**U.S. Department of Health and Human Services**

**National Institutes of Health**

National Institute of Allergy and Infectious Diseases (NIAID)

**RFP NIH-NIAID-DAIDS-07-25**

**IN VITRO TESTING RESOURCES FOR AIDS THERAPEUTICS DEVELOPMENT**

OMB Control Number 0990-0115

+----------------+-----+---+-----------+-----+---+---+------------------------+
| 1.  **OFFERORS |     |   |           |     |   |   |                        |
|     ARE        |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|    RESPONSIBLE |     |   |           |     |   |   |                        |
|     FOR        |     |   |           |     |   |   |                        |
|     ROUTINELY  |     |   |           |     |   |   |                        |
|     CHECKING   |     |   |           |     |   |   |                        |
|     THE        |     |   |           |     |   |   |                        |
|     FOLLOWING  |     |   |           |     |   |   |                        |
|     WEBSITE    |     |   |           |     |   |   |                        |
|     FOR ANY    |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|   SOLICITATION |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|    AMENDMENTS. |     |   |           |     |   |   |                        |
|     NO         |     |   |           |     |   |   |                        |
|     ADDITIONAL |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|   NOTIFICATION |     |   |           |     |   |   |                        |
|     OF ANY     |     |   |           |     |   |   |                        |
|     AMENDMENTS |     |   |           |     |   |   |                        |
|     WILL BE    |     |   |           |     |   |   |                        |
|     PROVIDED   |     |   |           |     |   |   |                        |
|     BY THIS    |     |   |           |     |   |   |                        |
|     OFFICE.    |     |   |           |     |   |   |                        |
|     <h         |     |   |           |     |   |   |                        |
| ttp://www.fedb |     |   |           |     |   |   |                        |
| izopps.gov/>** |     |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
| 2.  **SECTION  |     |   |           |     |   |   |                        |
|     A --       |     |   |           |     |   |   |                        |
|     SOLICIT    |     |   |           |     |   |   |                        |
| ATION/CONTRACT |     |   |           |     |   |   |                        |
|     FORM \--   |     |   |           |     |   |   |                        |
|     PURCHASE   |     |   |           |     |   |   |                        |
|     AUTHORITY: |     |   |           |     |   |   |                        |
|     FAR        |     |   |           |     |   |   |                        |
|     1.602-1**  |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
| NOTE: The      |     |   |           |     |   |   |                        |
| issuance of    |     |   |           |     |   |   |                        |
| this           |     |   |           |     |   |   |                        |
| solicitation   |     |   |           |     |   |   |                        |
| does not       |     |   |           |     |   |   |                        |
| commit the     |     |   |           |     |   |   |                        |
| government to  |     |   |           |     |   |   |                        |
| an award.      |     |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
| 3.  **Issue    | 4.  |   |           |     |   |   | 5.  **Small Bus.       |
|     Date:**    |  ** |   |           |     |   |   |     Set-Aside:** \[    |
|                | Due |   |           |     |   |   |     \]Yes \[X\] No     |
| **September 6, |     |   |           |     |   |   |                        |
| 2006**         |  Da |   |           |     |   |   | > **8(a) Set-Aside:**  |
|                | te: |   |           |     |   |   | > \[ \]Yes \[X\] No    |
|                |     |   |           |     |   |   | >                      |
|                |  De |   |           |     |   |   | > **NAICS:** 541710    |
|                | cem |   |           |     |   |   | >                      |
|                | ber |   |           |     |   |   | > (See Part IV,        |
|                |     |   |           |     |   |   | > Section L.)          |
|                |  6, |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                | 200 |   |           |     |   |   |                        |
|                | 6** |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                | > * |   |           |     |   |   |                        |
|                | *Ti |   |           |     |   |   |                        |
|                | me: |   |           |     |   |   |                        |
|                | > 4 |   |           |     |   |   |                        |
|                | :00 |   |           |     |   |   |                        |
|                | >   |   |           |     |   |   |                        |
|                |  p. |   |           |     |   |   |                        |
|                | m., |   |           |     |   |   |                        |
|                | >   |   |           |     |   |   |                        |
|                |  ES |   |           |     |   |   |                        |
|                | T** |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
|                |     |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
| 6.  **Just In  |     | 7 |           |     |   | 8 |                        |
|     Time:**    |     | . |           |     |   | . |                        |
|                |     |   |           |     |   |   |                        |
| > \[X\] No     |     |   |           |     |   |   |                        |
| >              |     | * |           |     |   | * |                        |
| > \[ \] Yes    |     | * |           |     |   | * |                        |
| > (See Part    |     | N |           |     |   | T |                        |
| > IV, Section  |     | u |           |     |   | e |                        |
| > L.)          |     | m |           |     |   | c |                        |
|                |     | b |           |     |   | h |                        |
|                |     | e |           |     |   | n |                        |
|                |     | r |           |     |   | i |                        |
|                |     |   |           |     |   | c |                        |
|                |     |   |           |     |   | a |                        |
|                |     |   |           |     |   | l |                        |
|                |     |   |           |     |   |   |                        |
|                |     | o |           |     |   |   |                        |
|                |     | f |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   | P |                        |
|                |     |   |           |     |   | r |                        |
|                |     |   |           |     |   | o |                        |
|                |     | A |           |     |   | p |                        |
|                |     | w |           |     |   | o |                        |
|                |     | a |           |     |   | s |                        |
|                |     | r |           |     |   | a |                        |
|                |     | d |           |     |   | l |                        |
|                |     | s |           |     |   |   |                        |
|                |     | : |           |     |   |   |                        |
|                |     | * |           |     |   |   |                        |
|                |     | * |           |     |   |   |                        |
|                |     |   |           |     |   | P |                        |
|                |     | > |           |     |   | a |                        |
|                |     |   |           |     |   | g |                        |
|                |     | \ |           |     |   | e |                        |
|                |     | [ |           |     |   |   |                        |
|                |     | > |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     | \ |           |     |   |   |                        |
|                |     | ] |           |     |   | L |                        |
|                |     | > |           |     |   | i |                        |
|                |     |   |           |     |   | m |                        |
|                |     | O |           |     |   | i |                        |
|                |     | n |           |     |   | t |                        |
|                |     | l |           |     |   | s |                        |
|                |     | y |           |     |   | : |                        |
|                |     | > |           |     |   | * |                        |
|                |     |   |           |     |   | * |                        |
|                |     | 1 |           |     |   |   |                        |
|                |     | > |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     | A |           |     |   | \ |                        |
|                |     | w |           |     |   | [ |                        |
|                |     | a |           |     |   | > |                        |
|                |     | r |           |     |   |   |                        |
|                |     | d |           |     |   | \ |                        |
|                |     | > |           |     |   | ] |                        |
|                |     | > |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     | \ |           |     |   | N |                        |
|                |     | [ |           |     |   | o |                        |
|                |     | X |           |     |   | > |                        |
|                |     | \ |           |     |   | > |                        |
|                |     | ] |           |     |   |   |                        |
|                |     | > |           |     |   | \ |                        |
|                |     |   |           |     |   | [ |                        |
|                |     | M |           |     |   | X |                        |
|                |     | u |           |     |   | \ |                        |
|                |     | l |           |     |   | ] |                        |
|                |     | t |           |     |   | > |                        |
|                |     | i |           |     |   |   |                        |
|                |     | p |           |     |   | Y |                        |
|                |     | l |           |     |   | e |                        |
|                |     | e |           |     |   | s |                        |
|                |     | > |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     | A |           |     |   | ( |                        |
|                |     | w |           |     |   | [ |                        |
|                |     | a |           |     |   | S |                        |
|                |     | r |           |     |   | e |                        |
|                |     | d |           |     |   | e |                        |
|                |     | s |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   | S |                        |
|                |     |   |           |     |   | e |                        |
|                |     |   |           |     |   | c |                        |
|                |     |   |           |     |   | t |                        |
|                |     |   |           |     |   | i |                        |
|                |     |   |           |     |   | o |                        |
|                |     |   |           |     |   | n |                        |
|                |     |   |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   | J |                        |
|                |     |   |           |     |   | , |                        |
|                |     |   |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   | A |                        |
|                |     |   |           |     |   | t |                        |
|                |     |   |           |     |   | t |                        |
|                |     |   |           |     |   | a |                        |
|                |     |   |           |     |   | c |                        |
|                |     |   |           |     |   | h |                        |
|                |     |   |           |     |   | m |                        |
|                |     |   |           |     |   | e |                        |
|                |     |   |           |     |   | n |                        |
|                |     |   |           |     |   | t |                        |
|                |     |   |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   | 1 |                        |
|                |     |   |           |     |   | , |                        |
|                |     |   |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   | P |                        |
|                |     |   |           |     |   | a |                        |
|                |     |   |           |     |   | c |                        |
|                |     |   |           |     |   | k |                        |
|                |     |   |           |     |   | a |                        |
|                |     |   |           |     |   | g |                        |
|                |     |   |           |     |   | i |                        |
|                |     |   |           |     |   | n |                        |
|                |     |   |           |     |   | g |                        |
|                |     |   |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   | a |                        |
|                |     |   |           |     |   | n |                        |
|                |     |   |           |     |   | d |                        |
|                |     |   |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   | D |                        |
|                |     |   |           |     |   | e |                        |
|                |     |   |           |     |   | l |                        |
|                |     |   |           |     |   | i |                        |
|                |     |   |           |     |   | v |                        |
|                |     |   |           |     |   | e |                        |
|                |     |   |           |     |   | r |                        |
|                |     |   |           |     |   | y |                        |
|                |     |   |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   | o |                        |
|                |     |   |           |     |   | f |                        |
|                |     |   |           |     |   | > |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   | P |                        |
|                |     |   |           |     |   | r |                        |
|                |     |   |           |     |   | o |                        |
|                |     |   |           |     |   | p |                        |
|                |     |   |           |     |   | o |                        |
|                |     |   |           |     |   | s |                        |
|                |     |   |           |     |   | a |                        |
|                |     |   |           |     |   | l |                        |
|                |     |   |           |     |   | ) |                        |
|                |     |   |           |     |   | ] |                        |
|                |     |   |           |     |   | ( |                        |
|                |     |   |           |     |   | # |                        |
|                |     |   |           |     |   | S |                        |
|                |     |   |           |     |   | e |                        |
|                |     |   |           |     |   | c |                        |
|                |     |   |           |     |   | t |                        |
|                |     |   |           |     |   | i |                        |
|                |     |   |           |     |   | o |                        |
|                |     |   |           |     |   | n |                        |
|                |     |   |           |     |   | _ |                        |
|                |     |   |           |     |   | J |                        |
|                |     |   |           |     |   | ) |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
|                |     |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
| 9.  **Issued   |     |   | 10. \[X\] |     |   |   |                        |
|     By:**      |     |   |           |     |   |   |                        |
|                |     |   |   **NIAID |     |   |   |                        |
| Nancy M.       |     |   |           |     |   |   |                        |
| Hershey        |     |   |  reserves |     |   |   |                        |
|                |     |   |     the   |     |   |   |                        |
| Contract       |     |   |     right |     |   |   |                        |
| Specialist     |     |   |     to    |     |   |   |                        |
|                |     |   |     make  |     |   |   |                        |
| Office of      |     |   |           |     |   |   |                        |
| Acquisitions,  |     |   |    awards |     |   |   |                        |
| DEA, NIAID,    |     |   |           |     |   |   |                        |
| NIH            |     |   |   without |     |   |   |                        |
|                |     |   |     disc  |     |   |   |                        |
| 6700-B         |     |   | ussion.** |     |   |   |                        |
| Rockledge      |     |   |           |     |   |   |                        |
| Drive          |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
| Room 3214, MSC |     |   |           |     |   |   |                        |
| 7612           |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
| Bethesda, MD   |     |   |           |     |   |   |                        |
| 20892-7612     |     |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
|                |     |   | 11. **O   |     | 1 |   |                        |
|                |     |   | ptions:** |     | 2 |   |                        |
|                |     |   |           |     | . |   |                        |
|                |     |   | ##        |     |   |   |                        |
|                |     |   |  \[ \] No |     | * |   |                        |
|                |     |   |  {#no .un |     | * |   |                        |
|                |     |   | numbered} |     | P |   |                        |
|                |     |   |           |     | e |   |                        |
|                |     |   | > **\[ X  |     | r |   |                        |
|                |     |   | > \]      |     | i |   |                        |
|                |     |   | > Yes**   |     | o |   |                        |
|                |     |   | > (See    |     | d |   |                        |
|                |     |   | > Part    |     |   |   |                        |
|                |     |   | > IV,     |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   | Section   |     |   |   |                        |
|                |     |   | L.)       |     | o |   |                        |
|                |     |   |           |     | f |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | P |   |                        |
|                |     |   |           |     | e |   |                        |
|                |     |   |           |     | r |   |                        |
|                |     |   |           |     | f |   |                        |
|                |     |   |           |     | o |   |                        |
|                |     |   |           |     | r |   |                        |
|                |     |   |           |     | m |   |                        |
|                |     |   |           |     | a |   |                        |
|                |     |   |           |     | n |   |                        |
|                |     |   |           |     | c |   |                        |
|                |     |   |           |     | e |   |                        |
|                |     |   |           |     | : |   |                        |
|                |     |   |           |     | * |   |                        |
|                |     |   |           |     | * |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | > |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | 7 |   |                        |
|                |     |   |           |     | > |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | y |   |                        |
|                |     |   |           |     | e |   |                        |
|                |     |   |           |     | a |   |                        |
|                |     |   |           |     | r |   |                        |
|                |     |   |           |     | s |   |                        |
|                |     |   |           |     | > |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | b |   |                        |
|                |     |   |           |     | e |   |                        |
|                |     |   |           |     | g |   |                        |
|                |     |   |           |     | i |   |                        |
|                |     |   |           |     | n |   |                        |
|                |     |   |           |     | n |   |                        |
|                |     |   |           |     | i |   |                        |
|                |     |   |           |     | n |   |                        |
|                |     |   |           |     | g |   |                        |
|                |     |   |           |     | > |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | o |   |                        |
|                |     |   |           |     | n |   |                        |
|                |     |   |           |     | > |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | o |   |                        |
|                |     |   |           |     | r |   |                        |
|                |     |   |           |     | > |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | a |   |                        |
|                |     |   |           |     | b |   |                        |
|                |     |   |           |     | o |   |                        |
|                |     |   |           |     | u |   |                        |
|                |     |   |           |     | t |   |                        |
|                |     |   |           |     | > |   |                        |
|                |     |   |           |     | > |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | * |   |                        |
|                |     |   |           |     | * |   |                        |
|                |     |   |           |     | J |   |                        |
|                |     |   |           |     | u |   |                        |
|                |     |   |           |     | l |   |                        |
|                |     |   |           |     | y |   |                        |
|                |     |   |           |     | > |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | 2 |   |                        |
|                |     |   |           |     | 3 |   |                        |
|                |     |   |           |     | , |   |                        |
|                |     |   |           |     | > |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | 2 |   |                        |
|                |     |   |           |     | 0 |   |                        |
|                |     |   |           |     | 0 |   |                        |
|                |     |   |           |     | 7 |   |                        |
|                |     |   |           |     | * |   |                        |
|                |     |   |           |     | * |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | # |   |                        |
|                |     |   |           |     | # |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | { |   |                        |
|                |     |   |           |     | # |   |                        |
|                |     |   |           |     | s |   |                        |
|                |     |   |           |     | e |   |                        |
|                |     |   |           |     | c |   |                        |
|                |     |   |           |     | t |   |                        |
|                |     |   |           |     | i |   |                        |
|                |     |   |           |     | o |   |                        |
|                |     |   |           |     | n |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |     | . |   |                        |
|                |     |   |           |     | u |   |                        |
|                |     |   |           |     | n |   |                        |
|                |     |   |           |     | n |   |                        |
|                |     |   |           |     | u |   |                        |
|                |     |   |           |     | m |   |                        |
|                |     |   |           |     | b |   |                        |
|                |     |   |           |     | e |   |                        |
|                |     |   |           |     | r |   |                        |
|                |     |   |           |     | e |   |                        |
|                |     |   |           |     | d |   |                        |
|                |     |   |           |     | } |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
| 13. Primary    |     |   | 14. **    |     |   |   | 15. **Protest          |
|     Point of   |     |   | Secondary |     |   |   |     Officer:**         |
|     Contact:   |     |   |     Point |     |   |   |                        |
|                |     |   |     of    |     |   |   | > Charles Grewe        |
| Name : Nancy   |     |   |     C     |     |   |   | >                      |
| Hershey        |     |   | ontact:** |     |   |   | > Director, OA         |
|                |     |   |           |     |   |   | >                      |
| Phone:         |     |   | Name:     |     |   |   | > Address (See Block   |
| 1-301-496-0193 |     |   | Eileen    |     |   |   | > 9.)                  |
|                |     |   | Webst     |     |   |   |                        |
| Fax:           |     |   | er-Cissel |     |   |   |                        |
| 301-402-0972   |     |   |           |     |   |   |                        |
|                |     |   | Phone:    |     |   |   |                        |
| E-Mail:        |     |   | 301       |     |   |   |                        |
| <nhershey@     |     |   | -496-0349 |     |   |   |                        |
| niaid.nih.gov> |     |   |           |     |   |   |                        |
|                |     |   | Fax:      |     |   |   |                        |
|                |     |   | 301       |     |   |   |                        |
|                |     |   | -402-0972 |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   | E-Mail:   |     |   |   |                        |
|                |     |   | <         |     |   |   |                        |
|                |     |   | ewc@niaid |     |   |   |                        |
|                |     |   | .nih.gov> |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
| 16. **COLLECT  |     |   |           |     |   |   |                        |
|     CALLS WILL |     |   |           |     |   |   |                        |
|     NOT BE     |     |   |           |     |   |   |                        |
|     ACCEPTED.  |     |   |           |     |   |   |                        |
|     FACSIMILE  |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|    SUBMISSIONS |     |   |           |     |   |   |                        |
|     ARE NOT    |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|  ACCEPTABLE.** |     |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
| 17. Offers     |     |   |           |     |   |   |                        |
|     will be    |     |   |           |     |   |   |                        |
|     valid for  |     |   |           |     |   |   |                        |
|     120 days   |     |   |           |     |   |   |                        |
|     unless a   |     |   |           |     |   |   |                        |
|     different  |     |   |           |     |   |   |                        |
|     period is  |     |   |           |     |   |   |                        |
|     specified  |     |   |           |     |   |   |                        |
|     by the     |     |   |           |     |   |   |                        |
|     Offeror on |     |   |           |     |   |   |                        |
|     the form   |     |   |           |     |   |   |                        |
|     entitled   |     |   |           |     |   |   |                        |
|     "Proposal  |     |   |           |     |   |   |                        |
|     Summary    |     |   |           |     |   |   |                        |
|     and Data   |     |   |           |     |   |   |                        |
|     Record,    |     |   |           |     |   |   |                        |
|     NIH-2043\" |     |   |           |     |   |   |                        |
|     (See Part  |     |   |           |     |   |   |                        |
|     III,       |     |   |           |     |   |   |                        |
|     SECTION J  |     |   |           |     |   |   |                        |
|     --         |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|   Attachments) |     |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
|                |     |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
| 18. DELIVERY   |     |   |           |     |   |   |                        |
|     ADDRESS    |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|    INFORMATION |     |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
| 19. Hand       |     |   |           | 20  |   |   |                        |
|     Delivery   |     |   |           | . U |   |   |                        |
|     or         |     |   |           | .S. |   |   |                        |
|     Overnight  |     |   |           |     |   |   |                        |
|     Service:   |     |   |           |     |   |   |                        |
|                |     |   |           | Pos |   |   |                        |
| Nancy M.       |     |   |           | tal |   |   |                        |
| Hershey        |     |   |           |     |   |   |                        |
|                |     |   |           |   S |   |   |                        |
| Office of      |     |   |           | erv |   |   |                        |
| Acquisitions   |     |   |           | ice |   |   |                        |
|                |     |   |           |     |   |   |                        |
| DEA, NIAID,    |     |   |           |  or |   |   |                        |
| NIH            |     |   |           |     |   |   |                        |
|                |     |   |           |  an |   |   |                        |
| 6700-B         |     |   |           |     |   |   |                        |
| Rockledge      |     |   |           |   E |   |   |                        |
| Drive, Room    |     |   |           | xpr |   |   |                        |
| 3214, MSC 7612 |     |   |           | ess |   |   |                        |
|                |     |   |           |     |   |   |                        |
| Bethesda, MD   |     |   |           |  De |   |   |                        |
| 20817-7612     |     |   |           | liv |   |   |                        |
|                |     |   |           | ery |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           |   S |   |   |                        |
|                |     |   |           | erv |   |   |                        |
|                |     |   |           | ice |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           | Na  |   |   |                        |
|                |     |   |           | ncy |   |   |                        |
|                |     |   |           | M.  |   |   |                        |
|                |     |   |           | H   |   |   |                        |
|                |     |   |           | ers |   |   |                        |
|                |     |   |           | hey |   |   |                        |
|                |     |   |           |     |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | Off |   |   |                        |
|                |     |   |           | ice |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           |  of |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | Acq |   |   |                        |
|                |     |   |           | uis |   |   |                        |
|                |     |   |           | iti |   |   |                        |
|                |     |   |           | ons |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | > D |   |   |                        |
|                |     |   |           | EA, |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | NIA |   |   |                        |
|                |     |   |           | ID, |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | NIH |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | 670 |   |   |                        |
|                |     |   |           | 0-B |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | Roc |   |   |                        |
|                |     |   |           | kle |   |   |                        |
|                |     |   |           | dge |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | Dri |   |   |                        |
|                |     |   |           | ve, |   |   |                        |
|                |     |   |           | > R |   |   |                        |
|                |     |   |           | oom |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           |  32 |   |   |                        |
|                |     |   |           | 14, |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | MSC |   |   |                        |
|                |     |   |           | > 7 |   |   |                        |
|                |     |   |           | 612 |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           | Bet |   |   |                        |
|                |     |   |           | hes |   |   |                        |
|                |     |   |           | da, |   |   |                        |
|                |     |   |           | >   |   |   |                        |
|                |     |   |           |  MD |   |   |                        |
|                |     |   |           | > 2 |   |   |                        |
|                |     |   |           | 089 |   |   |                        |
|                |     |   |           | 2-7 |   |   |                        |
|                |     |   |           | 612 |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+
| 21. The        |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|    **[Official |     |   |           |     |   |   |                        |
|     Point of   |     |   |           |     |   |   |                        |
|     Receipt]   |     |   |           |     |   |   |                        |
| {.underline}** |     |   |           |     |   |   |                        |
|     for the    |     |   |           |     |   |   |                        |
|     purpose of |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|    determining |     |   |           |     |   |   |                        |
|     timely     |     |   |           |     |   |   |                        |
|     delivery   |     |   |           |     |   |   |                        |
|     is the     |     |   |           |     |   |   |                        |
|     address    |     |   |           |     |   |   |                        |
|     provided   |     |   |           |     |   |   |                        |
|     in Block   |     |   |           |     |   |   |                        |
|     19, above. |     |   |           |     |   |   |                        |
|     The        |     |   |           |     |   |   |                        |
|     original   |     |   |           |     |   |   |                        |
|     paper copy |     |   |           |     |   |   |                        |
|     with       |     |   |           |     |   |   |                        |
|     original   |     |   |           |     |   |   |                        |
|     signatures |     |   |           |     |   |   |                        |
|     is the     |     |   |           |     |   |   |                        |
|     official   |     |   |           |     |   |   |                        |
|     copy for   |     |   |           |     |   |   |                        |
|     recording  |     |   |           |     |   |   |                        |
|     timely     |     |   |           |     |   |   |                        |
|     receipt.   |     |   |           |     |   |   |                        |
|     If the     |     |   |           |     |   |   |                        |
|     original   |     |   |           |     |   |   |                        |
|     paper copy |     |   |           |     |   |   |                        |
|     of your    |     |   |           |     |   |   |                        |
|     proposal   |     |   |           |     |   |   |                        |
|     is not     |     |   |           |     |   |   |                        |
|     received   |     |   |           |     |   |   |                        |
|     by the     |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|    Contracting |     |   |           |     |   |   |                        |
|     Officer or |     |   |           |     |   |   |                        |
|     Designee   |     |   |           |     |   |   |                        |
|     at the     |     |   |           |     |   |   |                        |
|     place and  |     |   |           |     |   |   |                        |
|     time       |     |   |           |     |   |   |                        |
|     specified, |     |   |           |     |   |   |                        |
|     then it    |     |   |           |     |   |   |                        |
|     will be    |     |   |           |     |   |   |                        |
|     considered |     |   |           |     |   |   |                        |
|     late and   |     |   |           |     |   |   |                        |
|     handled in |     |   |           |     |   |   |                        |
|     accordance |     |   |           |     |   |   |                        |
|     with FAR   |     |   |           |     |   |   |                        |
|     15.208     |     |   |           |     |   |   |                        |
|     entitled   |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|  \"Submission, |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|  Modification, |     |   |           |     |   |   |                        |
|     Revision,  |     |   |           |     |   |   |                        |
|     and        |     |   |           |     |   |   |                        |
|     Withdrawal |     |   |           |     |   |   |                        |
|     of         |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|   Proposals.\" |     |   |           |     |   |   |                        |
|     FACSIMILE  |     |   |           |     |   |   |                        |
|     AND E-MAIL |     |   |           |     |   |   |                        |
|     SUBMISSION |     |   |           |     |   |   |                        |
|     OF         |     |   |           |     |   |   |                        |
|     PROPOSALS  |     |   |           |     |   |   |                        |
|     IS NOT     |     |   |           |     |   |   |                        |
|                |     |   |           |     |   |   |                        |
|    ACCEPTABLE. |     |   |           |     |   |   |                        |
+----------------+-----+---+-----------+-----+---+---+------------------------+

Updated thru FAC 05-07

DETAILED TABLE OF RFP CONTENTS

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
[5](#__RefHeading___Toc142909245)

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
[5](#__RefHeading___Toc142909246)

ARTICLE B.2. PRICES/COSTS [5](#__RefHeading___Toc142909247)

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS
[5](#__RefHeading___Toc142909248)

ARTICLE B.4. ADVANCE UNDERSTANDINGS [5](#__RefHeading___Toc142909249)

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK
[5](#__RefHeading___Toc142909250)

ARTICLE C.1. STATEMENT OF WORK [5](#__RefHeading___Toc142909251)

ARTICLE C.2. REPORTING REQUIREMENTS [6](#__RefHeading___Toc142909252)

SECTION D - PACKAGING, MARKING AND SHIPPING
[6](#__RefHeading___Toc142909253)

SECTION E - INSPECTION AND ACCEPTANCE [6](#__RefHeading___Toc142909254)

SECTION F - DELIVERIES OR PERFORMANCE [6](#__RefHeading___Toc142909255)

ARTICLE F.1. DELIVERIES [6](#__RefHeading___Toc142909256)

ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE
[7](#__RefHeading___Toc142909258)

SECTION G - CONTRACT ADMINISTRATION DATA
[7](#__RefHeading___Toc142909259)

ARTICLE G.1. PROJECT OFFICER [7](#__RefHeading___Toc142909260)

ARTICLE G.2. KEY PERSONNEL [7](#__RefHeading___Toc142909261)

ARTICLE G.3. LETTER OF CREDIT PAYMENT INFORMATION. . . . . . . . . . . .
. . . . . . . . . . . . . 8

ARTICLE G.4. CONTRACT FINANCIAL REPORT 8

ARTICLE G.5. INDIRECT COST RATES 10

ARTICLE G.6. GOVERNMENT PROPERTY 11

ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE 11

SECTION H - SPECIAL CONTRACT REQUIREMENTS
[12](#__RefHeading___Toc142909270)

ARTICLE H.1. HUMAN SUBJECTS [12](#__RefHeading___Toc142909271)

ARTICLE H.2. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)
[12](#__RefHeading___Toc142909272)

ARTICLE H.3. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
[12](#__RefHeading___Toc142909273)

ARTICLE H.4. NEEDLE EXCHANGE [13](#__RefHeading___Toc142909274)

ARTICLE H.5. OPTION PROVISION [13](#__RefHeading___Toc142909275)

ARTICLE H.6. SUBCONTRACTING PROVISIONS
[13](#__RefHeading___Toc142909276)

ARTICLE H.7. SALARY RATE LIMITATION LEGISLATION PROVISIONS
[14](#__RefHeading___Toc142909278)

ARTICLE H.8. INFORMATION SECURITY 15

ARTICLE H.9. ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS 17

ARTICLE H.10. YEAR 2000 COMPLIANCE 17

ARTICLE H.11. PUBLICATION AND PUBLICITY 18

ARTICLE H.12. CONFIDENTIALITY OF INFORMATION 19

ARTICLE H.13. PRESS RELEASES 19

ARTICLE H.14. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE 19

ARTICLE H.15. ANTI-LOBBYING 19

ARTICLE H.16. SHARING RESEARCH DATA 20

ARTICLE H.17. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED
PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH 20

ARTICLE H.18. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)
[20](#__RefHeading___Toc142909287)

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES [21](#__RefHeading___Toc142909288)

ARTICLE I.I. GENERAL CLAUSE LISTING 21

ARTICLE I.2. AUTHORIZED SUBSTITION OF
CLAUSES.......................................... 21

ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES 21

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT 22

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF
ATTACHMENTS.............................................................................25

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF
OFFERORS 27

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS 28

EVALUATION FACTORS PART A 61

EVALUATION FACTORS PART B 64

SOLICITATION ATTACHMENTS INCLUDED WITH THE RFP 68

PART I - THE SCHEDULE

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN,

> CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS
> **NOT** AN EXACT REPRESENTATION OF THE PROPOSED CONTRACT DOCUMENT.
> CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (I.E., THOSE RELATING
> TO THE ORGANIZATIONAL STRUCTURE \[E.G., NON-PROFIT, COMMERCIAL\] AND
> SPECIFIC COST AUTHORIZATIONS UNIQUE TO THE OFFEROR\'S PROPOSAL AND
> REQUIRING CONTRACTING OFFICER PRIOR APPROVAL) WILL BE DISCUSSED IN THE
> NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT.
> HOWEVER, THE ENCLOSED CONTRACT SCHEDULE PROVIDES ALL THE NECESSARY
> INFORMATION FOR THE OFFEROR TO UNDERSTAND THE TERMS AND CONDITIONS OF
> THE RESULTANT CONTRACT.

[]{#__RefHeading___Toc142909245 .anchor}SECTION B - SUPPLIES OR SERVICES
AND PRICES/COSTS

[]{#__RefHeading___Toc142909246 .anchor}**ARTICLE B.1. BRIEF DESCRIPTION
OF SUPPLIES OR SERVICES**

The Division of AIDS (DAIDS), National Institute of Allergy and
Infectious Diseases (NIAID), National Institutes of Health (NIH), has a
requirement for the In Vitro Testing Resources for AIDS Therapeutics
Development.

THERE ARE TWO SEPARATE PARTS TO THIS SOLICITATION AND SEPARATE PROPOSALS
ARE SOLICITED FOR EACH PART. OFFERORS MAY RESPOND TO EITHER PART A OR
PART B, OR TO BOTH, BUT EACH PART MUST BE SUBMITTED AS A SEPARATE STAND
ALONE PROPOSAL. PROPOSALS FOR **PART A: CONFIRMATORY IN VITRO
EVALUATIONS OF HIV THERAPEUTICS** SHALL ADDRESS ALL ISSUES PRESENTED
BELOW PERTAINING TO PART A ONLY. SIMILARLY, PROPOSALS FOR **PART B:
SPECIALIZED IN VITRO VIROLOGICAL ASSAYS FOR HIV THERAPEUTICS AND TOPICAL
MICROBICIDES** SHALL ADDRESS ALL ISSUES PRESENTED BELOW PERTAINING TO
PART B ONLY. ANY PROPOSAL WHICH COMBINES BOTH PART A AND PART B IN THE
SAME PROPOSAL WILL BE RETURNED TO THE OFFEROR WITHOUT REVIEW OR FURTHER
CONSIDERATION.

[]{#__RefHeading___Toc142909247 .anchor}**ARTICLE B.2. PRICES/COSTS**

The final contract will contain the price/cost provisions agreed upon by
the Government and the Offeror.

[]{#__RefHeading___Toc142909248 .anchor}**ARTICLE B.3. PROVISIONS
APPLICABLE TO DIRECT COSTS**

This Article will prohibit or restrict the use of contract funds, unless
otherwise approved by the Contracting Officer. The following is a list
of items that may be included in the resultant contract as
applicable. 1) Acquisition, by purchase or lease, of any interest in
real property; 2) Special rearrangement or alteration of facilities; 3)
Purchase or lease of [any]{.underline} item of general purpose office
furniture or office equipment regardless of dollar value; 4) Travel
Costs; 5) Consultant Costs; 6) Subcontract Costs; 7) Patient Care Costs;
8) Accountable Government Property; and, 9) Research Funding.

[]{#__RefHeading___Toc142909249 .anchor}**ARTICLE B.4. ADVANCE
UNDERSTANDINGS**

Specific elements of cost, which normally require prior written approval
of the Contracting Officer before incurrence of the cost (e.g., foreign
travel, consultant fees, subcontracts) will be included in this Article
if the Contracting Officer has granted his/her approval prior to
contract award.

[]{#__RefHeading___Toc142909250 .anchor}SECTION C -
DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK

[]{#__RefHeading___Toc142909251 .anchor}**ARTICLE C.1. STATEMENT OF
WORK**

a\. Independently, and not as an agent of the Government, the Contractor
shall be required to furnish all the necessary services, qualified
personnel, material, equipment, and facilities, not otherwise provided
by the Government, as needed to perform the Statement of Work, dated
September 6, 2006, attached hereto and made a part of this Solicitation
**(See Section J - Attachments 4 and 7).**

[]{#__RefHeading___Toc142909252 .anchor}**ARTICLE C.2. REPORTING
REQUIREMENTS**

a.  Reporting Requirements and Deliverables

    In addition to the required reports set forth elsewhere in this
    Schedule, the preparation and submission of regularly recurring
    Technical Progress Reports will be required in any contract
    resulting from this solicitation. These reports will require
    descriptive information about the activities undertaken during the
    reporting period and will require information about planned
    activities for future reporting periods. **\[See Attachment 10 --
    "Reporting Requirements and Deliverables for Part A and B"\].**

[]{#__RefHeading___Toc142909253 .anchor}SECTION D - PACKAGING, MARKING
AND SHIPPING

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

[]{#__RefHeading___Toc142909254 .anchor}SECTION E - INSPECTION AND
ACCEPTANCE

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

b\. For the purpose of this SECTION, the Project Officer (named upon
award) is the authorized representative of the Contracting Officer.

c\. Inspection and acceptance will be performed at (named upon award).

