TITLE:  Aventis Pasteur, B-291584, January 23, 2003
BNUMBER:  B-291584
DATE:  January 23, 2003
**********************************************************************
Aventis Pasteur, B-291584, January 23, 2003

   DOCUMENT FOR PUBLIC RELEASE                                                
The decision issued on the date below was subject to a GAO Protective      
Order.  This redacted version has been approved for public release.        

   Decision
    
Matter of:    Aventis Pasteur
    
File:             B-291584
    
Date:              January 23, 2003
    
Frank M. Rapoport, Esq., and Thomas F. Burke, Esq., McKenna Long &
Aldridge, for the protester.
Jonathan A. Baker, Esq., and Michael Colvin, Department of Health and
Human Services, for the agency.
Linda S. Lebowitz, Esq., and Michael R. Golden, Esq., Office of the
General Counsel, GAO, participated in the preparation of the decision.
DIGEST
    
Protest is denied where it is clear from the record that the protester was
not misled during discussions concerning the criticality of an offeror's
proposed approach to satisfy the solicitation's milestone requirements.
DECISION
    
Aventis Pasteur protests the rejection of its proposal under request for
proposals (RFP) No. NIH-NIAID-DMID-02-26, issued by the Department of
Health and Human Services for the development and testing of anthrax
vaccines.  Aventis challenges the agency's conduct of discussions with the
firm.
    
We deny the protest.
    
The RFP, issued on April 22, 2002, explained that there was an urgent need
to devise appropriate and effective measures to protect the general
population from the harmful effects of anthrax spores used as instruments
of terror.  The RFP provided that in view of the events since September
11, 2001, there was sufficient justification to warrant the rapid
development, testing, and licensure of a vaccine to cover
pre‑exposure and post-exposure to anthrax, preferably in a single
dose.  Accordingly, the RFP stated that this procurement to develop,
manufacture, characterize, and evaluate a pilot lot of B. anthracis
recombinant protective antigen (rPA) vaccine would be *milestone-driven.* 
RFP Statement of Work.
    
The acquisition of an anthrax vaccine would be conducted in three phases,
with the first two phases covered by this RFP.  Under the first phase, the
agency anticipated making (in September 2002) multiple
cost-plus-fixed-fee, completion-type contract awards, under which the
contractors would be required to develop an anthrax vaccine in accordance
with the following milestones, as described in the RFP:  (1) within 3
months of award, produce a pilot lot of rPA vaccine suitable for phase 1
and optional phase 2 clinical trials;[1] (2) within 6 months of award,
provide 2,000 doses of the vaccine previously developed as a pilot lot so
that the agency could seek approval from the Food and Drug Administration
to conduct its own clinical trials; (3) furnish protocols for phase 1 and
optional phase 2 clinical trials; (4) conduct phase 1 clinical trials; and
(5) within 12 months of award, provide a plan for emergency production of
25 million doses of the vaccine previously developed as a pilot lot.  The
RFP provided that the milestones were considered contract deliverables. 
Under the second phase, an option under this RFP, the agency would select
one of the multiple awardees from the first phase to conduct phase 2
clinical trials.[2]
    
The RFP provided that the awards would be made to the offerors whose
proposals represented the best overall values to the government,
considering technical evaluation factors and cost.  The technical
evaluation factors included technical approach (70 points), personnel (15
points), and facilities (15 points).  Under technical approach, the
following areas would be evaluated:  (1) technical adequacy and
feasibility of proposed plan to develop candidate vaccine with attributes
included in the statement of work (30 points); (2) technical adequacy and
feasibility of proposed process development plan leading to the
manufacture of required amounts of vaccine approved for emergency use
within the specified time mentioned in the statement of work (30 points);
and (3) technical adequacy and feasibility of clinical development plan,
including proposed protocols for phase 1 and phase 2 clinical trials as
described in the statement of work (10 points).  The RFP provided that the
technical evaluation factors were significantly more important than cost.
    
