AMENDED AND RESTATED LICENSE AGREEMENT By and Between PRESIDIO PHARMACEUTICALS, INC. And XTL BIOPHARMACEUTICALS LTD.
CONFIDENTIAL TREATMENT
REQUESTED . Confidential portions of this document have been redacted
and have been separately filed with the Commission.
Exhibit 10.37
Execution
Version
AMENDED
AND RESTATED
By
and Between
PRESIDIO
PHARMACEUTICALS, INC.
And
TABLE OF
CONTENTS
Page
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Article
I
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Definitions
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1
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Section
1.1
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“Additional
Third Party Licenses”
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1
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Section
1.2
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“Affiliate”
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1
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Section
1.3
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“Assigned
Contracts”
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2
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Section
1.4
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“Bankruptcy
Code”
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2
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Section
1.5
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“Commercialization”
or “Commercialize”
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2
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Section
1.6
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“Commercially
Reasonable Efforts”
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2
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Section
1.7
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“Competing
Product”
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2
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Section
1.8
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“Confidential
Information”
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2
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Section
1.9
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“Control”
or “Controlled”
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2
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Section
1.10
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“Cover”,
“Covering” or “Covered”
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2
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Section
1.11
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“Derivative
Compounds”
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3
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Section
1.12
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“Development”
or “Develop”
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3
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Section
1.13
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“EMEA”
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3
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Section
1.14
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“EU”
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3
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Section
1.15
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“FDA”
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3
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Section
1.16
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“Field”
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3
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Section
1.17
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“Fiscal
Year”
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3
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Section
1.18
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“HCV”
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3
|
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Section
1.19
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“HCV
Field”
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3
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Section
1.20
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“IND”
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3
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Section
1.21
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“Know-How”
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4
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Section
1.22
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“Licensed
Compounds”
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4
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Section
1.23
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“Licensed
Patent Rights”
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4
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Section
1.24
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“Licensed
Product”
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4
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Section
1.25
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“Licensed
Technology”
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4
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Section
1.26
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“Major
EU Countries”
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4
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Section
1.27
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“NDA”
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4
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Section
1.28
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“Net
Sales”
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4
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Section
1.29
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“*****”
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6
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Section
1.30
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“Party”
or “Parties”
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6
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Section
1.31
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“Pass-Through
Costs”
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6
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Section
1.32
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“Patent
Rights”
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6
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Section
1.33
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“Person”
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6
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Section
1.34
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“Phase
I Trial”
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6
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Section
1.35
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“Phase
II Trial”
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6
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Section
1.36
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“Phase
III Trial”
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6
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Section
1.37
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“Regulatory
Approval”
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7
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Section
1.38
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“Regulatory
Authority”
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7
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Section
1.39
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“Regulatory
Filings”
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7
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* *****Confidential material redacted and filed separately
with the Commission.
-i-
Section
1.40
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“Royalty
Term”
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7
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Section
1.41
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“Senior
Executives”
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7
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Section
1.42
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“Series
1 Compounds”
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7
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Section
1.43
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“Series
1 Licensed Products”
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7
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Section
1.44
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“Series
1 Patent Rights”
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7
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Section
1.45
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“Series
2-4 Compounds”
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7
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Section
1.46
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“Series
2-4 Licensed Products”
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8
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Section
1.47
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“Series
2-4 Patent Rights”
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8
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Section
1.48
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“Series
5-50 Compounds”
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8
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Section
1.49
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“Sublicense
Income”
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8
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Section
1.50
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“Successful
Completion”
|
9
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Section
1.51
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“Territory”
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9
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Section
1.52
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“Third
Party”
|
9
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Section
1.53
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“Valid
Claim”
|
9
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Section
1.54
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“VivoQuest
Asset Purchase Agreement”
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9
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Section
1.55
|
*****
|
9
|
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Section
1.56
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“VivoQuest
License Agreement”
|
9
|
|
Section
1.57
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“VivoQuest
Licensed Patents”
|
9
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Section
1.58
|
Additional
Definitions
|
9
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|
Article
II
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Grant
of License; Assigned Contracts; Exclusivity
|
10
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Section
2.1
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License
Grant
|
10
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Section
2.2
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Assigned
Contracts
|
10
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|
Section
2.3
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Exclusivity.
|
11
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Section
2.4
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Retained
Rights; Other Limitations
|
11
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Section
2.5
|
Section
365(n) of the Bankruptcy Code
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11
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Article
III
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Technology
Transfer
|
12
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Section
3.1
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Technology
Transfer
|
12
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Section
3.2
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Technology
Transfer Committee; Decision-Making Authority.
|
12
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Article
IV
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Reports
and Meetings; Diligence; Certain Regulatory and Manufacturing
Activities
|
12
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Section
4.1
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Development
Reports; Meetings.
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12
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Section
4.2
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Commercially
Reasonable Efforts
|
13
|
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Section
4.3
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Certain
Regulatory and Manufacturing Activities
|
13
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Article
V
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Financial
Provisions
|
14
|
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Section 5.1
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License
Payment
|
14
|
|
Section 5.2
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Milestone
Payments for Series 1 Licensed Products
|
14
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Section 5.3
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Royalties
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16
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Section 5.4
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Sublicense
Income for Series 1 Licensed Products
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16
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Section 5.5
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Reduction
for Lack of Patent Coverage.
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17
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Section 5.6
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Reduction
for Pass-Through Costs Under Assigned Contracts and Additional Third Party
Licenses
|
17
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Section 5.7
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Priority
of Reduction
|
18
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* *****Confidential material redacted and filed separately
with the Commission.
-ii-
Section
5.8
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Offset
for Payment of VivoQuest Pass-Through Costs
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18
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Section
5.9
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Reports
and Accounting.
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19
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Section
5.10
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Currency
and Method of Payments
|
00
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Xxxxxxx
0.00
|
Xxxxxx
Xxxxxx Dollars
|
19
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Section
5.12
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Tax
Withholding
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19
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Section
5.13
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Late
Payments
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20
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Section
5.14
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Blocked
Payments
|
20
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Section
5.15
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Costs
and Expenses
|
20
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Article
VI
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Intellectual
Property Protection and Related Matters
|
20
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Section
6.1
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Prosecution
and Maintenance of Licensed Patent Rights.
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20
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Section
6.2
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Third
Party Infringement.
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21
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Section
6.3
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Claimed
Infringement
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22
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Section
6.4
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Patent
Invalidity Claim
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22
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Section
6.5
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Patent
Marking
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22
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Section
6.6
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Certain
Limitations
|
22
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Article
VII
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Confidentiality
|
23
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Section
7.1
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Confidential
Information
|
23
|
|
Section
7.2
|
Employee,
Director, Consultant and Advisor Obligations
|
23
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Section
7.3
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Publicity.
|
24
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Section
7.4
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Term
|
24
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Article
VIII
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Representations
and Warranties
|
24
|
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Section
8.1
|
Representations
of Authority
|
24
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Section
8.2
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Consents
|
24
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Section
8.3
|
No
Conflict
|
25
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Section
8.4
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Employee,
Director, Consultant and Advisor Obligations
|
25
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Section
8.5
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Intellectual
Property
|
25
|
|
Section
8.6
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No
Warranties
|
27
|
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Article
IX
|
Term
and Termination
|
28
|
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Section
9.1
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Term
|
28
|
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Section
9.2
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Termination
For Material Breach
|
28
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Section
9.3
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Termination
for Convenience
|
28
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Section
9.4
|
Effect
of Material Breach or Patent Validity Challenge by XTL or its
Affiliates.
|
29
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Section
9.5
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Effects
of Termination.
|
29
|
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Section
9.6
|
Survival
|
31
|
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Article
X
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Dispute
Resolution
|
31
|
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Section
10.1
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Referral
to Senior Executives
|
31
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Section
10.2
|
Mediation
|
32
|
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Section
10.3
|
Arbitration.
|
32
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Section
10.4
|
No
Limitation
|
33
|
|
Article
XI
|
Miscellaneous
Provisions
|
33
|
|
Section
11.1
|
Indemnification.
|
33
|
-iii-
Section 11.2
|
Governing
Law
|
34
|
Section 11.3
|
Assignment
|
35
|
Section 11.4
|
Entire
Agreement; Amendments
|
35
|
Section 11.5
|
Notices
|
35
|
Section 11.6
|
Force
Majeure
|
36
|
Section 11.7
|
Independent
Contractors
|
36
|
Section 11.8
|
No
Strict Construction
|
36
|
Section 11.9
|
Headings
|
36
|
Section 11.10
|
No
Implied Waivers; Rights Cumulative
|
36
|
Section 11.11
|
Severability
|
37
|
Section 11.12
|
Execution
in Counterparts
|
37
|
Section 11.13
|
No
Third Party Beneficiaries
|
37
|
Section 11.14
|
No
Consequential Damages
|
37
|
-iv-
Exhibits:
Exhibit A
– Assigned Contracts
Exhibit B
– VivoQuest Agreements
Exhibit C
– Series 1, 2, 3 and 4 Compounds in XTL Database and Other Records
Exhibit D
– Series 1 Patent Rights as of the Original Effective Date and the Restatement
Date
Exhibit E
– Series 2-4 Patent Rights as of the Original Effective Date and the Restatement
Date
Exhibit F
– Press Release
*****
* *****Confidential material redacted and filed separately
with the Commission.
-v-
AMENDED
AND RESTATED LICENSE AGREEMENT
This
Amended and Restated License Agreement (this “Agreement”), dated
the 4th day of
August, 2008 (the “Restatement Date”),
is by and between Presidio Pharmaceuticals, Inc., a Delaware corporation (“PRESIDIO”), and XTL
Biopharmaceuticals Ltd., a public company limited by shares organized under the
laws of Israel (“XTL”).
INTRODUCTION
1. XTL
owns or controls rights to Licensed Compounds, Licensed Patent Rights and
Licensed Technology (each as hereinafter defined).
2. PRESIDIO
is in the business of discovering, developing and marketing pharmaceutical
products.
3. Effective
as of March 19, 2008 (the “Original Effective
Date”), XTL and PRESIDIO entered into a License Agreement (the “Original License
Agreement”) pursuant to which XTL granted to PRESIDIO certain rights and
licenses to the Licensed Compounds, Licensed Patent Rights and Licensed
Technology to develop and commercialize certain products.
4. XTL
and PRESIDIO now desire to amend and restate the Original License Agreement in
its entirety with this Agreement to reflect the matters contemplated by XTL and
PRESIDIO as hereinafter set forth.
NOW,
THEREFORE, for good and valuable consideration, the receipt and sufficiency of
which are hereby acknowledged, PRESIDIO and XTL agree as follows:
Article
I
Definitions
When used
in this Agreement, each of the following terms shall have the meanings set forth
in this Article I:
Section
1.1 “Additional Third Party
Licenses”. Additional Third Party Licenses means licenses
under any Patent Rights of a Third Party (other than Licensed Patent Rights
licensed or sublicensed to PRESIDIO under the VivoQuest License Agreement or any
Assigned Contracts) which PRESIDIO and/or any of its Affiliates or Third Party
sublicensees reasonably determines are necessary for the Development and/or
Commercialization of a Licensed Compound or Licensed Product for use in the
Field in any country of the Territory.
Section
1.2 “Affiliate”. Affiliate
means, with respect to a Party, any Person that controls, is controlled by, or
is under common control with such Party. For purposes of this Section
1.2, “control” shall refer to (a) in the case of a Person that is a corporate
entity, direct or indirect ownership of fifty percent (50%) or more of the stock
or shares having the right to vote for the election of directors of such Person,
and (b) in the case of a Person that is not a corporate entity, the possession,
directly or indirectly, of the power to direct, or cause the direction of, the
management or policies of such Person, whether through the ownership of voting
securities, by contract or otherwise.
-1-
Section
1.3 “Assigned
Contracts”. Assigned Contracts means the agreements listed on
Exhibit
A.
Section
1.4 “Bankruptcy
Code”. Bankruptcy Code means 11 U.S.C §§ 101-1330, as
amended.
Section
1.5 “Commercialization” or
“Commercialize”. Commercialization or Commercialize means any
activities directed to producing or manufacturing for commercial distribution;
marketing, promoting, detailing or commercially distributing; importing, having
imported, exporting or having exported for commercial distribution; or selling
or offering to sell, a product.
Section
1.6 “Commercially Reasonable
Efforts”. Commercially Reasonable Efforts means the efforts
normally used by a United States biotechnology or pharmaceutical company with
resources similar to those of PRESIDIO to Develop or Commercialize a
pharmaceutical product or compound owned by it or to which it has rights, taking
into account its market potential and the stage in its development or product
life, relevant issues of safety and efficacy, product profile and labeling,
other medical and clinical considerations, difficulty in developing the product
or compound, competitiveness of the marketplace for the applicable product(s)
marketed or to be marketed, the proprietary position of the compound or product,
the regulatory structure involved, the potential profitability of the applicable
product(s) marketed or to be marketed, and other relevant factors affecting the
cost, risk and timing of Development and the total potential reward to be
obtained if a product is Commercialized. Such efforts and resources
that are used by PRESIDIO’s Affiliates and Third Party sublicensees shall be
attributed to PRESIDIO for purposes of this Agreement.
Section
1.7 “Competing
Product”. Competing Product means any prescription
pharmaceutical product that is *****.
Section
1.8 “Confidential
Information”. Confidential Information means all Know-How and
other information (whether or not patentable) regarding a Party’s technology,
products, business or objectives, that is disclosed by such Party to the other
Party in the course of such Party’s performance of the Original License
Agreement or this Agreement.
