TITLE:  Novartis Pharmaceuticals Corporation, B-285038, July 6, 2000
BNUMBER:  B-285038
DATE:  July 6, 2000
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Novartis Pharmaceuticals Corporation, B-285038, July 6, 2000

Decision

Matter of: Novartis Pharmaceuticals Corporation

File: B-285038

Date: July 6, 2000

Ronald K. Henry, Esq., and Larry J. Gusman, Esq., Kaye, Scholer, Fierman,
Hays & Handler, for the protester.

Maura C. Brown, Esq., Department of Veterans Affairs, for the agency.

John L. Formica, Esq., and James A. Spangenberg, Esq., Office of the General
Counsel, GAO, participated in the preparation of the decision.

DIGEST

Solicitation provision requesting the submission of an implementation plan
as part of the technical proposal is not ambiguous.

DECISION

Novartis Pharmaceuticals Corporation protests the terms of request for
proposals (RFP) No. 797-NC-00-0043, issued by the Department of Veterans
Affairs (VA), for the drug clozapine. Novartis argues that the RFP is
ambiguous with regard to the requirement that proposals address how the
contractor will operate and maintain a clozapine registry.

We deny the protest.

The RFP provides for the award of a fixed-price contract with a base period
of 1 year with four 1-year options. The RFP contemplates establishing a
supply source that will provide an estimated 33,401 bottles of clozapine per
year for purchase through VA's Pharmaceutical Prime Vendor (PPV) program.
[1] RFP at 3.

Clozapine, originally manufactured by Novartis under their trademark
Clozarilï¿½ , is used for the treatment of schizophrenia. [2] There are some
serious potential risks of side effects from the use of clozapine. The most
significant side effect is agranulocytosis or neutrapenia, a potentially
fatal blood disorder that can be reversed if detected early. The agency
explains that due to the risk of agranulocytosis, the Food and Drug
Administration (FDA) "has restricted the distribution of clozapine since its
introduction to the market" and mandated that a monitoring system be in
place before clozapine can be distributed. Agency Report at 2.

Novartis, as the original manufacturer of clozapine, developed the first
Clozapine National Registry, and agreed with FDA, upon the introduction in
1997 of a generic version of clozapine, to maintain a single database which
includes a list of those individuals who should not be treated with
clozapine again due to the occurrence of certain side effects. Id. at 2-3.
The registry is normally checked prior to the beginning of treatment with
clozapine, and all clozapine manufacturers, including Novartis, have access
to the registry. Id. at 3. Accordingly, in addition to supplying clozapine,
the contractor under the RFP will also be required to operate and maintain a
clozapine registry. RFP at 3.

The RFP includes detailed instructions for the preparation of proposals. The
solicitation requests that that offerors submit separate business and
technical proposals. RFP at 31. The solicitation specifies that technical
proposals shall include, among other things, an implementation plan. Id. The
RFP (at 4) states that the implementation plan

shall detail how and when the Clozapine registry database will be populated
and submitted to the National Clozapine Coordinating Center in Dallas,
Texas. This plan must also demonstrate how the offeror will accomplish all
the requirements of the Clozapine registry (See Attachment G for suggested
format for this plan).

The solicitation includes six pages detailing the minimum requirements for
the operation and maintenance of a clozapine registry. RFP at 5-10.

The solicitation adds that the offerors should address each issue concerning
their proposed implementation plans completely and in enough detail "to
assure the Government of the offeror's understanding and capability to
perform the cited requirements." RFP at 31. The RFP also states here that
"[t]he Government will assess the realism and viability of the offeror's
plan(s)," and that the implementation plan "will be evaluated to assure that
the offeror demonstrates how all required tasks would be met." RFP at 31-32.

The solicitation states that award will be made to the offeror submitting
the proposal determined to be most advantageous to the agency. The RFP
further provides that price will be the most important factor; followed by
the past performance and implementation plan evaluation factors, which are
equal in importance; and the small disadvantaged factor, which is
significantly less important. RFP at 32.

Novartis protests that the solicitation is ambiguous concerning the RFP's
requirement for the submission of an implementation plan. In this regard,
the protester points out that each section of the RFP outlining the
requirements for the implementation plan is followed by the parenthetical
"[s]ee Attachment G for suggested format for this plan." RFP at 4, 31.
Novartis argues that because attachment G is a one-page "milestone" chart,
the RFP is unclear as to whether offerors are permitted to respond to the
solicitation's requirements for an implementation plan in detail as the
above-quoted sections of the RFP suggest, or are limited to completing the
one-page chart set forth in attachment G. [3] Protester's Comments at 9-10.

