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| ASTELLAS PHARMA EUROPE LTD & NEUROGESX INC | Record Date: 1/13/2010
Contract Date: 6/19/2009 |
EX-10.1
2
dex101.htm
DISTRIBUTION, MARKETING AND LICENSE AGREEMENT
Distribution, Marketing and License Agreement
Exhibit 10.1 [***]CERTAIN INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934,
AS AMENDED. DATED 19th June 2009 NEUROGESX INC. - and - ASTELLAS PHARMA EUROPE LIMITED DISTRIBUTION, MARKETING AND LICENSE AGREEMENT
Confidential
TABLE OF CONTENTS
Page
1.
DEFINITIONS
1
2.
GRANT OF DISTRIBUTION RIGHTS
12
2.1
Appointment
12
2.2
License
12
2.3
Liquid Formulation Product Option
13
2.4
Subdistributors and Sublicensees
16
2.5
NGX IP Acquired after the Effective Date
17
2.6
No Modifications to the Product
18
2.7
No Conflict
18
3.
INITIAL PAYMENTS AND MILESTONES
19
3.1
Initial Payment
19
3.2
Sales Milestones
20
3.3
Option Fee/Option Exercise Fee
20
4.
ROYALTIES
21
4.1
Royalty
21
4.2
Certain Reductions to Royalties
21
4.3
[***]
22
4.4
Existing NGX Third Party Royalties
23
4.5
Discounting
23
4.6
Royalty Reports
24
5.
COOPERATION
25
5.1
Commercialization Plan
25
5.2
Joint Steering Committee
25
5.3
Joint Development Committee
26
5.4
Joint Commercialisation Committee
26
5.5
Joint Regulatory Committee
27
5.6
General Provisions relating to Committees
27
5.7
Alliance Managers
29
5.8
Kick-off Meeting
29
5.9
Documents
29
5.10
Co-operation
30
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
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TABLE OF CONTENTS (Continued)
6.
TRANSFER OF THE MARKETING AUTHORISATION
30
6.1
MAA Approval Transfer
30
6.2
[***]
30
6.3
NGX''''''''''''''''s Obligations
30
6.4
Prior to MAA Approval Transfer
31
6.5
After MAA Approval Transfer
31
6.6
Communications with Regulatory Authorities
31
7.
DEVELOPMENT
32
7.1
Development of Existing Product
32
7.2
Exchange of Data
34
7.3
Development of Liquid Formulation Product
35
7.4
Coordination
35
8.
COMMERCIALIZATION
36
8.1
Commercialization
36
8.2
Pricing and Reimbursement
36
8.3
Sales Materials
36
8.4
Reporting Adverse Drug Reactions/Experiences
37
8.5
Assistance for the Product
37
8.6
Medical Inquiries for the Product
38
8.7
Material Failure to Exploit
38
8.8
Commercialization of Liquid Formulation Product
39
9.
SUPPLY OF EXISTING PRODUCT
39
9.1
General
39
9.2
Inventory
39
9.3
General Supply Terms
39
9.4
Tripartite Agreements
40
9.5
Quality Agreement
40
10.
PAYMENTS; BOOKS AND RECORDS
40
10.1
Payment Method
40
10.2
Taxes
40
10.3
United States Dollars
41
10.4
Records; Inspection
41
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has been requested with respect to the omitted portions.
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TABLE OF CONTENTS (Continued)
11.
INTELLECTUAL PROPERTY
42
11.1
Ownership of Inventions
42
11.2
NGX Improvements
43
11.3
Maintenance of Patents
44
11.4
Third Party Patents and Trademarks
45
11.5
Enforcement of Patent Rights and Trademarks
47
11.6
Third Party Patent Rights
48
11.7
Patent Marking
48
12.
TRADEMARKS
49
12.1
Product Trademark
49
12.2
Trade Dress
49
12.3
License
49
12.4
Quality Standards
49
12.5
Alternative Trademark
50
12.6
Registration & Ownership
50
12.7
Recordation
50
12.8
Domain Names
50
12.9
Trademark for Liquid Formulation Product
51
12.10
Promotional Materials
51
12.11
Termination
51
13.
CONFIDENTIALITY
51
13.1
Confidential Information
51
13.2
Permitted Use and Disclosures
52
13.3
Terms of this Agreement
52
13.4
Prior Non-Disclosure Agreements
53
13.5
Publication of Product Information
53
14.
REPRESENTATIONS AND WARRANTIES
53
14.1
Mutual Warranties
53
14.2
NGX Warranties
53
14.3
NGX Covenants
58
14.4
Astellas Warranties
58
15.
LIABILITY
58
15.1
DISCLAIMER
58
15.2
LIMITATION OF LIABILITY
58
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has been requested with respect to the omitted portions.
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TABLE OF CONTENTS (Continued)
15.3
Exceptions
59
16.
INDEMNIFICATION
59
16.1
Indemnification of NGX
59
16.2
Indemnification of Astellas
59
16.3
Procedure
59
16.4
Consequences of Failure to Transfer MA
60
16.5
Insurance
60
17.
TERM AND TERMINATION
61
17.1
Term
61
17.2
Termination By Astellas
61
17.3
Termination for Material Breach
61
17.4
Termination for Insolvency
61
17.5
[***]
61
17.6
[***]
62
18.
EFFECT OF EXPIRATION OR TERMINATION
62
18.1
General
62
18.2
Rights on Expiration
62
18.3
Rights on Termination of a Product
63
18.4
Sublicenses
65
18.5
Rights on Termination of a non-European Union country (under Section 7.1.1) or Region
65
18.6
Rights on Termination of this Agreement
67
18.7
No Renewal, Extension or Waiver
67
18.8
Survival
67
18.9
Rights in Bankruptcy
68
19.
DISPUTE RESOLUTION
68
19.1
Disputes
68
19.2
Arbitration
69
20.
MISCELLANEOUS
70
20.1
Governing Law
70
20.2
Force Majeure
70
20.3
No Implied Waivers; Rights Cumulative
70
20.4
Independent Contractors
70
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has been requested with respect to the omitted portions.
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TABLE OF CONTENTS (Continued)
20.5
Notices
71
20.6
Assignment
71
20.7
Modification
71
20.8
Severability
71
20.9
Publicity Review
72
20.10
Counterparts
72
20.11
Headings
72
20.12
Export Laws
73
20.13
Entire Agreement
73
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
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DISTRIBUTION, MARKETING AND LICENSE AGREEMENT This DISTRIBUTION, MARKETING AND LICENSE Agreement (hereinafter “Agreement”), made as of the 19th day of June, 2009 (“Effective
Date”), between NeurogesX Inc., a Delaware corporation having a place of business at 2215 Bridgepointe Parkway, Suite 200, San Mateo, California 94404, United States of America (“NGX”) and Astellas Pharma Europe Ltd, a
corporation established under the laws of England and Wales having a place of business at Lovett House, Lovett Road, Staines, Middlesex, TW18 3AZ, United Kingdom (“Astellas”). Each of NGX and Astellas shall be a
“Party,” and together the “Parties.” RECITALS A. NGX has developed a patch product for the cutaneous delivery of capsaicin (as described below, the “Existing Product”).
B. NGX has obtained MAA Approval (as defined below) for the Existing Product in the European Union using the centralized procedure for treatment of
PNP (as defined below) in non-diabetic adults. C. Astellas desires to obtain (i) an exclusive right to commercialize and distribute
the Existing Product, and (ii) an option to obtain the exclusive right to co-develop, commercialize and distribute the Liquid Formulation Product (as defined below), in each case in Europe and certain other countries (as described below, the
“Territory”), and NGX desires to have the Existing Product and the Liquid Formulation Product commercialized in the Territory, in accordance with this Agreement. AGREEMENT 1. DEFINITIONS 1.1 “Affiliate” shall mean, in the case of a subject entity, another entity that controls, is controlled by or is under common control
with the subject entity, but only for so long as such control exists. For purposes of this definition only, “control” shall mean beneficial ownership (direct or indirect) of at least fifty percent (50%) of the shares of the subject
entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, in the election of the corresponding managing authority); provided that where the local law does not permit foreign equity ownership of at
least fifty percent (50%), then “control” shall mean the beneficial ownership (direct or indirect) of the maximum percentage of outstanding stock or voting rights permitted by local law. 1.2 “Alternative Trademark” shall mean the [***] trademarks for the Existing Product, which shall be owned by NGX worldwide, including
the applications and registrations for which are set out in Exhibit 1.44.
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has been requested with respect to the omitted portions.
1.3 “Brand Guiding Principles” shall mean the general framework for a common
understanding of the Existing Product and the commercial focus it should have worldwide, such general framework to include at minimum the items set forth in Exhibit 1.3. 1.4 “cGCP” or “current Good Clinical Practices” means a set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting,
recording and reporting clinical trials that involve the participation of human subjects as set forth in European Union Commission Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on
medicinal products for human use, and brought into law by European Union Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice as regards investigational medicinal products, as well as the
requirements for authorization of the manufacturing and importation of such products and any subsequent modifications or amendments thereto and any laws that apply in the location of performance of the clinical trial. 1.5 “cGLP” or “current Good Laboratory Practices” means the quality system concerned with the organizational process
and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported, as defined in European Commission Directive 87/18/EEC as amended and any subsequent modifications or amendments thereto and any laws that
apply in the location of performance of the laboratory studies. 1.6 “cGMP” or “current Good Manufacturing
Practices” means all applicable standards relating to manufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finished pharmaceutical products, including current good manufacturing
practices and standards as provided for (and as amended or superseded from time to time) in: 1.6.1 European Community
Directive 2003/94/EC (Principles and guidelines of good manufacturing practice for medicinal products); 1.6.2 21 C.F.R.
§§ 210, 211 and 600; 1.6.3 ICH Guidance for Industry Q7 Good Manufacturing Practice Guidance for Active
Pharmaceutical Ingredients; and 1.6.4 Part II of Volume IV of the EU Guide to Good Manufacturing Practice. 1.7 “Commercially Reasonable Efforts” shall mean [***].
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1.8 “Committee” shall mean the JSC, JDC, JRC and JCC or any other committee set up by
the JSC, as the case may be. 1.9 “Competitive Product” shall mean [***]. 1.10 “Component(s)” shall mean, individually or collectively, Patch and/or Gel. 1.11 “Consultation” shall mean, with respect to the representations, warranties and covenant of NGX, the diligent and informed
consultation between any of the individuals identified in Section 1.28 and NGX''''''''''''''''s external patent counsel who has meaningful responsibilities related to the prosecution, management and defense of NGX''''''''''''''''s intellectual property rights,
including the Patent Rights and the NGX Know-How, in each case, which consultation shall specifically concern the subject matter of the applicable representation, warranty or covenant, including any exceptions to the accuracy thereof. 1.12 “Control” shall mean possession of the ability to grant a license or sublicense, within the scope set forth in this Agreement,
without violating the terms of any agreement or other arrangement with any Third Party. 1.13 “CPL” shall mean Contract
Pharmaceuticals Limited Canada, 7600 Danbro Crescent, Mississauga, Ontario, L5N 6L6, Canada, and its successors. 1.14
“Data” shall mean any and all scientific, technical or test data pertaining to Product(s) that is generated by or under authority of either Party, including research data, clinical pharmacology data, CMC data (including analytical
and quality control data and stability data), preclinical data, clinical data and/or all submissions made in association with an IND or NDA or other MAA filed in or outside the Territory with respect to such Product(s), in each case to the extent
such data either (a) is Controlled by a Party on the Effective Date or (b) comes within a Party''''''''''''''''s Control during the term of this Agreement. 1.15 “Development Expenses” means the Direct Costs incurred by a Party in accordance with the approved budget included in the applicable development plan for the [***] (in accordance with
Section 2.3.14) or the [***] (in accordance with Section 7.1.1). Development Expenses shall include the cost of any studies detailed in an agreed development plan as well as, in relation to the [***], the costs related to the development
and testing of [***]. 1.16 “Direct Costs” means the incurred variable costs and fixed costs including, without limitation
(a) costs of services provided by contract research organizations and individuals , consultants and contractors, (b) the efforts of the employees of a Party or its Affiliates in performing
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its activities under [***], and (iii) may be different for each Party, and (c) any other direct costs including out of pocket external costs. In
determining “Direct Costs” chargeable under this Agreement, each Party will use its respective project accounting systems consistent with GAAP, and will review its respective project accounting methodologies with the other Party upon the
other Party''''''''''''''''s reasonable request. For the purpose of this definition: (a) “variable costs” shall be deemed to be [***], including, but not limited to, the [***]; (b) “fixed costs” shall be deemed to be the costs of [***] and other fixed costs allocable on a reasonable basis to the development of the Product. All cost determinations shall be made in accordance with GAAP.
1.17 “Existing Product” shall mean a product containing a Patch and/or Gel, whether alone or in combination, together with any
ancillary non-pharmacologically active components (e.g. gloves), if MAA Approval has been obtained for such a combination. 1.18
“First Commercial Sale” shall mean the first bona fide, arm''''''''''''''''s length sale of a Product in a country following receipt of MAA Approval of such Product in such country; provided that where such a first sale has occurred in a
country for which [***]. 1.19 “Field” shall mean the [***]. 1.20 “Fiscal Year” shall mean the twelve (12) month period beginning on 1 April and ending on 31 March each year.
1.21 “Formosa” shall mean Formosa Laboratories, Inc., No. 36-1 Hoping Street, Louchu County, Taoyan, Taiwan 338,
Republic of China, and its successors. 1.22 “GAAP” shall mean generally accepted accounting principles in the United
States or International Financial Reporting Standards (IFRS) consistently applied. 1.23 “Gel” shall mean the packaged
cleansing gel product, as further described in NGX''''''''''''''''s EMEA MAA Approval No. EMEA/H/C/000909 and any supplements and amendments to such MAA Approval existing as of the Effective Date, together with any improvements or modifications (including but
not limited to line extensions, enhanced or modified presentations and formulations) to such cleansing gel or any other cleansing gel [***], in each case developed by or on behalf of NGX during the term of this Agreement.
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1.24 “Gross Sales” shall mean (i) the gross amounts invoiced for sales of Product
by Astellas and its Affiliates and Sublicensees (but not Subdistributors) to Third Parties (including Subdistributors), and (ii) any royalties received by Astellas, its Affiliates or Sublicensees based on sales of Product by a Subdistributor,
and (iii) any lump sums received by Astellas, its Affiliates or Sublicensees for the grant of subdistribution rights. 1.25
“IND” shall mean the approval granted by the FDA to conduct the first clinical trial of any Product in man in the United States or the equivalent approval in any other country. 1.26 “Key Metrics” shall mean those criteria set forth in Exhibit 1.26. 1.27 “Know-How” shall mean any information, results and data of any type whatsoever, in any tangible or intangible form whatsoever,
including without limitation, databases, ideas, discoveries, inventions, trade secrets, practices, methods, tests, assays, techniques, specifications, processes, formulations, formulae, knowledge, know-how, skill, experience, materials, including
pharmaceutical, chemical and biological materials, products and compositions, Data, studies and procedures, drawings, plans, designs, diagrams, sketches, technology, documentation or descriptions. 1.28 “Knowledge of NGX” or “Knowledge” shall mean, with respect to the existence or absence of a fact, the actual
knowledge of: (a) [***]; (b) [***]; (c) [***]; (d) [***]; (e) [***]; (f) [***];
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(g) [***]; (h) [***]; and (i) [***]. 1.29 “Launch” shall mean First Commercial Sale. 1.30 “Liquid Formulation Product” shall mean NGX-1998, the high concentration liquid formulation of capsaicin currently under
development by NGX, together with [***] provided that [***] together with [***]. 1.31 “LTS” shall mean LTS
Therapie-Systeme AG with its head office at Lohmannstraße 2, 56626 Andernach, Germany, and its successors. 1.32 “LTS
Agreement” shall mean the Commercial Supply and License Agreement between NGX and LTS entered into on 28 January 2007 and attached as Exhibit 1.32. 1.33 “MAA” shall mean an application requesting regulatory approval, whether as a drug, device, or a combination thereof, for the commercialization of a Product for a particular indication in a
country in or outside the Territory, including without limitation a New Drug Application (“NDA”) filed with the U.S. Food and Drug Administration (“FDA”) or a marketing authorization application filed with the
FDA''''''''''''''''s counterpart in a country or a Region in the Territory. It is understood that MAA does not include applications for pricing or reimbursement approval. 1.34 “MAA Approval” shall mean, with respect to each country in or outside the Territory for a particular Product, approval by the health regulatory authority in such country that is the counterpart
of the FDA of the MAA for such Product filed in such country. It is understood that, as used herein, MAA Approval does not include pricing or reimbursement approval. 1.35 “Major Country” shall mean any of United Kingdom, Germany, France, Italy or Spain. 1.36 “Manufacture” shall mean: (a) the purchase of Patches from (i) LTS under the LTS
Tri-Partite Agreement (as defined in the Supply Agreement), (ii) an Alternative Patch Supplier (as defined in the Supply Agreement) in accordance with Section 13.4.4 of the Supply Agreement, or (iii) any other supplier of Patches
under the back up manufacturing provisions in Section 13.7.1 of the Supply Agreement or the corresponding provision of the LTS Tri-Partite Agreement;
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(b) the purchase of Gel from (i) CPL under the CPL Tri-Partite Agreement (as defined
in the Supply Agreement), (ii) an Alternative Gel Supplier (as defined in the Supply Agreement) in accordance with Section 2.4(b) of the Supply Agreement, or (iii) any other supplier of Gel under the back up manufacturing provisions
in Section 13.7.2 of the Supply Agreement or the corresponding provision of the CPL Tri-Partite Agreement; (c) the
right to manufacture Gel (i) in accordance with Section 2.4(b) of the Supply Agreement, or (ii) under the back up manufacturing provisions in Section 13.7.2 of the Supply Agreement or the corresponding provision of the CPL
Tri-Partite Agreement; (d) the purchase of capsaicin from (i) Formosa under the Formosa Tri-Partite Agreement (as
defined in the Supply Agreement), (ii) an Alternative API Supplier (as defined in the Supply Agreement) in accordance with Section 2.4(a) of the Supply Agreement; and (e) the right to manufacture capsaicin (i) in accordance with Section 2.4(a) of the Supply Agreement, or (ii) under the
back up manufacturing provisions of the Formosa Tri-Partite Agreement; in each of (a)-(e) above, either inside or outside the
Territory but solely for the purpose of importing, keeping, packaging and having packaged, promoting, marketing, offering for sale, selling, having sold, importing and otherwise distributing and using the Existing Product in the Territory.
1.37 “Net Sales” shall mean Gross Sales less deductions for (a) customary trade, quantity and cash discounts allowed
and actually taken; (b) credits to customers on account of rejection of Product; (c) sales and excise taxes and duties and any other similar governmental charges imposed upon the sale of Product (including VAT, but only to the extent such
VAT taxes are not reimbursable or refundable; and (d) outbound transportation including freight shipping and insurance costs prepaid or allowed. Notwithstanding the foregoing, the amounts described in clauses (c) and (d) above shall
be deducted only to the extent they are stated separately on the invoice and included within gross amounts received from sales of Product. If a Product is sold for consideration other than solely cash, the value of such other consideration shall be
included in the calculation of Net Sales. In the case of any sale or disposal of Products among Astellas and its Affiliates and Sublicensees (but not Subdistributors) for resale, Net Sales shall include only Astellas'''''''''''''''' or its Affiliates'''''''''''''''' or
Sublicensees'''''''''''''''' (but not Subdistributors'''''''''''''''') Gross Sales with respect to the resale of such Product to Third Parties (including Subdistributors), but not the amount invoiced among Astellas and its Affiliates and Sublicensees.
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1.38 “NGX Know-How” shall mean any Know-How that is necessary for the development or
commercialization of the Products in the Field in the Territory that either (a) is Controlled by NGX on the Effective Date or (b) comes within NGX''''''''''''''''s Control during the term of this Agreement. 1.39 “Patch” shall mean the capsaicin-containing cutaneous patch described in NGX''''''''''''''''s EMEA MA Approval No. EMEA/H/C/000909 and any
supplements or amendments to such MAA Approval, together with any changes to formulation or other aspects of such patch (including but not limited to line extensions, enhanced or modified presentations and formulations) developed by or on behalf of
NGX during the term of this Agreement, [***]. As used in this Agreement, a [***] means [***] such product comprising [***]. 1.40
“Patent Rights” shall mean all issued, unexpired patents and all reissues, renewals, re examinations and extensions thereof, and patent applications therefor, and any divisions or continuations, in whole or in part, thereof,
including those patents and applications set forth in Exhibit 1.40 which shall be updated from time to time, in each case which would, but for the license granted hereunder, be infringed by the Manufacture, packaging, importation, keeping,
promoting, offering for sale, sale, marketing, distributing or use of a Product by Astellas, any of its Affiliates, Sublicensees or Subdistributors within the Field in the Territory, in each case to the extent Controlled by NGX during the term of
this Agreement. Patent Rights also includes a Supplementary Certificate of Protection of a member state of the European Union or any similar protective rights in any country in the Territory. 1.41 “PDN” shall mean indication(s) for the Product relating to pain in connection with neuropathy or neuralgia associated with
diabetes. 1.42 “PNP” shall mean indication(s) for the Product relating to the general treatment or mitigation of
peripheral neuropathic pain. 1.43 “Product” shall mean (i) the Existing Product, and (ii) the Liquid
Formulation Product to the extent Astellas has executed its Option under Section 2.3 below. 1.44 “Product Trademark”
shall mean the QUTENZA trademark including those registered trademarks and applications for QUTENZA set forth in Exhibit 1.44, or another mutually agreed trademark for the Existing Product (including the Alternative Trademark), in either case
which shall be owned by NGX worldwide.
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1.45 “Region” shall mean a set of countries in the Territory, specified in Exhibit 1.48
as a single “region” for commercialization of the Products hereunder. It is understood and agreed that [***] constitute a single Region (“European Region”). 1.46 “Subdistributor” shall mean a Third Party appointed by Astellas or one of its Affiliates or Sublicensees as a distributor of a
Product, in accordance with Section 2.4.1 and 2.4.3, which Third Party purchases Product in [***]. For the avoidance of doubt, “Subdistributor” shall specifically exclude Sublicensees. 1.47 “Sublicensee” shall mean a Third Party to whom Astellas has granted, in accordance with Section 2.4.2 and 2.4.3, a sublicense
under the Patent Rights and/or NGX Know-How to Manufacture, package and have packaged, develop, register, keep, import, offer for sale, sell, have sold, use market, distribute and/or promote a Product in any country or countries in the Territory
other than [***] and the countries comprising [***]. 1.48 “Territory” shall mean the European Region (as defined in
Exhibit 1.48), the countries of the SATR Region and the Rest of the Territory Region (as defined in Exhibit 1.48), and such other countries as may be added by written agreement between the Parties. 1.49 “Third Party” shall mean any party other than Astellas, NGX and their Affiliates. 1.50 “UC” shall mean The Regents of the University of California, 1111 Franklin Street, Oakland, California 94607. 1.51 “UC License Agreement” shall mean the Exclusive License Agreement between NGX and UC, effective as of November 1, 2000,
together with any amendments in effect as of the Effective Date, as attached hereto as Exhibit 1.51. 1.52 “Valid Patent
Claim” shall mean a claim of an issued and unexpired patent included within the Patent Rights which has not been abandoned, cancelled or held permanently revoked, unenforceable or invalid by a decision of a court or other governmental
agency of competent jurisdiction unappealed within the time allowed for appeal, or which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise.
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In addition, the following terms shall have the meaning described in the corresponding section of this
Agreement. Other terms may be defined throughout the Agreement and its Exhibits.
Term
Section Defined
“Adverse Proceedings”
11.4.2
“Agreement”
Preamble
“Alliance Manager”
5.7
“Annual Net Sales”
4.1.1
“Applicator”
2.5.7
“Assumed Patent”
11.3.5
“Astellas”
Preamble
“Astellas Improvements”
11.1.4
“Astellas Indemnitees”
16.2
“Clinical Supplies”
4.2.1
“Commercialization Plan”
5.1
“Confidential Information”
13.1
“Costs”
11.4.2
“Damages”
11.4.1
“Developing Party”
7.1.1(a)(ii)(2)
“Document”
6.3.1
“Dominating Patent Rights”
4.2.3
“Earned Royalty”
4.1
“Effective Date”
Preamble
“EMEA Requirements”
7.1.1(a)(ii)
“Enforcement Actions”
11.5
“Exclusivity Period”
2.7.1
“Existing Product MAA Approval”
6.1
“Extraterritorial DPR”
4.3
“Floor”
4.2.3
“Generic Competition”
4.2.2(a)
“Generic Product”
4.2.2(a)
“Generic Sales”
4.2.2(b)(i)
“Indemnitee,” “Indemnitor”
16.3
“Infringement Actions”
11.4.1
“Infringing Product”
11.5
“Initiating Party”
11.5.2
“Joint IP”
11.1.2
“Joint Commercialisation Committee”, “JCC”
5.4
“Joint Development Committee”, “JDC”
5.3
“Joint Patents”
11.1.2
“Joint Steering Committee,” “JSC”
5.2
“Joint Regulatory Committee”, “JRC”
5.5
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Term
Section Defined
“LF Development Plan”
2.3.4
“LF Trademark”
12.9
“Liabilities”
16.1
“Licensing Option”
2.7.7
“Licensing Option Product”
2.7.7
“Licensing Option Term”
2.7.7(b)
“LTS Royalties”
4.4.2
“Maintenance”
6.5
“Marketing”
Exhibit 1.26
“Material Failure to Exploit”
Exhibit 1.26
“NGX”
Preamble
“NGX Improvements”
11.2.5
“NGX Indemnitees”
16.1
“Non-Generic Sales”
4.2.2(b)(i)
“Option Fee”
3.3.1
“Option Retention Fee”
3.3.2
“Option Exercise Fee”
3.3.3
“Option Period [***]”
2.3.2
“Option Period [***] Deliverables”
Exhibit 2.3.4
“Option Period [***]”
2.3.2
“Option Period [***] Deliverables”
Exhibit 2.3.7
“Party,” “Parties”
Preamble
“PDN Trial”
7.1.1(a)(ii)
“Post-Marketing Studies”
7.1.1(a)(iii)
“Product Liability Claim”
16.1
“Promotional Samples”
4.2.1
“Product Materials”
18.3.4
“QA Samples”
4.2.1
“QPPV”
8.4
“Reference Product”
4.2.2(a)(iii)
“Regulatory Request”
6.4
“Reimbursement Date”
2.5.5; 4.3.4
“Royalty Adjustment”
4.6.2(a)
“Rejected IP”
4.3.5
“Safety Study”
7.1.1(a)(i)
“Sales Materials”
8.3.2
“Supply Agreement”
9.1
“Terminated Product”
18.3
“Terminated Region”
18.4
“Third Party Claim”
16.1
“Third Party IP”
2.5
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Term
Section Defined
“Third Party Right”
11.4.1
“Total UC Royalties”
4.4.1
“UC Royalties”
4.4.1
“UC Royalty Cap”
4.4.1
“Wind-down Period”
18.3, 18.4
“Withdrawal Notice”
5.6.6
2.1 Appointment During the term of this Agreement, NGX appoints Astellas, and Astellas
hereby accepts such appointment, as the exclusive (even as to NGX and its Affiliates) distributor and marketer of the Existing Product in the Field in the Territory. 2.2 License 2.2.1 Subject to the terms and conditions of this Agreement, NGX grants
to Astellas: (a) an exclusive (even as to NGX and its Affiliates) license during the term of this Agreement under the
Patent Rights and NGX Know-How to: (i) register (including conducting such clinical trials as may be required to support such registrations) the Existing Product (ii) import, keep, package and have packaged the Components supplied by NGX,
and (iii) promote, market, offer for sale, sell, have sold, import and otherwise distribute and use the Existing Product in the Territory for any and all indications in the Field; and (b) a license (co-exclusive with NGX) during the term of this Agreement under the Patent Rights and NGX Know-How to Manufacture Components
for the exclusive use by Astellas in the Territory and Field. Notwithstanding the foregoing, it is understood that the licenses granted above shall
exclude [***]. NGX reserves all rights not expressly granted herein. Additionally it is understood and agreed that Astellas shall have the right to:
(x) carry out marketing activities outside the Territory, in co-operation with NGX, for the promotion of sales of Existing Product (by Astellas, any Astellas Affiliate, Sublicensee or Subdistributor) in the Territory strictly in accordance with
the license and terms set forth in Section 1.2 of Exhibit 2.2.1; and (y) carry out clinical trials outside the Territory, in co-operation with NGX, for the development (by Astellas or any Astellas Affiliate) of Existing Product
which is to be promoted, marketed and sold in the Territory, strictly in accordance with the license and terms set forth in Section 3 of Exhibit 2.2.1.
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2.2.2 During the term of this Agreement, NGX shall not, and shall not license or
authorise any Affiliate or Third Party to develop (save in accordance with this Agreement), register, promote, market, offer for sale, sell, have sold, import and otherwise distribute and use and sell (a) Components and/or Existing Products within the Field and Territory; or (b) [***], save that it may carry out pre-clinical development activities provided that notwithstanding the foregoing, NGX shall have the
right to (x) carry out marketing activities in the Territory, in co-operation with Astellas, for the promotion of sales of Existing Product and Liquid Formulation Product (by NGX, any NGX Affiliate or their licensees) outside of the Territory
strictly in accordance with the license and terms set forth in Section 1.3 of Exhibit 2.2.1. and (y) carry out clinical trials inside the Territory, in co-operation with Astellas, for the development by NGX of Existing Product which
is to be promoted, marketed and sold outside the Territory, strictly in accordance with the license and terms set forth in Section 3 of Exhibit 2.2.1. 2.2.3 Extension of License to Affiliates. Astellas shall have the right to exercise the licenses granted in Section 2.2
through one or more of its Affiliates, for as long as such entity remains an Affiliate of Astellas, provided that (a) Astellas hereby warrants and guarantees the performance of, and compliance with, the obligations set forth in this Agreement
by its Affiliates, and (b) Astellas shall remain responsible for all other payments and other obligations under this Agreement arising from activities of its Affiliates. 2.3 Liquid Formulation Product Option 2.3.1 Subject to the receipt by NGX of the Option Fee specified in Section 3.3.1, NGX shall grant and does hereby grant to Astellas an exclusive option to include the Liquid Formulation Product as a Product under
this Agreement (“Option”). 2.3.2 The Option shall commence upon receipt by NGX of the Option Fee and shall
continue until the expiry of the [***] in Section 2.3.12 (“Option Period”). The Option Period shall be [***] (as defined below). Following the exercise of the Option by Astellas in accordance with Section 2.3.12 the
Parties shall carry out Phase III trials of the Liquid Formulation Product in accordance with Section 2.3.14. 2.3.3 During the Option Period, NGX and its Affiliates shall not offer to or grant to any Third Party any right in or to the Liquid Formulation Product in the Field and Territory. 2.3.4 Within [***] of the payment of the Option Fee, NGX shall draw up a draft development plan for the Liquid Formulation Product
(“LF Development Plan [***]”) which shall include [***] of the LF Development Plan [***] being described in Exhibit 2.3.4.