Section
1.9 “Control” or
“Controlled”. Control or Controlled means, with respect to any
intellectual property right or other intangible property, the possession by a
Party or an Affiliate of a Party (whether by ownership or license, other than a
license granted pursuant to the Original License Agreement or this Agreement) of
the ability to grant access to, or a license or sublicense of, such rights or
property as contemplated under the Original License Agreement or this Agreement,
as applicable.
Section
1.10 “Cover”, “Covering” or
“Covered”. Cover, Covering or Covered means, as to Patent
Rights and a product, that, but for a license granted to a Party under a Valid
Claim of such Patent Rights, the Development or Commercialization of such
product would infringe such Valid Claim.
* *****Confidential material redacted and filed separately
with the Commission.
-2-
Section
1.11 “Derivative
Compounds”. Derivative Compounds means, with respect to any
Licensed Compound, any compounds actually chemically derived, in one or more
steps, by or on behalf of PRESIDIO, its Affiliates and/or Third Party
sublicensees from such Licensed Compound, provided that, compounds
derived by Third Party sublicensees or Third Party acquirers of PRESIDIO shall
not constitute Derivative Compounds if such compounds are so derived (i) prior
to the effective date of the grant by PRESIDIO of the sublicense to such
sublicensee or the acquisition by such acquirer, as evidenced by
contemporaneously prepared written records of such sublicensee or acquirer or
(ii) without any use, direct or indirect, of (A) proprietary know-how disclosed
to such Third Party in connection with the grant of the sublicense or the
acquisition, or (B) Licensed Compounds (including Derivative Compounds) on which
Development had previously been conducted by XTL or PRESIDIO, the results of
which prior Development are identified to such Third Party in connection with
the grant of the sublicense or the acquisition.
Section
1.12 “Development” or
“Develop”. Development or Develop means any research,
discovery, and preclinical and clinical drug development activities, including
without limitation test method development and stability testing, toxicology,
animal efficacy studies, formulation, quality assurance/quality control
development, statistical analysis, clinical studies, regulatory affairs, product
approval and registration, chemical development and manufacturing development,
packaging development and manufacturing and development documentation efforts in
support of development activities anywhere in the world.
Section
1.13 “EMEA”. EMEA
means the European Agency for the Evaluation of Medical Products, or any
successor agency thereof.
Section
1.14 “EU”. EU
means the European Union, as it may be constituted from time to
time.
Section
1.15 “FDA”. FDA
means the United States Food and Drug Administration, or any successor agency
thereof.
Section
1.16 “Field”. Field
means the prevention, treatment, palliation and/or control of any and all human
diseases and conditions, including without limitation the HCV
Field.
Section
1.17 “Fiscal
Year”. Fiscal Year means, with respect to a Party or any Third
Party sublicensee of a Party, the fiscal year of such Party or Third Party
sublicensee.
Section
1.18 “HCV”. HCV
means hepatitis C virus.
Section
1.19 “HCV
Field”. HCV Field means the prevention, treatment, palliation
and/or control of any and all HCV indications.
Section
1.20 “IND”. IND
means an Investigational New Drug application filed with the FDA.
-3-
Section
1.21 “Know-How”. Know-How
means any know-how, expertise, discoveries, inventions, information, trade
secrets, data or materials, whether or not patentable, proprietary or embodied
in tangible form, including without limitation ideas, concepts, formulas,
methods, procedures, designs, technologies, compositions, plans, applications,
technical data, samples, biological or chemical materials, laboratory notebooks,
preclinical or clinical data, databases, designs, assays, protocols, analytical
systems, discovery tools, reports, Regulatory Filings and manufacturing
documentation.
Section
1.22 “Licensed
Compounds”. Licensed Compounds means (a) the Series 1
Compounds, and (b) the Series 2-4 Compounds.
Section
1.23 “Licensed Patent
Rights”. Licensed Patent Rights means (a) the Series 1 Patent
Rights, (b) the Series 2-4 Patent Rights, and (c) any other Patent Rights
Controlled by XTL or any of its Affiliates, as of the Original Effective Date or
during the term of the Original License Agreement or this Agreement, that Cover
any Licensed Technology and/or the Development and/or Commercialization of any
Licensed Compounds or Licensed Products.
Section
1.24 “Licensed
Product”. Licensed Product means any product that contains one
or more Licensed Compounds as an active ingredient.
Section
1.25 “Licensed
Technology”. Licensed Technology means any Know-How Controlled
by XTL or any of its Affiliates, as of the Original Effective Date or during
term of the Original License Agreement or this Agreement, relating to the
Development and/or Commercialization of Licensed Compounds or Licensed Products,
and all intellectual property rights therein.
Section
1.26 “Major EU
Countries”. Major EU Countries means any of the United
Kingdom, Germany, France, Italy and Spain.
Section
1.27 “NDA”. NDA
means an application submitted to a Regulatory Authority for marketing approval
of a product, including without limitation a New Drug Application filed with the
FDA and any foreign equivalent thereof.
Section
1.28 “Net
Sales”. Net Sales means, with respect to a Licensed Product,
the gross amount invoiced by PRESIDIO and/or its Affiliates, or by Third Party
sublicensees, as the case may be, in respect of sales of such Licensed Product
to unrelated Third Parties, in each case less the following
deductions:
(a) Trade, cash
and/or quantity discounts actually allowed and taken with respect to such
sales;
(b) Discounts paid
under discount prescription programs and reductions for coupon and voucher
programs;
(c) Tariffs, duties,
excises, sales taxes, value-added taxes and other taxes imposed upon and paid by
PRESIDIO and/or one of its Affiliates, or by Third Party sublicensees, as the
case may be, with respect to the use, sale or importation of the Licensed
Product, to the extent that neither PRESIDIO nor any of its Affiliates is
entitled to a rebate, refund or credit for such amounts;
-4-
(d) Amounts repaid
or credited by reason of rejections, defects, recalls or returns or because of
chargebacks, refunds, rebates or retroactive price reductions;
(e) Negotiated payments
made to private sector and government third party payors (e.g., PBMs, HMOs and
PPOs) and purchasers/providers (e.g., staff model HMOs, hospitals and clinics),
regardless of the payment mechanism, including without limitation rebate,
chargeback and credit mechanisms;
(f) Freight,
insurance and other transportation charges incurred by PRESIDIO and/or its
Affiliates, or by Third Party sublicensees, as the case may be, in shipping a
Licensed Product to Third Parties;
(g) Sales commissions and
inventory management fees paid to wholesalers and distributors to the extent
allocable to Licensed Products;
(h) Amounts that are
written off as uncollectible and costs of collections; and
(i) Gross
amounts received in respect of sales for test marketing, sampling or promotional
use, clinical trial purposes or compassionate or similar use.
Such
amounts shall be determined from the books and records of PRESIDIO and/or its
Affiliates, or Third Party sublicensees, as the case may be, maintained in
accordance with generally accepted accounting principles applicable within a
particular country, consistently applied, including periodic adjustments to
reflect amounts actually incurred.
In the
event the Licensed Product is sold as part of a Combination Product (as defined
below), the Net Sales from the Combination Product, for the purposes of
determining royalty payments, shall be determined on a country-by-country basis
by multiplying the Net Sales (as determined above) of the Combination Product in
each country, during the applicable royalty reporting period, by the fraction
A/(A+B), where A is the average net selling price of the Licensed Product when
sold separately in finished form in such country and B is the average net
selling price of the other active ingredient(s) included in the Combination
Product when sold separately in finished form in such country, in each case
during the applicable royalty reporting period or, if sales of both the Licensed
Product and the other active ingredient(s) did not occur in such country in such
period, then in the most recent royalty reporting period in which sales of both
occurred in such country. In the event that such average net selling
price cannot be determined for both the Licensed Product and all other active
ingredient(s) included in such Combination Product for a country, Net Sales for
the purposes of determining royalty payments shall be calculated by multiplying
the Net Sales of the Combination Product in such country by the fraction of
C/(C+D) where C is the fair market value of the Licensed Product and D is the
fair market value of all other active ingredient(s) included in the Combination
Product. In such event, PRESIDIO shall in good faith make a
determination of the respective fair market values of the Licensed Product and
all other active ingredient(s) included in the Combination Product, and shall
notify XTL of such determination and provide XTL with data to support such
determination. XTL shall have the right to review such determination
of fair market values and, if XTL disagrees with such determination, to notify
PRESIDIO of such disagreement within ***** after PRESIDIO notifies XTL of such
determination. If XTL notifies PRESIDIO that XTL disagrees with such
determination within such ***** period and if thereafter the Parties are
unable to agree in good faith as to such respective fair market values, then
such matter shall be resolved as provided in Article X. If XTL does
not notify PRESIDIO that XTL disagrees with such determination within such
***** period, such determination shall be conclusive and binding on the
Parties.
-5-
As used
above, the term “Combination Product”
means any pharmaceutical product that includes both (x) a Licensed Product and
(y) other active ingredient(s).
Section
1.29 *****.
Section
1.30 “Party” or
“Parties”. Party means PRESIDIO or XTL; Parties means PRESIDIO
and XTL.
Section
1.31 “Pass-Through
Costs”. Pass-Through Costs means amounts payable to Third
Parties pursuant to (a) the Assigned Contracts attached hereto as Exhibit A, (b) the
VivoQuest License Agreement attached hereto as Exhibit B, and/or (c)
Additional Third Party Licenses, including without limitation upfront payments
or similar acquisition costs to obtain such licenses; in the case of each of the
foregoing clauses (a), (b) and (c), with respect to the Development and/or
Commercialization of Licensed Compounds or Licensed Products.
Section
1.32 “Patent
Rights”. Patent Rights means the rights and interest in and to
all issued patents and pending patent applications in any country in the
Territory, including without limitation all utility models, utility model
applications, provisionals, divisionals, substitutions, continuations,
continuations-in-part, continuing prosecution applications, patents of addition,
requests for continued examination, reexaminations, supplementary protection
certificates, extensions, registrations or confirmation patents, and reissues
thereof.
Section
1.33 “Person”. Person
means any natural person or any corporation, company, partnership, joint
venture, firm or other entity, including without limitation a
Party.
Section
1.34 “Phase I
Trial”. Phase I Trial means a clinical study of a Licensed
Product in human volunteers or patients with the endpoint of determining initial
tolerance, toxicity, safety and/or pharmacokinetic information.
Section
1.35 “Phase II
Trial”. Phase II Trial means a dose exploration, dose
response, duration of effect, kinetic/dynamic relationship and preliminary
efficacy and safety clinical study of a Licensed Product in
patients.
Section
1.36 “Phase III
Trial”. Phase III Trial means a pivotal clinical study of a
Licensed Product in patients designed to confirm with statistical significance
the efficacy and safety of a Licensed Product performed to provide a sufficient
basis for an application for Regulatory Approval of such Licensed
Product.
* *****Confidential material redacted and filed separately
with the Commission.
-6-
Section
1.37 “Regulatory
Approval”. Regulatory Approval means the approvals (including
any applicable governmental price and reimbursement approvals), licenses,
registrations or authorizations of Regulatory Authorities necessary for the
commercial manufacture and sale of a product in a country or
territory.
Section
1.38 “Regulatory
Authority”. Regulatory Authority means a federal, national,
multinational, state, provincial or local regulatory agency, department, bureau
or other governmental entity with authority over the testing, manufacture, use,
storage, import, promotion, marketing or sale of a product in a country or
territory.
Section
1.39 “Regulatory
Filings”. Regulatory Filings means any filing or application
with any Regulatory Authority with respect to a Licensed Compound or Licensed
Product, including without limitation any INDs or its foreign equivalent,
Regulatory Approvals, and correspondence with the relevant Regulatory
Authorities, as well as minutes of any material meetings, telephone conferences
or discussions with the relevant Regulatory Authorities.
Section
1.40 “Royalty
Term”. Royalty Term means, with respect to each Licensed
Product in each country of the Territory, the period commencing upon first
commercial sale of such Licensed Product in such country and ending upon the
later of (a) the expiration of the last-to-expire Valid Claim under the Licensed
Patent Rights Covering such Licensed Product in such country, or (b) ***** years
following first commercial sale of such Licensed Product in such
country. For avoidance of doubt, the Royalty Term shall be determined
on a country-by-country and Licensed Product-by-Licensed Product
basis.
Section
1.41 “Senior
Executives”. Senior Executives means, with respect to
PRESIDIO, the Chief Executive Officer (or a senior executive designated by such
officer) and, with respect to XTL, the Chief Executive Officer (or a senior
executive designated by such officer).
Section
1.42 “Series 1
Compounds”. Series 1 Compounds means (a) the compounds claimed
or disclosed in the Series 1 Patent Rights, (b) the compounds identified as
“Series 1 Compounds” on Exhibit C, and (c)
Derivative Compounds of any compound set forth in either of the foregoing
clauses (a) and (b); in the case of each of clauses (a), (b) and (c) above,
regardless of whether or not any such compound has been synthesized by XTL
and/or its Affiliates.
Section
1.43 “Series 1 Licensed
Products”. Series 1 Licensed Products means Licensed Products
that contain any Series 1 Compound(s).
Section
1.44 “Series 1 Patent
Rights”. Series 1 Patent Rights means (a) the Patent Rights
set forth on Exhibit
D, (b) counterparts of the Patent Rights set forth on Exhibit D in any
country of the Territory, and (c) all Patent Rights claiming priority from the
Patent Rights described in either of the foregoing clauses (a) and (b) in any
country of the Territory.