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

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

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

[]{#__RefHeading___Toc142909255 .anchor}SECTION F - DELIVERIES OR
PERFORMANCE

[]{#__RefHeading___Toc142909256 .anchor}**ARTICLE F.1. DELIVERIES**

Satisfactory performance of the final contract shall be deemed to occur
upon performance of the work described in Article C.1. and upon delivery
and acceptance by the Contracting Officer, or the duly authorized
representative, of the following items in SECTION C, ARTICLE C.2., in
accordance with the stated delivery schedules **\[See Attachment 10 --
"Reporting Requirements and Deliverables for Part A and B"\].**

a.  The items specified below as described in SECTION C, ARTICLE C.2.
    will be required to be delivered F.O.B.Destination as set forth in
    FAR Clause 52.247-35, F.O.B. Destination, Within Consignees Premises
    (April 1984), and in accordance with and by the date(s) specified in

> SECTION C, ARTICLE C.2.and any specifications stated in [SECTION D,
> PACKAGING]{.underline}, [MARKING AND SHIPPING]{.underline}, of the
> contract.

[]{#__RefHeading___Toc142909258 .anchor}**ARTICLE F.2. CLAUSES
INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)**

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

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

**52.242-15, Stop Work Order** (August 1989) with **Alternate I** (April
1984).

[]{#__RefHeading___Toc142909259 .anchor}SECTION G - CONTRACT
ADMINISTRATION DATA

[]{#__RefHeading___Toc142909260 .anchor}**ARTICLE G.1. PROJECT OFFICER**

The following Project Officer(s) will represent the Government for the
purpose of this contract:

\[To be specified prior to award\]

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

The Contracting Officer is the only person with authority to act as
agent of the Government under this contract. Only the Contracting
Officer has authority to: (1) direct or negotiate any changes in the
statement of work; (2) modify or extend the period of performance; (3)
change the delivery schedule; (4) authorize reimbursement to the
Contractor any costs incurred during the performance of this contract;
or, (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its Project Officer designation.

[]{#__RefHeading___Toc142909261 .anchor}**ARTICLE G.2. KEY PERSONNEL**

Pursuant to the Key Personnel clause incorporated in this contract, the
following individual(s) is/are considered to be essential to the work
being performed hereunder:

  --------------------- ------------------------- -----------------------
  **NAME**                                        **TITLE**

                        \[To be specified prior   
                        to award\]\]              
  --------------------- ------------------------- -----------------------

**ARTICLE G.3. LETTER OF CREDIT PAYMENT INFORMATION**

a\. Advance payments will be provided under Letter of Credit Number in
accordance with Alternate V, Advance Payments Without Special Bank
Account, of FAR Clause 52.232-12, Advance Payments. This clause is
provided in full text in Article I.4. of this contract.

> The Contractor shall withdraw funds pursuant to Department of Treasury
> Circular 1075 (31 CFR Part 205,
> <http://www.access.gpo.gov/nara/cfr/waisidx_00/31cfr205_00.html> ).

(1) Invoice/Financing Request Instructions for NIH Cost-Reimbursement
    Type Contracts, NIH(RC)-1, are attached and made a part of this
    contract for the submission of completion and/or final invoices. The
    invoice instructions and the following directions for the submission
    of invoices/financing requests must be followed to meet the
    requirements of a \"proper\" invoice, pursuant to FAR 32.9. The
    completion and/or final invoice shall be submitted as follows:

An original and two copies to the following office:

Contracting Officer

Office of Acquisitions

DEA, NIAID, NIH, DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612

Bethesda, Maryland 20892-7612

(Express Mail: Bethesda, MD 20817)

(1) Inquiries regarding payments should be directed to the following
    office administering advance payments:

> Division of Payment Management

11400 Rockville Pike

Rockwall Building #1, Suite 700

Rockville, MD 20852

(<http://www.dpm.psc.gov/> under Contacts)

b\. The Contractor shall include the following certification on every
invoice for reimbursable costs incurred with Fiscal Year funds subject
to the salary rate limitation provisions as specified in ARTICLE H.7.of
this contract. For billing purposes, certified invoices are required for
the billing period during which the applicable Fiscal Year funds were
initially charged through the final billing period utilizing the
applicable Fiscal Year funds:

> \"I hereby certify that the salaries charged in this invoice are in
> compliance with P.L. \[cite the applicable Public Law Number for the
> applicable Fiscal Year as stated in ARTICLE H.7.\] and ARTICLE H.7.of
> the above referenced contract.\"

**ARTICLE G.4. CONTRACT FINANCIAL REPORT**

a\. Financial reports on the attached Form NIH 2706, Financial Report of
Individual

Project/Contract, shall be submitted by the Contractor in accordance
with the Instructions for Completing Form NIH 2706, which accompany the
form, in an original and two copies, not later than the 30th working day
after the close of the reporting period. The line entries for
subdivisions of work and elements of cost (expenditure categories) which
shall be reported within the total

> contract are listed in paragraph e., below. Subsequent changes and/or
> additions in the line entries shall be made in writing.

b\. Unless otherwise stated in that part of the Instructions for
Completing Form NIH 2706, entitled \"**PREPARATION INSTRUCTIONS**,\" all
columns A through J, shall be completed for each report submitted.

c\. The first financial report shall cover the period consisting of the
(FIRST FULL CALENDAR MONTH/FIRST FULL THREE CALENDAR MONTHS) following
the date of the contract, in addition to any fractional part of the
initial month. Thereafter, reports will be due on a quarterly basis.

d\. The Contracting Officer may require the Contractor to submit
detailed support for costs contained in one or more interim financial
reports. This clause does not supersede the record retention
requirements in FAR Part 4.7.

e\. The following is a listing of expenditure categories to be reported:

f\. The Government may unilaterally revise the NIH 2706 to reflect the
allotment of additional funds.

**ARTICLE G.5. INDIRECT COST RATES *\[Only applicable to profit making
organizations\]***

In accordance with Federal Acquisition Regulation (FAR) (48 CFR
Chapter 1) Clause 52.216-7(d)(2), \"Allowable Cost and Payment\"
incorporated by reference in this contract in Part II, Section I, the

cognizant Contracting Officer representative responsible for negotiating
provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services

Office of Acquisition Management and Policy

National Institutes of Health

6100 Building, Room 6B05

6100 EXECUTIVE BLVD MSC 7540

BETHESDA MD 20892-7540

These rates are hereby incorporated without further action of the
Contracting Officer.

**ARTICLE G.6. GOVERNMENT PROPERTY**

If this RFP will result in the acquisition or use of Government Property
provided by the contracting agency or if the Contracting Officer
authorizes in the preaward negotiation process, the acquisition of
property (other than real property), this ARTICLE will include
applicable provisions and incorporate the DHHS Publication (OS) 686,
entitled, **Contractor\'s Guide for Control of Government Property**,
which can be found at:

**ARTICLE G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE**

a\. [Contractor Performance Evaluations]{.underline}

> Interim and final evaluations of Contractor performance will be
> prepared on this contract in accordance with FAR 42.15. The final
> performance evaluation will be prepared at the time of completion of
> work. In addition to the final evaluation, interim evaluations may be
> prepared Year 1, Year 3 and Year 5 to coincide with the anniversary
> date of the contract.
>
> Interim and final evaluations will be provided to the Contractor as
> soon as practicable after completion of the evaluation. The Contractor
> will be permitted thirty days to review the document and to submit
> additional information or a rebutting statement. If agreement cannot
> be reached between the parties, the matter will be referred to an
> individual one level above the Contracting Officer, whose decision
> will be final.
>
> Copies of the evaluations, Contractor responses, and review comments,
> if any, will be retained as part of the contract file, and may be used
> to support future award decisions.

b\. [Electronic Access to Contractor Performance
Evaluations]{.underline}

> Contractors that have Internet capability may access evaluations
> through a secure Web site for review and comment by completing the
> registration form that can be obtained at the following address:
>
> The registration process requires the Contractor to identify an
> individual that will serve as a primary contact and who will be
> authorized access to the evaluation for review and comment. In
> addition, the Contractor will be required to identify an alternate
> contact who will be responsible for notifying the cognizant
> Contracting Official in the event the primary contact is unavailable
> to process the evaluation within the required 30-day time frame.

[]{#__RefHeading___Toc142909270 .anchor}SECTION H - SPECIAL CONTRACT
REQUIREMENTS

[]{#__RefHeading___Toc142909271 .anchor}**ARTICLE H.1. HUMAN SUBJECTS**

It is hereby understood and agreed that research involving human
subjects shall not be conducted under this contract, and that no
material developed, modified, or delivered by or to the Government under
this contract, or any subsequent modification of such material, will be
used by the Contractor or made available by the Contractor for use by
anyone other than the Government, for experimental or therapeutic use
involving humans without the prior written approval of the Contracting
Officer.

[]{#__RefHeading___Toc142909272 .anchor}**ARTICLE H.2. HUMAN MATERIALS
(ASSURANCE OF OHRP COMPLIANCE)**

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

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

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

[]{#__RefHeading___Toc142909273 .anchor}**ARTICLE H.3. CONTINUED BAN ON
FUNDING OF HUMAN EMBRYO RESEARCH**

a\. Pursuant to Public Law(s) cited in paragraph b., below, NIH is
prohibited from using appropriated funds to support human embryo
research. Contract funds may not be used 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.

  ---------------------------- ------------- ----------------------------
  b\. **Public Law and Section **Fiscal      **Period Covered**
  No.**                        Year**        

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

*\[Applicable information to be included at award\]*

[]{#__RefHeading___Toc142909274 .anchor}**ARTICLE H.4. NEEDLE EXCHANGE**

a\. Pursuant to Public Law(s) cited in paragraph b., below, contract
funds shall not be used to carry out any program of distributing sterile
needles or syringes for the hypodermic injection of any illegal drug.

  ----------------------------- ------------- ---------------------------
  **b. Public Law and Section   **Fiscal      **Period Covered**
  Number**                      Year**        

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

*\[Applicable information to be included at award\]*

[]{#__RefHeading___Toc142909275 .anchor}**ARTICLE H.5. OPTION
PROVISION**

Unless the Government exercises its option pursuant to the Option Clause
set forth in ARTICLE I.3., the contract will consist only of seven (7)
years of the Statement of Work as defined in Sections C and F of the
contract. Pursuant to clause 52.217- 6 set forth in ARTICLE I.3. of this
contract, the Government may, by unilateral contract modification,
require the Contractor to perform the options in the Statement of Work
as also defined in Sections C and F of this contract. If the Government
exercises this option, notice must be given at least 60 days prior to
the expiration date of this contract, and the estimated cost plus fixed
fee of the contract will be increased as set forth in Article B.2.

[]{#__RefHeading___Toc142909276 .anchor}**ARTICLE H.6. SUBCONTRACTING
PROVISIONS**

**a. Small Business Subcontracting Plan**

> \(1\) The Small Business Subcontracting Plan, dated *to be determined
> during negotiations* is attached hereto and made a part of this
> contract.
>
> \(2\) The failure of any Contractor or Subcontractor to comply in good
> faith with FAR Clause 52.219-8, entitled \"Utilization of Small
> Business Concerns\" incorporated in this contract and the attached
> Subcontracting Plan, will be a material breach of such contract or
> subcontract and subject to the remedies reserved to the Government
> under FAR Clause 52.219-16 entitled, \"Liquidated
> Damages-Subcontracting Plan.\"

**b. Subcontracting Reports**

> The Contractor shall submit the following Subcontracting reports
> electronically via the \"electronic Subcontracting Reporting System
> (eSRS) at [http://www.esrs.gov](http://www.esrs.gov/).
>
> \(1\) Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be
submitted on the following dates for the entire life of this contract:

April 30th

October 30th

> \(2\) Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary
Subcontract Report shall be submitted annually on the following date for
the entire life of this contract:

October 30^th^

> For both the Individual and Summary Subcontract Reports, the Contract
> Specialist shall be included as a contact for notification purposes at
> the following e-mail address:

<nhershey@.nih.gov>

Nancy M. Hershey, Contract Specialist

Office of Acquisitions, DEA, NIAID, NIH, DHHS

***\[NOTE: The following ARTICLE will be revised accordingly in the
resultant contract to comply with the applicable Fiscal Year 2007 Public
Law covering the period 10/01/06-09/30/07\].***

[]{#__RefHeading___Toc142909278 .anchor}**ARTICLE H.7. SALARY RATE
LIMITATION LEGISLATION PROVISIONS**

a\. Pursuant to the P.L.(s) cited in paragraph b., below, no NIH Fiscal
Year funds may be used to pay the direct salary of an individual through
this contract at a rate in excess of the applicable amount shown or the
applicable Executive Level for the fiscal year covered. 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 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 per year 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\. **Public Law | **Fiscal Year**      | **Dollar Amount of**      |
| No.**            |                      |                           |
|                  |                      | **Salary Limitation\***   |
+------------------+----------------------+---------------------------+

*\[Applicable information to be included at award\]*

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.)*

**ARTICLE H.8. INFORMATION SECURITY**

The Statement of Work (SOW) requires the Contractor to (1) develop, (2)
have the ability to access, or (3) host and/or maintain a Federal
information system(s). Pursuant to Federal and HHS Information Security
Program Policies, the Contractor and any Subcontractor performing under
this contract shall comply with the following requirements:

Federal Information Security Management Act of 2002 (FISMA), Title III,
E‑Government Act of 2002, Pub. L. No. 107‑347 (Dec. 17, 2002);
[http://csrc.nist.gov/policies/FISMA‑final.pdf]{.underline}

a\. [Information Type]{.underline}

**\[ \]** Administrative, Management and Support Information:

**\[X\]** Mission Based Information:

b\. [Security Categories and Levels]{.underline}

Confidentiality Level: **\[X\]** Low **\[ \]** Moderate **\[ \]** High

Integrity Level: **\[X\]** Low **\[ \]** Moderate **\[ \]** High

> Availability Level: **\[X\]** Low **\[ \]** Moderate **\[ \]** High
>
> **Overall Level: \[X\] Low \[ \] Moderate \[ \] High**

c\. [Position Sensitivity Designations]{.underline}

> \(1\) The following position sensitivity designations and associated
> clearance and investigation requirements apply under this contract.
>
> **\[X\]** **Level 1: Non Sensitive (Requires Suitability Determination
> with an NACI)**. Contractor employees assigned to a Level 1 position
> are subject to a National Agency Check and Inquiry Investigation
> (NACI).
>
> \(2\) The Contractor shall submit a roster, by name, position and
> responsibility, of all staff (including Subcontractor staff) working
> under the contract who will develop, have the ability to access, or
> host and/or maintain a Federal information system(s). The roster shall
> be submitted to the Project Officer, with a copy to the Contracting
> Officer, within 14 calendar days of the effective date of the
> contract. Any revisions to the roster as a result of staffing changes
> shall be submitted within 15 calendar days of the change. The
> Contracting Officer shall notify the Contractor of the appropriate
> level of suitability investigations to be performed. An electronic
> template, \"Roster of Employees Requiring Suitability
> Investigations,\" is available for Contractor use at:
> [http://ais.nci.nih.gov/forms/Suitability‑roster.xls]{.underline}.
>
> Upon receipt of the Government\'s notification of applicable
> Suitability Investigations required, the contractor shall complete and
> submit the required forms within 30 days of the notification.
> Additional submission instructions can be found at the \"NCI
> Information Technology Security Policies, Background Investigation
> Process\" website: [http://ais.nci.nih.gov]{.underline}.
>
> Contractor/Subcontractor employees who have met investigative
> requirements within the past five years may only require an updated or
> upgraded investigation.
>
> \(3\) Contractor/Subcontractor employees shall comply with the HHS
> criteria for the assigned position sensitivity designations prior to
> performing any work under this contract. The following exceptions
> apply:
>
> Levels 5 and 1: Contractor/Subcontractor employees may begin work
> under the contract after the Contractor has submitted the name,
> position and responsibility of the employee to the Project Officer, as
> described in paragraph c. (2) above.

d\. [Information Security Training]{.underline}

> The Contractor shall ensure that each Contractor/Subcontractor
> employee has completed the NIH Computer Security Awareness Training
> course at: [http://irtsectraining.nih.gov/]{.underline} prior to
> performing any contract work, and thereafter completing the
> NIH‑specified fiscal year refresher course during the period of
> performance of the contract.
>
> The Contractor shall maintain a listing by name and title of each
> Contractor/Subcontractor employee working under this contract that has
> completed the NIH required training. Any additional security training
> completed by Contractor/Subcontractor staff shall be included on this
> listing. \[The listing of completed training shall be included in the
> first technical progress report. (See Article C.2. Reporting
> Requirements.) Any revisions to this listing as a result of staffing
> changes shall be submitted with next required technical progress
> report.\]
>
> Contractor/Subcontractor staff shall complete the following additional
> training prior to performing any work under this contract:

**\*\*\*\* \[List the required training courses here\] \*\*\*\***

e\. [Rules of Behavior]{.underline}

> The Contractor/Subcontractor employees shall comply with the NIH
> Information Technology General Rules of Behavior at:
> [http://irm.cit.nih.gov/security/nihitrob.html]{.underline}.

f\. [Personnel Security Responsibilities]{.underline}

> The Contractor shall perform and document the actions identified in
> the \"Employee Separation Checklist\", attached and made a part of
> this contract, when a Contractor/Subcontractor employee terminates
> work under this contract. All documentation shall be made available to
> the Project Officer and/or Contracting Officer upon request.

g\. [Commitment to Protect Non‑Public Departmental Information Systems
and Data]{.underline}

\(1\) Contractor Agreement

> The Contractor and its subcontractors performing under this Statement
> of Work shall not release, publish, or disclose non‑public
> Departmental information to unauthorized personnel, and shall protect
> such information in accordance with provisions of the following laws
> and any other pertinent laws and regulations governing the
> confidentiality of such information:

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

‑18 U.S.C. 1905 (Criminal Code: Disclosure of Confidential Information)

‑Public Law 96‑511 (Paperwork Reduction Act)

\(2\) Contractor‑Employee Non‑Disclosure Agreements

> Each Contractor/Subcontractor employee who may have access to
> non‑public Department information under this contract shall complete
> the Commitment to Protect Non‑Public Information ‑ Contractor
> Agreement. A copy of each signed and witnessed Non‑Disclosure
> agreement shall be submitted to the Project Officer prior to
> performing any work under the contract.

**ARTICLE H.9. ELECTRONIC AND INFORMATION TECHNOLOGY STANDARDS**

Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C.
794d) as amended by P.L. 105-220 under Title IV (Rehabilitation Act
Amendments of 1998) all Electronic and Information Technology (EIT)
developed, procured maintained and/or used under this contract shall be
in compliance with the "Electronic and Information Technology
Accessibility Standards" set forth by the Architectural and
Transportation Barriers Compliance Board (also referred to as the
"Access Board") in 36 CFR Part 1194). The complete text of Section 508
Final Standards can be accessed at <http://www.access-board.gov/>

**ARTICLE H.10. YEAR 2000 COMPLIANCE**

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

1\. **Service Involving the Use of Information Technology**

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

2\. **Noncommercial Supply Items Warranty**

> **YEAR 2000 WARRANTY\--NONCOMMERCIAL SUPPLY ITEMS**
>
> The Contractor warrants that each noncommercial item of hardware,
> software, and firmware delivered or developed under this contract and
> listed below shall be able to accurately process date data (including,
> but not limited to, calculating, comparing and sequencing) from, into
> and between the twentieth and twenty-first centuries and the Year 1999
> and the Year 2000 and leap year calculations, when used in accordance
> with the item documentation provided by the Contractor, provided that
> all listed or unlisted items (e.g., hardware, software and firmware)
> used in combination with such listed item properly exchange date data
> with it. If the contract requires that specific listed items must
> perform as a system in accordance with the foregoing warranty, then
> that warranty shall apply to those listed items as a system. The
> duration of this warranty and the remedies available to the Government
> for breach of this warranty shall be as defined in, and subject to,
> the terms and limitations of any general warranty provisions of this
> contract provided that notwithstanding any provision to the contrary
> in such warranty provision(s), or in the absence of any such warranty
> provision(s), the remedies available to the Government under this
> warranty shall include repair or replacement of any listed item whose
> noncompliance is discovered and made known to the Contractor in
> writing within ninety (90) days after acceptance. Nothing in this
> warranty shall be construed to limit any rights or remedies the
> Government may otherwise have under this contract with respect to
> defects other than Year 2000 performance.

**YEAR 2000 COMPLIANT ITEMS**

[Computers and related items]{.underline}

(end of clause)

3\. **Commercial Supply Products Warranty**

> **YEAR 2000 WARRANTY\--COMMERCIAL SUPPLY ITEMS**
>
> The Contractor warrants that each hardware, software and firmware
> product delivered under this contract and listed below shall be able
> to accurately process date data (including, but not limited to,
> calculating, comparing, and sequencing) from, into, and between the
> twentieth and twenty-first centuries and the Year 1999 and the Year
> 2000 and leap year calculations, when used in accordance with the
> product documentation provided by the Contractor, provided that all
> listed or unlisted products (e.g., hardware, software, firmware) used
> in combination with such listed product properly exchange date data
> with it. If the contract requires that specific listed products must
> perform as a system in accordance with the foregoing warranty, then
> that warranty shall apply to those listed products as a system. The
> duration of this warranty and the remedies available to the Government
> for breach of this warranty shall be as defined in, and subject to,
> the terms and limitations of the Contractor\'s standard commercial
> warranty or warranties contained in this contract, provided that
> notwithstanding any provision to the contrary in such commercial
> warranty or warranties, the remedies available to the Government under
> this warranty shall include repair or replacement of any listed
> product whose non-compliance is discovered and made known to the
> Contractor in writing within ninety (90) days after acceptance.
> Nothing in this warranty shall be construed to limit any rights or
> remedies the Government may otherwise have under this contract with
> respect to defects other than Year 2000 performance.

**YEAR 2000 COMPLIANT ITEMS**

[Computers and related items]{.underline}

(end of clause)

**ARTICLE H.11. PUBLICATION AND PUBLICITY**

The Contractor shall acknowledge the support of the National Institutes
of Health whenever publicizing the work under this contract in any media
by including an acknowledgment substantially as follows:

> \"This project has been funded in whole or in part with Federal funds
> from the National Institute of Allergy and Infectious Diseases,
> National Institutes of Health, Department of Health and Human
> Services, under Contract No. HHSN2662007XXXXXC."

**ARTICLE H.12. CONFIDENTIALITY OF INFORMATION**

The following information is covered by HHSAR 352.224-70 (March 2005)

*(To be determined during negotiations)*

**ARTICLE H.13. PRESS RELEASES**

a\. Pursuant to Public Law(s) cited in paragraph b., below, 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.

  ---------------------------- ------------- ----------------------------
  b\. **Public Law and Section **Fiscal      **Period Covered**
  No.**                        Year**        

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

\[Applicable information to be included at award\]

**ARTICLE H.14. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE**

Anyone who becomes aware of the existence or apparent existence of
fraud, waste and abuse in NIH funded programs is encouraged to report
such matters to the HHS Inspector General's Office in writing or on the
Inspector General's Hotline. The toll free number is **1-800-HHS-TIPS**
(**1-800-447-8477).** All telephone calls will be handled
confidentially. The e-mail address is
[**Htips@os.dhhs.gov**](mailto:Htips@os.dhhs.gov) and the mailing
address is:

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

**ARTICLE H.15. ANTI -LOBBYING**

a\. Pursuant to Public Law(s) cited in paragraph c., below, contract
funds shall only be used for normal and recognized executive-legislative
relationships. Contract funds shall not be used, for publicity or
propaganda purposes; or for the preparation, distribution, or use of any
kit, pamphlet, booklet, publication, radio, television, or video
presentation designed to support or defeat legislation pending before
the Congress or any State legislature, except in presentation to the
Congress or any State legislature itself.

b\. Contract funds shall not be used to pay salary or expenses of the
Contractor or any agent acting for the Contractor, related to any
activity designed to influence legislation or appropriations pending
before the Congress or any State legislature.

  ---------------------------- ------------- ----------------------------
  c\. **Public Law and Section **Fiscal      **Period Covered**
  No.**                        Year**        

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

\[Applicable information to be included at award\]

**ARTICLE H.16. SHARING RESEARCH DATA**

The Contractor's data sharing plan (to be completed upon award) is
hereby incorporated by reference. The Contractor agrees to adhere to its
plan and shall request prior approval of the Contracting Officer for any
changes in its plan.

The NIH endorses the sharing of final research data to serve health.
This contract is expected to generate research data that must be shared
with the public and other researchers. NIH's data sharing policy may be
found at the following Web site:

<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html>

NIH recognizes that data sharing may be complicated or limited in some
cases, by institutional policies, local IRB rules, as well as local,
state and Federal laws and regulations, including the Privacy Rule (see
HHS-published NIH-funded research must be protected at all times; thus,
data intended for broader use should be free of identifiers that would
permit linkages to individual research participants and variables that
could lead to deductive disclosure of the identity of individual
subjects.

**ARTICLE H.17. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED
PUBLICATIONS RESULTING FROM NIH‑FUNDED RESEARCH**

The Policy requests that beginning May 2, 2005, NIH‑funded investigators
submit to the NIH National Library of Medicine's (NLM) PubMed Central
(PMC) an electronic version of the author's final manuscript, upon
acceptance for publication, resulting from research supported in whole
or in part with direct costs from NIH. NIH defines the author's final
manuscript as the final version accepted for journal publication, and
includes all modifications from the publishing peer review process. The
PMC archive will preserve permanently these manuscripts for use by the
public, health care providers, educators, scientists, and NIH. The
Policy directs electronic submissions to the NIH/NLM/PMC:
[http://www.pubmedcentral.nih.gov](http://www.pubmedcentral.nih.gov/).

Additional information is available at:
[http://grants.nih.gov/grants/guide/notice files/NOT OD 05
022.html](http://grants.nih.gov/grants/guide/notice files/NOT OD 05 022.html)

[]{#__RefHeading___Toc142909287 .anchor}**ARTICLE H.18. HOTEL AND MOTEL
FIRE SAFETY ACT OF 1990 (P.L. 101-391)**

Pursuant to Public Law 101-391, no Federal funds may be used to sponsor
or fund in whole or in part a meeting, convention, conference or
training seminar that is conducted in, or that otherwise uses the rooms,
facilities, or services of a place of public accommodation that do not
meet the requirements of the fire prevention and control guidelines as
described in the Public Law. This restriction applies to public
accommodations both foreign and domestic. Public accommodations that
meet the requirements can be accessed at:
<http://www.usfa.fema.gov/hotel/index.htm>

**PART II - CONTRACT CLAUSES**

[]{#__RefHeading___Toc142909288 .anchor}SECTION I - CONTRACT CLAUSES

THE FOLLOWING **ARTICLE I.1 GENERAL CLAUSE LISTING(S)** WILL BE
APPLICABLE TO MOST CONTRACTS RESULTING FROM THIS RFP. HOWEVER, THE
ORGANIZATIONAL STRUCTURE OF THE SUCCESSFUL OFFEROR(S) WILL DETERMINE THE
SPECIFIC GENERAL CLAUSE LISTING TO BE CONTAINED IN THE CONTRACT(S)
AWARDED FROM THIS RFP:

> **General Clauses for a Cost-Reimbursement Research and Development
> Contract**
>
> **General Clauses for a Cost-Reimbursement Contract with Non-Profit
> Organizations Other Than Educational Institutions**

The complete listing of these clauses may be accessed at:

**ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES**

Any authorized substitutions and/or modifications other than the General
Clauses which will be based on the type of contract/Contractor will be
determined during negotiations.

It is expected that the following clause(s) will be made part of the
resultant contract:

> **Alternate IV** (October 1997) of FAR Clause **52.215-21,
> Requirements For Cost Or Pricing Data Or Information Other Than Cost
> Or Pricing Data\--Modifications** (October 1997) is added.
>
> FAR Clause **52.216-11**, **Cost Contract-No Fee** (April 1984) is
> deleted in its entirety and FAR Clause **52.216-8 Fixed Fee** (March
> 1997) is substituted therefore.
>
> **Alternate II** (October 2001) of FAR Clause **52.219-9, Small
> Business Subcontracting Plan** (July 2005) is added.
>
> FAR Clause **52.232-20, Limitation Of Cost** (April 1984), is deleted
> in its entirety and FAR Clause **52.232-22, Limitation Of Funds**
> (April 1984) is substituted therefor. ***\[NOTE: When this contract is
> fully funded, FAR Clause 52.232-22, LIMITATION OF FUNDS will no longer
> apply and FAR Clause 52.232-20, LIMITATION OF COST will become
> applicable.\]***

**ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES**

Additional clauses other than those listed below which are based on the
type of contract/Contractor shall be determined during negotiations. Any
contract awarded from this solicitation will contain the following:

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

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

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

\(2\) FAR Clause 52.217-6, Option for Increased Quantity (March 1989)

\(3\) FAR Clause 52.219-4, Notice of Price Evaluation Preference for
HUBZone Small Business Concerns (July 2005)

> \"(c) Waiver of evaluation preference\.....
>
> **\[ \]** Offeror elects to waive the evaluation preference.\"
>
> "...The Contracting Officer may exercise the option by written notice
> to the Contractor within 60 days prior to the expiration date of the
> contract."

\(4\) FAR Clause 52.219-25, Small Disadvantaged Business Participation
Program (Disadvantaged

Status and Reporting (October 1999)

\(5\) FAR Clause 52.227-14, Rights in Data - General (June 1987)

\(6\) FAR Clause 52.227-16, Additional Data Requirements (June 1987)

\(7\) FAR Clause 52.230-2, Cost Accounting Standards (April 1998)

\(8\) FAR Clause 52.230-6, Administration of Cost Accounting Standards
(April 2005)

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

\(1\) HHSAR Clause 352.223-70, Safety and Health (January 2001). *\[This
clause is provided in full text in Section J -- Attachment 25\]*

\(2\) HHSAR Clause 352.270-5, Key Personnel (April 1984).

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

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

\(1\) NIH (RC)-7, Procurement of Certain Equipment (April 1984) (OMB
Bulletin 81-16).

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

Additional clauses other than those listed below which are based on the
type of contract/Contractor shall be determined during negotiations. Any
contract awarded from this solicitation will contain the following:

> This contract incorporates the following clauses in full text.

FAR Clause **52.222‑39, Notification Of Employee Rights Concerning
Payment Of Union Dues**

**Or Fees** (December 2004)

> \(a\) Definition. As used in this clause‑‑
>
> *United States* means the 50 States, the District of Columbia, Puerto
> Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S.
> Virgin Islands, and Wake Island.

\(b\) Except as provided in paragraph (e) of this clause, during the
term of this contract, the Contractor shall post a notice, in the form
of a poster, informing employees of their rights concerning union
membership and payment of union dues and fees, in conspicuous places in
and about all its plants and offices, including all places where notices
to employees are customarily posted. The notice shall include the
following information (except that the information pertaining to
National Labor Relations Board shall not be included in notices

> posted in the plants or offices of carriers subject to the Railway
> Labor Act, as amended (45 U.S.C. 151‑188)).

Notice to Employees

> Under Federal law, employees cannot be required to join a union or
> maintain membership in a union in order to retain their jobs. Under
> certain conditions, the law permits a union and an employer to enter
> into a union‑security agreement requiring employees to pay uniform
> periodic dues and initiation fees. However, employees who are not
> union members can object to the use of their payments for certain
> purposes and can only be required to pay their share of union costs
> relating to collective bargaining, contract administration, and
> grievance adjustment.
>
> If you do not want to pay that portion of dues or fees used to support
> activities not related to collective bargaining, contract
> administration, or grievance adjustment, you are entitled to an
> appropriate reduction in your payment. If you believe that you have
> been required to pay dues or fees used in part to support activities
> not related to collective bargaining, contract administration, or
> grievance adjustment, you may be entitled to a refund and to an
> appropriate reduction in future payments.
>
> For further information concerning your rights, you may wish to
> contact the National Labor Relations Board (NLRB) either at one of its
> Regional offices or at the following address or toll free number:

National Labor Relations Board

Division of Information

1099 14th Street, N.W.

Washington, DC 20570

1‑866‑667‑6572

1‑866‑316‑6572 (TTY)

To locate the nearest NLRB office, see NLRB\'s website at
[http://www.nlrb.gov](http://www.nlrb.gov/).

