FIRST AMENDMENT TO PLATFORM TECHNOLOGY TRANSFER AND LICENSE AGREEMENT
Exhibit 99.1
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD
LIKELY CAUSE COMPETITIVE HARM TO ZYMEWORKS INC. IF PUBLICLY DISCLOSED. INFORMATION THAT HAS BEEN OMITTED HAS BEEN NOTED IN THIS DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE XXXX “[…***…]”.
Execution Copy
FIRST AMENDMENT TO
PLATFORM TECHNOLOGY TRANSFER AND LICENSE AGREEMENT
This First Amendment (the “Amendment”)
to that certain Platform Technology Transfer and License Agreement, dated April 21, 2016 (the “Agreement”) by and between GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LIMITED, a corporation organized and existing under the laws of England and Wales, with its registered office located at 000
Xxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx, XX0 0XX, Xxxxxx Xxxxxxx (“GSK”) and ZYMEWORKS INC., a corporation organized and existing under the laws of British Columbia, having an address at 000-0000 Xxxx 0xx Xxxxxx, Xxxxxxxxx, XX, Xxxxxx X0X 0X0 (“Zymeworks”), is entered into as of May 14, 2019 (the “First Amendment Effective Date”). Zymeworks and GSK
are each referred to individually as a “Party” and together as the “Parties.”
BACKGROUND
| A. |
GSK and Zymeworks entered into the Agreement, pursuant to which GSK obtained access to the Zymeworks Platform and certain licenses under the Zymeworks Intellectual
Property to research, develop and commercialize certain products comprising bi-specific antibodies created using the Zymeworks Platform.
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| B. |
GSK and Zymeworks now desire to amend the Agreement to provide GSK with access to […***…]1
Platform (as defined below), all as set forth herein.
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NOW THEREFORE, in
consideration of the mutual covenants and agreements contained herein, the sufficiency of which is acknowledged by both Parties, the Parties agree as follows:
AGREEMENT
| 1. |
Definitions. Unless otherwise defined in this Amendment,
initially capitalized terms used herein shall have the meanings given to them in the Agreement.
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| 2. |
Section 1.22. Field. Section 1.22 of the Agreement is hereby
deleted in its entirety and replaced with the following:
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““Field” means diagnosis,
prevention, palliation and treatment of human or animal disease and disorders. The Field includes the […***…]2 Field and the General Field.
1 Competitive Information – Discovery Information and Technical
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1.22.1. “General Field” means
diagnosis, prevention, palliation and treatment of human or animal disease and disorders outside of the […***…]3 Field.
1.22.2. “[…***…]4 Field” means treatment, prevention or cure of […***…]5.”
| 3. |
Section 1.25. GSK Antibody. The following sentence is hereby
added to the end of Section 1.25 of the Agreement:
|
“For clarity, GSK Antibodies derived and
generated from […***…]6 Sequence Pairs shall be limited to Antibodies made through the application of the […***…]7 Platform and the […***…]8 Platform (“[…***…]9 Antibodies”), and GSK
Antibodies derived and generated from […***…]10 Sequence Pairs shall be limited to Antibodies made through the application of the […***…]11 Platform, but not the […***…]12 Platform (“[…***…]13 Antibodies”).”
| 4. |
Section 1.39. Nomination Period. Section 1.39 of the Agreement
is hereby deleted in its entirety and replaced with the following:
|
““Nomination Period” means the period
commencing on the Effective Date and ending […***…]14.”
| 5. |
Section 1.47. Product. Section 1.47 of the Agreement is hereby
deleted in its entirety and replaced with the following:
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““Product” means (a) with respect to
any pharmaceutical or biopharmaceutical product that incorporates one (1) or more GSK Antibodies derived and generated from a […***…]15 Sequence Pair, a […***…]16 Product derived and generated from such […***…]17 Sequence Pair, but no other Antibodies, and (b) with respect to any pharmaceutical or biopharmaceutical product that incorporates one (1) or more GSK Antibodies derived and generated
from a […***…]18 Sequence Pair, a […***…]19 Product derived and generated from such […***…]20
3 Competitive Information – Technical Information.
4 Competitive Information – Technical Information.
5 Competitive Information – Technical Information.
6 Competitive Information – Technical Information.
7 Competitive Information – Discovery Information and Technical
Information.