Section
1.45 “Series 2-4
Compounds”. Series 2-4 Compounds means (a) any and all
compounds claimed or disclosed in any Series 2-4 Patent Right, (b) the compounds
identified as “Series 2, 3 or 4 Compounds” on Exhibit C, and (c)
Derivative Compounds of any compound set forth in either of the foregoing
clauses (a) and (b); in the case of each of clauses (a), (b) and (c) above,
regardless of whether or not any such compound has been synthesized by XTL
and/or its Affiliates.
* *****Confidential material redacted and filed separately
with the Commission.
-7-
Section
1.46 “Series 2-4 Licensed
Products”. Series 2-4 Licensed Products means Licensed
Products that contain any Series 2-4 Compound(s).
Section
1.47 “Series 2-4 Patent
Rights”. Series 2-4 Patent Rights means (a) the Patent Rights
set forth on Exhibit
E, (b) counterparts of the Patent Rights set forth on Exhibit E in any
country of the Territory, and (c) all Patent Rights claiming priority from the
Patent Rights described in either of the foregoing clauses (a) and (b) in any
country of the Territory.
Section
1.48 “Series 5-50
Compounds”. Series 5-50 Compounds means any and all compounds
claimed or disclosed in any Patent Rights licensed or acquired by XTL from
VivoQuest under the VivoQuest Asset Purchase Agreement or VivoQuest License
Agreement, excluding the Series 1 Compounds and the Series 2-4
Compounds.
Section
1.49 “Sublicense
Income”. Sublicense Income means, subject to Section 5.4, all
amounts received by PRESIDIO and/or its Affiliates from Third Parties in
connection with the sublicensing or licensing to such Third Parties of rights
under Licensed Patent Rights and/or Licensed Technology to Develop and/or
Commercialize any Series 1 Licensed Products, including without limitation all
license fees, milestone payments and royalties, but excluding any of the
following amounts received by PRESIDIO and/or its Affiliates from such Third
Parties:
(a) Amounts
received as the purchase price for PRESIDIO’s and/or its Affiliates’ debt or
equity securities, except to the extent such amounts exceed the fair market
value of such debt or equity securities;
(b) Amounts
received for bona fide research and development activities undertaken for, or in
collaboration with, such Third Parties, except to the extent such amounts exceed
reasonable and customary funding amounts for such activities (e.g., cost
reimbursement or reasonable FTE-based funding);
(c) Amounts
received for bona fide co-promotion and other commercial activities undertaken
for, or in collaboration with, such Third Parties, except to the extent such
amounts exceed reasonable and customary funding amounts for such activities
(e.g., fees calculated and paid as cost reimbursement, reasonable per-detail
fees or reasonable FTE-based funding);
(d) In the
event such license or sublicense is structured as a profit-sharing arrangement,
PRESIDIO’s and its Affiliates’ share of revenue amounts that are offset by
PRESIDIO’s and its Affiliates’ share of costs in the profit-share calculation
(i.e., only PRESIDIO’s and its Affiliates’ share of net profits, as opposed to
gross revenues, shall constitute Sublicense Income hereunder); and
(e) Amounts
received to cover Pass-Through Costs payable by PRESIDIO and/or its Affiliates
under this Agreement, including without limitation any Pass-Through Costs owed
by XTL to VivoQuest which are payable by PRESIDIO under Section 5.8 and any
Pass-Through Costs payable by PRESIDIO pursuant to any Assigned Contracts and
Additional Third Party Licenses.
-8-
Section
1.50 “Successful
Completion”. Successful Completion means (a) with respect to a
Phase I Trial for a Licensed Product, the completion of such Phase I Trial with
data that PRESIDIO determines is satisfactory to progress such Licensed Product
to a Phase II Trial, and (b) with respect to a Phase III Trial for a Licensed
Product, the completion of such Phase III Trial with data that (i) achieves the
primary endpoint of such Phase III Trial or (ii) that PRESIDIO reasonably
determines is suitable for inclusion as a pivotal trial in an NDA for such
Licensed Product to a Regulatory Authority.
Section
1.51 “Territory”. Territory
means all countries of the world.
Section
1.52 “Third
Party”. Third Party means any person or entity other than a
Party or any of its Affiliates.
Section
1.53 “Valid
Claim”. Valid Claim means, on a country-by-country basis, a
claim of (a) an issued patent that (i) has not expired; (ii) has not been
disclaimed; (iii) has not been cancelled or superseded, or if cancelled or
superseded, has not been reinstated; and (iv) has not been revoked, held
invalid, or otherwise declared unenforceable or not allowable by a tribunal or
patent authority of competent jurisdiction over such claim in such country from
which no further appeal has or may be taken; or (b) a patent application that
has been pending less than ***** years from the earliest date from which such
patent application claims priority and which claim has not been cancelled,
withdrawn or abandoned or finally rejected by an administrative agency action
from which no appeal can be taken.
Section
1.54 “VivoQuest Asset Purchase
Agreement”. VivoQuest Asset Purchase Agreement means the asset
purchase agreement, dated as of August 11, 2005, between XTL Biopharmaceuticals
Inc. and VivoQuest Inc. (including any successor-in-interest, “VivoQuest”), attached
hereto as Exhibit
B.
Section
1.55 *****.
Section
1.56 “VivoQuest License
Agreement”. VivoQuest License Agreement means the license
agreement, dated as of August 11, 2005, between XTL and VivoQuest, attached
hereto as Exhibit
B.
Section
1.57 “VivoQuest Licensed
Patents”. VivoQuest Licensed Patents means the “Licensed
Patents” as defined in the VivoQuest License Agreement.
Section
1.58 Additional
Definitions. Each of the following definitions is set forth in
the section of this Agreement indicated below:
* *****Confidential material redacted and filed separately
with the Commission.
-9-
Definitions
|
Section
|
Agreement
|
Preamble
|
Apath
License Agreement
|
Exhibit
A
|
Breaching
Party
|
9.2
|
Combination
Product
|
1.28
|
CPR
|
10.2
|
ICDR
|
10.3(a)
|
Indemnified
Party
|
11.1(c)
|
Indemnifying
Party
|
11.1(c)
|
Invalidity
Claim
|
6.4
|
Knowledge
|
8.5
|
Original
Effective Date
|
Preamble
|
Original
License Agreement
|
Preamble
|
PRESIDIO
|
Preamble
|
Restatement
Date
|
Preamble
|
Retained
Liabilities
|
11.1(b)
|
Severed
Clause
|
11.11
|
Technology
Transfer Period
|
3.1
|
TTC
|
3.2
|
Validity
Challenge
|
9.4(b)
|
VivoQuest
|
1.54
|
XTL
|
Preamble
|
Article
II
Grant of License; Assigned
Contracts; Exclusivity
Section
2.1 License
Grant. Subject to the terms and conditions of this Agreement,
XTL hereby grants to PRESIDIO an exclusive (even as to XTL), royalty-bearing
right and license under the Licensed Patent Rights and Licensed Technology, with
the right to grant sublicenses, to Develop and Commercialize Licensed Compounds
and Licensed Products in the Field in the Territory. Each sublicense
granted hereunder shall be pursuant to a written agreement that is consistent
with the terms and conditions of this Agreement, provided that further
sublicenses granted by any Third Party sublicensee to any of its affiliates
shall not be required to be pursuant to written agreements (the term
“affiliates” as used in this sentence shall mean, with respect to a Third Party
sublicensee, any Person that controls, is controlled by, or is under common
control with such Third Party sublicensee, with “control” having the meaning
provided in Section 1.2). PRESIDIO shall provide a copy of each such
sublicense agreement entered into by PRESIDIO promptly following its execution;
provided that, PRESIDIO shall
be entitled to redact from the copy of such sublicense agreement provided to XTL
terms that are not related to the determination of payments due to XTL under
this Agreement or the consistency of such sublicense agreement with the terms
and conditions of this Agreement; provided further that, such copies of
sublicense agreements provided by PRESIDIO to XTL shall constitute Confidential
Information of PRESIDIO hereunder.
Section
2.2 Assigned
Contracts. As of the Original Effective Date, XTL shall, and
shall cause its Affiliates to, assign to PRESIDIO, and PRESIDIO shall assume,
all of XTL’s or the applicable Affiliate’s rights and obligations under the
Assigned Contracts, provided, that XTL shall remain
responsible for the Retained Liabilities. XTL shall, and shall cause
its Affiliates to, take all reasonable further actions and execute all
assignments or other documents requested by PRESIDIO as may be necessary or
desirable to accomplish the foregoing assignments to PRESIDIO and to vest in
PRESIDIO the rights set forth in this Section 2.2.
-10-
Section
2.3 Exclusivity.
(a) During the
period commencing as of the Original Effective Date and continuing through the
term of this Agreement, neither XTL nor any of its Affiliates shall, or shall
license, permit or assist any Third Party to, use any of the Series 1 Compounds,
the Series 2-4 Compounds, the Series 5-50 Compounds, any Derivative Compounds of
the foregoing, or any other materials or Know-How licensed or acquired by XTL
from VivoQuest, for any Development or Commercialization purpose relating or
directed to the HCV Field in the Territory.
(b) During the
period commencing as of the Original Effective Date and continuing through the
term of this Agreement, neither XTL nor any of its Affiliates shall, or shall
license, permit or assist any Third Party to, Develop or Commercialize any
Competing Product in the Territory; provided, however, that in the event
that, after the Original Effective Date, a Third Party acquires XTL, then such
Third Party shall not be bound by the restrictions provided in this Section
2.3(b), and no Patents or Know-How owned or Controlled by such Third Party shall
be or become subject to the licenses granted herein, provided, that such Third Party
acquirer does not access or use any Licensed Compounds or Licensed Technology,
or practice any invention Covered by any Licensed Patent Rights, in connection
with such activities.
Section
2.4 Retained Rights; Other
Limitations. Without limiting Section 8.5(a), the rights
granted to PRESIDIO herein, including without limitation the license granted to
PRESIDIO in Section 2.1, as pertaining to Licensed Patent Rights and Licensed
Technology that are Controlled, but are not owned, by XTL, shall be limited by
any rights retained by Third Parties, or other limitations or conditions on
XTL’s sublicensee’s rights to such Licensed Patent Rights and Licensed
Technology. As of the Original Effective Date and the Restatement
Date, such retained rights and limitations consist solely of the rights retained
by the U.S. government pursuant to Section 2 of the VivoQuest License
Agreement.
Section
2.5 Section 365(n) of the
Bankruptcy Code. All rights and licenses granted to PRESIDIO
under or pursuant to this Agreement are, and shall otherwise be, deemed to be,
for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to
“intellectual property” as defined under Section 101(35A) of the Bankruptcy
Code. The Parties shall retain and may fully exercise all of their
respective rights and elections under the Bankruptcy Code.
-11-
Article
III
Technology
Transfer
Section
3.1 Technology
Transfer. Without limiting the license granted to PRESIDIO
pursuant to Section 2.1, XTL acknowledges and agrees that XTL was obligated
under the Original License Agreement to deliver, and to cause XTL’s Affiliates
to deliver, to PRESIDIO, commencing promptly following the Original Effective
Date and for no additional consideration, (a) all Licensed Compounds and all
other chemical or biological materials owned or Controlled by XTL or any of its
Affiliates, that are necessary or useful for producing the Licensed Compounds or
otherwise practicing the Licensed Patent Rights or Licensed Technology, (b) all
patent files associated with the Licensed Patent Rights, including without
limitation the complete texts of all patents and patent applications and copies
of all office actions, office action responses and other official communications
received from, or filed with, all relevant patent offices, in each case, in the
possession or Control of XTL or any of its Affiliates, and (c) all Licensed
Technology, including without limitation all laboratory notebooks, preclinical
or clinical data, databases, designs, assays, protocols, analytical systems,
discovery tools, reports and manufacturing documentation relating to the
Development and/or Commercialization of any Licensed Compounds or Licensed
Products, in each case, in the possession or Control of XTL or any of its
Affiliates. XTL was obligated to complete, and to cause XTL’s
Affiliates to complete, the delivery to PRESIDIO of all of the items listed in
each of the foregoing clauses (a), (b) and (c) within a period of three (3)
months following the Original Effective Date (the “Technology Transfer
Period”). XTL was obligated to make ***** reasonably available
to PRESIDIO until May 31, 2008, and ***** reasonably available to PRESIDIO
*****, in each case to answer any questions or provide instruction concerning
the Licensed Compounds, Licensed Patent Rights, Licensed Technology and/or any
of the other items delivered to PRESIDIO pursuant to this Section
3.1. During the Technology Transfer Period, XTL and its Affiliates
were obligated to take all such further reasonable actions as may be necessary
or desirable to accomplish the foregoing transfers to PRESIDIO and to put
PRESIDIO in actual possession of the foregoing information and
materials.
Section
3.2 Technology Transfer
Committee; Decision-Making Authority.
(a) Within
***** days following the Original Effective Date, the Parties shall establish a
technology transfer committee (the “TTC”) to facilitate
and oversee the technology transfer activities set forth in Section 3.1 during
the Technology Transfer Period. The TTC shall consist of no more than
two (2) representatives from each Party, each of whom shall be appointed by the
Senior Executive of the applicable Party. Each Party shall designate
one such representative to serve as the co-chair of the TTC. Unless
otherwise agreed by the Parties, the TTC shall remain in effect solely during
the Technology Transfer Period.
