Exhibit 10.47

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1.        CONTRACT ID CODE

PAGE OF PAGES

 

 

1

1

 

 

 

 

2.        AMENDMENT/MODIFICATION NO

3.  EFFECTIVE DATE

4.        REQUISITION/PURC

5.        PROJECT NO. (If applicable)

Mod #01

See Block 16 C

N/A

N/A

 

 

 

 

6.        ISSUED BY

CODE

 

7.        ADMINISTERED BY (If other than Item 6)

CODE

 

 

 

 

 

 

 

National Institutes of Health
Contract Management Program, NIAID
6700-B Rockledge Drive
Room 3214, MSC 7612
Bethesda, MD  20892-7612

 

 

 

 

 

 

 

8.

NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

x

9A.    AMENDMENT OF SOLICITATION NO.

 

 

 

 

 

Avecia Limited

 

9B.       DATED (SEE ITEM 11)

 

P.O. Box 42, Hexagon House

 

 

 

Billingham TS23 1YN, UK

 

 

 

Blackley, Manchester, M9 8ZS, UK

x

10A.   MODIFICATION OF CONTRACT/ORDER NO.

 

 

 

N01-AI-40034

 

 

 

 

CODE

 

FACILITY CODE

 

10B.    DATED (SEE ITEM 13)
September 30, 2004

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is amended as set forth in Item 14.  The hour
and date specified for receipt of Offers o is extended, o is not extended.

 

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods:

 

(a) By completing Items 8 and 15, and returning                    copies of the
amendment; (b) By acknowledging receipt of this amendment on each copy of the
offer submitted; or (c) By separate letter or telegram which includes a
reference to the solicitation and amendment numbers.  FAILURE OF YOUR
ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS
PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If
by virtue of this amendment, you desire to change an offer already submitted,
such change may be made by telegram or letter, provided each telegram or letter
makes reference to the solicitation and this amendment, and is received prior to
the opening hour and date specified.

 

12.     ACCOUNTING AND APPROPRIATION DATA (If required)

EIN#:  1-900216013-A1

SOC#:  25.55

[***]

 

 

 

13.     THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT/ORDERS, IT MODIFIES
THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

x

A.       THIS CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE
CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

 

 

x

B.       THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE
ADMINISTRATIVE CHANGES (such as changes in paying office, appropriate date,
etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

 

 

 

C.       THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

 

 

D.       OTHER (Specify type of modification and authority)

 

E.        IMPORTANT:  Contractor x is not, o is required to sign this document
and return          copies to the issuing office.

 

14.     DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section
headings, including solicitation/contract subject matter where feasible)

 

PURPOSE:  To deobligate funds on the Contract Award from the Common Account
Number (CAN) 8421247.

 

TOTAL AMOUNT FUNDED:  [***]

TOTAL ESTIMATED COST:  [***]

FUNDED THROUGH:  [***]

CONTRACT EXPIRATION DATE:  [***]

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

 

15A.       NAME AND TITLE OF SIGNER (Type or print)

16A.  NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

 

[***]

[***]

 

 

15B. CONTRACTOR/OFFEROR

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

16C. DATE SIGNED

 

 

BY

[***]

[***]

(Signature of person authorized to sign)

(Signature of Contracting Officer)

 

NSN 7540-01-152-8070

OMB No. 0990-0115

 

STANDARD FORM 30 (REV. 10-83)

FAR (48 CFR) 53.243

 

--------------------------------------------------------------------------------

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1.       CONTRACT ID CODE

PAGE OF PAGES

 

 

1

5

 

 

 

 

2.        AMENDMENT/MODIFICATION NO

3.  EFFECTIVE DATE

4.        REQUISITION/PURC

5.        PROJECT NO. (If applicable)

Mod #02

See Block 16 C

N/A

N/A

 

 

 

 

6.        ISSUED BY

CODE

 

7.        ADMINISTERED BY (If other than Item 6)

CODE

 

 

 

 

 

 

 

National Institutes of Health

Contract Management Program, NIAID

6700-B Rockledge Drive

Room 3214, MSC 7612

Bethesda, MD  20892-7612

 

 

8.

NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

x

9A.    AMENDMENT OF SOLICITATION NO.

 

 

 

 

 

Avecia Limited

 

9B.       DATED (SEE ITEM 11)

 

P.O. Box 42, Hexagon House

 

 

 

Blackley, Manchester, M9 8ZS, UK

 

 

 

 

x

10A.   MODIFICATION OF CONTRACT/ORDER NO.

 

 

 

N01-AI-40034

 

 

 

 

CODE

 

FACILITY CODE

 

10B.    DATED (SEE ITEM 13)
September 30, 2004

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is amended as set forth in Item 14.  The hour
and date specified for receipt of Offers o is extended, o is not extended.

 

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods:

 

(a) By completing Items 8 and 15, and returning                  copies of the
amendment; (b) By acknowledging receipt of this amendment on each copy of the
offer submitted; or (c) By separate letter or telegram which includes a
reference to the solicitation and amendment numbers.  FAILURE OF YOUR
ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS
PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If
by virtue of this amendment, you desire to change an offer already submitted,
such change may be made by telegram or letter, provided each telegram or letter
makes reference to the solicitation and this amendment, and is received prior to
the opening hour and date specified.

 

12.     ACCOUNTING AND APPROPRIATION DATA (If required)

 

13.     THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT/ORDERS, IT MODIFIES
THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

x

A.       THIS CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE
CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

 

 

 

B.       THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE
ADMINISTRATIVE CHANGES (such as changes in paying office, appropriate date,
etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

 

 

x

C.       THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

FAR 1.602-1

 

 

 

D.       OTHER (Specify type of modification and authority)

 

E.        IMPORTANT:  Contractor o is not, x is required to sign this document
and return 3 copies to the issuing office.

 

14.   DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings,
including solicitation/contract subject matter where feasible)

 

PURPOSE:  To update Article B.2., to revise the milestone payment schedule in
Article B.4. and to replace Limitation of Cost Clause with Limitation of Funds
in Article I.2.

 

TOTAL AMOUNT FUNDED:  [***] (unchanged)

TOTAL ESTIMATED COST:  [***] (unchanged)

FUNDED THROUGH:  [***] (unchanged)

CONTRACT EXPIRATION DATE:  March 29, 2007 (unchanged)

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

 

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

[***]

[***]

[***]

 

 

15B. CONTRACTOR/OFFEROR

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

16C. DATE SIGNED

[***]

5thJan2005

BY

[***]

[***]

(Signature of person authorized to sign)

 

(Signature of Contracting Officer)

 

 

NSN 7540-01-152-8070

OMB No. 0990-0115

 

STANDARD FORM 30 (REV. 10-83)

FAR (48 CFR) 53.243

 

--------------------------------------------------------------------------------

 

SPECIAL PROVISIONS

CONTRACT No. HHSN266200400034C
Modification No. 2

Page 2 of 5 pages

 

 

 

ARTICLE B.2. ESTIMATED COSTS AND FIXED FEE - paragraphs e., f. and g. are added
as follows:

 

 

 

e.     Total funds currently available for payment and allocated to Part A of
this contract are hereby decreased by [***] from [***]to [***], of which [***]
represents a decrease to the estimated cost from [***] to [***]; and of which
[***] represents a decrease to the fixed fee from [***] to [***].  For further
provisions on funding, see the LIMITATION OF FUNDS Clause referenced in Part II,
Article I.2., Authorized Substitution of Clauses.

 

f.      It is estimated that the amount currently allotted will cover
performance of the contract through [***].

 

g.     Future increments to be allotted to the contract are estimated as
follows:

 

 

PERIOD

 

ESTIMATED COST

 

FIXED FEE

 

TOTAL AMOUNT

 

 

 

 

 

 

 

 

 

 

 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

ARTICLE B.4.  ADVANCE UNDERSTANDINGS - paragraph i., is revised to read as
follows:

 

i.      Contract Milestones

 

The Contractor shall complete all work in accordance with the Statement of Work
and the contract milestones set forth below.  The distribution of the fixed fee
shall be paid in milestone based installments and payment of this fee shall be
determined by the Project Officer’s written certification that the milestone has
been satisfactorily performed and that the technical requirements have been met
regarding the completion of the following milestones:  If the Contractor meets
the milestones earlier than the dates set forth below, then the fee will be paid
at the earlier date after completion of the milestone.

 

 

 

MILESTONE FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

1

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in five installments of the total fee for this milestone based
on the completion of the following five items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

--------------------------------------------------------------------------------

 

SPECIAL PROVISIONS

CONTRACT No. HHSN266200400034C
Modification No. 2

Page 3 of 5 pages

 

 

 

2

 

 

 

 

 

 

 

 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in five installments of the total fee for this milestone based
on the completion of the following five items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

4

 

 

 

 

 

 

 

 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in two installments of the total fee for this milestone based
on the completion of the following two items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

--------------------------------------------------------------------------------

 

SPECIAL PROVISIONS

CONTRACT No. HHSN266200400034C
Modification No. 2

Page 4 of 5 pages

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

5

 

 

 

 

 

 

 

 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

6

 

 

 

 

 

 

 

 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in four installments of the total fee for this milestone based
on the completion of the following four items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

--------------------------------------------------------------------------------

 

SPECIAL PROVISIONS

CONTRACT No. HHSN266200400034C
Modification No. 2

Page 5 of 5 pages

 

 

 

7

 

 

 

 

 

 

 

 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following two items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

 

 

 

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in two installments of the total fee for this milestone based
on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

--------------------------------------------------------------------------------

* Milestone 3 was subject to discussion regarding the progress of this project
prior to NIAID involvement.  At the time of the RFP, Avecia described their
current projects status and it was agreed funds from this milestone should be
channeled towards [***] if needed.

 

ARTICLE I.2  AUTHORIZED SUBSTITUTION OF CLAUSES, is hereby modified to include
the following:

 

ARTICLE I.1. of this section is modified as follows:

 

FAR Clause 52.232-20, LIMITATION OF COST, is deleted in its entirety and FAR
Clause 52.232-22, LIMITATION OF FUNDS (APRIL 1984) is substituted therefore.
 Note:  When this contract is fully funded, FAR Clause 52.232-22, LIMITATIONS OF
FUNDS, will no longer apply and FAR Clause 52.232-20, LIMITATION OF COST will
become applicable.

