodging, subsistence, and incidental
expenses) incurred in the direct performance of this contract shall be
unallowable without the prior written approval of the Contracting Officer. No
retroactive active approvals will be issued and no travel costs incurred without
prior Contracting Officer approval will be approved.

 

All travel requests shall be sent to both the Contracting Officer’s
Representative (COR) and the Contracting Officer within ninety (90) calendar
days prior to the planned start date of the travel. Once the request is
received, the COR shall submit the required documentation to the appropriate
approving authority. Once it is determined that the request is approved or
disapproved the COR will notify the Contracting Officer so that they can issue
written approval or disapproval of the travel request.

 

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Contract Number: HHSN261201400048C

 

d.           Equipment:

 

The Contractor is hereby authorized to utilize contract funds towards the
purchase of the following equipment for an amount not to exceed * for the period
9/16/2014 through 9/15/2016.

 

Item   Unit Price   Unit Quantity   Subtotal 1. *   *   *   * 2. *   *   *   *
3. *   *   *   * Total Equipment Cost           *

 

***Note that Items 2 and 3 shall be leased; whereas, item 1 shall be purchased.

 

e.           Funding Variance

 

The Contractor agrees to immediately notify the Contracting Officer in writing
if there is an anticipated overrun (any amount) or unexpended balance (greater
than 10 percent) of the amount allotted to the contract, and the reasons for the
variance. Also refer to the requirements of the Limitation of Funds and
Limitation of Cost Clause in this contract.

 

f.            Site Visit

 

At the discretion of the Government, a site visit may be required during this
contract. The Contractor will either be required to host the site visit in
person or via teleconference.

 

g.           Consultants Consultant fees to be paid to the following
individuals:

  

Name   Rate
Per Day   Number of Hours   Total Cost
Excluding Travel
Not to Exceed *   *   *   * *   *   *   * *   *   *   * *   *   *   * Total    
      *

 

h.           Contract Number Designation

 

On all correspondence submitted under this contract, the Contractor agrees to
clearly identify the two contract numbers that appear on the face page of the
contract as follows:

 

Contract No. HHSN261201400048C

 

NCI Control No. N44CO201400048

 

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Contract Number: HHSN261201400048C

 

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS

 

a.           Items Unallowable Unless Otherwise Provided

 

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE,
incorporated in this contract, unless authorized in writing by the Contracting
Officer, the costs of the following items or activities shall be unallowable as
direct costs:

 

1.          Conferences and Meetings

 

2.          Food for Meals, Light Refreshments, and Beverages

 

3.          Promotional Items [includes, but is not limited to: clothing and
commemorative items such as pens, mugs/cups, folders/folios, lanyards, and
conference bags that are sometimes provided to visitors, employees, grantees, or
conference attendees.]

 

4.          Acquisition, by purchase or lease, of any interest in real property;

 

5.          Special rearrangement or alteration of facilities;

 

6.          Purchase or lease of any item of general purpose office furniture or
office equipment regardless of dollar value. (General purpose equipment is
defined as any items of personal property which are usable for purposes other
than research, such as office equipment and furnishings, pocket calculators,
etc.);

 

7.          Travel to attend general scientific meetings;

 

8.          Foreign travel;

 

9.          Consultant costs;

 

10.        Subcontracts;

 

11.        Patient care costs;

 

12.        Accountable Government Property (defined as non-expendable personal
property with an acquisition cost of $1,000 or more) and “sensitive items”
(defined as items of personal property (supplies and equipment that are highly
desirable and easily converted to personal use), regardless of acquisition
value.

 

13.        Printing Costs (as defined in the Government Printing and Binding
Regulations).

 

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Contract Number: HHSN261201400048C

 

b.           Travel Costs

 

1.          Domestic Travel

 

Total expenditures for domestic travel (transportation, lodging, subsistence,
and incidental expenses) incurred in direct performance of this contract shall
not exceed $7,091 without the prior written approval of the Contracting Officer.

 

2.          The Contractor shall invoice and be reimbursed for all travel costs
in accordance with Federal Acquisition Regulations (FAR) 31.2 - Contracts with
Commercial Organizations, Subsection 31.205-46, Travel Costs.

 

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

 

ARTICLE C.1. STATEMENT OF WORK

 

a.           Independently and not as an agent of the Government, the Contractor
shall furnish all the necessary services, qualified personnel, material,
equipment, and facilities, not otherwise provided by the Government as needed to
perform the Statement of Work, dated 9/4/2014, set forth in SECTION J-List of
Attachments, attached hereto and made a part of this contract.

 

Document Title   Date Statement of Work - Phase II   9/4/2014

 

ARTICLE C.2. REPORTING REQUIREMENTS

 

All reports required herein shall be submitted in an electronic format via email
as attachments to the following designated NCI Branch Distribution Mailbox:
Ncibranchcinvoices@mail.nih.gov

 

Each email submission shall contain only one deliverable. If the attached file
for the deliverable exceeds 50 MB, the Contractor shall divide the deliverable
into files of 50 MB each. All deliverables shall be limited to five file
attachments or less.

 

The subject line of the email shall read as follows:

 

Deliverable_Contract Number_Vendor’s Name_Deliverable Description_Due Date

 

All electronic reports submitted shall be compliant with Section 508 of the
Rehabilitation Act of 1973. Additional information about testing documents for
Section 508 compliance, including guidance and specific checklists, by
application, can be found at: http://www.hhs.gov/web/508/index.html under
“Making Files Accessible.”

 

a.           Technical Reports

 

In addition to those reports required by the other terms of this contract, the
Contractor shad prepare and submit the following reports in the manner stated
below and in accordance with the DELIVERIES Article in SECTION F of this
contract:

 

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Contract Number: HHSN261201400048C

 

[Note: Beginning May 25, 2008, the Contractor shall include, in any technical
progress report submitted, the applicable PubMed Central (PMC) or NIH Manuscript
Submission reference number when citing publications that arise from its NIH
funded research.]

 

1.          Quarterly Progress Report

 

a.           This report shall include a description of the activities during
the reporting period and the activities planned for the ensuing reporting
period. The first reporting period consists of the first full three months of
performance including any fractional part of the initial month. Thereafter, the
reporting period shall consist of three full calendar months.

 

b.           The first report shall be due January 10, 2015. Thereafter, reports
shall be due on or before the 10th Calendar day following each reporting period.

 

2.          Annual Progress Report

 

This report shall include a summation of the results of the entire contract work
for the period covered. An annual report will not be required for the period
when the Final Report is due. A Quarterly Report shall not be submitted when an
Annual Report is due.

 

The first report shall cover the period 09/16/2014 through 09/15/2015 of this
contract and shall be due on October 15, 2015. Thereafter, reports shall be due
on or before the 15th Calendar day following the reporting period.

 

3.          Annual Technical Progress Report for Clinical Research Study
Populations

 

The Contractor shall submit information about the inclusion of women and members
of minority groups and their subpopulations for each study being performed under
this contract. The Contractor shall submit this information in the format
indicated in the attachment entitled, “Inclusion Enrollment Report,” which is
set forth in SECTION J of this contract. The Contractor also shall use this
format, modified to indicate that it is a final report, for reporting purposes
in the final report. In addition, the NIH Policy and Guidelines on the Inclusion
of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001
applies. If this contract is for Phase III clinical trials, see II.B of these
guidelines. The Guidelines may be found at the following website:

 

http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm

 

Include a description of the plans to conduct analyses, as appropriate, by
sex/gender and/or racial/ethnic groups in the clinical trial protocol as
approved by the IRB, and provide a description of the progress in the conduct of
these analyses, as appropriate, in the annual progress report and the final
report. If the analysis reveals no subset differences, a brief statement to that
effect, indicating the subsets analyzed, will suffice. The Government strongly
encourages inclusion of the results of subset analysis in all publication
submissions. In the final report, the Contractor shall include all final
analyses of the data on sex/gender and race/ethnicity.

 

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Contract Number: HHSN261201400048C

 

4.          Draft and Final Report

 

This report shall consist of the work performed and results obtained for the
entire contract period of performance as stated in SECTION F of this contract.
This report shall be in sufficient detail to describe comprehensively the
results achieved. The Final Report shall be submitted on or before the last day
of the contract performance period. An Annual report shall not be required for
the period when the Final Report is due.

 

The Contractor shall provide the Contracting Officer with an electronic copy of
the Final Report in draft form (in accordance with the DELIVERIES Article in
SECTION F of this contract. The Contracting Officer’s Representative (COR) will
review the draft report and provide the Contracting Officer with comments within
15 Calendar days after receipt. The Final Report shall be corrected by the
Contractor, if necessary and the final version delivered as specified in the
above paragraph.

 

5.          Summary of Salient Results

 

The Contractor shall submit, with the Final Report, a summary (not to exceed 200
words) of salient results achieved during the performance of the contract.

 

b.           Other Reports/Deliverables

 

1.          Reporting of Financial Conflict of Interest (FCOI) - Phase II

 

All reports and documentation required by 45 CFR Part 94, Responsible
Prospective Contractors including, but not limited to, the New FCOI Report,
Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be
submitted to the Contracting Officer in Electronic format. Thereafter, reports
shall be due in accordance with the regulatory compliance requirements in 45 CFR
Part 94.

 

45 CFR Part 94 is available at:
http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.
See Part 94.5, Management and reporting of financial conflicts of interest for
complete information on reporting requirements.

 

(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING
INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this
contract.)

 

2.          Section 508 Annual Report - PHASE II

 

The Contractor shall submit an annual Section 508 report in accordance with the
schedule set forth in the ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY
Article in SECTION H of this contract. The Section 508 Report Template and
Instructions for completing the report are available at:
http://www.hhs.qov/web/508/contracting/technology/vendors.html under “Vendor
Information and Documents.”

 

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Contract Number: HHSN261201400048C

 

3.          NIH Small Business Innovation Research (SBIR) Program Life Cycle
Certification

 

In accordance with the SBIR/STTR Reauthorization Act of 2011, the Contractor
shall complete and submit the NIH Small Business Innovation Research (SBIR) Life
Cycle Certification form, located in SECTION J of the contract, to the
Contracting Officer. This certification is required to ensure the Contractor is
meeting the program’s requirements during the life cycle of the contract.

 

The Life Cycle Certification form shall be submitted as follows:

 

·Phase II SBIR Contractors shall submit the Certification prior to receiving
more than 50% of the total contract amount AND prior to final payment or
disbursement.

 

The Contracting Officer, may, at any time after award request further
clarifications and supporting documentation in order to assist in the
verification of any information provided by the Contractor.

 

For additional information, see NIH Policy Notice NOT-OD-13-116, entitled, “New
Program Certifications Required for SBIR and STTR Awards,” located at:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-116.html.

 

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

 

All reports and documentation required by FAR Clause 52.227-11, Patent
Rights-Ownership by the Contractor including, but not limited to, the invention
disclosure report, the confirmatory license, and the Government support
certification, shall be directed to the Division of Extramural Inventions and
Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310,
MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition,
one copy of an annual utilization report, and a copy of the final invention
statement, shall be submitted to the Contracting Officer. The final invention
statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting
Officer on the completion date of the contract.

