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FORM CD-450 U.S. Department of Commerce GRANT X COOPERATIVE AGREEMENT
(REV 10/98) -------------------------------------------------
ACCOUNTING CODE
cc: 9/4738343 Obj. Cl. 4110
FINANCIAL ASSISTANCE AWARD Req. No. 9/4733357 $666,666
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RECIPIENT NAME AWARD NUMBER
Reprogenesis, Inc. 70NANB9H3003
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STREET ADDRESS FEDERAL SHARE OF COST
21 Erie Street $2,000,000
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CITY, STATE, ZIP CODE SHARE OF COST
Cambridge, MA 02139 $999,800
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AWARD PERIOD TOTAL ESTIMATED COST
November 1, 1999 - October 31, 2002 $2,999,800
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AUTHORITY
P.L. 100-418, Section 5131 (codified at 15 USC 278n) as modified by P.L. 102-245
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CFDA NO. AND PROJECT TITLE 11.612, Advanced Technology Program (ATP), Proposal
No. 99-01-1021
Project Title: Development of Perivascular Endothelial Cell Implants
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This Award approved by the Grants Officer is issued in triplicate and constitutes an obligation of Federal
funding. By signing the three documents, the Recipient agrees to comply with the Award provisions checked
below and attached. Upon acceptance by the Recipient, two signed Award documents shall be returned to the
Grants Officer and the third document shall be retained by the Recipient. If not signed and returned
without modification by the Recipient within 30 days of receipt, the Grants Officer may unilaterally
terminate this Award.
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X Department of Commerce Financial Assistance Standard Terms and Conditions
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X Special Award Conditions
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X Line Item Budget
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X 15 CFR Part 14, Uniform Administrative Requirements for Grants and Agreements with Institutions
of Higher Education, Hospitals, Other Non-Profit, and Commercial Organizations
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15 CFR Part 24, Uniform Administrative Requirements for Grants and Agreements to State and Local
Governments
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OMB Circular A-21, Cost Principles for Educational Institutions
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OMB Circular A-87, Cost Principles for State, Local, and Indian Tribal Governments
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OMB Circular A-122, Cost Principles for Nonprofit Organizations
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X 48 CFR Part 31, Contract Cost Principles and Procedures
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OMB Circular A-133, Audits of States, Local Governments, and Non-Profit Organizations
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X Others(s) General Terms and Conditions, Advanced Technology Program (ATP)(9/99); Program Specific
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Audit Guidelines for ATP Cooperative Agreements with Single Companies (9/99)
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B-AE93-N-C-F-N-A-25-11000 EIN: 00-0000000 473/ X. Xxxxxxxx
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SIGNATURE OF DEPARTMENT OF COMMERCE GRANTS OFFICER TITLE DATE
Xxxx XxXxxxxx /s/ Xxxx XxXxxxxx Grants Officer 9/30/9
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TYPED NAME AND SIGNATURE OF AUTHORIZED RECIPIENT OFFICIAL TITLE DATE
Xxxxxxx X. Xxxxx /s/ Xxxxxxx X. Xxxxx Chief Financial 10-7-99
Officer
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SPECIAL AWARD CONDITIONS
ADVANCED TECHNOLOGY PROGRAMS - SINGLE RECIPIENT
REPROGENESIS, INC.
COOPERATIVE AGREEMENT NO. 70NANB9H3003
1. RECIPIENT ADMINISTRATOR CONTRACT
The Recipient Contract's name, title, address, and telephone number are:
(Technical) Xxxxx X. Xxxxxx, Ph.D.
00 Xxxx Xxxxxx
Xxxxxxxxx, XX 00000
(000) 000-0000, ext. 167
(Administrative) Xxxxxxx X. Xxxxx
Vice President & Chief Financial
Officer
00 Xxxx Xxxxxx
Xxxxxxxxx, XX 00000
(000) 000-0000, ext. 107
2. GRANTS OFFICER
The Grants Officer's name, address, and telephone number are:
Xxxx XxXxxxxx
National Institute of Standards and Technology
000 Xxxxxx Xxxxx, Xxxx. 000, Xx. A143, Mail Stop 3576
Gaithersburg, MD 20899-3576
(000) 000-0000
3. GRANTS SPECIALIST
The Grants Specialist's name, address, and telephone number are:
Xxxxxxx X. Xxxxx
National Institute of Standards and Technology
000 Xxxxxx Xxxxx, Xxxx. 000, Xx. A143, Mail Stop 3576
Gaithersburg, MD 20899-3576
(000) 000-0000
4. PROGRAM OFFICERS
a. The Technical Project Manager's name, address, and telephone number
are:
Xxxxxxxxx Xxxxxxxx
National Institute of Standards and Technology
000 Xxxxxx Xxxxx, Xxxx. 000, Xx. A225, Mail Stop 4730
Gaithersburg, MD 20899-4730
(000) 000-0000
b. The Business Project Manager's name, address, and telephone number are:
Xxxxxx Xxxxx
National Institute of Standards and Technology
000 Xxxxxx Xxxxx, Xxxx. 000, Xx. A225, Mail Stop 4730
Gaithersburg, MD 20899-4730
(000) 000-0000
5. PROJECT DESCRIPTION
All research shall be conducted in accordance with the Recipient's proposal
dated April 12, 1999, any additional documentation/revisions dated July 13,
1999, August 6, 1999, August 9, 1999, September 10, 1999, and revised budget
dated August 6, 1999.