 

All other terms and conditions of the contract remain unchanged.

 

--------------------------------------------------------------------------------

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1.      CONTRACT ID CODE

PAGE OF PAGES

 

 

1

 3

 

 

 

 

 

 

 

 

2.    AMENDMENT/MODIFICATION NO
Mod #03

3. EFFECTIVE DATE
See Block 16 C

4. REQUISITION/PURC

N/A

5. PROJECT NO. (If applicable)
N/A

 

 

 

 

6. ISSUED BY

CODE

 

7. ADMINISTERED BY (If other than item 6)

CODE

 

 

 

 

 

 

 

National Institutes of Health

Contract Management Program, NIAID

6700-B Rockledge Drive

Room 3214, MSC 7612

Bethesda, MD 20892-7612

 

 

 

 

 

 

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

x

9A. AMENDMENT OF SOLICITATION NO.

 

 

 

Avecia Limited
P.O. Box 42, Hexagon House
Blackley, Manchester, M9 8ZS, UK

 

9B. DATED (SEE ITEM 11)

 

 

 

 

x

10A. MODIFICATION OF CONTRACT/ORDER NO.

 

 

N01-AI—40034

 

 

 

 

 

10B. DATED (SEE ITEM 13)
September 30, 2004

CODE

FACILITY CODE

 

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is amended as set forth in Item 14.  The hour
and date specified for receipt of Offers o is extended.o is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods

 

(a) By competing Items 8 and 15, and returning                    copies of the
amendment; (b) By acknowledge receipt of this amendment on each copy of the
offer submitted; or (c) By separate letter or telegram which includes a
reference to the solicitation and amendment numbers.  FAILURE OF YOUR
ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS
PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If
by virtue of this amendment, you desire to change an offer already submitted,
such change may be made by telegram or letter, provided each telegram or letter
makes reference to the solicitations and this amendment, and is received prior
to the opening hour and date specified.

 

12. ACCOUNTING AND APPROPRIATION DATA (If required)

 

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE
CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

x

A.    THIS CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES
SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

 

 

 

B.     THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE
ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date,
etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

 

 

x

C.     THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
FAR 1.602-1

 

 

 

D.    OTHER (Specify type of modification and authority)

 

 

E.     IMPORTANT:  Contractor o is not, x is required to sign this document and
return 3 copies to the issuing office.

 

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings,
including solicitation/contract subject matter where feasible)

 

PURPOSE:  To revise the milestone 1 payment schedule, to add an Advance
Understanding containing DMID’s approval of data sharing between Avecia and the
UK Medicines Supply Agency in Article B.4. and to update Section H. articles.

 

TOTAL AMOUNT FUNDED:  [***] (unchanged)

TOTAL ESTIMATED COST:  [***] (unchanged)

FUNDED THROUGH:  [***] (unchanged)

CONTRACT EXPIRATION DATE:  [***] (unchanged)

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

 

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

[***]

 

[***]

 

 

[***]

 

 

 

15B. CONTRACTOR/OFFEROR

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

16C. DATE SIGNED

[***]

23-06-05

BY

[***]

7/20/05

(Signature of person authorized to sign)

 

(Signature of Contracting Officer)

 

 

NSN 7540-01-152-8070

OMB No. 0990-0115

 

STANDARD FORM 30 (REV. 10-83)
FAR (48 CFR) 53.243

 

--------------------------------------------------------------------------------

 

SPECIAL PROVISIONS

CONTRACT No. HHSN266200400034C
Modification No. 3

Page 2 of 3 pages

 

 

 

ARTICLE B.4.  ADVANCE UNDERSTANDINGS - paragraph i., item No. 1, is revised to
read as shown below and paragraph p. is added as follows:

 

 

 

i.      Contract Milestones

 

 

 

 

 

The Contractor shall complete all work in accordance with the Statement of Work
and the contract milestones set forth below.  The distribution of the fixed fee
shall be paid in milestone based installments and payment of this fee shall be
determined by the Project Officer’s written certification that the milestone has
been satisfactorily performed and that the technical requirements have been met
regarding the completion of the following milestones:  If the Contractor meets
the milestones earlier than the dates set forth below, then the fee will be paid
at the earlier date after completion of the milestone.

 

 

 

MILESTONE FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

 

 

 

 

 

 

 

 

 

1

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in five installments of the total fee for this milestone based
on the completion of the following five items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

f) [***]

 

 

 

f) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

p.             [***]

 

--------------------------------------------------------------------------------

 

SPECIAL PROVISIONS

CONTRACT No. HHSN266200400034C
Modification No. 3

Page 3 of 3 pages

 

 

 

[***]

 

 

All other terms and conditions of the contract remain unchanged.

 

--------------------------------------------------------------------------------

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1.  CONTRACT ID CODE

N/A

 

PAGE OF PAGES

 

1

      3

 

 

 

 

2.    AMENDMENT/MODIFICATION NO

3.  EFFECTIVE DATE

4.  REQUISITION/PURCHASE REQ. NO.

5.  PROJECT NO. (If applicable)

04

See Block 16 C, below

DMID 2 018

N/A

 

 

 

 

6.  ISSUED BY

CODE

 

7.  ADMINISTERED BY (If other than Item 6)

  CODE

N/A

 

 

 

 

 

 

National Institutes of Health

 

 

 

National Institute of Allergy and Infectious Diseases

 MID2 - RCB

 

 

DEA, Contract Management Branch

 

 

 

Room 2230, MSC 7612

 

 

 

6700-B Rockledge Drive

 

 

 

Bethesda, MD  20892-7612

 ADB Contract No. N01-AI-40034

 

 

 

 

 

 

8.  NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

x

9A.  AMENDMENT OF SOLICITATION NO.

 

 

 

Avecia Limited

 

9B.  DATED (SEE ITEM 11)

P.O. Box 42, Hexagon House

 

 

Blackley, Manchester, M9 8ZS, UK

x

10A.  MODIFICATION OF CONTRACT/ORDER NO.

 

 

HHSN266200400034C

 

 

 

 

10B.  DATED (SEE ITEM 13)

CODE

FACILITY CODE

September 30, 2004

 

 

 

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is amended as set forth in Item 14.  The hour
and date specified for receipt of Offers o is extended, o is not extended.

 

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods:

 

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment;
(b) By acknowledging receipt of this amendment on each copy of the offer
submitted; or (c) By separate letter or telegram which includes a reference to
the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this
amendment you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour
and date specified.

 

12.  ACCOUNTING AND APPROPRIATION DATA (If required)

EIN#:  1-900216013-A1                    SOCC  25.55  CAN 5-8460924
                [***]

 

13.  THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

x

A.

THIS CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET
FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

 

 

B.

THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
CHANGES (such as changes in paying office, appropriate date, etc.) SET FORTH IN
ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

 

 

 

C.

 

THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

 

x

D.

OTHER (Specify type of modification and authority)

 

     P.L. 1.602-1, Limitation of Funds Clause; FAR 52.217-8; and P.L. 108-447

 

 

E.  IMPORTANT:  Contractor x is not, o is required to sign this document and
return              copies to the issuing office.

 

14.  DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings,
including solicitation/contract subject matter where feasible)

PURPOSE:  To fund the final increment of funds for the base portion of the
contract and to exercise and incrementally fund Option Period - Part B.

 

 

 

Total Funds Currently Allotted

 

Total Estimated Cost

 

 

 

Cost

 

Fee

 

Total

 

Cost

 

Fee

 

Total

 

Prior to this Mod

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

This Mod #

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

Revised Total

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

FUNDED THROUGH DATE:  [***]   COMPLETION DATE:  [***]

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

 

15A.  NAME AND TITLE OF SIGNER (Type or print)

16A.  NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

 

[***]

 

[***]

 

 

15B.  CONTRACTOR/OFFEROR

15C.  DATE SIGNED

16B.  UNITED STATES OF AMERICA

16C.  DATE SIGNED

 

 

 

[***]

 

 

BY

 

[***]

 

(Signature of person authorized to sign)

 

 

(Signature of Contracting Officer)

 

 

 

 

NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE

30-105

Computer Generated

 

STANDARD FORM 30 (REV. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 04

 

SPECIAL PROVISIONS

 

Page 2 of 3

 

ARTICLE B.2. ESTIMATED COST AND FIXED FEE - paragraphs b. and c., are hereby
modified to read as follows:

 

a.

The estimated cost of this contract is increased by [***] from [***] to [***].

 

 

b.

The fixed fee of this contract is increased by [***] from [***].  The fixed fee
shall be paid in installments based on the negotiated milestones set forth in
ARTICLE B.4., paragraph i, 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 1.1., of this contract.  Payment shall not be
made in less than monthly installments.

 

 

c.

The Government’s obligation, represented by the sum of the estimated cost plus
the fixed fee of this contract is increased by [***] from [***] to [***]

 

 

e.

Total funds currently available for payment and allotted to this contract are
hereby increased by [***] from [***] to [***]; of which [***] represents an
increase to the estimated cost from [***] to [***]; and of which [***]
represents an increase to the fixed fee from [***] to [***].  For further
provisions on funding, see the LIMITATION OF FUNDS Clause referenced in Part II,
ARTICLE I.2., Authorized Substitutions of Clauses.

 

 

f.

It is estimated that the amount currently allotted will cover performance of the
contract through [***].

 

 

g.

The total of future increments to be allotted to the contract are estimated as
follows:

 

PERIOD

 

ESTIMATED COST

 

FIXED FEE

 

TOTAL AMOUNT

 

[***]

 

[***]

 

[***]

 

[***]

 

 

ARTICLE F.1.  PERIOD OF PERFORMANCE , paragraph a. is hereby modified to read as
follows:

 

a.

The period of performance of this contract shall be from [***] through
September [***].

 

ARTICLE H.5.  CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH, paragraph b. is
hereby modified to add the following:

 

b.

Public Law and Section No.