 

All reports shall be submitted in accordance with the DELIVERIES Article in
SECTION F of this contract. The final invention statement (see FAR
27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All
reports shall be sent to the following address:

 

OPERA, OEH, NIH
6705 Rockledge Drive
Suite 310, MSC 7980
Bethesda, MD 20892-7980

 

If no invention is disclosed or no activity has occurred on a previously
disclosed invention during the applicable reporting period, a negative report
shall be submitted to the Contracting Officer at the email address specified in
SECTION F.

 

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Contract Number: HHSN261201400048C

 

To assist contractors in complying with invention reporting requirements of the
clause, the NIH has developed “Interagency Edison,” an electronic invention
reporting system. Use of Interagency Edison is encouraged as it streamlines the
reporting process and greatly reduces paperwork. Access to the system is through
a secure interactive Web site to ensure that all information submitted is
protected. Interagency Edison and information relating to the capabilities of
the system can be obtained from the Web (http://www.iedison.gov), or by
contacting the Extramural Inventions and Technology Resources Branch, OPERA,
NIH.

 

SECTION D - PACKAGING, MARKING AND SHIPPING

 

All deliverables required under this contract shall be packaged, marked and
shipped in accordance with Government specifications. At a minimum, all
deliverables shall be marked with the contract number and Contractor name. The
Contractor shall guarantee that all required materials shall be delivered in
immediate usable and acceptable condition.

 

SECTION E - INSPECTION AND ACCEPTANCE

 

a.           The Contracting Officer or the duly authorized representative will
perform inspection and acceptance of materials and services to be provided.

 

b.           For the purpose of this SECTION, the Contracting Officer’s
Representative (COR) is the authorized representative of the Contracting
Officer.

 

c.           Inspection and acceptance will be performed at:

 

NCI, SBIR Program, MSC 9706
9609 Medical Center Drive, 1W544
Rockville, MD 20850-9706

 

Acceptance may be presumed unless otherwise indicated in writing by the
Contracting Officer or the duly authorized representative within 30 days of
receipt.

 

d.           This contract incorporates the following clause by reference, with
the same force and effect as if it were given in full text. Upon request, the
Contracting Officer will make its full text available.

 

FAR Clause 52.246-9, Inspection of Research and Development (Short Form) (April
1984).

 

SECTION F - DELIVERIES OR PERFORMANCE

 

ARTICLE F.1. PERIOD OF PERFORMANCE

 

a.           The period of performance of this contract shall be from 9/16/2014
through 9/15/2016.

 

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Contract Number: HHSN261201400048C

 

ARTICLE F.2. DELIVERIES

 

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

 

a.           The items specified below as described in the REPORTING
REQUIREMENTS Article in SECTION C of this contract will be required to be
delivered F.o.b. Destination as set forth in FAR 52.247-35, F.o.b. DESTINATION,
WITHIN CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the dates
specified below:

 

Item No.   Description   Delivery Schedule 1.   Quarterly Progress Report  
Quarterly, due within 15 calendar days after each reporting period. 2.   Annual
Progress Report   Annually, due each year after the start of Phase II. 3.  
Section 508 Annual Report   Annually, due each year after the start of Phase II.
4.   Annual Technical Progress Report for Clinical Research Study Populations  
Annually, due each year after the start of Phase II. 5.   Financial Conflict of
Interest (FCOI)   When applicable per 45 CFR Part 94. 6.   Draft Final   14 Days
Before Last Day of the Contract Performance Period. 7.   Final Report   Due on
or before the Phase II completion date. 8.   Summary of Salient Results   Due on
or before the completion of Phase II. 9.   Protection of Human Subjects
Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB
No. 0990-0263   Prior to starting any work involving human subjects. 10.  
Annual Utilization Report   Due one year after the start of Phase II. 11.  
Final Invention Statement   Due on or before contract completion date. 12.  
Invention Disclosure Report   Due on or before contract completion date. 13.  
New or Revised Financial Conflict of Interest (FCOI) Report and Mitigation
Report   Due as FCOI arises.

 

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Contract Number: HHSN261201400048C

 

Item No.   Description   Delivery Schedule 14.   SBIR Program Life Cycle
Certification - Phase II - Report 1   Due prior to receiving 50% of the total
contract amount. 15.   SBIR Program Life Cycle Certification - Phase II - Report
2   Due on or before Phase II completion date. 16.   Federal Wide Assurance
(FWA) (As applicable). - An approved FWA is effective for 5 years from issuance
date.   Prior to starting any work involving human subjects.  (Renewal
confirmation as required.) 17.   Institutional Review Board (IRB) (As
applicable) - An IRB registration is effective for 3 years after issuance.  
Prior to starting any work involving human subjects.  (Renewal confirmation as
required.)

  

b.           The above items shall be addressed and emailed to
ncibranchcinvoices@mail.nih.gov. The following addresses are provided for
general correspondence and other deliveries:

 

Addressee   Deliverable Item No.   Quantity Mandie S. White, Contracting Officer
National Cancer Institute
Office of Acquisitions, Room 4036
Riverside Five, Suite 400
8490 Progress Drive
Frederick, MD 21701   1-17  

One (1) electronic copy

*

         

*, COR

National Cancer Institute

NCI SBIR & STTR Programs, Room 9609 Medical Center Drive, MSC 9705
Bethesda, MD 20892-9705

  1-9  

One (1) electronic copy

*

         

OPERA, OEH, NIH

6705 Rockledge Drive

Suite 310, MSC 7980

Bethesda, Maryland 20892-7980

  12  

One (1) hard copy to OPERA;

One (1) electronic copy

 

*

 

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

 

This contract incorporates the following clause by reference, with the same
force and effect as if it were given in full text. Upon request, the Contracting
Officer will make its full text available. Also, the full text of a clause may
be accessed electronically at this address: http:/A/vww.acquisition.gov/far.

 

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FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

 

52.242-15, Stop WorkOrder, Alternate I (April 1984) is applicable to Phase II of
this contract.

 

SECTION G - CONTRACT ADMINISTRATION DATA

 

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

 

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

 

*

 

The COR is responsible for: (1) monitoring the Contractor’s technical progress,
including the surveillance and assessment of performance and recommending to the
Contracting Officer changes in requirements; (2) interpreting the statement of
work and any other technical performance requirements; (3) performing technical
evaluation as required; (4) performing technical inspections and acceptances
required by this contract; and (5) assisting in the resolution of technical
problems encountered during performance.

 

The Contracting Officer is the only person with authority to act as agent of the
Government under this contract. Only the Contracting Officer has authority to:
(1) direct or negotiate any changes in the statement of work; (2) modify or
extend the period of performance; (3) change the delivery schedule; (4)
authorize reimbursement to the Contractor for any costs incurred during the
performance of this contract; (5) otherwise change any terms and conditions of
this contract; or (6) sign written licensing agreements. Any signed agreement
shall be incorporated by reference in Section K of the contract

 

The Government may unilaterally change its COR designation.

 

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

 

The key personnel specified in this contract are considered to be essential to
work performance. At least 30 days prior to diverting any of the specified
individuals to other programs or contracts (or as soon as possible, if an
individual must be replaced, for example, as a result of leaving the employ of
the Contractor), the Contractor shall notify the Contracting Officer and shall
submit comprehensive justification for the diversion or replacement request
(including proposed substitutions for key personnel) to permit evaluation by the
Government of the impact on performance under this contract. The Contractor
shall not divert or otherwise replace any key personnel without the written
consent of the Contracting Officer. The Government may modify the contract to
add or delete key personnel at the request of the Contractor or Government.

 

(End of Clause)

 

The following individuals are considered to be essential to the work being
performed hereunder:

 

Name   Title Arthur Tinkelenberg   Principal Investigator, President & CEO *  
Senior Scientist *   Engineering Associate

 

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ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT

 

a.           Invoice Submission/Contract Financing Request and Contract
Financial Reporting, NIH(RC)-4 for NIH Cost- Reimbursement Type Contracts are
attached and made part of this contract. The Contractor shall follow the
attached instructions and submission procedures specified below to meet the
requirements of a “proper invoice” pursuant to FAR Subpart 32.9, Prompt Payment.

 

*

 

The Contractor shall submit an electronic copy of the payment request to the
approving official instead of a paper copy. The payment request shall be
transmitted as an attachment via e-mail to the address listed above in one of
the following formats: MSWord, MS Excel, or Adobe Portable Document Format
(PDF). Only one payment request shall be submitted per e-mail and the subject
line of the e-mail shall include the Contractor’s name, contract number, and
unique invoice number. [Note: The original payment request must still be
submitted in hard copy and mailed to the designated billing office to meet the
requirements of a “proper invoice.”]

 

ncibranchcinvoices@mail.nih.gov

 

The Contractor shall submit an electronic copy of the payment request to the
Central Point of Distribution mailbox. The payment request shall be transmitted
as an attachment via e-mail to the address listed above in one of the following
formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one
payment request shall be submitted per e-mail and the subject line of the e-mail
shall include the Contractor’s name, contract number, and unique invoice number.
[Note: The original payment request must still be submitted in hard copy and
mailed to the designated billing office to meet the requirements of a “proper
invoice.”]

 

1.          Payment requests shall be submitted to the offices identified below.
Do not submit supporting documentation (e.g., receipts, time sheets, vendor
invoices, etc.) with your payment request unless specified elsewhere in the
contract or requested by the Contracting Officer.

 

a.           The original invoice shall be submitted to the following designated
billing office:

 

National Institutes of Health
Office of Financial Management
Commercial Accounts
2115 East Jefferson Street, Room 4B-432, MSC 8500
Bethesda, MD 20892-8500

 

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b.           One courtesy copy of the original invoice shall be submitted
electronically as follows:

 

1.          The Contractor shall scan the original payment request (invoice) in
Adobe Portable Document Format (PDF) along with the necessary supporting
documentation as one single attachment.

 

2.          Save the single attachment (scanned invoice along with any
supporting documentation) in the following format: YourVendorName_Invoice number
(e.g., if you are submitting Invoice 123456, save the single attachment as “Ash
Stevens_Invoice 123456”) [Note: Please do not use special characters such as (#,
$, %,*, &, I) when saving your attachment. Only the underscore symbol (_) is
permitted.]

 

3.          Transmit the saved single attachment via e-mail to the appropriate
branch’s Central Point of Distribution. For the purpose of this contract, the
Central Point of Distribution is NCI OA Branch C -
ncibranchcinvoices@mail.nih.gov. Only one payment request shall be submitted per
e-mail and the subject line of the e-mail shall include the Contract Number_
Contract Title_ Contractor’s Name_ unique Invoice number (e.g,
HHSN2612XXXXXC_Clinical Genetics Support_Ash Stevens_Invoice 12345) [Note: The
original payment request must still be submitted in hard copy and mailed to the
designated billing office listed in subparagraph a, above, to meet the
requirements of a “proper invoice.” Also, The Contractor must certify on the
payment request that the electronic courtesy copy is a duplicate of the original
invoice mailed to NIH’s Office of Financial Management.]

 

2.          In addition to the requirements specified in FAR 32.905 for a proper
invoice, the Contractor shall include the following information on the face page
of all payment requests:

 

a.           Name of the Office of Acquisitions. The Office of Acquisitions for
this contract is National Cancer Institute.

 

b.           Federal Taxpayer Identification Number (TIN). If the Contractor
does not have a valid TIN, it shall identify the Vendor Identification Number
(VIN) on the payment request. The VIN is the number that appears after the
Contractor’s name on the face page of the contract. [Note: A VIN is assigned to
new contracts awarded on or after June 4, 2007, and any existing contract
modified to include the VIN number.] If the Contractor has neither a TIN, DUNS,
or VIN, contact the Contracting Officer.