6. FUNDING LIMITATIONS
The scope of work and budget incorporated into this award covers a THREE-year
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period (referred to as the "project period") for a total amount of $2,000,000.00
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in Federal funds. However, Federal funding available at this time is limited to
$666,666.00 for the first year period from 11/01/99 through 10/31/00 (referred
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to as the "budget period"). Receipt of any additional funding up to the level
projected under this award is contingent upon the availability of funds from
Congress, satisfactory performance, and will be at the sole discretion of the
National Institute of Standards and Technology (NIST). The Recipient may not
obligate, incur any expenditure, nor engage in any commitments which involve any
amount in excess of the Federal amount
presently available. No legal liability exists or will result on the part of the
Federal Government for payment of any portion of the remaining funds, which have
not been made available under the award. If additional funds are not made
available, any expenses incurred related to closeout activities must be funded
from the amount already made available under this award. The notice of
availability or non-availability of additional funding for the SECOND and THIRD
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years will be made in writing by the Grants Officer. Only the Grants Officer is
------ --------------
authorized to obligate funds. The Recipient should rely upon no other verbal or
written notice.
Anticipated Future Funding:
Year 2: $666,667 (From 11/01/00 to 10/31/01)
Year 3: $666,667 (From 11/01/01 to 10/31/02)
7. COST SHARE
For the first year period, the cost sharing ratio (direct costs only) applicable
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to this award is the Recipient's contribution of 39.56% ($436,334) and NIST's
contribution of 60.44% (666,666).
8. RESTRICTION ON VERTEBRATE ANIMALS
Based upon materials submitted to and reviewed by NIST Grants Officer, NIST has
determined that the Recipient complies, as applicable, with the Animal Welfare
Act as amended, implementing regulations (7 USC 2131 et seq., 9 CFR parts 1, 2
and 3), and other federal statutes and regulations relating to vertebrate
animals. Therefore, the research involving vertebrate animals is approved for
Facility 1: Brockton/West Roxbury VA
Medical Center, MA - (Pigs)
Facility 2: Pine Acres Research Facility - (Pigs)
(Housing Facility)
which are the only Facilities authorized to conduct research involving
vertebrate animals under this award.
In order to continue research involving vertebrate animals, the Recipient must
maintain the following valid, current approvals, and certifications.
Facility 1: Brockton/West Roxbury VA Medical Center, MA - (Pigs)
AWA #A3992-01
Expiration Date 6/30/03
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Protocol # AP443 "Vascular Biology of Stent Implantation and Injury to Vein
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Grafts in Swine" Expiration date 03/01/00
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Facility 2: Pine Acres Research Facility - (Pigs)
(Housing Facility)
USDA #14-R-0004
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Expiration date 02/20/02
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The Recipient shall provide documentation in evidence of the renewal of all
approvals and certifications no later than thirty (30) calendar days prior to
expiration date shown above. Failure to maintain current approval and
certification will be considered material non-compliance with the terms and
conditions of this award and may result in immediate suspension and/or
termination.
The Recipient shall immediately inform the ATP Project Manager and NIST Grants
Officer in writing of any proposed deviations from the procedures involving
vertebrate animals approved by NIST during the project period, and submit
documentation evidencing approval of the revised animal study proposal by the
IACUC for NIST review.
9. HUMAN SUBJECT EXEMPTIONS
Based upon review of the proposal and documentation dated April 12, 1999, July
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13, 1999, August 6, 1999, August 9, 1999, and September 10, 1999, NIST has
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concluded that the involvement of human subjects in research identified meets
the criteria to qualify for an exemption under 15 CFR Part 27.101(b)(4),
Protection of Human Subjects, which states:
"Research, involving the collection or study of existing data, documents,
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records, pathological specimens, or diagnostic specimens, if these sources are
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publicly available or if the information is recorded by the investigator in such
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a manner that subjects cannot be identified, directly or through identifiers
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linked to the subjects."
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This exemption applies exclusively to the use of endothelial cells obtained from
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Clonetics as referenced in the correspondence dated July 20, 1999 and August 9,
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1999.
No other involvement of human subjects in research is authorized by NIST within
this project.
