|
“[ * ]” =
omitted, confidential material, which material has been separately
filed with the Securities and Exchange Commission pursuant to a
request for confidential treatment.
Exhibit
10.46
A MENDMENT
N O . 1 TO
L ICENSE A
GREEMENT FOR R
ECOMBINANT F ACTOR
XIII
T HIS A
MENDMENT N O . 1
TO L ICENSE A GREEMENT
FOR R ECOMBINANT F
ACTOR XIII (“ Amendment
No. 1 ”) is entered into as of December 7,
2007 (“ Effective Date ”) by and among
ZymoGenetics, Inc., a Washington corporation whose address is 1201
Eastlake Ave. East, Seattle, WA 98102 (“ ZGEN
”), Novo Nordisk A/S, a Danish corporation whose address is
Novo Allé, DK-2880, Bagsvaerd, Denmark (“
Novo ”), and Novo Nordisk Health Care AG, a
Swiss corporation and wholly-owned affiliate of Novo whose address
is Andreasstrasse 15, 8050 Zürich, Switzerland (“
NN ”). ZGEN and NN are sometimes referred to
herein individually as a “ Party ” and
collectively as the “ Parties
”.
B
ACKGROUND
A. The Parties and Novo are
parties to the License Agreement for Recombinant Factor XIII,
effective as of October 4, 2004 (the “
Agreement ”).
B. Novo has expended
significant effort and made significant progress toward improving
the manufacturing process and developing a new
formulation.
C. The Parties and Novo
desire to amend the Agreement to, among other things, revise the
time-based milestone schedule and incorporate additional
milestones.
A
GREEMENT
N OW ,
THEREFORE , the Parties and Novo agree as
follows:
Terms used with initial
capital letters and not otherwise defined in this Amendment
No. 1 shall have the meanings given to them in the
Agreement.
Certain milestone fees shall
be amended as set forth in this Section 2.
| |
2.1 |
Congenital Factor XIII Deficiency |
(a) The first two rows below
the headings in the table in Section 4.2(a) of the Agreement
(i.e., rows relating to milestone fees of $
[ * ] and $
[ * ] respectively) shall be deleted
in their entirety.
(b) The new table in
Section 4.2(a) of the Agreement shall be as
follows:
|
|
|
|
|
| |
|
Earlier of:
|
|
Milestone Fee
|
|
Event
Milestone
|
|
Time
Milestone
(Subject to
Section 4.2(e))
|
|
U.S. $ [ * ]
|
|
First
Marketing Approval in the United States or European Union for a
Licensed Product |
|
[ * ] |
(a) The second row below the
headings in the table in Section 4.2(b) of the Agreement
(i.e., row relating to a milestone fee of $
[ * ] ) shall be deleted in its
entirety.
(b) The dates “
[ * ] ” and “
[ * ] ” in the fourth column
(headed “Time Milestone (subject to
Section 4.2(e)”) of the table in Section 4.2(b) of
the Agreement shall be deleted in their entirety and replaced in
each case with “ [ * ] ”.
(c) The milestone fee
“$ [ * ] ” in the first
column (headed “Milestone Fee”) of the table in
Section 4.2(b) of the Agreement shall be deleted in its
entirety and replaced with “$
[ * ] ”.
(d) The milestone fee
“$ [ * ] ” (for First
Marketing Approval for a Factor XIII Product or Combination
Product) in the second column (headed “Milestone Fee if
Licensed Product for Congenital Factor XIII Deficiency Not
Developed Due to Section 3.2(b)(*)”) of the table in
Section 4.2(b) of the Agreement shall be deleted in its
entirety and replaced with “$
[ * ] ”.
|
|
|
| 2 |
|
[ * ] Confidential Treatment
Requested |
(e) The new table in
Section 4.2(b) of the Agreement shall be as
follows:
|
|
|
|
|
|
|
| |
|
|
|
Earlier of: |
|
Milestone Fee
|
|
Milestone Fee if
Licensed
Product for
Congenital
Factor XIII
Deficiency
Not Developed Due
to
Section 3.2(b)(*)
|
|
Event Milestone |
|
Time Milestone
(subject to
Section 4.2(e)) |
|
U.S. $
[ * ]
|
|
U.S. $
[ * ] |
|
FPFV in first Dose
E |
|