[EXHIBIT 99.1.1]
[Letterhead of Pfizer Inc.]
February 28, 1997
Xxxxxx-Xxxxxxx Company
000 Xxxxx Xxxx
Xxxxxx Xxxxxx, Xxx Xxxxxx 00000
Attn: Xxxxxxx Xxxxxxx
Corporate Vice President
President, Xxxxx-Xxxxx, U.S. and Mexico
Re: First Amendment to Collaboration Agreement
Dear Xx. Xxxxxxx:
Xxxxxx-Xxxxxxx Company ("Xxxxxx-Xxxxxxx") and Pfizer Inc. ("Pfizer")
are parties to a Collaboration Agreement effective as of June 28, 1996 (the
"Collaboration Agreement"). The parties wish to amend the Collaboration
Agreement to reflect (1) certain changes to the definition of Product
Expenses regarding Product Lifecycle Plan Studies and (2) additional
detailing to be performed by Pfizer and Xxxxxx-Xxxxxxx and the compensation
to be paid to Pfizer in exchange for such additional detailing.
Accordingly, the Collaboration Agreement is hereby amended as follows:
1. The definition of "Product Expenses" is amended to include the
following:
"Product Expenses shall further include certain additional expenses
relating to certain Product Lifecycle Plan Studies identified by the
Operating Committee. With respect to each such agreed-upon Product
Lifecycle Plan Study, the amount to be included as Product Expenses
and thus shared by PFIZER and XXXXXX-XXXXXXX in accordance with the
terms of the Collaboration Agreement shall be the total of (i) all
direct Grant Costs (as hereinafter defined) for such Product Lifecycle
Plan Study, plus (ii) seventy-five percent (75%) of such Grant Costs
("Overhead Costs"). Inclusion of Overhead Costs as Product Expenses
is intended to reimburse the party conducting such Product Lifecycle
Plan Study (the "Conducting Party") for its overhead and internal
resources employed in connection therewith. Notwithstanding the
foregoing, Overhead Costs shall not be included as Product Expenses
for any Product Lifecycle Plan Study from the date that a Conducting
Party initiates the use of a clinical research organization to perform
substantially all clinical monitoring and data management activities
on behalf of the Conducting Party in connection with such Product
Lifecycle Plan Study. With respect to Product Lifecycle Plan Studies
currently ongoing and identified below, Overhead Costs shall be
applied retroactively from April 15, 1996 where applicable, subject to
the $6,000,000 cap on total out-of-pocket expenses from April 15, 1996
through June 30, 1996, as set forth in the definition of Product
Expenses. For purposes of this definition, "Grant Costs" means
out-of-pocket costs related to investigators, investigator meetings
and laboratory grants, but shall not include the costs of clinical
monitoring, data management, programming, biostatistics or report
writing.
The initial Product Lifecycle Plan Studies that PFIZER and
XXXXXX-XXXXXXX intend to be subject to this amendment are the
following:
Ongoing Studies Planned Trials
--------------- --------------
981-53 Usual Care 981-105 Unstable angina (MIRACLE)
981-68 AVERT 981-124 Cerebral Vascular Disease
981-71 NIDDM Intervention Trial
981-69 Pharmacoeconomic
981-70 Treat-to-Target Trials
981-72
2. Section 2.02 of the Collaboration Agreement is amended to insert the
following new subsections:
"(g) In addition to the Details to be performed by PFIZER pursuant to
Section 2.02(d), PFIZER shall perform an additional 500,000 Details
per year for a period of two (2) years commencing no later than May
1997. PFIZER shall use its Xxxxx sales force to satisfy this
additional detailing obligation. "Xxxxx Year One" shall mean the
twelve-month period commencing on May 1, 1997; references to Xxxxx
Years Two through Five shall mean the successive twelve-month periods
thereafter.
(h) In addition to the Details to be performed by XXXXXX-XXXXXXX
pursuant to Section 2.02(d), XXXXXX-XXXXXXX shall utilize an
additional sales force to perform an additional 250,000 Details per
year for each of Agreement Years One through Four."
3. Section 3.02 of the Collaboration Agreement is amended to insert the
following new subsection (h):
"(h) In consideration of the additional Details to be provided by
PFIZER pursuant to Section 2.02(g), PFIZER shall be compensated as
follows:
(i) Subject to any adjustments pursuant to Section 3.02(h)(iii)
and (iv) below, XXXXXX-XXXXXXX shall pay to PFIZER for each of
Xxxxx Years One and Two an additional 3.5% (the "Xxxxx
Percentage"), resulting in a total of 48%, of Net Sales in excess
of the Agreement Year Baseline Sales.