 

Fiscal Year

 

Period Covered

 

 

 

 

 

 

 

 

 

P.L. 108-447, Title V - General Provisions, Section 509

 

2005

 

10/01/04 - 09/30/05

 

 

ARTICLE H.6.  NEEDLE EXCHANGE, paragraph b. is hereby modified to add the
following:

 

b.

Public Law and Section No.

 

Fiscal Year

 

Period Covered

 

 

 

 

 

 

 

 

 

P.L. 108-447, Title V - General Provisions, Section 505

 

2005

 

10/01/04 - 09/30/05

 

 

ARTICLE H.11.  SALARY RATE LIMITATION LEGISLATION PROVISIONS, paragraphs b. and
c. are hereby modified to add the following:

 

b.

Public Law No.

 

Fiscal Year

 

Dollar Amount of
Salary Limitation*

 

 

 

 

 

 

 

 

 

P.L. 108-447, Title II - General Provisions, Section 204

 

2005

 

Executive Level I

 

 

c.

Direct salaries are limited to the Executive Level I rate which was in effect on
the date(s) the expense was incurred.

 

HHS-556

 

--------------------------------------------------------------------------------

 

--------------------------------------------------------------------------------

 

* For the period 10/1/04-12/31/04, the Executive Level I rate is $175,700. 
Effective 1/1/05, the Executive Level I rate increased to $180,100 and will
remain at that rate until it is revised.  See the web site listed below for
Executive Schedule rates of pay.

 

 

 

LINK to EXECUTIVE LEVEL SALARIES: http://www.opm.gov/oca/05tables/html/ex.asp 
(For previous years, go to: http://www.opm.gov/oca/05tables/index.asp  and click
on the year to locate the Executive Level salary rates.)

 

 

 

NOTE:  All prior Public Laws and related Executive Levels incorporated in the
Basic Award and all previous Modifications shall remain in effect for the
applicable fiscal year and related funds.

 

ARTICLE H.13.  PRESS RELEASES, paragraph b., is hereby modified to add the
following:

 

b.

Public Law and Section No.

 

Fiscal Year

 

Period Covered

 

 

 

 

 

 

 

 

 

P.L. 108-447, Title V - General Provisions, Section 506

 

2005

 

10/01/04 - 9/30/05

 

 

ARTICLE H.15.  ANTI-LOBBYING, paragraph c., is hereby modified to add the
following:

 

b.

Public Law and Section No.

 

Fiscal Year

 

Period Covered

 

 

 

 

 

 

 

 

 

for a., above: P.L. 108-447, Title V - General Provisions, Section 503a

 

2005

 

10/01/04 - 9/30/05

 

 

 

 

 

 

 

 

 

for b., above: P.L. 108-447, Title V - General Provisions, Section 503b

 

2005

 

10/01/04 - 9/30/05

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1.        CONTRACT ID CODE

PAGE OF PAGES

 

N/A

1

16

 

 

 

 

 

 

2.        AMENDMENT/MODIFICATION NO

3.        EFFECTIVE DATE

4.        REQUISITION/PURCHASE REQ NO.

5.        PROJECT NO. (If applicable)

 

05

See Block 16 C, below

2006-0361

N/A

 

 

 

 

 

 

 

 

6.

ISSUED BY

CODE

 

7.        ADMINISTERED BY (If other than Item 6)

CODE

N/A

 

 

 

 

 

 

 

 

 

 

National Institutes of Health

National Institute of Allergy and Infectious Diseases

DEA, Office of Acquisitions

Room 3214, MSC 7612

6700-B Rockledge Drive

Bethesda, MD  20892-7612

 

MID RCB-B

 

 

 

ADB Contract No. N01-AlI40034

 

 

 

 

8.        NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP
Code)

x

9A.

AMENDMENT OF SOLICITATION NO.

 

 

 

 

 

Avecia Limited
P.O. Box 42, Hexagon House
Blackley, Manchester, M9 8ZS, UK

 

 

 

9B.

DATED (SEE ITEM 11)

 

 

x

10A.

MODIFICATION OF CONTRACT/ORDER NO.

 

HHSN266200400034C

 

 

 

10B.

DATED (SEE ITEM 13)

September 30, 2004

CODE

FACILITY CODE

 

 

 

 

 

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

 

 

o The above numbered solicitation is amended as set forth in Item 14.  The hour
and date specified for receipt of Offers o is extended, o is not extended.

 

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods:

 

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment;
(b) By acknowledging receipt of this amendment on each copy of the offer
submitted; or (c) By separate letter or telegram which includes a reference to
the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this
amendment, you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour
and date specified.

 

 

 

12.     ACCOUNTING AND APPROPRIATION DATA (If required)

 

EIN#:  1-900216013-A1

   SOCC  25.55  CAN 5-8467101

[***]

 

 

 

 

 

13.   THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

 

 

x

A.

THIS CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET
FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

 

 

 

 

 

B.

THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
CHANGES (such as changes in paying office, appropriate date, etc.) SET FORTH IN
ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

 

 

 

 

 

C.

THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

 

 

 

x

D.

OTHER (Specify type of modification and authority)

 

FAR 1.602-1

 

 

 

 

E.

IMPORTANT:  Contractor o is not, x is required to sign this document and return
2 copies to the issuing office.

 

 

 

 

14.

DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings,
including solicitation/contract subject matter where feasible)

 

 

 

 

PURPOSE:  To add an increment of funds, thus fully funding the contract; to
clarify the Part B Option Statement of Work, required Deliverables, and revise
the related Milestone Estimated Cost and Fixed Fee distributions; to add the
Alternate Project Officer; to change the Principal Investigator; and make other
administrative changes..

 

 

 

 

 

Total Funds Currently Allotted

 

Total Estimated Cost

 

 

 

Cost

 

Fee

 

Total

 

Cost

 

Fee

 

Total

 

Prior to this Mod

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

This Mod #

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

Revised Total

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

 

FUNDED THROUGH DATE:  [***]   COMPLETION DATE:  [***]

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

 

15A.

NAME AND TITLE OF SIGNER (Type or print)

16A.

NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

 

[***]

 

[***]

[***]

 

 

15B. CONTRACTOR/OFFEROR

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

16C. DATE SIGNED

 

        21SEP06

 

[***]

[***]

 

BY

[***]

 

(Signature of person authorized to sign)

(Signature of Contracting Officer)

 

 

 

 

NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE

30-105

Computer Generated

 

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA
FAR (48 CFR) 53.243

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

 

SPECIAL PROVISIONS

 

Page 2 of 16

 

ARTICLE B.2. ESTIMATED COSTS AND FIXED FEE - paragraphs e. and f., are hereby
modified to read as follows and g. is deleted in its entirety:

 

e.               Total funds currently available for payment and allocated to
Part A of this contract are hereby increased by [***] from [***]to [***], of
which [***] represents an increase to the estimated cost from [***] to [***];
and of which [***] represents an increase to the fixed fee from [***] to [***].
For further provisions on funding, see the LIMITATION OF COST Clause referenced
in Part II, ARTICLE I.1., General Clauses for a Cost Reimbursement Research and
Development Contract.

 

f.                 By virtue of the fact that this contract is fully funded, it
is estimated that the amount currently allotted will cover performance through
the completion date of the contract.

 

ARTICLE B.4.  ADVANCE UNDERSTANDINGS - paragraph i., is hereby modified as
follows to update the Milestone Schedule:

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

 

 

 

 

 

 

 

 

 

1

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in six installments of the total fee for this milestone based
on the completion of the following six items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

f) [***]

 

 

 

f) [***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

 

SPECIAL PROVISIONS

 

Page 3 of 16

 

2

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in five installments of the total fee for this milestone based
on the completion of the following five items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

[***]

 

 

 

 

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

 

SPECIAL PROVISIONS

 

Page 4 of 16

 

4

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following two items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

5

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

6

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in four installments of the total fee for this milestone based
on the completion of the following four items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

 

SPECIAL PROVISIONS

 

Page 5 of 16

 

7

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in two installments of the total fee for this milestone based
on the completion of the following two items.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

8

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

9

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in six installments of the total fee for this milestone based
on the completion of the following six items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

f) [***]

 

 

 

f) [***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

 

SPECIAL PROVISIONS

 

Page 6 of 16

 

10

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in four installments of the total fee for this milestone based
on the completion of the following four items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

11

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in four installments of the total fee for this milestone based
on the completion of the following fouritems:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

 

SPECIAL PROVISIONS

 

Page 7 of 16

 

12

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in nine installments of the total fee for this milestone based
on the completion of the following nine items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

f) [***]

 

 

 

f) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

g) [***]

 

 

 

g) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

h) [***]

 

 

 

h) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

i) [***]

 

 

 

i) [***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

 

SPECIAL PROVISIONS

 

Page 8 of 16

 

13

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

14

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

SPECIAL PROVISIONS

Page 9 of 16

 

15

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in two installments of the total fee for this milestone based
on the completion of the following two items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

16

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in four installments of the total fee for this milestone based
on the completion of the following four items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

SPECIAL PROVISIONS

Page 10 of 16

 

17

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in five installments of the total fee for this milestone based
on the completion of the following five items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

ARTICLE C.1 STATEMENT OF WORK, is hereby modified to read as follows:

 

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, SECTION J, ATTACHMENT 1, dated September 30, 2004, and as
clarified by Modification No. 5 of the contract, attached hereto and made a part
of this contract.

 

ARTICLE C.3 OTHER DELIVERABLES, is hereby added as follows:

 

In addition to the deliverables required by ARTICLE C.2. and ARTICLE F.2, or
otherwise described by the Statement of Work of this contract, the following are
to be delivered per the direction of the Project Officer prior to the completion
date of the contract:

 

1.     Materials, supplied, and equipment purchased for this contract but not
expended in the execution of the Statement of Work.

 

2.     Drug Substance not allocated for retains (in amounts needed to maintain
GMP compliance), reference standard, clinical trials, or stability studies as
defined in the SOW.

 

3      Drug Product not allocated for retains (in amounts needed to maintain GMP
compliance), reference standard, clinical trials, or stability studies as
defined in the SOW.