Four firms, including Aventis, Avecia, Ltd., and VaxGen, Inc., submitted
initial proposals by the closing time on June 6.  As relevant here,
Aventis proposed an rPA vaccine produced by [deleted] to support the phase
1 clinical trials.  Aventis described items (e.g., yield, expression
level, and production process) that would be *optimized and scaled-up in
order to meet future demand,* and it also stated that ten extraneous amino
acid residues would be removed from the [deleted] vaccine.  Aventis
Initial Proposal, at 1-24.
    
The agency's technical evaluation panel assigned the Aventis initial
proposal a score of 89 out of a possible 100 points, the highest technical
score received.  (The other scores ranged from 56 to 64 points.)  Despite
this score, the evaluators determined that there were a number of
technical weaknesses and disadvantages in the Aventis proposal.  For
example, while noting that Aventis suggested that considerable additional
work in a number of areas would be needed before large‑scale
production could be initiated, and recognizing that this additional work
would optimize the final production and possibly the final product, the
evaluators nevertheless were concerned that a delay in any one of the
areas requiring additional work could affect the ability of Aventis to
meet the expected timelines.  In addition, since the vaccine used in the
phase 1 clinical trials would be structurally different from the vaccine
expected to be manufactured as the final product (as a result of removing
the extraneous amino acids), the evaluators expressed some concern that
the preclinical and clinical findings with the predecessor vaccine would
not predict the behavior of the production vaccine.  Technical Evaluation
Report for the Aventis Initial Proposal, at 34‑35, 37, 40.
    
The contracting officer included all four of the initial proposals in the
competitive range.  On August 5, the contracting officer conducted written
discussions with Aventis.  With respect to its technical approach, the
contracting officer noted that the evaluators had *comments and concerns
regarding the product proposed for use in the Phase 1 study [and the
ability of Aventis] to meet the RFP milestones.*  For example, the
contracting officer pointed out to Aventis that any delays in the
additional work identified as necessary to optimize trial production and
possibly the final product could affect the ability of Aventis to meet
expected timelines.  As a result, the contracting officer requested that
Aventis provide a clear timeline based upon previous experience with
product development and provide a risk management plan addressing each
critical phase.  The contracting officer also pointed out to Aventis that
the vaccine proposed for the phase 1 clinical trials was different from
the final product (as a result of having to remove the extraneous amino
acids) and that there was concern that preclinical and clinical findings
with the phase 1 product might not predict behavior of a future product;
as a result, the contracting officer requested that Aventis address how
quickly information would be obtained using the appropriate product that
would be taken forward to licensure.  E‑mail with Attach. from
Contracting Officer to Aventis, Aug. 5, 2002.
    
On August 6, the contracting officer furnished to Aventis a list of
supplemental technical issues to be addressed by the firm.  In relevant
part, the contracting officer stated that
    
[t]he reviewers found that significant optimization with the product
appears to be required prior to large-scale manufacturing.  The statement
on page ATC-6[,] * . . . represents substantial progress toward completion
of Milestone 2[,]* appears misleading, in that the proposed ability to
meet several early milestones appears to be both artificial and based upon
a sub-optimal and ill-defined product. . . . In addition, pages 1-14/25
cite proposed changes to the construct and require establishing new
expression systems and purification schemes.  Given this approach, the
product development appears to be immature.  Given that the current Phase
1 material lacks an efficient expression system and a manufacturing
process with acceptable yield, the government has no interest in receiving
2,000 doses of the same material.  Please review the overall approach and
timeline to determine if clinical trial data can be produced by December
2003, using vaccine material produced with methods now being optimized. .
. . The Government appreciates the significance of this request, but
believes the likelihood of attaining solicitation milestones post-award
would be enhanced by this approach.
E-mail with Attach. from Contracting Officer to Aventis, Aug. 6, 2002.
    