(ii) Subject to any adjustments pursuant to Section 3.02(h)(iii)
and (iv) below, XXXXXX-XXXXXXX shall pay to PFIZER for each of
Xxxxx Years Three, Four and Five an additional percentage of Net
Sales in excess of the Baseline Sales (the "Carryover
Percentage"). The Carryover Percentage shall be calculated as
follows:
Actual number of total additional PFIZER Details
performed during Xxxxx Years One and Two
------------------------------------------------- x 3.5%
1,000,000
(iii) PFIZER shall perform additional Details in both Xxxxx
Years One and Two, as set forth in Section 2.02(g), unless each
party, in its sole discretion, agrees in a writing signed by both
parties that PFIZER will not perform any additional Details in
Xxxxx Year Two. In the event of such an agreement, (a) PFIZER
shall be paid the Xxxxx Percentage (as defined in Section
3.02(h)(i) above) for Xxxxx Year One only and shall be paid the
Carryover Percentage (as defined in Section 3.02(h)(ii)
above) for Xxxxx Years Two, Three and Four only; and (b)
XXXXXX-XXXXXXX shall be required to perform an additional 250,000
Details per year for Agreement Years One and Two only.
(iv) Adjustments to the Xxxxx Percentage and Carryover Percentage
to be paid with respect to any given Agreement Year shall be made
as follows:
(a) In the event that PFIZER performs less than 500,000 total
additional Details in either of Xxxxx Years One or Two, the Xxxxx
Percentage to be paid to PFIZER for the corresponding Agreement
Year shall be calculated as follows:
Actual number of total additional PFIZER Details
performed during the relevant Xxxxx Year
------------------------------------------------ x 3.5%
500,000
(b) In the event that XXXXXX-XXXXXXX performs less than 250,000
total additional Details in any of Agreement Years One through
Four, the parties shall meet to discuss appropriate adjustments
to the compensation to be paid to PFIZER pursuant to this Section
3.02(h).
(v) For purposes of calculating the compensation to be paid to PFIZER
pursuant to this Section 3.02(h), the maximum number of additional
PFIZER Details to be credited to PFIZER in either Xxxxx Year One or
Xxxxx Year Two shall not exceed 500,000."
4. Section 3.03 of the Collaboration Agreement is amended to add the
following new subsections:
"(g) XXXXXX-XXXXXXX shall make payments to PFIZER arising under
Section 3.02(h) at the end of Agreement Years One through Six in
accordance with this Section 3.03 as set forth below:
Year End Action if Xxxxx Details for Two Years
-------- -------------------------------------
Agreement Year One Pay PFIZER the Xxxxx Percentage of Net Sales
in excess of the Baseline Sales in Agreement
Year One, prorated for number of Xxxxx Year
Months in Agreement Year One
Agreement Year Two Pay PFIZER the Xxxxx Percentage of Net Sales
in excess of the Baseline Sales in Agreement
Year Two
Xxxxx Year Two Calculate Carryover Percentage
(occurring mid-year
in Agreement Year
Three)
Agreement Years Pay PFIZER Carryover Percentage for Net Sales
Three, Four and Five in excess of the Baseline Sales in Agreement
Years Three, Four and Five
Agreement Year Six Pay PFIZER Carryover Percentage for Net Sales
in excess of the Baseline Sales in Agreement
Year Six, prorated for number of Xxxxx Year
Months in Agreement Year Six
(h) All payments to be made pursuant to Section 3.03 (g) shall be
made at the end of Agreement Years One through Six, as applicable, in
accordance with the provisions of Article III."
5. The second sentence of Section 5.02(a) is deleted in its entirety.
In all other respects, the Collaboration Agreement remains in full
force and effect. Please indicate your agreement to this amendment by
signing in the space provided and returning an original to me.
Very truly yours,
PFIZER INC.
By: /s/ Xxxxx X. Xxxxx
---------------------------------
Name: Xxxxx X. Xxxxx
Title: Vice President;
Executive Vice President,
President, USPG
AGREED AND ACCEPTED:
XXXXXX-XXXXXXX COMPANY
By: /s/ Xxxxxxx X. Xxxxxxx
---------------------------
Xxxxxxx X. Xxxxxxx
Title: Vice President;
President, Xxxxx-Xxxxx U.S. & Mexico
Date: 3/19/97