(b) The TTC
shall have decision-making authority with respect to any technical matter
relating to the technology transfer activities under Section 3.1, but shall have
no authority to amend the scope of the licenses granted to PRESIDIO under the
Original License Agreement or under this Agreement or amend any other
contractual rights or obligations of either Party under the Original License
Agreement or under this Agreement. All decisions of the TTC shall be
made by consensus of the TTC co-chairs. If the TTC co-chairs are
unable to reach consensus with respect to a particular matter within its
purview, the matter shall be referred to the Senior Executives for
resolution. If the Senior Executives are unable to resolve such
matter within ***** days following such referral, the matter shall be
resolved pursuant to Article X.
Article
IV
Reports and Meetings;
Diligence; Certain Regulatory and Manufacturing Activities
Section
4.1 Development Reports;
Meetings.
* *****Confidential material redacted and filed separately
with the Commission.
-12-
(a) Within
***** prior to the first commercial launch of the first Licensed Product by
PRESIDIO and/or any of its Affiliates or Third Party sublicensees, PRESIDIO
shall provide to XTL a written report summarizing the activities undertaken by
PRESIDIO, its Affiliates and Third Party sublicensees during the immediately
preceding six (6) month period (or such shorter period as may be applicable with
respect to the first and last such report) in connection with the Development
and Commercialization of Licensed Products.
(b) Prior to
the first commercial launch of the first Licensed Product hereunder, PRESIDIO
shall, upon reasonable request by XTL, at no cost to PRESIDIO, meet with XTL, no
more frequently than on a semi-annual basis and at PRESIDIO’s corporate
headquarters (or by telephone), to discuss generally the reports provided to XTL
under the foregoing Section 4.1(a).
(c) After the
first commercial launch of the first Licensed Product by PRESIDIO and/or any of
its Affiliates or Third Party sublicensees, PRESIDIO’s reporting obligations
shall be limited to those set forth in Section 5.9(a) below.
(d) Notwithstanding
any of the foregoing, in the event that XTL is acquired by, or otherwise becomes
an Affiliate of, a Person that is engaged in Development and/or
Commercialization activities relating or directed to the HCV Field, PRESIDIO’s
obligations under Section 4.1(a), Section 4.1(b) and Section 6.1(c) shall
terminate.
Section
4.2 Commercially Reasonable
Efforts. PRESIDIO shall use Commercially Reasonable Efforts to
Develop and Commercialize at least one Licensed Product for the prevention,
treatment, palliation and/or control of any HCV indication in the United States,
the EU and Japan. For purposes of clarity, PRESIDIO shall be deemed
to have used Commercially Reasonable Efforts hereunder with respect to its
Development and Commercialization activities in the EU if PRESIDIO Develops and
Commercializes at least one Licensed Product for the prevention, treatment,
palliation and/or control of any HCV indication in any ***** of the Major
EU Countries. Notwithstanding anything to the contrary in this
Agreement, however, XTL’s sole and exclusive remedy, and PRESIDIO’s sole and
exclusive liability, for any breach by PRESIDIO of such obligation to exercise
Commercially Reasonable Efforts shall be for XTL to exercise any right that XTL
may have to terminate this Agreement as provided in Section 9.2.
Section
4.3 Certain Regulatory and
Manufacturing Activities. As between the Parties, PRESIDIO
shall be responsible, at its expense, for all Development and Commercialization
activities conducted by PRESIDIO and/or its Affiliates or Third Party
sublicensees, including without limitation:
(a) Filing
applications for, and obtaining and maintaining, any necessary Regulatory
Approvals with respect to the Development and/or Commercialization of Licensed
Compounds or Licensed Products. As between the Parties, PRESIDIO
shall own all Regulatory Filings with respect to Licensed Compounds and/or
Licensed Products filed by or on behalf of PRESIDIO and/or its Affiliates or
Third Party sublicensees; and
* *****Confidential material redacted and filed separately
with the Commission.
-13-
(b) Manufacturing,
or having manufactured by a Third Party manufacturer, all preclinical, clinical
and commercial supply of Licensed Products, including without limitation
Licensed Compounds and/or other components necessary for such Licensed
Products.
Article
V
Financial
Provisions
Section
5.1 License
Payment. The Parties acknowledge and agree that a one-time,
non-refundable license payment of Three Million Nine Hundred Forty Thousand
Dollars ($3,940,000) was previously paid by PRESIDIO to XTL pursuant to Section
5.1 of the Original License Agreement. In addition to the foregoing
payment, in consideration of the execution and delivery of this Agreement,
PRESIDIO shall make the following non-refundable payments to XTL on or before
the dates indicated for payment: (i) within seven (7) days following the
Restatement Date, PRESIDIO shall pay XTL Five Hundred Thousand Dollars
($500,000), and (ii) on or before September 26, 2008, PRESIDIO shall pay XTL One
Million Five Hundred Thousand Dollars ($1,500,000).
Section
5.2 Milestone Payments for
Series 1 Licensed Products. Subject to Sections 5.4, 5.5(a),
5.6, 5.7 and 5.8(b), within ***** after achievement of each of the following
milestone events with respect to Series 1 Licensed Products by PRESIDIO or any
of its Affiliates, PRESIDIO shall make the indicated one-time milestone payment
to XTL; provided,
however, that where a portion of a milestone payment is payable by XTL to
VivoQuest as indicated in the parenthetical clauses included in the table below,
such amount (that is, such portion of the total milestone payment) shall be
payable by PRESIDIO to XTL within ***** after the achievement of the relevant
milestone event, except that the amount so payable upon the achievement of the
milestone event indicated in row (h) in the table below shall be payable by
PRESIDIO to XTL within ***** after the achievement of the relevant milestone
event. *****
* *****Confidential material redacted and filed separately
with the Commission.
-14-
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Each of
the milestone payments payable pursuant to this Section 5.2 upon achievement of
the corresponding milestone event shall be payable (x) only once, under either
Column A or Column B above (but not both), irrespective of how many
Licensed Products are Developed or Commercialized hereunder, (y) only upon
achievement of the corresponding milestone event by PRESIDIO and/or its
Affiliates, and not by any Third Party sublicensee of PRESIDIO or any of its
Affiliates, except as and to the extent required by Section 5.8(a) and (z) with
respect to the milestone payments set forth in clauses (a), (b), (c), (d), (e),
(f) and (g) of the table above, subject to the limitations set forth in Section
5.4. In addition to the foregoing, the milestone payments above shall
be reduced if PRESIDIO enters into an agreement with one or more Third Parties
pursuant to which PRESIDIO grants such Third Party(ies) a sublicense or license
under the Licensed Patent Rights and/or Licensed Technology to Develop and
Commercialize any Series 1 Licensed Product in any of the countries indicated
immediately below. Such reduction shall be given effect prior to any
reduction of the above milestones payments as provided in Section 5.5 and
Section 5.6 of this Agreement. Such reduction shall be in an amount
equal to the percentage of the applicable milestone payment indicated below in
connection with the grant of the foregoing rights in the specified country:
*****. Such reductions
shall only be applied to milestone payments that are payable in connection with
milestone events that are achieved after the execution and delivery of the
relevant agreement(s) between PRESIDIO and such Third Party(ies) and shall not
be given retroactive effect.
* *****Confidential material redacted and filed separately
with the Commission.
-15-
Section
5.3 Royalties. During
the Royalty Term applicable to sales of each Licensed Product in each country of
the Territory, PRESIDIO shall pay to XTL the royalties set forth in Section
5.3(a) or 5.3(b) below, as applicable, with the amount of such royalties
calculated as a percentage of worldwide Net Sales of such Licensed Product
during each Fiscal Year of PRESIDIO.
(a) Royalties for Series 1
Licensed Products. Subject to Sections 5.5(b), 5.6, 5.7 and
5.8(b), PRESIDIO shall pay XTL the following royalty with respect to Net Sales,
generated during the applicable Royalty Term, of each Series 1 Licensed Product
(on a product-by-product basis) by PRESIDIO and/or its Affiliates (but not by
any Third Party sublicensee of PRESIDIO or any of its Affiliates) during each
Fiscal Year of PRESIDIO:
Annual Worldwide Net Sales of
Series 1 Licensed Product
|
Percentage of
Incremental Net Sales Amount
|
|||
*****
|
*****
|
|||
*****
|
*****
|
|||
*****
|
*****
|
|||
*****
|
*****
|
*****.
(b) Royalties for Series 2-4
Licensed Products. PRESIDIO shall pay XTL a royalty of (i)
***** of Net Sales by PRESIDIO and/or its Affiliates of a Series 2-4
Licensed Product during any period that such Series 2-4 Licensed Product is
Covered by a Valid Claim of any Licensed Patent Right, and (ii) ***** of
Net Sales by any Third Party sublicensee of PRESIDIO and/or its Affiliates of a
Series 2-4 Licensed Product during any period that such Series 2-4 Licensed
Product is Covered by a Valid Claim of any Licensed Patent Right.
(c) Royalties Payable Only
Once. The obligation to pay royalties is imposed only once
with respect to Net Sales of the same unit of a Licensed Product.
Section
5.4 Sublicense Income for Series
1 Licensed Products. Subject to Section 5.8(a), PRESIDIO shall
pay XTL the following percentage of Sublicense Income, with respect to the
Development and/or Commercialization of any Series 1 Licensed Product by a Third
Party sublicensee, which Sublicense Income is received by PRESIDIO and/or its
Affiliates during Royalty Term applicable to such Series 1 Licensed Product in
the country(ies) in which the activities giving rise to the Sublicense Income
payment to PRESIDIO and/or its Affiliates occur:
(a) *****
(b) *****
* *****Confidential material redacted and filed separately
with the Commission.
-16-
Notwithstanding
Section 5.2 and the foregoing provisions of this Section 5.4, and subject to the
remaining provisions of this paragraph, PRESIDIO’s obligations to pay XTL (A)
milestone payments upon the achievement by PRESIDIO or its Affiliates of the
milestone events designated (a), (b), (c), (d), (e), (f) and (g) in the table in
Section 5.2 and (B) payments pursuant to this Section 5.4 based on Sublicense
Income comprised of upfront payments (that is, payments due in connection with
the execution and delivery of a sublicense that are not contingent on the
occurrence of other events or achievements) or milestone payments other than
milestone payments based on the achievement by a Third Party sublicensee of
sales milestones (i.e., the achievement of specified levels of sales of Series 1
Licensed Products and not, *****. Notwithstanding the limitation on
PRESIDIO’s payment obligations described in this Section, the amounts provided
in Section 5.8 shall remain due and payable in full in accordance with the terms
set forth in Section 5.8.
Section
5.5 Reduction for Lack of Patent
Coverage.
(a) Each
of the milestone payments payable by PRESIDIO pursuant to Section 5.2 above
shall be reduced by ***** in the event that the first Series 1 Licensed Product
with respect to which the corresponding milestone event is achieved is not
Covered by a Valid Claim of any Licensed Patent Rights at the time of such
achievement; provided that if the same milestone event is subsequently achieved
with one or more Series 1 Licensed Products that are Covered by a Valid Claim of
a Licensed Patent Right at the time of such achievement, then the remainder of
such milestone payment (i.e., the ***** not previously paid) shall then become
payable hereunder.
(b) The
royalty rate set forth in Section 5.3(a) above payable by PRESIDIO with respect
to Net Sales by PRESIDIO and/or its Affiliates of any Series 1 Licensed Product
for use in the Field in any country in the Territory shall be reduced to *****
of Net Sales during any portion of the Royalty Term for such Series 1 Licensed
Product in which such Series 1 Licensed Product in such country is not Covered
by a Valid Claim of any Licensed Patent Rights.
Section
5.6 Reduction for Pass-Through
Costs Under Assigned Contracts and Additional Third Party
Licenses. As between the Parties, PRESIDIO shall be
responsible for paying all Pass-Through Costs required to be paid under the
Assigned Contracts and any Additional Third Party Licenses; provided, however, that, PRESIDIO shall
have the right to reduce the milestone and royalty payments payable by PRESIDIO
under Sections 5.2 and 5.3(a) above ***** of all such Pass-Through Costs
payable by PRESIDIO hereunder, provided, that, in no event
shall any single milestone or royalty payment payable by PRESIDIO under Section
5.2 or 5.3(a) with respect to any Series 1 Licensed Product be reduced by more
than fifty percent (50%) of the amount otherwise due to XTL under Section 5.2 or
5.3(a). For the avoidance of doubt, no reduction shall be applied by
PRESIDIO under this Section 5.6 with respect to the Sixty Thousand Dollars
($60,000) required to be paid under the Apath License Agreement as a
“Retroactive Fee” (as defined in the Apath License Agreement), it being
understood that the amount of such Retroactive Fee has been accounted for in the
calculation of the upfront license payment set forth in Section
5.1.
* *****Confidential material redacted and filed separately
with the Commission.
-17-
Section
5.7 Priority of
Reduction. In the event that the reductions provided for in
Sections 5.5 and 5.6 would otherwise both be applicable to a milestone or
royalty payment payable by PRESIDIO under Section 5.2 or 5.3(a), then only the
reduction in Section 5.5 shall apply to such milestone or royalty
payment.
Section
5.8 Offset for Payment of
VivoQuest Pass-Through Costs. As between the Parties, XTL
shall be responsible for maintaining the VivoQuest License Agreement in full
force and effect and for paying all amounts due to VivoQuest
thereunder. Anything in this Agreement to the contrary
notwithstanding, in addition to (but subject to PRESIDIO’s offset rights as
provided below) any other amounts that may be payable hereunder:
(a) If,
at any time, Pass-Through Costs are owed by XTL to VivoQuest under the VivoQuest
License Agreement as a result of the Development and/or Commercialization of
Series 1 Licensed Products by a Third Party sublicensee of PRESIDIO or any of
its Affiliates (but not by PRESIDIO or any of its Affiliates), then PRESIDIO
shall pay XTL the amount of the Pass-Through Costs owed by XTL to VivoQuest;
provided, however, that PRESIDIO shall
have the right to offset such amount paid by PRESIDIO against any amounts
otherwise payable, concurrently or subsequently, by PRESIDIO to XTL under
Section 5.4.