> \(c\) The Contractor shall comply with all provisions of Executive
> Order 13201 of February 17, 2001, and related implementing regulations
> at 29 CFR part 470, and orders of the Secretary of Labor.
>
> \(d\) In the event that the Contractor does not comply with any of the
> requirements set forth in paragraphs (b), (c), or (g), the Secretary
> may direct that this contract be cancelled, terminated, or suspended
> in whole or in part, and declare the Contractor ineligible for further
> Government contracts in accordance with procedures at 29 CFR part 470,
> Subpart B‑‑Compliance Evaluations, Complaint Investigations and
> Enforcement Procedures. Such other sanctions or remedies may be
> imposed as are provided by 29 CFR part 470, which implements Executive
> Order 13201, or as are otherwise provided by law.
>
> \(e\) The requirement to post the employee notice in paragraph (b)
> does not apply to‑‑
>
> \(1\) Contractors and subcontractors that employ fewer than 15
> persons;
>
> \(2\) Contractor establishments or construction work sites where no
> union has been formally recognized by the Contractor or certified as
> the exclusive bargaining representative of the Contractor\'s
> employees;
>
> \(3\) Contractor establishments or construction work sites located in
> a jurisdiction named in the definition of the United States in which
> the law of that jurisdiction forbids enforcement of union‑security
> agreements;
>
> \(4\) Contractor facilities where upon the written request of the
> Contractor, the Department of Labor Deputy Assistant Secretary for
> Labor‑Management Programs has waived the posting requirements with
> respect to any of the Contractor\'s facilities if the Deputy Assistant
> Secretary finds that the Contractor has demonstrated that‑‑
>
> \(i\) The facility is in all respects separate and distinct from
> activities of the Contractor related to the performance of a contract;
> and
>
> \(ii\) Such a waiver will not interfere with or impede the
> effectuation of the Executive order; or,
>
> \(5\) Work outside the United States that does not involve the
> recruitment or employment of workers within the United States.
>
> \(f\) The Department of Labor publishes the official employee notice
> in two variations; one for contractors covered by the Railway Labor
> Act and a second for all other Contractors. The Contractor shall‑‑
>
> \(1\) Obtain the required employee notice poster from the Division of
> Interpretations and Standards, Office of Labor‑Management Standards,
> U.S. Department of Labor, 200 Constitution Avenue, NW, Room N‑5605,
> Washington, DC 20210, or from any field office of the Department\'s
> Office of Labor‑Management Standards or Office of Federal Contract
> Compliance Programs;
>
> \(2\) Download a copy of the poster from the Office of
> Labor‑Management Standards website at
> [http://www.olms.dol.gov](http://www.olms.dol.gov/); or,
>
> \(3\) Reproduce and use exact duplicate copies of the Department of
> Labor\'s official poster.
>
> \(g\) The Contractor shall include the substance of this clause in
> every subcontract or purchase order that exceeds the simplified
> acquisition threshold, entered into in connection with this contract,
> unless exempted by the Department of Labor Deputy Assistant Secretary
> for Labor‑Management Programs on account of special circumstances in
> the national interest under authority of 29 CFR 470.3(c). For
> indefinite quantity subcontracts, the Contractor shall include the
> substance of this clause if the value of orders in any calendar year
> of the subcontract is expected to exceed the simplified acquisition
> threshold. Pursuant to 29 CFR part 470, Subpart B‑‑Compliance
> Evaluations, Complaint Investigations and Enforcement Procedures, the
> Secretary of Labor may direct the Contractor to take such action in
> the enforcement of these regulations, including the imposition of
> sanctions for noncompliance with respect to any such subcontract or
> purchase order. If the Contractor becomes involved in litigation with
> a subcontractor or vendor, or is threatened with such involvement, as
> a result of such direction, the Contractor may request the United
> States, through the Secretary of Labor, to enter into such litigation
> to protect the interests of the United States.
>
> **PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS**
>
> **SECTION J - LIST OF ATTACH**[]{#Section_J .anchor}**MENTS**

The following documents are incorporated into this RFP:

**SOLICITATION ATTACHMENTS:**

+-------------+-------------------------------+-----------------------+
| *           | **Title**                     | **Location**          |
| *Attachment |                               |                       |
| No.**       |                               |                       |
+-------------+-------------------------------+-----------------------+
| Attachment  | Packaging and Delivery of     | [Linked to the        |
| 1:          | Proposal                      | Attachment Title](#L) |
+-------------+-------------------------------+-----------------------+
| Attachment  | Proposal Intent Response      | [Linked to the        |
| 2:          | Sheet -- Part A and B         | Attachment            |
|             |                               | Title](#Attachment_2) |
+-------------+-------------------------------+-----------------------+
| Attachment  | Background for Part A and B   | [Linked to the        |
| 3:          |                               | Attachment            |
|             |                               | Title](#Attachment_3) |
+-------------+-------------------------------+-----------------------+
| Attachment  | Introduction and Statement of | [Linked to the        |
| 4:          | Work - Part A                 | Attachment            |
|             |                               | Title](#Attachment_4) |
+-------------+-------------------------------+-----------------------+
| Attachment  | Appendix A -- Additional      | [Linked to the        |
| 5:          | Technical Proposal            | Attachment            |
|             | Instructions for Part A       | Title](#Attachment_5) |
+-------------+-------------------------------+-----------------------+
| Attachment  | Appendix B -- Additional      | [Linked to the        |
| 6:          | Business Proposal             | Attachment            |
|             | Instructions for Part A       | Title](#Attachment_6) |
+-------------+-------------------------------+-----------------------+
| Attachment  | Introduction and Statement of | [Linked to the        |
| 7:          | Work - Part B                 | Attachment            |
|             |                               | Title](#Attachment_7) |
+-------------+-------------------------------+-----------------------+
| Attachment  | Appendix A -- Additional      | [Linked to the        |
| 8:          | Technical Proposal            | Attachment            |
|             | Instructions for Part B       | Title](#Attachment_8) |
+-------------+-------------------------------+-----------------------+
| Attachment  | Appendix B -- Additional      | [Linked to the        |
| 9:          | Business Proposal             | Attachment            |
|             | Instructions for Part B       | Title](#Attachment_9) |
+-------------+-------------------------------+-----------------------+
| Attachment  | Reporting Requirements and    | [Linked to the        |
| 10:         | Deliverables                  | Attachment            |
|             |                               | T                     |
|             | For Part A and B              | itle](#Attachment_10) |
+-------------+-------------------------------+-----------------------+
| Attachment  | Appendix C -- Advance         | [Linked to the        |
| 11:         | Understandings                | Attachment            |
|             |                               | T                     |
|             |                               | itle](#Attachment_11) |
+-------------+-------------------------------+-----------------------+

**TECHNICAL PROPOSAL ATTACHMENTS:** (The following attachments must be
completed, where applicable, and submitted with the Technical Proposal.)

  -------------- -------------------------- --------------------------------------------------
  **Attachment   **Title**                  **Location**
  No.**                                     

  Attachment 12: Technical Proposal Cost    <http://www.niaid.nih.gov/contract/forms.htm>
                 Summary                    

  Attachment 13: Summary of Related         <http://www.niaid.nih.gov/contract/forms.htm>
                 Activities                 

  Attachment 14: Government Notice for      <http://www.niaid.nih.gov/contract/forms.htm>
                 Handling Proposals         

  Attachment 15: Project Objectives, NIH    <http://www.nih.gov/contract/forms/form1688.doc>
                 1688-1                     
  -------------- -------------------------- --------------------------------------------------

**BUSINESS PROPOSAL ATTACHMENTS:** (The following attachments must be
completed, where applicable, and submitted with the Business Proposal.)

+------------+--------------------------+------------------------------+
| **         | **Title**                | **Location**                 |
| Attachment |                          |                              |
| No.**      |                          |                              |
+------------+--------------------------+------------------------------+
| Attachment | Proposal Summary and     | <http://www.niaid            |
| 16:        | Data Record,             | .nih.gov/contract/forms.htm> |
|            |                          |                              |
|            | NIH-2043                 |                              |
+------------+--------------------------+------------------------------+
| Attachment | Small Business           | <http://www                  |
| 17:        | Subcontracting Plan      | .nih.gov/contract/forms.htm> |
+------------+--------------------------+------------------------------+
| Attachment | Breakdown of Proposed    | <http://www.niaid            |
| 18:        | Estimated Costs (plus    | .nih.gov/contract/forms.htm> |
|            | Fee) with Excel          |                              |
|            | Spreadsheet              | <http://ocm.od.nih.gov/      |
|            |                          | contracts/spsh/spshexcl.xls> |
+------------+--------------------------+------------------------------+
| Attachment | Offeror\'s Points of     | <http://www.niaid            |
| 19:        | Contact                  | .nih.gov/contract/forms.htm> |
+------------+--------------------------+------------------------------+
| Attachment | Disclosure of Lobbying   | <http://rcb.cancer.gov/rcb   |
| 20:        | Activities, OMB Form     | -internet/forms/sflllin.pdf> |
|            | SF-LLL                   |                              |
+------------+--------------------------+------------------------------+

**INFORMATIONAL ATTACHMENTS:** (The following Attachments and Reports
will become part of any

contract resulting from this RFP and will be required during contract
performance.)

+-------------+------------------------+------------------------------+
| *           | **Title**              | **Location**                 |
| *Attachment |                        |                              |
| No.**       |                        |                              |
+-------------+------------------------+------------------------------+
| Attachment  | Invoice/Financing      | <http://rcb.cancer.gov       |
| 21:         | Request and Contract   | /rcb-internet/forms/rc4.pdf> |
|             | Financial Reporting    |                              |
|             | Instructions\--Cost    |                              |
|             | Reimbursement,         |                              |
|             | NIH(RC)-1              |                              |
+-------------+------------------------+------------------------------+
| Attachment  | Financial Report for   | <http://www.nih.gov/         |
| 22:         | Individual Project/    | contract/forms/nih-2706.pdf> |
|             |                        |                              |
|             | Contract, NIH 2706     |                              |
+-------------+------------------------+------------------------------+
| Attachment  | Instructions for       | <http://www.nih.gov/contract |
| 23:         | Completing Form NIH    | /forms/instructions2706.pdf> |
|             | 2706                   |                              |
+-------------+------------------------+------------------------------+
| Attachment  | Procurement of Certain | [http://www..nih.go          |
| 24:         | Equipment, NIH(RC)-7   | v/contract/forms/NIH-RC-7.pd |
|             |                        | f](http://www.niaid.nih.gov/ |
|             |                        | contract/forms/NIH-RC-7.pdf) |
+-------------+------------------------+------------------------------+
| Attachment  | Safety and Health,     | <http://www.nih.gov/c        |
| 25:         | HHSAR Clause           | ontract/forms/NIH-RC-10.pdf> |
|             | 352.223-70             |                              |
+-------------+------------------------+------------------------------+
| Attachment  | Commitment To Protect  | <http://irm.cit.nih.gov      |
| 26:         | Non-Public Information | /security/Nondisclosure.pdf> |
|             | Contractor Agreement   |                              |
+-------------+------------------------+------------------------------+
| Attachment  | Roster of Employees    | <http://ais.niaid.nih.gov/f  |
| 27:         | Requiring Suitability  | orms/Suitability-roster.xls> |
|             | Investigations         |                              |
+-------------+------------------------+------------------------------+
| Attachment  | Employee Separation    | <http://                     |
| 28:         | Checklist              | rcb.cancer.gov/rcb-internet/ |
|             |                        | forms/Emp-sep-checklist.pdf> |
+-------------+------------------------+------------------------------+

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

                                           

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

**PART IV - REPRESENTATIONS AND INSTRUCTIONS**

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF
OFFERORS

SECTION K can be accessed electronically from the INTERNET at the
following address:

<http://rcb.cancer.gov/rcb-internet/wkf/sectionk.pdf>

If you are unable to access this document electronically, you may
request a copy from the Contracting Officer identified on the cover page
of this solicitation.

**IF YOU INTEND TO SUBMIT A PROPOSAL, YOU [MUST]{.underline} COMPLETE
SECTION K AND SUBMIT IT AS PART OF YOUR BUSINESS PROPOSAL.**

**SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO OFFERORS**

**1. GENERAL INFORMATION**

a.  **INSTRUCTIONS TO OFFERORS\--COMPETITIVE ACQUISITION** \[FAR
    Provision 52.215-1 (January 2004)\]

> \(a\) *Definitions*. As used in this provision\--
>
> *Discussions* are negotiations that occur after establishment of the
> competitive range that may, at the Contracting Officer\'s discretion,
> result in the offeror being allowed to revise its proposal.
>
> *\"In writing\"*, *\"writing\"*, or *\"written\"* means any worded or
> numbered expression that can be read, reproduced, and later
> communicated, and includes electronically transmitted and stored
> information.
>
> \"*Proposal modification*\" is a change made to a proposal before the
> solicitation\'s closing date and time, or made in response to an
> amendment, or made to correct a mistake at any time before award.
>
> \"*Proposal revision*\" is a change to a proposal made after the
> solicitation closing date, at the request of or as allowed by a
> Contracting Officer as the result of negotiations.
>
> \"*Time,*\" if stated as a number of days, is calculated using
> calendar days, unless otherwise specified, and will include Saturdays,
> Sundays, and legal holidays. However, if the last day falls on a
> Saturday, Sunday, or legal holiday, then the period shall include the
> next working day.
>
> \(b\) *Amendments to solicitations*. If this solicitation is amended,
> all terms and conditions that are not amended remain unchanged.
> Offerors shall acknowledge receipt of any amendment to this
> solicitation by the date and time specified in the amendment(s).
>
> **(**c) *Submission, modification, revision, and withdrawal of
> proposals*.
>
> \(1\) Unless other methods (*e.g.*, electronic commerce or facsimile)
> are permitted in the solicitation, proposals and modifications to
> proposals shall be submitted in paper media in sealed envelopes or
> packages (i) addressed to the office specified in the solicitation,
> and (ii) showing the time and date specified for receipt, the
> solicitation number, and the name and address of the offeror. Offerors
> using commercial carriers should ensure that the proposal is marked on
> the outermost wrapper with the information in paragraphs (c)(1)(i) and
> (c)(1)(ii) of this provision.
>
> \(2\) The first page of the proposal must show\--
>
> \(i\) The solicitation number;
>
> \(ii\) The name, address, and telephone and facsimile numbers of the
> offeror (and electronic address if available);

(iii) A statement specifying the extent of agreement with all terms,
      conditions, and provisions included in the solicitation and
      agreement to furnish any or all items upon which prices are
      offered at the price set opposite each item;

> \(iv\) Names, titles, and telephone and facsimile numbers (and
> electronic addresses if available) of persons authorized to negotiate
> on the offeror\'s behalf with the Government in connection with this
> solicitation; and,
>
> \(v\) Name, title, and signature of person authorized to sign the
> proposal. Proposals signed by an agent shall be accompanied by
> evidence of that agent\'s authority, unless that evidence has been
> previously furnished to the issuing office.
>
> \(3\) *Submission, modification, revision, and withdrawal of
> proposals*. (i) Offerors are responsible for submitting proposals, and
> any modifications or revisions, so as to reach the Government office
> designated in the solicitation by the time specified in the
> solicitation. If no time is specified in the solicitation, the time
> for receipt is 4:00 p.m., local time, for the designated Government
> office on the date that proposal or revision is due.
>
> \(i\) (A) Any proposal, modification, or revision received at the
> Government office designated in the solicitation after the exact time
> specified for receipt of offers is \"late\" and will not be considered
> unless it is received before award is made, the Contracting Officer
> determines that accepting the late offer would not unduly delay the
> acquisition; and\--
>
> (*1*) If it was transmitted through an electronic commerce method
> authorized by the solicitation, it was received at the initial point
> of entry to the Government infrastructure not later than 5:00 p.m. one
> working day prior to the date specified for receipt of proposals; or
>
> (*2*) There is acceptable evidence to establish that it was received
> at the Government installation designated for receipt of offers and
> was under the Government\'s control prior to the time set for receipt
> of offers; or,
>
> (*3*) It is the only proposal received.
>
> \(B\) However, a late modification of an otherwise successful proposal
> that makes its terms more favorable to the Government, will be
> considered at any time it is received and may be accepted.
>
> \(ii\) Acceptable evidence to establish the time of receipt at the
> Government installation includes the time/date stamp of that
> installation on the proposal wrapper, other documentary evidence of
> receipt maintained by the installation, or oral testimony or
> statements of Government personnel.
>
> \(iii\) If an emergency or unanticipated event interrupts normal
> Government processes so that proposals cannot be received at the
> office designated for receipt of proposals by the exact time specified
> in the solicitation, and urgent Government requirements preclude
> amendment of the solicitation, the time specified for receipt of
> proposals will be deemed to be extended to the same time of day
> specified in the solicitation on the first work day on which normal
> Government processes resume.
>
> \(iv\) Proposals may be withdrawn by written notice received at any
> time before award. Oral proposals in response to oral solicitations
> may be withdrawn orally. If the solicitation authorizes facsimile
> proposals, proposals may be withdrawn via facsimile received at any
> time before award, subject to the conditions specified in the
> provision at 52.215-5, Facsimile Proposals. Proposals may be withdrawn
> in person by an offeror or an authorized representative, if the
> identity of the person requesting withdrawal is established and the
> person signs a receipt for the proposal before award.
>
> \(4\) Unless otherwise specified in the solicitation, the offeror may
> propose to provide any item or combination of items.
>
> \(5\) Offerors shall submit proposals in response to this solicitation
> in English, unless otherwise permitted by the solicitation, and in
> U.S. dollars, unless the provision at FAR 52.225‑17, Evaluation of
> Foreign Currency Offers, is included in the solicitation.
>
> \(6\) Offerors may submit modifications to their proposals at any time
> before the solicitation closing date and time, and may submit
> modifications in response to an amendment, or to correct a mistake at
> any time before award.
>
> \(7\) Offerors may submit revised proposals only if requested or
> allowed by the Contracting Officer.
>
> \(8\) Proposals may be withdrawn at any time before award. Withdrawals
> are effective upon receipt of notice by the Contracting Officer.
>
> \(d\) *Offer expiration date*. Proposals in response to this
> solicitation will be valid for the number of days specified on the
> solicitation cover sheet (unless a different period is proposed by the
> offeror).
>
> \(e\) *Restriction on disclosure and use of data.*
>
> \(1\) The proposal submitted in response to this request may contain
> data (trade secrets; business data, e.g., commercial information,
> financial information, and cost and pricing data; and technical data)
> which the offeror, including its prospective subcontractor(s), does
> not want used or disclosed for any purpose other than for evaluation
> of the proposal. The use and disclosure of any data may be so
> restricted; provided, that the Government determines that the data is
> not required to be disclosed under the Freedom of Information Act, 5
> U.S.C. 552, as amended, and the offeror marks the cover sheet of the
> proposal with the following legend, specifying the particular portions
> of the proposal which are to be restricted in accordance with the
> conditions of the legend. The Government\'s determination to withhold
> or disclose a record will be based upon the particular circumstances
> involving the record in question and whether the record may be
> exempted from disclosure under the Freedom of Information Act. The
> legend reads:
>
> Unless disclosure is required by the Freedom of Information Act, 5
> U.S.C. 552, as amended, (the Act) as determined by Freedom of
> Information (FOI) officials of the Department of Health and Human
> Services, data contained in the portions of this proposal which have
> been specifically identified by page number, paragraph, etc. by the
> offeror as containing restricted information shall not be used or
> disclosed except for evaluation purposes.
>
> The offeror acknowledges that the Department may not be able to
> withhold a record (data, document, etc.) nor deny access to a record
> requested pursuant to the Act and that the Department\'s FOI officials
> must make that determination. The offeror hereby agrees that the
> Government is not liable for disclosure if the Department has
> determined that disclosure is required by the Act.
>
> If a contract is awarded to the offeror as a result of, or in
> connection with, the submission of this proposal, the Government shall
> have right to use or disclose the data to the extent provided in the
> contract. Proposals not resulting in a contract remain subject to the
> Act.
>
> The offeror also agrees that the Government is not liable for
> disclosure or use of unmarked data and may use or disclose the data
> for any purpose, including the release of the information pursuant to
> requests under the Act. The data subject to this restriction are
> contained in pages (insert page numbers, paragraph designations, etc.
> or other identification).
>
> \(2\) In addition, the offeror should mark each page of data it wishes
> to restrict with the following statement:
>
> AUse or disclosure of data contained on this page is subject to the
> restriction on the cover sheet of this proposal or quotation.@
>
> \(3\) Offerors are cautioned that proposals submitted with restrictive
> legends or statements differing in substance from the above legend may
> not be considered for award. The Government reserves the right to
> reject any proposal submitted with a nonconforming legend.
>
> \(f\) *Contract award*.
>
> \(1\) The Government intends to award a contract or contracts
> resulting from this solicitation to the responsible offeror(s) whose
> proposal(s) represents the best value after evaluation in accordance
> with the factors and subfactors in the solicitation.
>
> \(2\) The Government may reject any or all proposals if such action is
> in the Government\'s interest.
>
> \(3\) The Government may waive informalities and minor irregularities
> in proposals received.
>
> \(4\) The Government intends to evaluate proposals and award a
> contract without discussions with offerors (except clarifications as
> described in FAR 15.306(a)). Therefore, the offeror\'s initial
> proposal should contain the offeror\'s best terms from a cost or price
> and technical standpoint. The Government reserves the right to conduct
> discussions if the Contracting Officer later determines them to be
> necessary. If the Contracting Officer determines that the number of
> proposals that would otherwise be in the competitive range exceeds the
> number at which an efficient competition can be conducted, the
> Contracting Officer may limit the number of proposals in the
> competitive range to the greatest number that will permit an efficient
> competition among the most highly rated proposals.
>
> \(5\) The Government reserves the right to make an award on any item
> for a quantity less than the quantity offered, at the unit cost or
> prices offered, unless the offeror specifies otherwise in the
> proposal.
>
> \(6\) The Government reserves the right to make multiple awards if,
> after considering the additional administrative costs, it is in the
> Government\'s best interest to do so.
>
> \(7\) Exchanges with offerors after receipt of a proposal do not
> constitute a rejection or counteroffer by the Government.
>
> \(8\) The Government may determine that a proposal is unacceptable if
> the prices proposed are materially unbalanced between line items or
> subline items. Unbalanced pricing exists when, despite an acceptable
> total evaluated price, the price of one or more contract line items is
> significantly overstated or understated as indicated by the
> application of cost or price analysis techniques. A proposal may be
> rejected if the Contracting Officer determines that the lack of
> balance poses an unacceptable risk to the Government.
>
> \(9\) If a cost realism analysis is performed, cost realism may be
> considered by the source selection authority in evaluating performance
> or schedule risk.
>
> \(10\) A written award or acceptance of proposal mailed or otherwise
> furnished to the successful offeror within the time specified in the
> proposal shall result in a binding contract without further action by
> either party.
>
> \(11\) If a post-award debriefing is given to requesting offerors, the
> Government shall disclose the following information, if applicable:
>
> \(i\) The agency\'s evaluation of the significant weak or deficient
> factors in the debriefed offeror\'s offer.
>
> \(ii\) The overall evaluated cost or price and technical rating of the
> successful and debriefed offeror and past performance information on
> the debriefed offeror.
>
> \(iii\) The overall ranking of all offerors, when any ranking was
> developed by the agency during source selection;
>
> \(iv\) A summary of the rationale for award.
>
> \(v\) For acquisitions of commercial items, the make and model of the
> item to be delivered by the successful offeror.
>
> \(vi\) Reasonable responses to relevant questions posed by the
> debriefed offeror as to whether source-selection procedures set forth
> in the solicitation, applicable regulations, and other applicable
> authorities were followed by the agency.
>
> **Alternate I** (October 1997). As prescribed in 15.209(a)(1),
> substitute the following paragraph (f)(4) for paragraph (f)(4) of the
> basic provision:
>
> \(f\) (4) The Government intends to evaluate proposals and award a
> contract after conducting discussions with offerors whose proposals
> have been determined to be within the competitive range. If the
> Contracting Officer determines that the number of proposals that would
> otherwise be in the competitive range exceeds the number at which an
> efficient competition can be conducted, the Contracting Officer may
> limit the number of proposals in the competitive range to the greatest
> number that will permit an efficient competition among the most highly
> rated proposals. Therefore, the offeror\'s initial proposal should
> contain the offeror\'s best terms from a price and technical
> standpoint.

b.  **NAICS CODE AND SIZE STANDARD**

> Note: The following information is to be used by the offeror in
> preparing its Representations and Certifications (See Section K of
> this RFP), specifically in completing the provision entitled, SMALL
> BUSINESS PROGRAM REPRESENTATION, FAR Clause 52.219-1.

1.  The North American Industry Classification System (NAICS) code for
    this acquisition is

> 541710\.
>
> \(2\) The small business size standard is 500 employees.
>
> **THIS REQUIREMENT IS NOT SET-ASIDE FOR SMALL BUSINESS. However, the
> Federal Acquisition Regulation (FAR) requires in EVERY solicitation,
> (except for foreign acquisitions) the inclusion of the North American
> Industry Classification (NAICS) Code and corresponding size standard
> which best describes the nature of the requirement in the
> solicitation.**

c.  **TYPE OF CONTRACT AND NUMBER OF AWARD(S)**

> It is anticipated that multiple awards will be made from this
> solicitation and that the awards will be made on/about July 23, 2007.
>
> It is anticipated that the awards from this solicitation will be
> multiple-year cost reimbursement completion type contract with a
> period of performance of seven (7) years, and that incremental funding
> will be used \[see Section L.2.c. Business Proposal Instructions\].

d.  **ESTIMATE OF EFFORT**

> It is expected that a completion type contract will be awarded as a
> result of this RFP. To assist you in the preparation of your proposal,
> the Government considers the effort to be approximately 1.45 FTEs per
> year for seven (7) years for Part A: Confirmatory In Vitro Evaluations
> Of HIV Therapeutics and 4.0 FTEs year for seven (7) years for Part B:
> Specialized In Vitro Virological Assays. This information is furnished
> for the offeror\'s information only and is not to be considered
> restrictive for proposal purposes.

e.  **COMMITMENT OF PUBLIC FUNDS**

> The Contracting Officer is the only individual who can legally commit
> the Government to the expenditure of public funds in connection with
> the proposed procurement. Any other commitment, either explicit or
> implied, is invalid.

f.  **COMMUNICATIONS PRIOR TO CONTRACT AWARD**

> Offerors shall direct all communications to the attention of the
> Contract Specialist or Contracting Officer cited on the face page of
> this RFP. Communications with other officials may compromise the
> competitiveness of this acquisition and result in cancellation of the
> requirement.

g.  **RELEASE OF INFORMATION**

> Contract selection and award information will be disclosed to offerors
> in accordance with regulations applicable to negotiated acquisition.
> Prompt written notice will be given to unsuccessful offerors as they
> are eliminated from the competition, and to all offerors following
> award.

h.  **COMPARATIVE IMPORTANCE OF PROPOSALS**

> You are advised that paramount consideration shall be given to the
> evaluation of technical proposals. All evaluation factors other than
> cost or price, when combined, are significantly more important than
> cost or price. The relative importance of the evaluation factors are
> specified in SECTION M of this solicitation. However, the Government
> reserves the right to make an award to the best advantage of the
> Government, cost and other factors considered.

i.  **PREPARATION COSTS**

    This RFP does not commit the Government to pay for the preparation
    and submission of a proposal.

j.  **SERVICE OF PROTEST** (AUGUST 1996) - FAR 52.233-2

> \(a\) Protests, as defined in section 33.101 of the Federal
> Acquisition Regulation, that are filed directly with an agency, and
> copies of any protests that are filed with the Government
> Accountability Office (GAO), shall be served on the Contracting
> Officer (addressed as follows) by obtaining written and dated
> acknowledgment of receipt from:

Contracting Officer

> Office of Acquisitions, DEA, NIH, DHHS
>
> 6700-B Rockledge Drive, Room 3214, MSC 7612
>
> Bethesda, MD 20892-7612
>
> \(b\) The copy of any protest shall be received in the office
> designated above within one day of filing a protest with the GAO.

k.  **LATE PROPOSALS AND REVISIONS**, HHSAR 352.215-70

> Notwithstanding the procedures contained in FAR 52.215‑1(c)(3) of the
> provision of this solicitation entitled Instructions to
> Offerors‑Competitive Acquisition, a proposal received after the date
> specified for receipt may be considered if it offers significant cost
> or technical advantages to the Government; and it was received before
> proposals were distributed for evaluation, or within five calendar
> days after the exact time specified for receipt, whichever is earlier.

2\. INSTRUCTIONS TO OFFERORS

**a. GENERAL INSTRUCTIONS**

**INTRODUCTION**

> The following instructions will establish the acceptable minimum
> requirements for the format and contents of proposals. Special
> attention is directed to the requirements for technical and business
> proposals to be submitted in accordance with these instructions.

(1) **Contract Type and General Clauses**

> It is contemplated that a cost-reimbursement completion type contract
> will be awarded. (See General Information) Any resultant contract
> shall include the clauses applicable to the selected offeror\'s
> organization and type of contract awarded as required by Public Law,
> Executive Order, or acquisition regulations in effect at the time of
> execution of the proposed contract.

(2) **Authorized Official and Submission of Proposal**

> The proposal must be signed by an official authorized to bind your
> organization and must stipulate that it is predicated upon all the
> terms and conditions of this RFP. Your proposal shall be submitted in
> the number of copies, to the addresses, and marked as indicated in the
> Attachment 1 entitled, PACKAGING AND DELIVERY OF PROPOSAL, Part III,
> Section J hereof. Proposals will be typewritten, paginated, reproduced
> on letter size paper and will be legible in all required copies. To
> expedite the proposal evaluation, all documents required for
> responding to the RFP should be placed in the following order:
>
> **I. COVER PAGE**
>
> Include RFP title, number, name of organization, DUNS No.,
> identification of the proposal part, and indicate whether the proposal
> is an original or a copy.
>
> **II. TECHNICAL PROPOSAL**
>
> It is recommended that the technical proposal consist of a cover page,
> a table of contents, and the information requested in the Technical
> Proposal Instructions and as specified in SECTION J, List of
> Attachments, 5 and 8.
>
> **III. BUSINESS PROPOSAL**
>
> It is recommended that the business proposal consist of a cover page,
> a table of contents, and the information requested in the Business
> Proposal Instructions and as specified in SECTION J, List of
> Attachments, 6 and 9.

(3) **Proposal Summary and Data Record (NIH-2043)**

> The Offeror must complete the Form NIH-2043, attached, with particular
> attention to the length of time the proposal is firm and the
> designation of those personnel authorized to conduct negotiations.
> (See Section J, Attachment 16 entitled, PROPOSAL SUMMARY AND DATA
> RECORD.)

(4) **Separation of Technical and Business Proposals**

> The proposal must be prepared in two parts: a \"Technical Proposal\"
> and a \"Business Proposal.\" Each of the parts shall be separate and
> complete in itself so that evaluation of one may be accomplished
> independently of, and concurrently with, evaluation of the other. The
> technical proposal must include direct cost and resources information,
> such as labor-hours and categories and applicable rates, materials,
> subcontracts, travel, etc., and associated costs so that the
> offeror\'s understanding of the project may be evaluated (See
> Attachment 16 entitled, TECHNICAL PROPOSAL COST SUMMARY). However, the
> technical proposal should **not** include pricing data relating to
> individual salary information, indirect cost rates or amounts, fee
> amounts (if any), and total costs. The technical proposal should
> disclose your technical approach in as much detail as possible,
> including, but not limited to, the requirements of the technical
> proposal instructions.

(5) **Alternate Proposals**

> You may, at your discretion, submit alternate proposals, or proposals
> which deviate from the requirements; provided, that you also submit a
> proposal for performance of the work as specified in the Statement of
> Work. Such proposals may be considered if overall performance would be
> improved or not compromised and if they are in the best interests of
> the Government. Alternative proposals, or deviations from any
> requirements of this RFP, shall be clearly identified.

(6) **Evaluation of Proposals**

> The Government will evaluate technical proposals in accordance with
> the criteria set forth in Part IV, Section M of this RFP.

(7) **Potential Award Without Discussions**

> The Government reserves the right to award a contract without
> discussions if the Contracting Officer determines that the initial
> prices are fair and reasonable and that discussions are not necessary.

(8) **Use of the Metric System of Measurement**

> It is the policy of the Department of Health and Human Services to
> support the Federal transition to the metric system and to use the
> metric system of measurement in all procurement, grants, and other
> business related activities unless such use is impracticable or is
> likely to cause significant inefficiencies.
>
> The offeror is encouraged to prepare their proposal using either
> \"Hard Metric,\" \"Soft Metric,\" or \"Dual Systems\" of measurement.
> The following definitions are provided for your information:
>
> **Hard Metric** - The replacement of a standard inch-pound size with
> an accepted metric size for a particular purpose. An example of size
> substitution might be: selling or packaging liquids by the liter
> instead of by the pint or quart (as for soft drinks), or instead of by
> the gallon (as for gasoline).
>
> **Soft Metric** - The result of a mathematical conversion of
> inch-pound measurements to metric equivalents for a particular
> purpose. The physical characteristics are not changed.
>
> **Dual Systems** - The use of both inch-pound and metric systems. For
> example, an item is designed, produced, and described in inch-pound
> values with soft metric values also shown for information or
> comparison purposes.

(9) **Privacy Act - Treatment of Proposal Information**

> The Privacy Act of 1974 (P.L. 93-579) requires that a Federal agency
> advise each individual whom it asks to supply information, the
> authority which authorizes the solicitation, whether disclosure is
> voluntary or mandatory, the principal purpose or purposes for which
> the information is intended to be used, the uses outside the agency
> which may be made of the information, and the effects on the
> individual, if any, of not providing all or any part of the requested
> information.
>
> The NIH is requesting the information called for in this RFP pursuant
> to the authority provided by Sec. 301(a)(7) of the Public Health
> Service Act, as amended, and P.L. 92-218, as amended.
>
> Providing the information requested is entirely voluntary. The
> collection of this information is for the purpose of conducting an
> accurate, fair, and adequate review prior to a discussion as to
> whether to award a contract.

Failure to provide any or all of the requested information may result in
a less than adequate review.

> In addition, the Privacy Act of 1974 (P.L. 93-579, Section 7) requires
> that the following information be provided when individuals are
> requested to disclose their social security number.
>
> Provision of the social security number is voluntary. Social security
> numbers are requested for the purpose of accurate and efficient
> identification, referral, review and management of NIH contracting
> programs. Authority for requesting this information is provided by
> Section 301 and Title IV of the PHS Act, as amended.
>
> The information provided by you may be routinely disclosed for the
> following purposes:
>
> \- to the cognizant audit agency and the General Accounting Office for
> auditing.
>
> \- to the Department of Justice as required for litigation.
>
> \- to respond to congressional inquiries.
>
> \- to qualified experts, not within the definition of Department
> employees, for opinions as a part of the review process.

(10) **Selection of Offerors**

> a\) The acceptability of the scientific and technical portion of each
> research contract proposal will be evaluated by a technical review
> committee. The committee will evaluate each proposal in strict
> conformity with the evaluation criteria of the RFP, utilizing point
> scores and written critiques. The committee may suggest that the
> Contracting Officer request clarifying information from an offeror.
>
> b\) The business portion of each contract proposal will be subjected
> to a cost and price analysis, management analysis, etc.
>
> c\) If award will be made without conducting discussions, offerors may
> be given the opportunity to clarify certain aspects of their proposal
> (e.g., the relevance of an offeror\'s past performance information and
> adverse past performance information to which the offeror has not
> previously had an opportunity to respond) or to resolve minor or
> clerical errors.
>
> d\) If the Government intends to conduct discussions prior to awarding
> a contract-
>
> \(1\) Communications will be held with offerors whose past performance
> information is the determining factor preventing them from being
> placed within the competitive range. Such communications shall address
> adverse past performance information to which an offeror has not had a
> prior opportunity to respond. Also, communications may be held with
> any other offerors whose exclusion from, or inclusion in, the
> competitive range is uncertain.
>
> Such communications shall not be used to cure proposal deficiencies or
> omissions that alter the technical or cost elements of the proposal,
> and/or otherwise revise the proposal, but may be considered in rating
> proposals for the purpose of establishing the competitive range.
>
> \(2\) The Contracting Officer will, in concert with program staff,
> decide which proposals are in the competitive range. The competitive
> range will be comprised of all of the most highly rated proposals.
> Oral or written discussions will be conducted with all offerors in the
> competitive range.
>
> While it is NIAID\'s policy to conduct discussions with all offerors
> in the competitive range, NIAID reserves the right, in special
> circumstances, to limit the number of proposals included in the
> competitive range to the greatest number that will permit an efficient
> competition. All aspects of the proposals are subject to discussions,
> including cost, technical approach, past performance, and contractual
> terms and conditions. At the conclusion of discussions, each offeror
> still in the competitive range shall be given an opportunity to submit
> a written Final Proposal Revision (FPR) with the reservation of the
> right to conduct finalization of details with the selected source in
> accordance with HHSAR 315.370.
>
> e\) The process described in FAR 15.101-1 will be employed, which
> permits the Government to make tradeoffs among cost or price and
> non-cost factors and to consider award to other than the lowest price
> offeror or other than the highest technically rated
>
> offeror. This process will take into consideration the results of the
> technical evaluation, the past performance evaluation (if applicable)
> and the cost analysis.
>
> f\) The NIAID reserves the right to make a single award, multiple
> awards, or no award at all to the RFP. In addition, the RFP may be
> amended or canceled as necessary to meet NIAID requirements. Synopses
> of awards exceeding \$25,000 will be published in FedBizOpps.

