EXHIBIT 10.74
AMENDING AGREEMENT TO
PDT PRODUCT DEVELOPMENT, MANUFACTURING AND
DISTRIBUTION AGREEMENT
THIS AMENDING AGREEMENT is made effective July 23, 2001.
BETWEEN:
NOVARTIS OPHTHALMICS AG (formerly CIBA Vision AG), a Swiss
corporation having a principal place of business at
Xxxxxxxxxxxxxx 0, XX-0000 Xxxxxxxxxx, Xxxxxxxxxxx
("NVO")
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. NVO and QLT entered into a PDT Product Development, Manufacturing and
Distribution Agreement made effective July 1, 1994 (the "CO-DEVELOPMENT
AGREEMENT") under which NVO 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;
B. Pursuant to the Co-Development Agreement, NVO and QLT have and continue
to co-develop Verteporfin (as defined in this Amending Agreement) for
use in certain ophthalmological indications;
C. Verteporfin is now being marketed and sold by NVO pursuant to the
Co-Development Agreement under the trade-xxxx Visudyne(TM)for use in
wet age-related macular degeneration and pathological myopia and both
parties wish to further the development of and to promote and defend
the marketing of Visudyne(TM);
D. QLT completed a Phase IIb clinical study using photodynamic therapy
with Verteporfin for the treatment of non-melanoma skin cancer
("NMSC");
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E. NVO and QLT wish to co-develop Verteporfin for the treatment of NMSC
and other indications within the PDT Derm Field of Collaboration (as
defined in this Amending Agreement); and
F. NVO and QLT wish to enter into this Amending Agreement to include
within the scope of the Co-Development Agreement the development,
manufacture and distribution of Verteporfin for the treatment of NMSC
and other indications within the PDT Derm Field of Collaboration and to
make all consequential amendments resulting from that inclusion, all on
and subject to the terms and conditions set out in this Amending
Agreement.
NOW THEREFORE, in consideration of the premises and the mutual covenants and
agreements contained in this Amending Agreement, NVO and QLT agree as follows:
1. DEFINITIONS IN THE CO-DEVELOPMENT AGREEMENT TO APPLY
All capitalized terms used in this Amending Agreement and not otherwise defined
will have the meaning given to them in the Co-Development Agreement.
2. SECTION 1.1 - NEW OR AMENDED DEFINITIONS
All references in the Co-Development Agreement to "CIBA VISION" and references
in this Amending Agreement to "NVO" will be deemed to be one and the same. In
addition, Section 1.1 of the Co-Development Agreement is amended as follows:
(a) APPROVED PRODUCT - the definition of "Approved Product" in
Section 1.1.5 of the Co-Development Agreement is amended by
deleting the words "specific ophthalmological indication" in
the second line and replacing them with the words "specific
indications within the Field of Collaboration";
(b) BPD - the definition of "BPD" in Section 1.1.7 of the
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";
(c) DEVELOPMENT PROGRAM - the definition of "Development Program"
in Section 1.1.12 of the Co-Development Agreement is amended
by deleting the words "specific ophthalmological indications
within the Field of Collaboration" in the third and fourth
lines and replacing them by the words "specific indications
within the Field of Collaboration";
(d) FIELD OF COLLABORATION - the definition of "Field of
Collaboration" in Section 1.1.14 of the Co-Development
Agreement is deleted and replaced with the following:
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"1.1.14 "FIELD OF COLLABORATION" means,
collectively, the Ocular Field of
Collaboration and the PDT Derm Field of
Collaboration;";
(e) MARKETING APPROVAL - the definition of "Marketing Approval" in
Section 1.1.20 of the Co-Development Agreement is amended by
deleting the words "specific ophthalmological indication" in
the third and fourth lines and replacing them with the words
"specific indication within the Field of Collaboration";
(f) NMSC - the following definition is added as a new Section
1.1.24A to the Co-Development Agreement:
"1.1.24A "NMSC" means non-melanoma skin cancer,
including basal cell carcinoma, squamous
cell carcinoma and basal cell nevus
syndrome;"
(g) OCULAR FIELD OF COLLABORATION AND PDT DERM FIELD OF
COLLABORATION - the following definitions are added as new
Sections 1.1.24B, 1.1.24C and 1.1.24D to the Co-Development
Agreement:
"1.1.24B "OCULAR FIELD OF COLLABORATION" means
any usage of PDT for the treatment,
diagnosis or prevention of ophthalmological
conditions, including but not limited to,
age-related macular degeneration (AMD),
diabetic retinopathy, corneal
neovascularization, ocular tumours and
epithelial overgrowth following cataract
surgery (secondary cataracts);
1.1.24C "PDT DERM FIELD OF COLLABORATION" means
any usage of Verteporfin in PDT for the
treatment, diagnosis or prevention of:
.1 dermatological tumours, including NMSC
but excluding [*]; and
.2 pathological conditions of the skin in
which the primary cause is attributable to
vascular abnormality, including Xxxxx'x
disease, cutaneous T-cell lymphoma,
hemangioma and vascular malformations but,
for greater certainty, excluding psoriasis;
1.1.24D "[*]" means the use of a photosensitizer in
the photodynamic treatment of [*]";
*Material has been omitted and filed separately with the Commission.
