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

**National Institutes of Health**

**National Institute of Allergy and Infectious Diseases (NIAID)**

[]{#A .anchor}**RFP-NIH-NIAID-DAIDS-BAA-06-19**

**HIV Vaccine Design and Development Teams (HVDDT)**

+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 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     |
| June 20, 2005  |     |   |   |        |     |   |   |                        |
|                |   D |   |   |        |     |   |   | > **8(a) Set-Aside:**  |
|                | ate |   |   |        |     |   |   | > \[ \]Yes \[X\] No    |
|                | :** |   |   |        |     |   |   | >                      |
|                |     |   |   |        |     |   |   | > **NAICS #:** 541710  |
|                |  ** |   |   |        |     |   |   | >                      |
|                | Sep |   |   |        |     |   |   | > (See Part IV,        |
|                | tem |   |   |        |     |   |   | > Section L.)          |
|                | ber |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                | 26, |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                | 200 |   |   |        |     |   |   |                        |
|                | 5** |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                | >   |   |   |        |     |   |   |                        |
|                | **T |   |   |        |     |   |   |                        |
|                | ime |   |   |        |     |   |   |                        |
|                | :** |   |   |        |     |   |   |                        |
|                | >   |   |   |        |     |   |   |                        |
|                | 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 |                        |
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|                |     |   |   |        |     |   | n |                        |
|                |     |   |   |        |     |   | d |                        |
|                |     |   |   |        |     |   | a |                        |
|                |     |   |   |        |     |   | a |                        |
|                |     |   |   |        |     |   | n |                        |
|                |     |   |   |        |     |   | d |                        |
|                |     |   |   |        |     |   | a |                        |
|                |     |   |   |        |     |   | t |                        |
|                |     |   |   |        |     |   | t |                        |
|                |     |   |   |        |     |   | a |                        |
|                |     |   |   |        |     |   | c |                        |
|                |     |   |   |        |     |   | h |                        |
|                |     |   |   |        |     |   | m |                        |
|                |     |   |   |        |     |   | e |                        |
|                |     |   |   |        |     |   | n |                        |
|                |     |   |   |        |     |   | t |                        |
|                |     |   |   |        |     |   | s |                        |
|                |     |   |   |        |     |   | ) |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 9.  **Issued   |     |   |   | 10.    |     |   |   |                        |
|     By:**      |     |   |   |  \[X\] |     |   |   |                        |
|                |     |   |   |     *  |     |   |   |                        |
| Jacqueline C.  |     |   |   | *NIAID |     |   |   |                        |
| Holden,        |     |   |   |     re |     |   |   |                        |
| Contracting    |     |   |   | serves |     |   |   |                        |
| Officer        |     |   |   |        |     |   |   |                        |
|                |     |   |   |    the |     |   |   |                        |
| Contract       |     |   |   |        |     |   |   |                        |
| Management     |     |   |   |  right |     |   |   |                        |
| Program, DEA   |     |   |   |     to |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
| NIH, NIAID     |     |   |   |   make |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
| 6700-B         |     |   |   | awards |     |   |   |                        |
| Rockledge      |     |   |   |     w  |     |   |   |                        |
| Drive          |     |   |   | ithout |     |   |   |                        |
|                |     |   |   |     d  |     |   |   |                        |
| Room 3214, MSC |     |   |   | iscuss |     |   |   |                        |
| 7612           |     |   |   | ion.** |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
| Bethesda, MD   |     |   |   |        |     |   |   |                        |
| 20892-7612     |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
|                |     |   |   | ## Opt |     | 1 |   |                        |
|                |     |   |   | ions:  |     | 1 |   |                        |
|                |     |   |   |        |     | . |   |                        |
|                |     |   |   | ##     |     |   |   |                        |
|                |     |   |   |        |     | * |   |                        |
|                |     |   |   | ## \[  |     | * |   |                        |
|                |     |   |   | X\] No |     | P |   |                        |
|                |     |   |   |        |     | e |   |                        |
|                |     |   |   | > **\[ |     | r |   |                        |
|                |     |   |   | > \]   |     | i |   |                        |
|                |     |   |   | >      |     | o |   |                        |
|                |     |   |   |  Yes** |     | d |   |                        |
|                |     |   |   | > (See |     |   |   |                        |
|                |     |   |   | > Part |     |   |   |                        |
|                |     |   |   | > IV,  |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   | S      |     | o |   |                        |
|                |     |   |   | ection |     | f |   |                        |
|                |     |   |   | L.)    |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     | P |   |                        |
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|                |     |   |   |        |     | m |   |                        |
|                |     |   |   |        |     | a |   |                        |
|                |     |   |   |        |     | n |   |                        |
|                |     |   |   |        |     | c |   |                        |
|                |     |   |   |        |     | e |   |                        |
|                |     |   |   |        |     | : |   |                        |
|                |     |   |   |        |     | * |   |                        |
|                |     |   |   |        |     | * |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     | 5 |   |                        |
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|                |     |   |   |        |     | r |   |                        |
|                |     |   |   |        |     | a |   |                        |
|                |     |   |   |        |     | b |   |                        |
|                |     |   |   |        |     | o |   |                        |
|                |     |   |   |        |     | u |   |                        |
|                |     |   |   |        |     | t |   |                        |
|                |     |   |   |        |     | M |   |                        |
|                |     |   |   |        |     | a |   |                        |
|                |     |   |   |        |     | y |   |                        |
|                |     |   |   |        |     | 3 |   |                        |
|                |     |   |   |        |     | , |   |                        |
|                |     |   |   |        |     | 2 |   |                        |
|                |     |   |   |        |     | 0 |   |                        |
|                |     |   |   |        |     | 0 |   |                        |
|                |     |   |   |        |     | 6 |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     | # |   |                        |
|                |     |   |   |        |     | # |   |                        |
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 12. Primary    |     |   | 1 |        |     |   |   | 14. **Protest          |
|     Point of   |     |   | 3 |        |     |   |   |     Officer:**         |
|     Contact:   |     |   | . |        |     |   |   |                        |
|                |     |   |   |        |     |   |   | Charles W. Grewe       |
| Name : Jill M. |     |   | * |        |     |   |   |                        |
| Johnson        |     |   | * |        |     |   |   | > Program Director,    |
|                |     |   | S |        |     |   |   | > CMP                  |
| **Phone:**     |     |   | e |        |     |   |   | >                      |
| 301-451-6396   |     |   | c |        |     |   |   | > Address (see Block   |
|                |     |   | o |        |     |   |   | > 9.)                  |
| **Fax:**       |     |   | n |        |     |   |   |                        |
| 301-402-0972   |     |   | d |        |     |   |   |                        |
|                |     |   | a |        |     |   |   |                        |
| **E-Mail:**    |     |   | r |        |     |   |   |                        |
| <jmjohnson@    |     |   | y |        |     |   |   |                        |
| niaid.nih.gov> |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
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|                |     |   | 7 |        |     |   |   |                        |
|                |     |   | 2 |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   | * |        |     |   |   |                        |
|                |     |   | * |        |     |   |   |                        |
|                |     |   | E |        |     |   |   |                        |
|                |     |   | - |        |     |   |   |                        |
|                |     |   | M |        |     |   |   |                        |
|                |     |   | a |        |     |   |   |                        |
|                |     |   | i |        |     |   |   |                        |
|                |     |   | l |        |     |   |   |                        |
|                |     |   | : |        |     |   |   |                        |
|                |     |   | * |        |     |   |   |                        |
|                |     |   | * |        |     |   |   |                        |
|                |     |   | < |        |     |   |   |                        |
|                |     |   | d |        |     |   |   |                        |
|                |     |   | h |        |     |   |   |                        |
|                |     |   | i |        |     |   |   |                        |
|                |     |   | r |        |     |   |   |                        |
|                |     |   | n |        |     |   |   |                        |
|                |     |   | @ |        |     |   |   |                        |
|                |     |   | n |        |     |   |   |                        |
|                |     |   | i |        |     |   |   |                        |
|                |     |   | a |        |     |   |   |                        |
|                |     |   | i |        |     |   |   |                        |
|                |     |   | d |        |     |   |   |                        |
|                |     |   | . |        |     |   |   |                        |
|                |     |   | n |        |     |   |   |                        |
|                |     |   | i |        |     |   |   |                        |
|                |     |   | h |        |     |   |   |                        |
|                |     |   | . |        |     |   |   |                        |
|                |     |   | g |        |     |   |   |                        |
|                |     |   | o |        |     |   |   |                        |
|                |     |   | v |        |     |   |   |                        |
|                |     |   | > |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 15. **COLLECT  |     |   |   |        |     |   |   |                        |
|     CALLS WILL |     |   |   |        |     |   |   |                        |
|     NOT BE     |     |   |   |        |     |   |   |                        |
|     ACCEPTED.  |     |   |   |        |     |   |   |                        |
|     FACSIMILE  |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|    SUBMISSIONS |     |   |   |        |     |   |   |                        |
|     ARE NOT    |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|  ACCEPTABLE.** |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 16. 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) |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
|                |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| DELIVERY       |     |   |   |        |     |   |   |                        |
| ADDRESS        |     |   |   |        |     |   |   |                        |
| INFORMATION    |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 17. Hand       |     |   |   |        | ### |   |   |                        |
|     Delivery   |     |   |   |        |  U. |   |   |                        |
|     or         |     |   |   |        | S.  |   |   |                        |
|     Overnight  |     |   |   |        | Pos |   |   |                        |
|     Service:   |     |   |   |        | tal |   |   |                        |
|                |     |   |   |        |  Se |   |   |                        |
| Jill M.        |     |   |   |        | rvi |   |   |                        |
| Johnson        |     |   |   |        | ce  |   |   |                        |
|                |     |   |   |        | or  |   |   |                        |
| Contract       |     |   |   |        | an  |   |   |                        |
| Management     |     |   |   |        | Exp |   |   |                        |
| Program, DEA   |     |   |   |        | res |   |   |                        |
|                |     |   |   |        | s D |   |   |                        |
| NIAID, NIH     |     |   |   |        | eli |   |   |                        |
|                |     |   |   |        | ver |   |   |                        |
| 6700-B         |     |   |   |        | y S |   |   |                        |
| Rockledge      |     |   |   |        | erv |   |   |                        |
| Drive, Room    |     |   |   |        | ice |   |   |                        |
| 3214           |     |   |   |        |     |   |   |                        |
|                |     |   |   |        | J   |   |   |                        |
| Bethesda, MD   |     |   |   |        | ill |   |   |                        |
| 20817          |     |   |   |        | M.  |   |   |                        |
|                |     |   |   |        | J   |   |   |                        |
|                |     |   |   |        | ohn |   |   |                        |
|                |     |   |   |        | son |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        | Co  |   |   |                        |
|                |     |   |   |        | ntr |   |   |                        |
|                |     |   |   |        | act |   |   |                        |
|                |     |   |   |        | M   |   |   |                        |
|                |     |   |   |        | ana |   |   |                        |
|                |     |   |   |        | gem |   |   |                        |
|                |     |   |   |        | ent |   |   |                        |
|                |     |   |   |        | Pr  |   |   |                        |
|                |     |   |   |        | ogr |   |   |                        |
|                |     |   |   |        | am, |   |   |                        |
|                |     |   |   |        | DEA |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|                |     |   |   |        | 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 |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+
| 18. 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 HHSAR |     |   |   |        |     |   |   |                        |
|     352.215-70 |     |   |   |        |     |   |   |                        |
|     entitled   |     |   |   |        |     |   |   |                        |
|     \"Late     |     |   |   |        |     |   |   |                        |
|     Proposals  |     |   |   |        |     |   |   |                        |
|     and        |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|    Revisions\" |     |   |   |        |     |   |   |                        |
|     located in |     |   |   |        |     |   |   |                        |
|     this       |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|  Solicitation. |     |   |   |        |     |   |   |                        |
|     FACSIMILE  |     |   |   |        |     |   |   |                        |
|     SUBMISSION |     |   |   |        |     |   |   |                        |
|     OF         |     |   |   |        |     |   |   |                        |
|     PROPOSALS  |     |   |   |        |     |   |   |                        |
|     IS NOT     |     |   |   |        |     |   |   |                        |
|                |     |   |   |        |     |   |   |                        |
|    ACCEPTABLE. |     |   |   |        |     |   |   |                        |
+----------------+-----+---+---+--------+-----+---+---+------------------------+