8 Competitive Information – Discovery Information and Technical
Information.
9 Competitive Information – Discovery Information and Technical
Information.
10 Competitive Information – Technical Information.
11 Competitive Information – Discovery Information and Technical
Information.
12 Competitive Information – Discovery Information and Technical
Information.
13 Competitive Information – Technical Information.
14 Competitive Information – Other Commercially Sensitive Terms.
15 Competitive Information – Technical Information.
16 Competitive Information – Discovery Information and Technical
Information.
17 Competitive Information – Technical Information.
18 Competitive Information – Technical Information..
19 Competitive Information – Discovery Information and Technical
Information.
20 Competitive Information – Technical Information.
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Sequence Pair, but no other Antibodies. For clarity, a Product (i) shall include one or more GSK Antibody(ies); and (ii) may include
another antibody that is not an Antibody.
“1.47.1 “[…***…]21 Product” means a Product, with respect to which the GSK Antibody is made through the application of the […***…]22 Platform and the […***…]23 Platform.
“1.47.2 “[…***…]24 Product” means a Product, with respect to which the GSK Antibody is made through the application of the […***…]25 Platform, but not the […***…]26 Platform.”
| 6. |
Section 1.51.1. Research Sequence Pair. A new Section 1.51.1
is hereby added to the Agreement as follows:
|
“1.51.1. “Research Sequence Pair”
means a Sequence Pair Directed To a Target Pair, selected by GSK to be a Research Sequence Pair and found to be available in accordance with Section 3.4.3.”
| 7. |
Section 1.54. Technical Dossier. Exhibit 1.54 is hereby replaced with Exhibit 1.54 attached hereto.
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| 8. |
Section 1.61. Zymeworks Improvements. Section 1.61 of the
Agreement is hereby deleted and replaced with the following:
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“Zymeworks Improvement(s)” means any
modification or technical advance of the Zymeworks Platform, which (a): (i) […***…]27 or (ii) […***…]28 (b) comprises (i) […***…],29 or (ii) […***…]30, or (iii) […***…],31 or (iv) […***…],32 in each case that are […***…].” 33
| 9. |
Section 1.64. Zymeworks Patent Rights. Exhibit 1.64 is hereby replaced with Exhibit 1.64 attached hereto.
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| 10. |
Section 1.65. Zymeworks Platform. Section 1.65 of the Agreement
is hereby deleted and replaced with the following:
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21 Competitive Information – Discovery Information and Technical
Information..
22 Competitive Information – Discovery Information and Technical
Information.
23 Competitive Information – Discovery Information and Technical
Information.
24 Competitive Information – Discovery Information and Technical
Information..
25 Competitive Information – Discovery Information and Technical
Information.
26 Competitive Information – Discovery Information and Technical
Information.
27 Competitive Information – Other Commercially Sensitive Terms.
28 Competitive Information – Other Commercially Sensitive Terms.
29 Competitive Information – Discovery Information and Technical
Information.
30 Competitive Information – Discovery Information and Technical
Information.
31 Competitive Information – Discovery Information and Technical
Information.
32 Competitive Information – Discovery Information and Technical
Information.
33 Competitive Information – Technical Information and Other Commercially
Sensitive Terms.
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““Zymeworks Platform” means (a)
Zymeworks’ proprietary Azymetric™ […***…]34 technology platform, comprised of mutations which enable the efficient formation of […***…]35 and (b) Zymeworks’ proprietary Azymetric™ […***…]36, each as described in the Technical Dossier.”
| 11. |
Section 2.1.1. Research and Development License. The word “royalty-free” is hereby inserted immediately
after “non-exclusive, worldwide,” in the
first sentence.