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2.3.5 NGX shall present the LF Development Plan [***] to the JDC within the [***] period
described in Section 2.3.4, following which the JDC will finalise the LF Development Plan [***], which shall be agreed by the JSC within a further [***] period, such that the LF Development Plan [***] shall be agreed by the JSC within
[***]from the Effective Date. 2.3.6 Following the agreement of the LF Development Plan [***], NGX shall be responsible
for performing the tasks allocated to it under the LF Development Plan [***] in respect of Option Period [***], subject to the oversight of the JDC and ultimately the JSC. NGX shall carry out such tasks in a [***]. [***]. 2.3.7 Following completion of the activities set out in the LF Development Plan [***] that are to be carried out in [***], NGX shall
provide Astellas with the [***] and a draft “LF Development Plan [***]” setting out the activities to be carried out in [***] which shall include at least [***] and the [***]. 2.3.8 At any time up to [***] after the date of delivery to Astellas of the complete [***] and the draft LF Development Plan [***],
Astellas may provide NGX with written notice of its intent to retain the Option. If it wishes to retain the Option then it shall pay the Option Retention Fee in accordance with Section 3.3.2. 2.3.9 If Astellas notifies NGX in accordance with Section 2.3.8 that it wishes to retain the Option and has paid the Option Retention
Fee in accordance with Section 3.3.2, then within [***] of the payment of the Option Retention Fee the JDC shall finalise the LF Development Plan [***], which shall be agreed by the JSC within the same [***] period. For clarity, if Astellas
does not provide NGX with written notice of its intent to retain the Option within the period set forth in Section 2.3.8 above, or fails to pay the Option Retention Fee in accordance with Section 3.3.2, then Astellas will be deemed to have
declined to retain the Option, in which case the Option shall terminate and Sections 2.3.10 – 2.3.15 shall not apply. 2.3.10 Following the agreement of the LF Development Plan [***], NGX shall be responsible for performing the tasks allocated to it under the LF Development Plan [***] in respect of [***], subject to the oversight of the JDC and ultimately
the JSC. NGX shall carry out such tasks in a diligent and sustained manner. All Development Expenses connected therewith shall be the responsibility of NGX. 2.3.11 Following completion of the activities set out in the LF Development Plan [***] that are to be carried out in [***], NGX shall
provide Astellas with the [***] and a draft LF Development Plan [***] setting out the Phase III clinical trial activities that are to be carried out if Astellas exercises the Option. 2.3.12 At any time up to [***] after the date of delivery to Astellas of the complete [***] and the draft LF Development Plan [***],
Astellas may provide NGX with written notice of its intent to exercise the Option. If it wishes to exercise the Option then it shall pay the Option Exercise Fee in accordance with Section 3.3.3.
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2.3.13 If Astellas notifies NGX in accordance with Section 2.3.12 that it wishes to
exercise the Option and has paid the Option Exercise Fee in accordance with Section 3.3.3, then within two months of the payment of the Option Exercise Fee the JDC shall finalise the LF Development Plan [***], which shall be agreed by the JSC
within the same [***] period. If: (a) Astellas does not provide NGX with written notice of its intent to exercise the
Option within the period set forth in Section 2.3.12 above; (b) Astellas fails to pay the Option Exercise Fee in
accordance with Section 3.3.3; or (c) the JSC (acting through the JDC) is unable to agree upon a final LF Development
Plan [***] within the [***] period described above (or any extension of such period mutually agreed upon in writing by the Parties) due to deadlock; then
Astellas will be deemed to have declined to have exercised the Option, in which case the Option shall terminate and Sections 2.3.14 and 2.3.15 shall not apply. In the event of deadlock as described in Section 2.3.13(c), NGX shall refund
Astellas the Option Exercise Fee within [***] of the end of the [***] period described above (or any extension of such period mutually agreed upon in writing by the Parties). 2.3.14 Following the agreement of the LF Development Plan [***], the JDC shall oversee the performance of the Phase III clinical
trial activities and shall allocate responsibility for the performance of the various tasks required in connection with such activities based upon which Party is better situated to perform such tasks, taking into account among other things, the
estimated costs associated with having each Party perform such task. The aim of the LF Development Plan [***] will be to generate clinical data which is intended for, and in the correct format for, submission to satisfy the requirements of both the
EMEA and the FDA. The Development Expenses for such activities will be borne [***]. 2.3.15 If Astellas has exercised its
Option in accordance with Section 2.3.12 and upon NGX''''''''''''''''s receipt of the appropriate fee in accordance with Section 3.3.3, the Liquid Formulation Product shall thereafter be considered a “Product” for the purposes of this
Agreement and NGX shall: (a) appoint Astellas as the exclusive (even as to NGX and its Affiliates) distributor and marketer
of the Liquid Formulation Product in the Field in the Territory;
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(b) grant to Astellas an exclusive (even as to NGX and its Affiliates) license under the
Patent Rights and Know-How to co-develop, register, promote, market, sell, have sold, keep, import and otherwise distribute and use the Liquid Formulation Product in the Territory for any and all indications in the Field, and to appoint
Subdistributors to do the same, in each case as further described in Section 2.4; (c) grant to Astellas a license
under the Patent Rights and Know-How to make, have made, package, and have packaged the Liquid Formulation Product for the exclusive use by Astellas in the Territory and Field providing that the Parties shall use [***] to supply the Liquid
Formulation Product to each Party; and (d) grant to Astellas the right to: (x) carry out marketing activities outside
the Territory, in co-operation with NGX, for the promotion of sales of Liquid Formulation Product (by Astellas, any Astellas Affiliate, Sublicensee or their Subdistributor) in the Territory strictly in accordance with the license and terms of
Section 1.2 of Exhibit 2.2.1 and (y) carry out [***], strictly in accordance with the license and terms set forth in Section 3 of Exhibit 2.2.1, provided that Astellas shall grant to NGX the right to
(x) carry out [***] strictly in accordance with the license and terms set forth in Section 1.3 of Exhibit 2.2.1. and (y) carry out [***], strictly in accordance with the license and terms set forth in Section 3 of
Exhibit 2.2.1. 2.3.16 If Astellas does not retain the Option in accordance with Section 2.3.9 or does not
exercise the Option in accordance with Section 2.3.13, for the term of the Exclusivity Period [***]. For clarity, it is acknowledged and agreed that the only rights and obligations of Astellas and NGX under this Section 2.3 are as
expressly stated herein, and that there are no further implied obligations relating to the matters contemplated herein. As used herein, Regulatory Filing shall mean a marketing authorisation application in accordance with Title III, Chapter 1 of
Directive 2001/83/EC, as amended (i.e., either a full marketing authorisation application or an abbreviated marketing authorisation application), or any equivalent filing made with a regulatory authority in the Territory. 2.4 Subdistributors and Sublicensees 2.4.1 Subdistributors. Astellas shall have the right, upon the approval of NGX, not to be unreasonably withheld or delayed, to appoint Third Parties as Subdistributors to distribute, sell, market and promote
the Product in the Territory. For clarity, it is understood that the decision to treat sales to Subdistributors as Net Sales for royalty purposes under this Agreement (as opposed to basing Net Sales on such Subdistributors'''''''''''''''' subsequent sale to
Third Parties as is the case for sales by Affiliates and Sublicensees) was predicated on the understanding that Astellas'''''''''''''''' use of Subdistributors would be limited to countries [***]. Consequently, it is understood and agreed that it shall not be
unreasonable for NGX to withhold its approval with respect to the appointment of Subdistributors in [***] if such appointments would materially alter the economics for NGX under this Agreement with respect to the European Region.
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2.4.2 Sublicensees. Astellas shall have the right, upon the approval of NGX, not
to be unreasonably withheld or delayed, to grant sublicenses to Third Parties under the Patent Rights and/or NGX Know-How to Manufacture, package and have packaged, develop, register, keep, import, offer for sale, sell, have sold, use, market,
distribute and/or promote a Product in any country or countries in the Territory other than [***]. 2.4.3 Astellas shall
ensure that all Subdistributors and Sublicensees are bound by written agreements which (a) shall not conflict with, and shall be subordinate to, the terms and conditions of this Agreement, and (b) shall contain provisions which are as
protective of NGX and the Product(s) as those contained in this Agreement, including without limitation Sections 2.7.8, 7.2, 8.3 and 13. Astellas hereby warrants and guarantees the performance of, and compliance with, the obligations set forth
in this Agreement by its Sublicensees and Subdistributors and shall remain responsible for all payments and other obligations under this Agreement arising from activities of its Sublicensees and Subdistributors. Without limiting the foregoing, in
the event that Products supplied by Astellas, its Affiliates or Sublicensees to a Subdistributor are being directly or indirectly [***], Astellas agrees that, upon becoming aware of such sale or use or otherwise upon the request of NGX, it shall:
[***]. 2.5 NGX IP Acquired after the Effective Date If, after the Effective Date, NGX acquires from a Third Party subject matter that would fall within the definition of Patent Rights and/or NGX Know-How in each case only to the extent that the Patent Rights or NGX
Know How covers the Existing Product (“Third Party IP”), then the following shall apply: 2.5.1 Astellas at
its sole discretion can decide that it wishes to obtain a license to such Third Party IP. 2.5.2 If Astellas decides that it
wishes to obtain a license to the Third Party IP, the licenses granted under Section 2.2 above with respect to such Third Party IP shall be subject to [***] for the applicable Product outside the Territory to whom NGX has granted a license
under such Third Party IP. 2.5.3 To the extent such Third Party IP constitutes [***] below. 2.5.4 Upon request by Astellas, NGX shall disclose to Astellas a true, complete and correct written description of such payment
obligations including a copy of the license agreement between NGX and such Third Party, and Astellas'''''''''''''''' obligation to reimburse such amounts following such request shall be limited to those payment obligations so disclosed by NGX. 2.5.5 If Astellas decides not to obtain a license to the Third Party IP or in the event [***], having notified NGX that it wishes to
obtain a license to the Third Party IP, then such Third Party IP shall [***].
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2.5.6 Should Astellas have declined to accept a license to such Third Party IP, then in
the event that [***] then Astellas shall [***]. In the event of an [***] this Section 2.5, Section [***] shall apply to the defense and settlement of [***]. 2.5.7 For clarity, any Third Party intellectual property that NGX may elect to in-license with respect to the [***] shall not constitute
Third Party IP for purposes of this Section 2.5, and shall instead be subject to the following: [***] and (b) in the event Astellas exercises its Option under Section 2.3.12, [***] of the Liquid Formulation Product. 2.6 No Modifications to the Product Except upon mutual agreement of the Parties in writing, Astellas covenants and warrants that neither Astellas nor its Affiliates or Sublicensee shall: 2.6.1 save for any modifications that [***], make any modifications to the Existing Product save to [***] and add [***] provided this is
in accordance with the relevant MAA Approval and applicable laws and regulations; nor 2.6.2 use any Confidential
Information of NGX for any purpose other than in connection with this Agreement. 2.7 No Conflict 2.7.1 [***]. Subject to Sections 2.7.2 and 2.7.3, Astellas and its Affiliates shall not, by themselves or through any Third
Party(ies) [***] for a period starting on the Effective Date and ending [***] after the first First Commercial Sale of the Existing Product in a [***] unless NGX and Astellas have agreed in writing that such [***] are [***]. 2.7.2 Astellas shall not be in breach of Section 2.7.1 of this Agreement if, during the Exclusivity Period, [***]. For the avoidance
of doubt, [***]. 2.7.3 Astellas shall not be in breach of Section 2.7.1 of this Agreement if Astellas [***] following
the date that such [***] provides that Astellas (or its Affiliates) no longer [***] based on [***]. 2.7.4 [***]. Subject to
Sections 2.7.5 and 2.7.6, NGX and its Affiliates shall not, by themselves or through any Third Party(ies) [***]. 2.7.5
NGX shall not be in breach of Section 2.7.4 of this Agreement if, [***]. For the avoidance of doubt, [***]. 2.7.6 NGX
shall not be in breach of Section 2.7.4 of this Agreement if NGX [***] provided that NGX [***].
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2.7.7 [***]. If, at any time prior to the end of the Exclusivity Period, NGX wishes to
[***] for the Territory (a “Licensing Option Product”), NGX grants Astellas [***] in respect of such Licensing Option Product. The [***] as follows: (a) when NGX decides that it wishes to [***] for the Territory, it will [***] of the general type and quantity that NGX would typically
[***]; and (b) within [***] (or such other longer period as the Parties may agree) of receipt of the notice and [***] in
Section 2.7.7(a) above (the “[***]”), Astellas will inform NGX in writing whether [***]; (c) If Astellas
notifies NGX that it [***] in relation to the [***] that is the subject of the notice in Section 2.7.7(a), then the Parties will enter into negotiations to agree a licensing agreement between them. In such [***]. Such [***] shall be consistent
with the [***] within [***], and shall include, but not be limited to, [***]. (d) If Astellas notifies NGX pursuant to
Section 2.7.7(b) that it [***] that is the subject of the notice in Section 2.7.7(a), or Astellas [***] then NGX will have [***]. 2.7.8 Ex-Territory; No Exploitation except as Licensed. Except as otherwise permitted under Sections 1.2 and 3 of Exhibit 2.2.1 or required by applicable law, neither Astellas nor its Affiliates or
Sublicensees or their respective Subdistributors will [***], only in accordance with and under this Agreement. Astellas agrees that it and its Affiliates and Sublicensees shall not use nor otherwise exploit Patent Rights, Data and the Product
Trademark, except as licensed in this Agreement. 3. INITIAL PAYMENTS AND MILESTONES 3.1 Initial Payment In partial
consideration of the costs incurred by NGX in connection with the research and development of the Existing Product and in exchange for the exclusive rights granted herein, and provided that NGX has provided to Astellas an invoice for the total sum
(which may be sent by e-mail or facsimile), Astellas shall pay NGX Thirty Million Euros (€30,000,000) within [***] of the execution of this Agreement. For purposes of clarity, it is understood and agreed that this payment shall be
non-refundable and non-creditable save as set out in Section 16.4. For further clarity, the term “non-refundable and non-creditable” as used in this Agreement shall not act as any limitation on any amounts obtainable by
Astellas by way of damages resulting from NGX''''''''''''''''s breach of this Agreement or any obligation under it.
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3.2 Sales Milestones In further consideration of the exclusive rights granted herein, Astellas shall pay NGX in accordance with the procedure set out in Section 4.6.1(a)
and (b), the following milestone payments upon achievement of the corresponding sales milestones, which milestone payments shall be non-refundable and non-creditable: 3.2.1 Upon first achieving Annual Net Sales equal to or exceeding [***] in any Fiscal Year, Astellas shall pay NGX [***]. 3.2.2 Upon first achieving Annual Net Sales equal to or exceeding [***] in any Fiscal Year, Astellas shall pay NGX [***]. 3.2.3 Upon first achieving Annual Net Sales equal to or exceeding [***] in any Fiscal Year, Astellas shall pay NGX [***]. 3.2.4 Upon first achieving Annual Net Sales equal to or exceeding [***] in any Fiscal Year, Astellas shall pay NGX [***]. The sales milestones are payable only once and are not on a Product-by-Product basis. 3.3 Option Fee/Option Exercise Fee 3.3.1 Option Fee. In consideration for the Option granted to Astellas with respect to the Liquid Formulation Product, and provided that NGX has provided to Astellas an invoice for the total sum (which may be
sent by e-mail or facsimile), Astellas shall pay NGX Five Million Euros (€5,000,000) ) within [***] of the execution of this Agreement (“Option Fee”). For purposes of clarity, it is understood and agreed that this payment
shall be non-refundable and non-creditable [***]. 3.3.2 Option Retention Fee. In the event that Astellas elects to
retain its Option with respect to the Liquid Formulation Product pursuant to Section 2.3.8 above, Astellas shall pay NGX [***] within [***] of such notice of retention provided that NGX has provided to Astellas an invoice for the total sum
(which may be sent by e-mail or facsimile) (“Option Retention Fee”). For purposes of clarity, it is understood and agreed that this payment shall be non-refundable and non-creditable 3.3.3 Option Exercise Fee. In the event that Astellas elects to exercise its Option with respect to the Liquid Formulation Product
pursuant to Section 2.3.12 above, Astellas shall pay NGX [***] within [***] of such exercise provided that NGX has provided to Astellas an invoice for the total sum (which may be sent by e-mail or facsimile) (“Option Exercise
Fee”). For purposes of clarity, it is understood and agreed that this payment shall be non-refundable and non-creditable save as set out in Section 2.3.13.
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4. ROYALTIES 4.1 Royalty In further consideration of the exclusive rights granted herein, Astellas shall, subject to the reduction of royalty rate pursuant to Section 4.2 below, pay to NGX the following running
royalties on the Net Sales of the Product in the Territory (“Earned Royalty”):
Annual Net Sales
Percentage of Net Sales
That portion of Annual Net Sales up to and including [***]
[***] of such Net Sales
That portion of Annual Net Sales above [***] and up to and including [***]
[***] of such Net Sales
That portion of Annual Net Sales above [***] and up to and including [***]
[***] of such Net Sales
That portion of Annual Net Sales above [***]
[***] of such Net Sales
4.1.1 For purposes of this Agreement, “Annual Net Sales” shall
mean total Net Sales of Products in each Fiscal Year occurring in those countries in the Territory in which Astellas'''''''''''''''' royalty obligations have not yet expired. For clarity, it is understood that in the event that Astellas exercises its Option
with respect to the Liquid Formulation Product, Annual Net Sales shall mean [***] in the Territory by or under authority of Astellas in each Fiscal Year. Units of Product shall be considered sold upon [***]. Notwithstanding the foregoing, to the
extent that this Agreement would have expired with respect to a particular Product in a particular country but for the fact that [***], then it is understood that no Earned Royalties shall be payable in respect of such Joint Patents or Assumed
Patents in accordance with Sections 11.1.3 and 11.3.5. 4.2 Certain Reductions to Royalties 4.2.1 Non-Commercial Sales. No Earned Royalty shall be due hereunder with respect to (a) [***] of Product used as samples for
training programs, educational programs or customer demonstration (“Promotional Samples”) and (b) [***] of Product used for destructive testing, such as QA/QC or stability testing (“QA Samples”), and
(c) [***] of Product used in clinical trials of Product (“Clinical Supplies”) conducted in accordance with Section 7. 4.2.2 Loss of Exclusivity. In the event of Generic Competition with respect to a Product in a country in the Territory, the Earned Royalty applicable to units of the Product in such country shall be reduced to
[***] of the Net Sales from the Product from the beginning of the [***] after (a) [***] (b) [***].
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(a) Certain Definitions (i) “Generic Competition” in a country shall mean that one or more Generic Product(s) and/or Reference Product(s) is/are
sold by an entity (including but not limited to NGX) who is not acting under the authority of Astellas, its Affiliates, Sublicensees or Subdistributors without infringing any Patent Rights and/or regulatory exclusivity in such country.
(ii) “Generic Product” shall mean: (1) a product for [***], and (2) which has been [***]; or (3) [***]. (iii) “Reference Product” shall mean [***]. (b) Application of the Generic Royalty to the Tiered Earned Royalty Structure (i) The Parties agree that the Net Sales of Product subject to a reduction of the Earned Royalties in accordance with this
Section 4.2.2 (the “Generic Sales”) will be included in the Annual Net Sales for the relevant calendar year, for purposes of calculating the Earned Royalty for the rest of the Product sold in such calendar year (the
“Non-Generic Sales”) as follows: the [***]. (ii) [***]. 4.2.3 [***]. In the event Astellas or its Affiliates is required to pay to a Third Party [***] in order to obtain [***], Astellas may
[***] to NGX under this Agreement, provided that in no event shall the [***] under Section 4.1 (the “[***]”). If the existence of the [***] results in Astellas not being able to [***] then Astellas can [***]. As used herein,
“[***]” shall mean Third Party [***], including without limitation Third Party [***] under Section 11.4.1, without [***]. Notwithstanding the foregoing, it is agreed by the Parties that [***]. 4.3 [***] If Astellas'''''''''''''''' license to
[***] extends to the equivalent [***], then the following shall apply: 4.3.1 NGX at its sole discretion can decide that it
wishes to [***]. 4.3.2 If NGX decides that it wishes to obtain [***], then the grant of such [***] shall be subject to NGX
[***] by reason of NGX''''''''''''''''s [***] together with NGX''''''''''''''''s [***].
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4.3.3 Upon request by NGX, Astellas shall disclose to NGX a true, complete and correct
written description of such [***], and NGX''''''''''''''''s obligation to [***]. 4.3.4 If NGX decides not to obtain a [***] or in the
event NGX does not promptly [***] upon request, having notified Astellas that it wishes to obtain a [***], then such [***] to NGX, until NGX notifies Astellas that it wishes to obtain a [***]. 4.3.5 Should NGX have declined to accept [***], then in the event that Astellas is subsequently subject to [***] as a result of NGX''''''''''''''''s
acts of [***], then NGX shall [***]. In the event of [***]. 4.4 Existing NGX Third Party Royalties 4.4.1 UC License Agreement. [***] the royalties accruing on sales of Product by Astellas, its Affiliates, Sublicensees and
Subdistributors in the Territory under Section 7.1 of the UC License Agreement, at the royalty rate of zero point five percent (0.5%) [***] until such time as the total amount of royalties that have been paid to UC in a given calendar year on
world-wide sales of Products that would be considered “Licensed Product(s)” under the UC License Agreement (including amounts paid by NGX attributable to sales outside the Territory) (collectively, “Total UC Royalties”)
equals One Million Dollars (US $1,000,000) (“UC Royalty Cap”). At such time as the total amount of Total UC Royalties that has been paid to UC in a given calendar year reaches the UC Royalty Cap, [***] under this Section 4.4.1
during the remainder of such calendar year. For the avoidance of doubt, the UC Royalties shall [***] such that they are [***] to the extent that NGX has an obligation to account to UC for such royalties under the UC Agreement. 4.4.2 LTS Agreement. [***] the royalties at the rate of one point sixty-seven percent (1.67 %) accruing on sales of the Existing
Product by Astellas and its Affiliates and Sublicensees under Section 5.2(a) of the LTS Agreement, as of the Effective Date [***] after the end of each calendar half-year (i.e. after 30 June and 31 December of each calendar year). For
the avoidance of doubt, the LTS Royalties shall [***] such that they are [***] to the extent that NGX has an obligation to account to LTS for such royalties under the LTS Agreement. 4.5 Discounting Astellas and its Affiliates shall set prices for the Product in the Territory in the best interest of the commercial success of
the Product in the Territory. Without limiting the foregoing, if Astellas or its Affiliate, Sublicensee or Subdistributor sells any Product to a customer who also purchases other products or services from Astellas, its Affiliates, Sublicensees or
Subdistributors and receives a specific discount for such “bundling” of products, Astellas shall ensure that for purposes of calculating the Earned Royalty due to NGX, [***]. Without limiting the foregoing obligations, it is understood and
agreed that nothing in this Agreement is intended to dictate to Astellas, its Affiliates, Sublicensees and Subdistributors the resale prices for the Products in the Territory.
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
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4.6 Royalty Reports 4.6.1 Quarterly Report (a) Following the First Commercial Sale of a Product in the Territory, Astellas shall furnish to NGX a quarterly written report detailing on a country-by-country and product-by-product basis: (i) the Gross Sales
of all Product(s) sold during such calendar quarter on a country-by-country and product-by-product basis, the calculation of Net Sales of such Product(s) from such Gross Sales (with all the Net Sales of Product subject to a reduction of the Earned
Royalties in accordance with Section 4.2.2 (the “Generic Sales”) being clearly identified as such); (ii) the Earned Royalties, [***] (if applicable), payable in United States Dollars, which shall have accrued hereunder
based upon such Net Sales of such Product(s) by Astellas and its Affiliates and/or Sublicensees; (iii) any adjustments to the Earned Royalties in accordance with Section 4.2; (iv) the date of the First Commercial Sale of each Product
in each country in the Territory; (v) the exchange rates used in determining the amount of United States Dollars, as more specifically provided in Section 10.3 below, (vi) a statement as to whether any Sales Milestones in accordance
with Section 3.2 have been reached in such quarter and (vii) any additional information reasonably required to support NGX''''''''''''''''s reporting requirements as a public company. Reports shall be due [***] following the end of each calendar
quarter. (b) Following the delivery of each such report, within [***] following receipt of NGX''''''''''''''''s invoice (which may be
sent by e-mail or facsimile) Astellas shall, pay to NGX the total Earned Royalties, Sales Milestones, [***], if any, due to NGX for the period of such report. If no Earned Royalties, [***] are due, Astellas shall so report. (c) Additionally, in any calendar year in which the [***], then upon NGX''''''''''''''''s receipt of the final quarterly report for such calendar
year from Astellas, NGX shall calculate each Party''''''''''''''''s allocable share of the [***] based on each Party''''''''''''''''s contribution to the total global annual sales of the Existing Product in such calendar year. NGX will provide Astellas with a report
informing Astellas of the difference, if any, between each Party''''''''''''''''s allocable share of such [***] in royalties (as calculated above) and the royalty amounts actually paid by the Parties in connection with [***] in such calendar year. The Party
having paid higher royalties in connection with [***] than its calculated share shall provide the other Party with an invoice with respect to any amounts due. Payment of any such amounts owed to by either Party to the other shall be made within
twenty (20) days after receipt of the other Party''''''''''''''''s invoice. 4.6.2 Year End Report (a) In any Fiscal Year in which (i) Astellas, its Affiliates and/or Sublicensees have incurred payment obligations under
Section 4.1 above, and (ii) there are Generic Sales, Astellas shall provide to NGX a year end report detailing: (a) the total Generic Sales and Non-Generic Sales on a [***] for the just concluded calendar year; (b) the
calculation of the
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total Earned Royalties due for such calendar year based on the application of Section 4.2.2(b) above; and (c) the difference, if any, between the
amount calculated pursuant to subsection (b) of this Section 4.6.2 and the total Earned Royalties actually paid to NGX under Section 4.6.1 for such Fiscal Year (such difference, the “Royalty Adjustment”). Year end
reports shall be due [***] following the end of the Fiscal Year to which they relate. (b) Following the delivery of each
such report, Astellas shall, within [***] following receipt of NGX''''''''''''''''s invoice, pay to NGX any Royalty Adjustment owed to NGX. If a Royalty Adjustment is owed to Astellas by NGX, such Royalty Adjustments shall be [***]. (c) The year end report and the final quarterly report for a given Fiscal Year may be combined into a single document provided all
required information are combined therein. 5. COOPERATION JSC and Commercialization Plan for Existing Product 5.1 Commercialization Plan
The initial plan for Astellas'''''''''''''''' development and commercialization of the Existing Product in the Territory (“Commercialization
Plan”) will be provided by Astellas to the JSC [***] months, of the Effective Date. Astellas agrees to provide to NGX [***] updated versions of the Commercialization Plan at least [***] at the next JSC meeting [***], and any material
modification or addition to the Commercialization Plan within a reasonable period of time prior to adoption and implementation thereof. It is understood and agreed that the Commercialization Plan shall be reasonably detailed including without
limitation, [***]. The Parties agree that [***] shall be subject to NGX''''''''''''''''s (and not the JSC''''''''''''''''s) approval not to be unreasonably withheld, delayed or conditioned. 5.2 Joint Steering Committee The Parties shall establish a committee (the “Joint Steering
Committee” or “JSC”) to (a) oversee the development and commercialization activities relating to Products in the Territory during the term of this Agreement; (b) oversee the JDC, JRC and JCC (and any other
committees set up under the control of the JSC) and [***] and (c) resolve matters on [***]. Each of such Committees shall have the responsibilities and authority allocated to it in this Section 5.2. 5.2.1 In addition to its overall responsibilities described in Section 5.2, subject to Section 5.6.2 and its subsections, the
JSC shall, among other things: (a) review the [***];
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(b) discuss [***]; (c) review [***], for Product in the Territory and outside the Territory; (d) discuss [***]; (e) facilitate [***]; (f) coordinate [***]; (g) monitor and coordinate the [***]; and (h) discuss, undertake and/or approve [***]. 5.3 Joint Development Committee The Parties shall establish a committee (the “Joint Development Committee” or “JDC”) to oversee the development
activities relating to Products in the Territory during the term of this Agreement which shall, among other things: (a)
review and comment on [***]; (b) discuss [***] for Products in the Territory and outside the Territory; (c) review [***]; (d) monitor [***]; (e) manage [***]; and (f) coordinate [***]. 5.4
Joint Commercialisation Committee The Parties shall establish a committee (the “Joint Commercialisation Committee”
or “JCC”) to oversee the commercialisation activities relating to Products in the Territory during the term of this Agreement which shall, among other things: (a) review [***]; (b) discuss [***];
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(c) manage [***]; (d) cooperate [***]; (e) monitor [***]; and (f) [***]. 5.5 Joint Regulatory Committee NGX and Astellas shall establish [***] a committee (the “Joint
Regulatory Committee” or “JRC”) which shall co-ordinate [***]. 5.6 General Provisions relating to Committees
For each Committee the Parties shall each designate [***] to serve as members of such Committee. The JSC will consist of [***] from each
Party, [***] shall be a senior executive of each Party and the JSC shall determine the number of representatives of each Party for each other Committee; provided, however, that the JDC shall be composed of no less than [***] making representatives
of each Party, [***]. Each representative may serve on more than one Committee as appropriate in view of the individual''''''''''''''''s expertise. Each Party may replace its Committee representatives at any time upon written notice to the other Party,
provided that the Parties will use reasonable endeavors to keep such replacements to a minimum. The chairperson of each Committee shall [***] from one of its representatives on such Committee and thereafter, the Parties shall rotate annually as to
which Party selects such chairperson. The chairperson shall be responsible for calling meetings, preparing and circulating an agenda in advance of each meeting of such Committee, and preparing and issuing minutes of each meeting within [***]
thereafter; [***]. Such minutes will not be finalized until a representative of the other Party on such Committee has reviewed and confirmed the accuracy of such minutes in writing. 5.6.1 Meetings. The JSC shall meet [***] until the [***], and thereafter [***] during the term of this Agreement, unless otherwise
agreed by the Parties. The frequency of meetings of other Committees shall be decided by the JSC. All Committee meetings shall be in person at least [***] unless otherwise mutually agreed, and the other meetings may be through telephone or video
conference or other mutually agreeable means. With the consent of the Committee members, other representatives of NGX or Astellas may attend Committee meetings as non-voting observers. [***]. 5.6.2 Decisions. (a) Decisions of the Committees shall be made [***]. If a Committee other than the JSC is unable to reach unanimous consent on a particular matter within [***] of its initial consideration of such matter, then such
matter shall be referred to the JSC. In the event the JSC cannot reach agreement on a matter within [***] after it has met (whether in person or by telephone or video conference) and attempted to reach such agreement, the dispute [***]:
(i) by the [***] in good faith, giving appropriate consideration to the reasonable business and scientific concerns of [***], for all
matters relating to [***]; and
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(ii) by the [***] in good faith, giving appropriate consideration to the reasonable
business and scientific concerns of [***], for all matters relating to [***]. (b) Notwithstanding anything to the contrary
in Section 5.6.2(a) above: (i) With respect to disputes relating to [***] to the extent [***]. (ii) To the extent additional responsibilities are delegated to the JSC pursuant to Section 5.2(h)(ii), the Parties shall mutually
agree at the time of such delegation [***] to decide any matter encompassed by that responsibility in the event that [***] an agreement regarding that dispute. (iii) [***] over any dispute explicitly reserved for arbitration pursuant to Section 19.2. (iv) Neither Party shall [***]. 5.6.3 Authority. Notwithstanding the creation of the JSC or any other Committee, each Party shall [***] hereunder, and the JSC or any other Committee shall not [***]. No Committee shall have the power to amend
or modify this Agreement, and its decisions shall not be in contravention of any terms and conditions of this Agreement. It is understood and agreed that issues to be formally decided by a Committee are only those specific issues that are expressly
provided in this Agreement to be decided by such Committee. 5.6.4 From time to time, the JSC may establish further
committees as it deems appropriate to oversee specific matters, activities and obligations of the Parties under this Agreement or the Supply Agreement as set forth herein, and ensure an optimal coordination between the Parties with respect to such
matters, activities and obligations. 5.6.5 It is understood between the Parties that under no circumstances, the activities
to be performed by the JSC (or any subcommittee) are intended or allowed to violate any applicable law (including but not limited to any competition and/or antitrust law).