On August 13, Aventis responded to this supplemental technical question,
expressing surprise that by asking that question, the contracting officer
had *essentially rejected [the firm's] project plan.*  In relevant part,
Aventis stated that
               
according to our plan and approved resources, it is not feasible to
complete the Phase 1 clinical study using the new rPA clone and production
process by the requested December 2003 date.  Based on our experience, we
are simply unwilling to state that the work will be completed by December,
2003, in order to be awarded this contract, when we know this is
unlikely.  The current best estimate is that the 2,000 doses of [current
good manufacturing process] rPA to begin this study would not be available
until [the first quarter], 2004.  Of course, expanded resources
([full-time equivalent personnel] and budget) and the acceptance of more
risk (e.g., using smaller scale lots) could compress this timeline by
several months.  Our literal interpretation, however, is that the new
Aventis Team timeline fails to meet expectations of [the agency] and now
places us outside the competitive range.
E-mail from Aventis to Contracting Officer, Aug. 13, 2002.
    
On August 14, the contracting officer responded to Aventis, explaining
that the August 6 supplemental technical question was not meant to be a
rejection of the firm's project plan and that it was not the government's
intent to ask Aventis to submit a new proposal.  Rather, as explained by
the contracting officer, the purpose of the referenced question was to
clarify the evaluators' concerns related to the technical evaluation
factors, with specific focus on the need to ensure that the product would
be far enough along in development to meet the requirements of the
government as specified in the RFP's statement of work.  E‑mail from
Contracting Officer to Aventis, Aug. 14, 2002.
    
On August 22, the contracting officer requested that Aventis submit its
final proposal revision (FPR).  On August 29, Aventis submitted its FPR. 
In the executive summary, Aventis stated:
    
The insightful series of technical questions that we have received from
the [agency's] review panel has persuaded the Aventis Team to
substantially modify its original Anthrax Proposal.  Of the two sets of
technical questions, those that we received on August 6th were the most
challenging, since they questioned three fundamental aspects relating to
the competitiveness of our proposal.  First, the reviewers correctly
pointed out that our current rPA construct produced at [deleted] expressed
low levels of recombinant product with extraneous amino acids that would
require substantial changes to its sequence and purification protocol, as
we moved forward.  Second, the reviewers suggested that the 2,000 doses of
vaccine that we intended to produce under contract by [deleted] in [the
fourth quarter], 2002 were not truly representative of the rPA vaccine
that will eventually be developed.  In fact, it was stated categorically
that the Government had no interest in receiving the vaccine which would
be produced by [deleted].
. . . . .
As a result of [the agency's] constructive input, the Aventis Team has
substantially modified [its] proposal [by proposing a vaccine that Aventis
itself has been researching and developing].
. . . . .
Obviously, incorporating such substantial changes has impacted both our
timelines and our budgets.  Currently, we expect Milestone 1 to be
completed in [the fourth quarter], 2003.  This is approximately 12 months
later than the original proposal.  Milestone 2 will be completed in [the
first quarter], 2004, a difference of 12 months from the original
proposal.  Milestone 3 will be completed in [the first quarter], 2005. 
Milestone 4 will be completed in [the first quarter], 2006.  This is
approximately 20 months later than originally proposed.  Milestone 5 will
be completed by [the fourth quarter], 2003, as originally planned.
Aventis FPR, at E-1,-2.
    
The agency's source selection group evaluated FPRs, assigning the Aventis
FPR a score of 83 out of a possible 100 points.  (The Aventis FPR received
the second‑highest technical score; the other scores ranged from 59
to 87 points.)  The evaluators commented that the Aventis FPR offered a
*significant change that jeopardized seriously the chances of meeting the
ambitious timelines.*  Source Selection Group Summary of the Aventis FPR,
Sept. 10, 2002, at 6.  The evaluators pointed out that in response to
questions raised about the appropriateness of the proposed pilot lot of
rPA vaccine, Aventis withdrew its initially proposed pilot lot from
consideration, agreeing with the criticism that the [deleted] pilot lot
would have to be modified significantly before it was a candidate to be
developed fully to meet the RFP goals.  Id.  The evaluators summarized
their view of the Aventis FPR as follows:
    