(b) If
any amount payable by PRESIDIO to XTL under Section 5.2 or Section 5.3(a) is
less than the corresponding Pass-Through Costs that are owed by XTL to VivoQuest
under the VivoQuest License Agreement as a result of the Development and/or
Commercialization of Series 1 Licensed Products by PRESIDIO and/or any of its
Affiliates (but not by a Third Party sublicensee of PRESIDIO or any of its
Affiliates), then PRESIDIO shall pay XTL the difference between (i) the amount
paid by PRESIDIO under Section 5.2 or Section 5.3(a), and (ii) the amount of the
Pass-Through Costs owed by XTL to VivoQuest.
(c) PRESIDIO
shall be obligated to pay XTL any Pass-Through Costs that are owed by XTL to
VivoQuest under the VivoQuest License Agreement as a result of the Development
and/or Commercialization of Series 2-4 Licensed Products by PRESIDIO and/or any
of its Affiliates or Third Party sublicensees.
(d) In
the event that any Pass-Through Costs set forth in any of the foregoing clauses
(a) through (c) are payable by PRESIDIO under such provisions or any
Pass-Through Costs referenced in the parenthetical clauses in Column A of the
table in Section 5.2 are owed by XTL to VivoQuest, (i) *****
Section
5.9 Reports and
Accounting.
(a) Reports;
Payments. PRESIDIO shall deliver to XTL, within ***** days
after the end of each calendar quarter, a good faith estimate of the royalties
and Sublicense Income that will be paid to XTL for such calendar quarter
(excluding any estimate of royalties which may be payable by PRESIDIO under
Section 5.3(b)(ii) with respect to Net Sales of Series 2-4 Licensed Products by
Third Party sublicensees of PRESIDIO and/or its Affiliates), and, within
***** days after the end of each calendar quarter, reasonably detailed
written accountings of Net Sales and Sublicense Income of Licensed Products that
are subject to payment obligations to XTL for such calendar
quarter. Such quarterly reports shall indicate (i) gross sales, Net
Sales, gross amounts received from Third Party sublicensees, and Sublicense
Income on a Licensed Product-by-Licensed Product and country-by-country basis,
and (ii) the calculation of payment amounts owed to XTL from such Net Sales and
Sublicense Income. When PRESIDIO delivers such accounting to XTL,
PRESIDIO shall also deliver all amounts due under Sections 5.3 and 5.4 to XTL
for the calendar quarter.
* *****Confidential material redacted and filed separately
with the Commission.
-18-
(b) Audits by
XTL. PRESIDIO shall keep, and shall require its
Affiliates and
Third Party sublicensees to keep, records of the latest ***** years relating to
gross sales, Net Sales, gross amounts received from Third Party sublicensees,
and Sublicense Income, in each case as applicable, and all information relevant
under Sections 5.2, 5.3, 5.4, 5.6, 5.7 and 5.8. For the sole purpose
of verifying amounts payable to XTL, XTL shall have the right no more than once
each calendar year, at XTL’s expense, to have XTL’s independent certified public
accountants review such records in the location(s) where such records are
maintained by PRESIDIO and/or its Affiliates or, with respect to records of
Third Party sublicensees, either at PRESIDIO’s premises or the premises of such
Third Party sublicensees, in each case as may be designated by PRESIDIO, upon
***** prior notice and during regular business hours. Results of
such review shall be made available to PRESIDIO. If the review
reflects an underpayment to XTL, such underpayment shall be promptly remitted to
XTL, together with interest calculated in the manner provided in Section
5.13. If the underpayment is equal to or greater than ***** of
the aggregate amount that was otherwise due for any calendar year, PRESIDIO
shall promptly reimburse XTL for the reasonable costs incurred in connection
with such review. If the review reflects an overpayment to XTL, such
overpayment shall be promptly refunded by XTL to PRESIDIO.
Section
5.10 Currency and Method of
Payments. All payments under this Agreement shall be made in
United States dollars by transfer to such bank account as XTL may designate from
time to time. Any royalties or portions of Sublicense Income due
hereunder with respect to amounts in currencies other than United States dollars
shall be payable in their United States dollar equivalents, calculated using the
average applicable interbank transfer rate determined by reference to the
currency trading rates published by The Wall Street
Journal (Western U.S. edition) over all business days of the calendar
quarter to which the report under Section 5.9(a) relates.
Xxxxxxx
0.00 Xxxxxx Xxxxxx
Dollars. All dollar ($) amounts specified in this Agreement
are United States dollar amounts.
Section
5.12 Tax
Withholding. If withholding taxes are payable with respect to
payments to XTL hereunder, PRESIDIO may withhold the required amount and pay it
to the appropriate governmental authority. PRESIDIO will withhold
only such amounts as are required to be withheld by law in the country from
which payment is being made. PRESIDIO shall submit to XTL a copy of
the remittance voucher and reasonably satisfactory evidence of payment of the
corresponding taxes with the applicable royalty report, if possible, or within
***** days thereafter. PRESIDIO will make reasonable efforts and will
reasonably cooperate with XTL and provide such information and records as XTL
may reasonably require in connection with XTL obtaining any applicable reduction
or exemption from withholding tax from tax authorities in any
country.
* *****Confidential material redacted and filed separately
with the Commission.
-19-
Section
5.13 Late Payments.
PRESIDIO shall pay interest to XTL on the aggregate amount of any payment that
is not paid on or before the date such payment is due under this Agreement at a
rate per annum equal to *****.
Section
5.14 Blocked Payments. In
the event that, by reason of applicable laws or regulations in any country, it
becomes impossible or illegal for PRESIDIO or its Affiliates to transfer, or
have transferred on its behalf, royalties or other payments to XTL, such
royalties or other payments shall be deposited in local currency in the relevant
country to the credit of XTL in a recognized banking institution designated by
XTL or, if none is designated by XTL within a period of ***** days,
in a recognized banking institution selected by PRESIDIO or its
Affiliates.
Section
5.15 Costs and Expenses.
Except as otherwise expressly set forth herein, each Party shall bear its own
costs and expenses incurred in connection with the performance of its
obligations hereunder.
Article
VI
Intellectual Property
Protection and Related Matters
Section
6.1 Prosecution and Maintenance
of Licensed Patent Rights.
(a)
Right to Prosecute and
Maintain. As between the Parties, PRESIDIO shall have the first right to
file and prosecute patent applications and maintain patents within the Licensed
Patent Rights. Subject to Section 6.6 below, PRESIDIO shall use Commercially
Reasonable Efforts to file and prosecute patent applications and maintain
patents within the Licensed Patent Rights in the United States, Canada, the
Major EU Countries and Japan in a manner that is intended to provide optimal
protection for any Licensed Products that PRESIDIO may Develop and/or
Commercialize in such countries, including without limitation seeking claims of
reasonably broad scope, to the extent permitted under applicable law.
Notwithstanding the foregoing, in the event that PRESIDIO decides to abandon or
discontinue the filing, prosecution or maintenance of any non-provisional patent
application or patent within the Licensed Patent Rights in any such country,
then PRESIDIO shall notify XTL of such determination reasonably in advance of
any loss of rights by XTL with respect to such patent application or patent.
Thereafter, XTL shall have the right, upon written notice to PRESIDIO, to file,
prosecute and maintain such non-provisional patent applications and patents, in
its name and at its own expense, which patent applications and patents shall no
longer be deemed “Licensed Patent Rights” under this Agreement. Notwithstanding
anything in this Agreement to the contrary, XTL’s sole and exclusive remedy, and
PRESIDIO’s sole and exclusive liability, for any decision by PRESIDIO not to
file, prosecute and/or maintain any patent applications or patents hereunder
shall be for XTL to assume such filing, prosecution and maintenance activities
with respect to such patent applications or patents pursuant to this Section
6.1.
* *****Confidential material redacted and filed separately
with the Commission.
-20-
(b)
Disclosure of New
Inventions. XTL shall, and shall cause its Affiliates to, disclose to
PRESIDIO any and all new inventions or other Know-How that (i) would constitute
subject matter with respect to which a patent application within the Licensed
Patent Rights may be filed hereunder or would otherwise constitute Licensed
Technology hereunder, and (ii) becomes Controlled by XTL or any of its
Affiliates at any time during the period commencing as of the Original Effective
Date and continuing through the term of this Agreement. XTL shall, and shall
cause its Affiliates to, disclose such inventions or other such Know-How to
PRESIDIO within ***** days after such Control exists, including without
limitation reasonably detailed information with respect to such inventions or
other such Know-How to enable PRESIDIO to obtain appropriate patent protection
with respect to such inventions or other Know-How.
(c)
Cooperation.
Subject to Section 4.1(d), each Party agrees to cooperate with the other Party
with respect to the filing and prosecution of patent applications and
maintenance of patents within the Licensed Patent Rights pursuant to this
Section 6.1, including without limitation:
(i)
the execution of all such documents and instruments and the performance of such
acts as may be reasonably necessary in order to permit the other Party to file
and prosecute patent applications or maintain patents as provided for in Section
6.1(a);
(ii) making
its employees, agents and consultants reasonably available to the other Party
(or to the other Party’s authorized attorneys, agents or representatives), to
the extent reasonably necessary to enable such other Party to file and prosecute
patent applications or maintain patents as provided for in Section 6.1(a);
and
(iii)
to provide the other Party with copies of all material official communications
received from, or filed with, the relevant patent offices pertaining to the
filing and prosecution of patent applications and maintenance of patents as
provided for in Section 6.1(a).
Section
6.2 Third Party
Infringement.
(a)
Notifications of Third
Party Infringement. Each Party agrees to notify the other Party when it
becomes aware of any infringement of the Licensed Patent Rights or
misappropriation of Licensed Technology, or the reasonable probability of such
infringement or misappropriation, arising from or relating to the development,
manufacture, offer for sale, sale, import or other use of any Third Party
product.
(b)
Infringement
Action. PRESIDIO shall decide whether to institute an infringement suit
or take other appropriate action that it believes is reasonably required to
protect the Licensed Patent Rights or Licensed Technology from such infringement
or misappropriation. In the event that PRESIDIO brings an action pursuant to
this Section 6.2(b), XTL shall cooperate with PRESIDIO to the extent reasonably
requested by PRESIDIO, including without limitation joining the suit if
requested by PRESIDIO and necessary or desirable.
(c)
Costs. PRESIDIO
shall assume and pay all of its own and XTL’s out-of-pocket costs incurred in
connection with any litigation or proceedings described in this Section 6.2;
provided, however, that if XTL elects to
be represented in such litigation or proceedings by separate counsel, XTL shall
assume and pay for all of its own out-of-pocket costs incurred in connection
with such litigation or proceedings.
* *****Confidential material redacted and filed separately
with the Commission.
-21-
(d)
Recoveries. Any
recovery obtained by PRESIDIO as a result of any action or proceeding described
in this Section 6.2, or from any counterclaim or similar claim asserted in a
proceeding described in Section 6.3, by settlement or otherwise, shall be
applied in the following order of priority:
(i)
first, to reimburse PRESIDIO for all litigation costs in connection with such
proceeding paid by PRESIDIO and not otherwise recovered; and
(ii) second,
the remainder of the recovery shall be paid *****.
Section
6.3 Claimed Infringement.
In the event that a Party becomes aware of any claim that the Development or
Commercialization of Licensed Products infringes Patent Rights or
misappropriates the Know-How of any Third Party, such Party shall promptly
notify the other Party.
Section
6.4 Patent Invalidity
Claim. If a Third Party at any time asserts a claim that any Licensed
Patent Right is invalid, unenforceable and/or otherwise not infringed (an “Invalidity Claim”),
whether as a defense in an infringement action brought by PRESIDIO pursuant to
Section 6.2 or in an action brought against PRESIDIO or XTL referred to in
Section 6.3, PRESIDIO shall have the right to prepare and formulate all
responses to, and defend and settle, such Invalidity Claim. XTL shall cooperate
with PRESIDIO with respect to such activities upon reasonable request by
PRESIDIO.
Section
6.5 Patent Marking.
PRESIDIO agrees to comply with any applicable patent marking statutes in each
country in which Licensed Products are sold by PRESIDIO and/or its
Affiliates.
Section
6.6 Certain Limitations.
Without limiting the representations, warranties and covenants provided by XTL
pursuant to Section 8.5, the Parties acknowledge that PRESIDIO may not be
permitted to exercise all of the rights set forth in this Article VI with
respect to Licensed Patent Rights that are not owned by XTL. Under such
circumstances, XTL shall use reasonable efforts to obtain such rights for
PRESIDIO and XTL shall provide prompt written notice to PRESIDIO of any such
limitations on PRESIDIO’s rights under this Article VI. The existence of any
such limitations, or XTL’s inability to avoid or eliminate any such limitations
(provided XTL has used reasonable efforts to do so and subject to Section 8.5),
shall not constitute a breach of this Agreement by XTL.
* *****Confidential material redacted and filed separately
with the Commission.