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| 12. |
Section 2.1.3. License Limitations; […***…]37. A new Section 2.1.3 of the Agreement is hereby added as follows:
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“2.1.3. License Limitations; […***…]38. For clarity, the licenses set forth in this Section 2.1 shall be
subject to the limitations set forth in 3.4.3(a), based on the designations made by GSK. For […***…]39 Sequence Pairs only, during the Nomination Period but prior to
the selection of the GSK Sequence Pair Directed To the applicable Target Pair, (i) Zymeworks hereby grants to GSK an exclusive, worldwide, royalty-free, fully paid-up license, including the right to sublicense to Affiliates of GSK and any Third
Parties (in accordance with Section 2.2), under the Zymeworks Intellectual Property solely to […***…]40 with respect to Antibodies derived and generated from […***…]41 to […***…]42; and (ii) Zymeworks will not conduct, and will not grant to Third Parties a
license under Zymeworks Intellectual Property to, research, develop or commercialize products incorporating Antibodies derived and generated from the Research Sequence Pairs (each, a “Research Product”). For clarity, upon […***…]43, whichever is earlier, the foregoing exclusive license and Zymeworks’ obligation not
to conduct such activities, or grant a license to a Third Party, shall expire with respect to all Research Sequence Pairs and Research Products Directed To such Target Pair, and GSK’s rights and licenses with respect to the GSK Sequence Pair, GSK
Antibody and Product Directed to such Target Pair shall be pursuant to the commercial license set forth in Section 2.1.2. Notwithstanding the provisions of this Section 2.1.3, if, during the Term, (a) an Acquiring Entity merges or consolidates with
or acquires Zymeworks or any Affiliate of Zymeworks or (b) Zymeworks transfers all or substantially all of its assets to which this Agreement pertains to an Acquiring Entity ((a) and (b) each, a “Change in Control”), and the Acquiring Entity is either then commercializing a Research Product, or has initiated development activities with respect to a Research Product, such Change in Control, and the
development, manufacture and commercialization of such Research Product by or on behalf
34 Competitive Information – Technical Information.
35 Competitive Information – Discovery Information and Technical
Information.
36 Competitive Information – Discovery Information and Technical
Information.
37 Competitive Information – Discovery Information.
38 Competitive Information – Discovery Information.
39 Competitive Information – Discovery Information.
40 Competitive Information – Discovery Information and Technical
Information.
41 Competitive Information – Discovery Information and Technical
Information.
42 Competitive Information – Discovery Information and Technical
Information.
43 Competitive Information – Other Commercially Sensitive Terms.
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of such Acquiring Entity, or any of its Affiliates, shall not constitute a breach of this Section 2.1.3.”
| 13. |
Section 2.2.1 Sublicenses. The cross-references to “Section 2.1.1 and 2.1.2” in Section 2.2.1 of
the Agreement are replaced in each instance with the cross-references to “Section 2.1.1, 2.1.2 and 2.1.3”.
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| 14. |
Section 2.6 […***…]44 Continuation of Development. A new Section 2.6 of the Agreement is hereby added
as follows :
|
“If GSK suspends development of a GSK Antibody, is contractually obligated to provide […***…]45 with any information necessary to enable […***…]46 of such GSK Antibody, and demonstrates such contractual obligation to Zymeworks, Zymeworks shall use commercially reasonably efforts to […***…]”47
| 15. |
Section 3.4.3(a). Sequence Pair Designation. The following
sentences shall be inserted into Section 3.4.3(a) of the Agreement after the first two (2) sentences of that Section:
|
“In each such submission, GSK shall designate whether GSK Antibodies derived and generated from such GSK Sequence Pair will be
incorporated into […***…]48 Products, in which case such GSK Sequence Pair may be referred to herein as a “[…***…]49 Sequence Pair”, or
[…***…]50 Products, in which case such GSK Sequence Pair may be referred to herein as a “[…***…]51 Sequence Pair”. In addition, with
respect to each […***…]52 Sequence Pair, GSK shall designate GSK Antibodies derived and generated from such […***…]53 Sequence Pair to be developed and commercialized for used in the […***…]54 Field (each, an “[…***…]55 Sequence Pair”)
or in the General Field (each, a “General […***…]56 Sequence Pair”). The rights and licenses granted to GSK in Section 2.1.2., (x) with respect to Antibodies derived and generated from […***…]57 Sequence Pairs shall be limited to […***…]58 Antibodies and […***…]59 Products, (y) with respect to Antibodies derived and generated from […***…]60 Sequence