(11) **Institution Responsibility Regarding Conflicting Interests of
     Investigators**

     **EACH INSTITUTION MUST:**

> \(a\) Maintain an appropriate written, enforced policy on conflict of
> interest that complies with 42 CFR Part 50 Subpart F and/or 45 CFR
> Part 94 as appropriate and inform each investigator of the
> Institution\'s policy, the Investigator\'s reporting responsibilities,
> and the applicable regulations. If the Institution carries out the NIH
> funded research through subgrantees, Contractors or collaborators, the
> Institution must take reasonable steps to ensure that Investigators
> working for such entities comply with the regulations, either by
> requiring those investigators to comply with the Institution\'s policy
> or by requiring the entities to provide assurances to the Institution
> that will enable the Institution to comply with the regulations.
>
> \(b\) Designate an Institutional official(s) to solicit and review
> financial disclosure statements from each Investigator who is planning
> to participate in NIH-funded research.
>
> \(c\) Require that by the time an application/proposal is submitted to
> the NIH each investigator who is planning to participate in the
> NIH-funded research has submitted to the designated official(s) a
> listing of his/her known Significant Financial Interests (and those of
> his/her spouse and dependent children): (i) that would reasonably
> appear to be affected by the research for which the NIH funding is
> sought; and (ii) in entities whose financial interests would
> reasonably appear to be affected by the research. All financial
> disclosures must be updated during the period of the award, either on
> an annual basis or as new reportable Significant Financial Interests
> are obtained.
>
> \(d\) Provide guidelines consistent with the regulations for the
> designated official(s) to identify conflicting interests and take such
> actions as necessary to ensure that such conflicting interests will be
> managed, reduced, or eliminated.
>
> \(e\) Maintain records, identifiable to each award, of all financial
> disclosures and all actions taken by the institution with respect to
> each conflicting interest for: (1) in the case of grants, at least
> three years from the date of submission of the final expenditures
> report or, where applicable, from other dates specified in 45 CFR Part
> 74.53(b) and (2) in the case of contracts, 3 years after final payment
> or, where applicable, for the other time period specified in 48 CFR
> Part 4 Subpart 4.7, Contract Records Retention.
>
> \(f\) Establish adequate enforcement mechanisms and provide for
> sanctions where appropriate.
>
> \(g\) Certify, in each application/proposal for funding to which the
> regulations applies, that:

1\) there is in effect at the Institution a written and enforced
administrative process to identify and manage, reduce or eliminate
conflicting interests with respect to all research projects for which
funding is sought from the NIH;

2\) prior to the Institution\'s expenditure of any funds under the
award, the Institution will report to the awarding component the
existence of a conflicting interest (but not the nature of the interest
or other details) found by the Institution and assure that the interest
has been managed, reduced or eliminated in accord with the regulations;
and for any interest that the Institution identifies as conflicting
subsequent to the expenditure of funds after award, the report will be
made and the conflicting interest managed, reduced, or eliminated, at
least on a temporary basis within sixty days of that identification;

3\) the Institution agrees to make information available, upon request,
to the awarding component regarding all conflicting interests identified
by the Institution and how those interested have been managed, reduced,
or eliminated to protect the research from bias; and,

4\) the Institution will otherwise comply with the regulations.

**Institutional Management of Conflicting Interests**

\(a\) The designated official(s) must:

\(1\) review all financial disclosures; and,

\(2\) determine whether conflict of interest exists, and if so,
determine what actions should be taken by the Institution to manage,
reduce or eliminate such conflict of interest. **A conflict of interest
exists when the designated official(s) reasonably determines that a
Significant Financial Interest could directly and significantly affect
the design, conduct, or reporting of the NIH-funded research**.

> Examples of conditions or restrictions that might be imposed to manage
> actual or potential conflicts of interests include, but are not
> limited to:
>
> \(i\) public disclosure of significant financial interests;
>
> \(ii\) monitoring of research by independent reviewers;
>
> \(iii\) modification of the research plan;
>
> \(iv\) disqualification of the Investigator(s) from participation in
> all or a portion of the research funded by the awarding component;
>
> \(v\) divestiture of significant financial interests; or,
>
> \(vi\) severance of relationships that create actual or potential
> conflicts of interests.

a.  An Institution may require the management of other conflicting
    financial interests in addition to those described in paragraph (a)
    of this section, as the Institution deems appropriate.

```{=html}
<!-- -->
```
(12) **ROTC Access and Federal Military Recruiting on Campus**

> Section 514 of the FY 1997 Appropriations Act prohibits NIH from
> providing contract funds to educational institutions that the
> Secretary of Defense determines have a policy or practice (regardless
> of when implemented ) that either prohibits, or in effect prevents (1)
> the maintaining, establishing, or operation of a unit of the Senior
> Reserve Officer Training Corps at the covered education entity; or (2)
> a student at the covered educational entity from enrolling in a unit
> of the Senior Reserve Officer Training Corps at another institution of
> higher education.
>
> Further, contract funds may not be provided to educational
> institutions that have a policy or practice that prohibits or prevents
> (1) entry to campuses, or access to students (who are 17 years of age
> or older) on campuses, for purposes of Federal military recruiting; or
> (2) access by military recruiters for purposes of Federal military
> recruiting to information pertaining to students (who are 17 years of
> age or older) enrolled at the covered educational entity.

(13) **Past Performance Information**

> a\) Offerors shall submit the following information as part of their
> business proposal.
>
> A list of the contracts completed during the past three years and all
> contracts currently in process that are similar in nature to the
> solicitation workscope. Contracts listed may include those entered
> into by the Federal Government, agencies of state and local
> governments and commercial concerns. Offerors that are newly formed
> entities without prior contracts should list contracts and
> subcontracts as required above for all key personnel.
>
> Include the following information for each contract or subcontract:
>
> 1\. Name of Contracting Organization
>
> 2\. Contract Number (for subcontracts, provide the prime contract
> number and the subcontract number)
>
> 3\. Contract Type
>
> 4\. Total Contract Value
>
> 5\. Description of Requirement
>
> 6\. Contracting Officer\'s Name and Telephone Number
>
> 7\. Program Manager\'s Name and Telephone Number
>
> 8\. North American Industry Classification System (NAICS) code
>
> The offeror shall submit comparable information on all subcontractors
> that the offeror proposes to perform a major subcontract under this
> effort. For the purpose of this solicitation, a \"major subcontract\"
> is defined as a subcontract over \$500,000.
>
> The offeror may provide information on problems encountered on the
> identified contracts and the offeror\'s corrective actions.

b)  Each offeror will be evaluated on its performance under existing and
    prior contracts for similar products or services. The Government is
    not required to contact all references provided by the offeror.
    Also, references other than those identified by the offeror may be

> contacted by the Government to obtain additional information that will
> be used in the evaluation of the offeror\'s past performance.

(13) **Solicitation Provisions Incorporated by Reference, FAR 52.252-1
     (February 1998)**

> This Solicitation incorporates one or more solicitation provisions by
> reference, with the same force and effect as if they were given in
> full text. Upon request, the Contracting Officer will make their full
> text available. The offeror is cautioned that the listed provisions
> may include blocks that must be completed by the offeror and submitted
> with its quotation or offer. In lieu of submitting the full text
> provisions, the offeror may identify the provision by paragraph
> identifier and provide the appropriate information with its quotation
> or offer. Also, the full text of a solicitation provision may be
> accessed electronically at this address: <http://www.arnet.gov/far/>.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1):

a)  Data Universal Numbering System (DUNS) Number, FAR Clause 52.204-6
    (October 2003).

```{=html}
<!-- -->
```
a)  Facilities Capital Cost of Money, FAR Clause 52.215-16, (October
    1997).

b)  Order of Precedence-Uniform Contract Format, FAR Clause 52.215-8,
    (October 1997).

c)  Preaward On-Site Equal Opportunity Compliance Evaluation, (Over
    \$10,000,000), FAR Clause 52.222-24, (February 1999).

**b. TECHNICAL PROPOSAL INSTRUCTIONS**

> **THERE ARE TWO SEPARATE PARTS TO THIS SOLICITATION AND SEPARATE
> PROPOSALS ARE SOLICITED FOR EACH PART. OFFERORS MAY RESPOND TO EITHER
> PART A OR PART B, OR TO BOTH, BUT EACH PART MUST BE SUBMITTED AS A
> SEPARATE STAND ALONE PROPOSAL. PROPOSALS FOR [PART A: CONFIRMATORY IN
> VITRO EVALUATIONS OF HIV THERAPEUTICS]{.mark} SHALL ADDRESS ALL ISSUES
> PRESENTED BELOW PERTAINING TO PART A ONLY. SIMILARLY, PROPOSALS FOR
> [PART B: SPECIALIZED IN VITRO ASSAYS FOR HIV THERAPEUTICS]{.mark} AND
> TOPICAL MICROBICIDES SHALL ADDRESS ALL ISSUES PRESENTED BELOW
> PERTAINING TO PART B ONLY. ANY PROPOSAL WHICH COMBINES BOTH PART A AND
> PART B IN THE SAME PROPOSAL WILL BE RETURNED TO THE OFFEROR WITHOUT
> REVIEW OR FURTHER CONSIDERATION.**
>
> A detailed work plan must be submitted indicating how each aspect of
> the Statement of Work is to be accomplished. Your technical approach
> should be in as much detail as you consider necessary to fully explain
> your proposed technical approach or method. The technical proposal
> should reflect a clear understanding of the nature of the work being
> undertaken. The technical proposal must include information on how the
> project is to be organized, staffed, and managed. Information should
> be provided which will demonstrate your understanding and management
> of important events or tasks.

(1) **Technical Discussions**

> The technical discussion included in the technical proposal should
> respond to the items set forth below:
>
> a\) **Project Objectives, NIH-1688-1**
>
> The offeror shall insert a completed NIH Form 1688-1, Project
> Objective, as provided in Section J, Attachment 15, behind the Title
> Page of each copy of the proposal, along with the AGovernment Notice
> for Handling Proposals.@ The NIH Form 1688-1 is to be completed as
> follows:
>
> \- For an **Institution of Higher Education:** The form
> [MUST]{.underline} be completed in its entirety.
>
> \- For **OTHER** than an Institution of Higher Education: The starred
> items (Department, Service, Laboratory or Equivalent, and Major
> Subdivision) should be left blank.
>
> The information required under the "Summary of Objectives" portion of
> the form MUST meet the requirements set forth in the section of the
> form entitled, **"[INSTRUCTIONS]{.underline}:"**

b\) **Statement of Work**

> **(1) Objectives**
>
> State the overall objectives and the specific accomplish­ments you hope
> to achieve. Indicate the rationale for your plan, and relation to
> comparable work in progress elsewhere. Review pertinent work already
> published which is relevant to this project and your proposed
> approach. This should support the scope of the project as you perceive
> it.

**(2) Approach**

> Use as many subparagraphs, appropriately titled, as needed to clearly
> outline the general plan of work. Discuss phasing of research and, if
> appropriate, include experimental design and possible or probable
> outcome of approaches proposed.
>
> **(3) Methods**
>
> Describe in detail the methodologies you will use for the project,
> indicating your level of experience with each, areas of anticipated
> difficulties, and any unusual expenses you anticipate.
>
> **(4) Schedule**
>
> Provide a schedule for completion of the work and delivery of items
> specified in the statement of work. Performance or delivery schedules
> shall be indicated for phases or segments, as applicable, as well as
> for the overall program. Schedules shall be shown in terms of calendar
> months from the date of authorization to proceed or, where applicable,
> from the date of a stated event, as for example, receipt of a required
> approval by the Contracting Officer. Unless the request for proposal
> indicates that the stipulated schedules are mandatory, they shall be
> treated as desired or recommended schedules. In this event, proposals
> based upon the offeror\'s best alternative schedule, involving no
> overtime, extra shift or other premium, will be accepted for
> consideration.
>
> c\) **Personnel**
>
> Describe the experience and qualifications of personnel who will be
> assigned for direct work on this program. Information is required
> which will show the composition of the task or work group, its general
> qualifications, and recent experience with similar equipment or
> programs. Special mention shall be made of direct technical
> supervisors and key technical personnel, and the approximate
> percentage of the total time each will be available for this program.
>
> **OFFERORS SHOULD ASSURE THAT THE PRINCIPAL INVESTIGATOR, AND ALL
> OTHER PERSONNEL PROPOSED, SHALL NOT BE COMMITTED ON FEDERAL GRANTS AND
> CONTRACTS FOR MORE THAN A TOTAL OF 100% OF THEIR TIME. IF THE
> SITUATION ARISES WHERE IT IS DETERMINED THAT A PROPOSED EMPLOYEE IS
> COMMITTED FOR MORE THAN 100% OF HIS OR HER TIME, THE GOVERNMENT WILL
> REQUIRE ACTION ON THE PART OF THE OFFEROR TO CORRECT THE TIME
> COMMITMENT.**
>
> **(1) Principal Investigator/Project Director**
>
> List the name of the Principal Investigator/Project Director
> responsible for overall implementation of the contract and key contact
> for technical aspects of the project. Even though there may be
> Co-Investigators, identify the Principal Investigator/Project Director
> who will be responsible for the overall implementation of any awarded
> contract. Discuss the qualifications, experience, and accomplishments
> of the Principal Investigator/Project Director. State the estimated
> time to be spent on the project, his/her proposed duties, and the
> areas or phases for which he/she will be responsible.
>
> **(2) Other Investigators**
>
> List all other Investigators/professional personnel who will be
> participating in the project. Discuss the qualifications, experience,
> and accomplishments. State the estimated time each will spend on the
> project, proposed duties on the project, and the areas or phases for
> which each will be responsible.
>
> **(3) Additional Personnel**
>
> List names, titles, and proposed duties of additional personnel, if
> any, who will be required for full-time employment, or on a
> subcontract or consultant basis. The technical areas, character, and
> extent of subcontract or consultant activity will be indicated and the
> anticipated sources will be specified and qualified. For all proposed
> personnel who are not currently members of the offeror\'s staff, a
> letter of commitment or other evidence of availability is required. A
> resume does not meet this requirement. Commitment letters for use of
> consultants and other personnel to be hired must include:
>
> -The specific items or expertise they will provide.
>
> -Their availability to the project and the amount of time anticipated.
>
> -Willingness to act as a consultant.
>
> -How rights to publications and patents will be handled.
>
> **(4) Resumes**
>
> Resumes of all key personnel are required. Each must indicate
> educational background, recent experience, specific or technical
> accomplishments, and a listing of relevant publications.

(2) **Technical Evaluation**

> Proposals will be technically evaluated in accordance with the
> factors, weights, and order of relative importance as described in the
> Technical Evaluation Criteria (Section M.1., hereof).

(3) **Additional Technical Proposal Information**

> a\) Proposals which merely offer to conduct a program in accordance
> with the requirements of the Government\'s scope of work will not be
> eligible for award. The offeror must submit an explanation of the
> proposed technical approach in conjunction with the tasks to be
> performed in achieving the project objectives.
>
> b\) The technical evaluation is conducted in accordance with the
> weighted technical evaluation criteria by an initial review panel.
> This evaluation produces a numerical score (points) which is based
> upon the information contained in the offeror\'s proposal only.

(4) **Other Considerations**

> Record and discuss specific factors not included elsewhere which
> support your proposal. Using specifically titled subparagraphs, items
> may include:
>
> a\) Any agreements and/or arrangements with Subcontractor(s). Provide
> as much detail as necessary to explain how the statement of work will
> be accomplished within this working relationship.
>
> b\) Unique arrangements, equipment, etc., which none or very few
> organizations are likely to have which is advantageous for effective
> implementation of this project.
>
> c\) Equipment and unusual operating procedures established to protect
> personnel from hazards associated with this project.
>
> d\) Other factors you feel are important and support your proposed
> research.
>
> e\) Recommendations for changing reporting requirements if such
> changes would be more compatible with the offeror\'s proposed
> schedules.

\(5\) **Obtaining and Disseminating Biomedical Research Resources**

> As a public sponsor of biomedical research, the National Institutes of
> Health (NIH) has a dual interest in accelerating scientific discovery
> and facilitating product development. Intellectual property
> restrictions can stifle the broad dissemination of new discoveries and
> limit future avenues of research and product development. At the same
> time, reasonable restrictions on the dissemination of research tools
> are sometimes necessary to protect legitimate proprietary interests
> and to preserve incentives for commercial development. To assist NIH
> Contractors achieve an appropriate balance, the NIH has provided
> guidance in the form of a two-part document, consisting of Principles
> setting forth the fundamental concepts and Guidelines that provide
> specific information to patent and license professionals and sponsored
> research administrators for implementation.
>
> The purpose of these Principles and Guidelines is to assist NIH
> funding recipients in determining: 1) Reasonable terms and conditions
> for making NIH-funded research resources available to scientists in
> other institutions in the public and private sectors (disseminating
> research tools); and 2) Restrictions to accept as a condition of
> receiving access to research tools for use in NIH-funded research
> (acquiring research tools). The intent is to help recipients ensure
> that the conditions they impose and accept on the transfer of research
> tools will facilitate further biomedical research, consistent with the
> requirements of the Bayh-Dole Act and NIH funding policy.
>
> This policy, entitled, \"Sharing Biomedical Research Resources:
> Principles and Guidelines for Recipients of NIH Research Grants and
> Contracts,\" (Federal Register Notice, December 23, 1999 \[64 FR
> 72090\] will be included in any contract awarded from this
> solicitation. It can be found at the following website:
> <http://ott.od.nih.gov/NewPages/64FR72090.pdf>[.]{.underline}
>
> \(a\) **Sharing Research Data**
>
> *\[Note: This policy applies to **[all]{.underline}** NIH contracts,
> regardless of dollar value, that are expected to generate research
> data.\]*
>
> The NIH endorses the sharing of final research data to expedite the
> translation of research results into knowledge, products, and
> procedures to improve human health. This contract is expected to
> generate research data. Therefore, the offeror must submit a plan in
> its technical proposal for data sharing or state why data sharing is
> not possible. If data sharing is limited, the offeror should explain
> such limitations in its data sharing plan. NIH\'s data sharing policy
> may be found at the following Web site:

<http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html>

> \[If the resultant contract is part of a collaborative program
> involving multiple sites, the data sharing will be governed by a
> dissemination plan to be developed jointly following award. Offerors
> must include in their proposals a statement of willingness to work
> collaboratively after award with the other funded sites to prepare a
> joint dissemination plan. Coordinating Center proposals should
> describe methods to coordinate the dissemination planning and
> implementation. The Coordinating Center must include a budget and
> justification for any additional costs of this collaborative effort.\]

**(6) Information Security** is applicable to this solicitation and the
following information is provided to assist in proposal preparation.

> **IMPORTANT NOTE TO OFFERORS: The following information shall be
> addressed in a separate section of the Technical Proposal entitled,
> \"INFORMATION SECURITY.\"**
>
> The Federal Information Security Management Act of 2002 (P.L. 107‑347)
> (FISMA) requires each agency to develop, document, and implement an
> agency‑wide information security program to safeguard information and
> information systems that support the operations and assets of the
> agency, including those provided or managed by another agency,
> Contractor (including Subcontractor), or other source. The National
> Institute of Standards and Technology (NIST) has issued a number of
> publications that provide guidance in the establishment of minimum
> security controls for management, operational and technical safeguards
> needed to protect the confidentiality, integrity and availability of a
> Federal information system and its information.
>
> The Statement of Work (SOW) requires the successful offeror to (1)
> develop, (2) have the ability to access, or (3) host and/or maintain a
> Federal information system(s). Pursuant to Federal and HHS Information
> Security Program Policies the following requirements apply to this
> solicitation:
>
> Federal Information Security Management Act of 2002 (FISMA), Title
> III, E‑Government Act of 2002, Pub. L. No. 107‑347 (Dec. 17, 2002);
> [http://csrc.nist.gov/policies/FISMA‑final.pdf]{.underline}

\(a\) [Information Type]{.underline}

**\[ \]** **Administrative, Management and Support Information:**

**\[X\]** **Mission Based Information:**

\(b\) [Security Categories and Levels]{.underline}

Confidentiality Level: **\[X\]** Low **\[ \]** Moderate **\[ \]** High

Integrity Level: **\[X\]** Low **\[ \]** Moderate **\[ \]** High

> Availability Level: **\[X\]** Low **\[ \]** Moderate **\[ \]** High

**Overall Level: \[X\] Low \[ \] Moderate \[ \] High**

> \(c\) [Position Sensitivity Designations]{.underline}
>
> Prior to award, the Government will determine the position sensitivity
> designation for each Contractor (including subcontractor) employee
> that the successful offeror proposes for work under the contract. For
> proposal preparation purposes, the following designations apply:
>
> **\[X\]** **Level 1: Non Sensitive (Requires Suitability Determination
> with an NACI)**. Contractor employees assigned to a Level 1 position
> are subject to a National Agency Check and Inquiry Investigation
> (NACI).
>
> Upon award, the Contractor will be required to submit a roster of all
> staff (including subcontractor staff) working under the contract who
> will develop, have the ability to access, or host and/or maintain a
> federal information system(s). The Government will determine and
> notify the Contractor of the appropriate level of suitability
> investigation required for each staff member. An electronic template,
> \"Roster of Employees Requiring Suitability Investigations,\" is
> available for Contractor use at:

[http://ais.nci.nih.gov/forms/Suitability‑roster.xls]{.underline}

> Upon receipt of the Government\'s notification of applicable
> Suitability Investigations required, the Contractor shall complete and
> submit the required forms within 30 days of the notification.
> Additional submission instructions can be found at the \"NCI
> Information Technology Security Policies, Background Investigation
> Process\" website: [http://ais.nci.nih.gov]{.underline}.
>
> Contractor/Subcontractor employees who have met investigative
> requirements within the past five years may only require an updated or
> upgraded investigation.
>
> \(d\) [Information Security Training]{.underline}
>
> HHS policy requires Contractors/Subcontractors receive security
> training commensurate with their responsibilities for performing work
> under the terms and conditions of their contractual agreements.
>
> The successful offeror will be responsible for assuring that each
> Contractor/Subcontractor employee has completed the NIH Computer
> Security Awareness Training course at:
> [http://irtsectraining.nih.gov/]{.underline} prior to performing any
> contract work, and thereafter completing the NIH‑specified fiscal year
> refresher course during the period of performance of the contract. The
> successful offeror shall maintain a listing of all individuals who
> have completed this training and shall submit this listing to the
> Project Officer.
>
> Additional security training requirements commensurate with the
> position may be required as defined in NIST Special Publication
> 800‑16, Information Technology Security Training Requirements
> ([http://csrc.nist.gov/publications/nistpubs/800‑16/800‑16.pdf]{.underline}).
> This document provides information about information security training
> that may be useful to potential offerors.

\(e\) [Offeror\'s Official Responsible for Information
Security]{.underline}

> The offeror shall include in the \"Information Security\" part of its
> Technical Proposal the name and title of its official who will be
> responsible for all information security requirements should the
> offeror be selected for an award.

**c. BUSINESS PROPOSAL INSTRUCTIONS**

(1) **Basic Cost/Price Information**

> The business proposal must contain sufficient information to allow the
> Government to perform a basic analysis of the proposed cost or price
> of the work. This information shall include the amounts of the basic
> elements of the proposed cost or price. These elements will include,
> as applicable, direct labor, fringe benefits, travel, materials,
> subcontracts, purchased parts, shipping, indirect costs and rate, fee,
> and profit.

(1) **Proposal Cover Sheet**

> The following information shall be provided on the first page of your
> pricing proposal:
>
> 1\. Solicitation, contract, and/or modification number;
>
> 2\. Name and address of Offeror;
>
> 3\. Name and telephone number of point of contact;
>
> 4\. Name, address, and telephone number of Contract Administration
> Office, (if available);
>
> 5\. Name, address, and telephone number of Audit Office (if
> available);
>
> 6\. Proposed cost and/or price; profit or fee (as applicable); and
> total;
>
> 7\. The following statement: By submitting this proposal, the offeror,
> if selected for discussions, grants the Contracting Officer or an
> authorized representative the right to examine, at any time before
> award, any of those books, records, documents, or other records
> directly pertinent to the information requested or submitted.
>
> 8\. Date of submission; and,
>
> 9\. Name, title and signature of authorized representative.

10\. Information Other than Cost or Pricing Data

> The information submitted shall consist of data to permit the
> Contracting Officer and authorized representatives to determine price
> reasonableness or cost realism, e.g., information to support an
> analysis of material costs (when sufficient information on labor and
> overhead rates is already available), or information on prices and
> quantities at which the offeror has previously sold the same or
> similar items.
>
> Any information submitted must support the price proposed. Include
> sufficient detail or cross
>
> references to clearly establish the relationship of the information
> provided to the price proposed. Support any information provided by
> explanations or supporting rational as needed to permit the
> Contracting Officer and authorized representative to evaluate the
> documentation.
>
> This cover sheet information is for use by offerors to submit
> information to the Government when cost or pricing data are not
> required but information to help establish price reasonableness or
> cost realism is necessary. Such information is not considered cost or
> pricing data, and shall not be certified in accordance with FAR
> 15.406-2.
>
> 1\. **Direct Labor**
>
> Provide a time-phased (e.g., monthly, quarterly, etc.) breakdown of
> labor hours, rates, and cost by appropriate category. Key personnel
> will be separately estimated as above and identified. Give the basis
> for the estimates in each case.
>
> 2\. **Materials**
>
> Provide a consolidated price summary of individual material quantities
> included in the various tasks, orders, or contract line items being
> proposed and the basis for pricing (vendor quotes, invoice prices,
> etc.).
>
> 3\. **Subcontracted Items**
>
> Include parts, components, assemblies, and services that are to be
> produced or performed by others in accordance with offeror\'s design,
> specifications, or direction and that are applicable only to the prime
> contract. For each subcontract over \$550,000, the support should
> provide a listing by source, item, quantity, price, type of
> subcontract, degree of competition, and basis for establishing source
> and
>
> reasonableness of price, as well as the results of review and
> evaluation of subcontract proposals when required by FAR 15.404-3.
>
> 4\. **Raw Materials**
>
> Consists of material in a form or state that requires further
> processing. Provide priced quantities of items required for the
> proposal.
>
> 5\. **Purchased Parts**
>
> Includes material items not covered above. Provide priced quantities
> of items required for the proposal.

6\. **Fringe Benefits**

> Show fringe benefits as a separate line item. Include the rate(s)
> and/or method of calculating fringe benefits. Provide a copy of your
> fringe benefit rate or institution­al guidelines.
>
> 7\. **Indirect Costs**
>
> Indicate how offeror has computed and applied offeror\'s indirect
> costs, including cost breakdowns, and provide a basis for evaluating
> the reasonableness of proposed rates. Indicate the rates used and
> provide an appropriate explanation. Where a rate agreement exists,
> provide a copy.
>
> 8\. **Special Equipment**
>
> If direct charge, list any equipment proposed including description,
> price, quantity, total price, purchase or lease, and the basis for
> pricing.
>
> 9\. **Travel**
>
> Provide the cost of travel including destination, duration, purpose,
> per diem, transportation, and the basis for pricing.
>
> 10\. **Other Costs**
>
> List all other costs not otherwise included in the categories
> described above (e.g., computer services, consultant services) and
> provide basis for pricing.

(2) **Requirements for Cost or Pricing Data or Information Other than
    Cost and Pricing Data** \[FAR Clause 52.215-20 (October 1997)\]

> \(a\) Exceptions from cost or pricing data.
>
> \(1\) In lieu of submitting cost or pricing data, offerors may submit
> a written request for exception by submitting the information
> described in the following subparagraphs. The Contracting Officer may
> require additional supporting information, but only to the extent
> necessary to determine whether an exception should be granted, and
> whether the price is fair and reasonable.
>
> \(i\) Identification of the law or regulation establishing the price
> offered. If the price is controlled under law by periodic rulings,
> reviews, or similar actions of a governmental body, attach a copy of
> the controlling document, unless it was previously submitted to the
> contracting office.
>
> \(ii\) Commercial item exception. For a commercial item exception, the
> offeror shall submit, at a minimum, information on prices at which the
> same item or similar items have previously been sold in the commercial
> market that is adequate for evaluating the reasonableness of the price
> for this acquisition. Such information may include---
>
> \(A\) For catalog items, a copy of or identification of the catalog
> and its date, or the appropriate pages for the offered items, or a
> statement that the catalog is on file in the buying office to which
> the proposal is being submitted. Provide a copy or describe current
> discount policies and price lists (published or unpublished), e.g.,
> wholesale, original equipment manufacturer, or reseller. Also explain
> the basis of each offered price and its relationship to the
> established catalog price, including how the proposed price relates to
> the price of recent sales in quantities similar to the proposed
> quantities;
>
> \(B\) For market‑priced items, the source and date or period of the
> market quotation or other basis for market price, the base amount, and
> applicable discounts. In addition, describe the nature of the market;
>
> \(C\) For items included on an active Federal Supply Service Multiple
> Award Schedule contract, proof that an exception has been granted for
> the schedule item.
>
> \(2\) The offeror grants the Contracting Officer or an authorized
> representative the right to examine, at any time before award, books,
> records, documents, or other directly pertinent records to verify any
> request for an exception under this provision, and the reasonableness
> of price. For items priced using catalog or market prices, or law or
> regulation, access does not extend to cost or profit information or
> other data relevant
>
> solely to the offeror\'s determination of the prices to be offered in
> the catalog or marketplace.
>
> \(b\) Requirements for cost or pricing data. If the offeror is not
> granted an exception from the requirement to submit cost or pricing
> data, the following applies:
>
> \(1\) The offeror shall prepare and submit cost or pricing data and
> supporting attachments in accordance with Table 15‑2 of FAR 15.408.
>
> \(2\) As soon as practicable after agreement on price, but before
> contract award (except for unpriced actions such as letter contracts),
> the offeror shall submit a Certificate of Current Cost or Pricing
> Data, as prescribed by FAR 15.406‑2.

(3) **Salary Rate Limitation in Fiscal Year 2006**

> Offerors are advised that pursuant to P.L. 109-149, no NIH Fiscal Year
> 2006 (October 1, 2005 - September 30, 2006) funds may be used to pay
> the direct annual salary of an individual through any contract awarded
> as a result of this solicitation at a rate in excess of the Executive
> Schedule, Level I\* (direct salary is exclusive of Overhead, Fringe
> Benefits and General and Administrative expenses, also referred to as
> \"indirect cost\" 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 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.
>
> This does not preclude the offeror from absorbing that portion of an
> employee\'s annual salary (plus the dollar amount for fringe benefits
> and associated indirect costs) that exceeds a rate of the Executive
> Schedule, Level I\*. The salary rate limitation set by P.L. 109-149
> applies only to Fiscal Year 2006 funds, however, salary rate ceilings
> for subsequent years may be included in future DHHS appropriation
> acts. Multi-year contracts awarded pursuant to this solicitation may
> be subject to unilateral modifications by the Government if an
> individual\'s annual salary exceeds any salary rate ceiling
> established in future appropriations acts. The Executive Schedule,
> Level I\* annual salary rate limit also applies to individuals
> proposed under subcontracts, however it does not apply to consultants.
> P.L. 109-149 states in pertinent part:
>
> \"None of the funds appropriated in this Act for the National
> Institutes of Health, the Agency for Healthcare Research and Quality,
> and the Substance Abuse, and Mental Health Services Administration
> shall be used to pay the salary of an individual through a grant or
> other extramural mechanism at a rate in excess of Executive Level
> I\*.\"

**LINK TO EXECUTIVE SCHEDULE SALARIES:**
<http://www.opm.gov/oca/06tables/indexSES.asp>

> ***\*Note to Offerors:** The current Fiscal Year Executive Level I
> Salary Rate should be adhered to in the preparation of your proposal.
> All costs associated with any resultant contract award shall be in
> compliance with the current Fiscal Year 2006 Executive Level I Salary
> rates.*

(4) **Small Business Subcontracting Plan**

> If the proposed contract exceeds a total estimated cost of \$500,000
> for the entire period of performance, the apparent successful offeror
> shall be required to submit an acceptable subcontracting plan in
> accordance with the terms of the clause entitled \"Small Business
> Subcontracting Plan,\" FAR Clause No. 52.219-9, incorporated herein by
> reference in the Solicitation, Attachment 17 to this RFP is an example
> of such a plan.
>
> a\) THIS PROVISION DOES NOT APPLY TO SMALL BUSINESS CONCERNS.
>
> b\) The term \"subcontract\" means any agreement (other than one
> involving an employer-employee relationship) entered into by a Federal
> Government prime Contractor or Subcontractor calling for supplies or
> services required for the performance of the original contract or
> subcontract. This includes, but is not limited to, agreements/purchase
> orders for supplies and services such as equipment purchase, copying
> services, and travel services.
>
> c\) The offeror understands that:
>
> \(1\) No contract will be awarded unless and until an acceptable plan
> is negotiated with the Contracting Officer which plan will be
> incorporated into the contract, as a material part thereof.
>
> \(2\) An acceptable plan must, in the determination of the Contracting
> Officer, provide the maximum practicable opportunity for Small
> Businesses, Small Disadvantaged Businesses, Women-Owned Small
> businesses, HubZone Small Businesses, Veteran-Owned Small Businesses,
> and Service Disabled Veteran-Owned Small Businesses to participate in
> the performance of the contract.
>
> \(3\) If a subcontracting plan acceptable to the Contracting Officer
> is not negotiated within the time limits prescribed by the contracting
> activity and such failure arises out of causes within the control and
> with the fault or negligence of the offeror, the offeror shall be
> ineligible for an award. The Contracting Officer shall notify the
> Contractor in writing of the reasons for determining a subcontracting
> plan unacceptable early enough in the negotiation process to allow the
> Contractor to modify the plan within the time limits prescribed.
>
> \(4\) Prior compliance of the offeror with other such subcontracting
> plans under previous contracts will be considered by the Contracting
> Officer in determining the responsibility of the offeror for award of
> the contract.
>
> \(5\) It is the offeror\'s responsibility to develop a satisfactory
> subcontracting plan with respect to Small Business Concerns, Small
> Disadvantaged Business Concerns, Women-Owned Small Business Concerns,
> HubZone Small Business Concerns, Veteran-Owned Small Business
> Concerns, and Service Disabled Veteran-Owned Small Business Concerns
> that each such aspect of the offeror\'s plan will be judged
> independent of the other.
>
> \(6\) The offeror will submit, as required by the Contracting Officer,
> subcontracting reports in accordance with the instructions thereon,
> and as further directed by the Contracting Officer. Subcontractors
> will also submit these reports to the Government\'s Contracting
> Officer or as otherwise directed, with a copy to the prime
> Contractor\'s designated small and disadvantaged business liaison.
>
> d\) Each plan must contain the following:
>
> \(1\) Goals, expressed in terms of percentages of total planned
> subcontracting dollars, for the use of Small, Small Disadvantaged,
> Women-Owned, HUBZone, Veteran-Owned, and Service Disabled
> Veteran-Owned Small Business Concerns as Subcontractors.
>
> \(2\) A statement of total dollars planned to be subcontracted. A
> statement of total dollars to be subcontracted to each of the
> following type of small business concerns: Small, Small Disadvantaged,
> Women-Owned, HUBZone, Veteran-Owned, and Service Disabled
> Veteran-Owned Small Businesses.
>
> \(3\) A description of the principal types of supplies and services to
> be subcontracted with an identification of which supplies and services
> are expected to be subcontracted to Small, Small Disadvantaged,
> Women-Owned, HUBZone, Veteran-Owned, and/or Service Disabled
> Veteran-Owned Small Business Concerns.
>
> \(4\) A description of the method used to develop the subcontracting
> goals.
>
> \(5\) A description of the method used to identify potential sources
> for solicitation purposes.
>
> \(6\) A statement as to whether or not indirect costs were included in
> establishing subcontracting goals. If they were, a description of the
> method used to determine the proportionate share of indirect costs to
> be incurred with Small, Small Disadvantaged, Women-Owned, HUBZone,
> Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses.
>
> \(7\) The name of the individual employed by the offeror who will
> administer the offeror\'s subcontracting program and a description of
> his/her duties.
>
> \(8\) A description of the efforts the offeror will make to assure
> that Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned,
> and Service Disabled Veteran-Owned Small Businesses have an equitable
> chance to compete for subcontracts.
>
> \(9\) Assurances that the offeror will include in all subcontracts the
> contract clause \"Utilization of Small Business Concerns.\" Assure
> that all subcontractors, other than small businesses, in excess of
> \$500,000 adopt a plan similar to the plan agreed upon by the offeror.
>
> \(10\) Assurances that the offeror (and any required Subcontractors)
> will cooperate in studies or surveys as required and submit required
> reports (SF 294 and SF 295) to the Government.
>
> \(11\) List the types of records the offeror will maintain to
> demonstrate procedures that have been adopted to comply with the
> requirement and goals in the plan, including establishing source
> lists. Also, the offeror shall describe its efforts to locate Small,
> Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service
> Disabled Veteran-Owned Small Businesses and award subcontracts to
> them.
>
> For additional information about each of the above elements required
> to be contained the subcontracting plan, see FAR Clause 52.219-9,
> Small Business Subcontracting Plan, and the Sample Subcontracting Plan
> which is provided as an attachment to this RFP in SECTION J,
> Attachment 17.
>
> HHS expects each procuring activity to establish minimum
> subcontracting goals for all procurements. The anticipated minimum
> goals for this RFP are as follows:
>
> 23% for Small Business; 5% for Small Disadvantaged Business; 5% for
> Women-Owned Small Business; 3% for HUBZone Small Business; and 3% for
> Veteran-Owned Small Business and Service-Disabled Veteran-Owned Small
> Business.