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5.6.6 Upon the [***] the Effective Date the JSC and any other Committees then in
existence shall be disbanded, provided that at any time following the [***] of the Effective Date, NGX shall have the right to withdrawal from participation in the JSC and all other Committees upon written notice to Astellas, which notice shall be
effective [***] (“Withdrawal Notice”). Following the disbanding of the Committees (or if applicable, the issuance of a Withdrawal Notice), NGX shall no longer participate in any meetings of any Committees, nor shall NGX have any
right to vote on decisions within the authority of the JSC or any other Committees. Following the disbanding of the Committees (or if applicable, NGX''''''''''''''''s earlier withdrawal from the Committees), Astellas will have the sole decision with regard to
matters that affect the commercialization and development of the Existing Product within the Territory and [***]. 5.7 Alliance
Managers Promptly after the Effective Date, each Party shall appoint an individual to act as the alliance manager for such Party (the
“Alliance Manager”). Each Alliance Manager who is not otherwise a member of the JSC shall thereafter be permitted to attend meetings of the JSC. The Alliance Managers shall be the primary contact for the Parties regarding the
activities contemplated by this Agreement and shall facilitate all such activities hereunder. Each Party may replace its Alliance Manager with an alternative representative at any time with prior written notice to the other Party. The Alliance
Managers shall not, in any manner, take over the role of the JSC and shall not have any rights, powers or discretion except as expressly granted to the Alliance Managers hereunder. In no event shall the Alliance Managers have any power to modify or
amend this Agreement. 5.8 Kick-off Meeting The Parties agree to hold a face to face meeting, within [***] after the Effective Date, with the aim of NGX sharing with Astellas (at no cost to Astellas) the existing NGX Know-How reasonably necessary for
[***]. The Alliance Managers shall be responsible for co-ordinating and setting up the meeting. The agenda for the meeting will be mutually agreed by both Parties but will serve to exchange [***]. The Parties will also agree upon the subsequent
transfer of the documents and files encompassing copies of NGX Know-How in existence prior to the Effective Date, which shall include establishing a key contact list to facilitate the transfer of such NGX Know-How and enable clear and effective
communication thereafter. 5.9 Documents Notwithstanding the above, NGX shall provide Astellas with all the documents set out in Exhibit 5.9 upon the later of (a) [***], or (b) [***] after the Effective Date although NGX shall use reasonable
efforts to provide the documents within [***].
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5.10 Co-operation The Parties agree to the cooperation terms set out in Exhibit 2.2.1. 6. TRANSFER OF THE MARKETING
AUTHORISATION 6.1 MAA Approval Transfer At the Effective Date, NGX shall transfer the benefit of and interest in the NGX EMEA MAA Approval number EMEA/H/C/000909 (the “Existing Product MAA Approval”) to Astellas or its designated Affiliate
free from all encumbrances on the terms of and in accordance with this Section 6. 6.2 [***] [***] for preparing and submitting all notices, applications, submissions, reports and other instruments, documents, correspondence or filings necessary
to obtain a transfer to Astellas or its designated Affiliate of the Existing Product MAA Approval [***]. 6.3 NGX''''''''''''''''s Obligations
NGX shall or shall procure that any of its Affiliates will: 6.3.1 [***] after the Effective Date sign any notices, applications, submissions, reports and other instruments, documents, correspondence
or filings presented to it by Astellas or its designated Affiliate (any of these a “Document”) that are necessary for: (i) the transfer to Astellas or its designated Affiliate of the Existing Product MAA Approval; or
(ii) maintaining, renewing or varying the Existing Product MAA Approval in the period from the Effective Date until the transfer of the Existing Product MAA Approval in accordance with Section 6.1; 6.3.2 [***] provide notice of its consent to the transfer of Existing Product MAA Approval to Astellas or its designated Affiliate if
required by any applicable governmental or regulatory authority after the Effective Date; 6.3.3 [***] after the Effective
Date where permitted and reasonably practicable conduct all communications with the EMEA relating to the transfer of the Existing Product MAA Approval at the direction of Astellas; 6.3.4 subject to Astellas'''''''''''''''' or its designated Affiliate''''''''''''''''s right in each case to review and approve all written material prepared
by NGX prior to submission to the EMEA, NGX shall [***], and use [***]; and 6.3.5 [***] after the Effective Date provide
such reasonable assistance as Astellas (or its designated Affiliate) may reasonably request, [***], that is necessary to facilitate the transfer of the Existing Product MAA Approval to Astellas (or its designated Affiliate).
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6.4 Prior to MAA Approval Transfer After the Effective Date, and before the Existing Product MAA Approval is transferred to Astellas or its designated Affiliate, NGX shall hold the
Existing Product MAA on trust for Astellas, and shall without prejudice to Sections 6.3.4 and 6.5 maintain in force the Existing Product MAA Approval ([***]), and shall not encumber, amend, cancel or surrender the Existing Product MAA Approval
or take any step in relation thereto unless requested to do so by Astellas or any applicable governmental or regulatory authority (any such request of a governmental or regulatory authority a “Regulatory Request”). Before taking any
such step pursuant to a Regulatory Request, NGX shall act in accordance with any reasonable instruction given by Astellas in relation to such Regulatory Request unless action is required to be taken urgently by the relevant governmental or
regulatory authority, in which case NGX shall inform Astellas of such action as soon as possible thereafter. 6.5 After MAA Approval
Transfer Following transfer to Astellas of the Existing Product MAA Approval, Astellas shall be responsible for the Maintenance of the
Existing Product MAA Approval, as well as for the filing and Maintenance of all additional MAAs filed and MAA Approvals obtained in its, its Affiliates'''''''''''''''', Sublicensees'''''''''''''''' or Subdistributors'''''''''''''''' name in the Territory, [***], provided that
NGX shall, upon Astellas ‘ request, provide to Astellas reasonable assistance in relation with such Maintenance, as well as all electronic documents in its possession or under its Control that are reasonably necessary to perform such
Maintenance, including without limitation the relevant dossier for the Existing Product MAA Approval in the format of an electronic common technical document (eCTD). NGX shall also within [***] of the Effective Date provide Astellas with all
original documents comprising the Existing Product MAA Approval and to the extent that such original documents are required by NGX for regulatory filings outside the Territory, NGX shall allow Astellas to have access and to copy such original
documents at all reasonable times on reasonable notice for the purpose of the Maintenance of the MAA Approvals and filing of MAAs in relation to developments of the Products in the Territory. As used in this Section 6,
“Maintenance” with respect to MAA Approvals and/or MAA shall include, without limitation, payment of the annual fees, renewal of the MAA Approval, implementation of any variations with respect to such MAA Approval and/or MAA and
responding to requests by the relevant Regulatory Authorities. 6.6 Communications with Regulatory Authorities Subject to applicable laws, following transfer of the Existing Product MAA Approval to Astellas, Astellas shall be the Party responsible for
communicating directly with and appearing before the EMEA or any other regulatory authority, provided that Astellas shall [***]. NGX agrees, upon Astellas'''''''''''''''' request, to provide Astellas with reasonable assistance in connection with any such
communications and meetings.
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7. DEVELOPMENT 7.1 Development of Existing Product 7.1.1 European Union. (a) Additional Studies. (i) Safety Study. Initial MAA Approval for the Existing Product in the European Union is accompanied by a post approval commitment requiring that an open label safety study in on label patient populations be
carried out on the committed timelines with respect to the Existing Product (“Safety Study”), as further specified in Exhibit 7.1.1. Astellas shall be solely responsible for planning and overseeing the performance of the
Safety Study and liaising with the regulatory authorities, provided that Astellas shall keep the JDC informed about all study activities and provided that Astellas shall give reasonable consideration to any comments of the JDC. [***]. (ii) [***] Trial. [***]. The [***] Trial shall be designed and carried out as follows: (1) Astellas shall be responsible for drawing up a protocol that satisfies the EMEA''''''''''''''''s conditions and requirements (“EMEA
Requirements”) which may involve requesting scientific advice from the EMEA (the “Initial Protocol”); (2) Astellas shall provide a copy of the Initial Protocol for the [***] Trial, to NGX, through the JDC, for NGX''''''''''''''''s review and comment at which time NGX may request Astellas to add activities to the protocol to satisfy any requirements
of the FDA. Astellas will reasonably consider any such request(s) and agrees to implement such request(s) to the extent they are commercially reasonable, it being understood that in no event shall Astellas be required to include any activities in
the protocol which would conflict with EMEA Requirements for the [***] Trial, [***] and in all cases the final decision rests with Astellas; (3) Astellas shall negotiate with the EMEA to obtain approval for the protocol for the [***] Trial and shall be responsible for the execution and delivery of the [***] Trial; and (4) Astellas shall be responsible for [***] of the [***] Trial, provided that NGX shall be responsible for [***] relating to activities
that have been added to the Initial Protocol at NGX''''''''''''''''s request and to the extent that any communication or filings with the FDA are required in connection with such added activities, NGX shall be responsible for conducting such communications
and making such filings [***].
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(iii) Other Post-Marketing Studies. The Parties anticipate that it will be
desirable to conduct certain additional post-marketing studies of the Existing Product in order to maximize the potential market for the Existing Product in or outside the Territory (“Post-Marketing Studies”). The Parties shall
discuss all proposed Post-Marketing Studies at the JDC. In relation to the Territory, Astellas shall [***] for any Post-Marketing Study and shall present it to the JDC [***]. Astellas shall [***] any such Post-Marketing Studies in the Territory,
[***], and shall update the JDC on the progress of such studies. Astellas shall [***] performing Post-Marketing Studies in the Territory and shall [***] on such studies within the ten (10) year period commencing upon the first First Commercial
Sale of the Existing Product in the Territory, provided that in no event shall Astellas [***]. NGX shall be responsible for planning and overseeing the performance of any Post-Marketing Studies outside the Territory, subject to the oversight of the
JDC, and shall update the JDC on the progress of such studies. NGX shall be responsible for [***] of performing Post-Marketing Studies outside the Territory. (iv) Further Development of the Existing Product. If a Party wishes to develop the Existing Product for [***], then it shall raise
the issue at the JSC. If the JSC agrees to such further development then the JDC shall be responsible for drawing up a development plan which it shall present to the JSC for approval. (1) If both Parties wish to participate in the development then the JDC shall oversee the performance of such development and shall
allocate responsibility for the performance of the various tasks required in connection with such studies based upon which Party is better situated to perform such tasks, taking into account among other things, the estimated costs associated with
having each Party perform such task. The aim of the development plan will be to generate clinical data which is intended for, and in the correct format for, submission to [***]. To the extent that any activities under the development plan are
necessary to satisfy the requirements of [***]. To the extent that any activity is necessary to satisfy the requirements [***]. (2) If only one Party wishes to carry out any development under this Section 7.1.1(iv) (the “Developing Party”), and the JSC has approved the development plan then the Developing Party shall carry out the activities
under such development plan and shall be solely responsible for all Development Expenses related to such activities. If the other Party subsequently wishes to include any of the Data that has been created as a result of such development in its
regulatory filings for Product in its territory, then it can only do so if it reimburses the Developing Party [***] of all the Developing Party''''''''''''''''s Development Expenses incurred in relation to all the activities under the development plan.
7.1.2 Non-European Union Countries. Astellas shall be responsible, [***], for conducting such clinical trials as may
be necessary to file and obtain MAA Approval for the Existing Product in each non-European Union country in the Territory as may be required to meet its obligations under the Commercialization Plan. Additionally, to the extent that compliance
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with the regulatory requirements for obtaining MAA Approval in one or more non-European Union countries in the Territory would result [***]. If a regulatory
authority in a non-European Union country requires [***], then Astellas shall have the right to terminate this Agreement in respect of such non-European Union country by providing NGX at least ninety (90) days prior written notice.
7.1.3 Compliance with Laws. Each Party or its permitted Third Party contractors shall perform its responsibilities under this
Section 7 in accordance with all applicable laws, including, without limitation, cGLPs, cGCPs and cGMPs to the extent applicable. 7.1.4 Diligence. Each Party shall use [***] to carry out its development obligations under Section 7.1 and such obligations are subject to the other Party providing all relevant support and Data reasonably
necessary to perform such obligations. 7.2 Exchange of Data NGX and Astellas, respectively, shall provide to each other [***] for use of each of Astellas and NGX for the purposes set forth in Section 7.2.1 in
a timely fashion and as promptly as possible upon request of each of Astellas or NGX. In addition, (a) NGX shall provide Astellas with [***] within [***] of such submission, and (b) Astellas shall provide NGX with [***] within [***] of
such submission. Astellas shall have the right to withhold Data for a reasonable period to allow it to file for patent protection relating to such [***]. 7.2.1 Use; Disclosure. (a) Astellas will only use and disclose Data to Third Parties
as required to [***] including without limitation [***] in each case for commercialization of Products inside the Territory and NGX gives Astellas the right to [***], and as may be necessary in performing its obligations and exercising its rights
under this Agreement, i.e. [***] in each case solely to the extent necessary for development and commercialization of Products in Territory; or as may otherwise be agreed by NGX and Astellas. Astellas may not use any Data (or permit any Third Party
to use Data) outside the Territory, or outside the Field or for any products other than the Products, except for the assessment and validation of the Data by Affiliates or Third Party consultants outside the Territory but solely for purposes of
[***]. NGX may not use any Data (or permit any Third Party to use Data) inside the Territory (except as required to fulfill any development obligations it may have under a development plan agreed with Astellas pursuant to Sections 7.1.1, 2.3.6,
2.3.10 or 2.3.14), or outside the Field or for any products other than the Products, except for the [***] but solely for purposes of developing or commercializing Products outside the Territory. Notwithstanding anything to the contrary in this
Section 7.2.1(a) or Section 7.2.1(b) below, [***] shall be subject to the requirements set forth therein.
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(b) Astellas hereby grants NGX a non-exclusive sublicensable right and license to use the
Data provided by Astellas, and to disclose such Data to Third Parties, in each case as is reasonably necessary or useful for commercialization of Products outside the Territory including without limitation for use by NGX''''''''''''''''s licensees of the
Products and for [***] (and Astellas hereby gives NGX the right to so [***]), in each case for commercialization outside the Territory, provided that any disclosure of such Data to a non-governmental Third Party is made under reasonable and
customary confidentiality restrictions. Notwithstanding the foregoing, upon termination of this Agreement by Astellas pursuant to Section 17.2 or by NGX pursuant to Sections 17.3-17.5, the scope of NGX''''''''''''''''s license to Data provided by
Astellas shall thereafter be worldwide. 7.2.2 Third Parties. (a) In all agreements after the Effective Date with Third Parties or Affiliates involving the development of Data, Astellas and NGX,
respectively, shall require that such Third Parties and Affiliates provide the other Party access to all such Data, to the extent that such Data is required for [***] in accordance with this Agreement. (b) Notwithstanding Section 7.2.2(a) above, Astellas acknowledges that under NGX''''''''''''''''s agreement(s) with LTS prior to and after the
Effective Date, [***]. If any regulatory authority does not accept such a direct filing by LTS then the Parties and LTS shall cooperate to find an alternative route by which such LTS Data shall be filed with such regulatory authority. Such
arrangement with LTS shall not be deemed a breach by NGX of this Section 7.2.2. It is understood that NGX shall ensure that it obtains [***] for the use by each of NGX and Astellas as set forth in this Section 7.2. 7.2.3 All MAAs and MAA Approvals and any other regulatory filings relating to developments of the Existing Product in the Territory
including all variations and line extensions shall be owned by Astellas or its nominated Affiliate. 7.3 Development of Liquid
Formulation Product 7.3.1 In the event that Astellas exercises the Option under Section 2.3.12 Astellas shall be
responsible for [***] with respect to the Liquid Formulation Product in the Territory, in each case [***], provided that NGX shall, upon Astellas'''''''''''''''' request, provide to Astellas reasonable assistance in relation to such activities. 7.4 Coordination Each Party agrees to keep the other [***] informed as to the progress of its clinical development and regulatory activities
relating to the Liquid Formulation Product in and outside the Territory, including its correspondence and meetings with regulatory agencies, by way of updates to the JSC and JDC at its meetings and as otherwise [***] requested by the other Party.
The Party responsible for conducting the clinical development of the Liquid Formulation Product shall reasonably consider and [***] respond to any comments provided by the other Party with respect to such clinical development and regulatory
activities. Subject to
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Sections 18.3.2 and 18.5.2 below, all MAA filings and MAA Approvals in the Territory for the Liquid Formulation Product (including all variations and
line extensions) shall be in the name of, and owned by, Astellas or its Affiliates. 8. COMMERCIALIZATION 8.1 Commercialization Subject to
oversight by the JCC and ultimately the JSC, Astellas shall [***] to launch and commercialize the Existing Product in the Territory, in accordance with the Commercialization Plan in order to maximize the Net Sales of such Product in the Territory.
Astellas agrees to keep NGX [***] informed as to the progress of its launch and commercialization activities relating to Products in the Territory, by way of [***] at its meetings and as otherwise reasonably requested by NGX. Astellas shall [***]
consider and [***] respond to any comments provided by NGX with respect to such launch and commercialization activities, provided that any final decision is in the discretion of Astellas to the extent that it is consistent with the Key Metrics. It
is understood and agreed that all commercialization efforts for Products in the Territory shall, as between the Parties, [***]. Any failure of Astellas to comply with its obligations under the Commercialization Plan and the Key Metrics shall not be
considered a breach of this Agreement to the extent [***]. 8.2 Pricing and Reimbursement [***]. 8.2.1 Subject to
[***] the Existing Product pursuant to Section 8.2.2, Astellas shall [***] to (i) obtain pricing and/or reimbursement approvals for the Existing Product [***] and make such regulatory filings as are necessary to [***] that are [***] to
market the Existing Product in each country in the European Union, in each case in accordance with the Commercialization Plan and any development plans in accordance with Section 7.1, and (ii) subject to Section 7.1.2, obtain such
regulatory approvals, including MAA Approvals and [***], as may be necessary to market the Existing Product in [***], in accordance with the Commercialization Plan. 8.2.2 Notwithstanding Astellas'''''''''''''''' obligations under Section 8.2.1, Astellas shall always have the [***] the Existing Product in a
country in the Territory if [***], provided that this Section 8.2.2 shall in no event excuse any [***]. 8.3 Sales Materials
8.3.1 Brand Guiding Principles. Within [***] after the Effective Date, the Parties shall agree on Brand Guiding
Principles, to be updated from time to time. Astellas agrees to adhere, and to cause its Affiliates, Sublicensees and Subdistributors to adhere, to the Brand Guiding Principles in connection with the commercialization of the Existing Product in the
Territory. NGX agrees to adhere, and to cause its Affiliates and distributors and licensees to adhere, to the Brand Guiding Principles in connection with the commercialization of the Existing Product outside the Territory.
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8.3.2 Sales Materials. Any marketing and promotional materials and packaging
created or used by Astellas, its Affiliates, Sublicensees and Subdistributors for the Product shall be appropriate to the MAA Approval for the Product in the respective country, and, in the case of the Existing Product, consistent with the Brand
Guiding Principles. Upon each Party''''''''''''''''s reasonable request, the other Party shall [***]. It is understood and agreed that each Party shall have the right to [***] for purposes of commercializing Products in their respective territory provided
that each Party shall be solely responsible for the compliance of such Sales Materials with laws and regulations in its own territory. Any claim, message or other material item in the Sales Materials, which is not consistent with the Brand Guiding
Principles and [***], shall be subject to [***] provided that in the event of a dispute as to whether a claim complies with the laws and regulations in the Territory, Astellas'''''''''''''''' view shall prevail. NGX shall use all reasonable efforts to
complete any such review and provide Astellas with an answer within [***] from notification by Astellas to NGX of the relevant matter and in the absence of an answer within such [***] period such claim, message or other material item shall be deemed
[***]. 8.4 Reporting Adverse Drug Reactions/Experiences Each Party shall observe and comply with its respective obligations regarding the exchange of data concerning adverse drug events, as set out in a safety
agreement which the Parties shall enter into [***] after the Effective Date but in any event not later than [***] delivery of Product by NGX to Astellas and which will be attached to this Agreement as Exhibit 8.4 (hereinafter referred to as
“Safety Agreement”). NGX will be responsible for managing and maintaining (itself or through its designee) the worldwide drug safety database, provided that Astellas [***] and receive appropriate information in order to fulfill the
requirements specified in the EU Rules Governing Medicinal Products in the European Union, Volume 9A. The Parties agree that the management and maintenance of the worldwide drug safety database [***]. The costs associated with setting up the
worldwide drug safety database shall be the sole responsibility of NGX. Any fees charged by such Third Party contractor to NGX for specific activities relating to the use of the worldwide drug safety database which exclusively relate to [***] shall
[***]. 8.5 Assistance for the Product Each Party shall promptly inform the other Party of any notification of any action by, or notification or other information which it receives (directly or indirectly) from any governmental or regulatory authority
(together with copies of correspondence related thereto), which (a) raises any material concerns regarding the safety or efficacy of a Product, (b) indicates or suggests a potential material liability for either Party to Third Parties
arising in connection with a Product or (c) which indicates a reasonable potential for a recall or market withdrawal of a Product.
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8.6 Medical Inquiries for the Product Following the completion of the transfer of the Existing Product MAA Approval to Astellas in accordance with Section 6 above, Astellas shall be
responsible for handling all medical questions or inquiries for the Field in the Territory with regard to the Product ([***]), but shall consider in good faith input from NGX in connection therewith. NGX shall immediately forward any and all medical
questions or inquiries which it receives in relation to the Product for the Field in the Territory to Astellas in accordance with all applicable laws. 8.7 Material Failure to Exploit This Section 8.7 shall not limit any other remedies in damages
that NGX may have under this Agreement or applicable law but shall be NGX''''''''''''''''s sole remedy in relation to Astellas'''''''''''''''' obligations to commercialise the Products. 8.7.1 European Region. In the event Astellas commits a Material Failure to Exploit in the European Region [***]. Such notice shall
specify in reasonable detail the facts and circumstances constituting the Material Failure to Exploit. Upon the expiration of [***]. 8.7.2 Other Regions. In the event there is a Material Failure to Exploit with respect to Products in a Region (other than the European Region), then NGX shall have the right to [***]. 8.7.3 In the event there are no Regions then in effect after such exclusion, then this Agreement shall be deemed terminated in whole.
8.7.4 In the event of such termination by NGX of a Region or in the event of non-exclusivity imposed by NGX for such
Region, the Parties would adjust [***] set forth above in Section 4.1 as follows: (a) For each Region (other than the
European Region) excluded from the Territory (or in which Astellas'''''''''''''''' rights are reduced to non-exclusive status) pursuant to Section 8.7.2, the [***] shall be reduced by [***]. (b) If the European Region is excluded from the Territory (Astellas'''''''''''''''' rights in the European Region are reduced to non-exclusive
status) pursuant to Section 8.7.1, the [***] shall be reduced by [***]. 8.7.5 In the event Astellas commits a Material
Failure to Exploit with respect to the required minimum Marketing spending, NGX shall have the right to provide notice of its intention to terminate this Agreement or make Astellas'''''''''''''''' rights for the Territory non-exclusive. Such notice shall
specify in [***] detail the facts and circumstances constituting the Material Failure to Exploit. Upon the expiration of [***] after receipt by Astellas of such notice, if Astellas (a) has not cured such Material Failure to Exploit, or
(b) in the event that such Material Failure to Exploit is not capable of being cured in [***], is not [***] to cure such Material Failure to Exploit, NGX shall have the right to terminate this Agreement or make Astellas'''''''''''''''' rights in the
Territory non-exclusive by giving a notice, which shall be effective on the date such notice is given.
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8.8 Commercialization of Liquid Formulation Product In the event that Astellas elects to exercise its Option under Section 2.3.12 with respect to the Liquid Formulation Product, Astellas shall [***]
to launch the Liquid Formulation Product in the Territory, and thereafter to market, promote and sell the Liquid Formulation Product so as to maximize the Net Sales of both the Existing Product and Liquid Formulation Product as a portfolio of
products. 9. SUPPLY OF EXISTING PRODUCT 9.1 General It is understood that NGX procures supplies of Components from Third Party contractors. However, the Parties
anticipate that Astellas shall eventually enter into direct contractual relationships with such Third Party contractors for the supply of Components. Pending such direct agreements, on the Effective Date NGX enters into a separate written agreement
with Astellas (“Supply Agreement”) pursuant to which NGX shall obtain from its Third Party contractors quantities of Components sufficient to supply Astellas'''''''''''''''' reasonable requirements for Components in the Territory.
9.2 Inventory In addition,
Astellas shall purchase the Patch Inventory and Gel Inventory (both as defined in the Supply Agreement) in accordance with the Supply Agreement. 9.3 General Supply Terms Until Astellas enters into direct contractual relationships with Third Party contractors for the
supply of Components: 9.3.1 Astellas and its Affiliates shall exclusively purchase all of their requirements of Components
from NGX; 9.3.2 NGX shall procure Components on behalf of and as reasonably requested in writing by Astellas, consistent
with NGX''''''''''''''''s arrangements with its suppliers; 9.3.3 Components ordered by NGX from such supplier on behalf of Astellas,
shall be charged to Astellas at NGX''''''''''''''''s cost of goods as defined in the Supply Agreement;
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9.3.4 the Components supplied to Astellas under the Supply Agreement shall be supplied in
the same form as like Components are supplied to NGX (save as to artwork and text), or as otherwise established by the JSC or by agreement of the Parties, it being understood that any differences in such form requested by Astellas shall be at
Astellas'''''''''''''''' expense; and 9.3.5 in the event that NGX would be required to pay to LTS any fees under Section 3.4(c)
of the LTS Agreement in order to expand the “Territory” as defined in the LTS Agreement to be commensurate in scope with the “Territory” as defined in this Agreement, Astellas shall be responsible for such fees. 9.4 Tripartite Agreements It is
anticipated that NGX will also be a party to any direct agreements between Astellas and the Third Party suppliers so as to, among other things (a) [***]; (b) [***]; and (c) [***]. Irrespective of whether or not NGX is a party to
any direct supply agreement that Astellas may enter into with NGX''''''''''''''''s Third Party suppliers, it is understood that Astellas [***]. 9.5
Quality Agreement NGX and Astellas shall execute a quality agreement which allocates roles and responsibilities to each Party with
respect to quality control and regulatory compliance with respect to Components and the Existing Product. 10. PAYMENTS; BOOKS AND RECORDS
10.1 Payment Method All payments under this Agreement shall be made by bank wire transfer in immediately available funds to an account designated by the Party to which such payments are due. Any payments due under this Agreement which are not paid by the date
such payments are due under this Agreement shall bear interest to the extent permitted by applicable law at the interest rate applied by the [***] to its most recent refinancing operations ([***] bid rate or fixed rate as published on [***]), plus
[***], computed on the basis of the [***]. The applicable interest rate shall be adjusted each time there shall be a change in the aforementioned rate of the [***]. This Section 10.1 shall in no way limit any other remedies available to the
Parties. 10.2 Taxes Any tax (other than VAT) which Astellas is required to pay or withhold in respect of the payments to be made to NGX hereunder shall be deducted from the amount otherwise due provided that, in regard to any such deduction, Astellas shall
give NGX reasonable assistance, which shall
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include the provision of such documentation as may be required by any revenue authority and other revenue services, as may be necessary to enable NGX to
claim exemption therefrom or obtain a repayment thereof or a reduction thereof and shall upon request provide such additional documentation from time to time as is needed to confirm the payment of tax. 10.3 United States Dollars All
dollar amounts specified in this Agreement, and all payments made hereunder, are and shall be in U.S.dollars. For all payments other than the initial payment due under Section 3.1, the sales milestones due under Section 3.2, the Option
Fee due under Section 3.3.1, the Option Retention Fee due under Section 3.3.2 and the Option Exercise Fee due under Section 3.3.3, monetary conversion from the currency of a foreign country, in which Product is sold, into United
States currency shall be calculated for a calendar quarter in which such sales were made using an exchange rate equal to [***] prior to the date that the report detailed in Section 4.6.1(a) is delivered to NGX. With respect to the initial
payment due under Section 3.1 and the Option Fee due under Section 3.3.1, monetary conversion from Euros into United States currency shall be calculated using an exchange rate equal to [***] days prior to the execution of this Agreement.
With respect to the payments of the sales milestones due under Section 3.2, the Option Retention Fee due under Section 3.3.2 and the Option Exercise Fee due under Section 3.3.3, monetary conversion from Euros into United States
currency shall be calculated using an exchange rate equal to [***] prior to achieving the relevant milestone, the election by Astellas to retain the Option or the election by Astellas to exercise the Option, as the case may be. 10.4 Records; Inspection 10.4.1 Astellas. Astellas shall keep, and require its Affiliates and Sublicensees to keep, complete, true and accurate books of accounts and records for the purpose of determining the amounts payable (or reimbursable) under this
Agreement, including without limitation true and accurate records of Gross Sales, Net Sales and the costs incurred by Astellas in connection with the conduct of the clinical studies contemplated in Article 7. Such books and records shall be
kept at the principal place of business of Astellas (or the place of business of its Affiliates or Sublicensees, as applicable) for at least [***] following the end of the calendar quarter to which they pertain. Such records will be open for
inspection during such [***] period by an independent auditor chosen by NGX and reasonably acceptable to Astellas for the purpose of verifying the amounts payable by Astellas hereunder. Such inspections may be made no more than once each calendar
year (it being understood that a single audit may require multiple visits) and no more than once in respect of any audited period, at reasonable times and on reasonable notice. The independent auditor shall be obligated to execute a reasonable
confidentiality agreement prior to commencing any such inspection. Inspections conducted under this Section 10.4.1 shall be at the expense of NGX, unless a variation or error producing an underpayment in amounts payable exceeding [***] of the
amount paid for any period covered by the inspection is established in the course of any such inspection, whereupon all costs relating to the inspection for such period and any
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unpaid amounts that are discovered shall be paid by Astellas, together with interest on such unpaid amounts at the rate set forth in Section 10.1 above.
The Parties will endeavor to minimize disruption of Astellas'''''''''''''''' normal business activities to the extent reasonably practicable. To the extent that Astellas does not have the right to grant NGX the right to audit its Sublicensees'''''''''''''''' books and
records hereunder, Astellas shall obtain for itself such right and, at the request of NGX, Astellas shall exercise such audit right with respect to Sublicensees and provide the results of such audit for inspection by NGX pursuant to this
Section 10.4.1. 10.4.2 NGX. NGX shall keep complete, true and accurate books of accounts and records for the
purpose of determining the amounts payable (or reimbursable) under this Agreement, including without limitation true and accurate records of the costs incurred by NGX in connection with the conduct of those development studies contemplated in
Article 7 for which it is entitled to reimbursement from Astellas. Such books and records shall be kept open at the principal place of business of NGX and be for at least [***] following the end of the calendar quarter to which they pertain.
Such records will be open for inspection during such [***] period by an independent auditor chosen by Astellas and reasonably acceptable to NGX for the purpose of verifying the amounts payable by NGX hereunder. Such inspections may be made no more
than once each calendar year (it being understood that a single audit may require multiple visits) and no more than once in respect of any audited period, at reasonable times and on reasonable notice. Astellas'''''''''''''''' independent auditor shall be
obligated to execute a reasonable confidentiality agreement prior to commencing any such inspection. Inspections conducted under this Section 10.4.2 shall be at the expense of Astellas, unless a variation or error producing an overpayment in
amounts payable exceeding [***] of the amount paid for any period covered by the inspection is established in the course of any such inspection, whereupon all costs relating to the inspection for such period shall be paid by NGX and Astellas shall
receive a credit for any overpaid amounts that are discovered together with interest on such overpaid amounts at the rate set forth in Section 10.1 above. The Parties will endeavor to minimize disruption of NGX''''''''''''''''s normal business activities
to the extent reasonably practicable. 11. INTELLECTUAL PROPERTY 11.1 Ownership of Inventions 11.1.1 Title to all inventions and other intellectual property made solely by Astellas personnel in connection with this Agreement shall be owned by Astellas. Title to all inventions and other intellectual property made solely by NGX
personnel in connection with this Agreement shall be owned by NGX.