Updated thru FAC 2001-27 (3/28/2005)

**TABLE OF CONTENTS**

[**SECTION A \-- SOLICITATION/CONTRACT FORM COVER PAGE**](#A)

[**BROAD AGENCY ANNOUNCEMENT (BAA) DESCRIPTION**](#B)

[**BACKGROUND**](#C)

#### [**RESEARCH AND TECHNICAL OBJECTIVES**](#research-and-technical-objectives-1)

[**REPORTING REQUIREMENTS**](#E)

[**SECTIONS B -- H** \-- **UNIFORM CONTRACT FORMAT --
GENERAL**](#part-i---the-schedule)

[**SECTION I \-- GENERAL CLAUSES and ADDITIONAL CLAUSES / SUBSTITUTED
CLAUSES**](#part-ii-contract-clauses)

> **[ARTICLE I.1.](#L) General Clauses**

### [ARTICLE I.2](#M). Authorized Substitutions Of Clauses

### [ARTICLE I.3.](#M) Additional Contract Clauses

### [ARTICLE I.4.](#M) Additional Far Contract Clauses Included In Full Text

[**SECTION J \-- LIST OF
ATTACHMENTS**](#part-iii---list-of-documents-exhibits-and-other-attachments)

**\[includes proposal submission instructions and page limitations\]**

[**SECTION K -- REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF
OFFERORS OR QUOTERS
(NEGOTIATED)**](#part-iv-representations-and-instructions)

> **\[If you intend to submit a proposal, you MUST complete this
> document and submit it as part of your Business Proposal. If you are
> unable to access this document electronically, you may request a copy
> from the Contracting Officer identified on the cover page of this
> solicitation.\]**

[**SECTION L \-- INSTRUCTIONS, CONDITIONS AND NOTICES TO
OFFERORS**](#section-l---instructions-conditions-and-notices-to-offerors)

> [**I. General
> Information**](#section-l---instructions-conditions-and-notices-to-offerors)
>
> [**II. General Instructions**](#P)

[**III. Technical Proposal
Instructions**](#iii.-technical-proposal-instructions)

[**IV. Business Proposal
Instructions**](#iii.-technical-proposal-instructions)

[**SECTION M \-- EVALUATION FACTORS FOR
AWARD**](#section-m---evaluation-factors-for-award)

[**APPENDIX A - ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS**](#AppA)

[]{#B .anchor}BROAD AGENCY ANNOUNCEMENT (BAA) DESCRIPTION

You are invited to submit a proposal in accordance with the requirements
of this BROAD AGENCY ANNOUNCEMENT, NIH-NIAID-DAIDS-BAA-06-19, entitled
"HIV Vaccine Design and Development Teams." The Broad Agency
Announcement (BAA) is authorized by FAR 6.102 and further described in
FAR 35.016 as well as the NIH Manual Issuance 6035, Broad Agency
Announcements. A BAA is a general announcement of an agency's research
interest and constitutes a solicitation. The intent of a BAA is to
encourage the submission of creative and innovative approaches to
specific research areas identified by the Government.

A proposal submitted in response to this BAA must present a detailed
technical and cost proposal designed to meet the Research and Technical
Objectives described in this announcement. The proposal must be signed
by an official authorized to contractually commit the submitting
organization.

The Statement of Work, including the specific work requirements and
performance specifications, is developed and defined by the Offeror, not
the Government and negotiated and accepted by the NIAID. The Statement
of Work should not exceed ten (10) single spaced pages in length within
the technical proposal, which is limited to one hundred and fifty (150)
pages total (excluding all addenda and attachments)***.***

The Offeror's proposed Statement of Work should outline the steps to be
taken by the contractor during performance of the contract and should
begin as follows:

"Independently, and not as an agent of the Government, the Contractor
shall furnish all necessary services, qualified professional, technical,
and administrative personnel, material, equipment and facilities, not
otherwise provided by the Government under the terms of this contract,
as needed to perform the tasks set forth below. Specifically the
contractor shall:"

The opening paragraph should be followed by a full Statement of Work
describing each step the contractor shall perform **after the award of
the contract,** including: the tasks that will be performed to carry out
the research project; how these tasks will be accomplished; and the time
frame within which each task will be accomplished. Each step described
in the Statement of Work will begin with the words "The Contractor
shall...." Where appropriate, divide the Statement of Work into separate
tasks and subtasks. An outline format should be used. Briefly describe
the work related to each task and describe the tasks in the sequence in
which they will be carried out.

Proposals are [not]{.underline} evaluated against a specific Government
need, as in the case of a conventional Request for Proposal (RFP), since
they are not submitted in accordance with a common Statement of Work
issued by the Government. Instead, Research and Technical Objectives are
provided in the BAA that describes the research areas in which the
Government is interested. Proposals received as a result of the BAA are
evaluated by a Scientific Review Group (SRG) in accordance with the
Evaluation Criteria specified in the BAA.

There is no Source Selection Determination utilized under the BAA
process. All the competing proposals are ranked on the basis of their
respective relevance and scientific merit. The score assigned by the SRG
is considered the Order of Merit Ranking score. An Order of Merit
Ranking is established by the Contracting Officer in lieu of a
Competitive Range.

Negotiations are conducted with those Offerors in the Order of Merit
Ranking whose proposals would comprise the best group of contractors to
fill the NIAID's needs for this project based on technical merit,
scientific priority, programmatic balance and the availability of funds.
During negotiations, there is an opportunity to refine the proposed
Statement of Work in consultation with the Project Officer, including
the incorporation of the comments of the SRG, as appropriate. At the
conclusion of negotiations with the Offerors selected from the Order of
Merit Ranking, those Offerors are allowed the opportunity to submit a
Final Proposal Revision (FPR) to address weaknesses in the proposal,
based on questions identified by the SRG, and to revise costs as may be
appropriate.

It is anticipated that multiple awards will result from this
announcement and that these awards will be for multi-year,
cost-reimbursement, and completion type contracts. The NIAID anticipates
awarding approximately two (2) to four (4) contracts based on technical
merit, scientific priority, programmatic balance and the availability of
funds. Awards are expected to be made on or about May 2006. The NIAID
estimates that the average annual total cost (direct and indirect cost
combined) for these contracts will range from \$2.5 million to \$5
million per contract. However, it is anticipated that the total cost for
each award may vary substantially depending upon the scope of the
project and the technical objectives of the contract. The length of time
for which funding is requested should be consistent with the nature and
complexity of the proposed research. The maximum period of performance
is five (5) years.

The award document will be tailored to the final negotiations with the
selected Offeror(s) and modified as appropriate for the type of
contractor organization, cost and/or fee arrangements, and other
elements as negotiated prior to award.

[]{#C .anchor}BACKGROUND

The Division of Acquired Immune Deficiency Syndrome (DAIDS) of the
National Institute of Allergy and Infectious Diseases (NIAID), National
Institutes of Health (NIH), is committed to the development of
efficacious vaccines against HIV and AIDS for worldwide use in stemming
the AIDS epidemic. While industry, government, and academia have all
targeted considerable resources to this end over the past 20 years,
identification of an efficacious vaccine against HIV/AIDS has yet to be
accomplished. A wide assortment of candidate HIV-1 vaccines has already
been pursued and many have reached the stage of safety and
immunogenicity testing in humans. However, efficacy trials of only two
candidate HIV/AIDS preventive vaccines have been initiated. At this time
the highest priority of the DAIDS is the discovery, development, and
evaluation of HIV/AIDS vaccines. To augment the vaccine product
pipeline, DAIDS is seeking opportunities to advance vaccine concepts
toward the product stage via a focused, development-based approach.
Specifically, the goal of this solicitation is the development of new,
safe, and immunogenic vaccine candidates that merit further evaluation
in large human trials.

As part of the vaccine development effort, the concept of therapeutic
vaccination to induce or boost HIV-specific immunity in infected
individuals has received renewed interest. Research has demonstrated
that highly active antiretroviral therapy (HAART) results in only
partial immune reconstitution. In addition, the development of an
effective HIV therapeutic vaccine approach may improve the efficacy of
HAART. Complementary approaches to current antiretroviral therapy are
urgently needed for the following reasons: (1) the variety and severity
of life-threatening toxicities increase as patients live longer, (2)
adherence to complex, poorly tolerated, but life-long regimens becomes
increasingly difficult, (3) a cure for HIV infection remains elusive,
(4) multi-drug resistant HIV has become more frequent, and (5) an
inexpensive, "low maintenance" therapy that decreases the cost and
absolute dependence on antiretroviral drugs would be particularly useful
against the HIV epidemic in many resource-limited settings. Thus, this
solicitation also includes the design and development of vaccines to be
used as therapies.

The HIV Vaccine Design and Development Teams were first awarded in FY
2000 to establish consortia of scientists from industry and academia
with novel concepts as well as the product development experience to
advance vaccine concepts along a well-defined development path to a
vaccine product and into clinical testing. At the time of the first
competition it was limited to the development of preventive HIV/AIDS
vaccines. That competition attracted a high level of interest and
quality of Offerors, and four awards were made in June 2000. These
initial awards will expire in 2005. Each of these Contractors advanced
vaccine candidates into clinical trials by the fourth year of the award
period. The initiative was re-competed for award in FY2002. Again many
quality proposals were received; but available funds permitted only one
new award, in May 2002. The initiative was released again for award in
FY2003 and four new awards were made in September 2003. A new
competition for HIV Vaccine Teams contracts, which for the first time,
includes development of therapeutic AIDS vaccines, is currently
underway, and awards are anticipated to be made in Spring 2005. The
purpose of the present solicitation is to re-compete this research and
development program and award multiple new contracts for a term of a
maximum of five years to continue the development of additional novel
HIV vaccine concepts into products suitable for early-stage testing in
humans.

#### **RESEARCH AND TECHNICAL OBJECTIVES**

This section presents the research and technical objectives that the
Government seeks to achieve through this BAA. Proposals shall explain
how the Offeror will contribute to these overall objectives. [In
contracts awarded as a result of this BAA, the Statement of Work will be
the Statement of Work proposed by the Offeror and negotiated and
accepted by the Government]{.underline}.

**When preparing proposals in response to this BAA, Offerors must review
the "[Broad Agency Announcement (BAA) Description](#B)" included in this
RFP and the "[Evaluation Factors for
Award](#section-m---evaluation-factors-for-award)" included in Section M
of this BAA for additional information.**

This HIV Vaccine Design and Development Teams (herein referred to as HIV
Vaccine Teams) BAA solicitation seeks to fund consortia of scientists
with product development experience from industry and/or academia who
have (1) identified a promising vaccine candidate, and (2) devised a
comprehensive strategic research plan for targeted development of the
vaccine candidate into a product suitable for testing in humans. It is a
requirement of the contract that an HIV Vaccine Team advances the
vaccine concept(s) along a well-defined development path in a timely
manner to a vaccine product and into clinical testing by the beginning
of the fifth year of the award period. Offerors are strongly encouraged,
but not required, to conduct phase I/II trials in collaboration with an
NIAID/DAIDS-supported clinical trials network, such as the HIV/AIDS
Vaccine Trials Network (the HVTN; <http://www.hvtn.org/> ) for
preventive vaccines, the AIDS Clinical Trials Groups (ACTG;
<http://aactg.s-3.com/> ) for therapeutic vaccines, or the restructured
HIV/AIDS Clinical Trials Networks currently being solicited under NIAID
RFA-AI-05-001, Leadership for HIV/AIDS Clinical Trials Networks
(<http://grants2.nih.gov/grants/guide/rfa-files/RFA-AI-05-001.html>).