(5) **HUBZone Small Business Concerns**

> Small Business offerors located in underutilized business zones,
> called \"HUBZones,\" will be evaluated in accordance with FAR Clause
> 52.219-4, NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZONE SMALL
> BUSINESS CONCERNS, which is incorporated by reference in ARTICLE I.3.
> of this solicitation. Qualified HUBZone firms are identified in the
> Small Business Administration website at <http://www.sba.gov/hubzone>.

(6) **Extent of Small Disadvantaged Business Participation**

> In accordance with FAR Subpart 15.304(c)(4), the extent of
> participation of Small Disadvantaged Business (SDB) concerns in
> performance of the contract in the authorized NAICS Subsectors shall
> be evaluated in unrestricted competitive acquisitions expected to
> exceed \$500,000 (\$1,000,000 for construction) subject to certain
> limitations (see FAR 19.1202-1 and 19.1202-2(b). The dollar amounts
> cited above include any option years/option quantities that may be
> included in this solicitation. The definition of a \"small
> disadvantaged business\" is cited in FAR 19.001.
>
> The factor entitled AExtent of Small Disadvantaged Business
> Participation@ as set forth under the Evaluation Criteria in Section M
> shall be used for evaluation purposes.
>
> The Department of Commerce determines, on an annual basis, by
> Subsectors, as contained in the NAICS code, and region, if any, the
> authorized SDB procurement mechanisms and applicable factors
> (percentages). The NAICS codes can be found at:
> <http://www.sba.gov/size>.

The Department of Commerce website for the annual determination for
NAICS codes\* is:

<http://www.arnet.gov/References/sdbadjustments.htm>.

> \**Note: Public Law 103-355 which authorized the SDB Price Evaluation
> Adjustment (PEA) and associated percentages/factors expired on
> December 9, 2004, therefore, the percentages shown at this website are
> no longer applicable.*
>
> Offerors shall include with their offers, SDB targets, expressed as
> dollars and percentages of total contract value, in each of the
> applicable, authorized NAICS Subsector(s). The applicable authorized
> NAICS Subsector(s) for this project is (are) identified elsewhere in
> this RFP. A total target for SDB participation by the prime
> contractor, that includes any joint ventures and team members, shall
> be provided as well as a total target for SDB participation by
> subcontractors. In addition, offerors must provide information that
> describes their plans for meeting the targets set forth in their
> proposal. **This information shall be provided in one clearly marked
> section of the Business Proposal, which shall describe the extent of
> participation of SDB concerns in the performance of the contract.**
>
> If the evaluation factor in this solicitation includes an SDB
> evaluation factor or subfactor that considers the extent to which SDB
> concerns are specifically identified, the SDB concerns considered in
> the evaluation shall be listed in any resultant contract. Offerors
> should note that addressing the extent of small disadvantaged business
> participation **is not in any way intended to be a substitute** for
> submission of the subcontracting plan, if it is required by this
> solicitation. An [example]{.underline} of the type of information that
> might be given (in addition to the narrative describing the plan for
> meeting the targets) follows:

  -----------------------------------------------------------------------
  EXAMPLE

  Targets for SDB Participation - NAICS Subsector 223
  -----------------------------------------------------------------------

+-----------------------+---+------------------------+------------------+
|                       |   | **SDB Percentage of**  | **SDB Dollars**  |
|                       |   |                        |                  |
|                       |   | **Total Contract       |                  |
|                       |   | Value**                |                  |
+-----------------------+---+------------------------+------------------+
| Total Contract Value- | 2 |                        | \$250,000        |
| \$1,000,000           | 5 |                        |                  |
|                       | % |                        |                  |
+-----------------------+---+------------------------+------------------+
| SDB Participation by  | 1 |                        | \$100,000        |
| Prime                 | 0 |                        |                  |
|                       | % |                        |                  |
+-----------------------+---+------------------------+------------------+
| (Includes joint       |   |                        |                  |
| venture partners and  |   |                        |                  |
| team arrangements)\*  |   |                        |                  |
+-----------------------+---+------------------------+------------------+
| SDB Participation by  | 1 |                        | \$150,000        |
| subcontractors        | 5 |                        |                  |
|                       | % |                        |                  |
+-----------------------+---+------------------------+------------------+

> \*Note: FAR Subpart 9.6 defines AContractor team arrangements@ to
> include two or more companies forming a partnership or joint venture
> to act as a potential prime Contractor, or a potential prime
> Contractor who agrees with one or more companies to have them act as
> its Subcontractors on a specific contract or acquisition program. For
> purposes of evaluation of the SDB participation factor, FAR 19.1202-4
> requires that SDB joint ventures and teaming arrangements at the prime
> level be presented separately from SDB participation by
> subcontractors.

(7) **Qualifications of the Offeror**

> You are requested to submit a summary of your \"General Experience,
> Organizational Experience Related to this RFP, Performance History and
> Pertinent Contracts.\"
>
> a\) **General Experience**
>
> *General experience* is defined as general background, experience and
> qualifications of the offeror. A discussion of proposed facilities
> which can be devoted to the project may be appropriate.
>
> b\) **Organizational Experience Related to the RFP**
>
> *Organizational experience* is defined as the accomplishment of work,
> either past or on-going, which is comparable or related to the effort
> required by this RFP. This includes overall offeror or corporate
> experience, **but not** the experience and/or past performance of
> individuals who are proposed as personnel involved with the Statement
> of Work in this RFP.
>
> c\) **Performance History**
>
> *Performance history* is defined as meeting contract objectives within
> [delivery]{.underline} and [cost]{.underline} [schedules]{.underline}
> on efforts, either past or on-going, which is comparable or related to
> the effort required by this RFP.
>
> d\) **Pertinent Contracts**
>
> *Pertinent contracts* are defined as a listing of each related
> contract completed within the last three years or currently in
> process. The listing should include: 1) the contract number; 2)
> contracting agency; 3) contract dollar value; 4) dates contract began
> and ended (or ends); 5) description of contract work; 6) explanation
> of relevance of work to this RFP; 7) actual delivery and cost
> performance versus delivery and cost agreed to in the contract(s). For
> award fee contracts, separately state in dollars the base fee and
> award fee available and the award fee actually received. The same type
> of organizational experience and past performance data should be
> submitted.
>
> e\) **Pertinent Grants**
>
> List grants supported by the Government that involved similar or
> related work to that called for in this RFP. Include the grant number,
> involved agency, names of the grant specialist and the Science
> Administrator, identification of the work, and when performed.
>
> You are cautioned that omission or an inadequate or inaccurate
> response to this very important RFP requirement could have a negative
> effect on the overall selection process. Experience and past
> performance are factors which are relevant to the ability of the
> offerors to perform and are considered in the source selection
> process.

(8) **Other Administrative Data**

> a\) **Property**
>
> \(1\) It is DHHS policy that Contractors will provide all equipment
> and facilities necessary for performance of contracts. Exception may
> be granted to furnish Government-owned property, or to authorize
> purchase with contract funds, only when approved by the Contracting
> Officer. If the offeror is proposing that the Government provide any
> equipment, other than that specified under Government Furnished
> Property in the RFP, the proposal must include comprehensive
> justification which includes:
>
> \(a\) An explanation that the item is for a special use essential to
> the direct performance of the contract and the item will be used
> exclusively for the purpose. Office equipment such as desks, office
> machines, etc., will not be provided under a contract except under
> very exceptional circumstances.
>
> \(b\) No practical or economical alternative exists (e.g., rental,
> capital investment) that can be used to perform the work.
>
> \(2\) The offeror shall identify Government-owned property in its
> possession and/or Contractor titled property acquired from Federal
> funds, which it proposes to use in the performance of the prospective
> contract.
>
> \(3\) The management and control of any Government property shall be
> in accordance with DHHS Publication (OS) 686 entitled, \"Contractor\'s
> Guide for Control of Government Property (1990),\" which can be found
> at:
>
> <http://knownet.hhs.gov/log/AgencyPolicy/HHSLogPolicy/contractorsguide.htm>
>
> b\) **Submission of Electronic Funds Transfer Information with Offer,
> FAR Clause 52.232-38**, (May 1999)
>
> The offeror shall provide, with its offer, the following information
> that is required to make payment by electronic funds transfer (EFT)
> under any contract that results from this solicitation. This
> submission satisfies the requirement to provide EFT information under
> paragraphs (b)(1) and (j) of the clause at 52.232‑34, Payment by
> Electronic Funds Transfer‑‑Other than Central Contractor Registration.
>
> \(1\) The solicitation number (or other procurement identification
> number).
>
> \(2\) The offeror\'s name and remittance address, as stated in the
> offer.
>
> \(3\) The signature (manual or electronic, as appropriate), title, and
> telephone number of the offeror\'s official authorized to provide this
> information.
>
> \(4\) The name, address, and 9‑digit Routing Transit Number of the
> offeror\'s financial agent.
>
> \(5\) The offeror\'s account number and the type of account (checking,
> savings, or lockbox).
>
> \(6\) If applicable, the Fedwire Transfer System telegraphic
> abbreviation of the offeror\'s financial agent.
>
> \(7\) If applicable, the offeror shall also provide the name, address,
> telegraphic abbreviation, and 9‑digit Routing Transit Number of the
> correspondent financial institution receiving the wire transfer
> payment if the offeror\'s financial agent is not directly on‑line to
> the Fedwire and, therefore, not the receiver of the wire transfer
> payment.
>
> c\) **Financial Capacity**
>
> The offeror shall indicate if it has the necessary financial capacity,
> working capital, and other resources to perform the contract without
> assistance from any outside source. If not, indicate the amount
> required and the anticipated source.
>
> d\) **Incremental Funding**
>
> An incrementally funded cost-reimbursement contract is a contract in
> which the total work effort is to be performed over a multiple year
> period and funds are allotted, as they become available, to cover
> discernible phases or increments of performance. The incremental
> funding technique allows for contracts to be awarded for periods in
> excess of one year even though the total estimated amount of funds
> expected to be obligated for the contract are not available at the
> time of the contract award. If this requirement is specified elsewhere
> in this RFP, the offeror shall submit a cost proposal for each year.
> In addition, the following provisions are applicable:

**HHSAR 352.232-75, Incremental Funding (January 2001)**

> \(a\) It is the Government\'s intention to negotiate and award a
> contract using the incremental funding concepts described in the
> clause entitled Limitation of Funds. Under the clause, which will be
> included in the resultant contract, initial funds will be obligated
> under the contract to cover the first year of performance. Additional
> funds are intended to be allotted to the contract by contract
> modification, up to and including the full estimated cost of the
> contract, to accomplish the entire project. While it is the
> Government\'s intention to progressively fund this contract over the
> entire period of performance up to and including the full estimated
> cost, the Government will not be obligated to reimburse the Contractor
> for costs incurred in excess of the periodic allotments, nor will the
> Contractor be obligated to perform in excess of the amount allotted.
>
> \(b\) The Limitation of Funds clause to be included in the resultant
> contract shall supersede the Limitation of Cost clause found in the
> General Provisions.
>
> e\) **Facilities Capital Cost of Money**, FAR 52.215-16, (June 2003)
>
> (This is applicable if you are a commercial organization.)
>
> \(a\) Facilities capital cost of money will be an allowable cost under
> the contemplated contract, if the criteria for allowability in FAR
> 31.205-10(b) are met. One of the allowability criteria requires the
> prospective Contractor to propose facilities capital cost of money in
> its offer.
>
> \(b\) If the prospective Contractor does not propose this cost, the
> resulting contract will include the clause Waiver of Facilities
> Capital Cost of Money.
>
> If the offeror elects to claim this cost, the offeror shall
> specifically
>
> identify or propose it in the cost proposal for the contract by
> checking the appropriate box below.
>
> **\[ \]** The prospective Contractor has specifically identified or
> proposed facilities capital cost of money in its cost proposal and
> elects to claim this cost as an allowable cost under the contract.
> Submit Form CASB-CMF (see FAR 31.205-10).
>
> **\[ \]** The prospective Contractor has not specifically identified
> or proposed facilities capital cost of money in its proposal and
> elects not to claim it as an allowable cost under the contract.

(9) **Subcontractors**

> If subcontractors are proposed, please include a commitment letter
> from the Subcontractor detailing:
>
> a\) Willingness to perform as a Subcontractor for specific duties
> (list duties).
>
> b\) What priority the work will be given and how it will relate to
> other work.
>
> c\) The amount of time and facilities available to this project.
>
> d\) Information on their cognizant field audit offices.
>
> e\) How rights to publications and patents are to be handled.
>
> f\) A complete cost proposal in the same format as the offeror\'s cost
> proposal.
>
> Note: Organizations that plan to enter into a subcontract with an
> educational concern under a contract awarded under this RFP should
> refer to the following Web Site for a listing of clauses that are
> required to be incorporated in Research & Development (R&D)
> subcontracts with educational institutions:

<http://ocm.od.nih.gov/contracts/rfps/FDP/FDPclausecover.htm>

(10) **Proposer\'s Annual Financial Report**

     A copy of the organization\'s most recent annual report must be
     submitted as part of the business proposal.

(11) **Representations and Certifications**

> One copy of the Representations and Certifications attached as Section
> K shall be completed and be signed by an official authorized to bind
> your organization. Additionally, a completed copy of the
> Representations and Certifications shall be submitted from any
> proposed subcontractor.

(12) **Travel Costs/Travel Policy**

> a\) **Travel Costs - Commercial**
>
> Costs for lodging, meals, and incidental expenses incurred by
> Contractor personnel shall be considered to be reasonable and
> allowable to the extent they do not exceed on a daily basis the per
> diem rates set forth in the Federal Travel Regulations, General
> Services Administration (GSA). Therefore, if travel costs are
> applicable and proposed by offerors, please be advised that they shall
> be calculated using the per diem rate schedule as established by GSA.
> Reimbursement of travel costs under any contract awarded from this RFP
> shall be in accordance with FAR 31.205-46.
>
> b\) **Travel Policy**
>
> One copy of the offeror\'s (and any proposed subcontractor\'s) written
> travel policy shall be included in the business proposal (original
> only). If an offeror (or any proposed subcontractor) does not have a
> written travel policy, the offeror shall so state.

EVALUATION FACTORS

***IN VITRO* TESTING RESOURCES FOR AIDS THERAPEUTICS DEVELOPMENT**

**RFP NIH-NIAID-DAIDS-07-25**

**[PART A: CONFIRMATORY *IN VITRO* EVALUATIONS OF HIV
THERAPEUTICS]{.mark}**

**1. GENERAL**

Selection of an Offeror for a contract award will be based on an
evaluation of proposals against four factors. The factors in order of
importance are: technical, cost/price, past performance, and Small
Disadvantaged Business (SDB) participation. Although technical factors
are of paramount consideration in the award of the contract, cost/price,
past performance, and SDB Participation are also important to the
overall contract award decision. All evaluation factors other than
cost/price, when combined, are significantly more important than cost or
price. The trade-off process described in FAR 15.101-1 may be employed.
This process permits tradeoffs among cost/price and non-cost factors and
allows the Government to consider award to other than the lowest priced
or highest technically rated Offeror. In any event, the Government
reserves the right to make an award to that Offeror whose proposal
provides the best overall value to the Government.

The evaluation will be based on the demonstrated capabilities of the
prospective Contractors in relation to the needs of the project as set
forth in the RFP. The merits of each proposal will be evaluated
carefully. Each proposal must document the feasibility of successful
implementation of the requirements of the RFP. Offerors must submit
information sufficient to evaluate their proposals based on the detailed
criteria listed below.

**2. EVALUATION OF DATA SHARING PLAN**

The offeror\'s plan for the sharing of final research data shall be
assessed for appropriateness and adequacy. If your proposal does not
include a plan or if the plan in your proposal is considered
Aunacceptable@ and the Government includes your proposal in the
competitive range (for competitive proposals), or if the Government
holds discussions with the selected source (for sole source
acquisitions), you will be afforded the opportunity to further discuss,
clarify or modify your data sharing plan during discussions and in your
Final Proposal Revision (FPR). If your data sharing plan is still
considered Aunacceptable@ by the Government after discussions, your
proposal may not be considered further for award.

**3. PAST PERFORMANCE FACTOR**

An evaluation of offeror\'s past performance information will be
conducted subsequent to the technical evaluation. However, this
evaluation will not be conducted on any offeror whose proposal would not
be selected for award based on the results of the evaluation of factors
other than past performance.

The evaluation will be based on information obtained from references
provided by the offeror, other relevant past performance information
obtained from other sources known to the Government, and any information
supplied by the offeror concerning problems encountered on the
identified contracts and corrective action taken.

The government will assess the relative risks associated with each
offeror. Performance risks are those associated with an offeror\'s
likelihood of success in performing the acquisition requirements as
indicated by that offeror\'s record of past performance.

The assessment of performance risk is not intended to be a product of a
mechnical or mathematical analysis of an offeror\'s performance on a
list of contracts but rather the product of subjective judgment by the
Government after it considers relevant information.

When assessing performance risks, the Government will focus on the past
performance of the offeror as it relates to all acquisition
requirements, such as the offeror\'s record of performing according to
specifications, including standards of good workmanship; the offeror\'s
record of controlling and forecasting costs; the offeror\'s adherence to
contract schedules, including the administrative aspects of performance;
the offeror\'s reputation for reasonable and cooperative behavior and
commitment to customer satisfaction; and generally, the offeror\'s
business-like concern for the interest of the customer.

**4. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION**

**SDB participation will not be scored**, but the Government's
conclusions about overall commitment and realism of the offeror's SDB
Participation targets will be used in determining the relative merits of
the offeror's proposal and in selecting the offeror whose proposal is
considered to offer the best value to the Government.

The extent of the offeror's Small Disadvantaged Business Participation
Targets will be evaluated before determination of the competitive range.
Evaluation of SDB participation will be assessed based on consideration
of the information presented in the offeror's proposal. The Government
is seeking to determine whether the offeror has demonstrated a
commitment to use SDB concerns for the work that it intends to perform.

**5. TECHNICAL EVALUATION CRITERIA**

The evaluation criteria are used by the Technical Evaluation Committee
when reviewing Technical Proposals. Proposals will be judged solely on
the written material provided by the Offeror. The criteria listed below
are in the order of relative importance with weights assigned for
evaluation purposes.

Offerors and reviewers are advised to refer to Appendix A -- Additional
Technical Proposal Instructions (for Part A) of this solicitation
package for guidance and information related to the preparation and
format of Technical Proposals.

**[CRITERIA]{.underline}** **[WEIGHT]{.underline}**

**CRITERION 1: TECHNICAL APPROACH 50 points**

A. Soundness, adequacy, comprehensiveness, and scientific and technical
feasibility of the approaches and protocols, as well as the strategies
to overcome potential risks, problems, and obstacles, proposed to:

1\. Prepare, characterize, and maintain stocks of primary, lab-adapted,
and drug-resistant virus

isolates.

2\. Evaluate drug substances as single agents in cell-based *in vitro*
assays for antiviral efficacy

against HIV and for cytotoxicity.

3\. Evaluate drug substances in combination with FDA-approved drugs in
cell-based *in vitro* assays

for antiviral efficacy against HIV and for cytotoxicity.

> 4\. Develop drug-resistant isolates of HIV and characterize these
> isolates for genotypic and
>
> phenotypic changes from the parent virus isolate.
>
> **(30 points)**

B. Soundness, adequacy, appropriateness, comprehensiveness and
feasibility of the systems, approaches, and protocols proposed to:

> 1\. Store and retrieve contract data.
>
> 2\. Assess the acceptability of experimental data.
>
> 3\. Analyze experimental data from the evaluation of drug substances
> as single agents.
>
> 4\. Analyze experimental data from the evaluation of drug substances
> in combination.
>
> **(20 points)**

**CRITERION 2: RECEIPT, STORAGE, SHIPPING, AND TRACKING OF CONTRACT
RESOURCES; SAFETY AND TRAINING; PROJECT MANAGEMENT; and, CONFIDENTIALITY
OF INFORMATION 25 points**

Adequacy, thoroughness, soundness, and feasibility of the plans and
approaches proposed for:

1\. Receiving, storing, shipping, and tracking drug substances, viruses,
and other reagents.

2\. Training, implementing, and monitoring of safety procedures for
protection of personnel

and the environment from chemical and biological hazards.

3\. Providing project management, including the scientific, technical,
and administrative

infrastructure, the project management system, and the means of
communicating with

the Project Officer and Contracting Officer.

4.  Safeguarding the confidentiality of information provided to the
    Contractor and data

generated under the contract.

**CRITERION 3: SCIENTIFIC, TECHNICAL, AND ADMINISTRATIVE PERSONNEL**

**15 points**

Adequacy and suitability of the education, training, experience,
expertise, and accomplishments of the Principal Investigator in the
areas of HIV biology, antiviral evaluations of HIV therapeutics, and the
management of projects of the scope and complexity outlined in the
Statement of Work. Adequacy and suitability of the education, training,
experience, expertise, and accomplishments of other scientific and
technical personnel in supporting antiviral drug evaluation projects of
the scope and complexity outlined in the Statement of Work. Adequacy and
suitability of the education, training, experience, expertise, and
accomplishments of administrative personnel in the areas of financial
management and reporting.

**CRITERION 4: FACILITIES, EQUIPMENT, AND OTHER RESOURCES 10 points**

Adequacy, suitability, and documented availability during the contract
period of performance of the facilities, equipment and other resources
necessary to conduct all tasks outlined in the Statement of Work.

**TOTAL POSSIBLE POINTS 100 points**

EVALUATION FACTORS

***IN VITRO* TESTING RESOURCES FOR AIDS THERAPEUTICS DEVELOPMENT**

**RFP NIH-NIAID-DAIDS-07-25**

**[PART B: SPECIALIZED *IN VITRO* VIROLOGICAL ASSAYS FOR HIV
THERAPEUTICS AND TOPICAL MICROBICIDES]{.mark}**

**1. GENERAL**

Selection of an Offeror for a contract award will be based on an
evaluation of proposals against four factors. The factors in order of
importance are: technical, cost/price, past performance, and Small
Disadvantaged Business (SDB) participation. Although technical factors
are of paramount consideration in the award of the contract, cost/price,
past performance, and SDB Participation are also important to the
overall contract award decision. All evaluation factors other than
cost/price, when combined, are significantly more important than cost or
price. The trade-off process described in FAR 15.101-1 may be employed.
This process permits tradeoffs among cost/price and non-cost factors and
allows the Government to consider award to other than the lowest priced
or highest technically rated Offeror. In any event, the Government
reserves the right to make an award to that Offeror whose proposal
provides the best overall value to the Government.

The evaluation will be based on the demonstrated capabilities of the
prospective Contractors in relation to the needs of the project as set
forth in the RFP. The merits of each proposal will be evaluated
carefully. Each proposal must document the feasibility of successful
implementation of the requirements of the RFP. Offerors must submit
information sufficient to evaluate their proposals based on the detailed
criteria listed below.

**2. EVALUATION OF OPTIONS**

It is anticipated that any contract(s) awarded from this solicitation
will contain option provision(s) and period(s).

In accordance with FAR Clause 52.217-5, Evaluation of Options, (July
1990), the Government

will evaluate offers for award purposes by adding the total price for
all options to the total

price for the basic reqirement, except when it is determined in
accordance with FAR 17.206(b)

not to be in the Government's best interests. Evaluation of options will
not obligate the

Government to exercise the option(s).

**3. EVALUATION OF DATA SHARING PLAN**

The offeror\'s plan for the sharing of final research data shall be
assessed for appropriateness and adequacy. If your proposal does not
include a plan or if the plan in your proposal is considered
Aunacceptable@ and the Government includes your proposal in the
competitive range (for competitive proposals), or if the Government
holds discussions with the selected source (for sole source
acquisitions), you will be afforded the opportunity to further discuss,
clarify or modify your data sharing plan during discussions and in your
Final Proposal Revision (FPR). If your data sharing plan is still
considered Aunacceptable@ by the Government after discussions, your
proposal may not be considered further for award.

**4. PAST PERFORMANCE FACTOR**

An evaluation of offeror\'s past performance information will be
conducted subsequent to the technical evaluation. However, this
evaluation will not be conducted on any offeror whose proposal would not
be selected for award based on the results of the evaluation of factors
other than past performance.

The evaluation will be based on information obtained from references
provided by the offeror, other relevant past performance information
obtained from other sources known to the Government, and any information
supplied by the offeror concerning problems encountered on the
identified contracts and corrective action taken.

The government will assess the relative risks associated with each
offeror. Performance risks are those associated with an offeror\'s
likelihood of success in performing the acquisition requirements as
indicated by that offeror\'s record of past performance.

The assessment of performance risk is not intended to be a product of a
mechnical or mathematical analysis of an offeror\'s performance on a
list of contracts but rather the product of subjective judgment by the
Government after it considers relevant information.

When assessing performance risks, the Government will focus on the past
performance of the offeror as it relates to all acquisition
requirements, such as the offeror\'s record of performing according to
specifications, including standards of good workmanship; the offeror\'s
record of controlling and forecasting costs; the offeror\'s adherence to
contract schedules, including the administrative aspects of performance;
the offeror\'s reputation for reasonable and cooperative behavior and
commitment to customer satisfaction; and generally, the offeror\'s
business-like concern for the interest of the customer.

**5. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION**

**SDB participation will not be scored**, but the Government's
conclusions about overall commitment and realism of the offeror's SDB
Participation targets will be used in determining the relative merits of
the offeror's proposal and in selecting the offeror whose proposal is
considered to offer the best value to the Government.

The extent of the offeror's Small Disadvantaged Business Participation
Targets will be evaluated before determination of the competitive range.
Evaluation of SDB participation will be assessed based on consideration
of the information presented in the offeror's proposal. The Government
is seeking to determine whether the offeror has demonstrated a
commitment to use SDB concerns for the work that it intends to perform.

**6. TECHNICAL EVALUATION CRITERIA**

The evaluation criteria are used by the Technical Evaluation Committee
when reviewing Technical Proposals. Proposals will be judged solely on
the written material provided by the Offeror. The criteria listed below
are in the order of relative importance with weights assigned for
evaluation purposes.

Offerors and reviewers are advised to refer to Appendix A -- Additional
Technical Proposal Instructions (for Part B) of this solicitation
package for guidance and information related to the preparation and
format of Technical Proposals**.**

**[CRITERIA]{.underline} [WEIGHT]{.underline}**

**CRITERION 1: TECHNICAL APPROACH 50 points**

A.  Soundness, adequacy, comprehensiveness, and scientific and technical
    feasibility of the approaches and protocols, as well as the
    strategies to overcome potential risks, problems, and obstacles,
    proposed to:

1\. Conduct assays to evaluate the efficacy of potential anti-HIV
topical microbicides and

therapeutics in relevant primary cells, established cell lines and human
tissue/organ cultures.

2\. Conduct mechanism of action and cytotoxicity assays on potential
anti-HIV topical microbicides

and therapeutics.

3\. Conduct assays to measure the cytotoxicity of potential anti-HIV
topical microbicides and

therapeutics.

4\. Conduct HTS assays to measure the efficacy of potential anti-HIV
topical microbicides and

therapeutics.

> **(30 points)**

B.  Soundness, adequacy, appropriateness, comprehensiveness and
    feasibility of the systems, approaches and protocols proposed to:

> 1\. Store and retrieve contract data.
>
> 2\. Assess the acceptability of experimental data.
>
> 3\. Analyze experimental data from the evaluation of drug substances
> as anti-HIV topical
>
> microbicides and therapeutics.

**(20 points)**

**CRITERION 2: RECEIPT, STORAGE, SHIPPING, AND TRACKING OF CONTRACT
RESOURCES; SAFETY AND TRAINING; PROJECT MANAGEMENT; and CONFIDENTIALITY
OF INFORMATION 25 points**

Adequacy, thoroughness, soundness, and feasibility of the plans and
approaches proposed for:

1\. Receiving, storing, shipping, and tracking drug substances, viruses,
and other reagents.

2\. Training, implementing, and monitoring of safety procedures for
protection of personnel

and the environment from chemical and biological hazards.

3\. Providing project management, including the scientific, technical,
and administrative

infrastructure, the project management system, and the means of
communicating with the

Project Officer and Contracting Officer.

4.  Safeguarding the confidentiality of information provided to the
    Contractor and data

generated under the contract.

**CRITERION 3: SCIENTIFIC, TECHNICAL, AND ADMINISTRATIVE PERSONNEL**

**15 points**

Adequacy and suitability of education, training, experience, expertise
and accomplishments of the Principal Investigator in the testing of
anti-HIV topical microbicides and therapeutics and experience in the
management and coordination of antiviral drug evaluation projects of the
scope and complexity outlined in the Statement of Work. Adequacy and
suitability of education, training, experience, expertise, and
accomplishments of other scientific and technical personnel in
supporting antiviral drug evaluation projects of the scope and
complexity outlined in the Statement of Work. Adequacy and suitability
of education, training, experience, expertise, and accomplishments of
administrative personnel in the areas of financial management and
reporting.

**CRITERION 4: FACILITIES, EQUIPMENT, AND OTHER RESOURCES 10 points**

Adequacy, suitability, and documented availability during the contract
period of performance of the facilities, equipment and other resources
necessary to conduct all tasks outlined in the Statement of Work.

**TOTAL POINTS -- BASE PERIOD 100 points**

**CRITERION 5: OPTIONS**

**20 points**

Adequacy and feasibility of the proposed plans to implement the options
with regard to:

> 1\. Demonstrated ability of the Principal Investigator to oversee and
> manage the additional
>
> work to be carried out under the options, including the project
> management system.
>
> 2\. Qualifications of the proposed personnel and adequacy of the
> proposed level of effort.
>
> 3\. Adequacy, suitability and availability of proposed facilities,
> equipment and other resources.
>
> 4\. Adequacy of plans for subcontracting (if proposed) for expertise
> and/or capabilities to
>
> conduct work required in the options.

**TOTAL POSSIBLE POINTS -- BASE + OPTIONS 120 Points**

SOLICITATION ATTACHMENTS INCLUDED WITH THE RFP

The following pages include Attachments applicable to this RFP as
specified in SECTION J - List of Attachments

[]{#L .anchor}

PACKAGING AND DELIVERY OF THE PROPOSAL

[PAPER SUBMISSION]{.underline}: **The paper copy is the official copy
for recording timely receipt of proposals.**

[SUBMISSION OF PROPOSALS BY FACSIMILE OR E-MAIL IS NOT
ACCEPTABLE]{.underline}.

**A. EXTERNAL PACKAGE MARKING:**

> In addition to the address cited below, mark each package as follows:
>
> \"**RFP NO. NIH-NIAID-DAIDS-07-25 TO BE OPENED BY AUTHORIZED
> GOVERNMENT PERSONNEL ONLY**\"

**B. PAPER COPIES and CD-Rom to:**

+---------------------------------+------------------------------------+
| # If H                          | # If using U.S. Postal Service     |
| and Delivery or Express Service |                                    |
+---------------------------------+------------------------------------+
| Nancy M. Hershey                | Nancy M. Hershey                   |
|                                 |                                    |
| Contract Specialist             | Contract Specialist                |
|                                 |                                    |
| Office of Acquisitions, DEA,    | Office of Acquisitions, DEA, NIH,  |
| NIH, NIAID                      |                                    |
|                                 | NIAID                              |
| 6700-B Rockledge Drive, Room    |                                    |
| 3214, MSC 7612                  | 6700-B Rockledge Drive, Room 3214, |
|                                 | MSC 7612                           |
| Bethesda, Maryland 20817        |                                    |
|                                 | Bethesda, Maryland 20892-7612      |
+---------------------------------+------------------------------------+

> *NOTE: All material sent to this office by Federal Express should be
> sent to the Hand Carried Address.*

NOTE: The U.S. Postal Service\'s \"Express Mail\" does not deliver to
the hand delivered (20817 zip code) address. Any package sent to this
address via this service will be held at a local post office for
pick-up. THE GOVERNMENT IS NOT RESPONSIBLE FOR PICKING UP ANY MAIL AT A
LOCAL POST OFFICE. If a proposal is not received at the place, date, and
time specified herein, it will be considered a \"late proposal,\" in
accordance with HHSAR 352.215-70, Late Proposals and Revisions (NOV
1986).