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11.1.2 Title to all inventions and other intellectual property made jointly by personnel
of NGX and Astellas in connection with the performance of this Agreement (“Joint IP”) shall be jointly owned by Astellas and NGX. Prosecution of any patent applications and patents with respect to such jointly owned
inventions and intellectual property (“Joint Patents”) shall be as mutually agreed. 11.1.3 It is
understood that neither Party shall have any obligation to account to the other for profits, nor to obtain any approval of the other Party to exploit, license or assign any such Joint IP, by reason of joint ownership thereof, provided that to the
extent that such Joint IP covers or directly relates to Products neither Party shall until expiry of this Agreement, without obtaining the approval of the other Party, (a) license such Joint IP to a Third Party, other than to a Sublicensee in
the case of Astellas or a licensee of the Existing Product and/or the Liquid Formulation Product in the case of NGX, or (b) assign such Joint IP to a Third Party, other than to an assignee of all or substantially all of its assets or business
in any country pertaining to the Components and/or the Products. Such Joint Patents shall be considered a Patent Right for the purposes of extending the term of this Agreement but no Earned Royalties shall be payable to NGX in respect of any Joint
Patent. 11.1.4 Astellas Improvements. Astellas shall notify NGX of any Astellas Improvements in a [***]. Astellas
shall have the right to file and maintain patents for Astellas Improvements as it, in its sole discretion, decides, provided that if Astellas elects not to maintain patent application(s) and patent(s) for an Astellas Improvement that Astellas has
filed, Astellas shall notify NGX of such intention at least [***] prior to the date upon which such patent or patent application shall expire or be abandoned, and NGX shall thereupon have the right, but not the obligation, to assume responsibility
for the prosecution and maintenance thereof at its own expense, provided that it is understood that ownership of such Patent Right shall remain with Astellas. Astellas hereby grants to NGX an [***] outside the Territory, with the right to
sublicense, under any Astellas Improvements to make, have made, use, sell, offer for sale, import, practice and otherwise exploit the same for the Components and/or the Product outside the Territory (the “NGX License”). Upon the
expiration of this Agreement the NGX License shall thereafter be non-exclusive but in all other respects shall remain unchanged. Upon the termination of this Agreement by Astellas pursuant to Section 17.2 or by NGX pursuant to
Sections 17.3-17.5, the scope of the NGX License shall thereafter be worldwide but in all other respects shall remain unchanged. As used herein, “Astellas Improvements” means any patent rights or other intellectual property
made by or under authority of Astellas or its Affiliates in connection with development and/or commercialization of a Product under this Agreement that is applicable to the Components or Product or the manufacture, use or formulation thereof and
solely to the extent that such patent rights or other intellectual property cover a Product. 11.2 NGX Improvements NGX shall notify Astellas of any NGX Improvements [***].
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11.2.1 NGX shall license any Know-How comprised in NGX Improvements to Astellas under the
terms of Section 2.2. 11.2.2 NGX shall notify Astellas of the grant of any patent for NGX Improvements within [***] of
such grant and provide Astellas with a copy of the granted patent. 11.2.3 Within [***] of the date of the notice in
Section 11.2.2, Astellas shall notify NGX whether it wishes such patent for NGX Improvements to be added to the Patent Rights and thereby be licensed to Astellas under Section 2.2 and extend the term of this Agreement. 11.2.4 If Astellas does not notify NGX within the [***] period in Section 11.2.3 or notifies NGX that it does not wish such patent
for NGX Improvements to be added to the Patent Rights then Astellas shall not be licensed under such patent and the term of this Agreement shall not be extended. To the extent that such patent for an NGX Improvement is solely applicable to Products,
NGX and its Affiliates shall not exploit or license it to a Third Party in the Territory until the expiry or earlier termination of this Agreement. 11.2.5 As used herein, “NGX Improvements” means any patent rights or other intellectual property made by or under authority of NGX or its Affiliates in connection with development and/or
commercialization of a Product under this Agreement that is applicable to the Components or a Product or the manufacture, use or formulation thereof and solely to the extent that such patent rights or other intellectual property cover a Product.
11.3 Maintenance of Patents 11.3.1 Filings. As between Astellas and NGX, NGX shall have responsibility for and shall control the filing, prosecution and maintenance of all Patent Rights in the Territory. NGX agrees to keep Astellas
informed of the course of patent prosecution or other proceedings with respect to the Patent Rights within the Territory (including those licensed under the UC Agreement and LTS Agreement), and Astellas shall have the right to review pending patent
applications and make recommendations to NGX concerning the foregoing. NGX will consider in good faith all reasonable suggestions of Astellas with respect thereto. Astellas shall hold all information disclosed to it under this Section 11.3.1 as
confidential. 11.3.2 Patent Costs. The costs of prosecuting and maintaining the Patent Rights ([***]) in the
Territory will [***]. 11.3.3 Maintenance of Existing Product Patent Portfolio. In respect of the Existing Product
NGX [***]. 11.3.4 Maintenance of Liquid Formulation Product Patent Portfolio. Following Astellas'''''''''''''''' exercise of
its Option under Section 2.3.12 with respect to the Liquid Formulation Product, the Parties shall agree upon those Patent Rights with respect to the Liquid Formulation Product that constitute “Core Patent Rights”. Such patents shall
thereafter be added to Exhibit 1.40 and [***].
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11.3.5 If, during the term of this Agreement, NGX intends to allow any [***] (as
indicated in Exhibit 1.40) owned by NGX in the Territory to expire or otherwise be abandoned, NGX shall notify Astellas of such intention at least [***] prior to the date upon which such Patent Right shall expire or be abandoned, and Astellas
shall thereupon have the right, but not the obligation, to assume responsibility for the prosecution and maintenance thereof at its own expense, such Patent Right being an “Assumed Patent”, provided that it is understood that
ownership of such Patent Right shall remain with NGX. Although such Assumed Patent shall be licensed to Astellas under this Agreement and shall be considered a Patent Right for the purposes of extending the term of this Agreement no Earned Royalties
shall be payable to NGX in respect of any Assumed Patent. 11.3.6 NGX shall not during the term of the Agreement assign or
otherwise transfer any Patent Rights (owned by it) in the Territory for which it is the registered proprietor to any Third Party. 11.3.7 Extensions/Supplementary Protection Certificates. The Parties shall discuss and mutually agree upon the patent or patents within the Patent Rights to be extended in each country of the Territory and each Party shall cooperate
with the other in seeking any such agreed upon extensions of the terms of Patent Rights in the Territory. Without limiting the foregoing, NGX shall, at Astellas'''''''''''''''' request, either authorize Astellas to act as NGX''''''''''''''''s agent for the purpose of
making any application for any such agreed upon extensions or shall diligently seek to obtain such extensions, in either event, [***]. 11.4 Third Party Patents and Trademarks 11.4.1 Third Party Infringement Claims. If the production,
importation, keeping, sale, offering for sale, or use of any Product in the Territory pursuant to this Agreement results in a claim, suit or proceeding in the Territory by a Third Party alleging patent or trademark infringement against NGX or
Astellas (or their respective Affiliates, licensees or Subdistributors) (collectively, “Infringement Actions”), such Party shall promptly notify the other Party hereto in writing. The Party [***]. The Party controlling the defense
of such Infringement Action shall defend such Infringement Action using counsel of its own choice, and the Infringement Action shall be at such Party''''''''''''''''s [***]; provided, however, that the other Party may participate in the defense and/or
settlement thereof [***] with counsel of its choice. The Party controlling the Infringement Action agrees to keep the other Party hereto reasonably informed of all material developments in connection with any such Infringement Action. Astellas
agrees not to (i) make admissions regarding infringement by the Product of any patents outside of the Patent Rights, or (ii) settle such Infringement Action, or make any admissions or assert any position in such Infringement Action, in a
manner that would materially adversely affect the validity, enforceability or scope of the Patent
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Rights in or outside the Territory, in each case without obtaining the prior written consent of NGX which shall not be unreasonably withheld, conditioned or
delayed. Subject to any right of Astellas to be indemnified by NGX under the Supply Agreement, [***]. As used herein, “Damages” shall mean out-of-pocket costs incurred by a Party, including reasonable attorneys'''''''''''''''' fees and other
legal costs, damages and other liabilities that are part of any final judgment awarded against such Party, and any amounts paid by such Party in a settlement of the action that is approved by the other Party, such approval not to be unreasonably
withheld, delayed or conditioned. In respect of any infringement actions outside the Territory, NGX agrees not to settle such infringement action, or make any admissions or assert any position in such infringement action, in a manner that would
materially adversely affect the validity, enforceability or scope of the Patent Rights inside the Territory, without obtaining the prior written consent of Astellas which shall not be unreasonably withheld, conditioned or delayed. 11.4.2 Oppositions to Third Party Patents and Trademarks. If NGX or Astellas becomes aware of a Third Party patent and/or trademark
filed and/or registered in the Territory, which the production, sale or use of any Product in the Territory pursuant to this Agreement may infringe (a “Third Party Right”), such Party shall promptly notify the other Party hereto in
writing. [***]. In the event that the Parties agree that it would be advisable to bring such revocation or opposition proceedings (“Adverse Proceedings”), Astellas shall have the right, [***], to bring and control the Adverse
Proceedings using counsel of its own choice. Astellas agrees to keep NGX reasonably informed of all material developments in connection with any such Adverse Proceedings and shall reasonably consider NGX''''''''''''''''s advice and requests with respect to
such Adverse Proceeding. Astellas may treat its Costs from such Adverse Proceedings [***]. As used herein, “Costs” shall mean out-of-pocket costs incurred by Astellas, including reasonable attorneys'''''''''''''''' fees and other legal costs,
damages and other liabilities that are part of any final judgment awarded against Astellas, and any amounts paid by Astellas in a settlement of the action that is approved by the NGX, such approval not to be unreasonably withheld, delayed or
conditioned. In the event that the Parties cannot agree on whether an Adverse Proceeding should be initiated, the Party wishing to bring the Adverse Proceeding shall have the right to do so using counsel of its own choice, provided that it agrees to
[***] associated with such Adverse Proceeding and to keep the other Party reasonably informed of all material developments in connection with any such Adverse Proceedings. Notwithstanding the foregoing, in the event that the Parties cannot agree on
whether an Adverse Proceeding should be initiated but the Party wishing to bring the Adverse Proceeding can reasonably demonstrate that (a) failure to bring an Adverse Proceeding with respect to a particular Third Party Right would have a
material adverse effect on the commercialization of Product in the Territory, and (b) that the contemplated Adverse Proceeding has a reasonable chance of success, in each case through the reasoned legal opinion of such Party''''''''''''''''s outside
patent counsel, then the Party bringing such Adverse Proceeding [***] from such Adverse Proceedings [***], as applicable.
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11.5 Enforcement of Patent Rights and Trademarks Subject to the provisions of this Section 11.5, in the event that Astellas reasonably believes that the Product Trademark or any Patent Rights in
the Territory are infringed or misappropriated by a Third Party or are subject to a declaratory judgment action in the Territory arising from such infringement, in each case with respect to the sale or use within the Field in the Territory of a
[***] product comprising a [***] (each such product, an “Infringing Product”), Astellas shall promptly notify NGX. In such event, as between the Parties, NGX shall have the initial right (but not the obligation), to enforce the
Product Trademark or Patent Rights (save in respect of any Assumed Patent), as appropriate, with respect to such infringement, or defend any declaratory judgment action with respect thereto (for purposes of this Section 11.5, an
“Enforcement Action”). Astellas (or NGX in respect of any Assumed Patent) shall, [***], have the right to participate with counsel of its own choice, provided that it is understood that Astellas'''''''''''''''' right to participate in any
Enforcement Action with respect to the patents within the Patent Rights in-licensed to NGX under the LTS Agreement shall be subject to LTS'''''''''''''''' consent. NGX shall keep Astellas reasonably informed of the progress of any such Enforcement Action.
11.5.1 Initiating Enforcement Actions. In the event that NGX, or the owner of the Patent Rights, as applicable,
fails to initiate an Enforcement Action to enforce the Patent Rights or Product Trademark, as applicable, against an infringement by a Third Party in a country in the Territory, which infringement consists of the sale or use of an Infringing Product
in the Field in such country, within [***] of a request by Astellas to initiate such Enforcement Action (or such shorter period required to allow obtaining an interim injunction in the relevant country), Astellas may initiate an Enforcement Action
against such infringement. NGX shall cooperate in such Enforcement Action including by being joined as a party to such Enforcement Action. Astellas shall keep NGX reasonably informed of the progress of any such Enforcement Action. NGX shall, at its
expense, have the right to join in as a party plaintiff and to give reasonable assistance to such Enforcement Action. Astellas agrees not to settle any Enforcement Action, or make any admissions or assert any position in such Enforcement Action, in
a manner that would materially adversely affect the validity, enforceability or scope of the Patent Rights in or outside the Territory, without the prior written consent of NGX, which shall not be unreasonably withheld, delayed or conditioned. In
respect of any proceedings to enforce any patents outside the Territory that are equivalent to the Patent Rights, NGX agrees not to settle any such proceedings, or make any admissions or assert any position in such proceedings, in a manner that
would materially adversely affect the validity, enforceability or scope of the Patent Rights inside the Territory, without the prior written consent of Astellas, which shall not be unreasonably withheld, delayed or conditioned. 11.5.2 Recoveries. With respect to Enforcement Actions initiated by a Party (the “Initiating Party”) in a country,
with the other Party''''''''''''''''s prior written consent and upon mutual agreement not to be unreasonably withheld, delayed or conditioned, the other Party shall pay [***] of the costs and expenses (including attorneys'''''''''''''''' and professional fees) incurred
by the Initiating Party in such Enforcement Action. Any recovery received as a result of any Enforcement Action to enforce the Product Trademark or Patent Rights pursuant to this Section 11.5 by either Party shall, [***] incurred in connection
with such Enforcement Action, and the [***] (to the extent the same
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represents damages from sales of products within the Field in the Territory) equally between the Parties; provided, however, that if the Initiating Party
initiates the Enforcement Action and the other Party does not agree to pay [***] of the costs and expenses incurred by the Initiating Party therein, the other Party shall be entitled to any amount recovered in such Enforcement Action in a pro rata
amount to its contribution to the costs and expenses incurred by the Initiating Party. 11.6 Third Party Patent Rights 11.6.1 Subject to Section 11.6.2, the obligations of NGX and the rights of Astellas under Sections 11.3 and 11.5 shall be
subject to, and limited by, any agreements pursuant to which NGX acquired or licensed any particular Patent Rights or Data, including without limitation the UC License Agreement and LTS Agreement. Without limiting the foregoing, with respect to the
prosecution or enforcement of Patent Rights licensed by NGX from a Third Party, to the extent NGX has the right to do so, NGX shall cooperate with Astellas to prosecute and enforce such Patent Rights in the Territory in the same manner as set forth
in Sections 11.3 and 11.5 above. As between NGX and Astellas, any recoveries from enforcement of such Patent Rights licensed from a Third Party (including any amounts that NGX receives from the Third Party licensor as a result of such
enforcement) [***], after deducting from such recoveries any amounts owed to the Third Party licensor for such enforcement; provided that any Enforcement Actions initiated by the [***]. 11.6.2 NGX shall not [***]. 11.6.3 If NGX receives notification from LTS under Section 7.2(d) of the LTS Agreement that LTS has elected not to file, prosecute or maintain any patent or patent application licensed by NGX from LTS, then NGX
shall so notify Astellas within [***] of NGX''''''''''''''''s receipt of such notification. If Astellas wishes NGX to file, prosecute or maintain such patent or patent application it shall inform NGX within [***] of receipt of the notice from NGX and NGX
shall immediately (and in any event within the [***] period in Section 7.2(d) of the LTS Agreement) so inform LTS such that the provisions of Sections 7.2(d) and (e) of the LTS Agreement take effect. 11.7 Patent Marking Astellas agrees
to mark and have its Affiliates, Sublicensees and Subdistributors mark all patented Products they sell or distribute pursuant to this Agreement in accordance with the applicable patent statutes or regulations in the country or countries of
manufacture and sale thereof.
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12. TRADEMARKS 12.1 Product Trademark The Existing Product shall be distributed, promoted, marketed and sold in
the Territory by Astellas, its Affiliates, Sublicensees and Subdistributors exclusively under the Product Trademark. All packaging materials, labels and promotional materials for the Existing Product in the Territory shall display the Product
Trademark to the extent such packaging materials, labels and promotional materials have enough space for such display. In addition, to the extent reasonably desired by NGX, all product information leaflets and promotional materials for the Product
in the Territory shall include a statement acknowledging that the Product is sold under license from NGX. 12.2 Trade Dress
The Astellas trade dress and style of packaging with respect to the Existing Product may be determined by Astellas so as to be consistent
with Astellas'''''''''''''''' standard trade dress and style, provided that they conform to the Brand Guiding Principles. Any trade dress and style of packaging not consistent with the Brand Guiding Principles shall be subject to the prior written approval by
NGX not to be unreasonably withheld, delayed or conditioned. Astellas shall own rights to any trade dress which is created by Astellas or on its behalf and used in the commercialization of the Existing Product in the Territory. 12.3 License NGX hereby grants to
Astellas an exclusive, royalty-free license, to use the Product Trademark solely in connection with marketing, promoting, distributing and selling the Existing Product in the Field and Territory in accordance with this Agreement. This license is
sublicensable in accordance with Section 2.4.2 above. The ownership and all goodwill from the use of the Product Trademark shall vest in and inure to the benefit of NGX and will not create any right, title or interest for Astellas in the
Product Trademark. 12.4 Quality Standards 12.4.1 The use of the Product Trademark by Astellas shall be in accordance with the Brand Guiding Principles. Astellas shall not take any
action that impairs the validity or enforceability of the Product Trademark. 12.4.2 The quality of the Product associated
with the Product Trademark, as well as the quality of all marketing and promotional materials and packaging that include the Product Trademark, shall be in accordance with the MAA Approval for the Product in the respective country or jurisdiction.
Upon NGX''''''''''''''''s reasonable and periodic request, Astellas shall provide NGX with a sample of the Product associated with the Product Trademark. 12.4.3 NGX shall have the right to [***], and the [***] that include the Product Trademark provided by Astellas, and Astellas shall assist NGX [***] in accordance with Section 8.3.2.
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12.5 Alternative Trademark If the Product Trademark cannot be used for legal, regulatory or other material reasons outside the Parties'''''''''''''''' reasonable control, in one or more
countries of the Territory, the Parties shall mutually select one of the then available Alternative Trademarks and NGX shall license such Alternative Trademark to Astellas during the term of this Agreement, at no additional cost to Astellas in
accordance with Section 12.3 above. In such an event, the Alternative Trademark in such country or countries of the Territory shall become the Product Trademark. 12.6 Registration & Ownership NGX agrees to use commercially reasonable efforts to file,
register and maintain a registration for the Product Trademark (including, if appropriate pursuant to Section 12.5, the Alternative Trademark) in all countries of the European Union (and in countries of the Territory outside the European Union,
upon notice from Astellas that an MAA for the Product is being filed in such country), in each case for use with the Existing Product during the term of this Agreement. The costs of filing and maintaining such registrations in the Territory shall
[***]. Astellas hereby acknowledges NGX''''''''''''''''s exclusive ownership rights in the Product Trademark, and accordingly agrees that at no time during or after the term of this Agreement to challenge or assist others to challenge the Product Trademark or
the registration thereof or attempt to register any trademarks, marks or trade names confusingly similar to such Product Trademark. NGX shall not during the term of the Agreement assign or otherwise transfer any Product Trademark in the Territory
for which it is the registered proprietor to any Third Party. 12.7 Recordation In those countries where a trademark license must be recorded, NGX will provide and record a separate trademark license for the Product Trademark, at
NGX''''''''''''''''s sole expense. Astellas shall cooperate in the preparation and execution of such documents. 12.8 Domain Names
NGX shall own rights to any Internet domain names incorporating the Product Trademark or any variation or part of such Product Trademark as its URL
address or any part of such address where the relevant Product Trademarks are owned by it. NGX agrees to grant, and hereby grants to Astellas a royalty-free, fully paid-up exclusive license to use the domain names listed on Exhibit 12.8
(“Domain Names”) in connection with Astellas'''''''''''''''' commercialization of the Existing Product in the Territory in accordance with this Agreement, provided that [***]. If there is a requirement in any country in the Territory for
the domain name holder to have a presence in that country and NGX does not have a presence in that country then NGX shall transfer the relevant Domain Name to Astellas provided that upon termination of this Agreement (but not expiration) Astellas
shall promptly transfer such Domain Name back to NGX. The use rights granted to the Domain Names
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under this Section 12.8 are limited to the Territory, and Astellas shall not make or authorize any use, direct or otherwise, of the Domain Names outside
the Territory. Astellas shall not sublicense the Domain Names without NGX''''''''''''''''s prior written consent. For clarity, Astellas acknowledges and agrees that the Domain Names and the goodwill pertaining to such Domain Names shall belong to
NGX. NGX agrees to take such additional actions as may be reasonably required to extend to Astellas the benefits of this license. The Parties agree that any use of the Product Trademark in any content describing or referring to the
Existing Product in the Territory on any internet page or web site shall, subject to the terms of this Agreement, be in the sole control of Astellas. 12.9 Trademark for Liquid Formulation Product If Astellas exercises the Option pursuant to
Section 2.3.12 then the parties shall agree a trademark for use in relation to such Product (the “LF Trademark”). The terms of Sections 12.1 to 12.8 shall apply mutatis mutandis in relation to any such trademark
such that references to Existing Product shall be read as references to the Liquid Formulation Product, references to Product Trademark shall be read as references to the LF Trademark and references to the Alternative Trademark shall be read as
references to a mutually agreed alternative trademark for the Liquid Formulation Product. 12.10 Promotional Materials
All promotional materials and packaging for Product (whether of NGX, its Affiliates and licensees outside the Territory or Astellas, its Affiliates,
Sublicensees and Subdistributors inside the Territory) using the Product Trademark shall conform to the Brand Guiding Principles. 12.11
Termination Astellas'''''''''''''''' right to use the Product Trademark shall terminate in each country of the Territory in which
Astellas'''''''''''''''' rights to distribute the Product are terminated in accordance with this Agreement. Astellas shall cooperate in the cancellation of any trademark licenses recorded or entered into in such countries. In the event that the Agreement
expires then Astellas'''''''''''''''' rights to the Product Trademark shall continue pursuant to Section 18.2(b). 13. CONFIDENTIALITY
13.1 Confidential Information Except as expressly provided herein, the Parties agree that the receiving Party shall not publish nor otherwise
disclose, and shall not use for any purpose, any information furnished to it by the other Party hereto pursuant to this Agreement (collectively, “Confidential Information”). Notwithstanding the foregoing, Confidential Information
shall not include information which, in each case as demonstrated by written documentation: 13.1.1 was already known to the
receiving Party, other than under an obligation of confidentiality, at the time of disclosure;
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13.1.2 was generally available to the public or otherwise part of the public domain at
the time of its disclosure to the receiving Party; 13.1.3 became generally available to the public or otherwise part of the
public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; 13.1.4 was subsequently lawfully disclosed to the receiving Party by a person other than a Party, and who did not directly or indirectly receive such information from disclosing Party; or 13.1.5 was independently developed by the receiving Party without use of or reference to any information or materials disclosed by the
disclosing Party. 13.2 Permitted Use and Disclosures Notwithstanding the provisions of Section 13.1 above, each Party hereto may use and disclose the other Party''''''''''''''''s Confidential Information to the extent such disclosure is reasonably necessary to exercise the
rights granted to it, or reserved by it, under this Agreement (including the right to grant sublicenses, as applicable), prosecuting or defending litigation, complying with applicable governmental regulations, submitting information to tax or other
governmental authorities (including without limitation the European Commission), or conducting clinical trials hereunder with respect to Products, provided that if a Party is required to make any such disclosure of the other Party''''''''''''''''s
Confidential Information, to the extent it may legally do so, it will give reasonable advance notice to the latter Party of such disclosure and, save to the extent inappropriate in the case of patent applications or otherwise, will use its
reasonable efforts to secure confidential treatment of such information prior to its disclosure (whether through protective orders or otherwise). For any other disclosures of the other Party''''''''''''''''s Confidential Information, including to Affiliates,
licensees, Subdistributors and other Third Parties, a Party shall ensure that the recipient thereof is bound by a written confidentiality agreement as materially protective of such Confidential Information as this Section 13. If the Party whose
Confidential Information is to be disclosed has not filed a patent application with respect to such Confidential Information, it may require the other Party to delay the proposed disclosure (to the extent the disclosing Party may legally do so), for
up to [***], to allow for the filing of such an application. This Section 13 shall not limit either Party''''''''''''''''s right under Section 7.2.1 to use and disclose Data. 13.3 Terms of this Agreement Each
Party agrees not to disclose to any Third Party the terms of this Agreement without the prior written consent of the other Party hereto, except each Party may disclose the terms of this Agreement (a) as required by law (as determined by the
disclosing Party''''''''''''''''s legal counsel) or in filings with governmental entities, e.g. the SEC, IRS or with national stock exchanges, or (b) under reasonable conditions of confidentiality, to advisors, auditors and actual or potential
acquisition partners or private investors on a need to know basis.
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13.4 Prior Non-Disclosure Agreements Upon execution of this Agreement, the terms of this Section 13 shall supercede any prior non-disclosure, secrecy, or confidentiality agreement
between the Parties. Any information disclosed under such prior agreements shall be deemed disclosed under this Agreement. 13.5
Publication of Product Information Prior to publishing, publicly presenting and/or submitting for written or oral publication a
manuscript, abstract or the like that includes Data or other information relating to Product that has not previously been published pursuant to this Section 13.5, a Party shall provide the other Party a copy thereof in English for its review
for at least [***] (unless such Party is required by law to publish such information sooner). Such Party shall consider in good faith any comments provided by the other Party during such [***] period. In addition, such Party shall, at the request of
the other Party: (a) remove any Confidential Information of the other Party therefrom, except each Party shall have the right to publicly disclose any information, including Confidential Information, pertaining to safety or efficacy of the
Product that such Party believes in good faith it is obligated or appropriate to disclose; and (b) delay publication for a period not to exceed [***] in order to allow the other Party to file for patent protection in relation to its Data and
Confidential Information. The contribution of each Party shall be noted in all publications or presentations by acknowledgment or coauthorship, whichever is appropriate. 14. REPRESENTATIONS AND WARRANTIES 14.1 Mutual Warranties Each Party warrants and represents to the other that the Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance
with its terms. The execution, delivery and performance of the Agreement by such Party does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor to such Party''''''''''''''''s
knowledge, violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it. 14.2 NGX Warranties NGX warrants and represents to Astellas that as of the Effective Date: 14.2.1 it has the full right and authority to enter into this Agreement and grant the rights and licenses granted herein;
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Intellectual Property 14.2.2 it has not previously granted any right, license or interest in or to the Patent Rights, or any portion thereof, that is in
conflict with the rights or licenses granted to Astellas under this Agreement; 14.2.3 [***]; 14.2.4 there are no pending proceedings in any court, arbitration, patent office, administrative or other tribunal which are concerned
with the validity or ownership of any of the Patent Rights, NGX Know-How or the Product Trademark or the Alternative Trademark, [***] those that have been published in the following NGX SEC filings: (a) the Business and Risk Factors sections of
(i) the Form S-1A dated 16 March 2007, (ii) the Form 10-K for the year ended 31 December 2007 and (iii) the Form 10-K for the year ended 31 December 2008 and (b) the Risk Factors Section of the Form 10Q for the
quarter ended 31 March 2009 provided that in relation to Patent Rights which have been licensed to it and are not owned by it, the foregoing is given to the Knowledge of NGX having made reasonable enquiry of UC and LTS; 14.2.5 to the Knowledge of NGX, upon Consultation, [***]; 14.2.6 the details of the Patent Rights, the Product Trademark and the Alternative Trademark that are set out in Exhibit 1.40
and Exhibit 1.44 are [***]. Without derogation from the generality of the foregoing, the Patents Rights, the Product Trademark and the Alternative Trademark (to the extent they are granted) are subsisting and all applications for Patents
Rights, the Product Trademark or the Alternative Trademark indicated in Exhibit 1.40 and Exhibit 1.44 as pending are pending. The legal and beneficial owner or applicant for registration of each of the Patents Rights, the
Product Trademark or the Alternative Trademark specified in Exhibit 1.40 and Exhibit 1.44 is [***]; 14.2.7 [***] the Patent Rights and Product Trademarks set forth in Exhibit 1.40 and Exhibit 1.44; 14.2.8 the Patent Rights, the Product Trademark, the Alternative Trademark and the NGX Know-How are [***]; 14.2.9
all actions required to be taken [***] in good faith ([***]) have been taken [***]; 14.2.10 the Patent Rights owned by NGX
are not and, during the term of this Agreement, will not become subject to any rights granted in favor of a Third Party, including a lien or other encumbrance, which would conflict with the rights or licenses of Astellas hereunder;
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14.2.11 as of the Effective Date, [***] save for those that have been published in the
following NGX SEC filings: (a) the Business and Risk Factors sections of (i) the Form S-1A dated 16 March 2007, (ii) the Form 10-K for the year ended 31 December 2007 and (iii) the Form 10-K for the year ended
31 December 2008 and (b) the Risk Factors Section of the Form 10Q for the quarter ended 31 March 2009. Licenses
14.2.12 NGX has disclosed to Astellas true and complete copies of the UC Agreement and the LTS Agreement and all actual
amendments to these agreements and all contemplated amendments that have been discussed with, respectively, UC and LTS; 14.2.13 the UC Agreement and LTS Agreement are in full force and effect, each such agreement is binding on the parties and to the Knowledge of NGX no party is in material breach of any of its obligations under such agreements;
14.2.14 NGX (a) is not in breach and shall not breach its obligations under the UC Agreement or LTS Agreement or take any other
actions, in each case which would result in the termination of such agreement(s) and the subsequent loss by Astellas of its rights with respect to the Patent Rights in-licensed under such agreement(s), provided that NGX will not be deemed to be in
breach of this Section 14.2.14(a) in the event that Astellas'''''''''''''''' rights under such agreement(s) would have survived the termination of such agreement(s) but for Astellas'''''''''''''''' having failed to take the necessary steps to ensure the survival
of its rights, (b) shall promptly inform Astellas in the event that it receives written notice from UC or LTS purporting to unilaterally terminate the UC Agreement and LTS Agreement and will use commercially reasonable efforts to dispute any
allegation of material breach asserted by UC or LTS with respect to the UC Agreement and/or LTS Agreement as may be required to prevent termination of such licenses, and (c) shall not amend such agreements in a manner that would be to the
detriment of the rights and obligations of Astellas under this Agreement without Astellas'''''''''''''''' prior written consent; 14.2.15 NGX has provided UC with a copy of [***]; 14.2.16 NGX has not been notified by [***] that [***] has
commenced development [***]; Marketing Authorizations/Regulatory 14.2.17 EMEA MA Approval Number EMEA/H/C/000909 is the only MAA and MAA Approval held by NGX or its Affiliates in relation to the
marketing and sale of the Existing Product in the Territory; 14.2.18 Astellas has been granted access to true and complete
copies of all of NGX''''''''''''''''s regulatory filings relating to the Product;
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14.2.19 all clinical trials for the Existing Product conducted by or on behalf of NGX and
included in NGX''''''''''''''''s regulatory filings with the EMEA [***]; 14.2.20 [***] with respect to the Data used to support EMEA
MA Approval Number EMEA/H/C/000909; 14.2.21 that as of the Effective Date, NGX has disclosed to Astellas all clinical data
relating to SAEs relating to Products, such SAEs being set out in Exhibit 14.2.21; 14.2.22 NGX has not
knowingly withheld from any regulatory authority any material information in the possession of NGX or its Affiliates related to the safety, toxicity, quality or efficacy of the Components and/or the Existing Product (a) that has been requested
by a regulatory authority, or (b) that a biopharmaceutical company would reasonably consider to be material for the EMEA''''''''''''''''s evaluation of the safety, toxicity, quality and/or efficacy of the Components and/or the Existing Product;
14.2.23 neither NGX nor its Affiliates or any of its or their officers, agents or employees (during the course of their
duties) in relation to researching, and developing the Existing Product in the Territory has done or omitted to [***] adversely affect Astellas'''''''''''''''' ability to commercialize the Existing Product as contemplated herein; 14.2.24 there has been no failure to [***] that would materially adversely affect Astellas'''''''''''''''' ability to commercialize the Existing
Product as contemplated herein; 14.2.25 NGX and its Affiliates have developed the Existing Product and the Liquid
Formulation Product [***]; 14.2.26 EMEA MA Approval Number EMEA/H/C/000909 was granted by the European Commission upon the
submission by the NGX of a full dossier presented in accordance with Article 8.3 of EC Directive 2001/83 and does not refer to any other marketing approval; 14.2.27 the application for EMEA MA Approval Number EMEA/H/C/000909 includes the results of all clinical trials that have been started
(i.e., in which patients have been enrolled) by or on behalf of NGX relating to the Existing Product whether discontinued or completed with the exception of [***] for which only a synopsis has been provided to the EMEA; 14.2.28 Astellas has the right to [***];
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General 14.2.29 neither NGX nor any NGX Affiliate is engaged in any litigation, opposition or arbitration proceedings affecting or relating to the
Products anywhere in the world (including but not limited to claims relating to product liability) as plaintiff or defendant and [***] sections of (i) the Form S-1A dated 16 March 2007, (ii) the Form 10-K for the year ended
31 December 2007 and (iii) the Form 10-K for the year ended 31 December 2008 and (b) the Risk Factors Section of the Form 10Q for the quarter ended 31 March 2009; 14.2.30 NGX has not knowingly withheld from Astellas any material information in the possession of NGX related to the safety, toxicity,
quality or efficacy of the Components and/or the Existing Product (a) that has been requested by Astellas, or (b) that a biopharmaceutical company would reasonably consider to be material to Astellas'''''''''''''''' evaluation of the safety,
toxicity, quality and/or efficacy of the Components and/or the Existing Product; 14.2.31 NGX has not knowingly withheld
from Astellas any material CMC Information in the possession of NGX regarding the Existing Product (a) that has been requested by Astellas, or (b) that a biopharmaceutical company would reasonably consider to be material to Astellas''''''''''''''''
evaluation of the quality of the Components and/or the Existing Product. As used herein, “CMC Information” means information of the type required to appear in Module 3 of EMEA MAA Approval No. EMEA/H/C/000909; 14.2.32 NGX has not knowingly withheld from Astellas any material information in the possession of NGX related to the market and sales
potential of the Components and/or the Existing Product (a) that has been requested by Astellas, or (b) that a biopharmaceutical company would reasonably consider to be material to Astellas'''''''''''''''' evaluation of the market and sales
potential of the Components and/or the Existing Product in the Territory; 14.2.33 NGX and its Affiliates have no employees
in the Territory; 14.2.34 all necessary consents, approvals and authorizations of all governmental authorities and other
persons or entities required to be obtained by NGX in order to enter into this Agreement have been obtained; 14.2.35 other
than with respect to [***], no US export control license is required (a) in order to enter into this Agreement, (b) transfer NGX Know-How and Data to Astellas, (c) for Astellas to purchase any Components or Existing Products, or
(d) in order to enable Astellas to exercise its rights under this Agreement; 14.2.36 except as otherwise noted in
Section 14.2.35, no approval from U.S. federal government or any U.S. state government (including any agency or division thereof) or to its Knowledge under any applicable law, is required (a) in order to enter into this Agreement,
(b) transfer NGX Know-How and Data to Astellas, (c) for Components, Existing Products or the
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Liquid Formulation Product to be manufactured either inside or outside the US or (d) in order to enable Astellas to exercise its rights under this
Agreement, in each case which lack of approval would materially adversely affect Astellas'''''''''''''''' ability to commercialize the Existing Product as contemplated herein; 14.2.37 as of the Effective Date, [***]; and 14.2.38 except for the documents identified on Exhibit 14.2.38, all material information referred to in Sections 14.2.30, 14.2.31 and 14.2.32 has been made available to Astellas at least [***] prior to the
Effective Date. 14.3 NGX Covenants NGX covenants to Astellas that, during the term of this Agreement (a) it shall not grant any right, license or interest in or to the Patent Rights and NGX Know-How, or any portion thereof, that is in conflict
with the rights or licenses granted under this Agreement, and (b) it shall not grant a lien or other encumbrances on any of the subject matter of this Agreement or on any of NGX''''''''''''''''s rights, benefits or obligations hereunder or on any of the
Patent Rights, which would conflict with the rights or licenses of Astellas hereunder, provided that the Parties agree that this subsection (b) is not intended to, and shall not, restrict NGX from engaging in customary equity and debt
financings. 14.4 Astellas Warranties Astellas warrants and represents to NGX that, as of the Effective Date: (a) it has the full right and authority to enter into this Agreement and grant the rights and perform the obligations set forth herein;
(b) [***] (c) all necessary consents, approvals and authorizations of all governmental authorities and other persons or entities required to be obtained by Astellas in order to enter into this Agreement have been obtained save in respect
of any export control licenses. 15. LIABILITY 15.1 DISCLAIMER EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT TO THE CONTRARY, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING, BUT
NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, OR VALIDITY OF ANY PATENTS ISSUED OR PENDING. 15.2 LIMITATION OF LIABILITY NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR OTHERWISE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT, WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY, FOR ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES, LOST PROFITS, LOSS OF ROYALTIES AND MILESTONE PAYMENTS, LOSS OF USE, DAMAGE TO GOODWILL, OR LOSS OF
BUSINESS.