Proposals may be submitted in one or both of two areas:

**Part A: Preventive Vaccines**

**Part B: Therapeutic Vaccines**

Separate technical and cost proposals shall be submitted for Part A and
Part B.

**HIV Vaccine Team Requirements**

Each HIV Vaccine Team shall be required to perform the following
activities and provide the following resources:

1.  Develop a specific vaccine concept into a product capable of being
    tested in a clinical trial.

2.  Implement a comprehensive strategic research plan, with clearly
    defined goals and milestones, to advance the vaccine concept along a
    well-defined development path to a vaccine product suitable for
    testing in humans within the maximum 5-year period of contract
    award.

3.  Provide for the production of vaccine products under Good
    Manufacturing Practices (GMP).

4.  Provide a research, production and administrative team with the
    requisite expertise to perform the research and management
    activities of the contract.

5.  Provide the requisite infrastructure, facilities, and resources for
    performing all phases of the contract.

6.  Design and implement one or more clinical protocols, independently
    or in collaboration with a DAIDS-funded clinical trials network, by
    the beginning of the fifth year of the contract award period.

7.  Establish an independent External Advisory Committee to assist in
    the review of progress toward achieving defined goals and
    milestones.

8.  Conduct annual site visit reviews for NIAID contract and program
    staff and the External Advisory Committee.

[Additional information relevant to the Technical and Research
Objectives of the NIAID and the requirements of the contracts to be
awarded under this solicitation is provided below.]{.underline}

A. DEVELOP A SPECIFIC VACCINE CONCEPT.

For purposes of this BAA, a [vaccine product]{.underline} is defined to
be a material and its manner of administration that could reasonably
provide protection against HIV/AIDS. A [vaccine concept]{.underline}
includes both the antigens that the immune system encounters for the
purpose of inducing protection against HIV or progression to AIDS and
the method of delivery. Examples of antigens include virus-like
particles, pseudo-virions, proteins and peptides, either delivered
directly in the manner of a traditional vaccine composition or delivered
as part of a vector system and expressed in the recipient and processed
by the cellular machinery. These antigens may be delivered to the immune
system in a number of ways, including mucosally. The delivery of these
antigens to the immune system can be accomplished by DNA, vector
approaches, or direct administration. In these examples, the antigen is
the active part of the vaccine concept, while the DNA or vector(s) and
route(s)/mechanisms of administration are the method of delivery. It is
expected that the Offeror may propose to optimize the chosen delivery
system(s), as well as the antigenic components of the vaccine concept.
It is anticipated that optimization could include the development and
methods of adjuvanting/administration of vaccine candidates to enhance
the breadth, intensity, persistence and/or site (e.g. mucosal vs.
systemic) of the anti-HIV immune responses.

Concepts based on DNA plasmid, poxvirus-vectored and monomeric
gp120-based vaccines are not encouraged. If one of these concepts is
proposed, it must represent significant novelty compared to products
that have been or are currently being evaluated in clinical trials.

B. IMPLEMENT A COMPREHENSIVE STRATEGIC RESEARCH PLAN.

The strategic research plan shall include:

> 1\. Key development objectives and milestones for vaccine product
> development;
>
> 2\. A detailed work plan describing proposed time schedules for
> achieving contract objectives and
>
> milestones and maintaining quality control over the implementation and
> operation of the contract;
>
> 3\. For each milestone, a description of the process for making
> decisions to proceed or not proceed
>
> (go/no-go), i.e., specific [qualitative and quantitative]{.underline}
> criteria for advancement of vaccine molecules
>
> or constructs through each stage of preclinical product development,
> including decisions to proceed
>
> or not proceed vis a vis human safety, immunogenicity, and testing;

#### 4. A detailed product development plan, including a conceptual framework, design, iterative 

####  evaluations, the experimental approach and methodology proposed, and proposed assays to detect 

####  immune responses;

#### 5. Plans for quality control over the implementation and operation of the strategic plan; 

#### 6. Procedures to integrate adverse experimental or production results, or new scientific findings into 

####  the proposed goals and milestones;

> 7\. A Letter of Understanding (LOU) among collaborating parties to
> coordinate efforts to 1) protect
>
> intellectual property arising in performance of the contract, 2)
> facilitate the development for
>
> commercialization of the resulting HIV vaccine, and3) resolve disputes
> among collaborating parties
>
> should such disputes arise during performance of the contract;
>
> 8\. A plan for sharing data developed under the contract with the
> scientific research community; and
>
> 9\. A Technical Proposal Cost Summary.

C. PROVIDE FOR THE PRODUCTION OF VACCINE PRODUCTS UNDER GMP.

The HIV Vaccine Team shall produce vaccine products under Good
Manufacturing Practices (GMP, as defined in the U.S. Code of Federal
Regulations -- 21 CFR §211) (including the use of subcontractors where
appropriate) and for obtaining the necessary Government and
ethics-related approvals to proceed.

D. PROVIDE A RESEARCH, PRODUCTION AND ADMINISTRATIVE TEAM.

The HIV Vaccine Team shall include all expertise needed for the
development, optimization, pre-clinical and clinical testing, and
production of an HIV/AIDS vaccine based on the vaccine concept selected.
An HIV Vaccine Team must include strong scientific leadership, as well
as significant experience in the management, design, and execution of
large multi-faceted research and development programs focused on product
development, manufacture, and testing.

The Government is aware that no single organization or institution may
have the expertise and facilities required to perform all requirements
set forth in this BAA. Therefore, it may be necessary for the Contractor
to subcontract a portion of the work. Since DAIDS is seeking to support
the best possible HIV Vaccine Teams, the prime Contractor is not limited
to being a domestic institution or organization. In addition,
subcontracting to foreign organizations/institutions is permitted.

E. PROVIDE THE REQUISITE INFRASTRUCTURE, FACILITIES, AND RESOURCES FOR
PERFORMING ALL PHASES OF THE CONTRACT.

This shall include the infrastructure, facilities, and resources for
production of an optimized vaccine under GMP conditions, performance of
IND-enabling preclinical animal studies under Good Laboratory Practices
(GLP; as defined in 21 CFR §58), and performance of clinical trials in
humans under Good Clinical Practices (GCP; 21 CFR §312 and ICH
Guidelines document E6) if clinical trials will be performed by the
Contractor rather than by a DAIDS-supported clinical trials network.

F. DESIGN AND IMPLEMENT ONE OR MORE CLINICAL PROTOCOLS.

**Requirement for the Conduct of Phase I/II Clinical Trials:** As an
essential element of vaccine development and refinement, the design and
conduct of Phase I or I/II human clinical trials will be required under
this BAA. It is expected that vaccine product design and development are
sufficiently advanced to plan for the start of at least one clinical
trial of the newly developed candidate vaccine product by the beginning
of project year five. Candidate vaccines shall not advance to GMP
production for clinical trials until they meet the negotiated decision
criteria as to when the vaccine concept is sufficiently advanced for
human studies. NEITHER PHASE III CLINICAL TRIALS NOR PRODUCTION OF
VACCINE PRODUCT FOR PHASE III CLINICAL TRIALS WILL BE FUNDED UNDER THIS
SOLICITATION.

**Independent Clinical Trial Protocol Development and Implementation:**
Contractors who elect to perform clinical trials independently, rather
than through a DAIDS-supported clinical trials network, shall be
required to: (1) comply with NIAID Clinical Terms of Award
(<http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf>); (2) submit clinical
trial protocols to the appropriate NIAID review committee for approval;
(3) obtain final approval of protocols to be undertaken independently
prior to FDA IND submission and participant enrollment. In addition,
Contractors performing clinical trials independently shall be required
to provide some portion of the clinical trials data through the DAIDS
Enterprise System (DAIDS-ES) which includes separate systems for adverse
event reporting and protocol management. Contractors shall be required
to interface, integrate, or adapt their information system(s) to
interact with these and future components of the DAIDS-ES as necessary.
To achieve compatibility, DAIDS and its contractors will implement
applications or data exchange mechanisms using platform technology
standards such as: Web Services, eXtensible Markup Language (XML), XML
Schema Definitions (XSD), RDBMS, .NET Framework, UDDI, IIS, Internet
Explorer, Service Oriented Architecture (SOA), Design Patterns,
Frameworks and Templates as defined by the DAIDS-ES. DAIDS Contractors
shall adhere to these guidelines and standards on a continual basis.

G. ESTABLISH AN INDEPENDENT EXTERNAL ADVISORY COMMITTEE.

The Contract shall be subject to periodic review of performance by an
External Advisory Committee, as described under the "Reporting
Requirements" section of this BAA. Each HIV Vaccine Team will have an
independent External Advisory Committee. The membership of the External
Advisory Committee will be jointly proposed and agreed to by the
Contractor and NIAID after the award is made.

H. CONDUCT ANNUAL SITE VISIT REVIEWS.

At the middle (6 month mark) of each contract year, the Contractor shall
host a site visit review for NIAID contract and program staff and the
External Advisory Committee. The Contractor\'s Principal Investigator
(P.I.) and all co-investigators shall attend this meeting. An update and
summary of results generated on each sub-project shall be presented by
the co-investigator and/or other pertinent staff. These presentations
shall include summaries of all goals or milestones reached during the
review period, a description of all problems encountered that will
impact the achievement of particular goals and milestones as outlined in
the Contractor's strategic research plan, and proposed approaches to
overcoming problems encountered. The P.I., co-investigator(s) and staff
representing each sub-project shall describe goals and milestones and
development objectives for the coming year. Additionally, application of
the policies and procedures for monitoring the direction of specific
projects shall be presented. For Contractors with foreign subcontracts,
this annual site visit will also report details about approvals for
manufacturing, preclinical or clinical testing that have been obtained
from both the U.S. and foreign governments.

[]{#E .anchor}**REPORTING REQUIREMENTS**

The Contractor is required to formally report progress once each year
through submission of a written Technical Report, and once each year by
holding a formal Site Visit review to be attended by appropriate NIAID
contract staff and program officials, and the External Advisory
Committee of the HIV Vaccine Team. The Contractor is also required to
submit Goals and Milestones Achievement Reports during the contract
period at specified times. Distribution of written reports is listed
below in F.

A.  Within two (2) weeks after contract award, the Contractor shall
    submit a contract-specific information security plan for review and
    approval by NIAID.

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A.  [Goals and Milestones Achievement Reports.]{.underline} Management
    milestones, and their expected accomplishment dates, will be
    re-established yearly by discussion between the DAIDS Project
    Officer and the PI of each HIV Vaccine Team to facilitate monitoring
    contract progress; these milestones will not be written into the
    Contract document. The Contractor shall submit Goals and Milestones
    Achievement Reports for these milestones [during the contract period
    as specified by consultation with the DAIDS Project
    Officer]{.underline}. For for-profit Contractors, since the payment
    of contract fee portions will be tied to the accomplishment of
    predetermined goals and milestones specified in the Contract, the
    Contractor shall submit similar Goals and Milestones Achievement
    Reports for fee-attached milestones prior to invoicing for fee
    payments. The original hard copy of each milestone achievement
    report shall be submitted to the NIAID Contracting Officer, and
    two (2) copies (one hard copy and a copy in a digital medium) to the
    DAIDS Project Officer. Each report must consist of:

1\. A cover page identifying the Contract, Contractor, addressee, date
of submission, and milestone

2\. Two clearly marked sections:

> Section A -- An introduction describing the goal or milestone in
> detail
>
> Section B -- A complete description of the results. The description
> shall include pertinent data and/or figures in sufficient detail to
> explain any significant results from analysis and scientific
> evaluation of data accumulated to date under the goal or milestone.
> When appropriate, this report should detail specific requests and
> approvals for the conduct of human trials.