**C. NUMBER OF COPIES:**

> **TECHNICAL PROPOSAL PAGE LIMITS \[See Next Page(s)\]**
>
> **PAGES THAT ARE 2-SIDED WILL COUNT AS 2 PAGES.**
>
> **TOTAL PAGE COUNT DOES [NOT]{.underline} INCLUDE**: 1 Cover and Back
> Page; 1 Table of Contents; Section Dividers that do not contain
> information other than title of Section.
>
> **PAGES IN EXCESS OF THIS LIMITATION WILL BE REMOVED FROM THE PROPOSAL
> AND WILL NOT BE PROVIDED TO THE REVIEWERS TO BE READ OR EVALUATED.**
>
> The number of copies required of each part of your proposal are as
> specified below.
>
> **PART A: CONFIRMATORY IN VITRO EVALUATIONS OF HIV THERAPEUTICS**

+------------------+----------------------------------+---------------+
| **Document**     | Number of Copies                 | Page Limits   |
+------------------+----------------------------------+---------------+
| **Technical      | **[PAPER]{.underline}**          | Limited to    |
| Proposal and All |                                  | not-to-exceed |
| Appendices**     | One (1) unbound SIGNED ORIGINAL. | **200 pages   |
|                  |                                  | including all |
| All materials    | Five (5) unbound COPIES          | appendices.** |
| not available    |                                  |               |
| electronically   | **[ELECTRONIC FILES ON           |               |
| (i.e. SOPs,      | CD]{.underline}**                |               |
| Pertinent        |                                  |               |
| Manuals,         | Fifteen (15) Compact Disks       |               |
| Nonscannable     | containing an electronic copy of |               |
| Figures of Data, | the Technical Proposal in        |               |
| and Letters of   | portable document format (PDF)   |               |
| Collab           |                                  |               |
| oration/Intent). | [\[NOTE: 1 file on each          |               |
|                  | disk.\]]{.mark}                  |               |
+------------------+----------------------------------+---------------+
|                  |                                  |               |
+------------------+----------------------------------+---------------+
| **Business       | **[PAPER]{.underline}**          | N/A           |
| Proposal**       |                                  |               |
|                  | One (1) unbound SIGNED ORIGINAL. |               |
|                  |                                  |               |
|                  | Five (5) unbound COPIES          |               |
|                  |                                  |               |
|                  | **[ELECTRONIC FILES ON           |               |
|                  | CD]{.underline}**                |               |
|                  |                                  |               |
|                  | One (1) Compact Disks containing |               |
|                  | an electronic copy of the        |               |
|                  | Business Proposal in portable    |               |
|                  | document form (PDF).             |               |
+------------------+----------------------------------+---------------+
| **Breakdown of** | This Attachment should be        | N/A           |
|                  | submitted                        |               |
| **Proposal       |                                  |               |
| Estimated**      | Also as a separate excel file on |               |
|                  | the Business Proposal Compact    |               |
| **Cost Using     | Disk.                            |               |
| Electronic Cost  |                                  |               |
| Proposal Excel   | See Section J, Attachment        |               |
| Workbook**       | entitled                         |               |
|                  |                                  |               |
|                  | [Breakdown of Proposed Estimated |               |
|                  | Costs (plus Fee) with Excel      |               |
|                  | Spreadsheet to access the Excel  |               |
|                  | Workbook]{.underline}            |               |
+------------------+----------------------------------+---------------+

> **PART B: SPECIALIZED IN VITRO VIROLOGICAL ASSAYS FOR HIV THERAPEUTICS
> AND TOPICS MICROBIDES**

+------------------+----------------------------------+---------------+
| **Document**     | Number of Copies                 | Page Limits   |
+------------------+----------------------------------+---------------+
| **Technical      | **[PAPER]{.underline}**          | Limited to    |
| Proposal and All |                                  | not-to-exceed |
| Appendices**     | One (1) unbound SIGNED ORIGINAL. | **200 pages   |
|                  |                                  | including all |
| All materials    | Five (5) unbound COPIES          | appendices.** |
| not available    |                                  |               |
| electronically   | **[ELECTRONIC FILES ON           |               |
| (i.e. SOPs,      | CD]{.underline}**                |               |
| Pertinent        |                                  |               |
| Manuals,         | Fifteen (15) Compact Disks       |               |
| Nonscannable     | containing an electronic copy of |               |
| Figures of Data, | the Technical Proposal in        |               |
| and Letters of   | portable document format (PDF)   |               |
| Collab           |                                  |               |
| oration/Intent). | [\[NOTE: 1 file on each          |               |
|                  | disk.\]]{.mark}                  |               |
+------------------+----------------------------------+---------------+
|                  |                                  |               |
+------------------+----------------------------------+---------------+
| **Business       | **[PAPER]{.underline}**          | N/A           |
| Proposal**       |                                  |               |
|                  | One (1) unbound SIGNED ORIGINAL. |               |
|                  |                                  |               |
|                  | Five (5) unbound COPIES          |               |
|                  |                                  |               |
|                  | **[ELECTRONIC FILES ON           |               |
|                  | CD]{.underline}**                |               |
|                  |                                  |               |
|                  | One (1) Compact Disks containing |               |
|                  | an electronic copy of the        |               |
|                  | Business Proposal in portable    |               |
|                  | document form (PDF).             |               |
+------------------+----------------------------------+---------------+
| **Breakdown of** | This Attachment should be        | N/A           |
|                  | submitted                        |               |
| **Proposal       |                                  |               |
| Estimated**      | Also as a separate excel file on |               |
|                  | the Business Proposal Compact    |               |
| **Cost Using     | Disk.                            |               |
| Electronic Cost  |                                  |               |
| Proposal Excel   | See Section J, Attachment        |               |
| Workbook**       | entitled                         |               |
|                  |                                  |               |
|                  | [Breakdown of Proposed Estimated |               |
|                  | Costs (plus Fee) with Excel      |               |
|                  | Spreadsheet to access the Excel  |               |
|                  | Workbook]{.underline}            |               |
+------------------+----------------------------------+---------------+

> []{#Attachment_2 .anchor}**PROPOSAL INTENT RESPONSE SHEET**
>
> **RFP No.:** NIH-NIAID-DAIDS-07-25
>
> **RFP Title: "IN VITRO TESTING RESOURCES FOR AIDS THERAPEUTICS
> DEVELOPMENT"**
>
> **PART A: CONFIRMATORY IN VITRO EVALUATIONS OF HIV THERAPEUTICS**
>
> [Please review the attached Request for Proposal. Furnish the
> information requested below and return this page by 10/17/06. Your
> expression of intent is not binding but will greatly assist us in
> planning for proposal evaluation.]{.mark}
>
> \[ \] DO INTEND TO SUBMIT A PROPOSAL
>
> \[ \] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:
>
> **Company/Institution Name (print):**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Address (print):**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Project Director\'s Name (print):**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Title (print):**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Signature/Date:**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Telephone Number and E-mail Address (print clearly):**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **\*Name of individual to whom electronic proposal instructions should
> be sent:**
>
> **Name:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Title:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **E-Mail Address:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Telephone Number:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Names of Collaborating Institutions and Investigators (include
> Subcontractors and Consultants) (print):**
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> *(Continue list on a separate page if necessary)*
>
> RETURN VIA FAX OR E-MAIL TO:
>
> OA, DEA, NIAID, NIH, DHHS\
> 6700-B Rockledge Drive, Room 3214, MSC 7612\
> Bethesda, MD 20892-7612
>
> Attn: Nancy M. Hershey
>
> RFP-NIH-NIAID-DAIDS-07-21\
> FAX# (301) 402-0972
>
> Email : [nhershey@.nih.gov](mailto:nhershey@niaid.nih.gov)
>
> **PROPOSAL INTENT RESPONSE SHEET**
>
> **RFP No.:** NIH-NIAID-DAIDS-07-25
>
> **RFP Title: "IN VITRO TESTING RESOURCES FOR AIDS THERAPEUTICS
> DEVELOPMENT"**
>
> **PART B: SPECIALIZED IN VITRO VIROLOGICAL ASSAYS FOR HIV THERAPEUTICS
> AND TOPICAL MICROBICIDES**
>
> [Please review the attached Request for Proposal. Furnish the
> information requested below and return this page by 10/17/06. Your
> expression of intent is not binding but will greatly assist us in
> planning for proposal evaluation.]{.mark}
>
> \[ \] DO INTEND TO SUBMIT A PROPOSAL
>
> \[ \] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING REASONS:
>
> **Company/Institution Name (print):**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Address (print):**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Project Director\'s Name (print):**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Title (print):**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Signature/Date:**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **Telephone Number and E-mail Address (print clearly):**
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> **\*Name of individual to whom electronic proposal instructions should
> be sent:**
>
> **Name:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Title:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **E-Mail Address:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Telephone Number:
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_**
>
> **Names of Collaborating Institutions and Investigators (include
> Subcontractors and Consultants) (print):**
>
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\
> \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
>
> *(Continue list on a separate page if necessary)*
>
> RETURN VIA FAX OR E-MAIL TO:
>
> OA, DEA, NIAID, NIH\
> 6700-B Rockledge Drive, Room 3214, MSC 7612\
> Bethesda, MD 20892-7612
>
> Attn: Nancy M. Hershey
>
> RFP-NIH-NIAID-DAIDS-07-25\
> FAX# (301) 402-0972
>
> Email : [nhershey@.nih.gov](mailto:nhershey@niaid.nih.gov)

[]{#Attachment_3 .anchor}**BACKGROUND FOR PART A AND PART B**

***IN VITRO* TESTING RESOURCES FOR AIDS THERAPEUTICS DEVELOPMENT**

**RFP NIH-NIAID-DAIDS-07-25**

**BACKGROUND**

The Division of AIDS (DAIDS), National Institute of Allergy and
Infectious Diseases (NIAID), National Institutes of Health (NIH), funds
a comprehensive portfolio of grant and contract resources to discover
and develop novel agents for the prevention and treatment of infections
caused by the human immunodeficiency virus (HIV) and AIDS-associated
opportunistic pathogens, including tuberculosis. Investigators at
academic institutions and small biotechnology/pharmaceutical companies
who identify new therapeutic or prevention agents frequently do not have
the expertise or financial resources to conduct many of the additional
studies needed to convert promising leads into pharmaceutical agents
suitable for Phase I clinical evaluation. To facilitate further
development of promising leads, DAIDS supports a portfolio of *in
vitro*, animal model, and drug development contracts to assist these
investigators by providing the pharmaceutical-grade materials and
preclinical data needed to support submission of an Investigational New
Drug (IND) application to the Food and Drug Administration (FDA).

Several contracts in this research and development portfolio are being
recompeted for award in fiscal year 2007, including: (a) Tissue-based
Small Animal Model for HIV Drug Discovery; (b) Pharmaceutical and
Chemical Resources for AIDS Drug Development; (c) Safety Evaluation of
Anti-AIDS Agents; and (d) Management of Information Resources for AIDS
Drugs. Through this Request for Proposals (RFP), DAIDS is recompeting
contracts for the development and conduct of *in vitro* assays to assess
the potential of drug substances for further development as anti-HIV
agents. Proposals are solicited in two distinct areas, each to result in
the award of a separate contract:

**Part A:** **Confirmatory *In Vitro* Evaluations of HIV Therapeutics**

**Part B:** **Specialized *In Vitro* Virological Assays for HIV
Therapeutics and Topical Microbicides**

Proposals may be submitted for Part A alone, Part B alone, or both Part
A and Part B; however, separate Technical and Business Proposals are
required for each part. Any proposal which combines both Part A and Part
B will be returned to the Offeror without review or further
consideration. If an Offeror is awarded both Part A and Part B, NIAID
will consider merging the two awards into a single contract.

**[PART A: CONFIRMATORY *IN VITRO* EVALUATIONS OF HIV
THERAPEUTICS]{.mark}**

Part A will provide for *in vitro* confirmatory testing of drug
substances submitted to the DAIDS Preclinical Therapeutics Development
Committee (DPTDC) for further development as potential anti-HIV
therapies. The goal of this contract resource is to independently
confirm the initial observation of anti-HIV activity of promising drug
substances and then examine the spectrum of *in vitro* activity in
multiple cell types against panels of laboratory and/or primary HIV
isolates representing different co-receptor usage, clade classification,
and drug sensitivity. In addition, potential drug-drug interactions
shall be examined and drug-resistant HIV isolates shall be made for the
most promising drug substances. Part A will NOT support primary
screening of new drug substances for anti-HIV activity.

Drug substances for evaluation under Part A are submitted to DAIDS by
academic institutions, private biotechnology/pharmaceutical companies,
and government sources. Drug substances will be provided to the
Contractor in a blinded fashion and shall include small molecules,
peptides, oligonucleotides, or polymeric substances. Each drug substance
shall have different evaluation needs that will be dependent on the
nature of the drug substance, the proposed mode of action, and the needs
of the provider of the drug substance. Over 250 unique drug substances
have been evaluated by the incumbent Contractor employing a variety of
assays, including: assays that use multiple isolates of HIV-1 and HIV-2;
acute and chronic infection assays; virus inactivation assays; p24,
reverse transcriptase, and tetrazolium dye reduction as virologic
endpoints; and tetrazolium dye reduction and tritiated thymidine
incorporation as cytotoxicity endpoints. Drug substances submitted to
DAIDS for *in vitro* evaluation have originated 20% from academia, 40%
from small biotechnology/pharmaceutical companies, and 40% from
government sources.

This contract resource was first established by NIAID in 1990,
recompeted in 1995, 2000, and 2002, and is currently awarded to Southern
Research Institute, Frederick, Maryland (contract number N01-AI-25478).
This solicitation seeks to recompete this resource and award a contract
for a seven (7)-year period of performance.

[]{.mark}

**[PART B: SPECIALIZED *IN VITRO* VIROLOGICAL ASSAYS FOR HIV
THERAPEUTICS AND TOPICAL MICROBICIDES]{.mark}**

Part B will provide for biochemical, cell-based, and tissue-based assays
to be performed to evaluate the efficacy and toxicity of potential
topical microbicides submitted to the DAIDS Topical Microbicide Working
Group (DTMWG) and anti-HIV therapeutics submitted to the DPTDC. Support
will also be provided for the development of new, and the improvement of
existing, assays. High throughput screening capabilities are necessary.
The drug substances to be submitted to the Contractor for analysis or
assay development shall include small molecules, peptides,
oligonucleotides, or polymeric substances. Biological samples submitted
for analysis will not contain infectious agents, but could be derived
from once infectious material inactivated via chemical or thermal means
prior to submission.

In support of topical microbicide development, the assays to be
performed include: (1) evaluation of potential topical microbicides for
the ability to inhibit the transmission of HIV from infected to
uninfected cells, or to inhibit the replication of HIV in relevant
primary cells, established cell lines and tissue/organ cultures; (2)
monitoring the effect of seminal plasma on the effectiveness of
potential topical microbicides; (3) monitoring the toxicity of potential
topical microbicides to hydrogen peroxide-secreting *Lactobacillus*; (4)
mimicking the effect of pH transition that occurs during coitus on
potential topical microbicides; and (5) determining the mechanism(s) of
action of potential topical microbicides.

In support of anti-HIV therapeutic development, the assays to be
performed shall include biochemical and cell-based assays to access the
impact of potential inhibitors on the action of HIV proteins and
relevant host cell factors. Cytotoxicity and mechanism of action assays
shall also be employed.

This contract resource was first established by NIAID in 1995,
recompeted in 2000, and is currently awarded to Southern Research
Institute, Frederick, Maryland (contract number N01-AI-05415). This
solicitation seeks to recompete this resource and award a contract for a
seven (7)-year period of performance.

[]{#Attachment_4 .anchor}**STATEMENT OF WORK**

***IN VITRO* TESTING RESOURCES FOR AIDS THERAPEUTICS DEVELOPMENT**

**PA [PART A: CONFIRMATORY *IN VITRO* EVALUATIONS OF HIV
THERAPEUTICS]{.mark}**

**T A: CONFIRMAT*IN VITRO* EVALUATIONS OF HIV THERAPEUTICS**

**INTRODUCTION**

The Division of AIDS (DAIDS), National Institute of Allergy and
Infectious Diseases (NIAID), National Institutes of Health (NIH),
maintains an *in vitro* capacity to test drug substances for their
ability to inhibit HIV replication in cell lines, peripheral blood
mononuclear cells, macrophages and explant tissues to assist academic
investigators and small biotechnology/pharmaceutical companies in
obtaining preclinical data needed to support submission of an
Investigational New Drug (IND) application to the Food and Drug
Administration (FDA).

**SCOPE**

This contract performs *in vitro* confirmatory testing of drug
substances submitted to DAIDS for further development as potential
anti-HIV therapies. The goal is to independently confirm the initial
observation of anti-HIV activity of promising drug substances and then
examine the spectrum of *in vitro* activity in multiple cell types
against panels of laboratory and/or primary HIV isolates representing
viruses with different co-receptor usage, clade classification, and/or
drug sensitivity. In addition, potential drug-drug interactions shall be
examined and drug-resistant HIV isolates shall be made for the most
promising drug substances. This contract will NOT support primary
screening of new drug substances for anti-HIV activity. The Contractor
shall use state-of-the-art techniques and technologies in performing
these studies and shall incorporate new and improved techniques and
technologies into contract activities as they become available.

**TECHNICAL REQUIREMENTS**

Independently, and not as an agent of the Government, the Contractor
shall furnish all the necessary services, qualified personnel, material,
equipment, and facilities, not otherwise provided by the Government
under the terms of this contract, as needed to perform the Statement of
Work (SOW) below.

The major tasks to be carried out under Part A are:

1.  Initial Transition

```{=html}
<!-- -->
```
1.  *In Vitro* Assays for HIV Therapeutics

2.  Project Planning, Initiation, and Reporting

3.  Data Management and Analysis

4.  Receipt, Storage, Shipping, and Tracking of Contract Resources

5.  Safety and Training

6.  Project Management

7.  Scientific, Technical, and Administrative Personnel

8.  Facilities, Equipment, and Other Resources

9.  Final Transition

Specifically, the Contractor shall:

**1. INITIAL TRANSITION**

In the event that the incumbent Contractor is not successful in the
recompetition, within five (5) calendar days of the effective date of
the contract, the Project Officer will provide the Contractor with a
copy of the incumbent Contractor's Final Transition Plan. Within twenty
(20) calendar days of the effective date of the contract, the Contractor
shall submit an Initial Transition Plan for review and approval by the
Project Officer. This plan shall include:

> A. a summary of the current availability of all staff assigned to the
> contract;
>
> B. a summary of the Contractor's readiness for implementing each task
> of the Statement of Work;
>
> C. plans for coordinating all necessary shipments of drug substances
> and virus isolates, and the transfer of all data from the incumbent
> Contractor; and,
>
> D. plans and timelines for resumption of any unfinished studies
> initiated by the incumbent Contractor.

The Contractor shall ensure that all assigned personnel, facilities,
equipment and other resources are available and ready upon award of the
contract and shall implement and complete the Initial Transition within
thirty (30) calendar days of receipt of Project Officer written approval
of the Initial Transition Plan. The Initial Transition shall be
completed within three (3) months of contract award.

**2. *IN VITRO* ASSAYS FOR HIV THERAPEUTICS**

Each project will be assigned by the Project Officer and shall fall into
one of the three subtasks listed below. The drug substances to be
utilized in these subtasks will be provided by the Project Officer in a
blinded fashion and shall include small molecules, peptides,
oligonucleotides, or polymeric substances. Cells to be used in these
evaluations shall be of human origin and shall include established cell
lines, peripheral blood mononuclear cells, and macrophages. HIV isolates
to be used in these evaluations shall include viruses with different
subtype classifications, coreceptor-usage, and drug-resistance
characteristics. The Project Officer will specify the cell type(s) and
HIV isolate(s) to be used at the time each project is assigned.
Specifically, the Contractor shall:

> **A. *Single evaluations***: Evaluate drug substances as single agents
> in human cell-based *in vitro* assays for antiviral efficacy against
> HIV and for cytotoxicity. Each evaluation will have the following core
> requirements:
>
> 1\) antiviral efficacy and cytotoxicity assays shall be conducted
> concurrently using the same batch/lot of cells;
>
> 2\) assays shall incorporate both the drug substance under
> investigation and a positive control agent; and,
>
> 3\) at least five (5) concentrations of each drug substance and
> positive control agent shall be used to ascertain dose-response
> relationships, and each concentration shall be assessed in triplicate.
>
> **B. *Combination evaluations***: Evaluate drug substances in
> combination with FDA-approved drugs in human cell-based *in vitro*
> assays for antiviral efficacy against HIV and for cytotoxicity. Each
> evaluation will have the following core requirements:
>
> 1\) antiviral efficacy and cytotoxicity assays shall be conducted
> concurrently using the same batch/lot of cells;
>
> 2\) each assay shall examine the potential interaction between the
> drug substance under investigation and one FDA-approved drug;
>
> 3\) a two-drug combination known to interact in an antagonistic
> fashion shall be examined in parallel with each assay to serve as a
> positive antagonism control; and
>
> 4\) at least four (4) concentrations of each drug substance and
> FDA-approved drug shall be used to ascertain potential drug
> interactions and each concentration shall be assessed in triplicate.
>
> **C. *Development of isolates***: Develop and maintain drug-resistant
> isolates of HIV via *in vitro* passage of virus in the presence of
> increasing concentrations of drug substance. Characterize parent virus
> and passaged isolates for genotypic and phenotypic differences.

**3. PROJECT PLANNING, INITIATION, AND REPORTING**

> A. Project Planning and Initiation
>
> All projects will be assigned by the Project Officer via email. Within
> seven (7) calendar days of receipt of a project assignment, the
> Contractor shall submit, via email for Project Officer review and
> approval, a Project Plan containing the following information:

1\) a project number assigned by the Contractor;

2\) a summary of the services to be provided and the proposed technical
approaches and methodologies to be used;

3\) a listing and proposed timeline (including specific dates) of the
milestones to be met in conducting the project; and,

4\) literature citations when appropriate.

> The Contractor shall not initiate or conduct studies using contract
> funds without prior written approval of the Project Plan by the
> Project Officer.
>
> B. Project Reporting
>
> Within thirty (30) calendar days of completion of each project, or in
> the case of long-term projects, at intermediate intervals defined by
> the Project Officer, the Contractor shall submit for the Project
> Officer's review and approval, a Project Report that details the work
> performed on each project. Project Reports shall be submitted via
> email and shall include:
>
> 1\) a cover page listing:
>
> a\. contract title and number;
>
> b\. project title and number;
>
> c\. Contractor\'s name and address; and
>
> d\. date of submission;

2\) a table of contents;

3\) an introduction describing the assigned project;

4\) detailed description of the materials and methods employed;

5\) raw data and a graphical representation of the data;

6\) a narrative summary of the results; and,

7\) a discussion of the scientific significance of the results.

**4. DATA MANAGEMENT AND ANALYSIS**

The Contractor shall:

> A. provide and utilize an efficient, reliable and secure data
> management system to store and retrieve all contract data;
>
> B. establish quality assurance/quality control criteria for acceptance
> of experimental data;
>
> C. analyze experimental data from the evaluation of drug substances as
> single agents to ascertain both 50% and 90% inhibitory concentrations
> of the drug substance and positive control agent; and,
>
> D. analyze experimental data from the evaluation of drug substances in
> combinations to ascertain potential drug interactions.

**5. RECEIPT, STORAGE, SHIPPING, AND TRACKING OF CONTRACT RESOURCES**

The Contractor shall utilize efficient and effective procedures for
receiving, storing, shipping, and tracking drug substances, viruses, and
other reagents, including the following:

> A. obtaining appropriate licenses and permits required by
> international, Federal, State, and local authorities for the safe
> transport and storage of drug substances, viruses, and other reagents;
>
> B. providing and maintaining facilities and services for the secure
> and stable storage of drug substances, viruses, and other reagents;
> and,
>
> C. providing and utilizing a system to track the receipt, storage, and
> shipping of drug substances, viruses, and other reagents.

**6. SAFETY AND TRAINING**

The Contractor shall:

> A. Conduct work in accordance with all applicable Federal, State, and
> local guidelines and regulations regarding potentially hazardous
> materials, including:
>
> 1\) Biosafety in Microbiological and Biomedical Laboratories (BMBL)
> guidelines, U.S. Department of Health and Human Services, Centers for
> Disease Control and Prevention and the National Institutes of Health
> (<http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm>);
>
> 2\) Hazardous Materials: Revision to Standards for Infectious
> Substances (August 14, 2002), U.S. Department of Transportation
> (<http://www.cdc.gov/od/ohs/pdffiles/DOTHazMat8-14-02.pdf>);
>
> 3\) Occupational Safety and Health Administration (OSHA) guidelines on
> Bloodborne Pathogens (29 CFR Part 1910.1030), U.S. Dept. of Labor
> (<http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051>);
>
> 4\) Occupational Safety and Health Administration (OSHA) guidelines on
> Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR
> Part 1910.1450), U.S. Department of Labor
> (<http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10106>);
> and
>
> 5\) National Institutes of Health Guidelines for Research Involving
> Recombinant DNA Molecules
> (<http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html>); and,
>
> B. Provide appropriate training, protective garments, equipment, and
> monitoring for all personnel involved in the handling and transport of
> potentially hazardous materials.

**7. PROJECT MANAGEMENT**

The Contractor shall:

> A. provide for the overall management, integration, and coordination
> of all contract activities, including the management and coordination
> of activities carried out under subcontracts;
>
> B. provide a scientific, technical, and administrative infrastructure
> to ensure the efficient planning, initiation, implementation,
> management, and completion of all contract activities;
>
> C. establish a means of electronic communication with the Project
> Officer and Contracting Officer sufficient to support exchange of
> email, data files, and reports;
>
> D. provide updates of project status via telephone or email within 48
> hours of requests for such information by the Project Officer;
>
> E. submit all reports and deliverables in accordance with the
> deadlines stated in the Reporting Requirements and Deliverables
> section of the contract; and,
>
> F. meet with the Project Officer at periodic intervals to be scheduled
> after contract award for the purpose of reviewing project status,
> progress, and future plans. The dates, locations, and agendas for
> these meetings will be provided by the Project Officer after
> consultation with Contractor staff. Meetings will be closed to the
> public and attended by the Contractor's key personnel, the Project
> Officer, and other NIAID staff.

**8. SCIENTIFIC, TECHNICAL, AND ADMINISTRATIVE PERSONNEL**

The Contractor shall provide:

> A. a Principal Investigator with responsibility for overall project
> management and communications, tracking performance and cost,
> monitoring and reporting on project status and progress, and
> recommending modifications to project requirements and timelines,
> including projects undertaken by subcontractors. The Principal
> Investigator shall possess scientific and technical experience and
> expertise in HIV biology and antiviral evaluations of HIV
> therapeutics, and experience and expertise in managing projects
> focused on antiviral evaluation of HIV therapeutics;
>
> B. scientific and technical staff with the experience and expertise
> necessary to conduct *in vitro* assays for HIV therapeutics; manage
> and analyze data; receive, store, ship, and track contract resources;
> and conduct work in accordance with all applicable guidelines and
> regulations regarding potentially hazardous materials; and,
>
> C. administrative staff with experience and expertise in financial
> management and responsibility for financial reporting on all
> activities conducted by the Contractor and subcontractors.

**9. FACILITIES, EQUIPMENT, AND OTHER RESOURCES**

The Contractor shall provide the facilities, equipment, and other
resources needed to conduct *in vitro* assays for HIV therapeutics;
manage and analyze data; receive, store, ship, and track contract
resources; conduct work in accordance with all applicable guidelines and
regulations regarding potentially hazardous materials; and store
confidential information in a secure fashion.

**10. FINAL TRANSITION**

Three (3) months prior to the completion date of the contract, the
Contractor shall submit for the Project Officer's review and written
approval a Final Transition Plan to provide for an orderly, efficient,
and safe transfer of contract-relevant materials and data to a successor
Contractor or to the Government. The Final Transition Plan shall be
submitted via email and shall include:

A. an inventory of any remaining stocks of drug substances submitted to
the Contractor during the performance period of this contract;

B. a list of assigned projects anticipated to be unfinished by the
contract completion date and the remaining steps needed for a successor
Contractor to complete these projects; and

C. plans and timelines for coordinating all necessary shipments of drug
substances, virus isolates, study samples, reagents, and data to a
successor contractor or to the Government.

The Contractor shall complete the Final Transition prior to five (5)
calendar days of the expiration date of the contract.

[]{#Attachment_5 .anchor}***IN VITRO* TESTING RESOURCES FOR AIDS
THERAPEUTICS DEVELOPMENT**

**RFP NIH-NIAID-DAIDS-07-25**

**[APPENDIX A]{.underline} - ADDITIONAL TECHNICAL PROPOSAL
INSTRUCTIONS**

**FORMAT FOR TECHNICAL PROPOSAL -- [TABLE OF CONTENTS]{.underline}**

**[PART A: CONFIRMATORY IN VITRO EVALUATIONS OF HIV
THERAPEUTICS]{.mark}**

+-----------------------------------------------------------------------+
| **It is strongly recommended that Offerors use the following template |
| as the [Table of Contents]{.underline} for the technical proposal.    |
| All information presented in the technical proposal shall be          |
| presented in the order specified below.**                             |
|                                                                       |
| The following additional technical proposal instructions reflect the  |
| requirements of the RFP and are meant to provide additional           |
| instructions as well as a uniform format for technical proposals. The |
| information requested in these instructions shall be used as a guide  |
| for formatting and preparing the proposal. Offerors shall follow the  |
| instructions in Section L of the solicitation, including the          |
| information requested in this appendix.                               |
|                                                                       |
| Offerors are advised to give careful consideration to the Statement   |
| of Work, all reference material, appendices and attachments, the      |
| technical evaluation criteria, and, the RFP as a whole, in the        |
| development of their proposal.                                        |
|                                                                       |
| Offerors who propose subcontracts to perform portions of the          |
| Statement of Work shall clearly identify the specific tasks for which |
| they plan to utilize subcontractors, as well as the method and level  |
| of integration between the prime and subcontractor(s), and the        |
| expected advantages of such an approach.                              |
|                                                                       |
| Offerors are reminded that the total page limitation for the          |
| technical proposal package is **200** pages, including all appendices |
| and attachments. Any pages in excess of this limit will be expunged   |
| from the proposal and will not be considered in the technical review. |
+-----------------------------------------------------------------------+

**[TECHNICAL PROPOSAL -- TABLE OF CONTENTS]{.underline}**

**SECTION 1**

I.  PROPOSAL TITLE PAGE. Include RFP title and number, name of
    organization, DUNS number, proposal part, and identify if the
    proposal is an original or copy.

```{=html}
<!-- -->
```
I.  PROJECT OBJECTIVES, NIH FORM 1688

II. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

III. TABLE OF CONTENTS

IV. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043)

**SECTION 2: TECHNICAL PROPOSAL OVERVIEW (2-3 pages recommended)**

Provide a brief overview of the proposed *in vitro* confirmatory testing
services to be provided including descriptions of the following:

> 1\. the *in vitro* assays to be made available for confirmatory
> testing of potential anti-HIV therapeutics, to ascertain potential
> drug-drug interactions, and to develop drug-resistant HIV isolates;
>
> 2\. the activities to be performed by the Offeror and those that shall
> be provided by any proposed subcontractors, including the
> identification of the proposed subcontractors, and a list of key
> personnel of the Offeror and the proposed subcontractors with degrees
> and titles;
>
> 3\. the facilities, equipment, and other resources to be made
> available by the Offeror and any proposed subcontractors; and,
>
> 4\. the period of contract funding requested and the total budget for
> each year.

**SECTION 3: TECHNICAL APPROACH**

**A. *In Vitro* Assays: Virus Isolates (SOW 2)**

Discuss procedures proposed for preparing, characterizing, and
maintaining the stocks of primary, lab-adapted, and drug-resistant virus
isolates to be used in conducting *in vitro* assays.

**B. *In Vitro* Assays: Evaluations of Drug Substances as Single Agents
(SOW 2.A)**

> 1\. Provide a table that summarizes relevant cell-based *in vitro*
> assays with which you have experience and could offer on a routine
> basis in the evaluation of drug substances as single agents. Include
> only those assays that have actually been conducted by the Offeror and
> any proposed subcontractors within the past two years and can meet the
> core requirements specified in the Statement of Work. Provide a
> listing of HIV isolates you have experience using and could routinely
> offer in assays. The list need not include your entire virus
> inventory, but should provide a representative sampling of available
> viruses with different subtype classifications, coreceptor-usage, and
> drug-resistance characteristics.
>
> 2\. Select a representative antiviral efficacy and cytotoxicity assay
> pair from the table generated for item 1 above for each of the
> following human cell types: an established cell line, peripheral blood
> mononuclear cells, and macrophages (provide one assay pair per cell
> type). Provide detailed methodology for each assay pair and a
> graphical representation of the inhibitory effects of a representative
> FDA-approved antiretroviral drug in each of the example assays.
>
> 3\. Discuss strategies that might be employed to overcome potential
> risks, problems, and obstacles likely to be encountered in evaluating
> drug substances as single agents.

**C. *In Vitro* Assays: Evaluations of Drug Substances in Combination
(SOW 2.B)**

> 1\. Describe the cell-based *in vitro* assays with which you have
> experience and could offer on a routine basis in the evaluation of
> drug substances in combination with FDA-approved drugs. Include only
> those assays that have actually been used in combination studies by
> the Offeror and any proposed subcontractors within the past two years
> and can meet the core requirements specified in the Statement of Work.
>
> 2\. Provide detailed methodology for the evaluation of a two-drug
> combination in peripheral blood mononuclear cells. Provide
> representative results from an experiment that shows a synergistic
> interaction and from an experiment that shows an antagonistic
> interaction.
>
> 3\. Discuss strategies that might be employed to overcome potential
> risks, problems, and obstacles likely to be encountered in evaluating
> drug substances in combination.

**D. *In Vitro* Assays: Development of Drug-Resistant Isolates (SOW
2.C)**

> 1\. Describe the steps proposed to generate drug-resistant isolates of
> HIV by *in vitro* passage of virus in the presence of increasing
> concentrations of an experimental drug substance.
>
> 2\. Describe the techniques proposed to characterize parent virus and
> passaged isolates for genotypic and phenotypic differences.
>
> 3\. Discuss strategies that might be employed to overcome potential
> risks, problems, and obstacles likely to be encountered in developing
> and characterizing drug-resistant isolates.
>
> 4\. Document the experience of the Offeror and any proposed
> subcontractors in generating and characterizing drug-resistant HIV
> isolates.

**E. Data Management and Analysis (SOW 4)**

> 1\. Describe the proposed data management system for storing and
> retrieving contract data.
>
> 2\. Discuss quality assurance/quality control criteria to be used in
> assessing the acceptance of experimental data, and circumstances under
> which assay results might be determined to be unacceptable.
>
> 3\. Describe the statistical methods proposed for the analysis of
> experimental data from evaluations of drug substances as single
> agents. Discuss how 50% and 90% inhibitory concentrations are
> calculated (e.g., point-to-point, linear regression, curve fitting, or
> other).
>
> 4\. Describe the methods proposed for the analysis of data from an
> assay assessing drug interactions and include the criteria for
> concluding an interaction as additive, synergistic, or antagonistic.