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(h) PRODUCT - the definition of "Product" in Section 1.1.28 of the
Co-Development Agreement is deleted and replaced by the
following:
"1.1.28 "PRODUCT" means:
.1 with respect to the Ocular Field of
Collaboration:
(a) BPD;
(b) ZnPc; and/or
(c) any Additional Photosensitzer;
.2 with respect to the PDT Derm Field of
Collaboration, Verteporfin.";
(i) VERTEPORFIN - the following definition is added as a new
Sections 1.1.41A to the Co-Development Agreement:
"1.1.41A "VERTEPORFIN" means benzoporphyrin
derivative - mono acid ring A, as more
fully described in Exhibit A;".
3. SECTION 2.1 - DEVELOPMENT COMMITMENT
Section 2.1 of the Co-Development Agreement is amended by adding the word
"respective" to the first line before the words "Field of Collaboration".
4. SECTION 2.4 - DEVELOPMENT PROGRAMS AND BUDGETS
Section 2.4 of the Co-Development Agreement is amended as follows:
(a) by adding the following as a new Section 2.4.4 to the
Co-Development Agreement:
"2.4.4 the development of Verteporfin in NMSC
substantially in accordance with the
development plan for that Development
Program attached as Exhibit B to this
Amending Agreement. For greater certainty,
the Development of any Additional
Photosensitizers (other than Verteporfin)
within the PDT Derm Field of Collaboration
is excluded from the scope of this
Agreement;";
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(b) by deleting from Section 2.4 of the Co-Development Agreement
the following sentence:
"There will be at least one Development
Program, and, where appropriate, the JCC may
establish additional Development Programs
for significant ophthalmological
applications.";
and replacing that sentence with the following sentence:
"There will be at least [*]in each of the
Ocular Field of Collaboration and the PDT
Derm Field of Collaboration, and, where
appropriate, the JCC may establish
additional Development Programs for
significant indications within the Field of
Collaboration."; and
(c) by adding the following to the end of the last paragraph of
Section 2.4:
"The goal of the initial Development Program
for Verteporfin in the PDT Derm Field of
Collaboration is to [*]. If either NVO or
QLT wish to pursue a Development Program for
Verteporfin in any NMSC indications [*] to
achieve that objective, including the
financial terms and cost sharing
arrangements related to that Development
Program."
5. SECTION 4.3 - PDT DEVICES
Section 4.3 of the Co-Development Agreement is deleted and replaced with the
following:
"4.3 PDT DEVICES
Costs related to the development and acquisition of PDT devices
which are necessary for clinical and non-clinical use in
Development Programs will be considered as Development
Expenses as provided for in Section 1.1.11."
6. SECTION 12 - MANDATORY RIGHT OF FIRST REFUSAL ON ADDITIONAL
PHOTOSENSITIZERS
NVO and QLT acknowledge that Section 12 of the Co-Development Agreement is not
intended to provide the other with a right of first refusal for the use of
Additional Photosensitizers in the PDT Derm Field of Collaboration but is
intended only to apply to the use of Additional Photosensitizers in the Ocular
Field of Collaboration. Therefore, Sections 12.1 to and including 12.5 of the
Co-Development Agreement are amended by
*Material has been omitted and filed separately with the Commission.