If the conditions upon which this exemption are based change in any way, the
Recipient must notify the Grants Office immediately in writing and obtain prior
written approval from the Grants Officer before proceeding with any further
research involving human subjects. Failure to meet the above requirements prior
to the conduct of activities involving human subject research shall be
considered material non-compliance with the terms of the award. The Grants
Officer may take appropriate action under Article L.01 of the Department of
Commerce Financial Assistance Standard Terms and Conditions dated 10/98,
including termination of the award.
By accepting this award, the Recipient certifies to the accuracy of the
documentation cited above.
10. DEFERRAL OF HUMAN SUBJECT CERTIFICATION
Based upon review of the proposal and documentation dated April 12, 1999, July
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13, 1999, August 6, 1999, August 9, 1999, and September 10, 1999, NIST has
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concluded that the iproposed safety/feasibility study in male and female
patients scheduled for peripheral bypass grafting to be conducted in Years 2-3
meets the criteria to qualify for a deferred review. This award is made in
accordance with 15 CFR Part 27.118, which permits research that does not involve
human subjects to proceed even though human subjects may be involved at a later
stage during the project period. In accordance with 9/99 ATP General Terms and
Condition #19, the Recipient must submit the following documentation prior to
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the SECOND YEAR (November 1, 2000) of the project and prior to any research that
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may involve human subjects, to the NIST Grants Officer for review and approval:
a) Documentation establishing approval of the project by an Institutional
Review Board qualified under 15 CFR Part 27.103, OR
b) Documentation to support an exemption for the project from 15 CFR Part
27.101.
The documentation requirements are outlined in the ATP Proposal Preparation Kit,
November 1998, on pages 9-11. No involvement of human subjects in research may
be undertaken/conducted, or costs involving human subjects research
incurred/charged to the project, under the NIST Grants Officer's approval of the
above documentation is obtained in writing.
Failure to meet the above requirements prior to the conduct of activities
involving human subject research shall be considered material non-compliance
with the terms of the award. The Grants Officer may take appropriate action
under Article L.01 of the Department of Commerce Financial Assistance Standard
Terms and Conditions dated 10/98, including termination of the award.
11. TECHNICAL STAFFING REQUIREMENT
Within 30 days from the date of execution of this cooperative agreement, the
Recipient must hire a consultant or technical personnel with expertise in
cellular immunology. Failure to satisfy this requirement shall be considered
material non-compliance with the terms of this award and may result in
suspension of the award in accordance with Section L.01 of the Department of
Commerce Financial Assistance Standard Terms and Conditions dated 10/98.
ESTIMATED MULTI-YEAR BUDGET - SINGLE COMPANY
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Object Class Category Year 1 Year 2 Year 3 Total
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a. Technical Personnel 289,000 289,000 289,000 867,000
Salaries/Wages
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b. Tech-Fringe Benefits (20%) 57,800 57,800 57,800 173,400
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c. Administrative Personnel 10,500 10,500 10,500 31,500
Salaries/Wages
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d. Admin-Fringe Benefits (20%) 2,100 2,100 2,100 6,300
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e. Travel 24,000 34,000 34,000 92,000
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f. Equipment 42,000 31,000 0 73,000
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g. Materials/Supplies 406,400 282,600 135,000 824,000
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h. Audit costs 5,000 0 5,000 10,000
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i. Subcontracts 246,200 246,200 246,200 738,600
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j. Other 20,000 82,000 82,000 184,000
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k. Total Direct Costs (a to j) 1,103,000 1,035,200 861,600 2,999,800
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l. Total Direct Costs Requested 666,666 666,667 666,667 2,000,000
From ATP
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m. Total Direct Costs Shared by 436,334 368,533 194,933 999,800
Proposer
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n. Total Indirect Costs Absorbed by 17,970 17,970 17,970 53,910
Proposer
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o. Total Costs (k+n) 1,120,970 1,053,170 879,570 3,053,710
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Sources of Funds
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a. ATP (line 1) 666,666 666,667 666,667 2,000,000
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b. Reprogenesis (lines m+n) 454,304 386,503 212,903 1,053,710
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c. 0
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d. 0
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e. Total Sources of Funds (line o) 1,120,970 1,053,170 879,570 3,053,710
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Tasks
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a. SVG Animal Testing 486,278 255,996 0 742,274
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b. Device Animal Testing 0 395,180 131,142 526,322
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c. Cell Line Selection 221,899 0 0 221,899
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d. Technology Transfer (R&D to Mfg.) 19,991 60,262 0 80,253
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e. Packaging and Transportation System 113,948 50,846 106,951 271,745
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f. Evaluation of Alternative Matrices 137,938 97,925 0 235,863
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g. Device Development 77,965 75,327 70,696 223,988
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h. SVG Clinical Trial 19,991 80,832 242,905 343,728
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i. Device Clinical Trial 19,991 18,832 304,905 343,728
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j. Indirect costs (absorbed by proposer) 17,970 17,970 17,970 53,910
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k. Audit costs 5,000 0 5,000 10,000
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l. Total Costs of All Tasks (same as o) 1,120,970 1,053,170 879,570 3,053,710
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