 

c.           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 Central Contractor Registration (CCR) database. If the
Contractor does not have a valid DUNS number, it shall identify the Vendor
Identification Number (VIN) on the payment request. The VIN is the number that
appears after the Contractor’s name on the face page of the contract. [Note: A
VIN is assigned to new contracts awarded on or after June 4, 2007, and any
existing contract modified to include the VIN number.] If the Contractor has
neither a TIN, DUNS, or VIN, contact the Contracting Officer.

 

d.           Invoice Matching Option. This contract requires a two-way match.

 

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e.           Unique Invoice Number. Each payment request must be identified by a
unique invoice number, which can only be used one time regardless of the number
of contracts or orders held by an organization.

 

f.            The Contract Title is:

 

SBIR Phase II Topic 309: Deployment of Prototype System for Detection of
Multiple Analytes in Small Tissue Samples (9/16/14-9/15/16)

 

g.           Contract Line Items as follows:

 

Line Item #   Line Item Description 1   SBIR Phase II Topic 309:  Deployment of
Prototype System for Detection of Multiple Analytes in Small Tissue Samples
(9/16/14-9/15/16)

 

a.           Inquiries regarding payment of invoices shall be directed to the
designated billing office, (301) 496-6452.

 

b.           The Contractor shall include the following certification on every
invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR
Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract. For
billing purposes, certified invoices are required for the billing period during
which the applicable Fiscal Year funds were initially charged through the final
billing period utilizing the applicable Fiscal Year funds:

 

“I hereby certify that the salaries charged in this invoice are in compliance
with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above
referenced contract.”

 

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR
52.232-40 (December 2013)

 

a.           Upon receipt of accelerated payments from the Government, the
Contractor shall make accelerated payments to its small business subcontractors
under this contract, to the maximum extent practicable and prior to when such
payment is otherwise required under the applicable contract or subcontract,
after receipt of a proper invoice and all other required documentation from the
small business subcontractor.

 

b.           The acceleration of payments under this clause does not provide any
new rights under the prompt Payment Act.

 

c.           Include the substance of this clause, include this paragraph c, in
all subcontracts with small business concerns, including subcontracts with small
business concerns for the acquisition of commercial items.

 

(End of Clause)

 

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ARTICLE G.5. INDIRECT COST RATES

 

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1)
Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in
this contract in PART II, SECTION I, the cognizant Contracting Officer
representative responsible for negotiating provisional and/or final indirect
cost rates is identified as follows:

 

Director, Division of Financial Advisory Services
Office of Acquisition Management and Policy
National Institutes of Health
6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663
BETHESDA MD 20892-7663

 

These rates are hereby incorporated without further action of the Contracting
Officer if the Contractor has an active rate agreement. If no rate agreement is
in place, refer to ARTICLE B.3 ADVANCED UNDERSTANDINGS for specific terms.

 

ARTICLE G.6. GOVERNMENT PROPERTY

 

a.           In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in SECTION I of this contract, the Contractor shall comply with the
provisions of HHS Publication, “HHS Contracting Guide for Contract of Government
Property,” which is incorporated into this contract by reference. This document
can be accessed at: http://oamp.od.nih.gov/sites/default/files/appendix_g_hhs
contracting_guide.pdf. Among other issues, this publication provides a summary
of the Contractor’s responsibilities regarding purchasing authorizations and
inventory and reporting requirements under the contract.

 

Requests for information regarding property under this contract should be
directed to the following office:

 

Division of Logistics Services, NIH
Property Management Branch
6011 Building, Suite 639
6011 EXECUTIVE BLVD MSC 7670
BETHESDA MD 20892-7670
nihcontractproperty@nih.gov

 

b.           Notwithstanding the provisions outlined in the HHS Publication,
“HHS Contracting Guide for Contract of Government Property,” which is
incorporated in this contract in paragraph a. above, the Contractor shall use
the form entitled, “Report of Government Owned, Contractor Held Property” for
submitting summary reports required under this contract, as directed by the
Contracting Officer or his/her designee. This form is included as an attachment
in SECTION J of this contract.

 

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Contract Number: HHSN261201400048C

 

c.           Contractor-Acquired Government Property - Schedule I-A

 

Pursuant to the clause, GOVERNMENT PROPERTY, incorporated in this contract, the
Contractor is hereby authorized to acquire the property listed in the attached
Schedule I-A for use in direct performance of the contract. Schedule I-A is
included as an attachment in SECTION J of this contract.

 

ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

 

a.           Contractor Performance Evaluations

 

Interim and Final evaluations of Contractor performance will be prepared on this
contract in accordance with FAR Subpart 42.15. The Final performance evaluation
will be prepared at the time of completion of work. In addition to the Final
evaluation, Interim evaluations will be prepared Annually as determined by the
Contracting Officer.

 

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

 

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

 

b.           Electronic Access to Contractor Performance Evaluations

 

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

 

http://www.cpars.gov

 

SECTION H - SPECIAL CONTRACT REQUIREMENTS

 

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (January 2006)

 

a.           The Contractor agrees that the rights and welfare of human subjects
involved in research under this contract shall be protected in accordance with
45 CFR Part 46 and with the Contractor’s current Assurance of Compliance on file
with the Office for Human Research Protections (OHRP), Department of Health and
Human Services. The Contractor further agrees to provide certification at least
annually that the Institutional Review Board has reviewed and approved the
procedures, which involve human subjects in accordance with 45 CFR Part 46 and
the Assurance of Compliance.

 

b.           The Contractor shall bear full responsibility for the performance
of all work and services involving the use of human subjects under this contract
and shall ensure that work is conducted in a proper manner and as safely as is
feasible. The parties hereto agree that the Contractor retains the right to
control and direct the performance of all work under this contract. The
Contractor shall not deem anything in this contract to constitute the Contractor
or any subcontractor, agent or employee of the Contractor, or any other person,
organization, institution, or group of any kind whatsoever, as the agent or
employee of the Government. The Contractor agrees that it has entered into this
contract and will discharge its obligations, duties, and undertakings and the
work pursuant thereto, whether requiring professional judgment or otherwise, as
an independent contractor without imputing liability on the part of the
Government for the acts of the Contractor or its employees.

 

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c.           If at any time during the performance of this contract, the
Contracting Officer determines, in consultation with OHRP that the Contractor is
not in compliance with any of the requirements and/or standards stated in
paragraphs (a) and (b) above, the Contracting Officer may immediately suspend,
in whole or in part, work and further payments under this contract until the
Contractor corrects the non compliance. The Contracting Officer may communicate
the notice of suspension by telephone with confirmation in writing. If the
Contractor fails to complete corrective action within the period of time
designated in the Contracting Officer’s written notice of suspension, the
Contracting Officer may, after consultation with OHRP, terminate this contract
in whole or in part, and the Contractor’s name may be removed from the list of
those contractors with approved Human Subject Assurances.

 

(End of clause)

 

ARTICLE H.2. HUMAN SUBJECTS

 

Research involving human subjects shall not be conducted under this contract
until the protocol developed in Phase I has been approved by the National Cancer
Institute, written notice of such approval has been provided by the Contracting
Officer, and the Contractor has provided to the Contracting Officer a properly
completed “Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly
Optional Form 310) certifying IRB review and approval of the protocol. The human
subject certification can be met by submission of the Contractor’s self
designated form, provided that it contains the information required by the
“Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly
Optional Form 310).

 

When research involving Human Subjects will take place at collaborating sites or
other performance sites, the Contractor shall obtain, and keep on file, a
properly completed “Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly
Optional Form 310) certifying IRB review and approval of the research.

 

ARTICLE H.3. RESTRICTION ON USE OF HUMAN SUBJECTS, HHSAR 352.270-6 (January
2006)

 

Pursuant to 45 CFR part 46, Protection of Human Research Subjects, the
Contractor shall not expend funds under this award for research involving human
subjects or engage in any human subjects research activity prior to the
Contracting Officer’s receipt of a certification that the research has been
reviewed and approved by the Institutional Review Board (IRB) designated under
the Contractor’s Federal-wide assurance of compliance. This restriction applies
to all collaborating sites, whether domestic or foreign, and subcontractors. The
Contractor must ensure compliance by collaborators and subcontractors.

 

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Contract Number: HHSN261201400048C

 

(End of clause)

 

Prisoners shall not be enrolled in any HHS research activities until all
requirements of HHS Regulations at 45 CFR PART 46, Subpart C have been met. If a
Research Subject becomes a prisoner during the period of this contract, 45 CFR
PART 46, Subpart C will apply to research involving that individual.

 

ARTICLE H.4. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH PARTICIPANTS

 

NIH policy requires education on the protection of human subject participants
for all investigators receiving NIH contract awards for research involving human
subjects. For a complete description of the NIH Policy announcement on required
education in the protection of human subject participants, the Contractor should
access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at
the following website:

 

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

 

The information below is a summary of the NIH Policy Announcement:

 

The Contractor shall maintain the following information: (1) a list of the names
and titles of the principal investigator and any other individuals working under
the contract who are responsible for the design and/or conduct of the research;
(2) the title of the education program(s) in the protection of human subjects
that has been completed for each named personnel and; (3) a one sentence
description of the educational program(s) listed in (2) above. This requirement
extends to investigators and all individuals responsible for the design and/or
conduct of the research who are working as subcontractors or consultants under
the contract.

 

Prior to any substitution of the Principal Investigator or any other individuals
responsible for the design and/or conduct of the research under the contract,
the Contractor shall provide the following written information to the
Contracting Officer: the title of the education program and a one sentence
description of the program that has been completed by the replacement.

 

ARTICLE H.5. HUMAN MATERIALS

 

The acquisition and supply of all human specimen material (including fetal
material) used under this contract shall be obtained by the Contractor in full
compliance with applicable State and Local laws and the provisions of the
Uniform Anatomical Gift Act in the United States, and no undue inducements,
monetary or otherwise, will be offered to any person to influence their donation
of human material.

 

ARTICLE H.6. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

 

The acquisition and supply of all human specimen material (including fetal
material) used under this contract shall be obtained by the Contractor in full
compliance with applicable State and Local laws and the provisions of the
Uniform Anatomical Gift Act in the United States, and no undue inducements,
monetary or otherwise, will be offered to any person to influence their donation
of human material.

 

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Contract Number: HHSN261201400048C

 

The Contractor shall provide written documentation that all human materials
obtained as a result of research involving human subjects conducted under this
contract, by collaborating sites, or by subcontractors identified under this
contract, were obtained with prior approval by the Office for Human Research
Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46
to protect human research subjects. This restriction applies to all
collaborating sites without OHRP-approved Assurances, whether domestic or
foreign, and compliance must be ensured by the Contractor.

 

Provision by the Contractor to the Contracting Officer of a properly completed
“Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly
Optional Form 310), certifying IRB review and approval of the protocol from
which the human materials were obtained constitutes the written documentation
required. The human subject certification can be met by submission of a self
designated form, provided that it contains the information required by the
“Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly
Optional Form 310).