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deleting each reference to the "Field of Collaboration" in those Sections and
replacing them with the "Ocular Field of Collaboration".
In addition, Section 12.1 of the Co-Development Agreement is amended by adding
the following sentence to the end of Section 12.1:
"This Section 12 will not apply to the use (or proposed use) of any
Additional Photosensitizers in the PDT Derm Field of Collaboration.
However, while NVO will not be entitled to a right of first refusal
with respect to any Additional Photosensitizer in the PDT Derm Field of
Collaboration, [*] Field of Collaboration. QLT will provide that notice
following completion by QLT of the corresponding proof of principle
with that Additional Photosensitizer, or earlier at QLT's discretion."
The following is added as a new Section 12A to the Co-Development Agreement:
"12A RIGHT OF FIRST REFUSAL ON VERTEPORFIN IN OTHER DERM
INDICATIONS
12A.1 DERM RFR NOTICE
During the term of this Agreement, QLT will notify NVO in a timely
manner through the JCC (the "DERM RFR NOTICE") of any opportunities for
the development and commercialization of Verteporfin in PDT in the
treatment, prevention or diagnosis of any dermatological conditions
that are outside of the PDT Derm Field of Collaboration (the
"ADDITIONAL DERM FIELDS") that QLT may have developed, licensed,
acquired or otherwise has commercial access. QLT will provide the Derm
RFR Notice following completion by QLT of the corresponding proof of
principle for that opportunity, or earlier at QLT's discretion.
12A.2 TERMS OF DERM RFR NOTICE
The Derm RFR Notice will state a reasonably clear and complete
description of the opportunity which is the subject of the Derm RFR
Notice, and the terms on which QLT proposes to offer the opportunity to
NVO, including all monetary terms, all of which terms other than the
financial terms will be reasonably consistent with this Agreement.
12A.3 PROOF OF PRINCIPLE REQUIRED
The Derm RFR Notice will also be accompanied by sufficient preliminary
testing to establish the proof of principle for the use of Verteporfin
in PDT in the specified Additional Derm Field.
12A.4 VERTEPORFIN ACCEPTANCE NOTICE
Upon receipt of the Derm RFR Notice, NVO may elect to extend the terms
of this Agreement, as modified by the terms proposed in the Derm RFR
Notice, to
*Material has been omitted and filed separately with the commission.
7
include the development and commercialization of Verteporfin in PDT in
the Additional Derm Field specified in the Derm RFR Notice by
delivering to QLT notice of its intention to do so within [*] days
following receipt by NVO of the Derm RFR Notice (the "DERM ACCEPTANCE
NOTICE"). Thereafter, QLT and NVO will negotiate in good faith any
amendments necessary to this Agreement to reflect those terms.
12A.5 CONSEQUENCES SHOULD NVO NOT ACCEPT
If NVO fails to deliver the Derm Acceptance Notice in the time period
set out in Section 12A.4, then:
.1 subject to Section 12A.5.2 below, QLT
may pursue alone or offer and agree with
any Third Party for the development and/or
commercialization of Verteporfin in PDT in
the Additional Derm Field specified in the
Derm RFR Notice on terms and conditions no
more favourable than those set out in the
Derm RFR Notice; and
.2 notwithstanding Section 12A.5.1, QLT will
not commercialize Verteporfin in PDT alone
or with/by any Third Parties in any
Additional Derm Field, other than the use
of [*], without the prior written consent
of NVO. The consent of NVO will not be
required for QLT to pursue the
commercialization of [*]."
7. SECTION 13.2 - FUNDING FORMULA FOR DEVELOPMENT EXPENSES
Section 13.2 of the Co-Development Agreement is amended by adding the following
as a new Section 13.2.4:
"13.2.4 the Development Expenses and regulatory fees related to the
Development Program for North America and Europe for the use
of Verteporfin in NMSC (as part of the Development Program
outlined in Exhibit B) will be paid fully (100%) by NVO until
the first to occur of the following events:
.1 NVO has expended CDN$15,000,000 on those
Development Expenses; or
.2 the filing for Marketing Approval in the
United States and Europe for the use of
Verteporfin for one or more NMSC
indications; and
*Material has been omitted and filed separately with the Commission.