B.  [Clinical Trial Protocols and Data for Contractors who elect to
    perform clinical studies independently rather than through an
    NIAID/DAIDS-supported clinical trials network]{.underline}

> [Clinical Trial Protocol(s).]{.underline} NIAID has a responsibility
> to ensure that mechanisms and procedures are in place to protect the
> safety of participants in NIAID-supported clinical trials. Therefore,
> as described in the NIAID Clinical Terms of Award
> (<http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf>), the Contractors
> performing any clinical studies independently (i.e., not within a
> DAIDS-supported clinical trial network) with HIV Vaccine Team contract
> funds shall develop a protocol for each clinical trial. Those HIV
> Vaccine Teams developing a preventive vaccine shall submit all
> protocols for approval by the NIAID Prevention Science Review
> Committee (PSRC). Those HIV Vaccine Teams developing a therapeutic
> vaccine shall submit all protocols for review and approval by the
> NIAID Clinical Science Review Committee (CSRC). Protocols must
> include: (1) a description of the product; (2) the results of
> preclinical (IND-enabling) toxicology studies; (3) a description of
> the trial design including definition of objectives, approaches, and
> procedures for implementation; (4) the plan for participant
> recruitment, retention and follow-up; (5) the plan for data
> collection, quality control and management; (6) the data and safety
> monitoring plan; (7) the proposed approach to the analysis and
> interpretation of study data; (8) plans for publication of results;
> and (9) a sample Informed Consent. Final approval of the protocol must
> take place prior to FDA IND submission and participant enrollment.
> \[For trials to be conducted through DAIDS-sponsored Clinical Trial
> Networks, the protocol must be developed in conjunction with the
> appropriate network and will be submitted by the network.\].
>
> [DAIDS-Enterprise System (DAIDS-ES) Reporting.]{.underline} HIV
> Vaccine Teams Contractors who elect to perform clinical studies
> independently rather than through an NIAID/DAIDS-supported clinical
> trials network will be required to provide clinical trials data
> through the DAIDS-ES as the appropriate components of the system
> become operational. Reporting of adverse events will be done through
> the DAIDS Expedited Adverse Event Reporting System. Reporting on
> protocol development, registration, conduct, accrual, oversight, site
> monitoring, tracking and clinical trial closeout will be done through
> the DAIDS Protocol Management System. Details on interfacing with
> these information management systems will be provided as the systems
> become operational.
>
> C. [Annual Technical Report.]{.underline} By the fifteenth working day
> of the twelfth month of each contract year, the Contractor shall
> submit an Annual Technical Report as described below. The original
> hard copy shall be submitted to the NIAID Contracting Officer, and two
> (2) copies (one hard copy and one copy in a digital medium) to the
> DAIDS Project Officer. The report should be factual and concise and
> consist of the following:
>
> 1\. A cover page identifying the Contract, Contractor, addressee, and
> date of submission
>
> 2\. Four clearly marked sections:
>
> Section A -- An introduction covering the purpose and scope of the
> contract effort
>
> Section B -- A description of overall progress plus a separate
> description for each task or other logical segment of work on which
> effort was expended during the reporting period. The description shall
> include pertinent data and/or figures in sufficient detail to explain
> any significant results from analysis and scientific evaluation of
> data accumulated to date under the project. Special emphasis shall be
> placed on goals or milestones that were reached, or problems that were
> encountered that prevented reaching a scheduled goal or milestone
> during the reporting period and how those problems were/will be
> addressed. In addition, requests and approvals to conduct human
> trials, and Inclusion Enrollment Reports, when appropriate, shall be
> included.
>
> Section C -- A summary of the proposed goals and milestones for the
> duration of the Contract, including any proposed revisions based on
> results generated to date. For those goals and milestones expected to
> be completed during the next 12 months, provide a detailed description
> of the criteria to be used to define their accomplishment.
>
> Section D -- Human Subject Enrollment Reports for non-NIAID network
> clinical studies or trials underway. To aid NIAID in fulfilling
> reporting requirements, the Contractor must complete the Inclusion
> Enrollment Report showing cumulative accrual information for each
> active clinical study or clinical trial protocol. The format for the
> Inclusion Enrollment Report may be found at
> <http://grants.nih.gov/grants/funding/phs398/enrollmentreport.pdf> .
>
> D. [Annual Site Visit Review Report]{.underline}. A report of the
> annual site visit review shall be prepared by the Contractor and
> submitted to the DAIDS Project Officer (in hard copy and digital
> medium) and the NIAID Contracting Officer (original hard copy) within
> three weeks following the date of the site visit. This report shall
> include the slide presentations made at the review as well as
> summaries of all discussions about modifying goals or milestones, and
> discussions of approaches to overcoming problems encountered.

E.  [Final Technical Report]{.underline}. The Contractor shall submit
    the Final Technical Report, two (2) copies (one hard copy and one
    copy in a digital medium) to the DAIDS Project Officer, and the
    original hard copy to the NIAID Contracting Officer by the
    completion date of the Contract. The report should consist of the
    following:

> 1\. A cover page identifying the Contract, Contractor, addressee, and
> date of submission
>
> 2\. An introduction covering the purpose and scope of the contract
> effort including a short summary of salient results achieved during
> the performance of the contract
>
> 3\. A detailed summary of the results of the entire contract work for
> the complete performance period including the specifications of the
> optimized AIDS vaccine product developed during the course of the
> contract. These specifications shall include: (1) the identity of the
> vaccine strain or strains in the final product, (2) a detailed
> description of the manipulations used in the vaccine design, (3) a
> detailed description of all processes used to expand, attenuate,
> inactivate, or purify the final vaccine product, (4) a detailed
> description of any adjuvants or other potentiating agents used in the
> delivery of the final optimized product, (5) a detailed description of
> the suggested immunization schedule to be used for optimal reactivity
> in humans, (6) evidence that the vaccine product can be manufactured
> under GMP conditions for use in human vaccine trials, (7) a list of
> all patent filings that have resulted from this Contract, and (8) data
> from clinical trials using the vaccine. In addition, the Contractor
> shall indicate whether INDs were filed in relation to vaccine products
> developed during the course of the Contract, and provide a description
> of the IND and the results of the filings. For Contractors with
> foreign subcontracts, this report shall include details concerning
> approvals for manufacturing or testing that have been obtained for or
> by the foreign subcontractors.

F.  Report Distribution

+----------------------+--------------------+-------------------------+
| Type of Report       | No. of Copies      | Due Date                |
+----------------------+--------------------+-------------------------+
| Information Security | Original --NIAID   | Within two (2) weeks of |
| Plan                 | CO                 | contract award.         |
|                      |                    |                         |
|                      | 1 hard copy/1      |                         |
|                      | electronic copy    |                         |
|                      | --DAIDS PO         |                         |
+----------------------+--------------------+-------------------------+
| Goals and Milestones | Original --NIAID   | Specific dates will be  |
| Achievement Reports  | CO                 | negotiated with the     |
|                      |                    | DAIDS PO                |
|                      | 1 hard copy/1      |                         |
|                      | electronic copy    |                         |
|                      | --DAIDS PO         |                         |
+----------------------+--------------------+-------------------------+
| Annual Technical     | Original -- NIAID  | Due on/before the 15th  |
| Report               | CO                 | working day after the   |
|                      |                    | anniversary date of the |
|                      | 1 hard copy/1      | Contract. Not due when  |
|                      | electronic copy    | the Final Report is     |
|                      | --DAIDS PO         | due.                    |
+----------------------+--------------------+-------------------------+
| Annual Site Visit    | Original --NIAID   | Due within three weeks  |
| Review Report        | CO                 | following the date of   |
|                      |                    | the meeting.            |
|                      | 1 hard copy/1      |                         |
|                      | electronic copy    |                         |
|                      | --DAIDS PO         |                         |
+----------------------+--------------------+-------------------------+
| Final Technical      | Original --NIAID   | Due on/before the       |
| Report               | CO                 | completion date of the  |
|                      |                    | Contract.               |
|                      | 1 hard copy/1      |                         |
|                      | electronic copy    |                         |
|                      | --DAIDS PO         |                         |
+----------------------+--------------------+-------------------------+

G.  [Deliverables]{.underline}. The Contractor shall submit samples of
    candidate HIV/AIDS vaccines, as well as selected plasma/cell samples
    from preclinical animal immunogenicity studies of candidate HIV/AIDS
    vaccines, prior to GMP manufacture for testing in DAIDS-sponsored
    core laboratories. Contractors may also be asked to provide samples
    of GMP vaccine product for similar analyses in conjunction with
    clinical trials.

H.  If the Contractor is unable to deliver the reports specified
    hereunder within the established due dates because of unforeseen
    difficulties, notwithstanding the exercise of good faith and
    diligent efforts in performance of the work, the Contractor shall
    give the Contracting Officer immediate written notice of anticipated
    delays with reasons therefore. A new delivery date must be
    established.

I.  [Other Deliverables.]{.underline} Clinical Trial Protocols and
    DAIDS-Enterprise System (DAIDS-ES) Reporting.

J.  [Addressees]{.underline}:

> DAIDS Project Officer (Part A): National Institutes of Health, DHHS
>
> National Institute of Allergy and Infectious Diseases
>
> Division of AIDS, VPRP
>
> 6700-B Rockledge Drive, Room 5146, MSC 7628
>
> Bethesda, MD 20892-7628
>
> DAIDS Project Officer (Part B): National Institutes of Health, DHHS
>
> National Institute of Allergy and Infectious Diseases
>
> Division of AIDS, BSP
>
> 6700-B Rockledge Drive, Room 4100, MSC 7626
>
> Bethesda, MD 20892-7626
>
> NIAID Contracting Officer: National Institutes of Health, DHHS
>
> National Institute of Allergy and Infectious Diseases
>
> Division of Extramural Activities, CMP
>
> 6700-B Rockledge Drive, Room 3214, MSC 7612
>
> Bethesda, MD 20892-7612

# 

# 

# 

# 

# 

# 

# 

# 

# 

# PART I - THE SCHEDULE

## SECTIONS B - H \-- UNIFORM CONTRACT FORMAT - GENERAL

A Sample Uniform Contract Format may be found at the following website:

<http://rcb.cancer.gov/rcb-internet/wkf/sample-contract.htm>

# PART II -- CONTRACT CLAUSES

## SECTION I - CONTRACT CLAUSES

THE FOLLOWING PAGES CONTAIN A LISTING(S) OF GENERAL CLAUSES WHICH WILL
BE APPLICABLE TO MOST CONTRACTS RESULTING FROM THIS BAA. HOWEVER, THE
ORGANIZATIONAL STRUCTURE OF THE SUCCESSFUL OFFEROR(S) WILL DETERMINE THE
SPECIFIC GENERAL CLAUSES LISTING TO BE CONTAINED IN THE CONTRACT(S)
AWARDED FROM THIS BAA.

[]{#L .anchor}**ARTICLE I.1. GENERAL CLAUSES**

The complete listing of these clauses may be accessed at:
<http://rcb.cancer.gov/rcb-internet/appl/general-clauses/clauses.jsp>

The following General Clause Listings will be applicable to most
contracts resulting from this BAA. 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 BAA:

**General Clauses for a Cost-Reimbursement Research and Development
Contract**

[]{#M .anchor}**ARTICLE I.2. AUTHORIZED SUBSTITUTIONS OF CLAUSES**

ITEM 9: Alternate II (OCTOBER 2001) of FAR Clause 52.219-9, Small
Business Subcontracting Plan (JANUARY 2002) is added.

No additional or supplemental Authorized Substitutions of Clauses are
applicable to this solicitation. See **I.2 Authorized Substitutions of
Clauses** of SECTION I at
<http://rcb.cancer.gov/rcb-internet/wkf/sectioni.pdf> for the general
listing of Authorized Substitutions of Clauses.

### ARTICLE I.3. ADDITIONAL CONTRACT CLAUSES

ITEM 51: FAR Clause 52.227-16, Additional Data Requirements (JUNE 1987),
is applicable to this solicitation.

No additional or supplemental Additional Contract Clauses are applicable
to this solicitation. See **I.3 Additional Contract Clauses of** SECTION
I at <http://rcb.cancer.gov/rcb-internet/wkf/sectioni.pdf> for the
general listing of Additional Contract Clauses.