 

ARTICLE H.7. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS
RESULTING FROM NIH-FUNDED RESEARCH

 

NIH-funded investigators shall submit to the NIH National Library of Medicine’s
(NLM) PubMed Central (PMC) an electronic version of the author’s final
manuscript, upon acceptance for publication, resulting from research supported
in whole or in part with direct costs from NIH. NIH defines the author’s final
manuscript as the final version accepted for journal publication, and includes
all modifications from the publishing peer review process. The PMC archive will
preserve permanently these manuscripts for use by the public, health care
providers, educators, scientists, and NIH. The Policy directs electronic
submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov.

 

Additional information is available at
http://grants.nih.gov/grants/Guide/notice-files/NOT-OD-08-033.html.

 

ARTICLE H.8. NEEDLE DISTRIBUTION

 

The Contractor shall not use contract funds to carry out any program of
distributing sterile needles or syringes for the hypodermic injection of any
illegal drug.

 

ARTICLE H.9. ACKNOWLEDGEMENT OF FEDERAL FUNDING

 

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

 

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Contract Number: HHSN261201400048C

 

ARTICLE H.10. RESTRICTION ON ABORTIONS

 

The Contractor shall not use contract funds for any abortion.

 

ARTICLE H.11. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

 

The Contractor shall not use contract funds for (1) the creation of a human
embryo or embryos for research purposes; or (2) research in which a human embryo
or embryos are destroyed, discarded, or knowingly subjected to risk of injury or
death greater than that allowed for research on fetuses in utero under 45 CFR
46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C.
289g(b)). The term “human embryo or embryos” includes any organism, not
protected as a human subject under 45 CFR 46 as of the date of the enactment of
this Act, that is derived by fertilization, parthenogenesis, cloning, or any
other means from one or more human gametes or human diploid cells.

 

Additionally, in accordance with a March 4,1997 Presidential Memorandum, Federal
funds may not be used for cloning of human beings.

 

ARTICLE H.12. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

 

The Contractor shall not use contract funds to disseminate information that is
deliberately false or misleading.

 

ARTICLE H.13. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

 

The Contractor shall not use contract funds to maintain or establish a computer
network unless such network blocks the viewing, downloading, and exchanging of
pornography.

 

ARTICLE H.14. GUN CONTROL

 

The Contractor shall not use contract funds in whole or in part, to advocate or
promote gun control.

 

ARTICLE H.15. LIMITATIONS ON SUBCONTRACTING - SBIR

 

The Contractor shall perform a minimum of one half of the contract effort [total
contract costs less profit/fee] conducted under this contract. Any deviation
from this requirement must be approved in writing by the Contracting Officer.

 

ARTICLE H.16. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY, HHSAR
352.239-73(b) (January 2010)

 

a.           Pursuant to Section 508 of the Rehabilitation Act of 1973 (29
U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic
and information technology (EIT) products and services developed, acquired,
maintained, or used under this contract/order must comply with the “Electronic
and Information Technology Accessibility Provisions” set forth by the
Architectural and Transportation Barriers Compliance Board (also referred to as
the “Access Board”) in 36 CFR part 1194. Information about Section 508
provisions is available at http://www.section508.gov/. The complete text of
Section 508 Final provisions can be accessed at
http://www.access-board.gov/guidelines-and-standards.

 

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Contract Number: HHSN261201400048C

 

b.           The Section 508 standards applicable to this contract/order are
identified in the Statement of Work. The contractor must provide a written
Section 508 conformance certification due at the end of each contract/ order
exceeding $100,000 when the contract/order duration is one year or less, if it
is determined by the Government that EIT products and services provided by the
Contractor do not conform to the described accessibility standards in the
Product Assessment Template, remediation of the products or services to the
level of conformance specified in the Contractor’s Product Assessment Template
will be the responsibility of the Contractor at its own expense.

 

c.           In the event of a modification(s) to this contract/order, which
adds new EIT products or services or revises the type of, or specifications for,
products or services the Contractor is to provide, including EIT deliverables
such as electronic documents and reports, the Contracting Officer may require
that the contractor submit a completed HHS Section 508 Product Assessment
Template to assist the Government in determining that the EIT products or
services support Section 508 accessibility standards. Instructions for
documenting accessibility via the HHS Section 508 Product Assessment Template
may be found on the HHS Web site
(http://www.hhs.gov/web/508/contracting/technology/vendors.html).

 

[(End of HHSAR 352.239-73(b)]

 

d.           Prior to the Contracting Officer exercising an option for a
subsequent performance period/additional quantity or adding funding for a
subsequent performance period under this contract, as applicable, the Contractor
must provide a Section 508 Annual Report to the Contracting Officer and Project
Officer. Unless otherwise directed by the Contracting Officer in writing, the
Contractor shall provide the cited report in accordance with the following
schedule. Instructions for completing the report are available in the Section
508 policy on the HHS Office on Disability Web site under the heading Vendor
Information and Documents. The Contractor’s failure to submit a timely and
properly completed report may jeopardize the Contracting Officer’s exercising an
option or adding funding, as applicable.

 

Schedule for Contractor Submission of Section 508 Annual Report: Annually
[End of HHSAR 352.239-73(c)]

 

ARTICLE H.17. CONFIDENTIALITY OF INFORMATION

 

a.           Confidential information, as used in this article, 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.

 

b.           The Contracting Officer and the Contractor may, by mutual consent,
identify elsewhere in this contract specific information and/or categories of
information which the Government will furnish to the Contractor or that the
Contractor is expected to generate which is confidential. Similarly, the
Contracting Officer and the Contractor may, by mutual consent, identify such
confidential information from time to time during the performance of the
contract. Failure to agree will be settled pursuant to the “Disputes” clause.

 

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Contract Number: HHSN261201400048C

 

c.           If it is established elsewhere in this contract that information to
be utilized under this contract, or a portion thereof, is subject to the Privacy
Act, the Contractor will follow the rules and procedures of disclosure set forth
in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and
policies, with respect to systems of records determined to be subject to the
Privacy Act.

 

d.           Confidential information, as defined in paragraph (a) of this
article, shall not be disclosed without the prior written consent of the
individual, institution, or organization.

 

e.           Whenever the Contractor is uncertain with regard to the proper
handling of material under the contract, or if the material in question is
subject to the Privacy Act or is confidential information subject to the
provisions of this article, the Contractor should obtain a written determination
from the Contracting Officer prior to any release, disclosure, dissemination, or
publication.

 

f.            Contracting Officer determinations will reflect the result of
internal coordination with appropriate program and legal officials.

 

g.           The provisions of paragraph (d) of this article shall not apply to
conflicting or overlapping provisions in other Federal, State or local laws.

 

The following information is covered by this article:

 

There will be no data or PII collection under this project.

 

ARTICLE H.18. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL
CONFLICTS OF INTEREST - PHASE II

 

The Institution (includes any contractor, public or private, excluding a Federal
agency) shall comply with the requirements of 45 CFR Part 94, Responsible
Prospective Contractors, which promotes objectivity in research by establishing
standards to ensure that Investigators (defined as the project director or
principal Investigator and any other person, regardless of title or position,
who is responsible for the design, conduct, or reporting of research funded
under NIH contracts, or proposed for such funding, which may include, for
example, collaborators or consultants) will not be biased by any Investigator
financial conflicts of interest. 45 CFR Part 94 is available at the following
Web site: http://www.ecfr.gov/cgi-bin/text-idx?
c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.
As required by 45 CFR Part 94, the Institution shall, at a minimum:

 

a.           Maintain an up-to-date, written, enforceable policy on financial
conflicts of interest that complies with 45 CFR Part 94, inform each
Investigator of the policy, the Investigator’s reporting responsibilities
regarding disclosure of significant financial interests, and the applicable
regulation, and make such policy available via a publicly accessible Web site,
or if none currently exist, available to any requestor within five business days
of a request. A significant financial interest means a financial interest
consisting of one or more of the following interests of the Investigator (and
those of the Investigator’s spouse and dependent children) that reasonably
appears to be related to the Investigator’s institutional responsibilities:

 

27

 

 

Contract Number: HHSN261201400048C

 

1.          With regard to any publicly traded entity, a significant financial
interest exists if the value of any remuneration received from the entity in the
twelve months preceding the disclosure and the value of any equity interest in
the entity as of the date of disclosure, when aggregated, exceeds $5,000.
Included are payments and equity interests;

 

2.          With regard to any non-publicly traded entity, a significant
financial interest exists if the value of any remuneration received from the
entity in the twelve months preceding the disclosure, when aggregated, exceeds
$5,000, or when the Investigator (or the investigator’s spouse or dependent
children) holds any equity interest; or

 

3.          Intellectual property rights and interests, upon receipt of income
related to such rights and interest.

 

Significant financial interests do not include the following:

 

1.          Income from seminars, lectures, or teaching, and service on advisory
or review panels for government agencies, Institutions of higher education,
academic teaching hospitals, medical centers, or research institutes with an
Institution of higher learning; and

 

2.          Income from investment vehicles, such as mutual funds and retirement
accounts, as long as the Investigator does not directly control the investment
decisions made in these vehicles.

 

b.           Require each Investigator to complete training regarding the
Institution’s financial conflicts of interest policy prior to engaging in
research related to any NIH-funded contract and at least every four years. The
Institution must take reasonable steps [see Part 94.4(c)] to ensure that
investigators working as collaborators, consultants or subcontractors comply
with the regulations.

 

c.           Designate an official(s) to solicit and review disclosures of
significant financial interests from each Investigator who is planning to
participate in, or is participating in, the NIH-funded research.

 

d.           Require that each Investigator who is planning to participate in
the NIH-funded research disclose to the Institution’s designated official(s) the
Investigator’s significant financial interest (and those of the Investigator’s
spouse and dependent children) no later than the date of submission of the
Institution’s proposal for NIH-funded research. Require that each Investigator
who is participating in the NIH-funded research to submit an updated disclosure
of significant financial interests at least annually, in accordance with the
specific time period prescribed by the Institution during the period of the
award as well as within thirty days of discovering or acquiring a new
significant financial interest.

 

28

 

  

Contract Number: HHSN261201400048C

 

e.           Provide guidelines consistent with the regulations for the
designated official(s) to determine whether an Investigator’s significant
financial interest is related to NIH-funded research and, if so related, whether
the significant financial interest is a financial conflict of interest. An
Investigator’s significant financial interest is related to NIH-funded research
when the Institution, thorough its designated official(s), reasonably determines
that the significant financial interest: Could be affected by the NIH-funded
research; or is in an entity whose financial interest could be affected by the
research. A financial conflict of interest exists when the Institution, through
its designated official(s), reasonably determines that the significant financial
interest could directly and significantly affect the design, conduct, or
reporting of the NIH-funded research.

 

f.            Take such actions as necessary to manage financial conflicts of
interest, including any financial conflicts of a subcontractor Investigator.
Management of an identified financial conflict of interest requires development
and implementation of a management plan and, if necessary, a retrospective
review and mitigation report pursuant to Part 94.5(a).

 

g.           Provide initial and ongoing FCOI reports to the Contracting Officer
pursuant to Part 94.5(b).

 

h.           Maintain records relating to all Investigator disclosures of
financial interests and the Institution’s review of, and response to, such
disclosures, and all actions under the Institution’s policy or retrospective
review, if applicable, for at least 3 years from the date of final payment or,
where applicable, for the other time periods specified in 48 CFR Part 4, subpart
4.7, Contract Records Retention.

 

i.            Establish adequate enforcement mechanisms and provide for employee
sanctions or other administrative actions to ensure Investigator compliance as
appropriate.