-22-
Article
VII
Confidentiality
Section
7.1 Confidential
Information. All Confidential Information disclosed by a Party to the
other Party during the period commencing on the Original Effective Date and
continuing through the term of this Agreement shall not be used by the receiving
Party except in connection with the activities contemplated by this Agreement,
shall be maintained in confidence by the receiving Party (except to the extent
disclosure is reasonably necessary for Development and/or Commercialization of
Licensed Products, for the filing, prosecution and maintenance of Patent Rights
or to enforce the provisions of this Agreement), and shall not otherwise be
disclosed by the receiving Party to any other person, firm, or agency,
governmental or private (except as set forth Sections 7.2 or 7.3), without the
prior written consent of the disclosing Party, except to the extent that the
Confidential Information:
(a)
was known or used by the receiving Party prior to its date of disclosure to the
receiving Party; or
(b)
either before or after the date of the disclosure to the receiving Party is
lawfully disclosed to the receiving Party by sources other than the disclosing
Party rightfully in possession of the Confidential Information; or
(c)
either before or after the date of the disclosure to the receiving Party becomes
published or generally known to the public through no fault or omission on the
part of the receiving Party; or
(d)
is independently developed by or for the receiving Party without reference to or
reliance upon the Confidential Information; or
(e)
is required to be disclosed by the receiving Party to comply with applicable
laws, regulations or rules, to defend or prosecute litigation or to comply with
legal process, provided that the receiving
Party provides prior written notice of such disclosure to the disclosing Party
and only discloses Confidential Information of the other Party to the extent
necessary for such legal compliance or litigation purpose.
Section
7.2 Employee, Director,
Consultant and Advisor Obligations. PRESIDIO and XTL each agrees that it
and its Affiliates shall provide Confidential Information received from the
other Party only to the receiving Party’s respective (a) employees, directors,
consultants and advisors, and to the employees, directors, consultants and
advisors of the receiving Party’s Affiliates, who have a need to know such
Confidential Information to assist the receiving Party in fulfilling its
obligations under this Agreement, and (b) existing and prospective investors,
acquirers, lenders, sublicensees, collaborators and Third Party contractors
engaged in the Development and/or Commercialization of Licensed Compounds or
Licensed Products, or in connection with such Party’s financing activities;
provided that PRESIDIO and XTL
shall each remain responsible for any failure by any Person included in the
foregoing clauses (a) and (b) to treat such Confidential Information as required
under Section 7.1.
-23-
Section
7.3 Publicity.
(a)
Upon execution of this Agreement, the Parties shall issue a mutually agreed
joint press release announcing the execution of this Agreement, a copy of which
is attached hereto as Exhibit F. During the
term of this Agreement, neither Party nor its Affiliates shall disclose this
Agreement or make any public announcement, press release, filing or other
disclosure concerning the existence, terms and conditions of this Agreement
without the other Party’s prior written consent (which consent shall not be
unreasonably withheld, conditioned or delayed), except (i) as set forth in
Section 7.3(b) below, (ii) as required to comply with applicable laws,
regulation or rules (including without limitation any rules of the United States
Securities and Exchange Commission or similar regulatory agency, stock exchange
or securities trading institution of such other jurisdictions whose laws may
apply to a Party), or (iii) to existing and prospective investors, acquirers,
lenders and other Third Parties in connection with such Party’s financing
activities, provided, that each such Third
Party is bound to treat such information as confidential. If a Party is required
to make any such disclosure under applicable law, regulation or rule, such Party
shall provide the other Party with a copy of the proposed text of any such
written disclosure or the proposed content of any non-written disclosure,
sufficiently in advance (to the extent practicable or permitted under applicable
law, regulation or rule) of the scheduled release or disclosure thereof to
afford the other Party a reasonable opportunity to review and comment upon such
proposed disclosure and/or obtain confidential treatment with respect to such
proposed disclosure.
(b)
Notwithstanding the foregoing, (i) PRESIDIO and/or any of its Affiliates and
Third Party sublicensees shall have the right to disclose, in private
communications, public announcements, press releases, filings or other
disclosures, information concerning or related to its or their Development and
Commercialization activities with respect to Licensed Products hereunder, and
(ii) each Party and/or any of such Party’s Affiliates and/or, with respect to
PRESIDIO, Third Party sublicensees, shall have the right to disclose information
that is the same or substantially similar to information that has previously
been disclosed under this Section 7.3; in the case of each of the foregoing
clauses (i) and (ii), without having to grant the other Party the opportunity to
review and comment on such proposed disclosure or obtain such other Party’s
prior written consent.
Section
7.4 Term. All obligations
of confidentiality imposed under this Article VII shall expire ***** years
following termination or expiration of this Agreement.
Article
VIII
Representations and
Warranties
Section
8.1 Representations of
Authority. PRESIDIO and XTL each represents and warrants to the other
that it had, as of the Original Effective Date, and has, as of the Restatement
Date, full right, power and authority to enter into the Original License
Agreement and this Agreement, respectively, and to perform its respective
obligations under the Original License Agreement and this Agreement,
respectively.
Section
8.2 Consents. PRESIDIO
and XTL each represents and warrants that, as of the Original Effective Date and
the Restatement Date, all necessary consents, approvals and authorizations of
all government authorities and other Persons required to be obtained by such
Party in connection with the execution, delivery and performance of the Original
License Agreement and this Agreement, respectively, have been
obtained.
* *****Confidential material redacted and filed separately
with the Commission.
-24-
Section
8.3 No Conflict. PRESIDIO
and XTL each represents and warrants that, as of the Original Effective Date and
the Restatement Date, the execution and delivery of the Original License
Agreement and this Agreement and the performance of such Party’s obligations
hereunder (a) do not conflict with or violate any requirement of applicable laws
or regulations, and (b) do not conflict with, violate or breach or constitute a
default of, or require any consent under, any contractual obligations of such
Party, except such consents as have been obtained as of the Original Effective
Date or the Restatement Date, as applicable.
Section
8.4 Employee, Director,
Consultant and Advisor Obligations. PRESIDIO and XTL each represents and
warrants that, as of the Original Effective Date and the Restatement Date, each
of its and its Affiliates’ employees, directors, consultants and advisors has
executed an agreement or has an existing obligation under law obligating such
employee, director, consultant or advisor to maintain the confidentiality of
Confidential Information to the extent required under Article VII.
Section
8.5 Intellectual
Property. XTL represents, warrants and covenants to PRESIDIO that, as of
the Original Effective Date and the Restatement Date (unless otherwise
specifically stated below):
(a)
VivoQuest has assigned to XTL all right, title and interest in and to the
VivoQuest Licensed Patents, a complete and accurate list of which VivoQuest
Licensed Patents are included on Exhibit D and Exhibit E. XTL is the
sole and exclusive owner (subject to Section 2.4) of all right, title and
interest in and to the VivoQuest Licensed Patents and the other Patent Rights
set forth on Exhibit
D and Exhibit
E, and is the sole and exclusive owner of all right, title and interest
in and to, or has obtained exclusive rights to, the Licensed Compounds and
Licensed Technology;
(b)
Each of XTL’s and its Affiliates’ current and former employees, directors,
consultants and contractors has executed an agreement assigning to XTL or XTL’s
Affiliate all of its or his or her right, title and interest in and to any
inventions developed in the course of its or his or her employment or engagement
with XTL or XTL’s Affiliate, and such agreements are valid and binding on all
such current and former employees, directors, consultants and
contractors;
(c)
To the Knowledge of XTL, each patent and patent application included within the
Licensed Patent Rights sets forth a complete and accurate list of all
inventors;
(d)
XTL has the right to grant to PRESIDIO the rights and licenses to Licensed
Compounds, Licensed Patent Rights and Licensed Technology granted in this
Agreement;
(e)
XTL and its Affiliates have not granted, and during the term of this Agreement
XTL will not grant and will cause its Affiliates not to grant, any rights to any
Third Party (including without limitation VivoQuest or any of the counterparties
to any Assigned Contracts) which would conflict with the rights granted to
PRESIDIO hereunder;
(f)
None of the Licensed Patent Rights procured by XTL or its Affiliates and, to the
Knowledge of XTL, none of the Licensed Patent Rights procured by any Third Party
was fraudulently procured from the relevant governmental patent granting
authority;
-25-
(g)
To the Knowledge of XTL, the practice of the Licensed Patent Rights and Licensed
Technology as contemplated under this Agreement does not violate the
intellectual property rights of any Third Party, and no claim, demand or suit
has been made, or proceeding initiated, nor is any such claim, demand, suit or
proceeding pending or threatened, that asserts the invalidity, misuse or
unenforceability of the Licensed Patent Rights or Licensed Technology;
*****;
(h)
To the Knowledge of XTL, none of the Licensed Patent Rights are being infringed,
nor is any Licensed Technology being misappropriated, by any Third
Party;
(i)
All necessary registration, maintenance and renewal fees for Licensed Patent
Rights have been paid on time, *****;
(j)
Exhibits D and
E provide a complete and accurate listing of the Licensed Patent Rights,
including without limitation the VivoQuest Licensed Patents, and XTL does not
own or otherwise Control any Patent Rights other than the Patent Rights listed
on Exhibits D and
E that claim or disclose any Licensed Compounds or Licensed
Technology;
(k)
Exhibit C
provides a complete and accurate listing of all Series 1 Compounds and Series
2-4 Compounds that are included in XTL’s and/or its Affiliates’ databases,
laboratory notebooks and/or other records, or that have otherwise been
identified, studied, screened or evaluated by XTL and/or its Affiliates,
regardless of whether or not such compounds have been synthesized by XTL or any
of its Affiliates;
(l)
*****;
(m)
Attached as Exhibits A
and B are all complete and accurate copies of all Third Party agreements
to which XTL or any XTL Affiliate was a party as of the Original Effective Date
(or, solely with respect to the Assigned Contracts, immediately prior to the
Original Effective Date) relating to the Licensed Compounds, Licensed Patent
Rights and/or Licensed Technology. Except for the VivoQuest License Agreement,
the VivoQuest Asset Purchase Agreement and Assigned Contracts, neither XTL nor
any XTL Affiliate, as of the Original Effective Date (or, solely with respect to
the Assigned Contracts, immediately prior to the Original Effective Date) and
the Restatement Date, was or is, as applicable, a party to, or is otherwise
bound by, any agreement pursuant to which any Third Party has any economic or
other interest with respect to the Development and/or Commercialization of the
Licensed Compounds or Licensed Products, or any ownership rights in any of the
Licensed Compounds, Licensed Patent Rights and/or Licensed
Technology;
(n)
The VivoQuest License Agreement, the VivoQuest Asset Purchase Agreement were as
of the Original Effective Date and are as of the Restatement Date, and all
Assigned Contracts were as of the Original Effective Date, in full force and
effect, and XTL and/or its Affiliates were or are, as applicable, in full
compliance with the terms of such agreements *****, no dispute existed or presently exists, as
applicable, nor has XTL received any notice of any such claim of breach or
dispute nor, to the Knowledge of XTL, is any such claim pending or threatened,
between XTL and the counterparty to any such agreement that would jeopardize any
of the rights or licenses granted to PRESIDIO under this Agreement, and, to the
Knowledge of XTL, there was and is, as applicable, no basis for any such claim
of breach or dispute;
* *****Confidential material redacted and filed separately
with the Commission.
-26-
(o)
During the period commencing on the Original Effective Date and ending
continuing through the term of this Agreement, XTL shall, and shall cause its
Affiliates to, comply with all terms and conditions of, and shall not, and shall
cause its Affiliates not to, without the prior written consent of PRESIDIO,
amend, terminate, or make or waive any claims or rights under, or grant any
rights to VivoQuest or any other Third Party in connection with, the VivoQuest
License Agreement or the VivoQuest Asset Purchase Agreement, in any manner that
would adversely affect the rights granted to PRESIDIO under this Agreement, or
take any action or fail to take any action that would give VivoQuest the right
to amend or terminate the VivoQuest License Agreement or the VivoQuest Asset
Purchase Agreement or would otherwise adversely affect the rights granted to
PRESIDIO under this Agreement;
(p)
As of the Original Effective Date, XTL and its Affiliates had obtained all
necessary consents to assign the Assigned Contracts to PRESIDIO
hereunder;
(q)
To the Knowledge of XTL, all written statements and other writings furnished by
XTL or its Affiliates pursuant to or in connection with the Original License
Agreement or this Agreement or the transactions contemplated thereby and hereby
are complete and accurate in all material respects. No representation or
warranty by XTL in the Original License Agreement contained, and no
representation or warranty by XTL in this Agreement contains, any untrue
statement of a material fact or omits to state any material fact necessary in
order to make any statement contained herein not misleading. To the Knowledge of
XTL, there is no fact, event or condition that would adversely affect PRESIDIO’s
rights under this Agreement that has not been set forth in this Agreement or
disclosed by XTL to PRESIDIO in writing; and
(r)
*****.
The term
“Knowledge” means the actual knowledge of ***** as of the Original Effective Date and ***** as of
the Restatement Date, as the case may be. For avoidance of doubt, anything to
the contrary herein notwithstanding, XTL makes no representations or warranties
with respect to any Derivative Compounds.
Section
8.6 No Warranties. EXCEPT
AS OTHERWISE EXPRESSLY SET FORTH HEREIN, THE PARTIES MAKE NO REPRESENTATIONS AND
EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. IN PARTICULAR, PRESIDIO EXPRESSLY DISCLAIMS ANY REPRESENTATION OR
WARRANTY THAT ANY LICENSED COMPOUND OR LICENSED PRODUCT WILL BE SUCCESSFULLY
DEVELOPED OR COMMERCIALIZED.
* *****Confidential material redacted and filed separately
with the Commission.
-27-
Article
IX
Term and
Termination
Section
9.1 Term. This Agreement
became effective as of the Original Effective Date, may be terminated as set
forth in this Article IX, and otherwise remains in effect until the expiration
of all of PRESIDIO’s payments obligations pursuant to Article V. Upon expiration
of this Agreement, on a Licensed Product-by-Licensed Product and
country-by-country basis, the license granted to PRESIDIO under Section 2.1
shall convert to a non-exclusive, perpetual, fully paid-up, non-royalty-bearing
license.