Pairs shall be
44 Competitive Information – Other Commercially Sensitive Terms.
45 Competitive Information – Other Commercially Sensitive Terms.
46 Competitive Information – Discovery Information and Other Commercially
Sensitive Terms.
47 Competitive Information – Discovery Information and Other Commercially
Sensitive Terms.
48 Competitive Information – Technical Information.
49 Competitive Information – Discovery Information and Technical
Information.
50 Competitive Information – Discovery Information and Technical
Information.
51 Competitive Information – Discovery Information and Technical
Information.
52 Competitive Information – Discovery Information and Technical
Information.
53 Competitive Information – Discovery Information and Technical
Information.
54 Competitive Information – Discovery Information and Technical
Information.
55 Competitive Information – Discovery Information and Technical
Information.
56 Competitive Information – Discovery Information and Technical
Information.
57 Competitive Information – Technical Information.
58 Competitive Information – Technical Information.
59 Competitive Information – Technical Information.
60 Competitive Information – Discovery Information and Technical
Information.
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limited to […***…]61 Antibodies and […***…]62 Products for use in the […***…]63 Field, and (z) with respect to Antibodies derived and
generated from General […***…]64 Sequence Pairs shall be limited to […***…]65 Antibodies
and […***…]66 Products for use in the General Field. Solely with respect to […***…]67
Sequence Pairs, at any time prior to selecting a GSK Sequence Pair Directed To a particular Target Pair for use in the […***…]00 Xxxxx, XXX shall have the right to
select up to […***…]69 Research Sequence Pairs Directed to such Target Pair, for purposes of […***…]70 of Antibodies derived and generated from such […***…]71 Sequence Pairs to inform […***…]72, pursuant to the license set forth in Section 2.1.3.”
| 16. |
Section 3.4.4. Substitution of Sequence Pairs. The following
sentence is hereby added at the end of Section 3.4.4 of the Agreement:
|
“Notwithstanding the foregoing, in the event that GSK substitutes a GSK Sequence Pair that would have been subject to […***…]73 than the GSK Sequence Pair that it is replacing, […***…]74 upon making such
substitution.”
| 17. |
Section 3.4.5. Nomination of Timing. The following sentence is
hereby added at the end of Section 3.4.5 of the Agreement:
|
“Notwithstanding the foregoing, any […***…]75
conducted in accordance with Section 2.1.3 with respect to Antibodies derived and generated from Research Sequence Pairs shall not be prohibited by, or subject to this Section 3.4.5, nor shall such […***…]76 prohibit GSK from obtaining a commercial license with respect to such Research Sequence Pairs.”
| 18. |
Section 4.2. Sequence Pair Nomination Right Exercise Fee Payment.
Section 4.2 of the Agreement is hereby deleted in its entirety and replaced with the following:
|
“4.2. Sequence Pair Nomination Right Exercise Fee Payments. In partial consideration of the Licenses,
GSK shall pay Zymeworks up to six (6) nomination fees (each, a “Nomination Fee”) as
61 Competitive Information – Discovery Information and Technical
Information.
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Information.
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Information.
65 Competitive Information – Discovery Information and Technical
Information.
66 Competitive Information – Discovery Information and Technical
Information.
67 Competitive Information – Discovery Information and Technical
Information.
68 Competitive Information – Technical Information.
69 Competitive Information – Discovery Information and Other Commercially
Sensitive Terms.
70 Competitive Information – Discovery Information and Technical
Information.
71 Competitive Information – Discovery Information and Technical
Information.
72 Competitive Information – Discovery Information and Technical
Information.