 

j.            Complete the certification in Section K - Representations,
Certifications, and Other Statements of Offerors titled “Certification of
Institutional Policy on Financial Conflicts of interest”.

 

If the failure of an Institution to comply with an Institution’s financial
conflicts of interest policy or a financial conflict of interest management plan
appears to have biased the design, conduct, or reporting of the NIH-funded
research, the Institution must promptly notify the Contracting Officer of the
corrective action taken or to be taken. The Contracting Officer will consider
the situation and, as necessary, take appropriate action or refer the matter to
the Institution for further action, which may include directions to the
Institution on how to maintain appropriate objectivity in the NIH-funded
research project.

 

The Contracting Officer and/or HHS may inquire at any time before, during, or
after award into any Investigator disclosure of financial interests, and the
Institution’s review of, and response to, such disclosure, regardless of whether
the disclosure resulted in the Institution’s determination of a financial
conflict of interests. The Contracting Officer may require submission of the
records or review them on site. On the basis of this review of records or other
information that may be available, the Contracting Officer may decide that a
particular financial conflict of interest will bias the objectivity of the
NIH-funded research to such an extent that further corrective action is needed
or that the Institution has not managed the financial conflict of interest in
accordance with Part 94.6(b). The issuance of a Stop Work Order by the
Contracting Officer may be necessary until the matter is resolved.

 

29

 

  

Contract Number: HHSN261201400048C

 

If the Contracting Officer determines that NIH-funded clinical research, whose
purpose is to evaluate the safety or effectiveness of a drug, medical device, or
treatment, has been designed, conducted, or reported by an Investigator with a
financial conflict of interest that was not managed or reported by the
Institution, the Institution shall require the Investigator involved to disclose
the financial conflict of interest in each public presentation of the results of
the research and to request an addendum to previously published presentations.

 

ARTICLE H.19. PUBLICATION AND PUBLICITY

 

In addition to the requirements set forth in HHSAR Clause 352.227-70,
Publications and Publicity incorporated by reference in SECTION I of this
contract, the Contractor shall acknowledge the support of the National
Institutes of Health whenever publicizing the work under this contract in any
media by including an acknowledgment substantially as follows:

 

“This project has been funded in whole or in part with Federal funds from the
National Cancer Institute, National Institutes of Health, Department of Health
and Human Services, under Contract No. HHSN261201400048C”

 

ARTICLE H.20. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

 

Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in NIH funded programs is encouraged to report such matters to the HHS
Inspector General’s Office in writing or on the Inspector General’s Hotline. The
toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be
handled confidentially. The website to file a complaint on-line is:
http://oig.hhs.gov/fraud/hotline/ and the mailing address is:

 

US Department of Health and Human Services
Office of Inspector General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489
Washington, D.C. 20026

 

ARTICLE H.21. YEAR 2000 COMPLIANCE

 

In accordance with FAR 39.106, Information Technology acquired under this
contract must be Year 2000 compliant as set forth in the following clause(s):

 

1.          Service Involving the Use of Information Technology YEAR 2000
COMPLIANCE—SERVICE INVOLVING THE USE OF INFORMATION TECHNOLOGY

 

The Contractor agrees that each item of hardware, software, and firmware used
under this contract shall be able to accurately process date data (including,
but not limited to, calculating, comparing and sequencing) from, into and
between the twentieth and twenty-first centuries and the Year 1999 and the Year
2000 and leap year calculations.

 

(End of Clause)

 

30

 

  

Contract Number: HHSN261201400048C

 

PART II - CONTRACT CLAUSES

 

SECTION I - CONTRACT CLAUSES

 

ARTICLE I.1. GENERAL CLAUSES FOR A COST-REIMBURSEMENT SBIR PHASE II CONTRACT

 

This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text of
a clause may be accessed electronically as follows: FAR Clauses at:
http://www.acquisition.gov/far/. HHSAR Clauses at: http:// www.hhs.
gov/policies/hhsar/subpart352.html.

 

a.FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

 

FAR
CLAUSE NO.   DATE   TITLE 52.202-1   Nov 2013   Definitions (Over the Simplified
Acquisition Threshold) 52.203-3   Apr 1984   Gratuities (Over the Simplified
Acquisition Threshold) 52.203-5   May 2014   Covenant Against Contingent Fees
(Over the Simplified Acquisition Threshold) 52.203-6   Sep 2006   Restrictions
on Subcontractor Sales to the Government (Over the Simplified Acquisition
Threshold) 52.203-7   May 2014   Anti-Kickback Procedures (Over the Simplified
Acquisition Threshold) 52.203-8   May 2014   Cancellation, Rescission, and
Recovery of Funds for Illegal or Improper Activity (Over the Simplified
Acquisition Threshold) 52.203-10   May 2014   Price or Fee Adjustment for
Illegal or Improper Activity (Over the Simplified Acquisition Threshold)
52.203-12   Oct 2010   Limitation on Payments to Influence Certain Federal
Transactions (Over $150,000) 52.203-17   Apr 2014   Contractor Employee
Whistleblower Rights and Requirements to Inform Employees of Whistleblower
Rights (Over the Simplified Acquisition Threshold) 52.204-4   May 2011   Printed
or Copied Double-Sided on Postconsumer Fiber Content Paper(Over the Simplified
Acquisition Threshold) 52.204-10   Jul 2013   Reporting Executive Compensation
and First-Tier Subcontract Awards ($25,000 or more) 52.204-13   Jul 2013  
System for Award Management Maintenance 52.209-6   Aug 2013   Protecting the
Government’s Interest When Subcontracting With Contractors Debarred, Suspended,
or Proposed for Debarment (Over $30,000) 52.215-2   Oct 2010   Audit and Records
- Negotiation [Note:  Applies to ALL contracts funded in whole or in part with
Recovery Act funds, regardless of dollar value, AND contracts over the
Simplified Acquisition Threshold funded exclusively with non-Recovery Act
funds.]

 

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Contract Number: HHSN261201400048C

 

FAR
CLAUSE NO.   DATE   TITLE   52.215-8   Oct 1997   Order of Precedence - Uniform
Contract Format   52.215-10   Aug 2011   Price Reduction for Defective Certified
Cost or Pricing Data (Over $700,000)   52.215-12   Oct 2010   Subcontractor Cost
or Pricing Data (Over $700,000)   52.215-14   Oct 2010   Integrity of Unit
Prices (Over the Simplified Acquisition Threshold)   52.215-15   Oct 2010  
Pension Adjustments and Asset Reversions (Over $700,000) 52.215-18   Jul 2005  
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than
Pensions 52.215-19   Oct 1997   Notification of Ownership Changes 52.215-21  
Oct 2010   Requirements for Certified Cost or Pricing Data and Data Other Than
Certified Cost or Pricing Data - Modifications 52.215-23   Oct 2009  
Limitations on Pass-Through Charges (Over the Simplified Acquisition Threshold)
52.216-7   Jun 2013   Allowable Cost and Payment 52.216-8   Jun 2011   Fixed Fee
52.219-6   Jul 1996   Notice of Total Small Business Set-Aside 52.219-8   May
2014   Utilization of Small Business Concerns (Over the Simplified Acquisition
Threshold) 52.219-14   Dec 1996   Limitations on Subcontracting 52.222-2   Jul
1990   Payment for Overtime Premium (Over the Simplified Acquisition Threshold)
(Note:  The dollar amount in paragraph (a) of this clause is $0 unless otherwise
specified in the contract.) 52.222-3   Jun 2003   Convict Labor 52.222-21   Feb
1999   Prohibition of Segregated Facilities 52.222-26   Mar 2007   Equal
Opportunity 52.222-35   Jul 2014   Equal Opportunity for Veterans ($100,000 or
more) 52.222-36   Jul 2014   Equal Opportunity for Workers with Disabilities
52.222-37   Jul 2014   Employment Reports on Veterans ($100,000 or more)
52.222-40   Dec 2010   Notification of Employee Rights Under the National Labor
Relations Act (Over the Simplified Acquisition Threshold) 52.222-50   Feb 2009  
Combating Trafficking in Persons 52.222-54   Aug 2013   Employment Eligibility
Verification (Over the Simplified Acquisition Threshold) 52.223-6   May 2001  
Drug-Free Workplace 52.223-18   Aug 2011   Encouraging Contractor Policies to
Ban Text Messaging While Driving 52.225-1   May 2014   Buy American - Supplies
52.225-13   Jun 2008   Restrictions on Certain Foreign Purchases 52.227-1   Dec
2007   Authorization and Consent, Alternate I (Apr 1984) 52.227-2   Dec 2007  
Notice and Assistance Regarding Patent and Copyright Infringement 52.227-11  
May 2014   Patent Rights - Ownership by the Contractor (Note:  In accordance
with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in
FAR 27.303(b)(2)(i) through (iv).  The frequency of reporting in (i) is annual.

 

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Contract Number: HHSN261201400048C

 

FAR
CLAUSE NO.   DATE   TITLE 52.227-20   May 2014   Rights in Data - SBIR Program
52.232-9   Apr 1984   Limitation on Withholding of Payments 52.232-17   May 2014
  Interest (Over the Simplified Acquisition Threshold) 52.232-20   Apr 1984  
Limitation of Cost 52.232-23   May 2014   Assignment of Claims 52.232-25   Jul
2013   Prompt Payment, Alternate I (Feb 2002) 52.232-33   Jul 2013   Payment by
Electronic Funds Transfer—System for Award Management 52.232-39   Jun 2013  
Unenforceability of Unauthorized Obligations 52.233-1   May 2014   Disputes
52.233-3   Aug 1996   Protest After Award, Alternate I (Jun 1985) 52.233-4   Oct
2004   Applicable Law for Breach of Contract Claim 52.242-1   Apr 1984   Notice
of Intent to Disallow Costs 52.242-3   May 2014   Penalties for Unallowable
Costs (Over $700,000) 52.242-4   Jan 1997   Certification of Final Indirect
Costs 52.242-13   Jul 1995   Bankruptcy (Over the Simplified Acquisition
Threshold) 52.243-2   Aug 1987   Changes - Cost Reimbursement, Alternate V (Apr
1984) 52.244-2   Oct 2010   Subcontracts (Over the Simplified Acquisition
Threshold), Alternate I (June 2007) 52.244-5   Dec 1996   Competition in
Subcontracting (Over the Simplified Acquisition Threshold) 52.244-6   Jul 2014  
Subcontracts for Commercial Items 52.245-1   Apr 2012   Government Property
52.245-9   Apr 2012   Use and Charges 52.249-6   May 2004   Termination
(Cost-Reimbursement) 52.249-14   Apr 1984   Excusable Delays 52.253-1   Jan 1991
  Computer Generated Forms

 

b.           DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION
(HHSAR) (48 CFR CHAPTER 3) CLAUSES:

 

HHSAR
CLAUSE NO.   DATE   TITLE 352.202-1   Jan 2006   Definitions - with Alternate
paragraph (h) (Jan 2006) 352.203-70   Mar 2012   Anti-Lobbying 352.216-70   Jan
2006   Additional Cost Principles 352.222-70   Jan 2010   Contractor Cooperation
in Equal Employment Opportunity Investigations 352.227-70   Jan 2006  
Publications and Publicity 352.228-7   Dec 1991   Insurance - Liability to Third
Persons 352.233-71   Jan 2006   Litigation and Claims 352.242-70   Jan 2006  
Key Personnel

 

33

 

  

Contract Number: HHSN261201400048C

 

HHSAR
CLAUSE NO.   DATE   TITLE 352.242-73   Jan 2006   Withholding of Contract
Payments 352.242-74   Apr 1984   Final Decisions on Audit Findings

 

[End of GENERAL CLAUSES FOR A COST-REIMBURSEMENT SBIR PHASE II CONTRACT- Rev.
08/2014].