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15.3 Exceptions Nothing in this Agreement shall limit any Party''''''''''''''''s liability (a) caused by that Party''''''''''''''''s willful misconduct, (b) for death or personal injury caused by that Party''''''''''''''''s negligence, or (c) for
fraudulent misrepresentation by that Party. 16. INDEMNIFICATION 16.1 Indemnification of NGX Subject to Section 15.2, Astellas hereby agrees to indemnify,
defend and hold harmless NGX, its Affiliates, and their respective directors, officers, employees, agents and their respective successors, heirs and assigns (the “NGX Indemnitees”) from and against any losses, costs, claims,
damages, liabilities or expenses (including, without limitation, reasonable attorneys'''''''''''''''' and professional fees and other expenses of litigation) (collectively, “Liabilities”) from any claims, suits, actions or proceedings brought
by a Third Party (a “Third Party Claim”) incurred by any NGX Indemnitee as a result of: [***]. 16.2 Indemnification of
Astellas Subject to Section 15.2, NGX hereby agrees to indemnify, defend and hold harmless Astellas, its Affiliates, and their
respective directors, officers, employees, agents and their respective successors, heirs and assigns (the “Astellas Indemnitees”) from and against any Liabilities from any Third Party Claims incurred by any Astellas Indemnitee as a
result of: [***]. 16.3 Procedure Except with respect to Third Party infringement claims subject to Section 11.4 above, a Party that intends to claim indemnification under this Section 16 (the “Indemnitee”) shall promptly
notify the other Party (the “Indemnitor”) in writing of any Third Party Claim, in respect of which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have sole control of the defense and/or settlement
thereof; provided, that the Indemnitee shall have the right to participate in the defense or settlement of such Third Party Claim with counsel of its own choosing at its expense. The Indemnitor shall keep the Indemnitee fully informed of the
progress of any such Third Party Claim. The indemnity arrangement in this Section 16 shall not apply to amounts paid in settlement of any action with respect to a Third Party Claim, if such settlement is effected without the consent of the
Indemnitor, which consent shall not be withheld, delayed or conditioned unreasonably. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any action with respect to a Third Party Claim, if
prejudicial to its ability to defend such action,
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shall relieve such Indemnitor of any liability to the Indemnitee under this Section 16 to the extent it is so prejudiced, but the omission to so deliver
written notice to the Indemnitor shall not relieve the Indemnitor of any liability that it may have to any Indemnitee otherwise than under this Section 16. The Indemnitee under this Section 16 shall cooperate fully with the Indemnitor and
its legal representatives in the investigation of any action with respect to a Third Party Claim covered by this indemnification. 16.4
Consequences of Failure to Transfer MA The Parties acknowledge and agree that the transfer of the Existing Product MAA Approval is
fundamental to Astellas'''''''''''''''' ability to commercialize the Existing Product, and accordingly it is agreed that in the event that NGX materially breaches its obligations under Sections 6.1, 6.3.1, 6.3.2 or 6.4, and as a result, the Existing Product
MAA Approval is not transferred to Astellas or Astellas'''''''''''''''' designated Affiliate within [***] of Astellas'''''''''''''''' request for transfer, or is cancelled, withdrawn or substantially amended in a manner that is prevents the commercialisation of the
Existing Product in the Territory (each of the foregoing a “Default”), then Astellas shall have the right under this Section 16.4 to terminate this Agreement upon written notice to NGX within thirty (30) days of the occurrence of
a Default, in which case NGX shall refund to Astellas within thirty (30) days of the date of such notice, the Initial Payment of Thirty Million Euros (€30,000,000) together with the Option Fee of Five Million Euros
(€5,000,000) and the terms of Section 18.6 shall apply. Save for willful misconduct by NGX, and its employees, the foregoing shall be Astellas'''''''''''''''' sole remedy for a failure to transfer the Existing Product MAA Approval or the
cancellation, withdrawal or amendment of the Existing Product MAA Approval, in each case which is the result of NGX''''''''''''''''s breach of its obligations under Sections 6.1, 6.3.1, 6.3.2 or 6.4 16.5 Insurance Each Party shall
secure and maintain in effect during the term of this Agreement and for a period of [***] thereafter (a) commercial general liability insurance with a minimum coverage of [***] per occurrence and annual aggregate, (b) product liability
insurance with a minimum coverage of [***] per occurrence and annual aggregate, and (c) clinical trial insurance with limits as required by local laws and regulations or, in the absence of such requirements, standard and customary in the
relevant country, underwritten by a reputable insurance company in a form standard and customary for entities in the pharmaceutical industry for exposures related to this Agreement. Upon request by the other Party hereto, certificates of insurance
evidencing the coverage required above shall be provided to the other Party.
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17. TERM AND TERMINATION 17.1 Term This Agreement shall become effective as of the Effective Date and, unless earlier
terminated pursuant to the other provisions of this Section 17 or Section 8.7 above, shall continue on a country-by-country and Product-by-Product basis, until the later of (a) ten (10) years after the First Commercial Sale
thereof in the respective country, (b) the expiration or abandonment of the last Valid Patent Claim covering the respective Product in the respective country and (c) the expiration of all applicable periods of regulatory exclusivity (e.g.,
regulatory data exclusivity) covering the respective Product in the respective country. 17.2 Termination By Astellas Astellas may terminate this Agreement for any reason under this Section 17.2 without any penalty, consequence, termination compensation, loss of
profits, goodwill indemnity or otherwise solely by reason of such termination (i.e., without prejudice to any remedies NGX may have for a breach of this Agreement by Astellas prior to such termination), as a whole, or with respect to the European
Region, or on a country-by-country basis with respect to countries in the Territory (other than those countries comprising the European Region) and a Product-by-Product basis, in each case upon written notice to NGX. 17.3 Termination for Material Breach Without limiting either Party''''''''''''''''s ability to terminate in accordance with the other provisions of this Agreement, in the event of a Party''''''''''''''''s material breach of this Agreement, the non-breaching Party shall have the right to provide
notice of its intention to terminate this Agreement. Such notice shall specify in reasonable detail the facts and circumstances constituting the material breach of this Agreement. Upon the expiration of [***] after receipt by the breaching Party of
such notice, if the breaching Party has not cured such material breach, the non-breaching Party shall have the right to terminate this Agreement in whole by giving a notice of termination, which shall be effective on the date such notice is given.
17.4 Termination for Insolvency Either Party may terminate this Agreement upon written notice to other Party at any time, to the extent permitted by applicable law, if the other Party shall become insolvent, or shall make or seek to make or arrange
an assignment for the benefit of creditors, or if proceedings in voluntary or involuntary bankruptcy shall be initiated by, on behalf of or against such Party (and, in the case of any such involuntary proceeding, not dismissed within [***]), or if a
receiver or trustee of such Party''''''''''''''''s property shall be appointed and not discharged within [***]. 17.5 [***] NGX may terminate this Agreement in whole or in part (on a country-by-country basis) at any time upon [***] prior written notice to Astellas in the event
Astellas breaches Section 2.7.1 of this Agreement. Notwithstanding the foregoing, in the event that upon notice from NGX that Astellas is in breach of Section 2.7.1 (solely for the first such breach), Astellas ceases to [***], NGX''''''''''''''''s
right to terminate this Agreement shall cease.
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17.6 [***] Astellas may terminate this Agreement in whole or in part (on a country-by-country basis) at any time upon [***] prior written notice to NGX in the event NGX breaches Section 2.7.4 of this Agreement.
Notwithstanding the foregoing, in the event that upon notice from Astellas that NGX is in breach of Section 2.7.4 (solely for the first such breach), NGX ceases to [***], Astellas'''''''''''''''' right to terminate this Agreement shall cease.
18. EFFECT OF EXPIRATION OR TERMINATION 18.1 General 18.1.1 Accrued Obligations. Termination of this Agreement for any reason shall not
release any Party hereto from any liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination nor preclude either Party from pursuing all rights and remedies
it may have hereunder or at law or in equity with respect to any breach of this Agreement. For clarity, any sums owed to Astellas as a result of any overpayments (for example but not limited to Royalty Adjustments under Section 4.6.2(b) and
payments under Section 10.4.2) that have been rolled over in the form of a credit shall be immediately due and payable on termination. 18.1.2 Disbanding of the Committees. Expiration or termination of this Agreement for any reason shall result in the immediate disbanding and termination of all Committees. 18.2 Rights on Expiration (a) NGX Know-How. Upon the expiration, but not an earlier termination, of this Agreement with respect to a particular country in relation to a particular Product, if Astellas has not entered into direct agreements with Component
suppliers in respect of the Existing Product then Astellas may request that NGX continue to supply Astellas with its requirements for Components in accordance with the Supply Agreement (or Liquid Formulation Products in the event that NGX is
supplying Astellas with such Products), in which event the Parties shall revise the Supply Price (as defined in the Supply Agreement or Liquid Formulation Product supply agreement) to include a reasonable profit for NGX, and Astellas will have a
fully paid-up, non-exclusive license, which includes the right to sublicense, under the NGX Know-How to use, promote, market, sell, offer for sale, import, export and otherwise commercialize the Product within the Field in such country. If the
Parties are unable to agree upon a revised Supply Price or if Astellas has entered into direct agreements with Component suppliers or suppliers of the Liquid Formulation Product, Astellas shall have a paid-up, non-exclusive license, which includes
the right
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to sublicense, under the NGX Know-How to make, have made, use, promote, market, sell, offer for sale, import, export and otherwise commercialize the Product
within the Field in such country. For clarity, Astellas shall retain ownership of all MAA Approvals on expiration of this Agreement. (b) Trademark Rights. Upon the expiration, but not an earlier termination, of this Agreement, Sections 12.1 (first sentence), 12.3, 12.4, 12.6 (provided that Astellas shall be responsible for all costs of filing and maintaining
the registrations in the Territory), 12.7 (provided that Astellas shall be responsible for all costs of recordation), 12.8 and 12.9 above shall survive with respect to such Product and the Product Trademark in such country. Astellas shall have the
right to terminate its license to the Product Trademark with respect to any particular Product in any country upon [***] notice to NGX, in which case this Section 18.2 shall have no further force or effect, with respect to such Product in such
country, from and after the effective date of such termination. (c) Surviving Terms. Upon expiration (but not the
earlier termination) of this Agreement, all rights and obligations of the Parties under this Agreement shall terminate except: (i) Sections 1, 4.3.5 (to the extent the applicable Infringement Action arose from actions occurring prior to
expiration), 7.2.1(b), 4.6 and 10.1-10.3 (with respect to payment obligations accruing prior to expiration and not included in a prior Quarterly Report and Year End Report), 10.4 (for a period of 6 months from the final required royalty report),
11.1.4 (in respect of the NGX License), 11.4.1 (with respect to alleged infringement that occurred prior to the date of expiration of this Agreement), with respect to Costs arising prior to expiration, Astellas'''''''''''''''' rights under Section 11.4.2
to treat such Costs as Third Party Royalties, 11.5 (with respect to Enforcement Actions initiated prior to expiration), 13, 15, 16, 18, 19 and 20, and (ii) those provisions of this Agreement to the extent set forth above in Sections 18.2(a) and
18.2(b) as surviving expiration of this Agreement. 18.3 Rights on Termination of a Product Upon any termination (but not the expiration) of this Agreement with respect to a Product (the “Terminated Product”) pursuant to
Section 17: 18.3.1 Wind-down Period. (a) Development. In the event there are any on-going clinical trials of a Terminated Product in the Territory, at NGX''''''''''''''''s
request, Astellas agrees to either transition such clinical trials to NGX, or to continue for a period not to exceed [***] after such termination to conduct such clinical trials and shall be responsible for the Development Expenses on the same basis
as that in effect immediately prior to termination. In addition, to the extent NGX is then providing Astellas with any development support or services relating to the Terminated Product at the time of such termination, Astellas agrees to compensate
NGX for the FTE''''''''''''''''s actually used by Astellas in respect of such services at NGX''''''''''''''''s rate set out in the relevant development plan.
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(b) Commercialization. At NGX''''''''''''''''s request, Astellas and its Affiliates,
Sublicensees and Subdistributors shall continue to distribute in the same manner the Terminated Product in each country in the Territory for which MAA Approval therefor has been obtained, in accordance with the terms and conditions of this
Agreement, for a period not to exceed [***] from such termination (for purposes of this Section 18.3, the “Wind-down Period”); provided that NGX may after such request terminate such Wind-down Period upon [***] written notice
to Astellas. Notwithstanding any other provision of this Agreement, during the Wind-down Period, Astellas'''''''''''''''', its Affiliates'''''''''''''''', Sublicensees'''''''''''''''' and Subdistributors'''''''''''''''' rights with respect to the Terminated Product shall be non-exclusive,
and NGX shall have the right to engage one or more other distributor(s) and/or Subdistributor(s) of Terminated Products in all or part of the Territory. Sections 3 and 4 shall apply with respect to all Terminated Products sold, used or disposed
by Astellas, its Sublicensees or Affiliates during the Wind-down Period. All rights of Astellas with respect to Terminated Products shall be terminated after the Wind-down Period, and unless otherwise mutually agreed, any Terminated Products that
are not sold after such Wind-down Period shall be destroyed. 18.3.2 Assignment of MAA and MAA Approvals. Astellas
shall assign or cause to be assigned to NGX (or if not so assignable, Astellas shall take all reasonable actions to make available to NGX) all regulatory filings and registrations (including MAAs and MAA Approvals) for such Terminated Product in the
Territory. In each case the foregoing assignment (or availability) shall be made within [***] after termination of this Agreement with respect to such Product. In addition, Astellas shall promptly provide to NGX a copy of all Data pertaining to the
Terminated Product to the extent not previously provided to NGX, which together with the Data provided by Astellas during the term of this Agreement pertaining to the Terminated Product, NGX shall have the right to use and disclose for any purpose
directly relating to the commercialization of the Terminated Product in the Territory during the Wind-down Period and thereafter. 18.3.3 Transition. Astellas shall cooperate with NGX or its designee(s) and use Commercially Reasonable Efforts to effect a smooth and orderly transition in the sale of Terminated Products in the Territory during the Wind-down
Period. Without limiting the foregoing, subject to applicable laws and Third Party rights, Astellas shall provide NGX with copies of customer lists, customer data, Sales Materials and other customer information exclusively relating to the Terminated
Product that are Controlled by Astellas to the extent not previously provided to NGX, which together with such materials provided to NGX during the term of this Agreement, NGX shall have the right to use, disclose, modify, reproduce and distribute
for any purpose directly relating to the commercialization of the Terminated Product in the Territory during the Wind-down Period and thereafter. In addition, Astellas shall refer all inquiries regarding the Terminated Products after the Wind-down
Period to NGX or any newly appointed distributors. 18.3.4 Return of Materials. Within [***] after the end of the
Wind-down Period, Astellas shall destroy all tangible items comprising, bearing or containing trademarks, marks, trade names, patents, copyrights, designs, drawings, formulas or other data, photographs, samples,
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literature, sales and promotional aids (“Product Materials”) and all Confidential Information of NGX, in each case pertaining to the
Terminated Products, that is in Astellas'''''''''''''''' possession, and provide written certification of such destruction, or prepare such tangible items of Promotional Materials and Confidential Information for shipment to NGX, as NGX may direct, at
NGX''''''''''''''''s expense; provided that Astellas may retain and use copies of any such Promotional Materials and Confidential Information that also relate to products (including Products) other than Terminated Products, as reasonably necessary for its
continued promotion, marketing, sale and distribution of such products and non-terminated Products under this Agreement. Effective upon the end of the Wind-down Period, Astellas shall cease to use all trademarks and trade names of NGX with respect
to the Terminated Product in the Territory. 18.3.5 Subdistributors. Any Subdistributors or subdistributors of
Terminated Product in the Territory engaged by Astellas shall, at the request of NGX in its discretion, be assigned to NGX to the furthest extent possible. In the event NGX does not request assignment of such Subdistributors or subdistributors, then
the rights of such Subdistributors or subdistributors with respect to Terminated Product in the Territory shall terminate upon termination of Astellas'''''''''''''''' rights under this Agreement with respect to the Terminated Product. 18.4 Sublicenses If NGX terminates
this Agreement and the Agreement has been sublicensed by Astellas prior to such termination, then NGX shall enter into an agreement directly with such Sublicensee on the terms of this Agreement. 18.5 Rights on Termination of a non-European Union country (under Section 7.1.1) or Region Upon any termination (but not the expiration) of
this Agreement with respect to a particular Region (each, a “Terminated Country” or “Terminated Region”) including pursuant to Section 8.7 or Section 17: 18.5.1 Wind-down Period. (a) Development. In the event there are any on-going clinical trials of Products in a Terminated Country or Terminated Region, at NGX''''''''''''''''s request, Astellas agrees to either transition such clinical trials to
NGX, or to continue for a period not to exceed [***] after such termination to conduct such clinical trials and shall bear the Development Expenses on the same basis as that in effect immediately prior to termination. In addition, to the extent NGX
is then providing Astellas any development support or services relating to Product in the Terminated Country or Terminated Region at the time of such termination, Astellas agrees to compensate NGX for the FTEs actually used by NGX in respect of such
services at NGX''''''''''''''''s rate set out in the relevant development plan.
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(b) Commercialization. At NGX''''''''''''''''s request, Astellas and its Affiliates,
Sublicensees and Subdistributors shall continue to distribute Products in the Terminated Country or all countries of a Terminated Region for which MAA Approval therefor has been obtained, in accordance with the terms and conditions of this
Agreement, for a period not to exceed [***] from such termination (for purposes of this Section 18.4, the “Wind-down Period”); provided that NGX may after such request terminate such Wind-down Period upon [***] written notice
to Astellas. Notwithstanding any other provision of this Agreement, during the Wind-down Period, Astellas, its Affiliates'''''''''''''''', Sublicensees'''''''''''''''' and Subdistributors'''''''''''''''' rights with respect to Products in the Terminated Country or Terminated
Region shall be non-exclusive, and NGX shall have the right to engage one or more other distributor(s) and/or Subdistributor(s) of Products in all or part of the Terminated Country or Terminated Region. Sections 3 and 4 shall apply with respect
to all Products sold, used or disposed in the Terminated Country or Terminated Region by Astellas, its Sublicensees or Affiliates during the Wind-down Period. All rights of Astellas with respect to Products in the Terminated Country or Terminated
Region shall be terminated after the Wind-down Period. 18.5.2 Assignment of MAA and MAA Approvals. Astellas shall
assign or cause to be assigned to NGX (or if not so assignable, Astellas shall take all reasonable actions to make available to NGX) all regulatory filings and registrations (including MAAs and MAA Approvals) for Products in the Terminated Country
or Terminated Region. In each case the foregoing assignment (or availability) shall be made within [***] after termination of this Agreement with respect to such country or Region. In addition, Astellas shall promptly provide to NGX a copy of all
Data pertaining to Products in the Terminated Country or Terminated Region to the extent not previously provided to NGX, which together with the Data provided by Astellas during the term of this Agreement pertaining to the Terminated Country or
Terminated Region, NGX shall have the right to use and disclose for any purpose directly relating to the commercialization of the Terminated Product in the Territory during the Wind-down Period and thereafter. 18.5.3 Transition. Astellas shall cooperate with NGX or its designee(s) and use [***] to effect a smooth and orderly transition in
the sale of Products in the Terminated Country or Terminated Region during the Wind-down Period. Without limiting the foregoing, subject to applicable laws and Third Party rights, Astellas shall provide NGX copies of customer lists, customer data,
Sales Materials and other customer and marketing information that are Controlled by Astellas and exclusively relate to Products in the Terminated Country or Terminated Region to the extent not previously provided to NGX, which together with such
materials provided to NGX during the term of this Agreement, NGX shall have the right to use, disclose, modify, reproduce and distribute for any purpose directly relating to the commercialization of the Terminated Product in the Territory during the
Wind-down Period and thereafter. In addition, Astellas shall refer all inquiries regarding the Products from the Terminated Country or Terminated Region after the Wind-down Period to NGX or any newly appointed distributors.
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18.5.4 Return of Materials. Within [***] after the end of the Wind-down Period,
Astellas shall destroy all Product Materials and Confidential Information of NGX, in each case pertaining to the Terminated Country or Terminated Region, that is in Astellas'''''''''''''''' possession, and provide written certification of such destruction, or
prepare such tangible items of Promotional Materials and Confidential Information for shipment to NGX, as NGX may direct, at NGX''''''''''''''''s expense; provided that Astellas may retain and use copies of any such Promotional Materials and Confidential
Information that also relate to countries or Regions other than the Terminated Country or Terminated Region, as reasonably necessary for its continued promotion, marketing, sale and distribution of products (including Products) in such
non-terminated countries and Regions under this Agreement. Effective upon the end of the Wind-down Period, Astellas shall cease to use all trademarks and trade names of NGX in the Terminated Country or Terminated Region. 18.5.5 Subdistributors. Any Subdistributors of Products in the Terminated Country or Terminated Region engaged by Astellas shall,
at the request of NGX in its discretion, be assigned to NGX to the furthest extent possible. In the event NGX does not request assignment of such Subdistributors, then the rights of such Subdistributors with respect to Products in the Terminated
Country or Terminated Region shall terminate upon termination of Astellas'''''''''''''''' rights with respect to such Terminated Country or Terminated Region. 18.6 Rights on Termination of this Agreement The termination of this Agreement in whole shall be
treated a termination of this Agreement with respect to all Products and all Regions, and Sections 18.3 and 18.5 above shall apply to all Products and all Regions, each of which shall be deemed Terminated Products and Terminated Regions,
respectively. 18.7 No Renewal, Extension or Waiver Acceptance of any order from, or sale or license of, any Product to Astellas after the effective date of termination or expiration of this Agreement shall not be construed as a renewal or extension hereof, or as a
waiver of termination of this Agreement. 18.8 Survival Upon termination (but not expiration) of this Agreement in whole, all rights and obligations of the Parties under this Agreement shall terminate except:
(a) Sections 1, 2.5.6 and 4.3.5 to the extent the applicable Infringement Action arose from actions occurring prior to termination, 7.2.1(b), 4.6 and 10.1-10.3 (with respect to payment obligations accruing prior to termination and not
included in a prior Quarterly Report and Year End Report), 10.4 (for a period of 6 months from the final required royalty report), 11.1.4 (in respect of the NGX License), 11.4.1 (with respect to alleged infringement that occurred prior to the later
of the date of termination of this Agreement or the end
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of the Wind-down Period), with respect to Costs arising prior to termination, Astellas'''''''''''''''' rights under Section 11.4.2 to treat such Costs as Third
Party Royalties, 11.5 (with respect to Enforcement Actions initiated prior to termination), 12.8 (with respect to Astellas'''''''''''''''' obligations to assign back to NGX any Domain Names assigned to Astellas), 12.11, 13, 15, 16.1 and 16.2 (with respect to
actions occurring prior to the later of termination of this Agreement or the end of the Wind-down Period), 16.3 -16.5, 18, 19 and 20, and (b) those provisions of this Agreement to the extent set forth above in this Section 18 as surviving
during the Wind-down Period or after termination of this Agreement. For clarity, in the event this Agreement is terminated with respect to one or more countries or Regions, but not the entire Territory, then the affected country or Region shall
thereafter cease to be within the Territory for all purposes of this Agreement, but Sections 11.4 (with respect to alleged infringement occurring prior to the later of such termination or the end of the Wind-down Period in such country or
Region), 11.5 (with respect to Enforcement Actions for infringement if such infringement occurred prior to such termination), shall survive such termination with respect to such affected country or Region. 18.9 Rights in Bankruptcy All
rights and licenses granted under or pursuant to this Agreement by NGX are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under
Section 101 of the U.S.Bankruptcy Code. The Parties agree that Astellas, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S.Bankruptcy Code. The Parties further
agree that, in the event of the commencement of a bankruptcy proceeding by or against NGX under the U.S. Bankruptcy Code, which results in NGX''''''''''''''''s rejection of this Agreement, Astellas shall be entitled to (a) retain ownership of all MAA
Approvals and (b) a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in Astellas'''''''''''''''' possession, shall be promptly delivered
upon written request therefor by Astellas. 19. DISPUTE RESOLUTION 19.1 Disputes In the event of any
dispute between the Parties arising out of or in connection with this Agreement, either Party may, by written notice to the other, have such dispute referred to the [***] for attempted resolution by good faith negotiations within [***] after such
notice is received, and, in such event, each Party shall cause its representative to meet and be available to attempt to resolve such issue. Notwithstanding the foregoing, neither Party shall be obligated to negotiate for more than [***]. If the
Parties should resolve such dispute or claim, a memorandum setting forth their agreement will be prepared and signed by both Parties if requested by either Party.
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19.2 Arbitration Any dispute, controversy or claim with respect to the breach, interpretation or enforcement of this Agreement, including disputes relating to termination of this Agreement that cannot be resolved pursuant to
Section 19.1 (or which this Agreement directs shall be resolved pursuant to this Section 19.2) shall be settled by binding arbitration in the manner described in this Section 19. The arbitration shall be conducted by the [***] under
its rules of arbitration then in effect. Notwithstanding those rules, the following provisions shall apply to the arbitration hereunder: 19.2.1 Arbitrators. The arbitration shall be conducted by a single [***] arbitrator; provided that at the request of either Party, the arbitration shall be conducted by a panel of three (3) arbitrators,
with one (1) [***] arbitrator chosen by each of Astellas and NGX and the third appointed by the other two (2) arbitrators. If the Parties are unable to agree upon a single arbitrator, or the other two arbitrators are unable to agree upon
the third arbitrator in case of a panel of three (3), such single or third arbitrator (as the case may be) shall be appointed in accordance with the rules of [***]. In any event, the arbitrator or arbitrators selected in accordance with this
Section 19.2.1 are referred to herein as the “Panel” and shall be comprised of arbitrators who are familiar with worldwide research and business development in the pharmaceutical industry, unless otherwise agreed.