 

4      Consented clinical specimens collected during the course of any clinical
trial and not used in the protocol-specific studies or held as retains (in
amounts described in the clinical trial documentation).

 

5.     Copies of regulatory submissions.

 

6.     Analytical methods and models developed as part of the execution of this
SOW.

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

SPECIAL PROVISIONS

Page 11 of 16

 

7.     Quality audit reports subject to Avecia’s confidentiality obligations to
its contractors.

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

SPECIAL PROVISIONS

Page 12 of 16

 

ARTICLE F.2. DELIVERIES paragraph a., is hereby modified to include the
following table of deliverables in addition to those deliveries currently
required by the contract:

 

Item

 

Type of Deliverable

 

SOW Reference

 

Recipient

 

Delivery Schedule

 

1.

 

[***]

 

[***]

 

[***]

 

[***]

 

2.

 

[***]

 

[***]

 

[***]

 

[***]

 

3.

 

[***]

 

[***]

 

[***]

 

[***]

 

4.

 

[***]

 

[***]

 

[***]

 

[***]

 

6.

 

[***]

 

[***]

 

[***]

 

[***]

 

7.

 

[***]

 

[***]

 

[***]

 

[***]

 

8.

 

[***]

 

[***]

 

[***]

 

[***]

 

9.

 

[***]

 

[***]

 

[***]

 

[***]

 

10.

 

[***]

 

[***]

 

[***]

 

[***]

 

11.

 

[***]

 

[***]

 

[***]

 

[***]

 

12.

 

[***]

 

[***]

 

[***]

 

[***]

 

13.

 

[***]

 

[***]

 

[***]

 

[***]

 

14.

 

[***]

 

[***]

 

[***]

 

[***]

 

15.

 

[***]

 

[***]

 

[***]

 

[***]

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

SPECIAL PROVISIONS

Page 13 of 16

 

Item

 

Type of Deliverable

 

SOW Reference

 

Recipient

 

Delivery Schedule

 

16.

 

[***]

 

[***]

 

[***]

 

[***]

 

17.

 

[***]

 

[***]

 

[***]

 

[***]

 

18.

 

[***]

 

[***]

 

[***]

 

[***]

 

19.

 

[***]

 

[***]

 

[***]

 

[***]

 

 

ARTICLE G.1. PROJECT OFFICER, is hereby modified to include the following:

 

The following will represent the Government as the Alternate Project Officer for
the purposes of this contract:

 

[***]

[***]

[***]

[***]

Room 5006, MSC 6604

6610 Rockledge Drive

Bethesda, MD 20892-6604

 

ARTICLE G.2. KEY PERSONNEL, is hereby modified to delete Mark Carver as the
Principal Investigator and to insert Matthew Duchars as the Principal
Investigator.

 

ARTICLE H.5. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH, paragraph b. is
hereby modified to add the following:

 

b.

Public Law and Section No.

 

Fiscal Year

 

Period Covered

 

 

 

 

 

 

 

 

 

P.L. 109-149, Title V – General Provisions, Section 509

 

2006

 

10/01/05 – 9/30/06

 

 

ARTICLE H.6. NEEDLE EXCHANGE, paragraph b. is hereby modified to add the
following:

 

b.

Public Law and Section No.

 

Fiscal Year

 

Period Covered

 

 

 

 

 

 

 

 

 

P.L. 109-149, Title V – General Provisions, Section 505

 

2006

 

10/01/05 – 9/30/06

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

SPECIAL PROVISIONS

Page 14 of 16

 

ARTICLE H.11 SALARY RATE LIMITATION LEGISLATION PROVISIONS, paragraphs b. and c.
are hereby modified to add the following:

 

b.

Public Law No.

 

Fiscal Year

 

Dollar Amount of Salary Limitation*

 

 

 

 

 

 

 

 

 

P.L. 109149

 

2006

 

Executive Level I

 

 

c.               Payment of direct salaries is limited to the Executive Level I*
rate which was in effect on the date(s) the expense was incurred.

 

--------------------------------------------------------------------------------

*For the period 10/1/05 – 12/31/05, the Executive Level I rate is $180,100. 
Effective January 1, 2006, the Executive Level I rate increased to $183,500 and
will remain at that rate until it is revised.  See the web site listed below for
the Executive Schedule rates of pay:

 

FOR FY-06 EXECUTIVE LEVEL SALARIES EFFECTIVE JANUARY 1, 2006:

 

http://www.opm.gov/oca/06tables/html/ex.asp

(Note:  This site shows the FY-06 rates.  For previous years, click on “salaries
and wages” and then scroll down to the bottom of the page and click on the year
to locate the desired Executive Level salary rates.)

 

NOTE:  All prior Public Laws and related Executive Levels incorporated in the
Basic Award and all previous Modifications shall remain in effect for the
applicable fiscal year and related funds.

 

ARTICLE H.13.  PRESS RELEASES. paragraph b., is hereby modified to add the
following:

 

b.

Public Law and Section No.

 

Fiscal Year

 

Period Covered

 

 

 

 

 

 

 

 

 

P.L. 109-149, Title V – General Provisions, Section 506

 

2006

 

10/01/05 – 9/30/06

 

 

ARTICLE H.15.  ANTI-LOBBYING. paragraph c., is hereby modified to add the
following:

 

b.

Public Law and Section No.

 

Fiscal Year

 

Period Covered

 

 

 

 

 

 

 

 

 

for a., above:  P.L. 109-149, Title V – General Provisions, Section 503a

 

2006

 

10/1/05 – 9/30/06

 

 

for b., above:  P.L. 109-149, Title V – General Provisions, Section 503a

 

2006

 

10/1/05 – 9/30/06

 

 

 

ARTICLE I.2  AUTHORIZED SUBSTITUTION OF CLAUSES, is hereby modified to delete
FAR Clause 52.232-22, LIMITATION OF FUNDS (April 1984), reinstating the
applicability of FAR Clause 52.232-20, LIMITATION OF COST (April 1984) of
ARTICLE I.1.

 

SECTION J — LIST OF ATTACHMENTS, item no. 1., is hereby modified to read as
follows:

 

1.               Statement of Work, [***] (and as clarified by Modification
No. 5), 5 pages.

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

SPECIAL PROVISIONS

Page 15 of 16

 

ATTACHMENT 1 — STATEMENT OF WORK, is hereby modified to include the following
under the Part B Option section for clarification purposes:

 

[***]

[***]

[***]

[***]

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

SPECIAL PROVISIONS

Page 16 of 16

 

[***]

[***]

[***]

[***]

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 05

SPECIAL PROVISIONS

Page 17 of 16

 

[***]

 

HHS-556

 

--------------------------------------------------------------------------------

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1.

CONTRACT ID CODE

PAGE OF PAGES

 

N/A

1

2

 

 

 

 

2.        AMENDMENT/MODIFICATION NO

3.        EFFECTIVE DATE

4.        REQUISITION/PURCHASE REQ NO.

5.        PROJECT NO. (If applicable)

06

  See Block 16 C, below

 

N/A

 

 

 

 

6.        ISSUED BY

CODE

 

7.        ADMINISTERED BY (If other than Item 6)

CODE

N/A

 

 

 

 

 

 

National Institutes of Health, HHS
National Institute of Allergy and Infectious Diseases
DEA, Office of Acquisitions
6700-B Rockledge Drive, Room 3214, MSC 7612
Bethesda, MD  20892-7612

MID RCB-B

 

 

 

8.        NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP
Code)

x

9A.  AMENDMENT OF SOLICITATION NO.

 

Avecia Limited

 

9B.    DATED (SEE ITEM 11)

P.O. Box 42, Hexagon House

 

 

Blackley, Manchester, M9 8ZS, UK

x

10A. MODIFICATION OF CONTRACT/ORDER NO.

 

HHSN266200400034C

 

 

CODE

FACILITY CODE

10B. DATED (SEE ITEM 13)
September 30, 2004

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is amended as set forth in Item 14.  The hour
and date specified for receipt of Offers o is extended, o is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods:

 

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment;
(b) By acknowledging receipt of this amendment on each copy of the offer
submitted; or (c) By separate letter or telegram which includes a reference to
the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this
amendment, you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour
and date specified.

 

12.     ACCOUNTING AND APPROPRIATION DATA (If required)

 

EIN#:  1-900216013-A1

SOCC  25.55

 

 

13.                 THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

x

A.

THIS CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET
FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

 

 

 

 

B.

THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
CHANGES (such as changes in paying office, appropriate date, etc.) SET FORTH IN
ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

 

 

 

 

C.

THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

 

 

 

x

D.

OTHER (Specify type of modification and authority)

FAR 1.602-1

 

 

E.          IMPORTANT:  Contractor x is not, o is required to sign this document
and return               copies to the issuing office.

 

DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings,
including solicitation/contract subject matter where feasible)

 

PURPOSE:  Modify Invoice Payment Procedures under ARTICLE G.3.

 

FUNDED THROUGH DATE:

[***](Unchanged)

 

COMPLETION DATE:

[***] (Unchanged)

 

 

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

 

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

[***]

[***]
[***]

 

 

15B. CONTRACTOR/OFFEROR

15C. DATE SIGNED

16B. UNITED STATES OF AMERICA

16C. DATE SIGNED

 

14JUN07

 

[***]

[***]

 

BY

[***]

 

(Signature of person authorized to sign)

 

 

(Signature of Contracting Officer)

 

 

 

 

NSN 7540-01-152-8070
PREVIOUS EDITION UNUSABLE

30-105
Computer Generated

STANDARD FORM 30 (REV. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 6

 

SPECIAL PROVISIONS

 

Page 2 of 2

 

ARTICLE G.3.      INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT
FINANCIAL REPORT — is hereby modified to read as follows:

 

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

 

(1)                                  Payment requests shall be submitted as
follows:

 

One original 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

 

(2)                                  In addition to the requirements specified
in FAR Subpart 32.9 for a proper invoice, the Contractor shall include the
following information on all payment requests:

 

(a)                                  Name of the Office of Acquisitions.  The
Office of Acquisitions for this contract is NIAID.

 

(b)                                 Central Point of Distribution.  For the
purpose of this contract, the Central Point of Distribution is NIAIDOAInvoices.