When a dispute exists as to the actual meaning of a solicitation
requirement, our Office will resolve the matter by reading the solicitation
as a whole and in a manner that gives effect to all the provisions of the
solicitation. Energy Maintenance Corp., B-223328, Aug. 27, 1986, 86-2 CPD para.
234 at 4.

As mentioned previously, the RFP contains six pages detailing the minimum
requirements for the operation and maintenance of the clozapine registry,
RFP at 5-10, and states that proposals are to include an implementation plan
"demonstrat[ing] how the offeror will accomplish all the requirements of the
Clozapine registry." RFP at 4. With regard to the evaluation of proposals,
the RFP provides that the "realism and viability of the offeror's plan(s)
will be considered, and that each offeror's implementation plan "will be
evaluated to assure that [the] offeror demonstrates how all required tasks
would be met." RFP at 31-32.

The protester's contention that the RFP may be read as limiting an offeror's
implementation plan to a completed one-page attachment G is unreasonable.
First, the protester's interpretation is simply inconsistent with the plain
language of the parentheticals, where the attachment G format is "suggested"
rather than mandated. Additionally, the parentheticals only suggest the
attachment G format; there is no reference nor any indication that an
offeror deciding to follow the attachment G format would be required to
adhere to the attachment's one-page length. Most importantly, the
protester's argument that the RFP could be interpreted as requiring that
offerors submit only a completed one-page attachment G renders meaningless
the sections of the RFP described above which provide for the submission and
evaluation of a reasonably detailed implementation plan.

In any event, the record reflects that Novartis was not misled in preparing
its technical proposal by the RFP's reference to attachment G. That is, as
pointed out by the agency, Novartis did exactly what the RFP and agency
anticipated by following the format in attachment G in a submission of
several pages describing its proposed approach to the RFP's requirements
regarding the operation and maintenance of a clozapine registry. Given that
Novartis was not misled by the ambiguity it asserts exists in the RFP, but
rather prepared its technical proposal in the format anticipated by the
agency, we fail to see how Novartis was prejudiced by the alleged ambiguity.
See A-1 Postage Meters and Shipping Sys., B-266219, Feb. 7, 1996, 96-1 CPD
para. 47 at 4.

Novartis argues for the first time in its supplemental comments filed with
our Office that its implementation plan submission was actually a
"half-a-loaf compromise," such that it has been prejudiced by the allegedly
ambiguous RFP instructions regarding the implementation plan. Protester's
Supplemental Comments, June 23, 2000, at 5. In our view, this argument
cannot be reconciled with Novartis's previous assertions that the RFP was
ambiguous in that it could reasonably be read in a manner not anticipated by
the agency, that is, as limiting offerors to the submission of only a
completed one-page attachment G. It is clear from the record that Novartis
did not read the solicitation in this alternative manner, and we find
Novartis's self-serving contention that it was somehow misled by the RFP,
even though its proposal included an implementation plan in the format
anticipated by the agency and consistent with the agency's reading (and one
of Novartis's readings) of the RFP, to be insufficient to support a finding
of prejudice. [4] See Browning-Ferris Indus. of the S. Atl., Inc.; Reliable
Trash Serv. Co. of Md., Inc., B-217073, B-218131, Apr. 9, 1985, 85-1 CPD para.
406 at 4.

The protest is denied.

Comptroller General

of the United States

Notes

1. Under the PPV Program the VA awards separate contracts for the product
distribution and for the source and purchase price for the product itself.
Once a supply source is obtained for a product, it is distributed for use
nationwide. RFP at 3.

2. Novartis currently supplies virtually all of the clozapine required by
the VA for its patients. Agency Report at 2 n.1.

3. Attachment G consists of a 1-page chart entitled "implementation plan,"
with 4 columns entitled, among other things, "task" and "notes," and 10
rows, with the first row entitled "weeks 1 thru 4," and the following 9 rows
entitled "week 5" through "week 13." RFP attach. G.

4. Novartis also complains that the agency failed to develop acquisition and
evaluation plans for this procurement. Protester's Comments at 11-12;
Protester's Supplemental Comments at 6. However, since the protester does
not claim that it was prejudiced in any way by this alleged failure, we will
not consider Novartis's complaints in this regard further. See Champion Bus.
Servs., Inc., B-283927, Jan. 24, 2000, 2000 CPD para. ___ at 3 n.2.