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

No additional or supplemental Additional FAR Contract Clauses Included
in Full Text are applicable to this solicitation. See **I.4. Additional
FAR Contract Clauses Included in Full Text** of SECTION I at
<http://rcb.cancer.gov/rcb-internet/wkf/sectioni.pdf> for the general
listing of Additional FAR Contract Clauses Included in Full Text.

# PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

## SECTION J - LIST OF ATTACHMENTS

The following Attachments are provided in full text with this
Solicitation:

[PACKAGING AND DELIVERY OF
PROPOSALS](http://www.niaid.nih.gov/contract/eproposal.htm):
(http://www.niaid.nih.gov/contract/eproposal.htm)

[PROPOSAL INTENT RESPONSE
SHEET](http://www.niaid.nih.gov/contract/forms/form1.pdf) SUBMIT ON OR
BEFORE: September 6, 2005 (Attached to this listing)

> \[NOTE: Your attention is directed to the \"Proposal Intent Response
> Sheet\". If you intend to submit a proposal, you should complete this
> form and return it to this office via fax or e-mail on or before the
> date identified above.
>
> **BAA FORMS AND ATTACHMENTS:**
>
> THE BAA FORMS/ATTACHMENTS LISTED BELOW ARE AVAILABLE IN A VARIETY OF
> FORMATS AND MAY BE VIEWED OR DOWNLOADED DIRECTLY FROM THIS SITE:

<http://www.niaid.nih.gov/contract/forms.htm>

APPLICABLE TO TECHNICAL PROPOSAL (INCLUDE THESE DOCUMENTS/FORMS WITH
YOUR TECHNICAL PROPOSAL):

### Technical Proposal Cover Sheet {#technical-proposal-cover-sheet .Normal-Bold-(bullet)}

### NIH-1688-1, Project Objectives {#nih-1688-1-project-objectives .Normal-Bold-(bullet)}

### Technical Proposal Cost Information {#technical-proposal-cost-information .Normal-Bold-(bullet)}

### Summary of Related Activities {#summary-of-related-activities .Normal-Bold-(bullet)}

### Optional Form 310, Protection of Human Subjects Assurance Identification/Certification/Declaration \[When applicable, all institutions must have the form reviewed and approved by their Institutional Review Committee.\] {#optional-form-310-protection-of-human-subjects-assurance-identificationcertificationdeclaration-when-applicable-all-institutions-must-have-the-form-reviewed-and-approved-by-their-institutional-review-committee. .Normal-Bold-(bullet)}

### Government Notice for Handling Proposals {#government-notice-for-handling-proposals .Normal-Bold-(bullet)}

### Targeted/Planned Enrollment Table {#targetedplanned-enrollment-table .Normal-Bold-(bullet)}

### Annual Technical Progress Report Format for Each Study {#annual-technical-progress-report-format-for-each-study .Normal-Bold-(bullet)}

APPLICABLE TO BUSINESS PROPOSAL (INCLUDE WITH YOUR BUSINESS PROPOSAL):

### NIH-2043, Proposal Summary and Data Record {#nih-2043-proposal-summary-and-data-record .Normal-Bold-(bullet)}

### Small Business Subcontracting Plan Format {#small-business-subcontracting-plan-format .Normal-Bold-(bullet)}

### Breakdown of Proposed Estimated Cost (plus fee) and Labor Hours {#breakdown-of-proposed-estimated-cost-plus-fee-and-labor-hours .Normal-Bold-(bullet)}

### Offeror's Points of Contact  {#offerors-points-of-contact .Normal-Bold-(bullet)}

### Certificate of Current Cost and Pricing Data {#certificate-of-current-cost-and-pricing-data .Normal-Bold-(bullet)}

TO BECOME CONTRACT ATTACHMENTS (INFORMATION ONLY):

-   **Inclusion Enrollment Report**

### NIH(RC)-4: Invoice/Financing Request and Contract Financial Reporting Instructions for NIH Cost-Reimbursement Type Contracts {#nihrc-4-invoicefinancing-request-and-contract-financial-reporting-instructions-for-nih-cost-reimbursement-type-contracts .Normal-Bold-(bullet)}

### NIH(RC)-7: Procurement of Certain Equipment, (OMB Bulletin 81-16) {#nihrc-7-procurement-of-certain-equipment-omb-bulletin-81-16 .Normal-Bold-(bullet)}

### NIH(RC)-11: Research Patient Care Costs {#nihrc-11-research-patient-care-costs .Normal-Bold-(bullet)}

### Safety and Health, HHSAR Clause 352.223-70 {#safety-and-health-hhsar-clause-352.223-70 .Normal-Bold-(bullet)}

### Privacy Act System of Records {#privacy-act-system-of-records .Normal-Bold-(bullet)}

### Report of Government Owned, Contractor Held Property {#report-of-government-owned-contractor-held-property .Normal-Bold-(bullet)}

### Disclosure of Lobbying Activities, OMB Form LLL  {#disclosure-of-lobbying-activities-omb-form-lll .Normal-Bold-(bullet)}

# PART IV -- REPRESENTATIONS AND INSTRUCTIONS

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

Representations, Certifications, and Other Statements of Offerors or
Quoters (Negotiated).

1.  REPRESENTATIONS AND CERTIFICATIONS

The Representations and Certifications required by this particular
acquisition 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 COMPLETE THE
REPRESENTATIONS AND CERTIFICATIONS AS PART OF YOUR ORIGINAL BUSINESS
PROPOSAL. ADDITIONALLY, REPRESENTATIONS AND CERTIFICATIONS MUST ALSO BE
COMPLETED FOR ANY PROPOSED SUBCONTRACTORS.

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

**The following information is specific to this solicitation and is
provided to supplement and/or complete the associated ITEMS presented at
the SECTION L website at
<http://rcb.cancer.gov/rcb-internet/wkf/sectionl.pdf>**

**I. GENERAL INFORMATION**

ITEM 2: Alternate I, of FAR Clause 52.215-1, INSTRUCTIONS TO
OFFERORS-COMPETITIVE ACQUISTION, is applicable to this solicitation.

ITEM 5: JUST IN TIME PROCEDURES

> The submission of an acceptable subcontracting plan is required.
>
> If a subcontracting plan is required:
>
> \[X\] It will be requested from only those offerors in the order of
> merit ranking.
>
> \[ \] It will be requested from only the apparent successful offeror.
>
> \[ \] It WILL NOT be submitted in accordance with the JUST IN TIME
> procedures, therefore, a subcontracting plan will be requested from
> all offerors at the time of original submission in accordance with
> Alternate II, of FAR Clause 52.219-9, SMALL BUSINESS SUBCONTRACTING
> PLAN which is incorporated by reference.

ITEM 9: 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 BAA), specifically in completing
the provision entitled, SMALL BUSINESS PROGRAM REPRESENTATION, FAR
Clause 52.219-1.

\(1\) The NAICS Code is 541710.

\(2\) The small business size standard is 500 employees.

ITEM 10: THIS REQUIREMENT IS NOT SET ASIDE FOR SMALL BUSINESS, is
applicable to this solicitation.

ITEM 11: 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 or about May 3, 2006.

It is anticipated that the awards from this solicitation will be
multiple-year cost reimbursement type completion contracts with a period
of performance of 5 years, and that incremental funding will be used
\[see Section L, PART IV - Business Proposal Instructions\].

ITEM 13: ESTIMATE OF EFFORT

It is expected that a completion type contract will be awarded as a
result of this BAA. To assist you in the preparation of your proposal,
the Government considers the effort to be approximately 13.3 FTE's using
1880 hours as a base. This information is furnished for the offeror\'s
information only and is not to be considered restrictive for proposal
purposes.

ITEM 16: 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 is 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.

ITEM 20: LATE PROPOSALS AND REVISIONS, HHSAR 352.215-70, is applicable
to this solicitation.

[]{#P .anchor}**II. GENERAL INSTRUCTIONS**

ITEM 23: Potential Award Without Discussions, is applicable to this
solicitation.

ITEM 26: Care of Live Vertebrate Animals, is applicable to this
solicitation.

ITEM 29: Sharing Research Data, is applicable to this solicitation.

ITEM 33: Small Business Subcontracting Plan, is applicable to this
solicitation and the following information is provided to supplement
this item to assist in proposal preparation:

> The anticipated minimum subcontracting goals for this BAA 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 3% for Service-Disabled Veteran-Owned
> Small Business.

ITEM 35: Extent of Small Disadvantaged Business Participation, is
applicable to this solicitation.

ITEM 36: Salary Rate Limitation in Fiscal Year 2005, is applicable to
this solicitation.

ITEM 39: Past Performance Information

\(a\) Offerors shall submit the following information as part of their
business proposal.

> A list of the last three (3) contracts completed during the past three
> (3) years and the last three (3) contracts awarded currently in
> process that are similar in nature to the solicitation workscope.
>
> 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\. Contract Officer's Name and Telephone Number
>
> 7\. Program Manager's Name and Telephone Number
>
> 8\. Standard Industrial Code

0.  

> 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 subcontracts 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 and 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.

ITEM 48: Prohibition on Contractor Involvement with Terrorist
Activities, is applicable to this solicitation.

ITEM 49: Solicitation Provisions Incorporated by Reference: The
following provisions are applicable to this solicitation.

Facilities Capital Cost of Money, FAR Clause 52.215-16, (October 1997).

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

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

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

### III. TECHNICAL PROPOSAL INSTRUCTIONS

ITEM 51: Project Objectives, NIH-1688-1, is applicable to this
solicitation.

### IV. BUSINESS PROPOSAL INSTRUCTIONS

ITEM 59: Cost and Pricing Data is applicable to this solicitation.

> Subparagraph 3. Formats for Submission of Line Item Summaries:
>
> The format specified in SECTION L at
> [**http://rcb.cancer.gov/rcb-internet/wkf/sectionl.pdf**](http://rcb.cancer.gov/rcb-internet/wkf/sectionl.pdf)
> is applicable to this solicitation.

ITEM 60: Requirements for Cost or Pricing Data or Information Other than
Cost and Pricing Data \[FAR Clause 52.215-20 (October 1997)\], is
applicable to this solicitation.

ITEM 65: Incremental Funding, is applicable to this solicitation.

## SECTION M - EVALUATION FACTORS FOR AWARD

**I. GENERAL**

Selection of an Offeror for contract award will be based on an
evaluation of proposals against five factors. The factors in order of
importance are: technical, programmatic balance, cost, past performance
and Small and Disadvantaged Business (SDB) participation. Although
technical factors are of paramount consideration in the award of the
contract, programmatic balance, cost/price, past performance and SDB
participation are also important to the overall contract award decision.
Because of the uncertainty in candidate HIV/AIDS vaccine efficacy, the
need to maintain a balanced portfolio of different vaccine modalities in
order to meet NIAID's commitment to HIV/AIDS vaccine development is
critical and will be considered in making awards. Overlap with funding
made through other DAIDS funding mechanisms will also be considered as a
factor in achieving programmatic balance. **Thus the Government reserves
the right to make awards to cover significantly different vaccine
concepts as a mechanism to achieve programmatic balance even if this
means not funding technically meritorious Proposals for what are deemed
to be very similar or otherwise well funded approaches.** All evaluation
factors other than cost or price, when combined, are significantly more
important than cost or price. In any case, the Government reserves the
right to make awards to those Offerors whose proposals provide the best
overall value to the Government.

All technical proposals will undergo evaluation by a peer review group
also known as a Scientific Review Group (SRG). The evaluation will be
based on the demonstrated capabilities of the Offerors in relation to
the needs of the project as set forth in the BAA. The merits of each
proposal will be evaluated carefully. Each proposal must document the
feasibility of successful implementation of the requirements and
objectives of the BAA. Offerors must submit information sufficient to
evaluate their proposals based on the detailed criteria listed below.