 

ARTICLE I.2. AUTHORIZED SUBSTITUTION OF CLAUSES

 

ARTICLE 1.1. of this SECTION is hereby modified as follows:

 

a.           Alternate I (October 1997) of FAR Clause 52.215-14, Integrity of
Unit Prices (October 2010) is added.

 

b.           Alternate IV (October 2010) of FAR Clause 52.215-21, Requirements
for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing
Data—Modifications (October 2010) is added.

 

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

 

This contract incorporates the following clauses by reference, with the same
force and effect, as if they were given in full text. Upon request, the
Contracting Officer will make their full text available.

 

a.           FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

 

1.          FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money
(October 1997).

 

2.          FAR Clause 52.219-28, Post-Award Small Business Program
Representation (July 2013).

 

3.          FAR Clause 52.225-8, Duty-Free Entry (October 2010).

 

4.          FAR Clause 52.227-16, Additional Data Requirements (June 1987).

 

5.          FAR Clause 52.239-1, Privacy or Security Safeguards (August 1996).

 

6.          FAR Clause 52.242-3, Penalties for Unallowable Costs (May 2014).

 

7.          Alternate I (April 2012), FAR Clause 52.245-1, Government Property
(April 2012).

 

8.          FAR Clause 52.246-23, Limitation of Liability (February 1997).

 

34

 

 

Contract Number: HHSN261201400048C

 

b.           DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION
(HHSAR) (48 CHAPTER 3) CLAUSES:

 

1.          HHSAR Clause 352.201-70, Paperwork Reduction Act (January 2006).

 

2.          HHSAR Clause 352.231-70, Salary Rate Limitation (August 2012).

 

Note: The Salary Rate Limitation is at the Executive Level II Rate.

 

See the following website for Executive Schedule rates of pay:
http://www.opm.gov/oca/.

 

(For current year rates, click on Salaries and Wages/Executive Schedule/Rates of
Pay for the Executive Schedule. For prior year rates, click on Salaries and
Wages/select Another Year at the top of the page/Executive Schedule/Rates of Pay
for the Executive Schedule. Rates are effective January 1 of each calendar year
unless otherwise noted.)

 

c.           NATIONAL INSTITUTES OF HEALTH (NIH) RESEARCH CONTRACTING (RC)
CLAUSES:

 

The following clauses are attached and made a part of this contract:

 

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

 

This contract incorporates the following clauses in full text.

 

a.           DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION
(HHSAR) (48 CHAPTER 3) CLAUSES:

 

THERE ARE NO APPLICABLE CLAUSES IN THIS SECTION.

 

35

 

  

Contract Number: HHSN261201400048C

 

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

 

SECTION J - LIST OF ATTACHMENTS

 

The following documents are attached and incorporated in this contract:

 

1.           Statement of Work

 

Statement of Work - Phase II, dated 9/4/2014, 3 pages.

 

2.           Invoice/Financing Request and Contract Financial Reporting
Instructions for NIH Cost- Reimbursement Type Contracts, NIH(RC)-4

 

Invoice/Financing Request and Contract Financial Reporting Instructions for NIH
Cost-Reimbursement Type Contracts, NIH(RC)-4, (7/13), 6 pages.

 

3.           Disclosure of Lobbying Activities, SF-LLL

 

Disclosure of Lobbying Activities, SF-LLL, dated 7/97, 2 pages.

 

4.           Government Property - Schedule

 

Government Property - Schedule I-A, dated 9/4/14, 1 page.

 

5.           Report of Government Owned, Contractor Held Property

 

Report of Government Owned, Contractor Held Property, dated 3/2008, 1 page.
Located at:
http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Govt-Owned-Prop.pdf

 

6.           NIH Small Business Innovation Research (SBIR) Program Life Cycle
Certification

 

NIH Small Business Innovative Research (SBIR) Program Life Cycle Certification,
3 pages.

 

36

 

  

Contract Number: HHSN261201400048C

 

PART IV - REPRESENTATIONS AND INSTRUCTIONS

 

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

 

The following documents are incorporated by reference in this contract:

 

1.          Annual Representations and Certifications are completed and located
in The System for Award Management (SAM) website (http://www.sam.gov). This
includes the changes identified in paragraph (b) of the FAR provision 52.204-8,
Annual Representations and Certifications, contained in the Contractor’s
proposal.

 

2.          NIH Representations & Certifications, dated 2/24/14

 

3.          Human Subjects Assurance Identification Number FWA00003136.

 

END of the SCHEDULE

 

(CONTRACT)

 

37

 

  

Attachment 1: Statement of Work

 

HHSN261201400048C

 

Enumeral Biomedical Corp.

  

 

 

  

Statement of Work (Phase II) Dated 9/4/14
Contract No. HHSN261201400048C

 

STATEMENT OF WORK (Phase II)     TITLE: “Deployment of prototype system for
detection of multiple analytes in small tissue samples” PRINCIPAL
INVESTIGATOR(S): Arthur Tinkelenberg, PhD PROJECT DURATION: 24 Months COMPANY:
Enumeral Biomedical Corp SUBCONTRACTORS: *

 

I.           Background Information and Objectives

 

A.           Background Information

 

This proposal will build on the successful efforts from Phase I, which served to
characterize the technology’s accuracy and limits of detection and provide proof
of concept data on mucosal biopsy samples from patients with colorectal cancer.
We aim to (1) Develop a prototype analytical system incorporating Enumeral’s
technology, including automation, software and data analysis and (2)Test
prototypes on clinical samples in collaborating academic laboratories to
demonstrate clinical utility and advantages over analytical current techniques.

 

Our collaborators include *.

 

The use of Enumeral’s platform to understand * can potentially have a
significant impact on early cancer diagnosis, understanding mechanisms of
disease progression, and, ultimately development of novel, effective, and safe
immunotherapies.

 

B.           Technical Objectives

 

The technical objectives of this proposal are to (1) Develop a prototype
analytical system incorporating Enumeral’s technology, including automation,
software and data analysis (Tasks 1-5) and (2)Test prototypes on clinical
samples in collaborating academic laboratories to demonstrate clinical utility
and advantages over analytical current techniques (Tasks 6-8).

 

Objective 1: Develop a prototype analytical system incorporating Enumeral’s
technology, including automation, software and data analysis

 

Task 1 (Months 1-6): Design, source, and construct a prototype detection system.
Quantitative milestones for this task comprise *

 

Comparison   Quantitative Metric   Reasoning Milestone 1.1 Spot Assays  

-    *

-    *

  *

Milestone 1.2

Fluorescent

Microbeads

  -    *   * Milestone 1.3 Cellular Secretion (PBMCs)  

-    *

-    *

-    *

  *

 

 

 

 

Statement of Work (Phase II) Dated 9/4/14
Contract No. HHSN261201400048C

 

Task 2 (Months 1-10): Optimization of *

 

Milestone 2.1: The proposed loading procedure results in *

 

Milestone 2.2: The automation of cell loading step produces *

 

Task 3 (Months 1-8): Adaptation and optimization of integrated software platform

 

Milestone 3.1: Integrated software package can run a protocol that *.

 

Task 4 (Months 9-10): Develop assays to be used during system deployment

 

Milestone 4.1: Standard operating procedures will be written encompassing assays
for * (Task 6 and Task 7)

 

Task 5 (Month 11): Prepare for deployment

 

Milestone 5.1: Training is performed, and procedural feedback is received, for
end users at *

 

Objective 2: Test prototypes on clinical samples in collaborating academic
laboratories to demonstrate concordance, clinical utility and advantages over
analytical current techniques.

 

Task 6 (Months 12-17): Deploy platform to *

 

Milestone 6.1: Scientists at * collect and analyze data from *

 

Task 7 (Months 18-23): Deploy to *

 

Milestone 7.1: Scientists at * collect and analyze data from *

 

Task 8 (Month 24): Program Analysis, Defining Steps to Commercialization

 

Milestone 8.1: A report summarizing the data collected, concordance with
previous results, any significant results of analysis, and the potential for *
based on the experiments performed.

 

Milestone 8.2: A summary of the end-user observations, identifying the key
factors that should be considered in the efforts to progress from a prototype
system to a commercial device.

 

 

 

 

Statement of Work (Phase II) Dated 9/4/14
Contract No. HHSN261201400048C

 

II.          Services to be Performed

 

A.           General Requirements

 

1.          The contractor shall independently perform all work and furnish all
labor, materials, supplies, equipment, and services (except as otherwise
specified in the contract).

 

2.          All work will be monitored by the Government Project Officer
identified in Section G of the contract.

 

 

 

 

Statement of Work (Phase II) Dated 9/4/14
Contract No. HHSN261201400048C

 

B.           Specific Requirements

 

Phase II Milestones and Timeline

 

        Year 1   Year 2         Mo 1-3   Mo 4-6   Mo 7-9   Mo 10-12   Mo 13-15  
Mo 16-18   Mo 19-21   Mo 22-24 Objective 1   ———   ———   ———   ———              
  Task 1   Milestone 1.1   X                                 Milestone 1.2   X  
                              Milestone 1.3       X                         Task
2   Milestone 2.1       X                             Milestone 2.2            
  X                 Task 3   Milestone 3.1           X                     Task
4   Milestone 4.1               X                 Task 5   Milestone 5.1        
      X                                                       Objective 2      
        ———   ———   ———   ———   ——— Task 6   Milestone 6.1                      
X         Task 7   Milestone 7.1                               X Task 8  
Milestone 8.1                               X     Milestone 8.2                
              X

 

 

 

  

Attachment 2: Invoice/Financing for Cost Reimbursement Contracts, NIH (RC)-4

 

HHSN261201400048C

 

Enumeral Biomedical Corp.

  

 

 

  

INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
INSTRUCTIONS FOR NIH COST-REIMBURSEMENT CONTRACTS, NIH(RC)-4

 

Format: Submit payment requests on the Contractor’s self-generated form in the
manner and format prescribed herein and as illustrated in the Sample
Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and
Services Other Than Personal, may be used in lieu of the Contractor’s
self-generated form provided it contains all of the information shown on the
Sample Invoice/Financing Request. 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: Payment requests shall not be submitted more frequently than once
every two weeks in accordance with the Allowable Cost and Payment Clause
incorporated into this contract. Small business concerns may submit
invoices/financing requests more frequently than every two weeks.

 

Cost Incurrence Period: Costs incurred must be within the contract performance
period or covered by precontract cost provisions.

 

Billing of Costs Incurred: If billed costs include (1) costs of a prior billing
period, but not previously billed, or (2) costs incurred during the contract
period and claimed after the contract period has expired, the Contractor shall
cite the amount(s) and month(s) in which the costs were incurred.

 

Contractor’s Fiscal Year: Prepare payment requests in such a manner that the
Government can identify costs claimed with the Contractor’s fiscal year.

 

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 shall not exceed the United
States dollars authorized.