73 Competitive Information – Financial Provisions.
74 Competitive Information – Financial Provisions and Other Commercially
Sensitive Terms.
75 Competitive Information – Discovery Information and Technical
Information.
76 Competitive Information – Discovery Information and Technical
Information.
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follows: (a) upon […***…]77, (i) […***…]78 U.S. Dollars ($[…***…])79 if such […***…]80 or (ii) […***…]81 U.S. Dollars ($[…***…]82)
if such […***…]83 and (b) upon […***…]84, (i) a fee […***…]85 U.S. Dollars ($[…***…]86) if such […***…]87, or (ii) a fee […***…]88 U.S. Dollars ($[…***…]89) if such […***…]90. For clarity, the Nomination Fee for a […***…].91 […***…].”92
| 19. |
Section 4.3. Development Milestones. Section 4.3 of the
Agreement is hereby amended to delete the existing table and replace it with the following three tables:
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For […***…]93 Products:
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Development Milestone Event
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Development Milestone Payment Product 1
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Development Milestone Payment for Subsequent Products
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[…***…]94
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$[…***…]95
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$[…***…]96
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[…***…]97
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$[…***…]98
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$[…***…]99
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[…***…]100
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$[…***…]101
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$[…***…]102
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80 Competitive Information – Financial Provisions.
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82 Competitive Information – Financial Provisions.
83 Competitive Information – Discovery Information and Technical
Information.
84 Competitive Information – Other Commercially Sensitive Terms.
85 Competitive Information – Financial Provisions.
86 Competitive Information – Financial Provisions.
87 Competitive Information – Discovery Information and Technical
Information.
88 Competitive Information – Financial Provisions.
89 Competitive Information – Financial Provisions.
90 Competitive Information – Discovery Information and Technical
Information.
91 Competitive Information – Discovery Information, Technical Information
and Other Commercially Sensitive Terms.
92 Competitive Information – Discovery Information and Other Commercially
Sensitive Terms.
93 Competitive Information – Technical Information.
94 Competitive Information – Discovery Information.
95 Competitive Information – Financial Provisions.
96 Competitive Information – Financial Provisions.
97 Competitive Information – Discovery Information.
98 Competitive Information – Financial Provisions.
99 Competitive Information – Financial Provisions.
100 Competitive Information – Discovery Information.
101 Competitive Information – Financial Provisions.
102 Competitive Information – Financial Provisions.
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For […***…]103 Products incorporating Antibodies
derived and generated from General […***…]104 Sequence Pairs:
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Development Milestone Event
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Development Milestone Payment Product 1
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Development Milestone Payment for Subsequent Products
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[…***…]105
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$[…***…]106
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$[…***…]107
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[…***…]108
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$[…***…]109
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$[…***…]110
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[…***…]111
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$[…***…]112
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$[…***…]113
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For […***…]114 Products incorporating Antibodies
derived and generated from […***…]115 Sequence Pairs:
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Development Milestone Event
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Development Milestone Payment Product 1
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Development Milestone Payment for Subsequent Products
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[…***…]116
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$[…***…]117
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$[…***…]118
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[…***…]119
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$[…***…]120
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$[…***…]121
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[…***…]122
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$[…***…]123
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$[…***…]124
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103 Competitive Information – Discovery Information.
104 Competitive Information – Technical Information.
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106 Competitive Information – Financial Provisions.
107 Competitive Information – Financial Provisions.
108 Competitive Information – Discovery Information.
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110 Competitive Information – Financial Provisions.
111 Competitive Information – Discovery Information.
112 Competitive Information – Financial Provisions.
113 Competitive Information – Financial Provisions.
114 Competitive Information – Discovery Information and Technical
Information.
115 Competitive Information – Technical Information.
116 Competitive Information – Discovery Information.
117 Competitive Information – Financial Provisions.
118 Competitive Information – Financial Provisions.
119 Competitive Information – Discovery Information.
120 Competitive Information – Financial Provisions.
121 Competitive Information – Financial Provisions.
122 Competitive Information – Discovery Information.
123 Competitive Information – Financial Provisions.
124 Competitive Information – Financial Provisions.
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20.