19.2.2 Proceedings. Except as otherwise provided herein, the Parties and the arbitrators shall use their best efforts to
complete the arbitration within [***] after the appointment of the Panel under Section 19.2.1 above, unless a Party can demonstrate to the Panel that the complexity of the issues or other reasons warrant the extension of one or more of the time
tables. In such case, the Panel may extend such time table as reasonably required. The Panel shall, in rendering its decision, apply the substantive law of the [***], without regard to its conflicts of laws provisions, except that the interpretation
and enforcement of this Section 19 shall be governed by the [***]. The proceeding shall take place in [***]. The arbitral proceedings and all pleadings, responses and evidence shall be in the English language. If so requested by the
arbitrator(s), any evidence originally in a language other than English shall be submitted with an English translation accompanied by an original or true copy thereof. The decision and/or award rendered by the arbitrator(s) shall be written, final
and non-appealable, and judgment on such decision and/or award may be entered in any court of competent jurisdiction. If the Panel determines that it is reasonable to do so, the fees of the Panel shall be paid by the losing Party, which Party shall
be designated by the Panel. Otherwise, the fees of the Panel shall be split equally between the Parties. Each Party shall bear the costs of its own attorneys'''''''''''''''' and experts'''''''''''''''' fees; provided that the Panel may in its discretion award the
prevailing Party all or part of the costs and expenses incurred by the prevailing Party in connection with the arbitration proceedings. 19.2.3 Interim Relief. Notwithstanding anything in this Section 19.2 to the contrary, Astellas and NGX shall each have the right to apply to any court of competent jurisdiction for a temporary restraining
order, preliminary injunction or other similar interim or
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conservatory relief, as necessary, pending resolution under the above described arbitration procedures. Nothing in the preceding sentence shall be
interpreted as limiting the powers of the arbitrators with respect to any dispute subject to arbitration under this Agreement. The Panel may award injunctive relief. 20. MISCELLANEOUS 20.1 Governing Law This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with, the laws
of the [***], without reference to conflicts of laws principles. [***] shall not apply to this Agreement. 20.2 Force Majeure
Nonperformance of any Party, except for failure to pay amounts due hereunder, shall be excused to the extent that performance is rendered
impossible by fire, strike (other than of their own workforce), earthquake, flood, acts of terrorism, governmental acts or orders or restrictions, failure of suppliers, or any other reason where failure to perform is beyond the reasonable control of
the nonperforming Party. In such event Astellas or NGX, as the case may be, shall promptly notify the other Party of such inability and of the period for which such inability is anticipated to continue. Without limiting the foregoing, the Party
subject to such inability shall use reasonable efforts to minimize the duration of the impact of any force majeure event on its performance hereunder. 20.3 No Implied Waivers; Rights Cumulative No failure on the part of NGX or Astellas to exercise
and no delay in exercising any right 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, nor shall any partial exercise of any such right preclude any
other or further exercise thereof or the exercise of any other right. 20.4 Independent Contractors Nothing contained in this Agreement is intended implicitly, or is to be construed, to constitute NGX or Astellas as partners in the legal sense. No Party
hereto shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of any other Party or to bind any other Party to any contract, agreement or undertaking with any Third Party. This Agreement
does not create a partnership for USA federal income tax purposes (as defined in Section 761 of the USA Internal Revenue Code), for any USA state or local jurisdiction, or in any country other than the USA. Therefore there is no requirement to
file Form 1065, USA Partnership Return of Income, any similar USA state or local income tax return, or any similar document with tax authorities in any country other than the USA.
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20.5 Notices Any notice required or permitted to be given hereunder shall be in writing and shall be delivered in person, by a nationally recognized overnight courier, or by facsimile (receipt confirmed), to the addresses given
below or such other addresses as may be designated in writing by the Parties from time to time during the Term, and shall be deemed to have been given when received unless otherwise specified herein as when sent.
Astellas:
Astellas Pharma Europe Limited
[***]
[***]
NGX:
NeurogesX Inc.
[***]
with a copy to:
[***]
20.6 Assignment This Agreement shall not be assignable by either Party to any Third Party without the written consent of the other Party hereto; except either Party may
assign this Agreement without the other Party''''''''''''''''s consent to an entity that acquires substantially all of the business or assets of the assigning Party, in each case whether by merger, acquisition, or otherwise, provided the acquiring Party
assumes this Agreement in writing or by operation of law. In addition, either Party shall have the right to assign this Agreement to an Affiliate upon notice to the non-assigning Party; provided that the assigning Party guarantees the performance of
this Agreement by such Affiliate, and further provided that if the non-assigning Party reasonably believes such assignment could result in material adverse tax consequences to the non-assigning Party, such assignment shall not be made without the
non assigning Party''''''''''''''''s consent. 20.7 Modification No amendment or modification of any provision of this Agreement shall be effective unless in writing signed by all Parties hereto. No provision of this
Agreement shall be varied, contradicted or explained by any oral agreement, course of dealing or performance or any other matter not set forth in an agreement in writing and signed by all Parties. 20.8 Severability If any provision
hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other
provisions hereof shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability
shall not affect the validity, legality or enforceability of such provision in any other jurisdiction.
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20.9 Publicity Review Neither Party shall originate any written publicity, news release or other announcement or statement relating to the announcement or terms of this
Agreement (collectively, a “Written Disclosure”), without the prior review and written approval of the other Party, which approval shall not be unreasonably withheld, delayed or conditioned. Notwithstanding the foregoing, either
Party may make any public Written Disclosure it believes in good faith based upon the advice of counsel is required by applicable law, rule or regulation or any listing or trading agreement concerning its or its Affiliates'''''''''''''''' publicly traded
securities; provided, however, that such Written Disclosure shall minimize to the extent possible the financial information disclosed, and that prior to making such Written Disclosure, the disclosing Party shall provide to the other Party a copy of
the materials proposed to be disclosed and provide the receiving Party with an opportunity to promptly review the Written Disclosure. Notwithstanding the foregoing, the Parties have agreed upon a joint press release to announce the execution of this
Agreement, together with a corresponding Question & Answer outline for use in responding to inquiries about the Agreement which is at Exhibit 20.9; thereafter, Astellas and NGX may each disclose the information contained in such
press release and Question & Answer outline without the need for further approval by the other. In addition, notwithstanding anything to the contrary, each Party shall have the right to disclose the existence and terms of this Agreement as
required by law; or as advisable or required in connection with any government or regulatory filings, including without limitation filings with the U.S. Security and Exchange Commission provided that NGX provides Astellas with a reasonable period to
review the redactions of any confidential information prior to submission to the U.S. Security and Exchange Commission; or under reasonable obligations of confidentiality to its financial, legal and other advisors, auditors, potential or actual
investors, acquisition partners, and others on a need to know basis. 20.10 Counterparts This Agreement may be executed in two counterparts, each of which shall be deemed an original, and all of which together, shall constitute one and the
same instrument. 20.11 Headings Headings used herein are for convenience only and shall not in any way affect the construction of or be taken into consideration in interpreting this Agreement.
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20.12 Export Laws Notwithstanding anything to the contrary contained herein, all obligations of NGX and Astellas are subject to prior compliance with United States and foreign export regulations and such other United States and foreign
laws and regulations as may be applicable, and to obtaining all necessary approvals required by the applicable agencies of the governments of the United States and foreign jurisdictions. NGX and Astellas shall cooperate with each other and shall
provide assistance to the other as reasonably necessary to obtain any required approvals. 20.13 Entire Agreement This Agreement, together with all the Exhibits thereto, constitute the entire agreement, both written or oral, with respect to the subject matter hereof,
and supersede all prior or contemporaneous understandings or agreements, whether written or oral, between NGX and Astellas with respect to such subject matter. [signatures on next page]
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IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed and delivered in
duplicate originals as of the date first above written.
NEUROGESX, INC.
ASTELLAS PHARMA EUROPE LIMITED
By:
/s/ Anthony A. DiTonno
By:
/s/ Masao Yoshida
Name:
Anthony A. DiTonno
Name:
Masao Yoshida
Title:
President and Chief Executive Officer
Title:
President and Chief Executive Officer
EXHIBIT 1.3 [***] ***Certain information on this page has been omitted and filed separately with the Commission. Confidential
treatment has been requested with respect to the omitted portions.
EXHIBIT 1.26 KEY METRICS [***] ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
EXHIBIT 1.32 LTS AGREEMENT
[***]CERTAIN INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. COMMERCIAL SUPPLY AND LICENSE AGREEMENT This COMMERCIAL SUPPLY AND LICENSE AGREEMENT (this “Agreement”), is entered into as of
day of January, 2007 (“Effective Date”) by and between NeurogesX Inc., a California corporation with its
principal place of business at San Carlos Business Park, 981F Industrial Road, San Carlos, CA 94070, USA (“NeurogesX”) and LTS Lohmann Therapie-Systeme AG, a company existing under the laws of Germany and having its head office at Lohmannstraße 2, D-56626 Andernach, Germany
(“LTS”). Each of NeurogesX and LTS shall be a “Party,” and together shall be referred to as the “Parties.” RECITALS WHEREAS, NeurogesX and LTS
have previously entered into a Memorandum of Understanding dated May 29, 2001 (“MOU”) and a Clinical Supply, Development and License Agreement dated January 15, 2004 (“Clinical Supply Agreement”), pursuant to which the
Parties cooperated on the development of a Patch (as defined below) and LTS supplied Patches to NeurogesX for clinical trial purposes; WHEREAS, NeurogesX is in the process of seeking Marketing Approval (as herein defined) for and desires to commercialize the Patch, by itself or with its Sublicensees; WHEREAS, LTS is in the business of, and possesses the knowledge, technology, expertise and capacity, for manufacturing commercial supplies of transdermal
products, including, but not limited to the Patch; and WHEREAS, NeurogesX desires to engage LTS to exclusively manufacture and supply
NeurogesX''''''''''''''''s requirements for the Patch, and LTS desires to exclusively manufacture and supply such requirements for NeurogesX, in accordance with the terms and conditions of this Agreement. NOW THEREFORE, in consideration of the mutual agreements and covenants herein contained and intending to be legally bound thereby, NeurogesX and LTS
agree as follows: AGREEMENT ARTICLE 1 DEFINITIONS As used herein, the following terms will have the meanings set forth below: 1.1 “Active
Ingredient” means the active pharmaceutical ingredient capsaicin meeting the Specifications therefor. The specifications for the Active Ingredient as of the Effective Date are attached as Exhibit D hereto.
1.2 “Affiliates” of an entity means the other entities that control, are under common control
or are controlled by the subject entity. For purposes of this definition, an entity shall be regarded as in control of another entity if it owns or controls fifty percent (50%) or more of the shares of the subject entity entitled to vote in the
election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority). 1.3 “Batch Size” means the quantity of Patches produced from a [***] production run as established in accordance with Section 2.4(a). 1.4 “Blocking Patent” means an issued patent or similar intellectual property right (e.g., utility model) of a third party, not licensed to either Party, which would in the reasonable opinion of a
Party''''''''''''''''s counsel be infringed by (a) the manufacture or sale of the Patch by the Parties in accordance with the terms of this Agreement, or (b) any or all uses of the Patch, in a particular jurisdiction. 1.5 “Calendar Quarter” shall mean the calendar quarters of the year beginning first of January, April, July and October. 1.6 “Commercialization Patents” means patents anywhere in the world owned or Controlled by LTS covering or claiming any subject matter which is
incorporated into, or utilized as part of the operation of, the Patches, any method of use of the Patches, or otherwise which is necessary for the sale, distribution, marketing and/or commercialization of the Patches supplied to NeurogesX hereunder,
including but not limited to the patents listed in Exhibit H. 1.7 “Control” means, with respect to any patent or other
intellectual property right, the possession at any time during the term of this Agreement of the right or power of a Party to grant licenses under such patent or other intellectual property right within the scope set forth herein without violating
the terms of any of such Party''''''''''''''''s agreements with non-Affiliate third parties. 1.8 “Current GMP,” or “cGMP” means
then current Good Manufacturing Practices promulgated by the United States Food & Drug Administration (FDA) and its counterpart governmental agencies in the Territory outside the United States, in the form of laws, regulations or guidance
documents, including those practices and standards set forth in Current Good Manufacturing Practice Regulations of the US Code of Federal Regulations Title 21 (21 CFR §§210 and 211) in relation to the production of pharmaceutical products
and those practices and standards provided for (as amended from time to time) in the European Community Directive 91/356/EEC, as interpreted by the ICH Harmonized Tripartite Guideline, and any arrangements, additions or clarifications agreed from
time to time between the Parties. 1.9 “Defect” or “Defective” when applied to Patches means the failure of such
Patches to meet the warranty set forth in Section 8.2. 1.10 “Ex Works” shall have the meaning as set forth in the Incoterms
2000. 1.11 “Facility” means LTS'''''''''''''''' cGMP manufacturing facility for the Patches located at [***]. In the event the Parties
qualify a second source for the Patches pursuant to Section 4.5 below, then the term “Facility” shall also mean LTS'''''''''''''''' cGMP manufacturing facility for such second source.
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1.12 “Field” has the meaning as set forth in Section 6.3. 1.13 “Kit” means the commercial product form sold by NeurogesX, its Affiliates or Sublicensees of which the Patch(es) is a component.
1.14 “Launch Team” has the meaning as set forth in Section 4.1. 1.15 “Manufacturing Cost” shall mean the [***], in each case incurred by LTS during and allocable to the manufacture of Patches hereunder, and
[***] incurred by LTS in implementing new GMP requirements requested by NeurogesX hereunder, which are not otherwise paid for or reimbursed by NeurogesX, all calculated in accordance with Generally Accepted Accounting Principles in the United States
(“GAAP”) or its equivalent in Germany. 1.16 “Marketing Approval” means all approvals, registrations or authorizations
of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport and sale of Patches in a regulatory jurisdiction. 1.17 “Maximum Capacity” means NeurogesX''''''''''''''''s forecast of the maximum quantities of Patches that NeurogesX may require be supplied from LTS by
NeurogesX, its Affiliates or Sublicensees, per year of the term of this Agreement, as set forth on Exhibit G hereto. Such forecast may be amended from time to time in accordance with Section 3.4(d). It is understood that the Maximum Capacity is
not a commitment by NeurogesX to purchase such amounts from LTS hereunder 1.18 “Net Sales” means the [***] sold by NeurogesX,
its Affiliates or Sublicensees to a non-Affiliate third party in bona-fide, arms-length transactions, after deducting (to the extent actually incurred and to the extent not already deducted in the amount invoiced) (a) [***] determined in
accordance with GAAP (as defined in Section 1.15), consistently applied. If mutually agreed in writing by the Parties, some or all
such items may be [***] and subsequently adjusted. The Parties agree that items (b) and (f) above may be [***] and subsequently adjusted as part of customary practice in accordance with GAAP. If a Kit is sold for consideration other than
solely cash, the value of such other consideration attributable to the sale of the Kit shall be included in calculating Net Sales. In the event Kit is sold among NeurogesX and its Affiliates or Sublicensees for resale, Net Sales shall include the
amounts invoiced by such entities to third parties on the resale, but not the amounts invoiced among such entities prior to the resale. Net Sales shall not include any sales of Kits as [***] NeurogesX, its Affiliates or Sublicensees.
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1.19 “Patch” or “Patches” means the TTS containing the Active Ingredient developed by
the Parties under the MOU and the Clinical Supply Agreement. 1.20 “Patch Regulatory Information” means any and all information
in the possession of LTS relating to the Patches, as reasonably necessary for NeurogesX''''''''''''''''s, its Affiliates'''''''''''''''' and Sublicensees'''''''''''''''' efforts to file for, obtain or maintain Marketing Approvals for the Patch in any regulatory jurisdiction,
including without limitation (a) such information as is required for the Chemistry, Manufacturing and Controls (CMC) section of an Investigational New Drug application (IND) or New Drug Application (NDA) for the Patches, (b) all data
regarding stability, storage conditions and shelf life of Patches, and (c) all data reasonably required to qualify a manufacturing facility for the Patches under Regulatory Requirements or demonstrate compliance with cGMP. 1.21 “Quality Assurance Agreement” means the then-current quality assurance procedures as mutually agreed upon by the Parties in writing. The
template of Quality Assurance Agreement as of the Effective Date is attached as Exhibit E. The Parties agree that the commercial supply of Patches by LTS hereunder is subject to the Parties entering into a Quality Assurance Agreement, which the
Parties shall use good faith efforts to conclude at least three (3) months prior to the first delivery of Patches by LTS hereunder. Thereafter, the Parties shall update the Quality Assurance Agreement from time to time to reflect best practice
at such time. 1.22 “Raw Materials” means the Active Ingredient, excipients, components, labels, primary packaging material and
shipping containers, necessary for the manufacturing, processing and primary packaging of the Patch as set forth in the master batch record for the Patch. 1.23 “Reasonable Commercial Efforts” of a Party means [***]. 1.24 “Regulatory
Requirements” means all laws, regulations and other legal requirements applicable to the manufacture of Patches or components thereof, including without limitation cGMP, FDA regulations, ICH guidelines, any applicable local laws and regulations
in the place of manufacture, storage and handling, and any requirements set forth in any IND, NDA, applications for Marketing Approval and other regulatory filings or approvals for the Patches in the Territory. 1.25 “Specifications” means the specifications for the Patch (including the components thereof) as set forth in the Marketing Approval for the
Patch, as amended, clarified or supplemented from time to time upon mutual agreement of the Parties in writing. The Specifications for the Patch as of the Effective Date is attached as Exhibit C. For clarity, in the event there are different
Specifications set forth in the Marketing Approvals for different countries, the applicable Specifications shall be as set forth in the Marketing Approval for the country identified by NeurogesX or its designee on the purchase order for the Patch.
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1.26 “Sublicensees” means a non-Affiliate third party to whom NeurogesX has granted
(i) the right to market and sell Patches purchased from LTS under this Agreement, provided that such third party has [***] responsibility for and has the right to [***] the marketing and promotion of such Patches in its distribution territory
and the right to [***] of such Patches for its own account, or (ii) the right to make (to the extent NeurogesX has the right to do so pursuant to Section 6.4 below) and sell a Patch, with respect to Patches that are manufactured and then
sold by such third party pursuant to the license set forth in Section 6.4 below. For the [***], wholesalers, distributors or specialty distributors, but shall include [***] of NeurogesX for the Patches 1.27 “Territory” means the [***]. In addition, the Territory may be extended by NeurogesX to include additional countries and/or regulatory
jurisdictions in accordance with Section 3.4(c) below. 1.28 “Transfer Price” has the meaning as set forth in
Section 5.1 below. 1.29 “TTS” means transdermal therapeutic patches, including but not limited to liquid reservoir patches,
microreservoir patches, monolithic layer patches, or other patch products for delivering drugs topically. 1.30 “VR1-Ligand”
means any compound that bind to the vanilloid receptor subtype 1, as further described in Exhibit B. The Parties may amend Exhibit B from time to time upon mutual written agreement. ARTICLE 2 SUPPLY OF PATCHES 2.1 Supply of NeurogesX''''''''''''''''s Requirements. (a) Commercial Requirements. Subject to the terms and conditions of this Agreement, LTS shall manufacture and supply NeurogesX with all of NeurogesX''''''''''''''''s commercial requirements for Patches worldwide up to the Maximum Capacity for each
year, and shall use [***] to manufacture and supply NeurogesX with any of NeurogesX''''''''''''''''s commercial requirements exceeding the Maximum Capacity for each year. Subject to the terms and conditions of this Agreement, NeurogesX shall purchase all of
its commercial requirements for Patches worldwide from LTS. (b) Sublicensees. To the extent NeurogesX authorizes a Sublicensee to purchase
directly from LTS, LTS agrees to supply the commercial requirements for Patches of such Sublicensee subject to the Maximum Capacity in accordance with this Agreement, in the manner authorized by NeurogesX. (c) Clinical Supplies. NeurogesX and its designees may continue to purchase units of Patches for clinical trial purposes under the Clinical Supply
Agreement, provided that such units shall be designated as clinical supplies at the time of order. Unless otherwise designated, all
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orders for Patches submitted by NeurogesX and its designees after the First Forecast provided under Section 2.2 below shall be deemed orders for Patches
under this Agreement. To the extent LTS becomes aware that any Raw Materials or works-in-progress procured or made under this Agreement may be used to reduce the cost or price of units of Patches ordered under the Clinical Supply Agreement, LTS
shall notify NeurogesX and the Parties shall negotiate in good faith to so use such Raw Materials and works-in-progress and correspondingly reduce the price to NeurogesX of such units under the Clinical Supply Agreement. It is understood that this
Section 2.1(c) is not intended to prevent NeurogesX from using any supplies of Patches in its inventory that may have been purchased under this Agreement, for clinical trial purposes, provided however, that NeurogesX shall act in accordance
with all applicable laws and regulations. 2.2 First Forecast NeurogesX will provide LTS with a written forecast of the number of Patches
which will be required to be delivered during the first year following the first projected delivery hereunder (the “First Forecast”), at least [***] prior to the beginning of the Calendar Quarter in which the first delivery of Patches by
LTS is projected to occur. This First Forecast shall contain an estimate of the number of Patches required to be delivered, on a monthly basis, for such Calendar Quarter and the [***] three (3) Calendar Quarters. It is understood that only the
first Calendar Quarter of the First Forecast shall be binding on the Parties, and the subsequent Calendar Quarters in the First Forecast shall be non-binding for both Parties. NeurogesX agrees that the first Calendar Quarter in the first Rolling
Forecast (as defined below) shall specify the same quantities as specified in the first Calendar Quarter in the First Forecast. 2.3
Rolling Forecast. Each subsequent written forecast (each a “Rolling Forecast”) shall update the prior forecast, and will be provided by NeurogesX [***] prior to the beginning of each Calendar Quarter in which Patches are required to be
delivered. Each Rolling Forecast shall include an estimate of requirements on a monthly basis for such Calendar Quarter and the [***] three (3) Calendar Quarters, so that estimates for a rolling one (1) year period are always provided. The
Parties agree that only the first Calendar Quarter in each Rolling Forecast shall be binding on the Parties, as set forth in Section 2.4 below (quantities set forth in such first Calendar Quarter, the “Binding Quantities”). The
quantities forecasted for subsequent Calendar Quarters in such forecasts shall be non-binding for both Parties 2.4 Purchase Orders.
(a) Orders. NeurogesX shall place orders for quantities of Patches, on a [***] basis, [***] days before the month in which delivery of such
Patches is requested (the “Delivery Month”). For example, [***]. Each order shall specify the requested delivery date(s) within the Delivery Month, the shipping destination(s) and any shipping instructions. Unless otherwise agreed, the
quantities specified in each order shall be a [***] of the Batch Size. NeurogesX shall ensure that such orders, aggregated on a Calendar Quarter basis, specify a quantity of Patches to be delivered in such Calendar Quarter that is at least [***] of
the Binding Quantities for such Calendar Quarter. The Parties agree to use good faith efforts to establish the Batch Size by mutual written agreement after manufacture of the first [***] batches of Product based on actual batch sizes for production
hereunder; provided unfit such time the Batch Size for purposes of this Agreement shall be deemed to be the Theoretical Batch Size set forth in Exhibit A.
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(b) Acceptance. LTS shall accept and fill all orders from NeurogesX for quantities of Product, subject to
the terms and conditions of this Agreement, provided that LTS shall not be obligated to accept orders to the extent the quantity for delivery in a particular Calendar Quarter exceeds [***] of the Binding Quantities for such Calendar Quarter. In
addition, the exact delivery dates within the Delivery Month shall be subject to acceptance by LTS, which acceptance shall not be unreasonably withheld. In the event LTS does not accept a delivery date requested by NeurogesX, the Parties shall
mutually agree to a delivery date which is as close as reasonable to the delivery date requested by NeurogesX (but not more than [***] weeks before or after the requested delivery date). Any objection to the delivery date or the quantities or other
aspects of an order must be submitted by LTS within [***] days of receipt of the order from NeurogesX, or such order shall be deemed fully accepted. After acceptance of an order, such order shall be deemed a “Firm Order,” and the accepted
or agreed delivery date, the “Scheduled Delivery Date”. (c) Excess Quantities. LTS shall use [***] to accept and fill orders for
any quantities of Patches for delivery in a Calendar Quarter exceeding [***] of the Binding Quantities for such Calendar Quarter, on the requested delivery dates (“Excess Orders”). In the event LTS is unable to accept or fill any Excess
Orders despite using [***], LTS shall notify NeurogesX as soon as practicable, and such inability shall not be deemed a material breach of this Agreement entitling NeurogesX to terminate this Agreement nor a Failure Event under Section 6.4
below. LTS shall provide NeurogesX a Scheduled Delivery Date for Excess Orders within [***] days after receiving an Excess Order. 2.5
Packaging. Patches shall be shipped packaged in containers in accordance with the Quality Assurance Agreement, Exhibit E or as otherwise agreed by the Parties hereto in writing. Each such container shall be individually labeled with a description of
its contents, including the manufacturer lot number, quantity of Patches, and the date of manufacture. 2.6 Delivery. Subject to the terms
and conditions of this Agreement, including Section 2.8 below, LTS shall deliver quantities of Patches [***] on the Scheduled Delivery Dates. All Patches for delivery will be placed at the disposal of NeurogesX or its designee at the relevant
LTS manufacturing Facility. Title and risk of loss, delay or damage to the Patches in transit shall pass to NeurogesX [***]. Unless NeurogesX requests otherwise, all Patches shall be packed for shipment and storage fit for the respective way of
transportation and in compliance with any requirements set forth in the Quality Assurance Agreement. In the event NeurogesX has any special freight packaging or shipping instructions, it shall notify LTS and LTS will use [***] to comply with any
such instructions. All costs associated with such instructions shall be borne by [***]. [***] shall bear all costs of freight, shipping and insurance as well as indirect taxes, including import, customs, excise and sales taxes but not income taxes
related to the sale and purchase of Patches hereunder.
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2.7 Refusal to Supply. LTS, after good faith consultation with NeurogesX for at least [***] days, may
refuse to supply Patches in a particular country, if LTS can reasonably demonstrate by evidence prepared or corroborated by an expert (recognized in the industry and having substantial experience in matters of public safety and toxicollogy) that the
proper sale, distribution and use of the Patch hereunder is likely to unreasonably endanger the public health. 2.8 Invoicing; Payment. LTS
shall submit an invoice to NeurogesX upon shipment of the Patches ordered by NeurogesX hereunder. All invoices shall be sent to the address specified in the purchase order, and each such invoice shall state the aggregate and unit Transfer Price for
Patches in a given shipment, plus any insurance, taxes or other costs incident to the purchase or shipment initially paid by LTS but to be borne by NeurogesX hereunder. 2.9 Late delivery. For purpose of this Agreement, delivery within [***] business days before or [***] business days after the Scheduled Delivery Date shall be deemed meeting such delivery date; provided that it is
understood LTS is only obligated to employ Reasonable Commercial Efforts to meet the requested delivery dates for Excess Orders. In the event that LTS does not deliver the ordered Patches within such a seven (7) business day window (i.e. [***]
days before or [***] days after), then NeurogesX shall, as its sole remedy for LTS being late with its delivery of Patches within the time periods set forth in clause (a) and (b) below, have the right to reduce its payment of the Transfer
Price for such Patches by: (a) [***] if NeurogesX receives the Patches between [***] days and [***] days after the Scheduled Delivery Date; or (b) [***] if NeurogesX receives the Patches later than [***] days after the Scheduled Delivery
Date. In the event NeurogesX does not receive the Patches within [***] days after the Scheduled Delivery Date, then in addition to reduction of payment of the Transfer Price set forth in clause (b) above, NeurogesX shall be entitled to deem
such delivery as having been ordered but never made, for purposes of determining a Failure to Supply under Section 6.4(a) below. For the purpose of this Section 2.9, a “business day” shall exclude a weekend day or a public
holiday in Germany or regional legal holiday at the Facility where the Patch is manufactured and those days where LTS is closed down in the regular course of business, e.g. between Christmas and New Year. 2.10 Correct Quantities. In the event LTS delivers at least [***] of the order and not more than [***], LTS shall be deemed to have delivered the ordered
quantities of Patches. It is understood that NeurogesX shall however only pay for the Patches it actually received, but not more than [***] of the applicable order, and only the actual number of Patches ordered and received shall be used to
determine whether or not LTS has supplied [***] as the case may be, of the Binding Quantities under Section 6.4(a)(i)(1) below. 2.11
Letter of Credit. In the event NeurogesX has not paid the Transfer Price for [***] shipment of Patches, which payment is not disputed by NeurogesX and is overdue for [***] or more days, and such failure to pay adds to a total amount of [***] or
more, then upon LTS'''''''''''''''' reasonable request, NeurogesX shall cause to be delivered to LTS a confirmed letter of credit from an international bank (reasonably acceptable to LTS) at that point in time to secure its obligations hereunder to pay the
Transfer Price for any subsequent order of Patches, on terms and conditions reasonable and customary for such arrangements. NeurogesX shall maintain such letter of credit in effect until it has paid such outstanding overdue amount for the Transfer
Prices.
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2.12 Cancellation. Subject to the reimbursement set forth in Sections 2.14(a) and 2.14(b) below, it is
understood and agreed that NeurogesX may cancel an outstanding order by so notifying LTS in writing, provided LTS receives such notification at least [***] days prior to the Scheduled Delivery Date, and provided further that no more than one Firm
Order shall be cancelled by NeurogesX during a consecutive [***] month period unless otherwise mutually agreed. 2.13 Artwork and Text. The
artwork and text required to be printed on the primary Patch packaging and reasonably approved by LTS as to technical feasibility shall be furnished to LTS by NeurogesX or its licensees as soon as reasonably practicable within [***] months prior to
the first delivery of Patches hereunder, it being understood that LTS shall not be liable (including but not limited to the remedies foreseen pursuant to Section 6.4 hereof) for any complications or delivery failures resulting from delays in
the delivery of artwork and text by NeurogesX (or its designee). Any change to the artwork and text of the primary Patch packaging
reasonably requested by NeurogesX or its Sublicensees or required by any regulatory authority shall be communicated by NeurogesX to LTS in writing together with suitable samples of the revised artwork or text no later than [***] months prior to the
first delivery of Patches with such new primary Patch packaging. NeurogesX shall reimburse LTS for any packaging materials that can no longer be used as a result of any such change up to a maximum of [***] months inventory of such materials.
Provided that NeurogesX shall communicate such changes in the artwork and LTS has given its reasonable consent to such changes with a lead time of not less than [***] days, such changes shall not affect or modify the lead times for the supplies
pursuant to Section 2.4. 2.14 Raw Materials. All Raw Materials, other than the Active Ingredient, to be used in the manufacture of
the Patch shall be purchased by [***] at its own expense. LTS shall be responsible for testing and releasing all such Raw Materials in accordance with the Specifications, the Quality Assurance Agreement and all Regulatory Requirements.
In the event [***] orders or purchases appropriate quantities of Raw Materials in order to be able to supply the Patches as forecasted in the most
current [***] month period in the Rolling Forecast, as defined in Section 2.3, and has paid or has incurred a non-cancelable commitment to pay for such Raw Materials, and (A) [***] (i) cancels such orders pursuant to
Section 2.12; (ii) changes the forecasted quantities subject to the terms of this Agreement; or (iii) does not place orders in the amounts forecasted in such [***] month forecast; or (B) the Specifications or the artwork has
changed after the Raw Materials have been purchased or ordered, then: (a) such Raw Materials and any works-in-progress may, in a manner to
be reasonably agreed between LTS and NeurogesX, be kept in storage by LTS for future production of the Patches hereunder, provided that NeurogesX shall reimburse LTS for all costs and expenses associated with such storage; or
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(b) in the event such storage is not practicable or such Raw Materials become obsolete or unusable due to
one or more of the events specified under (i) – (iv) above or the Parties do not agree on the manner or compensation for such storage, NeurogesX shall reimburse LTS for all documented out-of-pocket costs and expenses incurred by LTS
for such Raw Materials (other than the Active Ingredient) and those reasonable costs and expenses incurred by LTS to produce the works-in-progress, which in each case, cannot be used by LTS for manufacturing Patches and cannot be used by LTS in the
manufacture of products for its other clients. NeurogesX may then, at its option upon prior written notice to LTS, take ownership of such Raw Materials and works-in-progress, it being understood that any costs and expenses for transport shall be
borne by [***]. If NeurogesX does not exercise such option, LTS will destroy such Raw Materials and works-in-progress, it being understood that NeurogesX shall pay any reasonable costs and expenses for destroying such Raw Materials and works-in-
progress. 2.15 Active Ingredient. Notwithstanding anything herein to the contrary, LTS'''''''''''''''' obligations to supply Patches hereunder is
subject to and conditioned upon NeurogesX making available to LTS appropriate quantities of the Active Ingredient. Accordingly, NeurogesX shall provide LTS with the amounts of the Active Ingredient that LTS reasonably (on the basis of the then
current First Forecast or Rolling Forecast) notifies NeurogesX (with a lead time of at least [***] months) that LTS will require to fulfill its supply obligations hereunder. LTS shall be responsible for conducting only identity testing of the Active
Ingredient. LTS shall use all quantities of Active Ingredient provided hereunder for the [***] purpose of producing Patches ordered by NeurogesX hereunder. (a) Wastage. LTS agrees to minimize the wastage of the Active Ingredient involved in the production of Patch hereunder and to maximize Patch yields, and will regularly report to and consult with NeurogesX regarding
its Active Ingredient / Patch yields, and its efforts to improve such yields. Without limiting the foregoing, promptly after [***] months from the [***] month in which Patches are delivered hereunder, or after manufacture of at least * full batches
of Patches, [***], the Parties agree to establish a minimum yield level for Active Ingredient / Patch based on the yield levels during such [***] month period, or after manufacture of [***] full batches of Patches, which ever comes later, (the
“Minimum Yield Level”). (b) Safety Stock. As requested by NeurogesX from time to time and at NeurogesX''''''''''''''''s cost (in
accordance with a budget agreed upon by the Parties in advance), LTS shall procure and maintain an additional quantity of Active Ingredient and other Raw Materials as a safety stock for its production of Patches hereunder (“Safety Stock”)
subject to LTS'''''''''''''''' available storage capacity. LTS shall [***] report to NeurogesX as requested, regarding the expenses incurred in procuring and maintaining the Safety Stock (documented and itemized in accordance with the budget), and the levels
of inventory and use of such safety stock. LTS agrees to manage such levels of inventory and use of the Safety Stock in accordance with the reasonable requests of NeurogesX, and in any event LTS shall use the Safety Stock for the sole purpose of
producing Patches for NeurogesX hereunder and shall use [***] to minimize expenses and wastage. When any unit of Safety Stock purchased at the expense of NeurogesX (“NeurogesX Stock”) is used in the production of Patches hereunder,
NeurogesX shall receive a credit, in the amount of the price paid by NeurogesX for such unit of Safety Stock excluding the Active Ingredient and excluding any storage costs incurred by LTS with respect thereto, which may be applied against
(i) the Transfer Price for the Patch or (ii) at NeurogesX''''''''''''''''s option, the costs of procuring replacement NeurogesX Stock.