 

Costs Requiring Advance Approval: Costs requiring advance approval by the
Contracting Officer, which are not set forth in the Contract Schedule shall be
identified by the Contracting Officer’s Authorization (COA) Number as a separate
expenditure category on the payment request. In addition, the Contractor shall
show any cost limitation or ceiling set forth in the Contract Schedule, i.e. an
Advance Understanding, as a separate expenditure category on the payment
request.

 

Invoice/Financing Request Identification: Identify each payment as either:

 

(a)          Interim Invoice/Contract Financing Request: These are interim
payment requests submitted during the contract performance period.

 

 

 

 

(b)          Completion Invoice: Submit the completion invoice promptly upon
completion of the work, but no later than one year from the contract completion
date, or within 120 days after settlement of the final indirect cost rates
covering the year in which the contract is physically complete (whichever date
is later). The Contractor shall submit the completion invoice when all costs
have been assigned to the contract and all performance provisions have been
completed.

 

(c)          Final invoice: A final invoice may be required after the amounts
owed have been settled between the Government and the Contractor (e.g.,
resolution of all suspensions and audit exceptions).

 

Preparation and Itemization of the Invoice/Financing Request:

 

The Contractor shall furnish the information set forth in the instructions
below. The instructions are keyed to the entries on the Sample Invoice/Financing
Request. 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
Award 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/Financing Request 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 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).

 

(d)          Date Invoice/Financing Request Prepared: Insert the date the
payment request is prepared.

 

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

 

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

 

(g)          Current Contract Period of Performance: Insert the contract start
date/effective date through the current completion date of the contract.

 

(h)          Total Estimated Cost of Contract/Order: Insert the total estimated
cost of the contract, exclusive of fee. If billing under an order, insert the
total estimated cost of the order, exclusive of fee. For contracts/orders with
options or incremental funding provisions, enter the amount currently obligated
and available for payment.

 

(i)          Total Fixed-Fee: Insert the total fixed-fee (where applicable). For
contracts/orders with options or incremental funding provisions, enter the
amount currently obligated and available for payment (where applicable). Note:
If the contract provides for another type of Fee, i.e. Award or Incentive Fee,
insert the amount available to be earned as identified in the contract and
indicate the type of fee to be billed on the payment request.

 

(j)          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.

 

(k)          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.

 

(l)          Central Point of Distribution: Insert the Central Point of
Distribution, as identified in the Invoice Submission Instructions in Section G
of the Contract Schedule.

 

(m)          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.

 

(n)          Amount Billed - Current Period: Insert the amount claimed for the
current billing period by major cost element, including any adjustments and fee.
If the Contract Schedule contains separately priced line items, identify the
contract line item(s) on the payment request and include a separate breakdown
(by major cost element) for each line item.

 

 

 

  

(o)          Amount Billed - Cumulative: Insert the cumulative amounts claimed
by major cost element, including any adjustments and fee. If the Contract
Schedule contains separately priced line items, identify the contract line
item(s) on the payment request and include a separate breakdown (by major cost
element) for each line item.

 

(p)          Direct Costs: Insert the major cost elements. For each element,
consider the application of the paragraph entitled “Costs Requiring Prior
Approval” on page 1 of these instructions.

 

1)          Direct Labor: Include salaries and wages paid (or accrued) for
direct performance of the contract.

 

For Level of Effort contracts only, the Contractor shall provide the following
information on a separate sheet of paper attached to the payment request:

 

-hours or percentage of effort and cost by labor category (as specified in the
Level of Effort Article in Section F of the Contract Schedule) for the current
billing period, and

 

-hours or percentage of effort and cost by labor category from contract
inception through the current billing period. (NOTE: The Contracting Officer may
require the Contractor to provide additional breakdown for direct labor, such as
position title, employee name, and salary or hourly rate.)

 

2)          Fringe Benefits: List any fringe benefits applicable to direct labor
and billed as a direct cost. Cite the rate(s) used to calculate fringe benefit
costs, if applicable.

 

3)           Accountable Personal Property: Include permanent research equipment
and general purpose equipment having a unit acquisition cost of $1,000 or more,
with a life expectancy of more than two years, and sensitive property regardless
of cost (see the HHS Contractor’s Guide for Contract of Government Property).
Show permanent research equipment separate from general purpose equipment.

 

On a separate sheet of paper attached to the payment request, list each item for
which reimbursement is requested. Precede the item with an asterisk (*) if the
equipment is below the $1,000 approval level. 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.

 

The Contracting Officer may require the Contractor to provide further
itemization of property having specific limitations set forth in the contract.

 

 

 

  

4)          Materials and Supplies: Include equipment with unit costs of less
than $1,000 or an expected service life of two years or less, and consumable
material and supplies regardless of amount.

 

5)          Premium Pay: List remuneration in excess of the basic hourly rate.

 

6)          Consultant Fee: List fees paid to consultants. Identify consultant
by name or category as set forth in the contract or COA, as well as the effort
(i.e., number of hours, days, etc.) and rate billed.

 

7)          Travel: Include domestic and foreign travel. Foreign travel is
travel outside of the United States and its territories and possessions.
However, for an organization located outside the United States and its
territories and possessions, foreign travel means travel outside that country.
Foreign travel must be billed separately from domestic travel.

 

8)          Subcontract Costs: List subcontractor(s) by name and amount billed.

 

9)          Other: List all other direct costs in total unless exceeding $1,000
in amount. If over $1,000, list cost elements and dollar amounts separately. If
the contract contains restrictions on any cost element, that cost element must
be listed separately.

 

(q)          Cost of Money (COM): Cite the COM factor and base in effect during
the time the cost was incurred and for which reimbursement is claimed.

 

(r)           Indirect Costs: Identify the indirect cost base (IDC), indirect
cost rate, and amount billed for each indirect cost category.

 

(s)           Fixed-Fee: Cite the formula or method of computation for
fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the
contract. Note: If the contract provides for another type of Fee, i.e. Award or
Incentive Fee, provide the same documentation for the amount claimed.

 

(t)            Total Amounts Claimed: Insert the total amounts claimed for the
current and cumulative periods.

 

(u)           Adjustments: Include amounts conceded by the Contractor,
outstanding suspensions, and/or disapprovals subject to appeal.

 

(v)           Grand Totals

 

(w)          Certification: The Contractor shall include the following
certification at the bottom of each payment request:

 

“Pursuant to authority vested in me, I certify that this voucher is correct and
proper for payment.”

 

 

 

  

Note: The contract may require additional certifications (See Invoice Submission
Instructions in Section G of the Contract Schedule)

 

The Contracting Officer may require the Contractor to submit detailed support
for costs claimed on one or more interim payment requests.

 

FINANCIAL REPORTING INSTRUCTIONS:

 

These instructions correspond to the Columns on the Sample Invoice/Financing
Request.

 

Column A - Expenditure Category: Enter the expenditure categories required by
the contract.

 

Column B - Cumulative Percentage of Effort/Hrs. - Negotiated: Enter the
percentage of effort or number of hours agreed to for each employee or labor
category listed in Column A.

 

Column C - Cumulative Percentage of Effort/Hrs. - Actual: Enter the percentage
of effort or number of hours worked by each employee or labor category listed in
Column A.

 

Column D - Amount Billed - Current: Enter amounts billed during the current
period.

 

Column E - Amount Billed - Cumulative: Enter the cumulative amounts to date.

 

Column F - Cost at Completion: Enter data only when the Contractor estimates
that a particular expenditure category will vary from the amount negotiated.
Realistic estimates are essential.

 

Column G - Contract Amount: Enter the costs agreed to for all expenditure
categories listed in Column A.

 

Column H - Variance (Over or Under): Show the difference between the estimated
costs at completion (Column F) and negotiated costs (Column G) when entries have
been made in Column F. This column need not be filled in when Column F is blank.
When a line item varies by plus or minus 10 percent, i.e., the percentage
arrived at by dividing Column F by Column G, an explanation of the variance
should be submitted. In the case of an overrun (net negative variance), this
submission shall not be deemed as notice under the Limitation of Cost Clause in
the contract.

 

Modifications: List all new modification(s) (not previously reported) in the
amount negotiated for an item in the appropriate cost category.

 

Expenditures Not Negotiated: An expenditure for an item for which no amount was
negotiated (e.g., at the discretion of the Contractor in performance of its
contract) should be listed in the appropriate cost category and all columns
filled in, except for G. Column H will of course show a 100 percent variance and
will be explained along with those identified under H above.

 

 

 

  

SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT  

(a)   Designated Billing Office Name and Address:
National Institutes of Health
Office of Financial Management
Commercial Accounts
2115 East Jefferson Street, Room 4B432,
MSC 8500
Bethesda, MD 20892-8500

 

(b)   Contractor’s Name, Address, Point of Contact,
TIN, and DUNS or DUNS+4 Number:
ABC CORPORATION
100 Main Street
Anywhere, U.S.A. Zip+4
Name, Title, Phone Number, and E-mail
Address of Contractor’s Point of Contact.
DUNS or DUNS+4: _________________
TIN: ______________________________

(c)   Invoice/Financing Request No.: ___________

(d)   Date Invoice/Financing Request Prepared:
______________________________________

(e)   Contract No. and Order No. (if applicable):
_______________________________________

(f)    Contract Title:
_______________________________________

(g)   Current Contract Period of Performance:
_______________________________________

(h)   Total Estimated Cost of Contract/Order:
_______________________________________

(i)    Total Fixed Fee (if applicable): ____________

 

(j)    Two-Way Match: _____
Three-Way Match: _____

(k)   Office of Acquisitions: __________________

(1)   Central Point of Distribution: ______________

    (m)          This invoice/financing request represents reimbursable costs
for the period from _____ to _____.

 

    Cumulative %
 of Effort/Hrs   Amount Billed             Expenditure Category*
A  

Neg.

B

 

Actual

C

 

(n)

Current

D

 

(o)

Cum

E

  Cost at
Comp
F  

Contract

Value

G

 

Variance

H

(p)          Direct Costs:                             (1)   Direct Labor      
                      (2)   Fringe Benefits ___%                            
(3)   Accountable Property                             (4)   Materials &
Supplies                             (5)   Premium Pay                          
  (6)   Consultant Fees                             (7)   Travel                
            (8)   Subcontracts                             (9)   Other          
                  Total Direct Costs                             (q)    Cost of
Money ___%                             (r)     Indirect Costs ___%              
              (s)    Fixed Fee ___%                             (t)     Total
Amount Claimed                             (u)    Adjustments                  
          (v)    Grand Totals                            

 

“Pursuant to authority vested in me, I certify that this voucher is correct and
proper for payment.”

 

      (Name of Official)   (Title)

 

* Attach details as specified in the contract or requested by the Contracting
Officer

 

 

 

  

Attachment 3: Disclosure of Lobbying Activities

 

HHSN261201400048C

 

Enumeral Biomedical Corp.

 

 

 

 

  

Approved by omb

0348-0046

DISCLOSURE OF LOBBYING ACTIVITIES

Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352
(See reverse for public burden disclosure.)