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Section 4.4. Commercialization Milestones. The table in Section
4.4 of the Agreement is hereby deleted and replaced with the following:
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Commercialization Milestone Event
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Commercialization Milestone Payment for […***…]125
Products
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Commercialization Milestone Payment for […***…]126
Products
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[…***…]127
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$[…***…]128
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$[…***…]129
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[…***…]130
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$[…***…]131
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$[…***…]132
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[…***…]133
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$[…***…]134
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$[…***…]135
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[…***…]136
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$[…***…]137
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$[…***…]138
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[…***…]139
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$[…***…]140
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$[…***…]141
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[…***…]142
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$[…***…]143
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$[…***…]144
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[…***…]145
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$[…***…]146
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$[…***…]147
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125 Competitive Information – Discovery Information and Technical
Information.
126 Competitive Information – Discovery Information and Technical
Information.
127 Competitive Information – Discovery Information.
128 Competitive Information – Financial Provisions.
129 Competitive Information – Financial Provisions.
130 Competitive Information – Discovery Information.
131 Competitive Information – Financial Provisions.
132 Competitive Information – Financial Provisions.
133 Competitive Information – Discovery Information.
134 Competitive Information – Financial Provisions.
135 Competitive Information – Financial Provisions.
136 Competitive Information – Discovery Information.
137 Competitive Information – Financial Provisions.
138 Competitive Information – Financial Provisions.
139 Competitive Information – Discovery Information.
140 Competitive Information – Financial Provisions.
141 Competitive Information – Financial Provisions.
142 Competitive Information – Discovery Information.
143 Competitive Information – Financial Provisions.
144 Competitive Information – Financial Provisions.
145 Competitive Information – Discovery Information.
146 Competitive Information – Financial Provisions.
147 Competitive Information – Financial Provisions.
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| 21. |
Section 4.5.1 Royalties. The table in Section 4.5.1 of the
Agreement is hereby deleted and replaced with the following:
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Annual Net Sales on a Product-by-Product basis
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Royalty Rate (as a percentage of Net Sales) for […***…]148 Products
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Royalty Rate (as a percentage of Net Sales) for […***…]149 Products
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$[…***…]150 to $[…***…]151
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[…***…]%152
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[…***…]%153
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Above $[…***…]154 to $[…***…]155
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[…***…]%156
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[…***…]%157
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Above $[…***…]158
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[…***…]%159
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[…***…]%160
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| 22. |
Section 4.5.4. Royalty Buy-Down. Section 4.5.4 of the Agreement
is hereby deleted in its entirety and replaced with the following:
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“4.5.4. Royalty Buy-Down. At any time prior to the initiation of the first Phase III Clinical Trial of a […***…]161 Product by or on behalf of GSK, GSK shall have the right, at its sole discretion, to buy down the royalty percentages set forth in Section 4.5.1, solely with respect to such […***…]162 Product, from […***…]%163, […***…]%164
and […***…]%165, respectively, to a floor of […***…]%166, […***…]%167 and […***…]%168 by making a one-time payment of […***…]169 U.S. Dollars ($[…***…]170) for such […***…]171 Product. At any time prior to the
148 Competitive Information – Discovery Information and Technical
Information.
149 Competitive Information – Discovery Information and Technical
Information.
150 Competitive Information – Financial Provisions.
151 Competitive Information – Financial Provisions.
152 Competitive Information – Financial Provisions.
153 Competitive Information – Financial Provisions.
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155 Competitive Information – Financial Provisions.
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157 Competitive Information – Financial Provisions.
158 Competitive Information – Financial Provisions.
159 Competitive Information – Financial Provisions.
160 Competitive Information – Financial Provisions.
161 Competitive Information – Discovery Information and Technical
Information.
162 Competitive Information – Discovery Information and Technical
Information.
163 Competitive Information – Financial Provisions.
164 Competitive Information – Financial Provisions.
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167 Competitive Information – Financial Provisions.