SECTION 4: RECEIPT, STORAGE, SHIPPING, AND TRACKING OF CONTRACT
RESOURCES; SAFETY AND TRAINING; PROJECT MANAGEMENT; and CONFIDENTIALITY
OF INFORMATION

**A. Receipt, Storage, Shipping, and Tracking of Contract Resources (SOW
5)**

Describe procedures and capabilities for receiving, storing, shipping,
and tracking drug substances, viruses, and other reagents. Discuss any
licenses and permits that might be required for the safe transport and
storage of these materials. Describe the proposed system for tracking
the receipt, storage, and shipping of these materials.

**B. Safety and Training (SOW 6)**

Describe your plan for training, implementing, and monitoring safety
procedures for protection of personnel and the environment from chemical
and biological hazards. Include a discussion of the use of protective
garments and equipment by personnel and protocols for dealing with
chemical and biological spills and accidents. Discuss your experience in
working with potential chemical and biological hazards.

**C. Project Management (SOW 7)**

> 1\. Describe the scientific, technical, and administrative
> infrastructure proposed for the planning, initiation, implementation,
> management, and completion of all contract activities. Describe this
> infrastructure in terms of job functions/responsibilities and levels
> of effort, not by the individual personnel assigned to fill these job
> functions/responsibilities (the latter will be requested in Section 5
> below). Clearly indicate lines of authority and reporting
> responsibilities. Document your organization's experience within the
> past two years in the management of projects similar in size and
> scope.
>
> 2\. Describe the project management system that will be used to track
> contract activities, including any proposed subcontracts, and keep
> multiple activities on time and within budget. Include a description
> of quality control methods that will be used to ensure the effective
> initiation, implementation, management, and oversight of contract
> activities.
>
> 3\. Describe how the Principal Investigator will communicate
> electronically with the Project Officer and Contracting Officer to
> support exchange of email, data files, and reports.

**D. Confidentiality of Information (Advance Understanding)**

Describe the procedures that will be employed to safeguard the
confidentiality of information provided to the Contractor by third
parties or the Government, as well as data generated during the
performance of the contract.

Three documents, entitled (1) "Confidentiality of Information and
Intellectual Property," (2) \"NIAID Non-Clinical Evaluation Agreement,\"
and (3) \"Intellectual Property Option to be Offered to NIAID's Third
Party Providers of Proprietary Material *and* Protection of Resultant
Proprietary Data\" are attached to this solicitation. The first
addresses the Contractor's handling of confidential information and
intellectual property responsibilities during the conduct of the
contract. The second illustrates the type of agreement made between the
DAIDS, NIAID, NIH and providers of drug substances to the Contractor for
*in vitro* testing. The third addresses licensing options that will be
offered to providers of drug substances in the event an invention is
made by the Contractor in conducting the work specified in the contract.
An Advance Understanding will be written into the final contract
incorporating these three documents.

SECTION 5: SCIENTIFIC, TECHNICAL, AND ADMINISTRATIVE PERSONNEL (SOW 8)

Describe the education, training, relevant experience, expertise, and
accomplishments of all proposed scientific, technical, and
administrative personnel of the Offeror and any proposed subcontractors,
including experience in planning, conducting, and managing antiviral
drug evaluation projects of the scope and complexity outlined in the
Statement of Work. Limit CVs to three (3) pages for the Principal
Investigator and two (2) pages for all other staff.

SECTION 6: FACILITIES, EQUIPMENT, AND OTHER RESOURCES (SOW 9)

Document the availability and adequacy of facilities, equipment, space,
and other resources necessary to carry out the Statement of Work,
including:

> 1\. a description of the facility, including floor diagrams;
>
> 2\. lease or ownership information; and
>
> 3\. identification and description of ALL required support resources,
> including IT systems.

**SECTION 7: TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER SECTION
L OF THE SOLICITATION**

Section L of the RFP provides minimum documentation requirements for the
following items. The required information described in Section L shall
be assembled together, in the following clearly marked sections of the
technical proposal. Refer to Section L of the RFP for specific
requirements. Also read each section, below, carefully. In some cases,
Offerors may be asked to provide documentation which is in addition to
the minimum requirements identified in Section L.

**Sharing Research Data (Plan)**

Section L of the RFP specifies the minimum documentation requirements
for Data Sharing. All related documentation shall be included in the
proposal in a clearly marked section. The Technical Proposal shall
include a plan for Data Sharing as required by the RFP.

**IT Systems Security**

Section L of the RFP specifies the minimum documentation requirements
for IT Systems security. All related documentation shall be included in
the proposal in this clearly marked section.

[]{.mark}

[]{#Attachment_6 .anchor}***IN VITRO* TESTING RESOURCES FOR AIDS
THERAPEUTICS DEVELOPMENT**

**RFP NIH-NIAID-DAIDS-07-25**

**[APPENDIX B]{.underline} - ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS**

**AND UNIFORM COST ASSUMPTIONS**

**[PART A: CONFIRMATORY *IN VITRO* EVALUATIONS OF HIV
THERAPEUTICS]{.mark}**

+-----------------------------------------------------------------------+
| **In addition to the format requirements for the business proposal    |
| that are contained in Section L of the solicitation, the information  |
| provided in this appendix is intended to provide uniform cost         |
| assumptions and business clarifications.**                            |
|                                                                       |
| Offerors are advised to give careful consideration to the Statement   |
| of Work, all reference material provided as appendices and            |
| attachments, and the technical evaluation criteria, and, the RFP as a |
| whole, in the development of their proposal. The information          |
| requested in these instructions shall be used as a guide for the      |
| development and formatting of your business proposal. Offerors shall  |
| consider and include the information requested in this appendix, as   |
| well as **any other** information which will benefit the proposal.    |
+-----------------------------------------------------------------------+

**[BUSINESS PROPOSAL -- TABLE OF CONTENTS]{.underline}**

**SECTION 1 --** **PROPOSAL COVERSHEET**

**SECTION 2 --** **COST OR PRICE SUPPORT**

Section L of the RFP specifies the minimum documentation requirements
for cost data and all cost related support. All related documentation
shall be included in the proposal in a clearly marked section.

**SECTION 3 --** **UNIFORM COST ASSUMPTIONS**

**Technical Cost Assumptions**

> **1. *Single evaluations*:** Assume performance of forty (40) single
> agent evaluations per year will be required in established cell lines,
> thirty (30) in peripheral blood mononuclear cells, and ten (10) in
> macrophages. (SOW 2.A)
>
> **2. *Combination evaluations***: Assume performance of twenty (20)
> combination evaluations per year in peripheral blood mononuclear cells
> will be required (SOW 2.B).
>
> **3. *Development of isolates*:** Assume performance of one (1)
> project per year to develop and characterize a drug-resistant isolate
> will be required (SOW 2.C).
>
> 4\. Assume an overall staffing requirement of approximately 1.45
> full-time equivalents (FTEs) per year.

**Travel**

Assume one (1) trip to Bethesda, MD per year, for one (1) day, for two
(2) persons.

**SECTION 4 - TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER SECTION
L OF THE SOLICITATION**

**I) Small Business Subcontracting Plan**

Section L of the RFP specifies the minimum documentation requirements
for completing a subcontracting plan. This plan shall be submitted with
the original proposal. All related documentation shall be included in
the proposal in a clearly marked section.

**II) Extent of Small Disadvantaged Business Participation**

Section L of the RFP specifies the minimum documentation requirements
for small disadvantaged business utilization. This information shall be
submitted with the original proposal. All related documentation shall be
included in the proposal in a clearly marked section.

**III) Past Performance Data, including references**

Section L of the RFP specifies the minimum documentation requirements
for providing past performance information. This information shall be
provided with the original proposal. All related documentation shall be
included in the proposal in a clearly marked section.

[]{.mark}

[]{#Attachment_7 .anchor}**STATEMENT OF WORK**

***IN VITRO* TESTING RESOURCES FOR AIDS THERAPEUTICS DEVELOPMENT**

[]{.mark}

**[PART B: SPECIALIZED *IN VITRO* VIROLOGICAL ASSAYS FOR HIV
THERAPEUTICS AND TOPICAL MICROBICIDES]{.mark}**

**INTRODUCTION**

The Division of AIDS (DAIDS), National Institute of Allergy and
Infectious Diseases (NIAID), National Institutes of Health (NIH),
maintains an *in vitro* capacity to test drug substances for their
ability to inhibit HIV replication in cell lines, peripheral blood
mononuclear cells, macrophages and explant tissues to assist academic
investigators and small biotechnology/pharmaceutical companies in
obtaining preclinical data needed to support submission of an
Investigational New Drug (IND) application to the Food and Drug
Administration (FDA).

**SCOPE:**

This contract shall perform *in vitro* specialized testing of drug
substances submitted to DAIDS for development as potential anti-HIV
topical microbicides and anti-HIV therapeutics. The Contractor shall
develop and conduct biochemical, cell-based, and tissue-based assays to
evaluate both the efficacy and toxicity of the drug substances. The
Contractor shall also use state-of-the-art techniques and technologies
in performing these studies and shall incorporate new and improved
techniques and technologies into the contract activities as they become
available. Options to conduct additional biochemical or cell-based
assays on potential anti-HIV topical microbicides and therapeutic drug
substances, or, to purchase chemical compound libraries and conduct high
throughput screening of potential anti-HIV topical microbicides and
therapeutic drug substances may be exercised by the Government.

**TECHNICAL REQUIREMENTS:**

Independently, and not as an agent of the Government, the Contractor
shall furnish all the necessary services, qualified personnel, material,
equipment, and facilities, not otherwise provided by the Government
under the terms of this contract, as needed to perform the Statement of
Work (SOW) below.

The major tasks to be carried out under Part B are:

1.  Initial Transition

```{=html}
<!-- -->
```
1.  Specialized *In Vitro* Virological Assays

2.  Project Planning, Initiation, and Reporting

3.  Data Management and Analysis

4.  Receipt, Storage, Shipping, and Tracking of Contract Resources

5.  Safety and Training

6.  Project Management

7.  Scientific, Technical, and Administrative Personnel

8.  Facilities, Equipment, and Other Resources

9.  Final Transition

10. Options

Specifically, the Contractor shall carry out the following tasks:

**1. INITIAL TRANSITION**

In the event that the incumbent Contractor is not successful in the
recompetition, within five (5) calendar days of the effective date of
the contract, the Project Officer will provide the Contractor with a
copy of the incumbent Contractor's Final Transition Plan. Within twenty
(20) calendar days of the effective date of the contract, the Contractor
shall submit an Initial Transition Plan for review and approval by the
Project Officer. This plan shall include:

> A. a summary of the current availability of all staff assigned to the
> contract;
>
> B. a summary of the Contractor's readiness for implementing each task
> of the Statement of Work;
>
> C. plans for coordinating all necessary shipments of drug substances
> and virus isolates, and the transfer of all data from the incumbent
> Contractor; and,
>
> D. plans and timelines for resumption of any unfinished studies
> initiated by the incumbent Contractor.

The Contractor shall ensure that all assigned personnel, facilities,
equipment and other resources are available and ready upon award of the
contract and shall implement and complete the Initial Transition within
thirty (30) calendar days of receipt of Project Officer written approval
of the Initial Transition Plan. The Initial Transition shall be
completed within three (3) months of contract award.

**2. SPECIALIZED *IN VITRO* VIROLOGICAL ASSAYS**

The Contractor shall develop, validate and conduct specialized *in
vitro* virological assays for the discovery and development of anti-HIV
topical microbicides and therapeutics. Assays shall be validated with
appropriate controls and replicated results shall be reproducible to
within 20% variation. The drug substances to be submitted to the
Contractor for analysis will be provided by the Project Officer and
shall include small molecules, peptides, oligonucleotides and polymeric
substances. Biological samples submitted for analysis will not contain
infectious agents, but could be derived from once infectious material
inactivated via chemical or thermal means prior to submission. Assays
shall be performed with one drug substance or a combination of drug
substances. Quantitative measures of viral or host cell parameters shall
include nucleic acid amplification-based technologies (e.g., polymerase
chain reaction assays), fluorescent protein assays (e.g., luciferase),
and standardized reverse transcriptase and p24 assays. The Contractor
shall incorporate new technologies and strategies as they become
available.

Specifically, the Contractor shall:

A.  ***Efficacy studies***: conduct assays to evaluate the efficacy of
    potential anti-HIV topical microbicides and therapeutics in
    uninfected primary cells, established cell lines and tissue/organ
    explant cultures. HIV isolates to be used in these evaluations shall
    include viruses with different subtype classifications,
    coreceptor-usage, and drug resistance characteristics. Each
    evaluation will have the following core requirements:

    a.  antiviral efficacy and cytotoxicity assays shall be conducted
        concurrently using the same batch/lot of cells;

    b.  assays shall incorporate both the drug substance under
        investigation and positive and negative control agents; and,

    c.  at least five (5) concentrations of each drug substance and
        control agents shall be used to ascertain dose-response
        relationships and each concentration shall be assessed in
        triplicate.

```{=html}
<!-- -->
```
A.  ***Mechanism of action studies***: conduct mechanism of action
    studies on potential topical microbicides and anti-HIV therapeutics
    to determine the location in the virus replication cycle where the
    drug substance exhibits inhibitory activity.

B.  ***Cytotoxicity assay studies***: conduct cellular or tissue
    cytotoxicity assays on potential anti-HIV topical microbicides and
    therapeutics.

C.  ***Topical microbicide suitability assay studies*:** conduct assays
    to assess the suitability of active drug substances for use as
    topical microbicides to:

    a.  determine the effect of seminal plasma or other biological
        substances on the efficacy of the potential topical microbicide;

    b.  determine the toxicity of the potential topical microbicide on
        hydrogen peroxide-secreting *Lactobacillus* bacteria or other
        microbial species; and,

    c.  determine the effect of pH transition on the effectiveness of
        the potential topical microbicide.

D.  ***High throughput screening (HTS)***: utilize robotic systems to
    conduct HTS of drug substances as anti-HIV topical microbicides and
    therapeutics.

**3. PROJECT PLANNING, INITIATION, AND REPORTING**

A. Project Planning and Initiation

> All projects shall be assigned by the Project Officer via email.
> Within seven (7) calendar days of receipt of a project assignment, the
> Contractor shall submit, via email for Project Officer review and
> approval, a Project Plan containing the following information:

1\) a project number assigned by the Contractor;

2\) a summary of the services to be provided and the proposed technical
approaches and methodologies to be used;

3\) a listing and proposed timeline (including specific dates) of the
milestones to be met in conducting the project; and

4\) literature citations when appropriate.

> The Contractor shall not initiate or conduct studies using contract
> funds without prior written approval of the Project Plan by the
> Project Officer.
>
> B. Project Reporting
>
> Within thirty (30) calendar days of completion of each project, or in
> the case of long-term projects, at intermediate intervals defined by
> the Project Officer, the Contractor shall submit for the Project
> Officer's review and approval a Project Report that details the work
> performed on each project. Project Reports shall be submitted via
> email and shall include:
>
> 1\) a cover page listing:
>
> a\. contract title and number;
>
> b\. project title and number;
>
> c\. Contractor\'s name and address; and,
>
> d\. date of submission;

2\) a table of contents;

3\) an introduction describing the assigned project;

4\) detailed description of the materials and methods employed;

5\) raw data and a graphical representation of the data;

6\) a narrative summary of the results; and,

7\) a discussion of the scientific significance of the results.

**4. DATA MANAGEMENT AND ANALYSIS**

The Contractor shall:

> A. provide and utilize an efficient, reliable and secure data
> management system to store and retrieve all contract data;
>
> B. establish quality assurance/quality control criteria for acceptance
> of experimental data; and,
>
> C. analyze experimental data from the evaluation of drug substances as
> single agents to ascertain both 50% and 90% inhibitory concentrations
> of the drug substance and positive control agent.

**5. RECEIPT, STORAGE, SHIPPING, AND TRACKING OF CONTRACT RESOURCES**

The Contractor shall utilize efficient and effective procedures for
receiving, storing, shipping, and tracking drug substances, viruses, and
other reagents, including the following:

> A. obtaining appropriate licenses and permits required by
> international, Federal, State, and local authorities for the safe
> transport and storage of drug substances, viruses, and other reagents;
>
> B. providing and maintaining facilities and services for the secure
> and stable storage of drug substances, viruses, and other reagents;
> and,
>
> C. providing and utilizing a system to track the receipt, storage, and
> shipping of drug substances, viruses, and other reagents.

**6. SAFETY AND TRAINING**

The Contractor shall:

> A. Conduct work in accordance with all applicable Federal, State, and
> local guidelines and regulations regarding potentially hazardous
> materials, including:
>
> 1\) Biosafety in Microbiological and Biomedical Laboratories (BMBL)
> guidelines, U.S. Department of Health and Human Services, Centers for
> Disease Control and Prevention and the National Institutes of Health
> (<http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm>);
>
> 2\) Hazardous Materials: Revision to Standards for Infectious
> Substances (August 14, 2002), U.S. Department of Transportation
> (<http://www.cdc.gov/od/ohs/pdffiles/DOTHazMat8-14-02.pdf>);
>
> 3\) Occupational Safety and Health Administration (OSHA) guidelines on
> Bloodborne Pathogens (29 CFR Part 1910.1030), U.S. Dept. of Labor
> (<http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051>);
>
> 4\) Occupational Safety and Health Administration (OSHA) guidelines on
> Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR
> Part 1910.1450), U.S. Department of Labor
> (<http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10106>);
> and
>
> 5\) National Institutes of Health Guidelines for Research Involving
> Recombinant DNA Molecules
> (<http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html>); and
>
> B. Provide appropriate training, protective garments, equipment, and
> monitoring for all personnel involved in the handling and transport of
> potentially hazardous materials.

**7. PROJECT MANAGEMENT**

The Contractor shall:

> A. provide for the overall management, integration, and coordination
> of all contract activities, including the management and coordination
> of activities carried out under subcontracts;
>
> B. provide a scientific, technical, and administrative infrastructure
> to ensure the efficient planning, initiation, implementation,
> management, and completion of all contract activities;
>
> C. establish a means of electronic communication with the Project
> Officer and Contracting Officer sufficient to support exchange of
> email, data files, and reports;
>
> D. provide updates of project status via telephone or email within 48
> hours of requests for such information by the Project Officer;
>
> E. submit all reports and deliverables in accordance with the
> deadlines stated in the Reporting Requirements and Deliverables
> section of the contract; and,
>
> F. meet with the Project Officer at periodic intervals to be scheduled
> after contract award for the purpose of reviewing project status,
> progress, and future plans. The dates, locations, and agendas for
> these meetings will be provided by the Project Officer after
> consultation with Contractor staff. Meetings will be closed to the
> public and attended by the Contractor's key personnel, the Project
> Officer, and other NIAID staff.

**8. SCIENTIFIC, TECHNICAL, AND ADMINISTRATIVE PERSONNEL**

The Contractor shall provide:

> A. a Principal Investigator with responsibility for overall project
> management and communications, tracking performance and cost,
> monitoring and reporting on project status and progress, and
> recommending modifications to project requirements and timelines,
> including projects undertaken by subcontractors. The Principal
> Investigator shall possess scientific and technical experience and
> expertise in HIV biology and evaluations of anti-HIV topical
> microbicides and therapeutics, and experience and expertise in
> managing projects in these scientific areas;
>
> B. scientific and technical staff with the experience and expertise
> necessary to conduct *in vitro* assays for anti-HIV topical
> microbicides and therapeutics; manage and analyze data; receive,
> store, ship, and track contract resources; and conduct work in
> accordance with all applicable guidelines and regulations regarding
> potentially hazardous materials; and,
>
> C. administrative staff with experience and expertise in financial
> management and responsibility for financial reporting on all
> activities conducted by the Contractor and subcontractors.

**9. FACILITIES, EQUIPMENT, AND OTHER RESOURCES**

The Contractor shall provide the facilities, equipment, and other
resources needed to conduct *in vitro* assays for anti-HIV topical
microbicides and therapeutics; manage and analyze data; receive, store,
ship, and track contract resources; conduct work in accordance with all
applicable guidelines and regulations regarding potentially hazardous
materials; and store confidential information in a secure fashion.

**10. FINAL TRANSITION**

Three (3) months prior to the completion date of the contract, the
Contractor shall submit for the Project Officer's review and written
approval a Final Transition Plan to provide for an orderly, efficient,
and safe transfer of contract-relevant materials and data to a successor
Contractor or to the Government. The Final Transition Plan shall be
submitted via email and shall include:

A. an inventory of any remaining stocks of drug substances submitted to
the Contractor during the performance period of this contract;

B. a list of assigned projects anticipated to be unfinished by the
contract completion date and the remaining steps needed for a successor
Contractor to complete these projects; and,

C. plans and timelines for coordinating all necessary shipments of drug
substances, virus isolates, study samples, reagents, and data to a
successor Contractor or to the Government.

The Contractor shall complete the Final Transition prior to five (5)
calendar days of the expiration date of the contract.

**11. OPTIONS**

Options to test additional drug substances using the assays cited within
the SOW may be exercised by the Government. The Government will decide
whether an option will be exercised in a contract year. If so, either
Option 1, Option 2, or both Options may be exercised.

The Government anticipates a potential need for the following tasks to
be performed during the course of the contract's seven (7)-year period
of performance:

> **Option 1:** Conduct additional biochemical or cell-based assays on
> potential anti-HIV topical microbicide and therapeutic drug
> substances.
>
> **Option 2:** Purchase chemical compound libraries and conduct HTS of
> potential anti-HIV topical microbicides and therapeutics.

Under each Option, the Contractor shall provide the following:

> **A. OPTION PLAN DEVELOPMENT:**
>
> The Contractor shall develop a plan for the necessary services called
> for by the Government's exercise of an option, including all tasks,
> staff, facilities, equipment and other resources required to implement
> the option and a timeline for completion of all tasks.
>
> **B. OPTION PLAN IMPLEMENTATION:**

Based on the Project Officer's recommendation to implement the Option
Plan, the Contracting Officer will authorize the exercise of each Option
through a Modification to the contract. The Project Officer will notify
the Contractor two months prior to exercising the option. The Contractor
shall begin the task upon execution of the subsequent modification.

[]{#Attachment_8 .anchor}***IN VITRO* TESTING RESOURCES FOR AIDS
THERAPEUTICS DEVELOPMENT**

**RFP NIH-NIAID-DAIDS-07-25**

**[APPENDIX A]{.underline} - ADDITIONAL TECHNICAL PROPOSAL
INSTRUCTIONS**

**FORMAT FOR TECHNICAL PROPOSAL -- [TABLE OF CONTENTS]{.underline}**

[]{.mark}

**[PART B: SPECIALIZED *IN VITRO* VIROLOGICAL ASSAYS FOR HIV
THERAPEUTICS AND TOPICAL MICROBICIDES]{.mark}**

+-----------------------------------------------------------------------+
| **It is strongly recommended that Offerors use the following template |
| as the [Table of Contents]{.underline} for the technical proposal.    |
| All information presented in the technical proposal shall be          |
| presented in the order specified below.**                             |
|                                                                       |
| The following additional technical proposal instructions reflect the  |
| requirements of the RFP and are meant to provide additional           |
| instructions as well as a uniform format for technical proposals. The |
| information requested in these instructions shall be used as a guide  |
| for formatting and preparing the proposal. Offerors shall follow the  |
| instructions in Section L of the solicitation, including the          |
| information requested in this appendix.                               |
|                                                                       |
| Offerors are advised to give careful consideration to the Statement   |
| of Work, all reference material, appendices and attachments, the      |
| technical evaluation criteria, and, the RFP as a whole in the         |
| development of their proposal.                                        |
|                                                                       |
| Offerors who propose subcontracts to perform portions of the          |
| Statement of Work shall clearly identify the specific tasks for which |
| they plan to utilize subcontractors, as well as the method and level  |
| of integration between the prime and subcontractor(s), and the        |
| expected advantages of such an approach.                              |
|                                                                       |
| Offerors are reminded that the total page limitation for the          |
| technical proposal package is **200** pages, including all appendices |
| and attachments. Any pages in excess of this limit will be expunged   |
| from the proposal and will not be considered in the technical review. |
+-----------------------------------------------------------------------+

**TECHNICAL PROPOSAL -- TABLE OF CONTENTS**

**SECTION 1**

I.  PROPOSAL TITLE PAGE. Include RFP title and number, name of
    organization, DUNS number, proposal part, and identify if the
    proposal is an original or copy.

```{=html}
<!-- -->
```
I.  PROJECT OBJECTIVES, NIH FORM 1688

II. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

III. TABLE OF CONTENTS

IV. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043)

**SECTION 2: TECHNICAL PROPOSAL OVERVIEW (2-3 pages recommended)**

Provide a brief overview of the proposed *in vitro* specialized testing
services to be provided including descriptions of the following:

> 1\. the *in vitro* assays to be made available for specialized testing
> of potential anti-HIV topical microbicides and therapeutics;
>
> 2\. the activities to be performed by the Offeror and those that shall
> be provided by any proposed subcontractors, including the
> identification of the proposed subcontractors, and a list of key
> personnel of the Offeror and the proposed subcontractors with degrees
> and titles;
>
> 3\. the facilities, equipment, and other resources to be made
> available by the Offeror and any proposed subcontractors; and,
>
> 4\. the period of contract funding requested and the total budget for
> each year.

**SECTION 3: TECHNICAL APPROACH**

**A. Specialized *In Vitro* Virological Assays (SOW 2)**

1\. Provide one or more tables that summarize relevant *in vitro* assays
used for primary screening with which you have experience and could
offer on a routine basis in the evaluation of drug substances as
potential anti-HIV topical microbicides and therapeutics. Include only
those assays that have actually been conducted by the Offeror and any
proposed subcontractors within the past two years and can meet the core
requirements specified in the Statement of Work. Document prior success
in assay development and drug substance testing.

2\. Provide a list of available viruses with different subtype
classifications, coreceptor-usage, and drug-resistance characteristics
that are currently available at your organization and at any proposed
subcontract organizations that will conduct the assays.

3\. Describe high throughput screening capabilities.

4\. Provide details for at least one mechanism of action assay with
which you have experience to evaluate drug substances that demonstrate
activity as either anti-HIV topical microbicides or therapeutics.

5\. Provide details for at least one cytotoxicity assay that could be
used to evaluate drug substances that demonstrates activity as either
anti-HIV topical microbicides or therapeutics.

**B. Data Management and Analysis (SOW 4)**

> 1\. Describe the proposed data management system for storing and
> retrieving contract data;
>
> 2\. Discuss quality assurance/quality control criteria to be used in
> assessing the acceptance of experimental data, and circumstances under
> which assay results might be determined to be unacceptable; and
>
> 3\. Describe the statistical methods proposed for the analysis of
> experimental data from evaluations of drug substances as single
> agents. Discuss how 50% and 90% inhibitory concentrations are
> calculated (e.g., point-to-point, linear regression, curve fitting, or
> other).

SECTION 4: RECEIPT, STORAGE, SHIPPING, AND TRACKING OF CONTRACT
RESOURCES; SAFETY AND TRAINING; PROJECT MANAGEMENT; and CONFIDENTIALITY
OF INFORMATION

**A. Receipt, Storage, Shipping, and Tracking of Contract Resources (SOW
5)**

Describe procedures and capabilities for receiving, storing, shipping,
and tracking drug substances, viruses, and other reagents. Discuss any
licenses and permits that might be required for the safe transport and
storage of these materials. Describe the proposed system for tracking
the receipt, storage, and shipping of these materials.

**B. Safety and Training (SOW 6)**

Describe your plan for training, implementing, and monitoring safety
procedures for protection of personnel and the environment from chemical
and biological hazards. Include a discussion of the use of protective
garments and equipment by personnel and protocols for dealing with
chemical and biological spills and accidents. Discuss your experience in
working with potential chemical and biological hazards.

**C. Project Management (SOW 7)**

> 1\. Describe the scientific, technical, and administrative
> infrastructure proposed for the planning, initiation, implementation,
> management, and completion of all contract activities. Describe this
> infrastructure in terms of job functions/responsibilities and levels
> of effort, not by the individual personnel assigned to fill these job
> functions/responsibilities (the latter will be requested in Section 5
> below). Clearly indicate lines of authority and reporting
> responsibilities. Document your organization's experience within the
> past two years in the management of projects similar in size and
> scope.
>
> 2\. Describe the project management system that will be used to track
> contract activities, including any proposed subcontracts, and to keep
> multiple activities on time and within budget. Include a description
> of quality control methods that will be used to ensure the effective
> initiation, implementation, management, and oversight of contract
> activities.
>
> 3\. Describe how the Principal Investigator will communicate
> electronically with the Project Officer and Contracting Officer to
> support exchange of email, data files, and reports.

**D. Confidentiality of Information (Advance Understanding)**

Describe the procedures that will be employed to safeguard the
confidentiality of information provided to the Contractor by third
parties or the Government, as well as data generated during the
performance of the contract.

Three documents, entitled (1) "Confidentiality of Information and
Intellectual Property," (2)

"NIAID Non-Clinical Evaluation Agreement," and (3) "Intellectual
Property Option to be Offered to NIAID's Third Party Providers of
Proprietary Material *and* Protection of Resultant Proprietary Data" are
attached to this solicitation. The first addresses the Contractor's
handling of confidential information and intellectual property
responsibilities during the conduct of the contract. The second
illustrates the type of agreement made between the DAIDS, NIAID, NIH and
providers of drug substances to the Contractor for *in vitro* testing.
The third addresses licensing options that will be offered to providers
of drug substances in the event an invention is made by the Contractor
in conducting the work specified in the contract. An Advance
Understanding will be written into the final contract incorporating
these three documents.

SECTION 5: SCIENTIFIC, TECHNICAL, AND ADMINISTRATIVE PERSONNEL (SOW 8)

Describe the education, training, relevant experience, expertise, and
accomplishments of all proposed scientific, technical, and
administrative personnel of the Offeror and any proposed subcontractors,
including experience in planning, conducting, and managing antiviral
drug evaluation projects of the scope and complexity outlined in the
Statement of Work. Limit CVs to three (3) pages for the Principal
Investigator and two (2) pages for all other staff.

SECTION 6: FACILITIES, EQUIPMENT, AND OTHER RESOURCES (SOW 9)

Document the availability and adequacy of facilities, equipment, space,
and other resources necessary to carry out the Statement of Work,
including:

> 1\. a description of the facility including floor diagrams
>
> 2\. lease or ownership information; and
>
> 3\. identification and description of ALL required support resources,
> including IT systems.

SECTION 7: OPTIONS

The Government anticipates a need for additional screening of potential
anti-HIV topical microbicides and therapeutic drug substances in assays
outlined in the Statement of Work. Thus, an increase in the Contractor's
activities may be required, at the discretion of the NIAID, through
exercise of Options for additional tasks under the terms of this
contract. The Government will decide whether an option will be exercised
in a contract year. If so, either Option 1, Option 2, or both Options
may be exercised.

> A. The Technical Proposal shall provide plans to implement the options
> based on the following assumptions:
>
> 1\. Conduct human cervical explant assays, mechanism of action studies
> and cytotoxicity assays on 100 anti-HIV topical microbicide candidate
> or therapeutic drug substances.
>
> 2\. Purchase and perform HTS on a chemical library consisting of
> 200,000 drug substances to evaluate efficacy in biochemical or
> cell-based assays designed to identify potential anti-HIV topical
> microbicides or therapeutics.
>
> B. Plans for implementing [each]{.underline} Option shall address the
> following:
>
> 1\. Identify and describe the adequacy, suitability, and availability
> of the facilities, equipment, and other resources required.
>
> 2\. Identify and describe the proposed scientific and technical
> personnel, their education, training, experience, responsibilities,
> and level of effort.
>
> 3\. Describe the project management system that will be used to track
> contract activities, including any proposed subcontracts, and keep
> activities under each option on time and within budget.

**SECTION 8: TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER SECTION
L OF THE SOLICITATION**

Section L of the RFP provides minimum documentation requirements for the
following items. The required information described in Section L shall
be assembled together, in the following clearly marked sections of the
technical proposal. Refer to Section L of the RFP for specific
requirements. Also read each section, below, carefully. In some cases,
Offerors may be asked to provide documentation which is in addition to
the minimum requirements identified in Section L.

**Sharing Research Data (Plan)**

Section L of the RFP specifies the minimum documentation requirements
for Data Sharing. All related documentation shall be included in the
proposal in a clearly marked section. The Technical Proposal shall
include a plan for Data Sharing as required by the RFP.

**IT Systems Security**

Section L of the RFP specifies the minimum documentation requirements
for IT Systems security. All related documentation shall be included in
the proposal in this clearly marked section.

[]{#Attachment_9 .anchor}***IN VITRO* TESTING RESOURCES FOR AIDS
THERAPEUTICS DEVELOPMENT**

**RFP NIH-NIAID-DAIDS-07-25**

**[APPENDIX B]{.underline} - ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS**

**AND UNIFORM COST ASSUMPTIONS**

**[PART B: SPECIALIZED IN VITRO VIROLOGICAL ASSAYS FOR HIV THERAPEUTICS
AND TOPICAL MICROBICIDES]{.mark}**

+-----------------------------------------------------------------------+
| **In addition to the format requirements for the business proposal    |
| that are contained in Section L of the solicitation, the information  |
| provided in this appendix is intended to provide uniform cost         |
| assumptions and business clarifications.**                            |
|                                                                       |
| Offerors are advised to give careful consideration to the Statement   |
| of Work, all reference material provided as appendices and            |
| attachments, and the technical evaluation criteria, and, the RFP as a |
| whole, in the development of your proposal. The information requested |
| in these instructions shall be used as a guide for the development    |
| and formatting of your business proposal. Offerors shall consider and |
| include the information requested in this appendix, as well as **any  |
| other** information which will benefit the proposal.                  |
+-----------------------------------------------------------------------+

**[BUSINESS PROPOSAL -- TABLE OF CONTENTS]{.underline}**

**SECTION 1 --** **PROPOSAL COVERSHEET**

**SECTION 2 --** **COST OR PRICE SUPPORT**

Section L of the RFP specifies the minimum documentation requirements
for cost data and all cost related support. All related documentation
shall be included in the proposal in a clearly marked section.