A principal question was raised in the primary review regarding the
appropriateness of the [deleted] pilot lot of rPA, and [Aventis] agreed in
the FPR that it would have to be modified considerably to qualify for the
product to be taken into production.  The responses were frank, but not
reassuring.  The reviewers did not agree that the [deleted] lot was an
adequate pilot lot for the purposes of this RFP, and since [Aventis] was
unable to rely on the [deleted] lot of rPA to meet early milestones of the
project[,] the technical adequacy and feasibility of the proposed plan to
develop a candidate vaccine with the attributes requested is weakened
considerably.  The offeror provided encouraging evidence that a
sufficiently modified rPA had been under the early stages of product
development, but the revised proposal failed to suggest these early
successes would be accelerated through the product development and
scale-up process.  Without accelerating the product development process,
which appeared to be technically feasible, it is not possible to meet the
timelines imposed by the RFP.  The score for this evaluation criterion was
reduced because the new information provided indicated the offeror could
not meet the milestone timelines.
Id. at 7.
    
Despite these concerns, the source selection authority made a preliminary
determination to award contracts to Aventis, Avecia, and VaxGen.  Source
Selection Decision, Sept. 16, 2002.  (No award notices were issued at this
time.)
    
On September 17, in response to a question from the contracting officer on
when Aventis intended to deliver on milestone 1 (under the RFP, within 3
months of award, the contractor was to provide a pilot lot of rPA
vaccine), Aventis appeared to take exception to milestone 1.  E-mail from
Aventis to Contracting Officer, Sept. 17, 2002.  Accordingly, on September
18, the contracting officer advised Aventis that additional discussions
with the firm were necessary in order to address, among other things,
discrepancies related to the milestone delivery dates proposed by Aventis
in its FPR versus those listed in the RFP's statement of work.  E-mail
from Contracting Officer to Aventis, Sept. 18, 2002.
    
On September 25, during a conference call, the agency explained that the
urgency of this procurement did not permit flexibility regarding delivery
of the requirements.  With reference to its FPR, Aventis acknowledged that
milestones 1, 2, and 4 would be delayed 1 year beyond the times stated in
the RFP; Aventis nevertheless requested that its FPR be considered under
modified (i.e., relaxed) milestone requirements.  Agency Summary of
Conference Call, Sept. 25, 2002.
    
On September 30, Aventis submitted a written follow-up to the September 25
conference call.  Aventis stated that based on the status of the pre-award
work and the government's rejection of the [deleted] approach to meet the
milestone dates, Aventis *[did] not believe, as set forth in the FPR, that
the milestone dates [could] be met by anyone.*  Aventis Letter to
Contracting Officer, Sept. 30, 2002.  Aventis reiterated its position that
the *proposed milestone dates [were] not consistent with delivering a
scaleable quality product to meet the ultimate goal, the 25 million dose
National Emergency Stockpile.  [Aventis would] not commit [itself] to
delivering something [it did] not believe . . . [was] possible.*  Id. 
Aventis stated that it *fail[ed] to see how meeting each of the
milestones, within the timeframe suggested by the RFP, [was] necessary and
sufficient to meet the overriding objective of [the agency] in providing a
reliable source of rPA vaccine for the stockpile.*  Id.
    
By letter dated October 2, the agency advised Aventis that its proposal
was being eliminated from further consideration because the firm would not
be able to meet the milestones set forth in the RFP and that a delay of up
to 12 months was unacceptable for vital research.  On October 3, at the
direction of the source selection authority, the contracting officer
amended the source selection document by removing Aventis as one of the
awardees because of, among other things, the firm's inability to reconcile
its proposed milestone schedule with the requirements of the RFP.  On the
same day, the agency announced that awards had been made to Avecia and
VaxGen.
    