The final stage of the evaluation is the establishment of an Order of
Merit Ranking in which all competing proposals are ranked on the basis
of their respective relevance and scientific merit evaluations. Final
selection of awards will depend upon the factors set forth above and are
contingent upon successful negotiations as determined by NIAID at the
time of award selection.

The estimated cost of an offer must be reasonable for the tasks to be
performed, and, in accordance with FAR 15.305, will be subject to a cost
realism analysis by the Government.

Offerors must demonstrate in their proposals that they have the
necessary expertise and capabilities for conducting the research as
requested by this solicitation. Each proposal must document the
feasibility of successful implementation of the requirements of the BAA.

Offerors determined, upon completion of the Scientific/Technical Peer
Review, to be in the Order of Merit Ranking may be subject to auditing
of their GMP, GLP, and QC/QA capabilities. If audits are performed
during the negotiations, the results of these audits will be a factor in
final selection for award of Contract.

If an Offeror has submitted proposals for Parts A and B, each will be
reviewed and evaluated separately. For the purposes of review, Parts A
and B must be individually responsive and will be reviewed separately
against the evaluation criteria. A separate Order of Merit Ranking will
be established for Part A and for Part B, and ranking by vaccine
modality may differ between Part A and Part B.

II. HUMAN SUBJECT EVALUATION

> This research project involves human subjects. NIH Policy requires:

a.  **Protection of Human Subjects from Research Risks**

> The offeror's proposal must address the involvement of human subjects
> and protections from research risk relating to their participation, or
> provide sufficient information on the research subjects to allow a
> determination by Institute that a designated exemption is appropriate.
>
> If you claim that this research should be considered exempt from
> coverage by the Federal Regulations at 45 CFR 46, the proposal should
> address why you believe it is exempt, and under which exemption it
> applies.
>
> The reviewers will evaluate the proposal with regard to four issues:
> Risks to Human Subjects, Adequacy of Protection Against Risks,
> Potential Benefits of the Proposed Research to the Subjects and
> Others, and Importance of the Knowledge to be Gained. See Section L
> for a complete discussion of what is required to be addressed for each
> of these issues. Based on the response to this criterion, this section
> of the proposal may be rated "unacceptable" (i.e., concerns are
> identified as to the protections described against risk to human
> subjects or no discussion is found regarding protections against risk
> to human subjects) or "acceptable". If the reviewers find that this
> portion of the proposal is "unacceptable" they will provide a
> narrative supporting their finding.
>
> If 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 address the concerns raised by the
> reviewers. You will be able to further discuss and/or clarify your
> position until submission of your Final Proposal Submission (FPR).
> Once discussions are closed with the submission of your FPR, if your
> proposed plan for the protection of human subjects from research risks
> is still found to be unacceptable, then your proposal may not be
> considered further for award.

b.  **Data and Safety Monitoring**

> The offeror's proposal must include a general description of the Data
> and Safety Monitoring Plan for all clinical trials. The principles of
> data and safety monitoring require that all biomedical and behavioral
> clinical trails be monitored to ensure the safe and effective conduct
> of human subjects research, and to recommend conclusion of the trial
> when significant benefits or risks are identified or if it is unlikely
> that the trial can be concluded successfully. Risks associated with
> participation in research must be minimized to the extent practical
> and the method and degree of monitoring should be commensurate with
> risk. Additionally, all plans must include procedures for adverse
> event reporting. Finally, generally, for Phase III clinical trials,
> the establishment of a Data and Safety Monitoring Board (DSMB) is
> required, whereas for Phase I and II clinical trials, the
> establishment of a DSMB is optional. The reviewers will rely on the
> Statement of Work and Section L in the solicitation, as well as any
> further technical evaluation criteria in this Section M, as
> applicable, for the solicitations specific requirements for data and
> safety monitoring.
>
> As a part of the evaluation for proposals, the reviewers will consider
> the acceptability of the proposed data and safety monitoring plan with
> respect to the potential risks to human participants, complexity of
> study design, and methods for data analysis. Based on the evaluation
> of the response to this criterion, this section of the proposal may be
> rated "unacceptable" (i.e., concerns are identified as to the adequacy
> of the monitoring plan or no discussion can be found regarding the
> proposed monitoring plans) or "acceptable." If the reviewers find that
> this portion of the proposal is "unacceptable" they will provide a
> narrative supporting their finding.
>
> If 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 address the concerns raised by the
> reviewers. You will be able to further discuss and/or clarify your
> position until submission of your Final Proposal Submission (FPR).
> Once discussions are closed with the submission of your FPR, if your
> proposed plan for data and safety monitoring is still found to be
> unacceptable, then your proposal may not be considered further for
> award.

c.  **Women and Minorities**

> Women and members of minority groups and their subpopulations must be
> included in the study population of research involving human subjects,
> unless a clear and compelling rationale and justification are provided
> indicating that inclusion is inappropriate with respect to the health
> of the subjects or the purpose of the research. In addition, for
> NIH-Defined Phase III clinical trials, all proposals and/or protocols
> must provide a description of plans to conduct analyses, as
> appropriate, to detect significant differences in intervention effect
> (see NIH Guide , Definitions - Significant Difference) by sex/gender,
> racial/ethnic groups, and relevant subpopulations, if applicable,
> unless the Government has specified that this solicitation involves a
> sex/gender specific study or a single or limited number of minority
> population groups. The proposal also must include one of the following
> plans:
>
> []{.mark}

-   Plans to conduct valid analysis to detect significant differences in
    intervention effect among sex/gender and/or racial/ethnic subgroups
    when prior studies strongly support these significant differences
    among subgroups, OR

-   Plans to include and analyze sex/gender and/or racial/ethnic
    subgroups when prior studies strongly support no significant
    differences in intervention effect between subgroups (representation
    of sex/gender and/or racial/ethnic groups as subject selection
    criterion is not required; however, inclusion and analyses are
    encouraged), OR

-   Plans to conduct valid analyses of the intervention effect in
    sex/gender and/or racial/ethnic subgroups (without requiring high
    statistical power for each subgroup) when the prior studies neither
    support nor negate significant differences in intervention effect
    between subgroups.

> []{.mark}
>
> Also, the proposal must address the proposed outreach programs for
> recruiting women and minorities as participants.

Reviewers will consider the areas covered here and in Section L of the
solicitation in narrative form in their evaluation. Some of the issues
they will evaluate include:

> []{.mark}

-   whether the plan proposed includes minorities and both genders in
    adequate representation

-   how the offeror addresses the inclusion of women and members of
    minority groups and their subpopulations in the development of a
    proposal that is appropriate to the scientific objectives of the
    solicitation

-   the description of the proposed study populations in terms of
    sex/gender and racial/ethnic groups and the rationale for selection
    of such subjects

-   if exclusion is proposed, that the rationale is appropriate with
    respect to the health of the subjects and/or to the purpose of the
    research.

-   In addition, for gender exclusion, the reviewers will examine the
    rationale to determine if it is because:

```{=html}
<!-- -->
```
-   the purpose of the research constrains the offeror's selection of
    study participants by gender (e.g., uniquely valuable stored
    specimens or existing datasets are single gender; very small numbers
    of subjects are involved; or

-   overriding factors dictate selection of subjects); or

-   gender representation of specimens or existing datasets cannot be
    accurately determined, [and]{.underline} this does not compromise
    the scientific objectives of the research.

```{=html}
<!-- -->
```
-   For minority group exclusion, the reviewers will examine the
    rationale to determine if those minority groups are excluded
    because:

```{=html}
<!-- -->
```
-   inclusion of those groups would be inappropriate with respect to
    their health; or

-   inclusion of those groups would be inappropriate with respect to the
    purpose of the research.

```{=html}
<!-- -->
```
-   For NIH-defined Phase III clinical trials, reviewers will also
    consider whether there is an adequate description of plans to
    conduct analyses to detect significant differences of clinical or
    public health importance in intervention effect(s) by sex/gender
    and/or racial ethnic subgroups when the intervention effect(s) is
    expected in the primary analyses, or if there is an adequate
    description of plans to conduct valid analyses of the intervention
    effect in subgroups when the intervention effect(s) is
    [not]{.underline} expected in the primary analyses.

> []{.mark}
>
> If you determine that inclusion of women and minority populations is
> not feasible, you must submit a detailed rationale and justification
> for exclusion of one or both groups from the study population with the
> technical proposal. The Government will review the rationale to
> determine if it is appropriate with respect to the health of the
> subjects and/or the purpose of the research
>
> Based on the evaluation of the response to this criterion, this
> section of the proposal may be rated "unacceptable" (i.e., no
> discussion can be found regarding the proposed gender/minority
> inclusion plans, or concerns are identified as to the gender or
> minority representation, or the proposal does not adequately address
> limited representation of one gender or minority; or the plan is not
> in accordance with NIH policy guidelines) or "acceptable." See Section
> L of the solicitation for the requirements of women/minorities
> inclusion. If the reviewers find that this portion of the proposal is
> "unacceptable" they will provide a narrative supporting their finding.
>
> If 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 address the concerns raised by the
> reviewers. You will be able to further discuss and/or clarify your
> position until submission of your Final Proposal Submission (FPR).
> Once discussions are closed with the submission of your FPR, if your
> proposed plan for inclusion/exclusion of women and minorities is still
> found to be unacceptable, then your proposal may not be considered
> further for award.

a.  **Children**

> Children (i.e. individuals under the age of 21) must be included in
> all human subject research unless there are clear and compelling
> reasons not to include them. Your proposal must include a description
> of plans for including children. If you plan to exclude children from
> the required research, your proposal must present an acceptable
> justification for the exclusion. If you determine that exclusion of a
> specific age range of child is appropriate, your proposal must also
> address the rationale for such exclusion. Also, the plan must include
> a description of the expertise of the investigative team for dealing
> with children at the ages included, of the appropriateness of the
> available facilities to accommodate the children, and the inclusion of
> a sufficient number of children to contribute to a meaningful analysis
> relative to the purpose/objective of the solicitation. Also, see
> Section L of the solicitation for further specific requirements on
> inclusion of children.
>
> Based on the reviewers' narrative evaluation of the offeror's response
> to this evaluation criterion, this section of the proposal may be
> rated "unacceptable" (i.e., no discussion can be found regarding the
> proposed inclusion plans for children; or concerns are identified as
> to the offeror's response regarding the inclusion of children; or the
> plan is not in accordance wit h NIH policy guidelines) or
> "acceptable." If the reviewers find that this portion of the proposal
> is "unacceptable" they will provide a narrative supporting their
> finding.
>
> If 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 address the concerns raised by the
> reviewers. You will be able to further discuss and/or clarify your
> position until submission of your Final Proposal Submission (FPR).
> Once discussions are closed with the submission of your FPR, if your
> proposed plan for the inclusion of children is still found to be
> unacceptable, then your proposal may not be considered further for
> award.

b.  **HIV Antiretroviral Treatment Trials**

> The offeror's proposal must address a plan to have host countries
> authorities and/or other stakeholders identify sources available, if
> any, to provide antiretroviral treatment to HIV-affected populations
> that have participated in the contract-funded HIV antiretroviral
> treatment trial. Or describe why the offeror believes that there are
> no such sources available. The information provided must be in
> accordance with Section L.
>
> The Project Officer will evaluate the documentation provided. While an
> offeror's documentation of the lack of available resources for
> antiretroviral treatment will not, of itself, constitute denial of a
> contract award, priority for contract awards may be given to those
> offerors who identify sources for the provision of antiretroviral
> treatment following the completion of the trial.