 

(c)                                  Vendor Identification Number.  This is the
7 digit number that appears after the Contractor’s name in Block 7 of Standard
Form 26.  (Note:  This only applies to new contracts awarded on/after June 4,
2007, and any existing contract modified to include the number.)

 

(d)                                 DUNS number or DUNS+4 that identifies the
Contractor’s name and address exactly as stated on the face page of the
contract.

 

(e)                                  Identification of whether payment is to be
made using a two-way or three-way match.  This contract requires a two-way
match.

 

b.                                      Inquires regarding payment shall be
directed to the designated office, (301) 496-6088.

 

SECTION J — Attachment 2, Invoice/Financing Request Instructions and Contract
Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 is
hereby replaced with the following updated attachment.

 

HHS-556

 

--------------------------------------------------------------------------------

 

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

 

Format:  Payment requests shall be submitted 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:  Payment requests shall be submitted in the quantity specified
in the Invoice Submission Instructions in Section G of the Contract Schedule.

 

Frequency:  Payment request 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 when authorized
by the Contracting Officer.

 

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 has expired, the Contractor shall site the
amount(s) and month(s) in which it incurred such costs.

 

Contractor’s Fiscal Year:  Payment requests shall be prepared 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
may not exceed the United States dollars authorized.

 

Costs Requiring Prior Approval:  Costs requiring the Contracting Officer’s
approval, which are not set forth in an Advance Understanding in the contract,
shall be identified and reference the Contracting Officer’s Authorization (COA)
Number.  In addition, the Contractor shall show any cost set forth in an Advance
Understanding as a separate line item on the payment request.

 

Invoice/Financing Request Identification:  Each payment request shall be
identified as either.

 

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

 

(b)        Completion Invoice:  The completion invoice shall be submitted
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 costs 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 it completes all
performance provisions.

 

(c)         Final Invoice:  A final invoice may be required after the amounts
owed have been settled between the Government and 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.

 

NIH(RC)-4

 

Attachment 2

Rev. 05/2007

 

Page 1

 

--------------------------------------------------------------------------------

 

(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, VIN, and DUNS or DUNS+4
Number:  Show the Contractor’s name and address exactly as they appear in the
contract, along with the name, title, phone number, and e-mail address of the
person to notify in the event of an improper invoice or, in the case of payment
by method other than Electronic Funds Transfer, to whom payment is to be sent. 
Provide the Contractor’s vendor Identification Number (VIN), and Data Universal
Numbering System (DUNS) number or DUNS+4.  The DUNS number must identify the
Contractor’s name and address exactly as stated on the face page of the
contract.  When an approved assignment has been made by the Contractor, or a
different payee has been designated, provide the same information for the payee
as is required for the Contractor (i.e., name, address, point of contact, VIN,
and DUNS).

 

(c)         Invoice/Financing Request Number:  Insert the appropriate serial
number of the payment request.

 

(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 (if applicable)

 

(f)           Effective Date:  Insert the effective date of the contract or if
billing under an order, the effective date of the order.

 

(g)        Total Estimated Cost of Contract/Order:  Insert the total estimated
cost of the contract, exclusive of fixed-fee.  If billing under an order, insert
the total estimated cost of the order, exclusive of fixed-fee.  For
incrementally funded contracts/orders, enter the amount currently obligated and
available for payment.

 

(h)        Total Fixed-Fee:  Insert the total fixed-fee (where applicable).  For
incrementally funded contracts/orders, enter the amount currently obligated and
available for payment.

 

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

 

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

 

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

 

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

 

(m)      Amount Billed — Current Period:  Insert the cumulative amounts claimed
for the current billing period by major cost element, including any adjustments
and fixed-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.

 

(n)        Amount Billed — Cumulative:  Insert the cumulative amounts claimed by
major cost element, including any adjustments and fixed-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)        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.

 

NIH(RC)-4

 

Attachment 2

Rev. 05/2007

 

Page 2

 

--------------------------------------------------------------------------------

 

(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) 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.  Do not include in this category fringe benefits
that are included in indirect costs.

 

(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 Control 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.  An asterisk (*) shall precede the item 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
· 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 Canada, the United States and its territories and
possessions.  However, for an organization located outside Canada, 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.

 

(p)        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.

 

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

 

NIH(RC)-4

 

Attachment 2

Rev. 05/2007

 

Page 3

 

--------------------------------------------------------------------------------

 

(r)           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.

 

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

 

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

 

(u)        Grand Totals

 

(v)        Certification of Salary Rate Limitation:  If required by the contract
(see Invoice Submission Instructions in Section G of the Contract Schedule), the
Contractor shall include the following certification at the bottom of the
payment request:

 

“I hereby certify that the salaries billed in this payment request are in
compliance with the Salary Rate Limitation Provisions in Section H of the
contract.”

 

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 are keyed 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 (Funds) Clause of the contract.

 

Modifications:  Any modification in the amount negotiated for an item since the
preceding report should be listed 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.

 

NIH(RC)-4

 

Attachment 2

Rev. 05/2007

 

Page 4

 

--------------------------------------------------------------------------------

 

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, VIN, and DUNS or DUNS+4 Number:

 

 

 

ABC Corporation

 

100 Main Street

 

Anywhere, USA Zip Code

 

 

 

Name, Title, Phone Number, and E-mail Address of person to notify in the event
of an improper invoice or, in the case of payment by method other than
Electronic Funds Transfer, to whom payment is to be sent.

 

 

 

VIN:

 

DUNS or DUNS+4:

 

 

(c)

Invoice/Financing Request No:

 

 

(d)

Date Invoice Prepared:

 

 

(e)

Contract No. and Order No. (If applicable):         

 

 

(f)

Effective Date:

 

 

(g)

Total Estimated Cost of Contract/Order:

 

 

(h)

Total Fixed-Fee (if applicable):

 

 

(i)

o Two-Way Match o Three-Way Match

 

 

(j)

Office of Acquisitions:

 

 

(k)

Central Point of Distribution:

 

 

(l)

This invoice/financing request represents reimbursable costs for the period from
            to           

 

 

 

Cumulative Percentage of
Effort/Hrs.

 

Amount Billed

 

Cost of
Completion
F

 

Contract Amount
G

 

Variance
H

 

Expenditure Category*
A

 

Negotiated
B

 

Actual
C

 

(m)
Current
D

 

(n)
Cumulative
E

 

(o) 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(p) Cost of Money

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(q) Indirect Costs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(r) Fixed Fee

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(s) Total Amount Claimed

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(t) Adjustments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(u) Grand Totals

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

I certify that all payments are for appropriate purposes and in accordance with
the contract.

 

 

 

 

 

 

 

(Name of Official)

 

(Title)

 

 

--------------------------------------------------------------------------------

*Attach details as specified in the contract.

 

NIH(RC)-4

 

Attachment 2

Rev. 05/2007

 

Page 5

 

--------------------------------------------------------------------------------

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1.   CONTRACT ID CODE

PAGE OF PAGES

 

N/A

1

20

 

 

 

 

2.   AMENDMENT/MODIFICATION NO

3.   EFFECTIVE DATE

4.   REQUISITION/PURCHASE REQ NO.

5.   PROJECT NO. (If applicable)

07

See Block 16 C, below

 

N/A

 

 

 

 

6.   ISSUED BY

CODE

 

7.   ADMINISTERED BY (If other than Item 6)

CODE

N/A

 

 

 

 

 

 

National Institutes of Health, HHS

National Institute of Allergy and Infectious Diseases

DEA, Office of Acquisitions

Room 3214, MSC 7612

6700-B Rockledge Drive,

Bethesda, MD  20892-7612

 

MID RCB-B

 

 

VIN:  1109979

 

8.   NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

x

9A.    AMENDMENT OF SOLICITATION NO.

 

 

 

 

 

Avecia Limited

 

 

 

9B.    DATED (SEE ITEM 11)

P.O. Box 42, Hexagon House

 

 

 

 

Blackley, Manchester, M9 8ZS, UK

 

 

x

10A.  MODIFICATION OF CONTRACT/ORDER NO.

 

 

 

 

HHSN266200400034C

 

 

 

 

 

 

 

 

 

10B.  DATED (SEE ITEM 13)

CODE

 

FACILITY CODE

 

   September 30, 2004

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is amended as set forth in Item 14.  The hour
and date specified for receipt of Offers o is extended, o is not extended. 

 

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods: 

 

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment;
(b) By acknowledging receipt of this amendment on each copy of the offer
submitted; or (c) By separate letter or telegram which includes a reference to
the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this
amendment, you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour
and date specified.

 

12.     ACCOUNTING AND APPROPRIATION DATA (If required)

EIN#:  1-900216013-A1

SOCC  25.55

 

 

 

 

 

13.     THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

 

x

A.       THIS CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE
CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

 

 

 

B.       THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE
ADMINISTRATIVE CHANGES (such as changes in paying office, appropriate date,
etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

 

 

x

C.       THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

FAR 1.602-1

 

 

 

D.       OTHER (Specify type of modification and authority)

 

 

E.       IMPORTANT:  Contractor o is not, x is required to sign this document
and return 2 copies to the issuing office.

 

14.     DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section
headings, including solicitation/contract subject matter where feasible)

 

PURPOSE:  To clarify the Part B Option Statement of Work, required Deliverables;
and revise the related Milestone Estimated Cost and Fixed Fee distributions, as
well as change the contract funded through and completion dates:

 

TOTAL ESTIMATED COST:[***]

CONTRACT COMPLETION DATE: [***]

TOTAL ALLOTTED TO DATE: [***]

FUNDED THROUGH DATE:  [***]

 

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

 

 

15A.  NAME AND TITLE OF SIGNER (Type or print)

16A.  NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

[***]

[***]

[***]

 

 

 

 

15B.  CONTRACTOR/OFFEROR

15C.  DATE SIGNED

16B.  UNITED STATES OF AMERICA

16C.  DATE SIGNED

[***]

      9July’07

 

BY

[***]

[***]

(Signature of person authorized to sign)

(Signature of Contracting Officer)

 

 

 

NSN 7540-01-152-8070

PREVIOUS EDITION UNUSABLE

30-105

Computer Generated

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

SPECIAL PROVISIONS

Page 2 of 20

 

ARTICLE B.2. ESTIMATED COST AND FIXED FEE, paragraph f., is hereby modified to
read as follows:

 

f.      It is estimated that the amount currently allotted will cover
performance of the contract through [***].