Section
9.2 Termination For Material
Breach. Upon any material breach of this Agreement by either Party (in
such capacity, the “Breaching Party”),
the other Party may terminate this Agreement by providing ***** days’ written notice to the Breaching
Party, specifying the material breach. The termination shall become effective at
the end of the ***** day period unless (a)
the Breaching Party cures such material breach during such ***** day
period or (b) if the material breach is not susceptible to cure within such
***** day period, the Breaching Party is
diligently pursuing a cure and effects such cure within an additional ***** days
after the end of such initial ***** day
period. Notwithstanding any of the foregoing, (x) if the non-Breaching Party
gives the Breaching Party notice pursuant to this Section 9.2 of a material
breach by such Breaching Party, and the Breaching Party notifies the
non-Breaching Party within the applicable cure period set forth in the
immediately preceding sentence that such Breaching Party disputes such basis for
termination pursuant to this Section 9.2, then this Agreement shall not
terminate unless and until the arbitrator issues a final award pursuant to
Article X upholding such basis for termination (or unless and until the
Breaching Party is no longer disputing such basis, if earlier) and within ***** days
thereafter the Breaching Party fails to comply with the terms of such final
award issued by the arbitrator, and (y) if any uncured material breach by
PRESIDIO of its diligence obligations under Section 4.2 is limited to only one
or two of the following territories, then XTL may terminate this Agreement
solely with respect to such territory or territories: (i) the EU, (ii) the
United States, and (iii) Japan. Both Parties shall perform all of their
respective obligations hereunder during the process of conducting any dispute
resolution hereunder, including without limitation, the payment of all
undisputed amounts as and when they become due and payable
hereunder.
Section
9.3 Termination for
Convenience. PRESIDIO may terminate this Agreement at any time upon *****
days prior written notice to XTL for any or no reason.
* *****Confidential material redacted and filed separately
with the Commission.
-28-
Section
9.4 Effect of Material Breach or
Patent Validity Challenge by XTL or its Affiliates.
(a)
In the event that this Agreement is terminated by PRESIDIO pursuant to Section
9.2 above as a result of XTL’s uncured material breach (other than a material
breach by a Third Party acquirer of XTL, or by XTL or any of its Affiliates,
following an acquisition transaction resulting in a change of control of XTL or
of all or substantially all of its business or assets), then PRESIDIO shall have
the option of (i) actually terminating this license, in which case the
provisions of Section 9.5(c) shall apply and become effective, and pursuing any
remedies that may be available to it hereunder or at law, or (ii) not exercising
such termination right and continuing the licenses and this Agreement, in
accordance with the terms and conditions set forth herein, provided that (A) the
amounts that become due under Article V shall, as of the date of such waiver and
for the remainder of the term of this Agreement, be reduced by ***** (after
application of all other reductions and offsets that may be applicable);
provided that the amounts provided in Section 5.8 shall remain due and payable
in full in accordance with the terms set forth in Section 5.8 and (B) PRESIDIO
shall cease to have any further obligation pursuant to Article IV as of the date
of such waiver and for the remainder of the term of this Agreement.
(b)
If (i) XTL or any of its Affiliates intentionally initiates, or encourages or
knowingly provides assistance to any Third Party with respect to, any action
seeking a determination that any of the Licensed Patent Rights in any country
are invalid, unenforceable and/or not infringed (including without limitation a
request for reexamination of any Licensed Patent Rights or the institution of or
participation in any opposition, interference or similar administrative
proceeding adverse to the validity or enforceability of any Licensed Patent
Rights) (“Validity
Challenge”) or (ii) a Third Party acquirer of XTL, or XTL or any of its
Affiliates, following an acquisition transaction resulting in a change of
control of XTL or of all or substantially all of its business or assets,
materially breaches this Agreement and fails to cure the breach such that
PRESIDIO has the right to terminate this Agreement pursuant to Section 9.2
above, then (A) the license granted to PRESIDIO under Section 2.1 shall
automatically convert to a perpetual, fully paid-up, non-royalty-bearing
license; provided that the amounts provided in Section 5.8 shall remain due and
payable in full in accordance with the terms set forth in Section 5.8 and (B)
PRESIDIO shall cease to have any further obligation pursuant to Article IV or
Article V (other than Section 5.8 and, to the extent applicable to payments owed
to VivoQuest, Sections 5.9, 5.10 and 5.11).
(c)
The reduction of payments in connection with PRESIDIO’s election not to exercise
its termination right referenced above in Section 9.4(a)(ii) and in connection
with the license conversion referenced above in Section 9.4(b) is used for the
convenience of the Parties and is not intended to be a penalty to be paid by
XTL. The Parties acknowledge that there will be difficulties in proving the
amount and extent of PRESIDIO’s losses resulting from such uncured material
breach or Validity Challenge. The Parties also agree that the compensation
attributable to such reduction of payments is a reasonable pre-estimate of the
probable losses which would be suffered by PRESIDIO.
Section
9.5 Effects of
Termination.
(a)
If this Agreement is terminated in its entirety by XTL as a result of PRESIDIO’s
uncured material breach pursuant to Section 9.2 above, or on a
territory-by-territory basis as a result of PRESIDIO’s uncured material breach
of its diligence obligations with respect to a territory as described in Section
9.2(y) above, then the following provisions shall be applicable:
* *****Confidential material redacted and filed separately
with the Commission.
-29-
(i)
In each of the above instances of a termination of this Agreement, XTL shall
have the right to terminate the license granted by XTL to PRESIDIO under Section
2.1, subject to Section 9.6 below and, in the case of an uncured material breach
by PRESIDIO of its diligence obligations which breach is limited to only one or
two of the territories identified in Section 9.2(y), the termination shall be
limited to such territory(ies); and
(ii) PRESIDIO
shall return to XTL all Licensed Technology and other items delivered by XTL to
PRESIDIO pursuant to Section 3.1, to the extent such Licensed Technology and
other items remain in existence as of such termination; provided that PRESIDIO
shall not be required to return the Licensed Technology or other items delivered
by XTL to PRESIDIO pursuant to Section 3.1 if XTL terminates PRESIDIO’s rights
hereunder only in regard to certain territories and not the entire Territory as
provided in Section 9.2(y) above; and
(iii) PRESIDIO
shall not, directly or with or through its Affiliates, and subject to Section
9.6 below, Third Party sublicensees or other Third Parties, continue the
Commercialization of any Licensed Compounds or Licensed Products for a period of
***** following such termination, such restriction to apply to the entire
Territory if XTL
terminates the Agreement pursuant to Section 9.2, and, if such termination is
only applicable to certain territories, then such restriction shall apply only
to the territories to which such termination applies; provided that if, at the time
of such termination, PRESIDIO and/or any of its Affiliates and/or Third Party
sublicensees is engaged in the Commercialization of Licensed Products and has
commercial inventory (including work-in-process inventory) of Licensed Products,
PRESIDIO and/or such Affiliate(s) and/or Third Party sublicensee(s) may complete
the manufacture of any work-in-process inventory and continue to commercially
distribute and sell all such existing inventory following termination, subject
to PRESIDIO continuing to pay XTL all amounts due under this Agreement with
respect to such continuing Commercialization.
(b)
If this Agreement is terminated by PRESIDIO pursuant to Section 9.3, then the
following provisions shall be applicable:
(i)
The license granted by XTL to PRESIDIO under Section 2.1 shall terminate;
and
(ii)
PRESIDIO shall return to XTL all Licensed Technology and other items delivered
by XTL to PRESIDIO pursuant to Section 3.1, to the extent such Licensed
Technology and other items remain in existence as of such termination;
and
(iii)
PRESIDIO shall not, directly or with or through its Affiliates, Third Party
sublicensees or other Third Parties, continue the Development and
Commercialization of any Licensed Compounds or Licensed Products for a period of
***** following such
termination.
(c)
If this Agreement is terminated by PRESIDIO as described in Section 9.4(a)(i),
then the following provisions shall be applicable:
* *****Confidential material redacted and filed separately
with the Commission.
-30-
(i)
The license granted by XTL to PRESIDIO under Section 2.1 shall terminate;
and
(ii)
PRESIDIO shall return to XTL all Licensed Technology and other items delivered
by XTL to PRESIDIO pursuant to Section 3.1, to the extent such Licensed
Technology and other items remain in existence as of such termination;
and
(iii)
PRESIDIO shall not, directly or with or through its Affiliates, Third Party
sublicensees or other Third Parties, continue the Commercialization of any
Licensed Compounds or Licensed Products for a period of ***** following such termination.
(d)
The license termination and other rights set forth in this Section 9.5 shall,
subject to Section 4.2, be in addition to any and all other remedies that XTL
may have in connection with such a termination of this Agreement.
Section
9.6 Survival. Upon
expiration or termination of this Agreement for any reason, nothing in this
Agreement shall be construed to release either Party from any obligations that
accrue prior to the effective date of expiration or termination, and the
following provisions shall expressly survive any such expiration or termination:
Section 2.2, Section 2.5, Section 9.1, Section 9.4, Section 9.5, this Section
9.6 and Article V (solely as pertaining to payment obligations (a) that are due
and payable as of the effective date of termination or expiration, (b) that have
accrued prior to the date of termination or expiration but for which the payment
due date falls after the date of termination or expiration or (c) that become
payable after termination pursuant to Section 9.5(a)(iii)), Article VII, Article
X and Article XI. In addition, any sublicense granted by PRESIDIO and/or any of
its Affiliates to a Third Party under the license granted by XTL to PRESIDIO in
Section 2.1 shall survive expiration or termination of this Agreement, provided that such termination
did not arise out of the actions of such Third Party; provided further that the Third Party
continues to comply in all material respects with the terms and conditions of
such sublicense.
Article
X
Dispute
Resolution
Section
10.1 Referral to Senior
Executives. Except as set forth in Section 3.2(b), any dispute arising
out of or relating to this Agreement shall first be referred to the Senior
Executives of both Parties for resolution. Such Senior Executives shall attempt
in good faith to resolve such dispute within ***** following such referral. If
the Senior Executives cannot resolve such dispute within such *****
period, then either Party may make a written demand for formal dispute
resolution pursuant to Section 10.2.
* *****Confidential material redacted and filed separately
with the Commission.
-31-
Section
10.2 Mediation. If the
Senior Executives are unable to resolve any dispute referred to them as set
forth in Section 10.1, such dispute shall then be referred to non-binding
mediation upon either Party’s written demand for formal dispute resolution. Such
mediation shall be conducted by an impartial mediator in accordance with The CPR
Mediation Procedure for Business Disputes (Revised 1998) of the CPR Institute
for Dispute Resolution (“CPR”). The Parties
shall select, by mutual agreement, a mediator who has had both training and
experience as a mediator of general corporate and commercial matters in the
biotechnology and/or pharmaceutical industry. If the Parties cannot agree upon
the selection of the mediator within ***** after
initiation thereof, the mediator shall be appointed by the President of the CPR
in accordance with the criteria set forth in the preceding sentence. Within
*****
after the selection of the mediator, the Parties and their respective
legal counsel will meet with the mediator for one mediation session of at least
four hours. If any dispute cannot be settled during such mediation session or
during any mutually agreed continuation of such session, either Party may give
to the mediator and the other Party written notice declaring the mediation
process at an end, and such dispute will be resolved by binding arbitration
pursuant to Section 10.3 below. The costs of any mediation pursuant to this
Section 10.2 will be shared equally by the Parties.
Section
10.3 Arbitration.
(a)
If any dispute is not resolved by the Senior Executives pursuant to Section 10.1
or through mediation pursuant to Section 10.2, either Party may submit such
dispute to arbitration upon written notice to the other Party. Within ***** after
receipt of such notice, the Parties shall designate in writing a single
arbitrator to resolve the dispute; provided, however, that if the Parties
cannot agree on an arbitrator within such *****
period, the arbitrator shall be selected by the International Centre for
Dispute Resolution (the “ICDR”). The
arbitrator shall be a lawyer with biotechnology and/or pharmaceutical industry
legal experience, and shall not be an Affiliate, employee, consultant, officer,
director or stockholder of any Party.
(b)
Within *****
after the designation of the arbitrator, the arbitrator and the Parties
shall meet, at which time the Parties shall be required to set forth in writing
all disputed issues and a proposed ruling on the merits of each such
issue.
(c)
The arbitrator shall set a date for a hearing, which shall be no later than
***** after the submission of written proposals pursuant to Section 10.3(b), to
discuss each of the issues identified by the Parties. The Parties shall have the
right to be represented by counsel. Except as provided herein, the arbitration
shall be governed by the International Dispute Resolution Procedures of the
ICDR; provided,
however, that
the United States Federal Rules of Evidence shall apply with regard to the
admissibility of evidence and the arbitration shall be conducted by a single
arbitrator.
(d)
The arbitrator shall use his or her best efforts to rule on each disputed issue
within ***** after the completion of the
hearings described in Section 10.3(c). The determination of the arbitrator as to
the resolution of any dispute shall be binding and conclusive upon all Parties.
All rulings of the arbitrator shall be in writing and shall be delivered to the
Parties.
(e)
The (i) attorneys’ fees of the Parties in any arbitration, (ii) fees of the
arbitrator and (iii) costs and expenses of the arbitration shall be borne by the
Parties as determined by the arbitrator.
* *****Confidential material redacted and filed separately
with the Commission.