168 Competitive Information – Financial Provisions.
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170 Competitive Information – Financial Provisions.
171 Competitive Information – Discovery Information and Technical
Information.
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initiation of the first Phase III Clinical Trial of a […***…]172 Product by or on behalf of GSK, GSK shall have the right, at its sole discretion, to buy down the royalty percentages set forth in Section 4.5.1, solely with respect to such […***…]173 Product, from […***…]%174, […***…]%175
and […***…]%176, respectively, to a floor of […***…]%177, […***…]%178 and […***…]%179 by making a one-time payment of […***…]180 U.S. Dollars ($[…***…]181) for such […***…]182 Product.”
| 23. |
Section 7.1. Duty of Confidence. The reference to Article 8 in
the second to last sentence of Section 7.1 of the Agreement is hereby corrected to refer to Article 7.
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| 24. |
Section 8.1. Publicity. The Parties hereby consent to the
issuance of the press release attached hereto as Exhibit 8.1(a).
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| 25. |
Section 13.9. Notices. GSK hereby updates its notice
information in Section 13.9 of the Agreement as follows:
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172 Competitive Information – Discovery Information and Technical
Information.
173 Competitive Information – Discovery Information and Technical
Information.
174 Competitive Information – Financial Provisions.
175 Competitive Information – Financial Provisions.
176 Competitive Information – Financial Provisions.
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181 Competitive Information – Financial Provisions.
182 Competitive Information – Discovery Information and Technical
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If to GSK: GSK Medicines Research Centre
Xxxxxxx Xxxx Xxxx
Xxxxxxxxx, Xxxxxxxxxxxxx
XX0 0XX
Attention: […***…] 183
E-mail address: […***…] 184
and
GSK
000 Xxxxx Xxxx Xxxx
Xxxxxxxxx, Xxxxxxxxx
XX0 0XX
Attention: […***…] 185
E-mail address: […***…]186
| 26. |
No Other Modifications. Except as specifically set forth in this Amendment, the terms and conditions of the Agreement shall remain in full force and effect. No waiver of the performance of any obligation under
this Amendment shall be effective unless it has been given in writing and signed by the Party giving such waiver. No provision of this Amendment may be amended or modified other than by a written document signed by authorized
representatives of each Party.
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THIS AMENDMENT AND THE AGREEMENT AS AMENDED BY THIS AMENDMENT SET FORTH THE ENTIRE AGREEMENT AND
UNDERSTANDING OF GSK AND ZYMEWORKS WITH RESPECT TO THE SUBJECT MATTER HEREOF, AND SUPERCEDES ALL PRIOR DISCUSSIONS, AGREEMENTS AND WRITINGS IN RELATION THERETO, OTHER THAN THE CDA.
| 27. |
Miscellaneous. This Amendment may be executed in two (2) or
more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Amendment shall be governed by and construed in accordance with the laws of the State of Delaware
and the patent laws of the United States, without reference to any rules of conflict of laws.
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IN WITNESS WHEREOF, the Parties
intending to be bound have caused this Amendment to be executed by their duly authorized representatives.
183 Personal Information – Contact Information.
184 Personal Information – Contact Information.
185 Personal Information – Contact Information.
186 Personal Information – Contact Information.
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By:
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/s/ Xxxx Xxxxxxx |
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Name:
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Xxxx Xxxxxxx
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Title:
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Chief Financial Officer
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Date:
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May 15, 2019
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GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LIMITED
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By:
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/s/ Xxxx Xxxxxxxxxx |
By:
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/s/ Xxxx Xxxxxx |
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Authorized Signatory
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Authorized Signatory
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For and on behalf of
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For and on behalf of
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Edinburgh Pharmaceutical Industries Limited
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Glaxo Group Limited
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Corporate Director
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Corporate Director
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CONFIDENTIAL
Execution Copy
Exhibit 1.54
Technical Dossier Outline
[…***…]187
187 Competitive
Information – Discovery Information and Technical Information.
