EXHIBIT 10.77
AMENDING AGREEMENT - PDT DERM
THIS AGREEMENT entered into on July 22, 2003 but having effect from and as of
May 31, 2003 (the "Effective Date").
BETWEEN:
NOVARTIS PHARMA AG, Business Unit Ophthalmics, a Swiss
corporation having a registered office at Xxxxxxxxxxxx 00,
0000 Xxxxx, Xxxxxxxxxxx
("NOVARTIS")
AND:
QLT INC. (formerly Quadra Logic Technologies Inc.), a British
Columbia company having a principal place of business at 000
Xxxxx Xxxxxxxx Xxx, Xxxxxxxxx, Xxxxxxx Xxxxxxxx, Xxxxxx, X0X
0X0
("QLT")
WHEREAS:
A. Novartis Ophthalmics AG (formerly Ciba Vision AG) and Novartis Pharma
AG merged effective July 1, 2003 to become Novartis Pharma AG;
B. Novartis and QLT entered into a PDT Product Development, Manufacturing
and Distribution Agreement made effective July 1, 1994 (the "ORIGINAL
CO-DEVELOPMENT AGREEMENT") under which Novartis and QLT agreed to
cooperate in the development, manufacturing and distribution of
photosensitizers in photodynamic therapy for the treatment, diagnosis
and prevention of ophthalmological conditions;
C. Novartis and QLT entered into an Amending Agreement made effective July
23, 2001 (the "DERM AMENDMENT") under which QLT and Novartis agreed to
co-develop Verteporfin (as defined herein) in the PDT Derm Field of
Collaboration (as defined in the Derm Amendment) on the terms and
conditions set out therein;
D. QLT and Novartis wish to terminate the Derm Amendment and return to QLT
all rights granted thereunder;
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E. QLT wishes to grant to Novartis a right of first option to negotiate to
participate in the commercialization of Verteporfin in PDT in
dermatological conditions other than dermatological tumors;
F. QLT and Novartis wish to confirm that QLT will be entitled to pursue
independently the development, manufacture, use and sale of Verteporfin
in all fields outside the Ocular Field of Collaboration (as defined
herein) except and unless Novartis and QLT enter into a subsequent
agreement with respect to the commercialization of Verteporfin in PDT
for a particular dermatological condition pursuant to the right of
first option provided for herein; and
G. QLT and Novartis wish to increase the size of the JCC so that it
consists of four appointees from each of QLT and Novartis.
NOW THEREFORE, in consideration of the premises and the mutual covenants and
agreements contained in this Amending Agreement, Novartis and QLT agree as
follows:
1. DEFINITIONS
All capitalized terms used in this Agreement and not otherwise defined will have
the meaning given to them in the Original Co-Development Agreement. The term
"Ocular Field of Collaboration" as used in this Amending Agreement will have the
same meaning given to the term "Field of Collaboration" in the Original
Co-Development Agreement.
2. SECTION 1.1 - NEW DEFINITIONS
All references in the Original Co-Development Agreement to "CIBA VISION" and
references in this Amending Agreement to "Novartis" will be deemed to be one and
the same. In addition, as of the Effective Date, Section 1.1 of the Original
Co-Development Agreement is amended as follows:
(a) BPD - the definition of "BPD" in Section 1.1.7 of the Original
Co-Development Agreement is amended by adding the words "and, for
greater certainty, includes Verteporfin" after the words "means
any pharmaceutical product which contains Benzoporphyrin
derivative as an active ingredient for use in PDT";
(b) VERTEPORFIN - the following definition is added as a new Section
1.1.41A to the Original Co-Development Agreement:
"1.1.41A "VERTEPORFIN" means benzoporphyrin derivative - mono
acid ring A, as more fully described in Exhibit A;".