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(c) Consignment. NeurogesX shall retain all right, title and interest in the Active Ingredients provided
hereunder and the NeurogesX Stock. The Active Ingredients and NeurogesX Stock and shall be (i) clearly marked as property of NeurogesX, (ii) stored under conditions specified in the Specifications at the Facility, (iii) kept free of
any liens and encumbrances, and (iv) subject to inspection by NeurogesX at any time during LTS'''''''''''''''' business hours upon reasonable notice to LTS. LTS shall maintain an accurate inventory of the Active Ingredients and the NeurogesX Stock.
NeurogesX shall keep the Active Ingredient and NeurogesX Safety Stock adequately insured during storage at LTS. Upon termination or expiration of this Agreement (or an earlier request of NeurogesX), LTS will promptly deliver to NeurogesX or
NeurogesX''''''''''''''''s designee all quantities of Active Ingredient and NeurogesX Stock [***] LTS Facility. 2.16 Conflicting Terms and
Conditions. The supply of Patches by LTS to NeurogesX and of Active Ingredient by NeurogesX to LTS shall be solely in accordance with the terms and conditions of this Agreement. ANY TERMS OR CONDITIONS OF ANY PURCHASE ORDER OR ACKNOWLEDGMENT GIVEN
OR RECEIVED WHICH ARE ADDITIONAL TO OR INCONSISTENT WITH THIS AGREEMENT SHALL HAVE NO EFFECT AND SUCH TERMS AND CONDITIONS ARE HEREBY EXCLUDED AND REJECTED BY EACH PARTY. 2.17 Delegation to LTS Affiliates. LTS shall have the right to delegate all or any portion of its obligations under this Agreement to its Affiliates, provided that such delegation does not affect any Marketing
Approvals filed or obtained by NeurogesX, its Affiliates or Sublicensees or in case any Marketing Approval would be affected, NeurogesX has given its prior written consent. Any such Affiliates shall be bound by all of the terms and conditions set
forth herein as if named as a party hereto, and LTS shall remain responsible for the performance of such Affiliates under this Agreement. ARTICLE 3 QUALITY; REGULATORY ISSUES 3.1 Quality Assurances. LTS shall comply with each requirement set forth in the Quality Assurance Agreement with respect to manufacturing and associated support functions including storage, handling and delivery of
Patches to NeurogesX and its designees hereunder; provided, however, the provisions concerning LTS responsibility and liability as set forth in this Agreement shall [***] any provisions that in the event of a conflict between the terms in the
Quality Assurance Agreement or any amendment thereof and this Agreement, the terms of this Agreement shall [***]. 3.2 Patch Regulatory
Information. LTS shall provide NeurogesX with Patch Regulatory Information upon NeurogesX''''''''''''''''s request. To the extent that portions of the Patch Regulatory Information constitute specific LTS'''''''''''''''' manufacturing or patch trade secrets not
previously disclosed to NeurogesX and involving confidential information of LTS'''''''''''''''' other customers, LTS may notify NeurogesX and provide a general description thereof, and if
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requested by NeurogesX, LTS may, instead of providing such parts of the Patch Regulatory Information to NeurogesX, elect to directly provide such parts of
the Patch Regulatory Information to the applicable regulatory authority in support of the regulatory filings of NeurogesX and its designees (and if so elected, will diligently do so), and will grant NeurogesX and its designees rights to reference
such filings made by LTS. Except as set forth in this Section 3.2 or otherwise required by law, LTS shall not correspond directly with the FDA or other health regulatory agencies relating to the process of obtaining Marketing Approvals or any
obtained Marketing Approvals for the Patch, without NeurogesX''''''''''''''''s permission. It is understood and agreed that the license of Section 7.1 of the Clinical Supply Agreement shall apply with respect to Patch Regulatory Information disclosed
under this Agreement, and that NeurogesX may disclose any and all Patch Regulatory Information to regulatory authorities in connection with obtaining and maintaining Marketing Approval for the Patches worldwide. 3.3 Support of Registration. If NeurogesX reasonably requests LTS to undertake such activities LTS shall use its [***] to support NeurogesX''''''''''''''''s
efforts to obtain and maintain Marketing Approvals for the Patch, provided, however, that NeurogesX shall pay for all labor costs of such activities at the then current man-hour rates of LTS and reimburse LTS for third party costs incurred with
respect thereto, in each case as requested by NeurogesX. 3.4 Changes. (a) Specifications. Neither Party shall make any changes to the Specifications except as mutually agreed. If such changes result in a material change in
the Manufacturing Cost, the Parties shall agree on an appropriate adjustment to the Transfer Price of the Product hereunder covering at least the increased costs]. If such modifications result in a delay in delivery, the Parties shall negotiate a
reasonable extension of the affected lead times. Notwithstanding the foregoing, the Parties agree that they shall not withhold approval for any changes to the Specifications (i) requested by NeurogesX which are necessary to make them comply
with Regulatory Requirements in any country in which the Patches are being commercialized by NeurogesX, its Affiliates and/or Sublicensees or manufactured by LTS, or to address concerns regarding the toxicity, safety and/or efficacy of the Patch,
provided that NeurogesX agrees to pay LTS for the reasonable, documented, incremental labor and material costs incurred in connection with implementing such change, to the extent such costs are not covered by the mechanism for adjusting the Transfer
Price in Section 5.6, or (ii) requested by LTS as a result of events beyond its reasonable control (e.g. bankruptcy of its supplier), and such changes to Specifications as are necessary so that LTS can meet the Marketing Approval.
(b) Manufacturing Process. Unless otherwise required by applicable laws or regulations, LTS shall not, without the prior written consent
of NeurogesX, change any aspect of manufacture, including the facilities, equipment, processes, vendors, sub-contractors or record keeping procedures, in any manner (i) which to LTS'''''''''''''''' [***] knowledge has the potential to [***] affect the
Patch, including any changes which may impact its safety or effectiveness, or (ii) which would delay or otherwise impact any filings for Marketing Approval for the Patch or would require an affirmative approval of the FDA, or any other health
regulatory authority in the Territory in which the Patch is being marketed, prior to its implementation. In the event NeurogesX requests a change or adjustment of any aspect of manufacture, including
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the facilities, equipment, processes, vendors, sub-contractors or record keeping procedures and LTS agrees to implement such change or adjustment, or if such
change or adjustment is necessary, in case the annual requirements of the Patch can no longer be supplied according the current manufacturing process (including but not limited to facilities and equipment), however subject to the prior written
consent of NeurogesX as foreseen in the preceding sentence, NeurogesX shall pay LTS for the reasonable, documented, incremental labor and material costs incurred in connection with implementing such change, to the extent such costs are not covered
by the mechanism for adjusting the Transfer Price in Section 5.6. (c) Territory. NeurogesX shall have the right to elect from time to
time to commercialize Patches in countries or regulatory jurisdictions outside the Territory upon written notice to LTS, with a reasonable lead time. In the event NeurogesX''''''''''''''''s decision to add any country or regulatory jurisdiction to the
Territory will cause LTS to (i) incur additional costs, as a result of specific Regulatory Requirements of such country or regulatory jurisdiction (“Territory-specific Costs”), and/or (ii) impose requirements beyond LTS''''''''''''''''
standard manufacturing practice, LTS shall in due time notify and discuss with NeurogesX such costs and such additional requirements. Upon such mutual agreement of the Territory-specific Costs and ways of accommodating such additional requirements,
NeurogesX shall have the option to either (1) modify or limit such addition to the Territory, or (2) include such countries or regulatory jurisdiction within the Territory and reimburse LTS for the Territory-specific Costs. It is
understood that LTS shall use [***] to mitigate any Territory-specific Costs and accommodate such reasonable requirements. (d) Maximum
Capacity. NeurogesX shall update the Maximum Capacity - if necessary - to cover the whole term of the Agreement and shall have the right to elect from time to time to [***] the Maximum Capacity under this Agreement, upon written notice to LTS with a
reasonable lead time, provided, however, that any increase of the Maximum Capacity exceeding [***] Patches per year is subject to LTS prior written agreement, not to be unreasonably withheld. 3.5 Facility. All Patches supplied by LTS hereunder shall be manufactured at the Facility. The Facility (and any other facility that is involved in the
manufacture of Patches by or under authority of LTS) is and shall continue to be in compliance with cGMP and Regulatory Requirements and shall be available for governmental inspection if any competent governmental authority or governmental
organization so requests. LTS shall promptly provide to NeurogesX any cGMP certificate issued by any such competent governmental authority or organization. 3.6 Regulatory Issues. LTS will notify NeurogesX in due time (and no later than [***] days after LTS obtaining notice thereof) of any inspections, written notice of findings and/or actions by regulatory agencies or
other enforcement bodies of LTS facilities and/or processes which will directly affect the Patch or the manufacture thereof. Where reasonably possible, LTS shall afford NeurogesX the opportunity to be present at any such inspections. LTS shall
consult with NeurogesX in responding to any such inspections, written notice of findings and/or actions that directly affect the manufacture of the Patch, including by providing NeurogesX copies of any responses thereto for NeurogesX''''''''''''''''s review
and comment in advance of their submission to the regulatory agency, and using [***] to incorporate therein NeurogesX''''''''''''''''s comments as appropriate.
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3.7 Audits. NeurogesX, its Affiliates and its Sublicensees shall have the right to audit LTS, its
Affiliates and any sub-contractors and vendors of LTS with respect to the Patches, as shall other third parties designated by NeurogesX and approved by LTS in written form (which approval shall not be unreasonably withheld) for compliance with this
Agreement, at [***]; provided that to the extent that a particular vendor does not allow audits by LTS customers, LTS shall use [***] to (i) receive the consent of its vendor to have such audit conducted by a third party or (ii) to the
extent it has the right to do so, perform such audit on NeurogesX''''''''''''''''s behalf at NeurogesX''''''''''''''''s expense. To the extent LTS is required under the “Arzneimittelgesetz” (German pharmaceutical law) to audit the other sub-contractors or
vendors of NeurogesX with respect to the Patches LTS shall have the right to do so at [***], subject to audit procedures to be reasonably agreed between the Parties and the particular sub-contractor or vendor. 3.8 Reporting Safety and Toxicity Problems. Each Party shall promptly advise the other Party of any safety or toxicity problems of which it becomes aware
regarding the Patches or Raw Materials used in the manufacture of the Patches. 3.9 Recalls. To the extent (i) any governmental or
regulatory authority issues a request, directive or order that the Patches be recalled or withdrawn, or (ii) a court of competent jurisdiction orders a recall or withdrawal of Patches, or (iii) either Party determines after consultation
with the other Party, that the Patches should be recalled or withdrawn due to safety issues, the Parties shall recall or withdraw the Patches as set forth in this Section 3.9. (a) Control of Recall Activities. As between the Parties, NeurogesX shall control and coordinate all activities, including making all contacts with
regulatory authorities, it deems necessary in connection with such recall or withdrawal. (b) Initial Allocation of Recall Expenses. The
Parties shall initially allocate all expenses (including out-of-pocket expenses) [***] related to the execution of any recall or withdrawal of the Patches (“Logistic Costs”) [***] between the Parties, provided that in the case of
Section 3.9(iii) above, if the Parties do not mutually agree on having the Patches recalled or withdrawn, then the Party requesting the recall or withdrawal [***], in each case subject to the final allocation between the Parties as set forth in
Section 3.9(c). (c) Final Allocation of Recall Expenses. All Logistic Costs shall be borne by the Party which is [***]. The
responsibility of a Party shall be determined in accordance with the principles of Article 9. For example, [***]. Notwithstanding the foregoing, LTS'''''''''''''''' total liability under this Section 3.9(c) for Logistic Costs shall be limited to an
amount equal to [***] plus any additional amounts covered by LTS'''''''''''''''' insurance coverage, except in the case of LTS'''''''''''''''' gross negligence or willful misconduct. In case of LTS'''''''''''''''' [***], LTS'''''''''''''''' liability for Logistic Costs shall not be so
limited.
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3.10 Stability Testing. LTS shall use [***] to perform the stability testing of the Patches as set forth
in Exhibit I; provided that NeurogesX may terminate the activities under this Section 3.10 at any time by providing at least [***] days'''''''''''''''' prior written notice referencing this Section 3.10. NeurogesX shall pay for those activities
initiated prior to any termination pursuant to this Section 3.10, the compensation as set forth in Exhibit I with respect thereto. ARTICLE 4 COORDINATION 4.1 Launch Team. Shortly before NeurogesX provides the First Forecast under Section 2.2 above, the Parties will form a team (the “Launch Team”) to facilitate communications and decision making by the
Parties regarding the activities to be carried out pursuant to this Agreement during the initial phase of commercial supply starting [***] months prior to first manufacturing of Patches and ending one year after launch of the Patch. The Launch
Team''''''''''''''''s responsibilities shall include, but not be limited to: overseeing the ramp up to commercial production and addressing manufacturing or quality problems. 4.2 Composition. The Launch Team shall consist of [***] representatives from each Party, one of which shall be a designated project leader for such Party (the “Project Leader”). Each Party shall provide the
other Party written notice of, and contact information for, its representatives on the Launch Team. In the event that a member of the Launch Team resigns, or a Party desires to replace one of its members, such Party will provide the other Party
written notice of such event and the name of the member''''''''''''''''s replacement 4.3 Meetings. The Launch Team will conduct formal meetings via
teleconference or in person on at least a quarterly basis until [***] after the first Calendar Quarter in which Patches were delivered hereunder, and thereafter from time to time as mutually agreed between the Parties and will issue minutes of those
meetings within [***] days to the management of each respective company. 4.4 Decisions. All decisions made by the Launch Team shall be
based on the [***] agreement of the Project Leaders. Each Project Leader shall have the authority to fully represent the position of his company and the decision of his company management, except with respect to any aspects of [***]. In case the
Project Leaders do not agree, the [***] of NeurogesX and LTS or their designees shall try to resolve the dispute. Notwithstanding the foregoing, no action, inaction, decision or inability to reach a decision by or of the Launch Team shall vary the
terms and conditions of this Agreement, or the rights and obligations of the Parties hereunder. 4.5 Qualifying a Second Site. LTS shall
use Reasonable Commercial Efforts to implement NeurogesX''''''''''''''''s requests, if any, to qualify LTS'''''''''''''''' GMP facility in [***] as a second site for the manufacture of Patches under this Agreement. It is understood that NeurogesX shall pay for the cost
of such qualification; provided that the total cost, along with any other relevant terms and conditions such as a project plan, timeline, budget, etc., shall be mutually agreed to in writing by the Parties in advance. Upon the request of NeurogesX,
the Parties shall negotiate in good faith the total cost and any other relevant terms and conditions based on the proposal provided by LTS in its letter to NeurogesX dated [***].
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ARTICLE 5 PAYMENT 5.1 Transfer Price. NeurogesX shall pay LTS the price set forth in Exhibit A (the
“Transfer Price”) for each Patch ordered by NeurogesX and delivered by LTS hereunder. All payments hereunder shall be made in [***], by direct bank transfer to an account as designated in LTS'''''''''''''''' invoice. Such payments shall be made by
NeurogesX within [***] days after the later of (a) receipt of an invoice, or (b) the end of the Acceptance Period (as defined in Section 8.2(a) below) for the respective Patches. In addition, in the event NeurogesX has rejected, in
accordance with Section 8.2(a), the Patches prior to the time payment of the Transfer Price is due and LTS is required to deliver replacement Patches in accordance with Section 8.2(b), then the Transfer Price shall not be due until
replacements therefore have been received in accordance with Section 8.2(b). In the event LTS disagrees that Patches rejected were Defective, then NeurogesX shall pay [***] of the Transfer Price until a laboratory has determined whether such
Patches were Defective in accordance with Section 8.2(c). In case the laboratory determines that Patches were Defective, then such payment shall be [***]. In case the laboratory determines that Patches were not Defective, NeurogesX shall
immediately pay the remaining [***] of the Transfer Price. NeurogesX shall pay interest at an annual rate of [***] above [***] for any payments of Transfer Price which LTS did not receive on the date payment is due under this Section 5.1.
5.2 Royalties. (a) As
further consideration for the supply of Patches and the other rights and licenses granted hereunder, NeurogesX shall pay LTS royalties at the rate of [***] on the Net Sales of Kits sold by NeurogesX, its Affiliates or Sublicensees, containing
Patch(es) purchased from LTS under this Agreement. (b) Notwithstanding Section 5.2(a) above, NeurogesX has the option to pay LTS
royalties at the rate of [***] rather than [***] on the Net Sales of Kits sold by NeurogesX, its Affiliates or Sublicensees, containing Patch(es) purchased from LTS under this Agreement, in certain jurisdictions selected by NeurogesX as follows.
NeurogesX shall exercise such option with respect to a jurisdiction within [***] days after the first commercial sale of a Kit in such jurisdiction. In the event NeurogesX exercises such option with respect to a jurisdiction, NeurogesX shall be
entitled to a [***] share of recoveries from an Infringement as set forth in Sections 7.3(a)(ii) and 7.3(b)(ii) below. (c) For the
avoidance of doubt, if NeurogesX elects to exercise the option set forth in Section 5.2 (b), the royalty set forth in Section 5.2 (b) shall not be additional to those in Section 5.2 (a), NeurogesX shall in this case only pay the
royalty set forth in Section 5.2 (b) with respect to the selected jurisdiction.
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5.3 Reporting and Records. (a) Reporting. The royalties set forth in Section 5.2 and Section 6.4 shall be computed for each applicable [***] ([***]), and shall be due and payable within [***] days after such [***] period. For purposes
of computing royalties, each Kit will be considered sold when paid for. NeurogesX shall report to LTS, within [***] days after the end of each such [***] period during the term of this Agreement, and thereafter until all dispositions made pursuant
to this Agreement have been accounted for, any and all royalties under Section 5.2 and Section 6.4 below accruing during such six months period. (b) Records. NeurogesX shall keep records in sufficient detail to enable the royalties payable under Section 5.2 and Section 6.4 below to be determined. The records of NeurogesX shall be available during
reasonable business hours for inspection not more than [***] period, by an independent Certified Public Accountant reasonably acceptable to NeurogesX acting in confidence and retained by LTS at LTS'''''''''''''''' expense, for the purpose of verifying royalty
reports and payments due hereunder. In the event of an underpayment by NeurogesX of more than [***] of the total is found, NeurogesX shall bear the reasonable costs connected with the verification. 5.4 Marketing Approval Milestone. As further consideration for the supply of Patches and the other rights and licenses granted hereunder, NeurogesX shall
pay LTS an amount equal to [***] within [***] days after receipt by NeurogesX of the [***] Marketing Approval to sell the Patch in the Territory. 5.5 No Setoff nor Suspension of Performance. (a) NeurogesX. NeurogesX shall not exercise any right of setoff, net-out or
deduction, take any credit, or otherwise reduce the balance owed to LTS, in each case with respect to payments under Sections 5.1 of this Agreement, unless otherwise expressly provided herein, the Parties otherwise agree or until NeurogesX has
obtained a final determination under Section 12.1(b) against LTS in the amount asserted by NeurogesX. (b) LTS. LTS shall not have the
right to suspend performance (including without limitation refusing or withholding delivery of Patches) under this Agreement (i) unless and until LTS has obtained a [***] determination under Section 12.1(b) that NeurogesX has [***] failed
to perform its obligations under this Agreement relating thereto, (ii) in the case where NeurogesX has failed to pay the Transfer Price for [***] shipments of Patches, which payment is not disputed by NeurogesX, is outstanding for longer than
[***] or more days and, in the aggregate, exceeds a total amount of [***] unless NeurogesX fails to provide a letter of credit upon the request of LTS as set forth in Section 2.11; (iii) except as set forth in Section 7.6 below, or
(iv) unless otherwise mandated by applicable laws, regulations or orders. (c) No Other Charges. Except as otherwise set forth in this
Agreement, LTS shall perform all of its obligations hereunder at its [***], and shall not [***] NeurogesX any amounts for the manufacture and supply of Patches hereunder except as expressly set forth in this Article 5 or otherwise mutually
agreed in writing.
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5.6 Adjustment to the Transfer Price. (a) Prior to first launch of Patch the Parties shall annually review the Transfer Price but starting not earlier than [***] Thereafter, beginning [***]
years after the first calendar month in which Patches are delivered hereunder, the Parties shall annually review the Transfer Price and negotiate in good faith an adjustment for the Transfer Price taking into account all relevant factors, including
but not limited to Manufacturing Costs, provided, that any increase will be commensurate with actual changes in the relevant factors relating to the manufacture of the Patch. (b) LTS shall have the right to adjust the Transfer Price up to [***] over the Transfer Price set forth in Exhibit A for increases in costs for raw
materials, labor or waste. Any further increases are subject to the mutual agreement of the Parties. (c) If LTS requests an increase of
the Transfer Price by more than [***] then NeurogesX shall have the right to have the Manufacturing Cost audited by an independent Certified Public Accountant (CPA), reasonably acceptable to LTS acting in confidence and retained by NeurogesX at
NeurogesX''''''''''''''''s expense, for purposes of confirming such increase in Manufacturing Costs. Such CPA shall however not disclose details of such Manufacturing Costs. (d) LTS shall use [***] to avoid substantial increases in its Manufacturing Costs. In addition, at the request of NeurogesX from [***] LTS shall use [***] to suggest, and the Parties shall discuss, methods to reduce
Manufacturing Costs and to provide a commensurate reduction in Transfer Price hereunder; provided it is agreed that any such methods shall be implemented only upon mutual agreement. (e) In case the Transfer Price is adjusted according to the foregoing, Exhibit A shall be amended accordingly. ARTICLE 6 LICENSES
6.1 Manufacturing License to LTS. NeurogesX hereby grants to LTS a non-exclusive, non-transferable license under NeurogesX Patents to manufacture the
Patches ordered by NeurogesX hereunder and deliver such Patches to NeurogesX or its designee as specified in this Agreement. As used herein, “NeurogesX Patents” means any and all patents owned or Controlled by NeurogesX which cover, is
incorporated in or is used as part of the Patch, or which relate to a method of use or manufacture of the Patch. 6.2 Commercialization
License to NeurogesX. LTS hereby grants NeurogesX a worldwide, royalty-free, sublicensable right and license under the Commercialization Patents to use, sell, offer to sell, import, market, promote, distribute and otherwise commercialize the Patches
purchased hereunder. The license set forth in this Section 6.2 shall be exclusive in the Field.
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6.3 Limited Exclusivity of LTS. (a) LTS shall for the duration of this Agreement not develop for, sell or license to, any third parties any TTS with capsaicin (1) with an area based
content above [***], or (2) that is covered by LTS'''''''''''''''' U.S. patent application no. [***], continuations, continuations-in-part, divisions and foreign counterparts thereof, patents issuing thereon, including renewals, reissues and extensions
(such TTS with capsaicin as described in clauses (1) or (2), the “Field”). For clarity, during the term of this Agreement LTS shall not exploit on its own nor directly or indirectly license, assist or enable any third party under any
patent rights, know-how, data or other intellectual property owned or Controlled by LTS to make, use, offer for sale, sell or import any TTS with capsaicin in the Field, provided, however, that LTS shall at all times have the right to toll
manufacture (including performing manufacturing scale-up of) any products containing capsaicin the design and technical aspects solely developed by a third party and not falling within the scope of the Commercialization Patents. (b) LTS shall not use, manufacture, sell, distribute or license for or to any third party any Patches, except as authorized in writing by NeurogesX.
(c) Except as set forth in this Sections 6.3, and subject to Section 7.1 below, LTS shall at all times have the right to develop
and/or manufacture any other TTS''''''''''''''''s or products developed by LTS and/or a third party, even if it contains any VRI-Ligand. (d) During
the term of the Agreement and except as otherwise provided herein, NeurogesX shall not purchase or otherwise procure Patches from any supplier other than LTS or its Affiliates. 6.4 Backup Manufacturing License. (a)
Definitions. For the purpose of this Section 6.4, the following terms will have the meanings set forth below. (i) “Failure
Event” means any of the following events: a Force Majeure Event, Failure to Supply, an Anticipated Failure to Supply, receipt of a Notice of Suspension (as defined in Section 7.6 below), termination by either Party under Section 11.3
below or termination by NeurogesX under Section 11.2 below. (ii) “Force Majeure Event” means a failure of LTS to perform
its obligations to supply the Patches to NeurogesX in accordance with the terms and conditions set forth herein due to Force Majeure (as defined in Section 12.6) causing an interruption of supply of Patches to the customer, and then a failure
to remove any such cause by employing [***] and resume supply hereunder within [***] days thereafter. (iii) “Failure to Supply”
means either: (A) not including cases of Force Majeure, an inability of LTS to supply in accordance with this Agreement at least [***] in any one Calendar Quarter and at least [***] in the subsequent Calendar Quarter of the Binding Quantities
of Patches ordered by NeurogesX for delivery in such quarters, provided that such failure is not due to failure of NeurogesX to supply Active Ingredient in accordance with Section 2.5 or otherwise caused by NeurogesX; or (B) a material
breach of this Agreement by LTS causing an interruption of supply of Patches to the customer, which is not cured within [***] days after notice specifying such breach.
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(iv) “Anticipated Failure to Supply” means either: (A) a written notice by LTS that it
anticipates that it will be unable to supply NeurogesX''''''''''''''''s requirements of the Patch in accordance with this Agreement for at least [***] consecutive orders, when it can be foreseen by LTS that the following [***] consecutive orders cannot be
fulfilled even though such orders were placed in accordance with Section 2.4 (a); or (B) a failure of LTS to maintain compliance with all Regulatory Requirements relating to the Facility and its manufacturing activities hereunder, which
non-compliance cannot (or LTS anticipates will not) be or is not cured by using [***] and such non-compliance causes interruption of supply of Patches by LTS for [***] or more. LTS shall promptly notify NeurogesX in the event of clauses (A) or
(B) above, and in the case of clause (B), shall keep NeurogesX updated as to its efforts to cure any such non-compliance. (v)
“LTS Know-how” means instructions, specifications, know-how, technology, materials and intellectual property describing the composition and manufacture of the Patches, including a description of the suppliers, raw materials, processes,
equipment and instruments used for such manufacture and all Patch Regulatory Information. It is understood that LTS Know-how shall include all information or materials disclosed or provided under this Agreement, the Clinical Supply Agreement, the
MOU and the Secrecy Agreement. (vi) “LTS Technology” means LTS Know-how, the Commercialization Patents, and any and all other
patents or intellectual property worldwide owned or Controlled by LTS which cover, is incorporated in or is used as part of any of the Patches, or which relate to a method of use or manufacture of any of the Patches (or equipment used in such
manufacturing). (b) Delivery of Technology. Upon any Failure Event, in order to permit NeurogesX to manufacture or have manufactured and
to commercialize the Patch, LTS shall, upon NeurogesX''''''''''''''''s request, deliver to NeurogesX at no additional cost, information regarding the then existing manufacturing process and quality procedures relating to the Patch, and all LTS Know-how, which
would be reasonably required for a third party manufacturer of ordinary skill in the art of manufacturing TTS, to manufacture for NeurogesX Patches conforming to the Specifications. EXCEPT AS SET FORTH IN THIS SECTION 6.4(b), LTS SHALL IN NO CASE BE
OBLIGATED TO PROVIDE ITS PROPRIETARY KNOW-HOW WITH REGARD TO GENERAL TTS MANUFACTURING METHODS, BUT SHALL IF REQUESTED BY NEUROGESX AND AT NEUROGESX''''''''''''''''S COST AND EXPENSE ASSIST NEUROGESX OR ITS THIRD PARTY MANUFACTURER IN THE PRODUCTION OF THE
FIRST THREE (3) COMMERCIAL BATCHES OF THE PATCHES. Upon a Failure Event, NeurogesX, its Affiliates and Sublicensee shall thereafter be relieved of any obligations under this Agreement, including under Section 2.1 above, to purchase all or
any of their commercial, clinical or other requirements of Patches from LTS, and NeurogesX, its Affiliates and Sublicensees shall be free to purchase some or all of its Patches from third party(ies). (c) Other LTS Facilities. Upon any Failure Event LTS shall have the option, exercisable upon written notice to NeurogesX given within [***] days of the
notice of the Failure Event to qualify LTS'''''''''''''''' facility at LTS Lohmann Therapy Systems Corp., [***]
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and to have the Patches manufactured at this facility or, in the event the facility has already been qualified according to Section 4.5, to have the
Patches manufactured at the LTS facility at LTS Lohmann Therapy Systems Corp. or any other Facility; provided that the Parties enter into an agreement on bearing of the costs, the timelines for qualification and the manufacturing capacity within
[***] days after execution of the option (such [***] day period, the “Negotiation Period”). (d) Backup License. LTS hereby
grants NeurogesX a world-wide right and license, with the right to grant and authorize sublicenses, under LTS Technology, to use, make, have made, sell, offer for sale, import, promote, market, develop, obtain regulatory approval for and otherwise
commercialize Patches and any derivatives or improvements thereof made by or for NeurogesX, its Affiliates or Sublicensees, and to practice any methods, processes or procedures described or claimed therein in connection with the foregoing; provided
that NeurogesX, its Affiliates or Sublicensees shall not exercise any rights set forth in this Section 6.4(d) except and until after a Failure Event and after LTS has informed NeurogesX in writing that LTS will not exercise the option set forth
in Section 6.4(c), or such option or the Negotiation Period have expired and the Parties have not come to an agreement as contemplated under Section 6.4(c) above. NeurogesX shall not disclose any LTS Know-how to any third party except in
connection with exercising the rights set forth in this Section 6.4(d), and subject to reasonable confidentiality obligations on the part of such third party. The license set forth in this Section 6.4(d) (the “Backup License”)
shall be exclusive for any LTS patent in the Field as defined in Section 6.3 in case of a Failure Event for a period of five years, unless such LTS patent expires or is abandoned earlier. The period shall be referred to as the “Maximum
Backup License Exclusivity Period.” Notwithstanding Section 6.3, this Section and subject to Section 6.4(e) below, beginning [***] months after a Force Majeure Event or a Notice of Suspension, LTS shall have the right to develop, by
itself or with third parties, manufacture and supply products to [***] in the Field; provided that it does not utilize any [***] of the patent application referred to in Section 6.3(a)(2) and / or the patent possibly resulting therefrom for a
period of [***] years, unless such patent expires or is abandoned earlier, it being understood that this exemption shall only pertain to the patent and the claims granted, if any. In the event NeurogesX desires at any time to have the license set
forth in this Section 6.4(d) become non-exclusive, NeurogesX shall notify LTS in writing. This Section 6.4 shall be NeurogesX''''''''''''''''s [***] for the breach of LTS'''''''''''''''' general obligation under this Agreement to supply Patches ordered by
NeurogesX, provided that LTS has employed its [***] to do so; but the foregoing shall not limit any remedies set forth in this Agreement NeurogesX may have for the breach of any specific obligations of LTS. (e) LTS Supply after Failure Event. In case of any Failure Event, if after NeurogesX has exercised its License set forth under Section 6.4(d) and
NeurogesX has qualified a third party manufacturer for the Patches, LTS is able to demonstrate by a statement of an independent expert ([***]) that it is able to resume manufacturing and supply of Patches, NeurogesX shall offer to have LTS
supply [***] of its requirements of Patches from LTS. In the event LTS accepts such offer, its supply of Patches shall be subject to all of the terms and conditions of this Agreement; provided that if NeurogesX offers to have LTS supply less than
[***] of its requirements for Patches, then notwithstanding Section 6.3 and Section 6.4(d), LTS shall have the right to develop by itself or with third parties, manufacture and supply products to third parties in the Field.