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CONFIDENTIAL
Execution Copy
Exhibit 1.64
Zymeworks Patent Rights
[…***…]188
188 Competitive
Information –Technical Information.
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CONFIDENTIAL
Execution Copy
Exhibit 8.1(a)
Press Release
Zymeworks and GSK Expand 0000 XxxxxxxxxXX
Xxxxxxxxxx Xxxxxxxxx
Xxxxxxxxx, Xxxxxx (May 16,
2019) – Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that
GSK has expanded its 2016 licensing and collaboration agreement with Zymeworks for the research, development, and commercialization of bispecific antibodies across multiple disease areas. Under the expanded agreement, GSK will now have access to
Zymeworks’ unique heavy-light chain pairing technology, part of its proprietary Azymetricä platform. Zymeworks’ Azymetric platform enables the development of bispecific and
multifunctional therapeutics while maintaining the characteristics of naturally-occurring human antibodies.
“We are pleased to see GSK broaden their technology license and believe that it reflects their increased commitment to develop
differentiated bispecific therapeutics,” said Xxx Xxxxxxx, Ph.D., President and CEO of Zymeworks. “As part of this expansion, GSK expects to use our Azymetric technology to develop bispecifics for the treatment of infectious diseases, which
highlights the utility of our platform beyond traditional indications like oncology and inflammatory disease.”
Under the updated terms of the expanded agreement, GSK will have the option to develop and commercialize bispecific drugs across
different disease areas and Zymeworks will be eligible to receive increased preclinical, development and commercial milestone payments. If all six programs are developed and commercialized, the new potential value of the collaboration would be up to
US$1.1 billion. Additionally, Zymeworks is eligible to receive increased tiered royalties on worldwide sales.
About the Azymetric™ Platform
The Azymetric platform enables the transformation of monospecific antibodies into bispecific antibodies, giving the antibodies the ability to
simultaneously bind two different targets. Azymetric bispecific technology enables the development of multifunctional biotherapeutics that can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor clustering degradation,
and increase tumor-specific targeting. These features are intended to enhance efficacy while reducing toxicities and the potential for drug resistance. Azymetric bispecifics have been engineered to retain the desirable drug-like qualities of
naturally occurring antibodies, including low immunogenicity, long half-life, and high stability. In addition, they are compatible with standard manufacturing processes with high yields and purity, potentially significantly reducing drug development
costs and timelines.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. The Company’s
suite of therapeutic platforms and its fully integrated drug
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development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, ZW25, is a novel
Azymetric™ bispecific antibody currently in Phase 2 clinical development. The Company’s second clinical candidate, ZW49, is a bispecific antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody
framework of ZW25 with Zymeworks’ proprietary ZymeLink™ cytotoxic payload. Zymeworks is also advancing a deep preclinical pipeline in immuno-oncology and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through
multiple strategic partnerships with eight global biopharmaceutical companies. For more information, visit xxx.xxxxxxxxx.xxx.
Zymeworks Cautionary Note Regarding Zymeworks’ Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and
“forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements that relate to future development
activities in accordance with the terms of Zymeworks’ agreements with GSK, potential payments and/or royalties payable to Zymeworks under these agreements, the speed and outcome of drug development plans, Zymeworks’ potential global growth, and other
information that is not historical information. When used herein, words and phrases such as “enable”, “plan”, “will”, “may”, “eligible to”, “expects”, and similar expressions are intended to identify forward-looking statements. In addition, any
statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking
statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its
beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under
“Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended March 31, 2019 (a copy of which may be obtained at xxx.xxx.xxx and xxx.xxxxx.xxx). Consequently, forward-looking statements should be regarded solely as Zymeworks’
current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and
specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
Contacts:
Investor Inquiries:
Xxxx Xxxxxx, Ph.D.
(000) 000-0000
xx@xxxxxxxxx.xxx
Xxxxxxx Xxxxxx
(000) 000-0000
xx@xxxxxxxxx.xxx
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Media Inquiries:
Xxxxxx Xxxxxxx
(000) 000-0000
x.xxxxxxx@xxxxxxx.xxx
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