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3. TERMINATION OF THE DERM AMENDMENT
As of the Effective Date, the Derm Amendment is hereby terminated, is no longer
of any force or effect and neither party has any further obligation thereunder
except as provided in Section 4 below. For greater certainty, notwithstanding
any arrangements or understandings made by the parties or the JCC, except as
expressly provided in Section 6 below, QLT and Novartis acknowledge and agree
that:
(a) Novartis no longer has any right to co-develop, manufacture, use or
distribute Verteporfin in the PDT Derm Field of Collaboration and
Novartis holds no rights of any kind to or interest in Verteporfin
(including, without limitation, any right to co-develop, manufacture,
use, distribute or right of first refusal to or notification or control
regarding Verteporfin) outside of the Ocular Field of Collaboration;
(b) Novartis has no further obligation to pursue the co-development,
manufacture, use or distribution of Verteporfin in the PDT Derm Field
of Collaboration;
(c) Novartis is not entitled to any payments or other compensation arising
from the development, manufacture, use or distribution of Verteporfin
by QLT, its affiliates and licensees outside of the Ocular Field of
Collaboration; and
(d) Novartis has no further obligation to provide the development funding
to QLT in respect of the PDT Derm Field of Collaboration or to provide
to QLT the milestone payments contemplated in the Derm Amendment.
Additionally, for greater clarity, the parties agree to revert to the term in
the Original Co-Development Agreement set forth in section 23.1; therefore, as
of the Effective Date, the term of the Original Co-Development Agreement will
end on June 30, 2014, subject to any further renewal rights that may be
exercised pursuant to Section 23.1 of the Original Co-Development Agreement.
4. FINAL ACCOUNTING
Following the date hereof, and in a manner consistent with the past practice
developed between the parties in the performance of the PDT Derm Amendment, QLT
will prepare a final accounting of those Development Expenses incurred by QLT in
April 2003 and May 2003 pursuant to the Derm Amendment and Novartis will
reimburse QLT for any such Development Expenses properly incurred by QLT.
5. TRANSITION OF ACTIVITIES IN THE PDT DERM FIELD OF COLLABORATION
QLT and Novartis will reasonably cooperate with one another to transition from
Novartis to QLT any activities previously being undertaken by Novartis in
connection with the co-development of Verteporfin in the PDT Derm Field of
Collaboration.
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6. RIGHT OF FIRST OPTION TO VERTEPORFIN IN CERTAIN PDT DERMATOLOGY FIELDS
The following is added as of the Effective Date as a new Section 12A to the
Original Co-Development Agreement:
"12A RIGHT OF FIRST OPTION TO COMMERCIALIZE VERTEPORFIN IN CERTAIN PDT
DERMATOLOGY FIELDS
As used in this Section 12A "OPTION FIELD" will mean the use of
Verteporfin in PDT for the treatment, prevention or diagnosis of any
dermatological condition excluding the treatment, prevention or
diagnosis of dermatological tumors. For greater certainty,
dermatological tumors include all forms of non-melanoma skin cancer,
including multiple basal cell carcinoma, and such conditions are
outside of the Option Field. Novartis will have no rights or
entitlements whatsoever with respect to any existing or future
development programs or the marketing and sale of Verteporfin for the
treatment, prevention or diagnosis of dermatological tumors.
At least 60 days prior to the date that QLT anticipates holding an end
of phase II clinical trial meeting with the United States Food and Drug
Administration with respect to any phase II clinical trials conducted
by QLT with respect to the use of Verteporfin in the Option Field, QLT
will notify Novartis (the "OPTION NOTICE") of its intention to further
develop and commercialize the use of Verteporfin in one or more
dermatological conditions in the specified Option Field. Upon
Novartis's request, QLT will provide reasonably promptly to Novartis
its views on the clinical and pre-clinical data possessed by QLT
related to the use of Verteporfin for the dermatological conditions
that are the subject of the Option Notice, along with QLT's then
current plans for the continued development and commercialization of
Verteporfin for those dermatological conditions and will reasonably
discuss the same with Novartis.