 

ARTICLE B.4. ADVANCED UNDERSTANDINGS, paragraph i., is hereby modified as
follows to update the Milestone Schedule:

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

 

 

 

 

 

 

 

 

 

1

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in six installments of the total fee for this milestone based
on the completion of the following six items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

f) [***]

 

 

 

f) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

SPECIAL PROVISIONS

Page 3 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

 

 

 

 

 

 

 

 

 

2

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in five installments of the total fee for this milestone based
on the completion of the following five items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

f) [***]

 

 

 

f) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

SPECIAL PROVISIONS

Page 4 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

3

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

4

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following two items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee of Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

SPECIAL PROVISIONS

Page 5 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

5

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

6

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in four installments of the total fee for this milestone based
on the completion of the following four items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee of Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

SPECIAL PROVISIONS

Page 6 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

7

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in two installments of the total fee for this milestone based
on the completion of the following two items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

8

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee of Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

SPECIAL PROVISIONS

Page 7 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

9

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in six installments of the total fee for this milestone based
on the completion of the following six items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

f) [***]

 

 

 

f) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

SPECIAL PROVISIONS

Page 8 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

10

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in four installments of the total fee for this milestone based
on the completion of the following four items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

SPECIAL PROVISIONS

Page 9 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

11

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in four installments of the total fee for this milestone based
on the completion of the following four items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

SPECIAL PROVISIONS

Page 10 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

12

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in nine installments of the total fee for this milestone based
on the completion of the following nine items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

f) [***]

 

 

 

f) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

g) [***]

 

 

 

g) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

h) [***]

 

 

 

h) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

 

SPECIAL PROVISIONS

 

Page 11 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

13

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in eight installments of the total fee for this milestone
based on the completion of the following eight items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

f) [***]

 

 

 

f) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

g) [***]

 

 

 

g) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

h) [***]

 

 

 

h) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

 

SPECIAL PROVISIONS

 

Page 12 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

14

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in five installments of the total fee for this milestone based
on the completion of the following five items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

 

SPECIAL PROVISIONS

 

Page 13 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

15

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in five installments of the total fee for this milestone based
on the completion of the following five items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

 

SPECIAL PROVISIONS

 

Page 14 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

16

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in four installments of the total fee for this milestone based
on the completion of the following four items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

d) [***]

 

 

 

d) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

e) [***]

 

 

 

e) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

 

SPECIAL PROVISIONS

 

Page 15 of 20

 

 

 

MILESTONES FOR AVECIA

 

ESTIMATED
COST

 

FIXED FEE

 

TOTAL
CPFF

17

 

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

Fee shall be paid in three installments of the total fee for this milestone
based on the completion of the following three items:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a) [***]

 

 

 

a) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

b) [***]

 

 

 

b) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

c) [***]

 

 

 

c) [***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Fee for Milestone

 

 

 

[***]

 

 

 

ARTICLE C.1. STATEMENT OF WORK, is hereby modified to read as follows:

 

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 Government as needed to perform the
Statement of Work, SECTION J, ATTACHMENT 1, dated September 30, 2004, and as
clarified by Modification No. 7 of the contract, attached hereto and made part
of this contract.

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

 

SPECIAL PROVISIONS

 

Page 16 of 20

 

ARTICLE F.1. PERIOD OF PERFORMANCE, paragraph a, is hereby modified to read as
follows:

 

a.             The period of performance of this contract shall be from [***]
through [***].

 

ARTICLE F.2. DELIVERIES, paragraph a., is hereby modified to include the
following table of deliverables in addition to those deliveries currently
required by the contract.

 

Item

 

Type of Deliverable

 

SOW Reference

 

Recipient

 

Delivery Schedule

1.

 

[***]

 

[***]

 

[***]

 

[***]

2.

 

[***]

 

[***]

 

[***]

 

[***]

3.

 

[***]

 

[***]

 

[***]

 

[***]

4.

 

[***]

 

[***]

 

[***]

 

[***]

5.

 

[***]

 

[***]

 

[***]

 

[***]

6.

 

[***]

 

[***]

 

[***]

 

[***]

7.

 

[***]

 

[***]

 

[***]

 

[***]

8.

 

[***]

 

[***]

 

[***]

 

[***]

9.

 

[***]

 

[***]

 

[***]

 

[***]

10.

 

[***]

 

[***]

 

[***]

 

[***]

11.

 

[***]

 

[***]

 

[***]

 

[***]

12.

 

[***]

 

[***]

 

[***]

 

[***]

13.

 

[***]

 

[***]

 

[***]

 

[***]

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

 

SPECIAL PROVISIONS

 

Page 17 of 20

 

Item

 

Type of Deliverable

 

SOW Reference

 

Recipient

 

Delivery Schedule

14.

 

[***]

 

[***]

 

[***]

 

[***]

15.

 

[***]

 

[***]

 

[***]

 

[***]

16.

 

[***]

 

[***]

 

[***]

 

[***]

17.

 

[***]

 

[***]

 

[***]

 

[***]

18.

 

[***]

 

[***]

 

[***]

 

[***]

19.

 

[***]

 

[***]

 

[***]

 

[***]

20.

 

[***]

 

[***]

 

[***]

 

[***]

 

SECTION J — LIST OF ATTACHMENTS, items no. 1., is hereby modified to read as
follows:

 

1. [***] (and as clarified by Modification No. 7), 5 pages.

 

ATTACHMENT 1 — STATEMENT OF WORK,  is hereby modified to include the following
under the Part B Option section for clarification purposes:

 

[***]

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

 

SPECIAL PROVISIONS

 

Page 18 of 20

 

[***]

 

[***]

 

[***]

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

 

SPECIAL PROVISIONS

 

Page 19 of 20

 

[***]

 

[***]

 

[***]

 

[***]

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 07

 

SPECIAL PROVISIONS

 

Page 20 of 20

 

[***]

 

[***]

 

HHS-556

 

--------------------------------------------------------------------------------

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1.     CONTRACT ID CODE

PAGE       OF     PAGES

 

N/A

1

4

 

 

 

 

2.     AMENDMENT/MODIFICATION NO

3.

EFFECTIVE DATE

4.     REQUISITION/PURCHASE REQ. NO

5.     PROJECT NO. (if applicable)

09

 

See block 16C, below

 

N/A

 

 

 

 

6.     ISSUED BY

CODE

 

7.     ADMINISTERED BY (if other than Item 6)

CODE

N/A

 

 

 

 

 

 

 

National Institutes of Health
National Institute of Allergy and Infectious Diseases
DEA, Office of Acquisitions
Room 3214, MSC 7612
6700-B Rockledge Drive
Bethesda, MD  20892-7612

 

   MID RCB-B

 

   N01-AI-40034

 

8.     NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and ZIP Code)

x

9A.

AMENDMENT OF SOLICITATION NO.

 

 

 

Avecia Biologics Limited VIN:  1140323

 

9B.

DATED (SEE ITEM 11)

P.O. Box 42, Hexagon Tower

 

 

Blackley, Manchester, M9 8ZS, UK

 

 

 

x

10A.

MODIFICATION OF CONTRACT/ORDER NO.

 

 

 

HHSN266200400034C

 

 

 

 

 

 

10B.

DATED (SEE ITEM 13)

CODE

FACILITY CODE

 

 

September 30, 2004

 

 

 

 

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is amended as set forth in Item 14.  The hour
and date specified for receipt of Offers o is extended, o is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment,
(b) By acknowledging receipt of this amendment on each copy of the offer
submitted or (c) By separate letter or telegram which includes a reference to
the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this
amendment you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour
and data specified.

 

12.   ACCOUNTING AND APPROPRIATION DATA (if required)

 

N/A

 

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

 

(D)

 A.  THIS CHANGE ORDER IS ISSUED PURSUANT TO (Specify authority) THE CHANGES SET
FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A

 

 

 

 B.  THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH
IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b)

 

 

 

 C.  THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF

 

x

 D.  OTHER (Specify type of modification and authority)
FAR 1.602-1 and Article G.1. Project Officer

 

E.     IMPORTANT:  Contractor x is not, o is required to sign this document and
return       copies to the issuing office

 

14.        DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section
headings, including solicitation/contract subject matter where feasible)

 

PURPOSE:  To revise ARTICLE G.1. and update Section H and I Articles.

 

 

 

Total Funds Currently Allotted

 

 

 

Total Estimated Cost

 

 

 

 

 

Cost

 

Fee

 

Total

 

Cost

 

Fee

 

Total

 

Prior to this Mod

 

[***]

 

[***]

 

$

50,701,800

 

[***]

 

[***]

 

$

50,701,800

 

This Mod #

 

[***]

 

[***]

 

$

0

 

[***]

 

[***]

 

$

0

 

Revised Total

 

[***]

 

[***]

 

$

50,701,800

 

[***]

 

[***]

 

$

50,701,800

 

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

 

 

15A.        NAME AND TITLE OF SIGNER (Type or print)

16A.

NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

 

 

Karen M. Gamble
Contracting Officer, OA, DEA, NIAID

 

 

 

 

15B. CONTRACTOR/OFFEROR

15C. DATE SIGNED

16B.    UNITED STATES OF AMERICA

16C. DATE SIGNED

 

 

BY

/s/ Karen M. Gamble

7/11/2008

 

(Signature of person authorized to sign)

 (Signature of Contracting Officer)

 

 

 

 

NSN 7540-01-152-8070
PREVIOUS EDITION UNUSABLE

30-105
Computer Generated

 

STANDARD FORM 30 (REV. 10-83)
Prescribed by GSA

FAR (48 CFR) 53 243

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 09

 

SPECIAL PROVISIONS

 

Page 2 of 4

 

ARTICLE G.1.  PROJECT OFFICER, Marlene Hammer is deleted as Alternate Project
Officer.