III. MANDATORY QUALIFICATION CRITERIA

> Listed below are mandatory qualification criteria. THE OFFEROR SHALL
> INCLUDE ALL INFORMATION WHICH DOCUMENTS AND/OR SUPPORTS THE
> QUALIFICATION CRITERIA IN ONE CLEARLY MARKED SECTION OF ITS PROPOSAL.
>
> **The following [qualification]{.underline} criterion establishes a
> condition that [MUST]{.underline} BE MET AT THE TIME OF PROPOSAL
> SUBMISSION in order for proposals to be reviewed and considered for
> award:**
>
> The Offeror **[must]{.underline}** provide a Letter of Understanding
> (LOU), signed by persons with authority to legally bind each
> collaborating party involved in the proposed work. The LOU must
> describe how the collaborating parties will coordinate their efforts
> to 1) protect intellectual property arising in performance of the
> contract, 2) facilitate the development for commercialization of the
> resulting HIV vaccine, and 3) resolve disputes among the collaborating
> parties should such disputes arise in performance of the contract.
> **PROPOSALS THAT DO NOT INCLUDE THIS AGREEMENT WILL BE RETURNED TO THE
> OFFEROR WITHOUT FURTHER REVIEW AND [WILL NOT BE
> CONSIDERED]{.underline} FOR AWARD.**

IV. EVALUATION OF DATA SHARING PLAN

> The offeror\'s plan for the sharing of final research data, or, if
> data sharing is not possible, the offeror\'s documentation of its
> inability to share research data, shall be assessed for
> appropriateness and adequacy.

V.  TECHNICAL EVALUATION CRITERIA

Proposals submitted in response to this BAA will be evaluated based on
the following factors weighted according to their relative importance.

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

1\. [Technical Approach]{.underline} 40

a)  The suitability and feasibility of the proposed goals and milestones
    for optimizing the vaccine concept

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a)  The suitability and feasibility of the methods and procedures for
    implementing the scientific plans and achieving the proposed goals
    and milestones

b)  The appropriateness and adequacy of the proposed experimental
    approach and methodologies (including the assays to detect immune
    responses)

c)  The appropriateness and feasibility of the proposed time schedule
    for achieving contract objectives and milestones

d)  The appropriateness and feasibility of the proposed qualitative AND
    quantitative criteria that will be used in deciding whether and when
    to proceed to the next phase of development toward a candidate
    vaccine product

e)  The suitability and feasibility of the plans for modifying the goals
    and milestones based on adverse experimental or production results,
    or on new scientific findings along the development path

f)  The adequacy and feasibility of any proposed plans for conducting
    and managing clinical trials, including protection of human subjects
    from research risks, representation of appropriate genders,
    racial/ethnic and age groups, data and safety monitoring and
    reporting, and valid analysis of data (see section IV. below)

2\. [Scientific Rationale]{.underline} 30

a)  Soundness of the scientific rationale of the proposed vaccine
    concept, including the choice of development of the vaccine concept
    as a preventive (Part A) or therapeutic (Part B) vaccine

b)  Soundness and feasibility of the rationale and data supporting the
    likelihood of moving the candidate vaccine product through the
    product development/production process leading to human clinical
    trials

c~1~) For Part A, the soundness and feasibility of rationale for the
suitability and applicability of the envisioned product for worldwide
use, including potential for large-scale manufacture and widespread
acceptance of the proposed product

c~2~) For Part B, the soundness and feasibility of the rationale for the
product as part of the therapeutic armamentarium, including feasibility
for large-scale manufacture

d)  Suitability and uniqueness of the approach for surmounting
    scientific obstacles to HIV/AIDS vaccine development (e.g., the
    difficulty of inducing strong cell-mediated immunity to divergent
    HIV antigens, or broadly cross-reactive neutralizing antibodies in
    uninfected individuals, and for HIV-infected individuals the
    induction of immunity in those with low CD4 counts in the presence
    of a changing treatment environment)

e)  Appropriateness of the clinical trial design to test the proposed
    vaccine concept

3\. [Qualifications/Availability of Proposed Scientific, Technical and
Management Staff]{.underline} 15

a)  Leadership and Management Structure

    -   Documented training, experience, education, leadership, and
        > availability of the Principal Investigator as well as the
        > overall ability and availability of the proposed scientific
        > and administrative leadership, and project management of the
        > HIV Vaccine Team to successfully manage a project of this size
        > and complexity

    -   Adequacy of the administrative framework, including clear lines
        > of authority and responsibility for successful project
        > management and time commitment of the leadership and
        > management staff

b\) Scientific and Technical Staff

-   Documented training, experience, education and availability of the
    > proposed other professionals, research, technical, management, and
    > support staff, and their documented capability to perform their
    > roles in the proposed studies, including evidence of previous
    > experience with similar projects

-   The adequacy of the staffing plan for the conduct of the project,
    > including the responsibilities and time commitment of the
    > professional and technical staff

c\) Subcontractors

-   The adequacy of the plan for use of the subcontractor(s) in the
    conduct of the project, including the time commitments of the
    professional and technical staff

-   Documented training, experience, education and availability of
    proposed subcontractors, their documented capability to perform the
    proposed work, and expertise in similar projects

-   Adequacy of plans for selecting and evaluating the performance of
    subcontractors

-   Quality and feasibility of the plan to identify the need to add,
    replace, or remove subcontractors dependent on the progress or
    change in scientific direction

4\. [Facilities and Resources]{.underline} 15

> Documented availability and adequacy of facilities, equipment, and
> resources necessary to safely perform all phases of the proposed
> project, including:

a)  detailed laboratory layouts, including location of major equipment

b)  information regarding ownership/lease of the facility, including its
    demonstrated availability for the duration of the proposed contract

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b)  plans for compliance with all safety guidelines and regulations,
    including training and monitoring of personnel for exposure to
    infectious and other hazardous materials

c)  a plan for production of the vaccine product under GMP conditions

d)  documentation of the availability and adequacy of facilities and
    resources to perform FDA-required safety, immunogenicity, and other
    pre-clinical studies, and any associated human clinical trials along
    with a justification for studies at international sites

e)  a plan demonstrating capacity to perform regulatory- and human
    subjects protection-compliant clinical trials, or describing intent
    to collaborate with a NIAID/DAIDS-sponsored clinical trial network
    to perform a clinical trial with the Offeror's proposed vaccine
    product(s)

f)  a plan for obtaining, adding or deleting facilities as necessary due
    to progress during the course of product development

[TOTAL POINTS:]{.underline} [100]{.underline}

VI. 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 mechanical or mathematical analysis of an offeror\'s performance on
> a list of contracts but rather the product of subjective judgement 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.
>
> The Government will consider the currency and relevance of the
> information, source of the information, context of the data, and
> general trends in the offeror\'s performance.
>
> The lack of a relevant performance record may result in an unknown
> performance risk assessment, which will neither be used to the
> advantage nor disadvantage of the offeror.

VII. 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.
>
> 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.
>
> Offers will be evaluated on the following sub-factors:
>
> \(a\) Complexity and variety of the work SDB concerns are to perform.
> Greater emphasis will be given for the arrangements where the SDB
> shall be performing work appropriate to the scientific objectives
> expressed in the Offeror's Statement of Work.
>
> \(b\) Extent of participation of SDB concerns in terms of the value of
> the total acquisition.

[]{#AppA .anchor}**APPENDIX A -- ADDITIONAL TECHNICAL PROPOSAL
INSTRUCTIONS**

A.  IDENTIFY A SPECIFIC VACCINE CONCEPT TO BE DEVELOPED

> Technical Proposals shall provide adequate justification to warrant
> the extensive effort of optimization, production and testing of the
> vaccine concept(s) chosen for development. This justification shall
> include the rationale for the selection of specific antigens
> \[sequences or epitopes\] and delivery vehicles relative to the
> proposed clinical trial population. As the underlying rationale for
> the design of preventive versus therapeutic vaccines can be quite
> different, the Technical Proposal must contain a discussion of why the
> vaccine concept is particularly suited for use as a preventive or a
> therapeutic vaccine, or both. Safety and regulatory issues must also
> be addressed as they relate to the testing of the proposed vaccine in
> relevant trial populations. In addition, Offerors shall provide a
> scientific justification for how a proposed preventive vaccine concept
> will be developed into a product suitable for worldwide use. As part
> of the justification for a therapeutic vaccine, the Offeror shall
> justify the choice of concept based upon how the vaccine will overcome
> or compensate for the change in immune function in HIV+ individuals.
>
> Additionally, the Offeror shall include relevant information from
> other vaccines or previously tested candidate AIDS vaccines. For those
> concepts where there is a paucity of supporting in vivo or in vitro
> data, the Offeror shall provide other justification, such as positive
> data from the use of the concept in vaccines for other diseases. In
> these cases, provision of information concerning similarity of these
> diseases to AIDS, or information on correlates of immunity,
> effectiveness, and breadth of protection induced by these vaccines
> will be of paramount importance.

B.  ARTICULATE A COMPREHENSIVE STRATEGIC RESEARCH PLAN

> Technical Proposals shall include a proposed comprehensive strategic
> research plan that addresses the items listed under Research and
> Technical Objectives, item B. IMPLEMENT A COMPREHENSIVE STRATEGIC
> RESEARCH PLAN.
>
> The Offeror shall identify appropriate milestones and time schedules
> for vaccine product development, setting qualitative and quantitative
> criteria for determining milestone accomplishment. If the proposed
> vaccine concept is for a mixed modality vaccine, or if an iterative
> design will result in multiple Phase I clinical trials, a separate set
> of milestones should be submitted for each component or trial. The
> progress of the HIV Vaccine Teams will be determined by the completion
> of the negotiated goals and milestones according to the negotiated
> schedule.
>
> Examples of milestones include the following:

1)  Synthesis of test molecules

2)  Immunogenicity Testing of test molecules

3)  Selection of Vaccine Molecules/Decision to Start GMP Production
    Process Development

4)  Preparation/Submission of CBER pre-IND meeting materials

5)  Contact NIAID/DAIDS-supported clinical trials network for approval
    of Phase I Clinical

> Trial Concept

6)  Completion of GMP Process Development and Production of GMP Pilot
    Lots

7)  Development of Phase I Protocol with NIAID/DAIDS-supported clinical
    trials network

8)  Pre-IND Meeting

9)  Initiation of IND Enabling Studies

    a.  Immunogenicity

    b.  Toxicology

    c.  Other

10) Completion of IND-Enabling Studies

11) DMF/IND Filing

12) Phase I Clinical Trial Initiation

13) Phase I Clinical Trial Completion

14) Evaluation of Safety and Immunogenicity Data from Phase I Clinical
    Trial

15) Decision on Proceeding with Phase II Clinical Trial(s)

16) Plan the Phase II Clinical Trial

> The Offeror **[must]{.underline}** provide a Letter of Understanding
> (LOU), signed by persons with authority to legally bind each
> collaborating party involved in the proposed work. The LOU must
> describe how the collaborating parties will coordinate their efforts
> to 1) protect intellectual property arising in performance of the
> contract, 2) facilitate the development for commercialization of the
> resulting HIV vaccine, and 3) resolve disputes among the collaborating
> parties should such disputes arise in performance of the contract.
> **PROPOSALS THAT DO NOT INCLUDE THIS AGREEMENT WILL BE RETURNED TO THE
> OFFEROR WITHOUT FURTHER REVIEW AND WILL NOT BE CONSIDERED FOR AWARD.**
>
> Offeror shall include a plan for sharing their data. The NIH policy on
> the sharing of data can be found at
> <http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html>
> . Stating that results will be published may not be an adequate plan.
> Additional information about data sharing, including examples, can be
> found at
> <http://grants.nih.gov/grants/policy/data_sharing/>[.]{.underline} The
> plan will be evaluated by the Scientific Review Group with respect to
> its feasibility and appropriateness.
>
> Technical Proposal shall include a Technical Proposal Cost Information
> (5 year) Summary \[see BAA REFERENCES: FORMS, FORMATS and
> ATTACHMENTS\]. List all subcontracts by task (e.g., GMP manufacture,
> IND-enabling toxicologic studies, formulation and fill, etc.).
>
> C. PROVIDE FOR THE PRODUCTION OF VACCINE PRODUCTS UNDER GOOD
> MANUFACTURING PRACTICES
>
> Offerors shall provide a plan for the production of vaccine products
> under Good Manufacturing Practices. In order to focus the description
> of GMP manufacture of your vaccine candidate(s) and facilitate review,
> consider in your Technical Proposal all of the appropriate items in
> the following list of generic issues to be addressed for
> biopharmaceutical production candidates:

1.  Provide a comparison of your concept/construct with
    [closely]{.underline} related concepts/constructs in use or under
    development (e.g. other poxvirus vectors if you are developing a
    poxvirus vector; other DNA vaccines if you are developing a DNA
    vaccine, etc.). Describe how your product expected to perform
    differently and/or better (immunogenicity, safety, manufacture
    capability).