If Novartis wishes to participate in the commercialization of
Verteporfin in the dermatological conditions described in the Option
Notice, Novartis will notify QLT of such intent within thirty days
after receipt of the Option Notice and QLT and Novartis will then
negotiate each in good faith the financial and all other material terms
of an agreement pertaining to the commercialization of Visudyne in such
dermatological indications. If:
(a) Novartis notifies QLT that it does not wish to participate in such
commercialization of Verteporfin;
(b) Novartis fails to notify QLT that it wishes to participate in such
commercialization of Verteporfin in the time period set out above;
or
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(c) Novartis and QLT fail to enter into a letter of intent with
respect to the commercialization of Verteporfin in the
dermatological conditions described in the Option Notice prior to
the 60th day after the date of QLT's Option Notice or if Novartis
and QLT fail to enter into a binding agreement with respect to the
commercialization of Verteporfin in the dermatological conditions
described in the Option Notice within 60 days thereafter;
then QLT will be free to pursue alone, or enter into agreements with
one or more Third Parties for, the promotion, distribution and/or sale
of Verteporfin in the dermatological conditions that were the subject
of the Option Notice. Except where the events referred to in (a) and
(b) above occurred, for a period of one year following the date that
QLT and Novartis discontinue such negotiations such agreements with
Third Parties will not be on terms and conditions that are materially
more favorable to the Third Party than those previously offered by QLT
to Novartis.
Nothing in this Section 12A will obligate QLT to pursue the
development, regulatory approval or commercialization of Verteporfin
for use in any dermatological condition."
7. JCC COMPOSITION
The parties wish to increase the number of members on the JCC so that the JCC
will consist of four appointees from each of QLT and Novartis. Therefore, as of
the Effective Dater, Section 5.1 of the Original Co-Development Agreement is
amended by replacing the word "three" in the first sentence thereof with the
word "four".
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8. SECTION 24.12 - NOTICE
The address for notice for each of QLT and Novartis in Section 24.12 of the
Original Co-Development Agreement is deleted and replaced with the following:
"If to QLT:
---------
QLT Inc.
000 Xxxxx Xxxxxxxx Xxx
Xxxxxxxxx, Xxxxxxx Xxxxxxxx, Xxxxxx
X0X 0X0
Attention: President and Chief Executive Officer
with a copy to:
QLT Inc.
000 Xxxxx Xxxxxxxx Xxx
Xxxxxxxxx, Xxxxxxx Xxxxxxxx, Xxxxxx
X0X 0X0
Attention: Chief Legal Officer
If to Novartis:
Novartis Pharma AG
Business Unit Ophthalmics
Postfach
XX-0000 Xxxxx
Xxxxxxxxxxx
Attention: Head of Ophthalmics Business Unit
with a copy to:
Novartis Pharma AG
Xxxxxxxxxxxx 00
Xxxxx, Xx-0000
Xxxxxxxxx: Head of Legal, Ophthalmics"
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9. CONFIRMATION
Other than as expressly amended by the terms of this Amending Agreement, the
Original Co-Development Agreement remains in full force and effect in accordance
with its terms.
10. COUNTERPARTS
This Amending Agreement may be signed in any number of counterparts (including
by facsimile) and each counterpart will constitute an original document and all
counterparts, taken together, will constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed this Amending Agreement as of the
day and year first written above.
QLT INC. NOVARTIS PHARMA AG
by its authorized signatory: by its authorized signatory:
Per: Per:
---------------------------- --------------------------
Name: Xxxx X. Xxxxxxxx Name:
Title: President and CEO Title:
Per: Per:
-------------------------------- --------------------------
Name: Xxxxxxx X. Xxxxxx Name:
Title: Senior Vice President and Title:
Chief Business Officer
EXHIBIT A
VERTEPORFIN
[MOLECULAR STRUCTURES]