Aventis, which does not dispute that under its FPR, it would be unable to
satisfy the RFP's stated milestones, Protester's Comments, Dec. 2, 2002,
at 4-5, argues that it was misled during discussions to replace its highly
rated, technically acceptable approach as contained in its initial
proposal with an approach that was more time‑consuming.  This
argument, however, is belied by the underlying contemporaneous record.
     
Here, the RFP's statement of work provided that this procurement was
*milestone‑driven* and clearly detailed the requirements under each
of five stated milestones.  Moreover, the RFP's evaluation scheme made
specific reference to the statement of work requirements, which included
the five milestones.[3]  In its initial proposal, Aventis proposed a
vaccine produced by [deleted].  While the technical approach described in
the Aventis initial proposal received the highest technical rating, this
approach was also determined to have numerous technical weaknesses and
disadvantages, including the need to modify the proposed [deleted] vaccine
in a number of respects before large-scale production could begin, with
the risk that the modifications could delay the ability of Aventis to meet
the milestones set forth in the RFP.
    
As detailed above, during discussions, Aventis was advised of specific
agency concerns with the [deleted] vaccine proposed by the firm for use in
the phase 1 clinical trials and with the ability of Aventis to satisfy the
RFP's milestone requirements.  Contrary to the position taken by Aventis
in this protest that it was misled during discussions, Aventis, in its
FPR, characterized the agency's discussion questions as *insightful* and
*constructive,* conceding that the [deleted] vaccine would not be
representative of the vaccine that would eventually be developed and
recognizing that the agency had no interest in receiving the [deleted]
vaccine.  In its FPR, Aventis revised its technical approach, proposing a
vaccine that was in the early stages of product development and that would
lag approximately 1 year behind the milestones required by the RFP.  The
agency ultimately downgraded and rejected the Aventis FPR because Aventis
failed to address how the product development process for the newly
proposed vaccine would be accelerated in order to meet the RFP's
milestones.
    
It is clear from this record that Aventis was not misled during
discussions concerning the agency's critical need for an offeror's
proposed technical approach to satisfy the RFP's milestones.  After being
advised during discussions of technical weaknesses and disadvantages in
its initial proposal as they related to the milestones described in the
RFP, Aventis modified its proposed technical approach in a manner that
clearly took exception to the RFP's milestone requirements, apparently
based on its hope that the agency would ultimately relax these
requirements.[4]  On this record, Aventis has not made any credible
argument to support its current position that it was misled during
discussions.  Accordingly, we have no basis to question the agency's
decision to reject the FPR submitted by Aventis because of the firm's
failure to submit a proposal that would satisfy the express terms of the
RFP.[5]
    
The protest is denied.[6]
    
Anthony H. Gamboa
General Counsel
    
    

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

   [1] Phase 1 clinical trials involve introducing a drug into people in
order to gather metabolic and pharmacologic data, as well as to study the
side effects of escalating doses and to glean preliminary information on
effectiveness.  Phase 2 clinical trials study the efficacy of a drug and
assess its short-term side effects.  Legal Memorandum at 3 n.2.
[2] For the third phase, this RFP announced that the agency intended to
issue, on a full and open competitive basis, a solicitation for the
production and acquisition of an anthrax vaccine; participation in the
procurement under protest here will not be a prerequisite for
participating in the production/acquisition procurement. 
[3] To the extent Aventis questions the materiality of the RFP's
*milestone-driven* requirements, this argument constitutes an untimely
challenge of an alleged solicitation impropriety.  Bid Protest
Regulations, 4 C.F.R. S: 21.2(a)(1) (2002).
[4] The record shows that even after Aventis submitted its FPR, the agency
conducted discussions with Aventis in order to obtain a conforming
proposal from the firm.
[5] While Aventis makes much of the fact that the agency initially had
determined to include the firm as one of the multiple awardees, we
conclude that the agency reasonably determined that an award to Aventis
would not be in accordance with the terms of the RFP because the firm took
exception to the RFP's milestone requirements.
[6] Aventis has raised other collateral issues and arguments, each of
which we have considered and find without merit.