 

The second paragraph is hereby modified to replace the Project Officer as
follows:

Freyja Lynn
Office of Biodefense Research Affairs
Division of Microbiology and Infectious Diseases
DHHS/NIH/NIAID
Room 5064, MSC 6604
6610 Rockledge Drive
Bethesda, MD 20892-6604
lynnf@niaid.nih.gov

 

THE FOLLOWING SECTION H ARTICLES ARE UPDATED IN COMPLIANCE WITH PUBLIC LAW
(P.L.) 110-161:

 

ARTICLE H.5.  CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH is deleted in
its entirety and replaced with:

 

Pursuant to the current HHS annual appropriations act, 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.6.  NEEDLE EXCHANGE is deleted in its entirety and replaced with:

 

Pursuant to the current HHS annual appropriations act, 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.11.  SALARY RATE LIMITATION LEGISLATION PROVISIONS is deleted in its
entirety and replaced with:

 

a.               Pursuant to the current HHS annual appropriations act, the
Contractor shall not use NIH Fiscal Year funds to pay the direct salary of an
individual through this contract at a rate in excess of Executive Level I. 
Direct salary is exclusive of fringe benefits, overhead and general and
administrative expenses (also referred to as “indirect costs” or “facilities and
administrative (F&A) costs”).  Direct salary has the same meaning as the term
“institutional base salary.”  An individual’s direct salary (or institutional
base salary) is the annual compensation that the Contractor pays for an
individual’s appointment whether that individual’s time is spent

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 09

SPECIAL PROVISIONS

Page 3 of 4

 

on research, teaching, patient care or other activities.  Direct salary (or
institutional base salary) excludes any income that an individual may be
permitted to earn outside of duties to the Contractor.  The annual salary rate
limitation also applies to individuals proposed under subcontracts.  It does not
apply to fees paid to consultants.  If this is a multiple year contract, it may
be subject to unilateral modifications by the Government if an individual’s
salary rate used to establish contract funding exceeds any salary rate
limitation subsequently established in future HHS appropriation acts.

 

b.              Payment of direct salaries is limited to the Executive Level I
rate which was in effect on the date(s) the expense was incurred.  See the
following Web site 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 / cursor to bottom of page and select year
/Executive Schedule / Rates of Pay for the Executive Schedule.  Rates are
effective January 1 of each calendar year unless otherwise noted.)

 

NOTE:

All prior Public Laws and related Executive Levels incorporated in the Basic
Award and all previous Modifications shall remain in effect for the applicable
fiscal year and related funds.

 

ARTICLE H.13.  PRESS RELEASES  is deleted in its entirety and replaced with:

 

Pursuant to the current HHS annual appropriations act, 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.

 

THE FOLLOWING ARTICLE IS DELETED IN COMPLIANCE WITH PUBLIC LAW (P.L.) 110-161:

 

ARTICLE H.15.  ANTI-LOBBYING is deleted in its entirety.  It is now covered
under HHSAR Clause 352.270¬10, incorporated in ARTICLE 1.1.

 

ARTICLE H.16.  OBTAINING AND DISSEMINATING BIOMEDICAL RESEARCH RESOURCES, is
renumbered to read ARTICLE H.15.

 

ARTICLE H.17.  SHARING RESEARCH DATA, is renumbered to read ARTICLE H.16.

 

ARTICLE H.18.  POSSESSION USE AN TRANSFR OF SECLECT BIOLOGICAL AGENTS OR TOXINS,
is renumbered to read ARTICLE H.17.

 

ARTICLE H.19.  PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST  ACTIVITIES,
is renumbered to read ARTICLE H.18.

 

HHS-556

 

--------------------------------------------------------------------------------

 

Contract No. HHSN266200400034C
Modification No. 09

SPECIAL PROVISIONS

Page 4 of 4

 

THE FOLLOWING NEW PROVISIONS ARE HEREBY ADDED TO THIS CONTRACT IN COMPLIANCE
WITH THE CONTINUING LEGISLATIVE MANDATES FOR FY2008 (P.L. 110-161).

 

ARTICLE H.19.  DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING SCIENTIFIC 
INFORMATION

 

Pursuant to the current HHS annual appropriations act, the Contractor shall not
use contract funds to disseminate scientific information that is deliberately
false or misleading.

 

ARTICLE H.20.  RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

 

Pursuant to the current HHS annual appropriations act, the Contractor shall not
use contract funds to employ workers described in section 274A(h)(3) of the
Immigration and Nationality Act, which reads as follows:

 

“(3) Definition of unauthorized alien.  As used in this section, the term
‘unauthorized alien’ means, with respect to the employment of an alien at a
particular time, that the alien is not at that time either (A) an alien lawfully
admitted for permanent residence, or (B) authorized to be so employed by this
Act or by the Attorney General.”

 

ARTICLE H.21.  RESTRICTION ON ABORTIONS

 

Pursuant to the current HHS annual appropriations act, the Contractor shall not
use contract funds for any abortion.

 

THE FOLLOWING SECTON H ARTICLE IS ADDED IN COMPLIANCE WITH PUBLIC LAW (P.L.)
110-85:

 

ARTICLE H.22.  REGISTRATION OF CLINICAL TRIALS IN THE GOVERNMENT DATABASE
(ClinicalTrials.gov)

 

Pursuant to Public Law 110-85, Food and Drug Administration Amendments Act of
2007, Title VIII-Clinical Trial Databases, the Contractor shall register the
clinical trial(s) performed under this contract in the Government database,
ClinicalTrials.gov ( http://www.ClinicalTrials.gov) by the later of December 27,
2007, or 21 days after the first patient is enrolled.

 

Additional information is available at:  http://prsinfo.clinicaltrials.gov.

 

THE FOLLOWING SECTON I ARTICLE IS UPDATED IN COMPLIANCE WITH PUBLIC LAW (P.L.)
110-161:

 

ARTICLE I.1.  GENERAL CONTRACT CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND
DEVELOPMENT CONTRACT, subparagraph b., is revised to add the following clause:

 

HHSAR Clause No. 352.270-10, Jan 2006, Anti-Lobbying

 

HHS-556

 

--------------------------------------------------------------------------------

 

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1.   CONTRACT ID CODE

PAGE    OF    PAGES

 

N/A

1

 2

 

 

 

 

 

 

 

 

 

 

2.        AMENDMENT/MODIFICATION NO

3.

EFFECTIVE DATE
See block 16C, below

4.        REQUISITION/PURCHASE REQ. NO

5.

PROJECT NO. (if applicable)

 

10

 

N/A

 

 

 

 

 

 

6.        ISSUED BY

CODE

 

7.        ADMINISTERED BY (if other than item 6)

CODE

N/A

 

 

 

 

 

 

 

National Institutes of Health
National Institute of Allergy and Infectious Diseases
DEA, Office of Acquisitions
Room 3214, MSC 7612
6700-B Rockledge Drive
Bethesda, MD  20892-7612

 

MID RCB-B

 

 

8.        NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and ZIP
Code)

x

9A.

AMENDMENT OF SOLICITATION NO.

 

 

 

 

 

 

PharmAthene UK Limited VIN:  1148445

 

 

 

9B.

DATED (SEE ITEM 11)

Johnson Matthey Building

 

 

 

 

 

PO Box 88, Haverton Hill Road

 

 

x

10A.

MODIFICATION OF CONTRACT/ORDER NO.

Billingham, T523 1KN

 

 

 

 

HHSN266200400034C

 

 

 

 

 

 

 

 

 

 

10B.

DATED (SEE ITEM 13)

CODE

FACILITY CODE

 

 

september 30, 2004

 

11.  THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

o The above numbered solicitation is amended as set forth in Item 14.  The hour
and date specified for receipt of Offers o is extended, o is not extended.

 

Offers must acknowledge receipt of this amendment prior to the hour and date
specified in the solicitation or as amended, by one of the following methods:

 

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment: 
(b) By acknowledging receipt of this amendment on each copy of the offer
submitted; or (c) By separate letter or telegram which includes a reference to
the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND
DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this
amendment you desire to change an offer already submitted, such change may be
made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour
and data specified.

 

12.

ACCOUNTING AND APPROPRIATION DATA (if required)

 

SOCC 25.55

 

 

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACT/ORDERS,
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

 

(C)

A.

THIS CHANGE ORDER IS ISSUED PURSUANT TO (specify authority) THE CHANGES SET
FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

 

 

 

 

B.

THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE
CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH
IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

 

 

 

x

C.

THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF
FAR 42.12 and FAR 1.602-1

 

 

 

 

D.

OTHER (Specify type of modification and authority)

 

E.       IMPORTANT:  Contractor o is not, x is required to sign this document
and return    2   copies to the issuing office.

 

14.     DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section
headings, including solicitation/contract subject matter where feasible)

 

PURPOSE:  To recognize the Contractor’s successor in interest from Avecia
Biologics Limited to PharmAthene UK, Limited; to revise ARTICLE B4 ADVANCE
UNDERSTANDINGS and ARTICLE G4. PROJECT OFFICER

 

 

 

total funds currently allotted

 

 

 

total estimated cost

 

 

 

 

 

cost

 

fee

 

total

 

cost

 

fee

 

total

 

Prior to this Mod

 

[***]

 

[***]

 

$

50,701,800

 

[***]

 

[***]

 

$

50,701,800

 

This Mod #

 

[***]

 

[***]

 

$

-0-

 

[***]

 

[***]

 

$

-0-

 

Revised Total

 

[***]

 

[***]

 

$

50,701,800

 

[***]

 

[***]

 

$

50,701,800

 

 

FUNDED THROUGH DATE:  September 29, 2010 (Unchanged)

 

CONTRACT COMPLETION DATE:  September 29, 2010 (Unchanged)

 

Except as provided herein, all terms and conditions of the document referenced
in Item 9A or 10A, as heretofore changed, remains unchanged and in full force
and effect.

 

15A.             NAME AND TITLE OF SIGNER (Type or print)

16A.

NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Chris Camut, VP, CFO/ UK Board of Directors

 

Karen M. Gamble
Contracting Officer, MID, RCB, B-OA, DEA, NIAID

 

 

 

 

15B. CONTRACTOR/OFFEROR

15C. DATE SIGNED

16B.