1. Type of Federal Action:

¨  a. contract

      b. grant

      c. cooperative agreement

      d. loan

      e. loan guarantee

      f.  loan insurance

2. Status of Federal Action:

¨    a. bid/offer/application

        b. initial award

c. post-award

3. Report Type:

¨    a. initial filing

        b. material change

For Material Change Only:

year ______ quarter _________

date of last report ___________

4. Name and Address of Reporting Entity:

¨ Prime ¨ Subawardee

Tier ________, if known:

 

 

 

Congressional District, if known: 4c

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

 

 

 

 

 

Congressional District, if known:

6. Federal Department/Agency:

7. Federal Program Name/Description:

 

 

 

CFDA Number, if applicable: _______________

 

8. Federal Action Number, if known:

9. Award Amount, if known:

 

$

10. a. Name and Address of Lobbying Registrant

(if individual, last name, first name, MI):

b. Individuals Performing Services (including address if different from No. 10a)

(last name, first name, MI):

 

 

11. 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
this transaction was made or entered into. This disclosure is required pursuant
to 31 U.S.C. 1352. This information 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.

 

Signature: ________________________

 

Print Name: ________________________

 

Title: ________________________

 

Telephone No.: ______________ Date: ______________

 

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

 

 

  

INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES

 

This disclosure form shall be completed by the reporting entity, whether
subawardee or prime Federal recipient, at the initiation or receipt of a covered
Federal action, or a material change to a previous filing, pursuant to title 31
U.S.C. section 1352. The filing of a form is required for each payment or
agreement to make payment to any lobbying entity for influencing or attempting
to influence an officer or employee of any agency, a Member of Congress, an
officer or employee of Congress, or an employee of a Member of Congress in
connection with a covered Federal action. Complete all items that apply for both
the initial filing and material change report. Refer to the implementing
guidance published by the Office of Management and Budget for additional
information.

 

1.          Identify the type of covered Federal action for which lobbying
activity is and/or has been secured to influence the outcome of a covered
Federal action.

 

2.          Identify the status of the covered Federal action.

 

3.          Identify the appropriate classification of this report. If this is a
followup report caused by a material change to the information previously
reported, enter the year and quarter in which the change occurred. Enter the
date of the last previously submitted report by this reporting entity for this
covered Federal action.

 

4.          Enter the full name, address, city, State and zip code of the
reporting entity. Include Congressional District, if known. Check the
appropriate classification of the reporting entity that designates if it is, or
expects to be, a prime or subaward recipient. Identify the tier of the
subawardee, e.g., the first subawardee of the prime is the 1st tier. Subawards
include but are not limited to subcontracts, subgrants and contract awards under
grants.

 

5.          If the organization filing the report in item 4 checks “Subawardee,”
then enter the full name, address, city, State and zip code of the prime Federal
recipient. Include Congressional District, if known.

 

6.          Enter the name of the Federal agency making the award or loan
commitment. Include at least one organizational level below agency name, if
known. For example, Department of Transportation, United States Coast Guard.

 

7.          Enter the Federal program name or description for the covered
Federal action (item 1). If known, enter the full Catalog of Federal Domestic
Assistance (CFDA) number for grants, cooperative agreements, loans, and loan
commitments.

 

8.          Enter the most appropriate Federal identifying number available for
the Federal action identified in item 1 (e.g., Request for Proposal (RFP)
number; Invitation for Bid (IFB) number; grant announcement number; the
contract, grant, or loan award number; the application/proposal control number
assigned by the Federal agency). Include prefixes, e.g., “RFP-DE-90-001.”

 

 

 

  

9.          For a covered Federal action where there has been an award or loan
commitment by the Federal agency, enter the Federal amount of the award/loan
commitment for the prime entity identified in item 4 or 5.

 

10.        (a) Enter the full name, address, city, State and zip code of the
lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the
reporting entity identified in item 4 to influence the covered Federal action.

 

(b) Enter the full names of the individual(s) performing services, and include
full address if different from 10 (a). Enter Last Name, First Name, and Middle
Initial (MI).

 

11.         The certifying official shall sign and date the form, print his/her
name, title, and telephone number.

 

According to the Paperwork Reduction Act, as amended, no persons are required to
respond to a collection of information unless it displays a valid OMB Control
Number. The valid OMB control number for this information collection is OMB No.
0348-0046. Public reporting burden for this collection of information is
estimated to average 10 minutes per response, including time for reviewing
instructions, searching existing data sources, gathering and maintaining the
data needed, and completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to the Office of
Management and Budget, Paperwork Reduction Project (0348-0046), Washington, DC
20503.

 

 

 

  

Attachment 4: Government Property Schedule I-A

 

HHSN261201400048C

 

Enumeral Biomedical Corp.

 

 

 

  

Government Property-Schedule I-A
Enumeral Biomedical Corp.
HHSN261201400048C
9/4/14

 

    Period I   Period
II     ITEM   Unit
Price  

Unit

Quantity

  Subtotal   Unit
Price   Unit
Quantity   Subtotal   TOTAL 1  *   *   *   *   *   *   *   * 2  *   *   *   *  
*   *   *   * 3  *   *   *   *   *   *   *   * TOTAL =           *           *  
*

 

Items (2) and (3) shall be leased; whereas, item (1) shall be purchased. Title
to Government Property shall vest with the Government.

 

 

 

  

Attachment 5: Report of Government Owned, Contractor Help Property

 

HHSN261201400048C

 

Enumeral Biomedical Corp.

 

 

 

  

REPORT OF GOVERNMENT OWNED, CONTRACTOR HELD
PROPERTY

CONTRACTOR:

  

CONTRACT NUMBER ADDRESS

REPORT DATE:

 

 

  FISCAL YEAR:        

CLASSIFICATION   BEGINNING
OF PERIOD   ADJUSTMENTS   END OF PERIOD     #ITEMS   VALUE   GFP ADDED   CAP
ADDED   DELETIONS   #ITEMS   VALUE LAND>=$25K                            
LAND<$25K                             OTHER REAL>=$25K                          
  OTHER REAL <$25K                             PROPERTY UNDER CONST>=$25K      
                      PROPERTY UNDER CONST<$25K                            
PLANT EQUIP>=$25K                             PLANT EQUIP<$25K                  
          SPECIAL TOOLING>=$25K                             SPECIAL TOOLING<$25K
                            SPECIAL TEST EQUIP >=$25K                          
  SPECIAL TEST EQUIP<$25K                             AGENCY PECULIAR>=$25K    
                        AGENCY PECULIAR<$25K                            
MATERIAL>=$25K (CUMULATIVE)                             PROPERTY UNDER MFR>=$25K
                            PROPERTY UNDER MFR<$25K                            

  

SIGNED BY:   DATE SIGNED:

 

(SIGNATURE)      

 

(NAME PRINTED)     (TELEPHONE)  

 

(TITLE)      

 

Report of Government Owned, Contractor Held Property (Rev 3/2008)

 

 

 

  

Attachment 6: NIH SBIR Program Life Cycle Certification

 

HHSN261201200048C

 

Enumeral Biomedical Corp.

 

 

 

  

NIH Small Business Innovation Research Program
Life Cycle Certification

 

All SBIR Phase I and Phase II Contractors must complete this certification at
all times set forth in the funding agreement (see § 8(h) of the SBIR Policy
Directive). This includes checking all of the boxes and having an authorized
officer of the Contractor sign and date the certification each time it is
required.

 

A certification is required at the following times:

 

·For SBIR Phase I Contractors: At the time of receiving final payment or
disbursement.

 

·For SBIR Phase II Contractors: prior to receiving more than 50% of the total
contract amount and prior to final payment or disbursement.

 

If the Contractor cannot complete this certification or cannot ensure compliance
with the certification process, it should notify the Contracting Officer
immediately. If resolution cannot be reached, the Contracting Officer will void
or terminate the award, as appropriate.

 

Contract Number:

 

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)):

 

Please read carefully the following certification statements. The Federal
government relies on the information to ensure compliance with specific program
requirements during the life of the funding agreement. The definitions for the
terms used in this certification are set forth in the Small Business Act, the
SBIR Policy Directive, and also any statutory and regulatory provisions
referenced in those authorities.

 

If the Contracting Officer believes that the business is not meeting certain
funding agreement requirements, the agency may request further clarification and
supporting documentation in order to assist in the verification of any of the
information provided.

 

Even if correct information has been included in other materials submitted to
the Federal government, any action taken with respect to this certification does
not affect the Government’s right to pursue criminal, civil or administrative
remedies for incorrect or incomplete information given in the certification.
Each person signing this certification may be prosecuted if they have provided
false information.

 

The undersigned has reviewed, verified and certifies that (all boxes must be
checked):

 

1.           The principal investigator spent more than one half of his/her time
as an employee of the Contractor or has requested and received a written
deviation from this requirement from the Contracting Officer.

 

¨Yes ¨No Deviation approved in writing by Contracting Officer:  ____%

 

 

 

  

2.           All, essentially equivalent work, or a portion of the work
performed under this project (check the applicable line):

 

¨Has not been submitted for funding by another Federal agency.

 

¨Has been submitted for funding by another Federal agency but has not been
funded under any other Federal grant, contract, subcontract, or other
transaction.

 

¨A portion has been funded by another grant, contract, or subcontract as
described in detail in the proposal and approved in writing by the Contracting
Officer.

 

3.           Upon completion of the contract it will have performed the
applicable percentage of work, unless a deviation from this requirement is
approved in writing by the Contracting Officer (check the applicable line and
fill in if needed):

 

¨SBIR Phase I: at least two-thirds (66 2/3%) of the research

 

¨SBIR Phase II: at least half (50%) of the research

 

¨Deviation approved in writing by the Contracting Officer:      %

 

4.           The work is completed and it has performed the applicable
percentage of work, unless a deviation from this requirement is approved in
writing by the Contracting Officer (check the applicable line and fill in if
needed).

 

¨SBIR Phase I: at least two-thirds (66 2/3%) of the research

 

¨SBIR Phase II: at least half (50%) of the research

 

¨Deviation approved in writing by the Contracting Officer:     %

 

¨N/A because work is not completed

 

5.           The research/research and development is performed in the United
States unless a deviation is approved in writing by the Contracting Officer.

 

¨Yes ¨No Waiver has been granted

 

6.           The research/research and development is performed at my facilities
with my employees, except as otherwise indicated in the SBIR proposal and
approved in the contract.

 

¨Yes ¨No  

 

¨I will notify the Federal agency immediately if all or a portion of the work
proposed is subsequently funded by another Federal agency.

 

¨I understand that the information submitted may be given to Federal, State and
local agencies for determining violations of law and other purposes.

 

 

 

  

¨I am an officer of the business concern authorized to represent it and sign
this certification on its behalf. By signing this certification, I am
representing on my own behalf, and on behalf of the business concern that the
information provided in this certification, the proposal, and all other
information submitted in connection with the award, is true and correct as of
the date of submission. I acknowledge that any intentional or negligent
misrepresentation of the information contained in this certification may result
in criminal, civil or administrative sanctions, including but not limited to:
(1) fines, restitution and/or imprisonment under 18 U.S.C. § 1001; (2) treble
damages and civil penalties under the False Claims Act (31 U.S.C. § 3729 et
seq.); (3) double damages and civil penalties under the Program Fraud Civil
Remedies Act (31 U.S.C. §3801 et seq.); (4) civil recovery of award funds; (5)
suspension and/or debarment from all Federal procurement and nonprocurement
transactions (FAR Subpart 9.4 or 2 C.F.R. part 180); and (6) other
administrative penalties including termination of SBIR/STTR awards.

 

Date   Signature   Printed Name (First, Middle, Last)   Title   Business Name