2.  Provide details of your construct including starting materials (e.g.
    plasmids, relevant vector maps, detailed vector construction scheme,
    cell substrates and their derivation history, etc.).

3.  If a recombinant construct is proposed, does the construct contain
    an antibiotic-resistance gene or other selectable marker? If so,
    indicate which one. Are alternative methods of selection available?
    If so, these methods are to be described.

4.  If the candidate is a vectored vaccine, is the vector
    replication-competent or replication-defective? For
    replication-selective vectors, describe the molecular basis of the
    selectivity and the conditions under which the vector would
    replicate. Does your vector have an altered cell tropism? Describe.
    Discuss the impact of pre-existing immunity to the vector on the
    vaccine.

5.  Do you have data evaluating the genetic stability of the recombinant
    vector? Have you established mutation rates and/or rates of
    reversion to either wild type or alternate viral genomes? If so,
    these data are to be provided in the Technical Proposal.

6.  Do you have data evaluating the potential for genetic recombination
    with other organisms in the patient or in the environment? Describe.

7.  Is the organism currently being grown in a qualified cGMP cell line?
    If not, is there a qualified cell line available for propagation of
    this vector? Was the cell line genetically modified to support this
    vector? If so, describe the details of its construction and any
    information you have regarding the stability of the genetic
    alteration in the cell line. What other expression systems have been
    tried for the product?

8.  Delineate any issues with the cell line or viral seed with regard to
    BSE. Is there clear documentation of all serum exposure subsequent
    to 1980? If not, has a risk assessment been performed?

9.  Provide details of your production method.

10. Indicate whether this material ever been produced for laboratory or
    clinical studies using this production system.

11. Has this material ever been produced in a related or other
    production system? If so, provide the details.

12. Provide details of your purification methods. Virus inactivation or
    elimination from products produced in mammalian cell lines may
    involve treatment with acid, detergent, or filtration. Provide
    information, if available, about the stability of your product(s) in
    these conditions.

13. What is the average yield of your production system before and after
    purification? What is the largest amount of material that you have
    produced in your laboratory in a single production batch? What is
    the largest amount that you have purified in a single batch? Provide
    average ratios obtained by this production method for virus
    particle/infectious unit and/or infectious units/cell.

14. Are there concerns about the physical properties (e.g. folding,
    soluble or secreted form, dimerization) and stability of your
    product? If so, describe.

15. Do you have reproducible assays for your product? Describe the
    following assays for evaluating your material, if available:

    a.  Identity:

    b.  Purity:

    c.  Safety:

    d.  Potency (Immunologic):

16. Do you have a proposed list of release criteria for your product? If
    so, provide the information.

17. What is the largest single dose expected to be used in clinical
    trials? Indicate the doses, routes and schedules of inoculations to
    be used in planned clinical trials.

18. In what form (lyophilized, formulated product, etc.) and fill size
    will the final product be? What is the desired final product
    formulation?

19. Are there issues of formulation and vialing that must be resolved?
    If so, describe.

20. What is known about the stability of your product with respect to
    physical integrity and activity? Have you performed stability
    studies, and if so what were the results?

21. Are there any safety issues connected with the production,
    purification, and/or handling of your product? If so, describe.

22. Do applicable Materials Transfer Agreements permit clinical trials
    with your product(s)?

23. Have you had or are you preparing to have any meeting with
    regulatory agencies, such as a pre-IND meeting with the U.S. FDA or
    a presentation to the NIH Recombinant DNA Advisory Committee (RAC)?
    If so, indicate the type of meeting, the regulatory agency, and the
    date or proposed date.

24. If you have had a pre-IND or RAC meeting, were any issues concerning
    manufacturing, safety, or stability raised by the FDA that will have
    an impact on producing your product? If so, describe.

> D. PROVIDE A RESEARCH, PRODUCTION AND ADMINISTRATIVE TEAM
>
> The Technical Proposal must describe in detail the responsibilities
> and level of effort of all proposed personnel who will be assigned to
> the contract. In addition, the Offeror shall describe an
> administrative framework indicating clear lines of authority and
> responsibility for the management of all aspects of the contract.
>
> Provide documentation of the qualifications, knowledge, experience,
> education, competence, availability, and decision-making authority of
> the Principal Investigator, as well as project management, technical
> and administrative staff. Resumes, endorsements, and documentation of
> previous relevant efforts provided on behalf of the Principal
> Investigator and co-investigator(s) shall clearly demonstrate relevant
> knowledge, training, experience, and specific accomplishments. Resumes
> should be limited to 3 pages, single-spaced. If the HIV Vaccine Team
> elects to have both a scientific and a management leader, the proposal
> must also include the documented training, experience, and leadership
> of the management expert. Documentation shall include all previous and
> current projects of a similar nature, including, where applicable, the
> contract number or grant number, the sponsoring agency, the Project
> Officer, the name and a description of the project. \[The resumes,
> endorsements, explanations and documentation requested in this
> paragraph are excluded from the 150 page Technical Proposal limit.\]
>
> The Technical Proposal must also identify all proposed subcontractors
> and consultants and provide the same information and documentation as
> noted above with respect to the qualifications, knowledge, training,
> experience, education, availability, and specific responsibilities,
> including documentation of previous work relevant to the proposed
> tasks to be carried out by all such subcontractors and consultants.
> Additionally, the relationship between the subcontractor(s) and the
> Prime Contractor in decision-making, management and conducting the
> work shall be clearly delineated. The review and selection criteria
> for adding additional subcontractors during Contract performance, as
> well as the plan for evaluating the performance and determining the
> need to replace or remove subcontractors depending on performance or
> changing requirements of the overall project shall be clearly
> delineated.
>
> The level of effort required on the part of the Principal Investigator
> and key personnel will make it difficult for most Offerors to
> effectively manage/staff two or more concurrent HIV Vaccine Team
> contracts. Therefore, any current HIV Vaccine Team Principal
> Investigator responding to this solicitation must clearly demonstrate
> the capacity to manage/staff more than one HIV Vaccine Team contract
> award.
>
> E. PROVIDE THE INFRASTRUCTURE, FACILITIES, AND RESOURCES FOR
> PERFORMING ALL PHASES OF THE CONTRACT
>
> The Technical Proposal must document the availability and adequacy of
> infrastructure, facilities, and resources available for performance of
> the contract with detailed laboratory layouts, information regarding
> ownership/lease of the facility (including its demonstrated
> availability for the duration of the proposed contract), plans for
> compliance with all safety guidelines and regulations (including
> training and monitoring of personnel for exposure to infectious and
> other hazardous materials), and plans for obtaining, adding or
> deleting facilities as necessary due to progress during the course of
> product development

Since vertebrate animals will be needed for preclinical studies to
satisfy regulatory agency requirements and are likely to be used in
other studies required for product development, the Technical Proposal
must address provisions for complying with NIH guidelines for the humane
care and use of laboratory animals as delineated by the Office of
Laboratory Animal Welfare (OLAW;
<http://grants.nih.gov/grants/olaw/olaw.htm>).

> F. PROVIDE CLINICAL TRIALS SYNOPSIS OR PROTOCOL(S)
>
> **Clinical Trials to be Conducted within DAIDS-support Clinical Trial
> Networks:** Offerors proposing to collaborate with a DAIDS-sponsored
> clinical trials network to perform Phase I or I/II clinical trials
> with the proposed vaccine products must include a clear statement of
> their intent to collaborate with an appropriate DAIDS-sponsored
> clinical trials network and a synopsis (including: primary and
> secondary objectives of the trial, trial design, immunogenic/virologic
> assays to be performed, requisite qualifications of the clinical trial
> director, and time schedule for the clinical trial) of the proposed
> clinical trial protocol(s) in the Technical Proposal.

**Clinical Trials to be Conducted Independently:**

> Offerors proposing to design and conduct Phase I/II clinical trial
> independently must include in the Technical Proposal: (1) a protocol
> for each proposed clinical trial; (2) the name(s) of the
> individual(s), organization(s), and site(s) that will perform the
> clinical trial(s), (3) documentation of their willingness to
> participate, and (4) a description of the capabilities of all proposed
> participating organizations, sites and clinical investigators with
> respect to the conduct of the proposed clinical trial(s). The Offeror
> shall also address issues of human subjects protection (justification
> of potential benefits to subjects and/or society vs. risks to subjects
> and the adequacy of protection against risks including informed
> consent measures), provisions for data and safety monitoring (adequacy
> of monitoring approach and reporting procedures), and appropriateness
> of representation of women, minorities and children (including
> justification for any exclusions, adequacy of plans for recruitment,
> outreach, analysis, and risks to participants). Copies of the
> Department of Health and Human Services (DHHS) regulations for the
> protection of human subjects, 45 CFR Part 46, are available from the
> Office for Human Research Protections (OHRP), Office of the Secretary
> (OS), DHHS --
> (<http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm>). The
> NIH guidelines for inclusion of women and minorities, and for
> inclusion of children as subjects in clinical research are available
> at
> <http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm>
> and at
> <http://grants.nih.gov/grants/guide/notice-files/not98-024.html>,
> respectively.
>
> In addition, Offerors proposing to conduct clinical trials
> independently shall be required to provide some portion of clinical
> trials data through the DAIDS Enterprise System (DAIDS-ES). The
> DAIDS-ES is a comprehensive information management system that
> supports the business functions, management and oversight
> responsibilities of the DAIDS. The currently developed components of
> the DAIDS-ES include a DAIDS Expedited Adverse Event Reporting System
> (DAERS) and a DAIDS Protocol Management System. The DAERS is a
> web-based application for expedited reporting of adverse events in
> DAIDS sponsored clinical trials. The DAERS is a 21 CFR Part 11
> compliant system developed for use in therapeutic, vaccine and
> prevention trials. Activation of DAERS is anticipated in the third
> quarter of FY 2005. The DAIDS Protocol Management System supports
> end-to-end clinical trials processes, including: protocol development,
> registration, conduct, accrual, oversight, site monitoring, tracking
> and closeout. The system is CDISC and HL7 compliant with full auditing
> capabilities. Activation of the DAIDS Protocol Management System is
> anticipated in the fourth quarter of FY 2005. Offerors shall include
> plans for interfacing with, or adapting their information system(s) to
> interact with these and future components of the DAIDS-ES.

**Clinical Trials Involving Non-U.S. Clinical Trials Sites:**

Clinical trials at international sites are encouraged for Part A:
Preventive Vaccines, and will be considered under Part B: Therapeutic
Vaccines. For international clinical trials to be performed
independently of a DAIDS-supported clinical trial network, the Offeror
must include a plan that details how the HIV Vaccine Team will satisfy
human research subject protection concerns, as expressed by the DHHS
OHRP, in accordance with the norms and standards governing such studies
performed using U.S. Government funds. In addition, if international
sites are proposed for clinical trials, the Offeror must describe how
necessary approvals from the foreign government(s) to conduct the
studies will be obtained.

G. ESTABLISH AN INDEPENDENT EXTERNAL ADVISORY COMMITTEE

> **[DO NOT PROPOSE MEMBERS OF THE EXTERNAL ADVISORY COMMITTEE IN THE
> PROPOSAL]{.underline}**.
>
> H. ESTABLISH AN INFORMATION SECURITY PLAN
>
> In the Technical Proposal, Offerors must indicate their willingness to
> establish an information security plan within two (2) weeks after
> contract award for review and approval by NIAID.