-32-
(f)
Any arbitration pursuant to this Section 10.3 shall be conducted in New York,
New York. Any arbitration award may be entered in and enforced by any court of
competent jurisdiction.
Section
10.4 No Limitation.
Nothing in Section 10.1, Section 10.2 or Section 10.3 shall be construed as
limiting in any way the right of a Party to seek an injunction or other
equitable relief with respect to any actual or threatened breach of this
Agreement or to bring an action in aid of arbitration. Should any Party seek an
injunction or other equitable relief, or bring an action in aid of arbitration,
then for purposes of determining whether to grant such injunction or other
equitable relief, or whether to issue any order in aid of arbitration, the
dispute underlying the request for such injunction or other equitable relief, or
action in aid of arbitration, may be heard by the court in which such action or
proceeding is brought.
Article
XI
Miscellaneous
Provisions
Section
11.1 Indemnification.
(a)
PRESIDIO.
PRESIDIO agrees to defend XTL, its Affiliates and their respective directors,
officers, employees and agents at PRESIDIO’s cost and expense, and shall
indemnify and hold harmless XTL and its Affiliates and their respective
directors, officers, employees and agents from and against any liabilities,
losses, costs, damages, fees or expenses (including without limitation
reasonable attorneys’ fees) arising out of any Third Party claim relating to or
arising out of (i) any breach by PRESIDIO of any of its representations,
warranties or covenants pursuant to this Agreement, (ii) any failure by PRESIDIO
to make payment of any Pass-Through Costs which are payable by PRESIDIO under
this Agreement as a result of the Development and/or Commercialization of
Licensed Products by PRESIDIO or its Affiliates or Third Party sublicensees,
(iii) any liabilities and obligations of PRESIDIO under the Assigned Contracts
that arise after the Original Effective Date, excluding the Retained
Liabilities, (iv) any action by PRESIDIO in breach of this Agreement causing a
breach of the VivoQuest License Agreement, (v) any action by PRESIDIO causing a
breach of any Additional Third Party Agreements or any Assigned Contracts, or
(vi) the Development and/or Commercialization of a Licensed Product by PRESIDIO
or its Affiliates or Third Party sublicensees, in each case except to the extent
that such claim relates to or arises out of any breach by XTL of any of its
representations or warranties pursuant to this Agreement or any breach by XTL or
its Affiliates of the VivoQuest License Agreement, the VivoQuest Asset Purchase
Agreement or any Assigned Contract.
(b)
XTL. XTL agrees
to defend PRESIDIO, its Affiliates and their respective directors, officers,
employees and agents at XTL’s cost and expense, and shall indemnify and hold
harmless PRESIDIO and its Affiliates and their respective directors, officers,
employees and agents from and against any liabilities, losses, costs, damages,
fees or expenses (including without limitation reasonable attorneys’ fees)
arising out of (i) any Third Party claim relating to or arising out of (A) any
breach by XTL of any of its representations, warranties or covenants pursuant to
this Agreement, (B) any liabilities and obligations of XTL and/or its Affiliates
under the Assigned Contracts that have accrued prior to the Original Effective
Date (the “Retained
Liabilities”), or (C) without limiting the foregoing clauses (A) or (B),
or any of XTL’s representations, warranties or covenants in Section 8.5, any
breach by XTL or its Affiliates of the VivoQuest License Agreement, the
VivoQuest Asset Purchase Agreement or any Assigned Contract; (ii) any claim by
any existing or former employee, director, shareholder or consultant of XTL or
any of its Affiliates, or of VivoQuest, to any right, title or interest in any
of the Licensed Patent Rights, Licensed Compounds or Licensed Technology which,
if such claim were successful, would limit or impair any of the rights granted
hereunder to PRESIDIO; *****.
-33-
(c)
Claims for
Indemnification. A Person entitled to indemnification under this Section
11.1 (an “Indemnified
Party”) shall give prompt written notification to the Person from whom
indemnification is sought (the “Indemnifying Party”)
of the commencement of any action, suit or proceeding relating to a Third Party
claim for which indemnification may be sought or, if earlier, upon the assertion
of any such claim by a Third Party (it being understood and agreed, however,
that the failure by an Indemnified Party to give notice of a third-party claim
as provided in this Section 11.1(c) shall not relieve the Indemnifying Party of
its indemnification obligation under this Agreement except and only to the
extent that such Indemnifying Party is actually damaged as a result of such
failure to give notice). Within ***** after
delivery of such notification, the Indemnifying Party may, upon written notice
thereof to the Indemnified Party, assume control of the defense of such action,
suit, proceeding or claim with counsel reasonably satisfactory to the
Indemnified Party. If the Indemnifying Party does not assume control of such
defense, the Indemnified Party shall control such defense. The Party not
controlling such defense may participate therein at its own expense; provided that, if the
Indemnifying Party assumes control of such defense and the Indemnified Party
reasonably concludes, based on advice from counsel, that the Indemnifying Party
and the Indemnified Party have conflicting interests with respect to such
action, suit, proceeding or claim, the Indemnifying Party shall be responsible
for the reasonable fees and expenses of counsel to the Indemnified Party solely
in connection therewith; provided, however, that in no event
shall the Indemnifying Party be responsible for the fees and expenses of more
than one counsel for all Indemnified Parties. The Party controlling such defense
shall keep the other Party advised of the status of such action, suit,
proceeding or claim and the defense thereof and shall consider recommendations
made by the other Party with respect thereto. The Indemnified Party shall not
agree to any settlement of such action, suit, proceeding or claim without the
prior written consent of the Indemnifying Party, which shall not be unreasonably
withheld, delayed or conditioned. The Indemnifying Party shall not agree to any
settlement of such action, suit, proceeding or claim or consent to any judgment
in respect thereof that does not include a complete and unconditional release of
the Indemnified Party from all liability with respect thereto or that imposes
any liability or obligation on the Indemnified Party without the prior written
consent of the Indemnified Party.
Section
11.2 Governing Law. This
Agreement shall be construed and the respective rights of the Parties determined
(including the validity and applicability of the arbitration provision set forth
in Section 10.3, and the conduct of any arbitration, enforcement of any arbitral
award and any other questions of arbitration law or procedure arising
thereunder) according to the substantive laws of the State of New York, USA,
notwithstanding the provisions governing conflict of laws under such New York
law to the contrary.
* *****Confidential material redacted and filed separately
with the Commission.
-34-
Section
11.3 Assignment. Neither
XTL nor PRESIDIO may assign this Agreement in whole or in part without the
consent of the other, except if such assignment occurs in connection with the
merger, sale or transfer of all or substantially all of the business and assets
of XTL, on the one hand, or PRESIDIO, on the other, to which the subject matter
of this Agreement pertains. Notwithstanding the foregoing, any Party may assign
its rights (but not its obligations) pursuant to this Agreement in whole or in
part to an Affiliate of such Party, provided, that the assigning
Party shall remain primarily liable to the other Party for any breach of this
Agreement by such Affiliate.
Section
11.4 Entire Agreement;
Amendments. This Agreement (including all exhibits and attachments
hereto) constitutes the entire agreement between the Parties with respect to the
subject matter hereof, and supersedes all previous arrangements with respect to
the subject matter hereof, whether written or oral, including without limitation
the Original License Agreement (except as set forth in Section 11.10 below). Any
amendment or modification to this Agreement shall be made in writing signed by
both Parties.
Section
11.5 Notices. Any notice
required or provided for by the terms of this Agreement shall be in writing and
shall be (a) sent by registered or certified mail, return receipt requested,
postage prepaid, (b) sent via a reputable overnight or international express
courier service, (c) sent by facsimile transmission, or (d) personally
delivered, in each case properly addressed in accordance with the paragraph
below. The effective date of notice shall be the actual date of receipt by the
Party receiving the same.
Notices
to XTL shall be addressed to:
000
Xxxxxxxxx Xxxx., Xxxxx X
Xxxxxx
Xxxxxxx, XX 00000
Attention:
Chief Executive Officer
Facsimile
No.: 000-000-0000
with a
copy to:
Xxxxxxx
Procter
Exchange
Place
Boston,
MA 02109
Attention:
Xxxxxxxxxxx Xxxx
Facsimile
No.: 000-000-0000
Notices
to PRESIDIO shall be addressed to:
Presidio
Pharmaceuticals, Inc.
0000
Xxxxx Xxxxxx
Xxxxx
000
Xxx
Xxxxxxxxx, XX 00000
XXX
Attention:
President and Chief Executive Officer
Facsimile
No.: 000-000-0000
-35-
with a
copy to:
WilmerHale
00 Xxxxx
Xxxxxx
Xxxxxx,
XX 00000
XXX
Attention:
Xxxxx X. Xxxxxxx, Esq.
Facsimile
No.: 617-526-5000
Any Party
may change its address by giving notice to the other Party in the manner herein
provided.
Section
11.6 Force Majeure. No
failure or omission by a Party in the performance of any obligation of this
Agreement shall be deemed a breach of this Agreement or create any liability if
the same shall arise from any cause or causes beyond the reasonable control of
such Party, including, but not limited to, the following: acts of God; acts or
omissions of any government; any rules, regulations or orders issued by any
governmental authority or by any officer, department, agency or instrumentality
thereof; fire; storm; flood; earthquake; accident; war; terrorism; rebellion;
insurrection; riot; and invasion. The Party claiming force majeure shall notify
the other Party with notice of the force majeure event as soon as practicable,
but in no event longer than ***** after its occurrence, which notice shall
reasonably identify such obligations under this Agreement and the extent to
which performance thereof will be affected.
Section
11.7 Independent
Contractors. It is understood and agreed that the relationship between
the Parties hereunder is that of independent contractors and that nothing in
this Agreement shall be construed as authorization for either XTL or PRESIDIO to
act as agent for the other.
Section
11.8 No Strict
Construction. This Agreement has been prepared jointly and shall not be
strictly construed against any Party.
Section
11.9 Headings. The
captions or headings of the sections or other subdivisions hereof are inserted
only as a matter of convenience or for reference and shall have no effect on the
meaning of the provisions hereof.
Section
11.10 No Implied
Waivers; Rights Cumulative. No failure on the part of XTL or PRESIDIO to
exercise, and no delay in exercising, any right, power, remedy or privilege
under this Agreement, or provided by statute or at law or in equity or
otherwise, shall impair, prejudice or constitute a waiver of any such right,
power, remedy or privilege or be construed as a waiver of any breach of this
Agreement or as an acquiescence therein, nor shall any single or partial
exercise of any such right, power, remedy or privilege preclude any other or
further exercise thereof or the exercise of any other right, power, remedy or
privilege. For purposes of clarity, except as expressly set forth hereunder,
nothing in this Agreement (including without limitation the execution or
performance hereof) shall be construed as a waiver by either Party of any rights
or claims that such Party may have under the Original License Agreement arising
during the period commencing as of the Original Effective Date and ending on the
Restatement Date.
* *****Confidential material redacted and filed separately
with the Commission.
-36-
Section
11.11 Severability. If,
under applicable law or regulation, any provision of this Agreement is invalid
or unenforceable, or otherwise directly or indirectly affects the validity of
any other material provision(s) of this Agreement (such invalid or unenforceable
provision, a “Severed
Clause”), this Agreement shall endure except for the Severed Clause.
The Parties shall consult one another and use reasonable efforts to agree
upon a valid and enforceable provision that is a reasonable substitute for the
Severed Clause in view of the intent of this Agreement.
Section
11.12 Execution in
Counterparts. This Agreement may be executed in counterparts,
each of which counterparts, when so executed and delivered, shall be deemed to
be an original, and all of which counterparts, taken together, shall constitute
one and the same instrument.
Section
11.13 No Third Party
Beneficiaries. No person or entity other than XTL, PRESIDIO
and their respective Affiliates and permitted assignees hereunder shall be
deemed an intended beneficiary hereunder or have any right to enforce any
obligation of this Agreement.
Section
11.14 No Consequential
Damages. NEITHER PARTY HERETO WILL BE LIABLE FOR INDIRECT,
INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES ARISING OUT OF
THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, OR FOR LOST PROFITS
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 11.14 IS INTENDED TO
LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH
RESPECT TO THIRD PARTY CLAIMS.
[Remainder of This Page Intentionally
Left Blank]
-37-
IN
WITNESS WHEREOF, the Parties have executed this Amended and Restated License
Agreement as of the Restatement Date.
PRESIDIO
PHARMACEUTICALS, INC.
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By:
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Name:
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Title:
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By:
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Name:
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Title:
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-38-
Exhibit
A
Assigned
Contracts
*****
*****
*****
Copies
of the foregoing contracts have been provided by XTL to PRESIDIO as of the
Original Effective Date.
* *****Confidential material redacted and filed separately
with the Commission.
Exhibit
B
VivoQuest
Agreements
Copies
of the VivoQuest License Agreement and the VivoQuest Asset Purchase Agreement
have been provided by XTL to PRESIDIO as of the Original Effective
Date.
Exhibit
C
Series 1, 2, 3 and 4
Compounds in XTL Database and Other Records
*****.
* *****Confidential material redacted and filed separately
with the Commission.
Exhibit
D
Series 1 Patent Rights as of
the Original Effective Date
and the Restatement
Date
*****
* *****Confidential material redacted and filed separately
with the Commission.
Exhibit
E
Series 2-4 Patent Rights as
of the Original Effective Date
and the Restatement
Date
*****
* *****Confidential material redacted and filed separately
with the Commission.
Exhibit
F
Press
Release
See
attached.
Exhibit
G
*****
*****
* *****Confidential material redacted and filed separately
with the Commission.