UNITED STATES OF AMERICA

16C. DATE SIGNED

/s/ Chris Camut

12/4/08

BY

/s/ Karen M. Gamble

12/4/2008

(Signature of person authorized to sign)

 

(Signature of Contracting Officer)

 

 

 

 

NSN 7540-01-152-8070
PREVIOUS EDITION UNUSABLE

30-105
Computer Generated

 

STANDARD FORM 30 (REV. 10-83)
Prescribed by GSA

FAR (48 CFR) 53.243

 

--------------------------------------------------------------------------------

 

Contract no. HHSN266200400034C
Modification No. 10

 

SPECIAL PROVISIONS

 

page 2 of 2

 

Pursuant to far 42.12, Block 8 of the Standard Form 38 shall read as follows:

 

PharmAthene UK Limited  VIN:  1148448
Johnson Matthey Building
PO Box 88, Haverton Hill Road
Billingham TS23 1XN

 

The following is attached and made part of this modification:

 

Novation Agreement
Exhibit A, List of all Affected Contracts

 

ARTICLE B.4.  ADVANCED UNDERSTANDINGS, is modified to add the following:

 

9.               ceilings

 

As a result of this novation, it is agreed that the Total Estimated Cost of this
Contract shall not exceed the current value of $50,701,800, due to any variances
in the indirect costs.

 

ARTICLE G.1.  PROJECT OFFICER, is modified to add the following.

 

The Alternate Project Officer named below will represent the Government for the
purpose of this contract:

 

Nancy Wilkie
Office of Biodefense Research Affaris (OBRA)
Division of Microbiology and Infectious Diseases
DHHS/NIH/NIAID
Room 5004, MSC 6604
6610 Rockledge Drive
Bethesda, MD  20892-6604
wilkien@niaid.nih.gov

 

HHS-556

 

--------------------------------------------------------------------------------

 

NOVATION AGREEMENT

 

AVECIA BIOLOGICS LIMITED (Transferor), a corporation duly organized and existing
under the laws of England and Wales with its principal office in Manchester
United Kingdom; PHARMATHENE UK LIMITED (Transferee), a corporation duly
organized and existing under the laws of England and Wales with its principal
office in Billingham, UK; and the UNITED STATES OF AMERICA (Government) enter
into this Agreement as of 2nd April, 2008.

 

(a) The parties agree to the following facts:

 

(1) The Government, represented by various Contracting Officers of the National
Institute for Allergies and Infectious Diseases, has entered into certain
contracts with the Transferor as shown in the attached list marked ‘Exhibit A’
and incorporated in this Agreement by reference.  The term “the contracts,” as
used in this Agreement, means the above contracts and purchase orders and all
other contracts and purchase orders, including all modifications, made between
the Government and the Transferor before the effective date of this Agreement
(whether or not performance and payment have been completed and releases
executed if the Government or the Transferor has any remaining rights, duties,
or obligations under these contracts and purchase orders).  Included in the term
“the contracts” are also all modifications made under the terms and conditions
of these contracts and purchase orders between the Government and the
Transferee, on or after the effective date of this Agreement.

 

(2) As of 2nd April, 2008, the Transferor has transferred to the Transferee all
the assets of the Transferor by virtue of a Sale and Purchase Agreement between
the Transferor and the Transferee.

 

(3) The Transferee has acquired all the assets of the Transferor by virtue of
the above transfer.

 

(4) The Transferee has assumed all obligations and liabilities of the Transferor
under the contracts by virtue of the above transfer.

 

(5) The Transferee is in a position to fully perform all obligations that may
exist under the contracts.

 

(6) It is consistent with the Government’s interest to recognize the Transferee
as the successor party to the contracts.

 

(7) Evidence of the above transfer has been filed with the Government.

 

(b) In consideration of these facts, the parties agree that by this Agreement—

 

(1) The Transferor confirms the transfer to the Transferee, and waives any
claims and rights against the Government that it now has or may have in the
future in connection with the contracts.

 

(2) The Transferee agrees to be bound by and to perform each contract in
accordance with the conditions contained in the contracts.  The Transferee also

 

--------------------------------------------------------------------------------

 

assumes all obligations and liabilities of, and all claims against, the
Transferor under the contracts as if the Transferee were the original party to
the contracts.

 

(3) The Transferee ratifies all previous actions taken by the Transferor with
respect to the contracts, with the same force and effect as if the action had
been taken by the Transferee.

 

(4) The Government recognizes the Transferee as the Transferor’s successor in
interest in and to the contracts.  The Transferee by this Agreement becomes
entitled to all rights, titles, and interests of the Transferor in and to the
contracts as if the Transferee were the original party to the contracts. 
Following the effective date of this Agreement, the term “Contractor,” as used
in the contracts, shall refer to the Transferee.

 

(5) Except as expressly provided in this Agreement, nothing in it shall be
construed as a waiver of any rights of the Government against the Transferor.

 

(6) All payments and reimbursements previously made by the Government to the
Transferor, and all other previous actions taken by the Government under the
contracts, shall be considered to have discharged those parts of the
Government’s obligations under the contracts.  All payments and reimbursements
made by the Government after the date of this Agreement in the name of or to the
Transferor shah have the same force and effect as if made to the Transferee, and
shall constitute a complete discharge of the Government’s obligations under the
contracts, to the extent of the amounts paid or reimbursed.

 

(7) The Transferor and the Transferee agree that the Government is not obligated
to pay or reimburse either of them for, or otherwise give effect to, any costs,
taxes, or other expenses, or any related increases, directly or indirectly
arising out of or resulting from the transfer or this Agreement, other than
those that the Government in the absence of this transfer or Agreement would
have been obligated to pay or reimburse under the terms of the contracts.

 

(8) The Transferor guarantees payment of all liabilities and the performance of
all obligations that the Transferee—

 

(i) Assumes under this Agreement; or

 

(ii) May undertake in the future should these contracts be modified under their
terms and conditions.  The Transferor waives notice of, and consents to, any
such future modifications.

 

(9) The contracts shall remain in full force and effect, except as modified by
this Agreement.  Each party has executed this Agreement as of the day and year
first above written.

 

UNITED STATES OF AMERICA,

 

Signed

[ * * * ]

 

 

 

 

Name and Title

[ * * * ]

 

 

--------------------------------------------------------------------------------

 

AVECIA BIOLOGICS LIMITED,

 

Signed

/s/ Duncan McLellan

 

Name and Title

Duncan McLellan, Director and Chief Financial Officer

 

 

PHARMATHENE UK LIMITED,

 

Signed

/s/ David P. Wright

 

Name and Title

David P. Wright - CEO

 

 

CERTIFICATE

 

I, Richard clements, certify that I am the Company Secretary of AVECIA BIOLOGICS
LIMITED, that Duncan McLellan, who signed this Agreement for this corporation,
was then a Director and the Chief Financial Officer of this corporation; and
that this Agreement was duly signed for and on behalf of this corporation by
authority of its governing body and within the scope of its corporate powers. 
Witness my hand this day of 2nd June 2008.

 

Signed

/s/ Richard Clements

 

 

CERTIFICATE

 

I, Christopher c. camut, certify that I am the Company Secretary of PHARMATHENE
UK LIMITED, that David P. Wright, who signed this Agreement for this
corporation, was then a Director of this corporation; and that this Agreement
was duly signed for and on behalf of this corporation by authority of its
governing body and within the scope of its corporate powers.  Witness my hand
this day of 23 June 2008.

 

Signed

/s/ Christopher C. Camut

 

 

--------------------------------------------------------------------------------

 

Exhibit A

 

The Contracts

 

Contract number N01-Al-25492

 

Contract between Avecia Biologics Limited and the National Institute of Allergy
and Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Development and Testing of Vaccines Against Anthrax.”

 

Contract number N01-Al-30052

 

Contract between Avecia Biologics Limited and the National Institute of Allergy
and Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Production and Testing of Anthrax Recombinant Protective Antigen.”

 

Contract number HHSN266200400034C, N01-Al-40034

 

Contract between Avecia Biologics Limited and the National Institute of Allergy
and Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Development, Testing and Evaluation of Candidate Vaccines Against
Plague.”

 

--------------------------------------------------------------------------------

 

List of Affected Contracts

 

Contract number N01-Al-25492

 

Contract between Avecia Biologics Limited and the National Institute of Allergy
and Infectious Diseases (NAID), part of the US National Institutes of Health
(NIH), for “Development and Testing of Vaccines Against Anthrax.”

 

This contract is substantially complete.  As at 15th January 2008, the total
contract amount was $10,155,120 and there was an [ * * * ] which is under
discussion between Avecia Biologics Limited and NAID.

 

Contracting Office:

National Institutes of Health

 

Office of Acquisitions, NIAID

 

Room 3214

 

6700-8 Rockledge Dr., MSC 7612

 

Bethesda, Maryland 20892-7612

 

Contract number N01-Al-30052

 

Contract between Avecia Biologics Limited and the National Institute of Allergy
and Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Production and Testing of Anthrax Recombinant Protective Antigen.’

 

As at 15th April 2008, the total contract value was $118,036,200 and the total
estimated costs remaining to complete were  [ * * * ].

 

Contracting Office:

National Institutes of Health

 

Office of Acquisitions, NIAID

 

Room 3214

 

6700-B Rockledge Dr., MSC 7612

 

Bethesda, Maryland 20892-7612

 

Contract number HHSN266200400034C, N01-AI-40034

 

Contract between Avecia Biologics Limited and the National Institute of Allergy
and Infectious Diseases (NIAID), part of the US National Institutes of Health
(NIH), for “Development, Testing and Evaluation of Candidate Vaccines Against
Plague.”

 

As at 15th April 2008, the total contract value was $50,701,714 and the total
estimated costs remaining to complete were [ * * * ].

 

Contracting Office:

National Institutes of Health

 

Office of Acquisitions, NIAID

 

Room 3214

 

6700-B Rockledge Dr., MSC 7612

 

Bethesda, Maryland 20892-7612

 

--------------------------------------------------------------------------------