Exhibit 4.3
[DEPRENYL LOGO]
[LETTERHEAD]
CONFIDENTIAL
DELIVERED BY FAX AND MAIL
December 22, 1999
Xx. Xxxxxx X. Xxxxxx
Vice President Business Development
Pfizer Animal Health
000 Xxxx 00xx Xxxxxx
Xxx Xxxx, XX 00000-0000
Dear Bob:
RE: ANIPRYL-Registered Trademark-
In November 1997, Pfizer, Inc. ("Pfizer"), Deprenyl Animal Health, Inc.
("DAHI") and Draxis Health Inc. ("Draxis") entered into a Master Agreement, a
License Agreement, a Research Agreement and a Manufacturing Agreement for
each of the US and Canada and the rest of the world (collectively, the
"Pfizer Agreements"). Terms capitalized herein and not otherwise defined
shall have the meanings attributed thereto in the Pfizer Agreements.
*
00000 Xxxx 00xx Xxxxxx, Xxxxx 000, Xxxxxxxx Xxxx, Xxxxxx 00000
Telephone: (000) 000-0000 Facsimile: (000) 000-0000
* Material has been omitted and filed separately with the Securities and
Exchange Commission
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*
Pfizer and DAHI hereby agree to the following and, as required, the Master
Agreement is hereby amended:
1. Section 3 of the Master Agreement is hereby amended to delete, in
respect of Cushings Disease and Cognitive Dysfunction, milestones in
respect of each of the United Kingdom, France and Germany, amounting to
$9 million in total with no further application of such unpaid
milestones to other Major Countries pursuant to Section 8(i) of the
Master Agreement. For greater certainty, pursuant to Section 8(i) of
the Master Agreement, Pfizer is not obligated to launch
Anipryl-Registered Trademark- in Europe and reserves the right to
decide on the feasibility of launching Anipryl-Registered Trademark- on
a country by country basis if and when a Registration is obtained. In
the event that Pfizer determines not to launch Anipryl-Registered
Trademark- in any such country, it shall surrender such Registration
and rights shall be reassigned to DAHI in accordance with Sections 8(I)
and 8(j) of the Master Agreement. Where Pfizer does decide to launch
Anipryl-Registered Trademark-, royalties on sales of Anipryl-Registered
Trademark- in Europe shall be paid in accordance with Section 3 of the
License Agreement;
2. In the event that DAHI does not submit the regulatory dossier to the
FDA in connection * within 6 months of completion of the statistical
report referred to in paragraph 4(b) below, or such later date as may
be reasonable in the circumstances, or having so submitted the dossier
it is rejected by FDA, DAHI shall enter into the agreements with Pfizer
and * provided * is in agreement at that time, on substantially the
terms and conditions contained in the * with such amendments as may
be necessary or desirable to exclude rights to the * in Europe and to
delete milestones of US$3 million which would have been owing to DAHI
in respect of the * provided that, other than the outcome of the ILE
trial, there have been no material intervening developments affecting
DAHI's and Pfizer's business rationale for entering into the *
3. Pfizer shall provide an additional US$244,000 of funding to *
4. Subject to extensions which may be agreed to by XXXX, acting
reasonably, due to unexpected difficulties or factors outside Pfizer's
control, and subject to DAHI's agreement as to content, acting
reasonably, Pfizer shall for the benefit of, and under the supervision
of XXXX:
(a) Return to DAHI the print outs of data entered by Pfizer on
behalf of DAHI on * within two weeks of any request (or such
later date as may be reasonable under the circumstances)
therefor by XXXX, provided that the raw data has been submitted
to DAHI at least two weeks in advance.
(b) Complete the statistical analysis and the Quality Assurance
audit on * * together with the statistical report, no
later than eight (8) weeks (or such later date as may be
reasonable under the circumstances) after the locking of the
electronic database, such timeline to commence when the
* Material has been omitted and filed separately with the Securities and
Exchange Commission
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Anipryl-Registered Trademark- Research Committee agrees that
all data have been entered, verified and locked with all
queries resolved, all original data in-house and all study
files in order;
(c) Review and provide comments on the DAHI-authored Sponsor's
report, including auditing of the Sponsor's report, no later
than one month (or such later date as may be reasonable under
the circumstances) after receipt of the draft report;
(d) Draft a summary module to accompany the US regulatory filing,
to be completed no later than two weeks (or such later date as
may be reasonable under the circumstances) after the
finalization of the Sponsor's report, subject to review and
approval by XXXX.
(e) Assemble the US regulatory dossier, including the summary
module, within 30 days (or such later date as may be reasonable
under the circumstances) of finalization of the Sponsor's
report; and
(f) Provide to DAHI within 7 days (or such later date as may be
reasonable under the circumstances) of completion of each item
an electronic copy of the database and the completed dossier,
including summary module, in a PC SAS format.
5. Each of DAHI and Pfizer will be responsible for its own internal costs
and DAHI shall be responsible for any regulatory fees payable in respect
of filing * regulatory dossier in all countries, other than Japan
where Pfizer shall be responsible for such expenses pursuant to
Section 8(b) of the Master Agreement;
6. Pfizer shall be entitled to participate in the registration process
with the FDA and the HPB with DAHI in respect of the ILE indication for
Anipryl-Registered Trademark- as described in Section 8(c) of the
Master Agreement;
7. Upon execution of this letter, Pfizer shall provide to DAHI a hard
copy and, if available, an electronic copy, of the following:
(a) Available long term stability data for batches of
Anipryl-Registered Trademark- manufactured by Mikart;
(b) for batches of Anipryl-Registered Trademark- manufactured by
Pfizer using bulk from Chinoin:
(i) Manufacturing batch records;
(ii) Certificates of analysis; and
(iii) Available results on any long term stability studies.
(c) Certificates of Analysis for commercial batches of
Anipryl-Registered Trademark- released by Pfizer and any
available long term stability studies conducted by Pfizer on
such batches.
for DAHI's use in applications for foreign registrations of
Anipryl-Registered Trademark-. At DAHI's request, Pfizer shall also
authorize, in writing, such regulatory authorities as may be
designated by DAHI to refer to the foregoing information for purposes
only of
* Material has been omitted and filed separately with the Securities and
Exchange Commission
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completing foreign registrations of Anipryl-Registered Trademark- and
DAHI shall be entitled to designate Pfizer as an Anipryl-Registered
Trademark- manufacturing site.
8. All other terms of the Pfizer Agreements are ratified and confirmed.
Yours very truly,
DEPRENYL ANIMAL HEALTH, INC. DRAXIS HEALTH INC.
Per: /s/ Xxxxxxxxxx Xx Xxxx Per: /s/ Xxxxxxxxxx Xx Xxxx
---------------------------- -----------------------------
Xxxxxxxxxx X. X. Xx Xxxx, Xxxxxxxxxx X. X. Xx Xxxx,
President Senior Vice President, Secretary and
Chief Development Officer
The foregoing is acknowledged and agreed to:
PFIZER INC.
Per: /s/ Xxxxxx X. Xxxxxx
----------------------------
Xxxxxx X. Xxxxxx
Vice President Business Development
JHRLS/II
c. Xxxxxx Xxxxxx
Xxxxxx Xxxxxx