8
thereafter those Development Expenses and regulatory fees
will be split 50% to NVO and 50% to QLT."
8. NMSC MILESTONE PAYMENTS
The following is added as a new Section 14A to the Co-Development Agreement:
"14A NVO will make the following payments to QLT with respect to
the first Product which has received Marketing Approval for
use in the PDT Derm Field of Collaboration:
.1 [*] upon filing of a submission for
Marketing Approval for the use of
Verteporfin in an indication within the
PDT Derm Field of Collaboration in the
first of North America or Europe; and
.2 [*] upon receipt of Marketing Approval
for the use of Verteporfin in an
indication within the PDT Derm Field of
Collaboration in the first of North
America or Europe;
subject to adjustment as set out below. The milestone
payments set out above will be paid only the first time the
events referred to in Sections 14A.1 and 14A.2 occur.
Each milestone payment will be made by cheque or wire
transfer payable to QLT within 30 days after the date that
the corresponding milestone event occurs.
9. SECTION 23.1 - TERM
NVO and QLT hereby exercise their right under Section 23.1 of the Co-Development
Agreement to renew the term of the Co-Development Agreement for an additional
period of 5 years beyond the current 20 year term. Therefore, effective upon
execution of this Amending Agreement, the term of the Co-Development Agreement
will extend until June 30, 2019, subject to any further renewal rights that may
be exercised pursuant to Section 23.1 of the Co-Development Agreement.
10. SECTION 24.12 - NOTICE
The address for notice for QLT in Section 24.12 of the Co-Development Agreement
is deleted and replaced with the following:
"If to QLT:
QLT Inc.
000 Xxxxx Xxxxxxxx Xxx
*Material has been omitted and filed separately with the Commission.
0
Xxxxxxxxx, Xxxxxxx Xxxxxxxx, Xxxxxx
X0X 0X0
Attention: President and Chief Executive Officer
with a copy to:
Farris, Vaughan, Xxxxx & Xxxxxx
Xxxxxxxxxx & Xxxxxxxxxx
X.X. Xxx 00000 Xxxxxxx Xxxxxx
2600 - 000 Xxxx Xxxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxx Xxxxxxxx, Xxxxxx
X0X 0X0
Attention: R. Xxxxxx XxxXxx-Xxxx"
11. CONFIRMATION
Other than as expressly amended by the terms of this Amending Agreement, the
Co-Development Agreement remains in full force and effect in accordance with its
terms.
12. INTERPRETATION/GENERAL
Sections 24.1 to and including 24.10 of the Co-Development Agreement and
Sections 24.12, 24.13, 24.15 and 24.18 of the Co-Development Agreement are
incorporated by reference into this Amending Agreement.
13. 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 OPHTHALMICS AG
by its authorized signatory: by its authorized signatory:
Per: Per:
/s/ Xxxxx Xxxx /s/ Xxxx von Bidder
---------------------------- ----------------------------
Name: Xxxxx Xxxx Name: Xxxx von Bidder
Title: President and CEO Title: President, Ophthalmics
Business Unit
Per: Per: /s/ Xx. Xxxxxxx Xxxxx
----------------------------
Name: Xx. Xxxxxxx Xxxxx
Title: Vice President,
Business Development
and Licensing
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/s/ Xxxxx Xxxx
----------------------------
Name: Xxxxx Xxxx
Title: Senior Vice President,
Corporate Development
EXHIBIT A
VERTEPORFIN
[MOLECULAR STRUCTURES]
EXHIBIT B
NMSC OUTLINE OF DEVELOPMENT PROGRAM
The following is a high level summary of the proposed Development
Program for the first indication to be pursued within the PDT Derm Field of
Collaboration, as contemplated in Section 2.4.4 of the Co-Development Agreement:
INDICATION: [*].
DRUG: Verteporfin.
FORMULATION: [*].
CLINICAL DEVELOPMENT PLAN AND ASSUMPTIONS:
[*]
*Material has been omitted and filed separately with the Commission.
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PROPOSED DEVELOPMENT TIMELINE (US DRIVEN):
[*]
*Material has been omitted and filed separately with the Commission.