**SECTION 3 --** **UNIFORM COST ASSUMPTIONS**

**Technical Cost Assumptions**

> **1. Assays to evaluate the efficacy of potential anti-HIV topical
> microbicides and therapeutics (SOW 2.A)**
>
> a\. Assume 400 drug substances per year will be screened to evaluate
> potential inhibitors of the transmission of HIV-1 from infected to
> uninfected cells in a CD4- and CCR5-dependent assay. Assays shall be
> performed in triplicate with appropriate positive and negative
> controls and include cytotoxicity monitoring in uninfected
> cells/tissues of the same lineage; and,
>
> b\. Assume 500 drug substances per year will be screened in cell-based
> assays to identify inhibitors of HIV Rev and Tat.
>
> **2. Cervical explant assay (SOW 2.A)** Assume six (6) topical
> microbicide candidates per year will be screened for efficacy in a
> human cervical explant model.
>
> **3. Mechanism of action assays for potential topical microbicides
> (SOW 2.B)** Assume 50 topical microbicide candidates will be screened
> per year each in both HIV-1 attachment and fusion, or other relevant
> assays to determine the mechanism of action.
>
> **4. Cytotoxicity assay (SOW 2.C)** Assume 50 topical microbicide
> candidates will be evaluated each year in two (2) commercially
> available test kits to monitor potential cellular cytotoxicity.
>
> **5. Seminal plasma inhibition assay (SOW 2.D)** Assume 50 assays will
> be performed per year to monitor the effect of seminal plasma on
> potential topical microbicides.
>
> **6. Lactobacillus toxicity assay (SOW 2.D)** Assume 50 assays will be
> performed per year to monitor the toxicity of potential topical
> microbicides on two species of hydrogen peroxide-secreting
> *Lactobacillus*.
>
> **7. pH transition assay (SOW 2.D)** Assume 50 assays will be
> performed per year to mimic the effect of pH transition from 4.5 to
> 7.0 on potential topical microbicides.
>
> **8. High throughput assay to identify inhibitors of HIV-1 replication
> (SOW 2.E)** Assume 10,000 drug substances will be tested per year in a
> cell-based HTS assay to identify potential anti-HIV topical
> microbicides or HIV therapeutics.
>
> **9. Assume an overall staffing requirement of approximately 4 (four)
> full-time equivalents (FTEs) per year.**

**Travel**

Assume \$1,500 per year for meeting travel requirements.

**SECTION 4 --** **OPTIONS** (If and to the extent exercised)

Offerors submitting a proposal under this solicitation must prepare a
Technical Proposal and Business Proposal for the entire Statement of
Work including options. Proposals for the basic effort alone, or the
options alone will not be accepted for review or considered for award.

Options will be included in the contract as the Government anticipates a
need for additional screening for potential anti-HIV topical
microbicides and therapeutics drug substances. Exercise of the options
shall be solely at the discretion of the Government.

The Offeror shall price each option separately based on the following
assumptions:

> 1\. Conduct human cervical explant assays, mechanism of action
> studies, and cytotoxicity assays on 100 anti-HIV topical microbicides
> or therapeutic drug substances.
>
> 2\. Purchase a chemical library consisting of 200,000 drug substances
> and conduct a cell-based assay in a HTS format to identify potential
> anti-HIV topical microbicides or therapeutics.

**SECTION 5 - TABLE OF CONTENTS FOR DOCUMENTATION REQUIRED UNDER SECTION
L OF THE SOLICITATION**

**I) Small Business Subcontracting Plan**

Section L of the RFP specifies the minimum documentation requirements
for completing a subcontracting plan. This plan shall be turned in with
the original proposal. All related documentation shall be included in
the proposal in a clearly marked section.

**II) Extent of Small Disadvantaged Business Participation**

Section L of the RFP specifies the minimum documentation requirements
for small disadvantaged business utilization. This information shall be
turned in with the original proposal. All related documentation shall be
included in the proposal in a clearly marked section.

**III) Past Performance Data, including references**

Section L of the RFP specifies the minimum documentation requirements
for providing past performance information. This information shall be
turned in with the original proposal. All related documentation shall be
included in the proposal in a clearly marked section.

[]{#Attachment_10 .anchor}**REPORTING REQUIREMENTS AND DELIVERABLES**

***IN VITRO* TESTING RESOURCES FOR AIDS THERAPEUTICS DEVELOPMENT**

**RFP NIH-NIAID-DAIDS-07-25**

**[PART A: CONFIRMATORY *IN VITRO* EVALUATIONS OF HIV
THERAPEUTICS]{.mark}**

**[And PART B: SPECIALIZED *IN VITRO* VIROLOGICAL ASSAYS FOR HIV
THERAPEUTICS AND TOPICAL MICROBICIDES]{.mark}**

**A.** **TECHNICAL REPORTS**

In addition to those reports required by the other terms of this
contract, the Contractor shall prepare and submit the following reports
in the manner stated below and in accordance with ARTICLE F.1.
DELIVERIES of this contract:

**1. Project Reports**

Project Reports shall detail the work performed on [each]{.underline}
assigned project. Project Reports shall be submitted via email at the
completion of each project or, in the case of long-term projects, at
intermediate intervals identified by the Project Officer. Each Project
Report shall contain:

> a\. a cover page listing:
>
> 1\) contract title and number;

2\) project title and number;

3\) Contractor\'s name and address; and,

4\) date of submission;

b\. a table of contents;

c\. an introduction describing the assigned task;

d\. detailed description of the materials and methods employed;

e\. raw data and a graphical representation of the data;

f\. a narrative summary of the results; and,

g\. a discussion of the scientific significance of the results.

**2. Monthly Progress Reports**

Monthly Progress Reports shall summarize the status of all ongoing
projects (those for which a Project Report has not been submitted and
approved by the Project Officer). Monthly Project Reports shall identify
deviations from approved Project Plans, provide updated timelines for
all ongoing projects, and include a description of technical or
administrative problems encountered since the last Monthly Progress
Report, their resolution, or the proposed corrective action. A Monthly
Progress Report is not due when the Final Report is due. Monthly
Progress Reports shall be submitted via email and include a cover page
which includes:

> a\. contract title and number;

b\. type of report;

c\. period of performance being reported;

d\. Contractor\'s name and address; and,

e\. date of submission.

**3. Draft Final Report**

A Draft Final Report shall be submitted via email 30 calendar days prior
to the completion date of the contract. The Project Officer will review
the Draft Final Report and provide the Contractor with

comments within 15 calendar days of receipt. These comments shall be
used by the Contractor in preparing the Final Report.

**4. Final Report**

The Final Report shall summarize all work accomplished during the entire
contract period of performance. The Final Report shall not include
detailed copies of information previously submitted in Project Reports
or Monthly Progress Reports, but shall include enough detail to document
the contract's accomplishments. The Final Report shall include a
cumulative listing of all projects assigned since the contract award
date. This listing shall include each project's assignment date and
Project Report approval date. A listing of any meeting abstracts or
publications derived from research conducted under the contract shall be
included in the Final Report. The Final Report shall be submitted via
email by the completion date of the contract and shall include a cover
page which follows the format described above for Monthly Progress
Reports.

**5. Summary of Salient Results (Form 1688-1)**

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

**B.** **TECHNICAL REPORTS DELIVERY SCHEDULE**

+----+-------+-------------+-----------+-----------------------------+
| ** | ###   | **Initial   | ### Re    | **Subsequent Reports Due**  |
| It |  Type | Report      | cipients  |                             |
| em |  of R | Due**       | & Number  |                             |
| ** | eport |             | of Copies |                             |
+----+-------+-------------+-----------+-----------------------------+
| 1  | Pr    | Within 30   | 1 Email   | Within 30 calendar days of  |
| \. | oject | calendar    | Copy to   | completion of each project  |
|    | Re    | days of     | PO;       | or, in the case of          |
|    | ports | completion  |           | long-term projects, at      |
|    |       | of first    | 1 Email   | intermediate intervals      |
|    |       | project     | Copy to   | identified by the Project   |
|    |       |             | CO        | Officer                     |
+----+-------+-------------+-----------+-----------------------------+
| 2  | Mo    | The end of  | 1 Email   | Monthly, due within 3       |
| \. | nthly | the first   | Copy to   | calendar days of the end of |
|    | Pro   | full        | PO;       | each month. A Monthly       |
|    | gress | calendar    |           | Progress Report is not due  |
|    | Re    | month after | 1 Email   | when a Final Report is due. |
|    | ports | the         | Copy to   |                             |
|    |       | effective   | CO        |                             |
|    |       | date of the |           |                             |
|    |       | contract    |           |                             |
+----+-------+-------------+-----------+-----------------------------+
| 3  | Draft | 30 calendar | 1 Email   | None                        |
| \. | Final | days prior  | Copy to   |                             |
|    | R     | to the      | PO;       |                             |
|    | eport | completion  |           |                             |
|    |       | date of the | 1 Email   |                             |
|    |       | contract    | Copy to   |                             |
|    |       |             | CO        |                             |
+----+-------+-------------+-----------+-----------------------------+
| 4  | Final | By          | 1 Email   | None                        |
| \. | R     | completion  | Copy and  |                             |
|    | eport | date of the | 1 hard    |                             |
|    |       | contract    | copy to   |                             |
|    |       |             | PO;       |                             |
|    |       |             |           |                             |
|    |       |             | 1 Email   |                             |
|    |       |             | Copy to   |                             |
|    |       |             | CO        |                             |
+----+-------+-------------+-----------+-----------------------------+
| 5  | Form  | By          | 1 Hard    | None                        |
| \. | 1     | completion  | Copy to   |                             |
|    | 688-1 | date of the | PO;       |                             |
|    |       | contract    |           |                             |
|    |       |             | 1         |                             |
|    |       |             | Original  |                             |
|    |       |             | Email     |                             |
|    |       |             | Copy to   |                             |
|    |       |             | CO        |                             |
+----+-------+-------------+-----------+-----------------------------+

**C. OTHER REPORTS/DELIVERABLES**

**1. Project Plans**

Prior to initiating each assigned project, the Contractor shall submit,
via email for Project Officer review and approval, a Project Plan
containing the following information:

a\. a project number assigned by the Contractor;

b\. a summary of the services to be provided and the proposed technical
approaches and methodologies to be used;

c\. a listing and proposed timeline (including specific dates) of the
milestones to be met in conducting the project; and,

d\. literature citations when appropriate.

2\. **Invention Report**

Invention Reports shall be submitted as necessary to the if patents are
filed by the Contractor as a result of intellectual property which may
derive from projects assigned throughout the course of the contract
award.

**3. Initial Transition Plan**

Within twenty (20) calendar days of the effective date of the contract,
the Contractor shall submit an Initial Transition Plan for Project
Officer review and approval to have the proposed facility ready to start
conducting studies under this contract. The Plan shall be submitted via
email and include:

a.  a summary of the current availability of all staff assigned to the
    contract;

```{=html}
<!-- -->
```
a.  a summary of the Contractor's readiness for implementing each task
    of the Statement of Work;

b.  plans for coordinating all necessary shipments of drug substances
    and virus isolates, and the transfer of all data from the incumbent
    Contractor; and,

c.  plans and timelines for resumption of any unfinished studies
    initiated by the incumbent Contractor.

    **4. Final Transition Plan**

    Three (3) months prior to the completion date of the contract, the
    Contractor shall submit for Project Officer review and written
    approval a Final Transition Plan to provide for an orderly,
    efficient, and safe transfer of contract-relevant materials and data
    to a successor contractor or to the Government. The Final Transition
    Plan shall be submitted via email and shall include:

    A. an inventory of any remaining stocks of drug substances submitted
    to the Contractor during the performance period of this contract;

    B. a list of assigned projects anticipated to be unfinished by the
    contract completion date and the remaining steps needed for a
    successor Contractor to complete these projects; and,

    C. plans and timelines for coordinating all necessary shipments of
    drug substances, virus isolates, study samples, reagents, and data
    to a successor Contractor or to the Government.

**D. OTHER REPORTS/DELIVERABLES DELIVERY SCHEDULE**

+----+-----------+----------+-----------+-----------+----------------+
| ** | ### T     | #        | ### Due   | ### Re    | ###            |
| It | ype of De | ## SOW R |           | cipients  |  Subsequent De |
| em | liverable | eference |           | & Number  | liverables Due |
| ** |           |          |           | of Copies |                |
|    |           | PART A & |           |           |                |
|    |           | B        |           |           |                |
+----+-----------+----------+-----------+-----------+----------------+
| 1  | Project   | 3        | Within 7  | 1 Email   | Within 7       |
| \. | Plans     |          | calendar  | Copy to   | calendar days  |
|    |           |          | days of   | PO        | of each        |
|    |           |          | the first |           | subsequent     |
|    |           |          | project   |           | project        |
|    |           |          | a         |           | assignment     |
|    |           |          | ssignment |           |                |
+----+-----------+----------+-----------+-----------+----------------+
| 2  | Invention |          | As        | 1 Hard    | As necessary   |
| \. | Report    |          | necessary | Copy to   |                |
|    |           |          |           | PO        |                |
|    |           |          |           |           |                |
|    |           |          |           | 1 Hard    |                |
|    |           |          |           | Copy to   |                |
|    |           |          |           | CO        |                |
+----+-----------+----------+-----------+-----------+----------------+
| 3  | Initial   | 1        | Within 20 | 1 Email   | None           |
| \. | T         |          | calendar  | Copy to   |                |
|    | ransition |          | days of   | PO        |                |
|    | Plan      |          | the       |           |                |
|    |           |          | effective | 1 Email   |                |
|    |           |          | date of   | Copy to   |                |
|    |           |          | the       | CO        |                |
|    |           |          | contract  |           |                |
+----+-----------+----------+-----------+-----------+----------------+
| 4  | Final     | 10       | 3 months  | 1 Email   | None           |
| \. | T         |          | prior to  | Copy to   |                |
|    | ransition |          | the       | PO        |                |
|    | Plan      |          | c         |           |                |
|    |           |          | ompletion | 1 Email   |                |
|    |           |          | date of   | Copy to   |                |
|    |           |          | the       | CO        |                |
|    |           |          | contract  |           |                |
+----+-----------+----------+-----------+-----------+----------------+

**E. COPIES OF REPORTS SHALL BE SENT TO THE FOLLOWING ADDRESSES:**

Project Officer (PO)

Division of AIDS, DAIDS, NIH, DHHS

6700-B Rockledge Drive, Room 4153, MSC 7624

Bethesda, MD 20892-7624 (20817 for overnight deliveries)

Contracting Officer (CO)

Office of Acquisitions

Division of Extramural Activities, NIAID, NIH, DHHS

6700-B Rockledge Drive, Room 3214, MSC 7612

Bethesda, MD 20892-7612 (20817 for overnight deliveries)

[]{#Attachment_11 .anchor}**IN VITRO TESTING RESOURCES FOR AIDS
THERAPEUTICS DEVELOPMENT**

**NIH-NIAID-DAIDS-07-25**

**APPENDIX C - ADVANCE UNDERSTANDINGS**

**[PART A: CONFIRMATORY *IN VITRO* EVALUATIONS OF HIV
THERAPEUTICS]{.mark}**

**And [PART B: SPECIALIZED *IN VITRO* VIROLOGICAL ASSAYS FOR HIV
THERAPEUTICS AND TOPICAL MICROBICIDES]{.mark}**

**Confidentiality of Information and Intellectual Property**

**Confidentiality of Information**

Information and data provided to or generated by the Contractor under
this contract shall be treated confidentially and protected by an
Advance Understanding to be included in the resulting contract and
worded as follows:

"Because there is a likelihood that the Contractor will be utilizing and
evaluating materials provided to the Government by a third party
Provider, it is essential to include provisions that will protect the
proprietary rights of the Provider. These materials generally are
supplied to the Government as proprietary and confidential. The
Contractor shall be bound by the same terms and conditions as the
Government in these agreements, with respect to the proprietary and
confidential nature of the information provided by the Provider.

All information provided by the Provider or Project Officer shall be
assumed to be confidential unless specifically identified as
non-confidential in writing by the Project Officer. Confidential
information may not be revealed without written permission. All
materials supplied to the Contractor and all test results similarly are
to be considered confidential. All materials supplied to the Contractor
shall be utilized solely for contract-related research purposes and no
unauthorized use or distribution of these materials will be permitted.

Any manuscript or scientific meeting abstract containing data generated
under this contract must be submitted for review and written approval by
the Project Officer before submission for public presentation or
publication. Contract support shall be acknowledged in all such
publications. A \"publication\" is defined as an issue of printed
material offered for distribution or any communication or oral
presentation of information. The Project Officer will review all
manuscripts/abstracts in a period of time not to exceed 20 calendar days
from receipt, and will either grant clearance for
publication/disclosure, recommend changes or, as applicable, refer the
document to the Provider of the drug substance for their review. When
the Provider does not consent to publication of the manuscript or
abstract, the Project Officer shall withhold approval to publish in
accordance with the terms and conditions of any existing Evaluation
Agreement or Material Transfer Agreement between NIAID and the Provider.
NIAID will use its best efforts to assist and expedite the review and
approval process by the Provider."

**Intellectual Property**

Contractors acknowledge that:

\* If needed for the project, Contractor is solely responsible for the
timely acquisition of any proprietary rights, including intellectual
property rights, and all materials appropriate for Contractor to perform
the project;

\* Contractor acknowledges that prior to, during, and subsequent to the
award, the U.S. Government is not required to obtain for Contractor any
proprietary rights, including intellectual property rights, or any
materials needed by Contractor to perform the project;

\* Contractor acknowledges the requirement to report to the U.S.
Government all inventions made in the performance of the project, as
specified at 35 U.S.C. Sect. 202 (Bayh-Dole Act).

Contractor is encouraged to reach early consensus with any proposed
partners regarding any appropriate intellectual property or other legal
issues that may arise during the project. In addition, Contractors are
expected to exercise their Bayh-Dole rights in a manner that does not
conflict with the goals of this award or the intent of the Bayh-Dole Act
to promote the utilization, commercialization and availability of U.S.
Government-funded inventions for public benefit. Finally, Contractor is
expected to make new information and materials known to the research
community in a timely manner through publications, web announcements,
and reports to the NIAID or other mechanisms consistent with laws,
regulations, and NIH policies.

Should patents arise from this contract, they will be subject to laws
governing federally funded inventions. The Government retains, for
government purposes, a non-exclusive, irrevocable, paid-up license to
federally funded inventions.

**NIAID Division of Acquired Immunodeficiency Syndrome, NIAID**

**Non-Clinical Evaluation Agreement**

**NIAID Non-Clinical Evaluation Agreement**

**This Agreement** is made and entered into between the National
Institute of Allergy and Infectious Diseases ("NIAID"), having offices
at Bethesda, Maryland 20892, and [\<insert institution\>]{.underline},
having offices at [\<insert institution's city, state zip\>]{.underline}
("Provider").

Provider has requested to participate in one or more of the
anti-infective or other non-clinical evaluation programs funded by the
Division of Acquired Immunodeficiency Syndrome (DAIDS), part of the
National Institute of Allergy and Infectious Diseases (NIAID), an
institute of the National Institutes of Health (NIH), which is a
component of the Department of Health and Human Services (DHHS), an
agency of the U.S. Government.

Provider may request to submit without charge patented or unpatented
drugs, compounds or other products to NIAID. Through its contract
testing laboratories or contract coordinating facilities, NIAID may
evaluate the submitted material for possible activity against infectious
organisms or perform other non-clinical evaluations.

NIAID and Provider therefore agree as follows:

**1. Definitions.**

## "Confidential Information" is scientific, business or financial information the Provider or NIAID deem to be proprietary or confidential and which information is identified in writing on submitted materials.

## "Contractors" are NIAID approved non-profit and for-profit testing laboratories with contractual obligations to NIAID that NIAID represents to be consistent with the terms of this Agreement. 

## "Evaluations" will include the testing of the Materials by the protocols described [in]{.mark} Appendix A. 

## "Invention" means any invention or discovery which is or may be patentable or otherwise protected under title 35, United States Code, or any novel variety or plant which is or may be protectable under the Plant Variety Protection Act (7 U.S.C. 2321 et seq.).

## "Materials" means chemical matter and compositions submitted by the Provider and described in Appendix A.

## "Results" means all recorded data, results, and technical information first produced from the Evaluations of the Materials under this Agreement and not previously disclosed by the Provider.

# 2. Evaluation of Materials. {#evaluation-of-materials. .unnumbered}

##  NIAID has the right to decline to conduct Evaluations of any Materials. Provider understands that not all Evaluations offered by NIAID are available at all times. Evaluations will be approved jointly by NIAID and the Provider.

## At Provider's request and with the prior approval of NIAID, material to be evaluated may be submitted to Contractors under code. NIAID must be provided with the key to the code and the chemical structures of the encoded material to prevent duplication of evaluations.

## Under the direction of NIAID, Provider will forward to NIAID the Materials and data sheets of the Materials which contain pertinent available data as to chemical composition, purity, solubility, toxicity, previous biological efficacy and any precautions that need to be followed in the handling, storing, and shipping of Materials. 

##  NIAID will work in conjunction with Contractors to ensure rapid ongoing communication of Results to the Provider, and Provider will in turn use reasonable efforts to keep NIAID informed of Provider's own concurrent studies with the Materials that may affect Evaluations or Results. 

## Materials are to be used by Contractors for Evaluations under this Agreement only and for no other purpose. In addition, the Materials will not be chemically modified, replicated, derived or reverse engineered unless specifically necessary for the performance of the Evaluations. Upon completion of Evaluations, all unused Materials will be returned to Provider or destroyed as directed by Provider.

# Confidentiality.

## Provider may provide Confidential Information relevant to the Evaluation of the Materials to NIAID and the Contractors. NIAID represents that the Contractors are required by their NIAID contracts to protect such Confidential Information with reasonable efforts as specified in 3.3 below.

## To the extent permitted by law, Confidential Information disclosed to or the Contractors will remain confidential for five (5) years after the effective date of this Agreement unless the information:

a)  Is known by the public or becomes known by the public through no
    fault of NIAID

> or the Contractors;

a.  Was obtained by NIAID or the Contractors, without restriction, from
    a third party having no confidentiality obligation to the Provider;

```{=html}
<!-- -->
```
a.  Has been independently developed by NIAID or the Contractors without
    reference to the Provider's Confidential information; or

```{=html}
<!-- -->
```
a.  Is required to be disclosed by law, regulation or court order
    provided that Provider has been notified and or the NIAID
    Contractors has taken reasonable efforts to minimize the extent of
    the required disclosure.

## NIAID will ensure that Confidential Information is kept in restricted-access files. Only personnel directly involved in the Evaluations will have access to the files containing Confidential Information. Provider acknowledges that Results are not Confidential Information, unless deemed otherwise by NIAID, and may be disclosed by NIAID and the Contractors in accordance with Article 4 below.

# Disclosure of Results.

##  NIAID and the Contractors may publish or otherwise publicly disclose Results after a period of six (6) months from the date of transfer of Results to Provider. After this period of time NIAID will consult with Provider, and will require the Contractors to consult with Provider, whenever Results are included in any publication or other public disclosure such as a press release. The six month delay in disclosure is intended to allow Provider time to file patent applications if desired. 

## Publication of Results earlier than the six (6) month period by NIAID or Contractors will require Provider's prior written consent, which will not be unreasonably withheld. 

## Provider will not be identified in NIAID or Contractor publications as the source of Materials without Provider's prior written approval. 

## Provider will allow NIAID fourteen (14) days to review and comment of any proposed press releases, paper, or abstract for publication relating to the Evaluations or Results. Provider will not construe the involvement of NIAID in Evaluations as an endorsement of Materials by the U.S. Government or any of its agencies, employees or Contractors. 

## Provider will include acknowledgement of NIAID and the contracts providing support in any publication or press release. 

# Intellectual Property.

1.  NIAID acknowledges that this Agreement may not be construed as a
    grant by the Provider

of a license or any other right or interest to the Materials beyond
those expressly set forth

herein.

## Provider acknowledges that the Contractors have the right to elect to retain title to any new Invention(s) made under NIAID sponsored contracts \[37 CFR 401.14(b)\]. However, Contractors have agreed to an "Intellectual Property Option" as part of their contracts with NIAID. Under the Intellectual Property Option the Contractors are required to: 

> a\) Promptly notify NIAID and the Provider of any new Invention(s)
> made by the Contractors in the performance of the Evaluations under
> this Agreement;
>
> b\) Grant Provider a paid-up, nonexclusive, nontransferable,
> royalty-free, world-wide license to all such new Invention(s) for
> research purposes only; and
>
> c\) Grant Provider a time-limited first option to negotiate an
> exclusive, world-wide royalty-bearing license to Contractor's interest
> in all such new Invention(s) for all commercial purposes, including
> the right to grant sub-licenses, on terms to be negotiated in good
> faith by Provider and the Contractor.

# Warranty and Limitation of Liability. 

## NIAID acknowledges and agrees that the Materials are experimental in nature. Provider makes no representations and extends no warranty of any kind, either expressed or implied, including any warranty of merchantability or fitness for a particular purpose, or warranty that the use of Materials will not infringe any patent, copyright, trademark or other proprietary right. 

## It is the intention of NIAID that Provider not be liable for any claims or damages arising from use of the Material by NIAID; however, no indemnification for any loss, claim, damage, or liability is intended or provided by NIAID under this Agreement. NIAID shall be liable for any loss, claim, damage, or liability that NIAID incurs as a result of its activities under this Agreement, except that NIAID, as part of an agency of the United States, assumes liability only to the extent provided under the Federal Tort Claims Act, 28 U.S.C. §§ 2671 et seq.

# Term and Termination. 

## This Agreement will be in effect for five (5) years from the date of the last signature below. 

## Either NIAID or Provider may terminate this Agreement at any time by giving written notice at least thirty (30) days prior to the desired termination date.

# Amendments. 

## If NIAID or Provider desires an extension of, or other modification to this Agreement they will, upon reasonable notice to the other, confer in good faith to determine the desirability of the modification. No modification is effective until a written amendment is signed by authorized representatives of NIAID and Provider. 

## If Provider desires to add Materials or Evaluations not originally agreed to, prior approval from NIAID is required and an amendment to this Agreement must be made. All terms and conditions of this Agreement will remain in full force and effect.

# Governing Law. 

> The construction, validity, performance and effect of this Agreement
> shall be governed by Federal law, as applied by the Federal Courts in
> the District of Columbia. Federal law and regulations will preempt any
> conflicting or inconsistent provisions in this Agreement. The
> illegality or invalidity of any provisions of this Agreement shall not
> impair, affect, or invalidate the other provisions of this Agreement.

# Survivability. 

> The provisions of Articles 3, 4, 5, 6, 9 and 10 will survive the
> termination or expiration of this Agreement.

# Points of Contact. 

+-----------------------------------+----------------------------------+
| > **[NIAID Agreement              | **[NIAID Scientific              |
| > POC]{.underline}**              | POC]{.underline}**               |
|                                   |                                  |
| Name:                             | Name:                            |
|                                   |                                  |
| Title:                            | Title:                           |
|                                   |                                  |
| Organization:                     | Organization:                    |
|                                   |                                  |
| Street/Bldg:                      | Street/Bldg:                     |
|                                   |                                  |
| City:      State:      Zip:       | City:      State:      Zip:      |
|                                   |                                  |
| Phone:                            |                                  |
|                                   | Phone:                           |
| Fax:                              |                                  |
|                                   | Fax:                             |
| Email:                            |                                  |
|                                   | Email:                           |
+-----------------------------------+----------------------------------+

# 

+-----------------------------------+-----------------------------------+
| **[Provider Agreement             | **[Provider Scientific            |
| POC]{.underline}**                | POC]{.underline}**                |
|                                   |                                   |
| Name:                             | Name:                             |
|                                   |                                   |
| Title:                            | Title:                            |
|                                   |                                   |
| Organization:                     | Organization:                     |
|                                   |                                   |
| Street/Bldg:                      | Street/Bldg:                      |
|                                   |                                   |
| City:      State:      Zip:       | City:      State:      Zip:       |
|                                   |                                   |
| Phone:                            | Phone:                            |
|                                   |                                   |
| Fax:                              | Fax:                              |
|                                   |                                   |
| Email:                            | Email:                            |
+-----------------------------------+-----------------------------------+

Accepted and agreed by the Parties through their duly authorized
representatives as of the last date of signature below.

**FOR NIAID:**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name: Edmund C. Tramont, MD Date:

Title: Director, DAIDS, NIAID

Address:

Phone/Fax:

**FOR PROVIDER:**

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Name: Date:

Title:

Organization:

Address:

Phone/Fax:

**Intellectual Property Option to be offered to NIAID's Third Party
Providers of Proprietary Material *and* Protection of Resultant
Proprietary Data.**

**This Article Must be Included In Any Subcontract for Evaluation of
Material. The Subcontractor Shall Then Have All the Obligations of the
Contractor.**

The goal of this contract is to promote the development of critical
biological information by evaluating various materials for
anti-microbial activity. For the purposes of this agreement, "material"
includes compositions of matter, and associated information such as
methods of making or using the compositions. It is expected that the
great majority of materials will be proprietary to third parties. It is
clear from the NIAID's experience that third party providers
("Provider") will not provide their proprietary material ("Material")
without assurance that the intellectual property rights associated with
their Materials will be protected. Accordingly, to encourage Providers
to provide their Materials for evaluation under this contract the
Contractor agrees to the Article pertaining to the Intellectual Property
Option to the Provider, which requires the Contractor and its
subcontractors to provide a research use license and a commercialization
license option to Subject Inventions made under the contract to the
Providers as follows:

The Contractor agrees to promptly notify the NIAID and the Provider in
writing of any Subject Inventions of the Contractor, its Principal
Investigator and/or any other employees or agents of the Contractor,
whether patentable or not, which are conceived and/or first actually
reduced to practice in the performance of work under this contract using
a Provider's Material (hereinafter "Contractor Invention"). The notice
shall inform the Provider(s) of its right to the option set forth
herein. This may be accomplished by attaching a copy of the Article to
the notice.

**(1) Single Provider**

With respect to Contractor Inventions resulting from the use of Material
provided by one Provider, the Contractor agrees to grant to the
Provider: (i) a paid-up nonexclusive, nontransferable, royalty-free,
world-wide license to all Contractor Inventions for research purposes
only; and (ii) a time-limited first option to negotiate an exclusive,
world-wide royalty-bearing license for all commercial purposes,
including the right to grant sub-licenses, to any Contractor Invention
on terms to be negotiated in good faith by the Provider and the
Contractor, subject to the following conditions:

The Contractor will allow Provider three (3) months from the date the
Contractor sends written notice to the Provider of the existence of a
Contractor Invention (or such additional period as the Provider and the
Contractor may agree) to notify the Contractor in writing, whether or
not it wants to obtain an exclusive license to the Contractor Invention.
If the Provider fails to notify the Contractor, in a timely fashion then
the Contractor's obligation to offer Provider a license option with
respect to that Contractor Invention will expire, and the Contractor
will be free to dispose of its interests in such Contractor Invention in
accordance with the Contractor's policies. If the Contractor and the
Provider fail to reach agreement within ninety (90) days, (or such
additional period as the Provider and the Contractor may agree) on the
terms for an exclusive license for a particular Contractor Invention,
then for a period of six (6) months thereafter the Contractor will not
offer to license that Contractor Invention to any third party on
materially better terms than those last offered to the Provider without
first offering such terms to the Provider, in which case the Contractor
will offer the Provider a period of thirty (30) days in which the
Provider can accept or reject the offer.

**(2) Multiple Providers**

With respect to a Contractor Invention resulting from the use of
Materials provided by multiple Providers, but which is an improvement
only to a Material of a specific Provider, the Contractor agrees to
grant to that Provider the rights described above in (1).

With respect to any Contractor Inventions resulting from the use of
Material from multiple Providers, but that are not improvements to or
specific to a single Material, the Contractor agrees to grant to each
Provider who provided Material: (i) a paid-up nonexclusive,
nontransferable, royalty-free, world-wide license to all Contractor
Inventions for research purposes only; and (ii) a time-limited first
option to negotiate a co-exclusive, world-wide royalty-bearing license
for all commercial purposes, including the right to grant sub-licenses,
to all such Contractor Inventions on terms to be negotiated in good
faith by each Provider and the Contractor subject to the following
conditions:

The Contractor will allow each Provider three (3) months from the time
the Provider is sent written notice by the Contractor of the existence
of a Contractor Invention (or such additional period as each Provider
and the Contractor may agree) to notify the Contractor, in writing,
whether or not the Provider wants to obtain a co-exclusive license to
the Contractor Invention. If a Provider fails to notify the Contractor,
in a timely fashion then Contractor's obligation to offer that Provider
a license option with respect to that Contractor Invention will expire
and the Contractor will continue to offer an option to a co-exclusive
license to the other Providers as set forth herein. If there is a single
other Provider, it shall be offered an option to an exclusive license as
though it were a single Provider. If no Provider notifies the Contractor
in a timely fashion the Contractor will be free to dispose of its
interests in such Contractor Invention in accordance with the
Contractor's policies.

**Provider Inventions**

The Contractor agrees that notwithstanding anything herein to the
contrary, any invention or discovery, whether patentable or not, which
is not a Subject Invention as defined in **35 USC 201(e)^1^** but arises
out of an intentional and unauthorized use or modification of the
Provider's Material by the Contractor and/or any other employees or
agents of the Contractor, will be the property of the Provider
(hereinafter "Provider Invention"). The Contractor will promptly notify
the Provider in writing of any such Provider Inventions and, at the
Provider's request and expense, the Contractor will cause to be assigned
to the Provider all right, title and interest in and to any such
Provider Inventions and give Provider any assistance reasonably
necessary to obtain patents (including causing the execution of any
invention assignment or other documents). The NIAID recognizes that the
Contractor may also be conducting other research using the Provider's
Material under the authority of a separate agreement with the Provider
during the term of this contract; any invention arising under such
separate agreement will not be subject to the terms of this provision
entitled, **"Provider Inventions."**

**Protection of Proprietary Data**

All Materials, data and other information supplied by the Provider or
the Project Officer shall be assumed to be confidential unless
specifically identified as not confidential in writing by the Project
Officer. The Contractor agrees that its Principal Investigator and/or
any other employees or agents of the Contractor will provide the data
generated under this contract exclusively to the NIAID or if directed by
the NIAID, to the Provider and the FDA or other appropriate Federal
agency. The Contractor understands that the NIAID must negotiate
individual agreements with the various Providers to obtain Materials and
that the terms of the agreements may vary. The NIAID intends that these
agreements will provide for the Contractor's right to publish results
generated by the Contractor under this contract after a reasonable
period of time to allow the Provider to file patent applications and to
protect its proprietary information. The Contractor agrees to enter into
confidentiality agreements with Providers when required by the Providers
as a condition for the Contractor to receive Materials. Such agreements
shall reference this contract by contract number and shall be consistent
with any agreement the NIAID has entered into with the Provider to
obtain Materials. In the event the Contractor reasonably objects to the
terms of the confidentiality agreement, the Contractor shall promptly
bring such objection to the attention of the Contracting Officer for an
appropriate resolution.

^1^35 USC 201(e): The term \'\'subject invention\'\' means any invention
of the Contractor conceived or first actually reduced to practice in the
performance of work under a funding agreement: Provided, That in the
case of a variety of plant, the date of determination (as defined in
section 41(d) of the Plant Variety Protection Act (7 U.S.C. 2401(d))
must also occur during the period of contract performance.