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(f) Royalties. (i) In consideration of the license set forth in this Section 6.4, NeurogesX shall pay LTS a [***] on the [***] by NeurogesX, its Affiliates or Sublicensees of Kits made under the license set forth in this
Section 6.4 after a Failure Event, calculated as follows. The royalty shall be [***] for the exclusive Backup License, and [***] in case of a non exclusive Backup-License. (ii) Notwithstanding Section 6.4(f)(i) above, NeurogesX shall have the option to pay LTS a royalty at the rate of [***] in case of a non-exclusive
Backup License and [***] in case of an exclusive Backup License, rather than the percentage calculated in accordance with Section 6.4(f)(i), on the Net Sales by NeurogesX, its Affiliates or Sublicensees of Kits made under the license set forth
in this Section 6.4 after a Failure Event, in certain jurisdictions selected by NeurogesX as follows. NeurogesX shall exercise such option with respect to a jurisdiction within [***] days after the first commercial sale of a Kit in such
jurisdiction after the Failure Event. In the event NeurogesX exercises such option with respect to a jurisdiction, NeurogesX shall be entitled to a [***] share of recoveries from Infringement as set forth in Sections 7.3(a)(ii) and 7.3(b)(ii) below.
(iii) For the avoidance of doubt, if NeurogesX elects to exercise the option set forth in Section 6.4(f)(ii), the royalty set forth
in Section 6.4(f)(ii) shall not be additional to those in Section 6.4(f)(i), NeurogesX shall in this case only pay the royalty set forth in Section 6.4(f)(ii) with respect to the selected jurisdictions. In addition, for the avoidance
of doubt, the royalty set forth in Section 5.2 above shall not apply to the Patches made under the license set forth in this Section 6.4, and the royalty set forth in this Section 6.4(f) shall not apply to the Patches purchased from
LTS. 6.5 Sublicensing. In the event NeurogesX desires to grant a sublicense to any third party under the licenses set forth in
Section 6.2 and/or 6.4, NeurogesX is free to do so, provided that (a) LTS is informed of the identity of the Sublicensee and the
scope of rights that are being granted; (b) those Sublicensees shall be obligated to indemnify LTS regarding IP Claims and product
liability to the extent NeurogesX is so obligated under Sections 9.2 and 9.3(b); and (c) those Sublicensees shall be obligated to maintain
a customary and reasonable level of product liability insurance which covers the Patch, for those countries in which such Sublicensee is authorized by NeurogesX to distribute the Patch.
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ARTICLE 7 INTELLECTUAL PROPERTY 7.1 Inventions relating to the Patch. (a) LTS Owned. All inventions developed by the Parties or by either Party under this Agreement or the Clinical Supply Agreement solely relating to
LTS'''''''''''''''' existing TTS technology, including but not limited to design, formulation, manufacturing, testing and packaging of TTS, shall be the property of LTS (“LTS IP”). LTS shall not use any LTS IP for the development of TTS containing
VR1-Ligand until [***], other than for NeurogesX. Thereafter, until [***], NeurogesX shall have a right of first refusal in case LTS commences development of TTS which contain any VR1-Ligand using LTS IP. NeurogesX hereby irrevocably assigns, and
agrees to assign to LTS any right, title and interest it may have in and to the LTS IP, and shall assist LTS, upon reasonable request and at LTS''''''''''''''''[s] sole expense, to secure or perfect any and all such rights. (b) NeurogesX Owned. All inventions developed by the Parties or by either Party under this Agreement or the Clinical Supply Agreement solely relating to
medical uses of any VR1-Ligand shall be the property of NeurogesX (“NeurogesX IP”). LTS hereby irrevocably assigns, and agrees to assign to NeurogesX all of its right, title and interest in and to NeurogesX IP, and shall assist NeurogesX,
upon reasonable request and at NeurogesX''''''''''''''''s sole expense, to secure or perfect any and all such rights. (c) Jointly Owned. All other
inventions developed by the Parties or by either Party under this Agreement or the Clinical Supply Agreement shall be the joint property of the Parties (“Joint IP”), provided that it does not belong under Section 7.1(a) or (b) to
either LTS IP or NeurogesX IP. Neither Party shall have any obligation to account to the other Party for profits with respect to, or to obtain any approval of the other Party to license or exploit, any Joint IP by reason of their joint ownership,
and each Party waives any such right it might have under the applicable laws in any country; provided, that NeurogesX shall only have the right to exploit and license the Joint IP for VR1-Ligand applications and products, and LTS shall only have the
right to exploit or license the Joint IP for any applications and products other than VR1-Ligand applications and products. (d) Exclusive
License. Accordingly, the Parties grant to each other licenses under the Joint IP (which to avoid any doubt for purposes of these licenses includes all patent applications and patents claiming the inventions included therein) as follows:
(i) NeurogesX hereby grants to LTS an exclusive (even as to NeurogesX), royalty-free, fully-paid, freely sublicensable (though one or more layers of
sublicensees without consent), perpetual, irrevocable, worldwide license under the Joint IP to [***] Notwithstanding Section 7.3 below, LTS shall have the [***] to enforce the Joint IP against infringement within the scope of the license set
forth in this Section 7.1(d)(i) and to retain [***] recoveries therefrom, and NeurogesX shall cooperate with LTS, at LTS'''''''''''''''' reasonable request and expense; however, nothing herein shall require NeurogesX to join any such action as a party to
any such action. For clarity, the Parties intend that LTS shall have sufficient rights to enforce such Joint IP as set forth in this Section 7.1(d)(i) without NeurogesX joining as a co-plaintiff. (ii) LTS hereby grants to NeurogesX an exclusive (even as to LTS), royalty-free, fully-paid, freely sublicensable (though one or more layers of
sublicensees without consent),
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perpetual, irrevocable, worldwide license under the Joint IP to make, have made, use, sell, offer to sell, and import product candidates and products that
contain any VR-1 Ligand(s) and/or are VR-1 Ligand applications and products. Notwithstanding Section 7.3 below, NeurogesX shall have the sole right to enforce the Joint IP against infringement within the scope of the license set forth in this
Section 7.1(d)(ii) and to retain all recoveries therefrom, and LTS shall cooperate with NeurogesX, at NeurogesX''''''''''''''''s reasonable request and expense; however, nothing herein shall require LTS to join any such action as a party to any such
action. For clarity, the Parties intend that NeurogesX shall have sufficient rights to enforce such Joint IP as set forth in this Section 7.1(d)(ii) without LTS joining as a co-plaintiff. 7.2 Prosecution of Patents Covering the Patch. (a) As used in Sections 7.2 and 7.4, “prosecute” means the procedure(s) involved in securing patent rights in patent offices worldwide. (b) LTS shall have the right, [***] to file, prosecute and/or maintain any patent or patent application solely owned by LTS covering the Patches. With respect to such LTS patents and patent applications that are
specific to the Patch, including [***] and foreign counterparts thereof, NeurogesX shall have the right to review and consult with LTS regarding the prosecution and maintenance thereof; provided however that in the event NeurogesX does not provide
comments within a period of [***] days after receipt of a respective draft brief or office action by LTS, NeurogesX shall be deemed to have waived its right to review and consult. (c) If LTS elects to file, prosecute and maintain any such patent or patent application, the expenses of such action shall be borne by LTS.
(d) If LTS elects not to file, prosecute or maintain any such patent or patent application in any jurisdiction, it shall notify NeurogesX at least
[***] days prior to the due date for any action or payment. NeurogesX shall then have the right, to file, prosecute and/or maintain any such patent or patent application. (e) If NeurogesX elects to file, prosecute and maintain any such patent or patent application in such jurisdiction, the expenses of such action shall be borne by NeurogesX, and NeurogesX shall have a [***] (except as
set forth in this Section 7.2(e[***]. The foregoing license shall be exclusive for the Field. NeurogesX shall have the first right to enforce such patents and patent applications in the Field and retain all revenues therefrom, notwithstanding
Section 7.3 below. 7.3 Third Party Infringement in the Field. Each Party agrees to [***] notify the other Party if it becomes aware
of any third party''''''''''''''''s TTS in the Field that infringes LTS'''''''''''''''' patents covering the Patch (an “Infringement”). LTS shall have the [***], but not the obligation, to enforce its patents against any Infringement. LTS shall [***] control
any such enforcement action. LTS shall keep NeurogesX informed of the proceeding of such enforcement. In case NeurogesX believes LTS is not [***] pursuing the enforcement, NeurogesX shall have the
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[***] with LTS. LTS agrees not to settle or otherwise terminate or delay its enforcement against any Infringement in a manner which would permit the third
party to continue manufacturing and/or selling infringing TTS in the Field in contravention of the exclusivity granted to NeurogesX under Article 6 of this Agreement. LTS shall not settle any Infringement action without the prior written approval of
NeurogesX. In the event LTS notifies NeurogesX within [***] days after notice of an alleged Infringement by either Party that it intends to file suit against any alleged Infringement, or does not give any notification whether it intends to file suit
within [***] days after notice of an alleged Infringement by either Party or drops any action against an alleged Infringement, then NeurogesX shall have the right, but not the obligation, to enforce LTS'''''''''''''''' patents covering the Patch against such
alleged Infringement. LTS agrees to use Reasonable Commercial Efforts to assist and cooperate with NeurogesX in any enforcement by NeurogesX under this Section 7.3, at NeurogesX''''''''''''''''s cost and expense. (a) If LTS decides to enforce its patents against Infringement and NeurogesX permits LTS to claim NeurogesX damages, then any proceeds from such
enforcement of its Patents recovered from any such Infringement action shall be divided (i) [***] between NeurogesX and LTS unless clause (ii) applies, or (ii) [***] to NeurogesX and [***] to LTS with respect to recoveries for
Infringement in a jurisdiction for which NeurogesX has elected to pay a higher royalty under Section 5.2(b) or 6.4(f)(ii) above, in each case after first subtracting [***]. (b) In the event NeurogesX is given the right to enforce LTS'''''''''''''''' patents against Infringement and LTS permits NeurogesX to claim LTS'''''''''''''''' damages,
then any proceeds from such enforcement of LTS'''''''''''''''' patents recovered from any such Infringement action shall be divided (i) [***] between NeurogesX and LTS unless clause (ii) applies, or (ii) [***] to NeurogesX and [***] to LTS with
respect to recoveries for Infringement in a jurisdiction for which NeurogesX has elected to pay a higher royalty under Section 5.2(b) above or 6.4(f)(ii), in each case after first subtracting [***]. 7.4 Cooperation. Each Party shall cooperate with the other Party at the other Party''''''''''''''''s expense to execute all lawful papers and instruments, to make
all rightful oaths and declarations, and to otherwise assist, including without limitation participating (but not joining as a plaintiff) in enforcement actions, the other Party as may be necessary and reasonably requested in the preparation and
prosecution of any or all patents and patents applications regarding the Patches, and the enforcement thereof. 7.5 IP Review by LTS. LTS
shall review on a [***] basis the intellectual property rights relevant for LTS'''''''''''''''' obligations hereunder. LTS shall give NeurogesX a confirmation in writing [***] a year (on or about [***] of each year) that, to the best of its actual knowledge,
LTS does not infringe third parties'''''''''''''''' intellectual property rights with respect to the Patches. 7.6 Blocking Patents. (a) In the event a Party becomes aware of a Blocking Patent, such Party shall [***] notify the other Party giving such [***] details as such Party may be
aware, and
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the Parties shall discuss the situation in [***] and agree on a plan to address the situation, with the mutual objective of removing the risk posed by such
Blocking Patent so that the Parties may continue performance under this Agreement, including if appropriate and agreed by the Parties, by licensing and/or challenging such Blocking Patent. In the event the Parties agree on a plan to address such
Blocking Patent, the Parties shall designate a lead Party to use Reasonable Commercial Efforts to perform such plan. It is understood that the costs of any license obtained with respect to a Blocking Patent (to the extent allocable to the
manufacture, use or sale of Patches hereunder) will be shared by the Parties in proportion to their indemnification obligations for IP Claims under Section 9.2. It is understood and agreed that notices, communications and discussions under this
Section 7.6 shall not be construed as [***] by either Party. In addition, all notices, communications and discussions under this Section 7.6 shall be deemed protected by the [***]. (b) After discussing the matter in [***] as described in Section 7.6(a) above, LTS and NeurogesX shall each have the right to [***] under this
Agreement with respect to the affected country upon written notice (“Notice of Suspension”), until the risk of infringing such Blocking Patent has been removed, including if a Party or a Sublicensee has obtained a license with respect to
the Blocking Patent for such country, or otherwise if in the [***] opinion of the Suspending Party''''''''''''''''s counsel, such risk is removed. In the event LTS elects to provide a Notice of Suspension, then such notice shall be deemed a “Failure
Event” under Section 6.4(a) above, effective upon receipt of the Notice of Suspension, provided however that the Parties shall discuss resuming their obligations as foreseen in case of termination under Section 11.3. (c) Notwithstanding the foregoing, in the event that upon receiving a Notice of Suspension, a Party disputes in good faith such notice, then the Party
providing the Notice of Suspension may [***] its performance as set forth in this Section 7.6 if it can show by an opinion of an independent counsel, approved by the other Party (whose approval shall not be unreasonably withheld), that the
determination of its counsel that a third party''''''''''''''''s intellectual property right would be infringed is [***]. Such opinion shall also summarize the underlying facts. The Parties shall cooperate to ensure that all attorney-client privilege and work
product privilege shall be protected with respect to the opinion. If the Party providing the Notice of Suspension does not propose an independent counsel, which is [***] to the other Party, then an independent counsel shall be appointed by the ICC
International Centre for Expertise in accordance with the rules for Expertise of the International Chamber of Commerce. Such independent counsel shall be a [***]. ARTICLE 8 REPRESENTATIONS AND WARRANTIES; DISCLAIMER; LIMITATION OF LIABILITY 8.1 General Warranties. Each Party represents and warrants to the other Party that it is a corporation duly organized and validly existing under the laws
of the state or country of its incorporation, the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action, and it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder. Each Party warrants and represents to the other Party that it has not previously granted and will not grant any rights in conflict with the rights granted herein.
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8.2 Patches. Subject to the limited liability provisions set forth in this Agreement, LTS represents and
warrants that the Patches delivered to NeurogesX (a) shall (i) be in conformity with the Specifications, (ii) be manufactured in accordance with Current GMP and the Quality Assurance Agreement, and (iii) comply with all
Regulatory Requirements, and (b) no later than [***] days after initiation of the manufacture thereof, be released for shipment by LTS and made available for ex works delivery to NeurogesX. (a) Rejection of Defective Patches. NeurogesX may reject Defective Patches, subject to NeurogesX providing sufficient evidence of appropriate and correct
storage at all times according to the storage conditions set forth in the applicable Specifications (which evidence is subject to confirmation under Section 8.2(c) below), by delivering to LTS written notice of rejection, and if practical,
specifying the nature of the Defect and the Patches lot number, within [***] days after actual receipt by NeurogesX or its designee of the applicable shipment (the “Acceptance Period”). In the case of Patches with Defects that are not
reasonably discoverable upon NeurogesX''''''''''''''''s [***] incoming quality control testing (“Latent Defects”), NeurogesX may reject such Patches within [***] days after discovery of the Latent Defects. After said [***] days period or after the
Acceptance Period, whichever is applicable, the Patches shall be deemed accepted. (b) Replacement of Defective Patches. During the [***]
month period commencing on the date the Patches are delivered to NeurogesX, LTS shall promptly (and in any event within [***] days of receipt of notice of rejection) deliver to NeurogesX, at LTS'''''''''''''''' own cost and risk, including shipping costs and
Active Ingredient costs, replacements for any rejected Defective Patches, up to the [***] contained in the applicable lot. The foregoing shall be NeurogesX''''''''''''''''s [***] for the rejection of Defective Patches, but does not limit any remedies
NeurogesX may have under other sections of this Agreement. (c) Confirmation of Cause of Defects. LTS shall have the right to examine any
Patches rejected by NeurogesX, provided such examination shall not delay the shipping of replacement Patches. In the case LTS disagrees that the rejected Patches are subject to this Section 8.2, the claim may be submitted for tests and a
decision by a mutually agreed upon, independent and reputable third party laboratory in the United States, which appointment shall not be unreasonably withheld or delayed by either Party. In making its determination, such laboratory shall take into
consideration any evidence provided by LTS that the Patches complied with the Specifications at the time of shipment, and also any evidence provided by NeurogesX that the Patches were correctly handled and stored (i.e. in accordance with the
Specifications) by NeurogesX and third parties under authority of NeurogesX. The determination of such laboratory shall be [***] upon the Parties. The Party against whom the determination is made shall be responsible for the [***], as well as the
costs of the replacements for the rejected Patches at issue, including [***]. 8.3 Disclaimer of Warranties. EXCEPT AS EXPRESSLY SET FORTH
IN THIS AGREEMENT, NEITHER PARTY MAKES ANY WARRANTIES EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE PATCHES AND
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ACTIVE INGREDIENT SUPPLIED HEREUNDER, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. THE
WARRANTIES GIVEN UNDER THIS AGREEMENT ARE EXPRESSLY IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED. 8.4 Limitation of Liability.
EXCEPT WITH RESPECT TO ARTICLES 9 AS RELATED TO THIRD PARTIES, AND ARTICLE 10, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY OR INCIDENTAL DAMAGES (INCLUDING LOST OR ANTICIPATED REVENUES OR
PROFITS RELATING TO THE SAME), ARISING FROM ANY CLAIM RELATING TO THIS AGREEMENT, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, EVEN IF ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME. ARTICLE 9 INDEMNIFICATION
9.1 Product Claims. LTS shall indemnify NeurogesX from any third party claims, damages, losses, costs, expenses arising from the
development, manufacturing and supply under this Agreement of Patches which, at the time of delivery, do not conform to the Specifications (“Product Claims”). NOTWITHSTANDING THE FOREGOING, LTS'''''''''''''''' AGGREGATE LIABILITY UNDER THIS SECTION
9.1 IN EACH CALENDAR YEAR FOR PRODUCT CLAIMS THAT DO NOT RESULT FROM LTS'''''''''''''''' GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, SHALL NOT EXCEED THE LIMITS OF LTS'''''''''''''''' INSURANCE COVERAGE FOR SUCH INDEMNIFIABLE CLAIMS IN SUCH YEAR PLUS [***] 9.2 Intellectual Property Claims. (a)
NeurogesX Caused. NeurogesX shall indemnify and hold harmless LTS from any third party claims, actions, proceedings alleging the infringement of any patent, trade secrets or other intellectual property of a third party (“IP Claims”),
arising from LTS'''''''''''''''' development, manufacturing, sale and using the Patches for or to NeurogesX, which IP Claims are caused by LTS'''''''''''''''' use of any technology or intellectual property owned or supplied by NeurogesX. (b) LTS Caused. With respect to any IP Claims arising from the development, manufacture, sale and use of the Patches under this Agreement by or for
NeurogesX, which IP Claims are caused by use of any technology or intellectual property owned or supplied by LTS, including without limitation the design of the Patch and any LTS Technology (as defined in Section 6.4(a)(iii)) (an “LTS
Infringement”), the following shall apply: (i) If either Party is sued for an alleged LTS Infringement, LTS is liable up to an amount
of [***] incurred by NeurogesX in connection with the defense of such IP Claims, provided that this does not apply in the event that NeurogesX is sued for an alleged LTS Infringement in case the Patches being subject of such IP Claims were
manufactured by a third party in accordance with Section 6.4. For all costs and expenses
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incurred by NeurogesX in defense of such IP Claims in excess of [***], NeurogesX is liable and shall indemnify and hold harmless LTS. In the event LTS is the
Party sued for an alleged LTS Infringement, and LTS desires indemnification from NeurogesX, LTS shall [***] notify NeurogesX of the alleged LTS Infringement, permit NeurogesX [***] of the defense and/or settlement of the alleged LTS Infringement as
requested (but LTS may participate in such defense and/or settlement with counsel of its choice and its own expense), and cooperate with NeurogesX with respect to such defense and settlement. (ii) LTS agrees to automatically reduce the royalty rates under this Agreement by the royalty rate or other amounts a court may require NeurogesX to pay
to a third party claiming a LTS Infringement in satisfaction of a judgment against NeurogesX, or by the royalty rate or other amounts owed by NeurogesX in any settlement of the LTS Infringement; provided, that in no event shall the royalty rate
under this Agreement fall below [***] (iii) In case of a final and non-appealable court judgment which prohibits NeurogesX from using or
selling Patches as a result of an LTS Infringement, LTS shall reimburse NeurogesX for [***] of the Development Costs (as defined in the Clinical Supply Agreement). This obligation shall only be valid during the term of this Agreement. (c) Sole Remedy for IP Claims. Notwithstanding any other provision of this Agreement, this Section 9.2 and Sections 3.9 and 7.6 and 11.3 state the
entirety of each Party''''''''''''''''s obligations to indemnify and/or hold harmless the other Party and the entirety of each Party''''''''''''''''s remedy from the other Party, with respect to IP Claims arising from the development, manufacturing, sale and/or use of
the Patches. 9.3 Other Indemnification. (a) Employee Claims. Each Party shall indemnify the other Party against any claims against such other Party by the indemnifying Party''''''''''''''''s employees, directors, officers and other persons involved from the
indemnifying Party''''''''''''''''s side in the performance of obligations under this Agreement (“Employees”) to the extent such claims relate to such Employees'''''''''''''''' inventorship of, rights in or right to receive proceeds from any inventions
conceived or reduced to practice under this Agreement, and are inconsistent with Section 7.1. (b) LTS. Without regard to LTS
insurance, LTS shall indemnify and hold NeurogesX harmless from any third party claims, damages, losses, costs and expenses (including attorney''''''''''''''''s fees) (“Claims”) that arise from LTS'''''''''''''''' gross negligence or willful misconduct in
connection with the use, development, manufacturing, sale, distribution or application of the Patch. (c) NeurogesX. Other than (i) to
the extent that LTS is obligated to indemnify NeurogesX pursuant to this Article 9, to the extent arising from LTS'''''''''''''''' gross negligence or willful misconduct, and (iii) to the extent in excess of LTS'''''''''''''''' limitation on liability hereunder,
NeurogesX shall indemnify and hold LTS harmless from any Claims that arise from the use, development, manufacturing, sale, distribution or application of the Patch by NeurogesX, its Sublicensees, or its distributors, including claims under Sections
9.1 and 9.2; provided that (i) LTS promptly
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notifies NeurogesX of the Claim, (ii) NeurogesX has sole control of the defense and/or settlement of the Claim (but LTS may participate in such defense
and/or settlement with counsel of its choice and its own expense), and (iii) LTS fully cooperates with NeurogesX with respect to such defense and settlement. 9.4 Insurance. (a) NeurogesX. Prior to [***] of the Patches, NeurogesX shall obtain and maintain during the
term of this Agreement sufficient insurance coverage of an amount reasonable and customary in the pharmaceutical industry considering the nature of the Patch, which insurance coverage can also be self insurance. (b) LTS. LTS shall obtain and maintain during the term of this Agreement and thereafter liability insurance covering its activities under this Agreement
at a level no lower than that set forth in Exhibit F, to the extent such coverage is available at terms and conditions not substantially more unfavorable than LTS'''''''''''''''' present insurance coverage. LTS shall certify to NeurogesX each year of the
extent of its insurance coverage, and shall promptly notify NeurogesX in the event its liability insurance covering its activities under this Agreement falls below the level set forth in Exhibit F. ARTICLE 10 CONFIDENTIALITY
10.1 Confidential Information. Except as expressly provided in this Article 10, each Party shall, during the term of this Agreement plus
[***] years thereafter, keep completely confidential and shall not use, put into production, publish nor otherwise disclose the Confidential Information received from the other Party under this Agreement, the MOU or the Clinical Supply Agreement. As
used herein, “Confidential Information” means all information, including but not limited to data, know-how, formulas, processes, specifications, organizational information, mechanical equipment and/or trade secrets which have been or may
hereafter be disclosed, directly or indirectly by a Party to the other Party, either orally or in writing, or through inspection as well as samples; except that Confidential Information shall not include information and know-how which the receiving
Party can show by competent proof: (a) was, at the time of disclosure, in the public domain, (b) has subsequent to disclosure, become part of the public domain through no fault, act, omission, or violation by the receiving Party of the
confidentiality obligations hereunder or under the MOU, the Secrecy Agreement dated of January 23, 2001 or the Clinical Supply Agreement, (c) was, at the time of disclosure, in the possession of the receiving Party and not otherwise acquired, directly or indirectly, from the disclosing Party, (d) has been developed independently by the receiving Party without access to the Confidential Information of the disclosing Party, or
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(e) has subsequent to disclosure been obtained by the receiving Party from any other third party,
provided however, that it was not obtained by said third party, directly or indirectly, from the disclosing Party under any obligation of confidentiality. 10.2 It is understood that a specific item of the Confidential Information shall not be deemed to be within the exceptions set forth in Section 10.1 above, if it is merely embraced by more general Confidential
Information within one of such exceptions. 10.3 Each receiving Party shall limit access to the Confidential Information from the
disclosing Party to those of its officers, employees and consultants who need to know such Confidential Information for the purpose of this Agreement and who will be advised of the conditions of this Agreement. In case a receiving Party wishes to
disclose Confidential Information to one of its consultants, it may only do so on a need to know basis and provided that such consultant agrees in writing to be bound to the terms of this Article 10 and gives LTS the right to enforce any breach of
such an agreement. 10.4 Each receiving Party shall not use Confidential Information of the disclosing Party to contest or challenge any
protected rights of, or applications for protection of rights by, the disclosing Party concerning such Confidential Information. 10.5
Permitted Uses and Disclosures. (a) Performance of this Agreement. Each Party hereto may use Confidential Information of the other Party as
is [***] necessary or to perform obligations hereunder or to exercise rights granted to it hereunder. (b) Disclosure to certain Third
Parties. NeurogesX may disclose Confidential Information of LTS to third parties in connection with sublicenses, strategic collaborations, equity or debt financing, IPO, merger, acquisition, changes of control or other similar transactions
(“Transactions”), for the sole purposes of enabling such third parties to conduct such Transactions and/or any diligence in connection with such Transactions. In the case of Confidential Information comprising batch records, manufacturing
instructions, details of the manufacturing process, specifications for materials, Transfer Price, quality audit reports and regulatory filings detailing manufacturing know-how and LTS patent applications, in each case relating to the Patch, prior to
disclosing such Confidential Information of LTS to a third party as described in this Section 10.5(b), NeurogesX shall first obtain a written confidentiality agreement with such third party that is reasonable and customary for such Transaction
or diligence, which specifies LTS as a third party beneficiary with respect to the Confidential Information of LTS disclosed to such third party. (c) Legal Requirements or Governmental Filings. In addition, each Party may use and disclose Confidential Information of the other Party to the extent such use or disclosure is necessary in prosecuting or defending litigation in accordance
with this Agreement, complying with applicable governmental laws, regulations, such as SEC regulations, or court order or otherwise submitting information to tax or other governmental authorities, in submissions to regulatory authorities, as a part
of patent applications filed on inventions made under this Agreement, or as a part of health registration applications; provided that if a Party is required by
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law to make any such disclosure, other than pursuant to a confidentiality agreement, it will give reasonable advance notice to the other Party of such
disclosure and, save to the extent inappropriate in the case of patent applications or the like, will use Reasonable Commercial Efforts to secure confidential treatment of such information. 10.6 Confidential Terms/Publicity. Each Party agrees not to disclose to any third party the terms of this Agreement without the prior written consent of
the other Party hereto, except each Party may disclose the terms of this Agreement (a) as required by securities or other applicable laws or regulations, such as SEC regulations or (b) to advisors, actual or potential investors,
acquisition partners, Sublicensees, and others on a need to know basis; provided, however, that in the case of clause (b), prior to disclosing the Transfer Price for the Patches to a third party, NeurogesX shall first obtain a written
confidentiality agreement with such third party that complies with Section 10.5(b) above. 10.7 Expiration or Termination of this
Agreement. Upon any expiration or termination of this Agreement, each Party shall promptly return all Confidential Information of the other Party, provided however, that each Party may retain such Confidential Information as reasonably necessary to
exercise rights hereunder or perform obligations hereunder that survive such expiration or termination, and each Party may retain one copy of the Confidential Information thereof in its legal files solely for archival purposes. ARTICLE 11 TERM AND TERMINATION
11.1 Term. Unless terminated in accordance with this Article 11, this Agreement shall be in effect until ten (10) years after the
first Calendar Quarter of delivery of Patches hereunder. The term shall be automatically renewed for additional two (2) year terms, unless terminated by either Party with two (2) years prior written notice. 11.2 Termination for Breach. Each Party shall have the right to terminate this Agreement upon written notice, in the event of the other Party''''''''''''''''s (the
“Breaching Party”) material breach hereof which is not cured within sixty (60) after notice specifying such breach. Notwithstanding the foregoing, in the event that within the sixty (60) day period after receiving a notice under
this Section 11.2, the Breaching Party disputes in good faith that there has been a material breach, then such dispute shall be resolved in accordance with Section 12.1 below, and this Agreement shall not be terminated under this
Section 11.2 until it has been finally determined in accordance with Section 12.1(b) below that the Breaching Party has materially breached this Agreement, and such Breaching Party fails to comply with this Agreement within sixty
(60) days thereafter. 11.3 Termination due to Blocking Patents in a Country. Either Party shall have the right to terminate this
Agreement with respect to a particular country upon written notice, in the event that a court of competent jurisdiction determines in a final non-appealable judgment, in a case involving one of the Parties or a Sublicensee of NeurogesX, that the
manufacture or sale of the Patch in such country pursuant to this Agreement infringes a Blocking Patent. In the event a Party or a Sublicensee thereafter obtains a license with respect to such Blocking Patent in such country, or otherwise removes in
the reasonable opinion of the other Party''''''''''''''''s counsel the risk of
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infringing a Blocking Patent in such jurisdiction, the Parties shall discuss in good faith to resume their obligations (including the terms and conditions
thereof) under this Agreement with respect to such country. 11.4 Other Termination. (a) Failure Event. NeurogesX shall have the right to terminate this Agreement at any time in the case of a Failure Event (as defined in Section 6.4),
provided that such Failure Event is due to LTS not employing [***] to supply Patches. In case NeurogesX purchases all its commercial requirements of Patches from a third party after a Failure Event, then LTS shall have the right to terminate the
Agreement upon written notice. In case LTS declines the offer to supply NeurogesX''''''''''''''''s requirements set forth in Section 6.4(e), either Party shall have the right to terminate the Agreement upon written notice. (b) Termination upon Abandonment of the Patch. NeurogesX shall have the right to terminate this Agreement upon [***] months written notice in the event
NeurogesX and its Sublicensees have abandoned development and commercialization of the Patch worldwide. In this case LTS may discuss with NeurogesX obtaining a license for its development and commercialization of the Patches on terms (financial and
otherwise) to be mutually agreed; provided that neither Party shall be obligated to discuss such license for more than [***] and neither Party shall be obligated to agree to granting or accepting such license, nor any particular terms and conditions
for such license. 11.5 Survival. Sections 3.2, 3.8 (to the extent necessary to comply with the other Party''''''''''''''''s legal obligations after
expiration or termination), 3.9 (with respect to Patches supplied by LTS to NeurogesX prior to such expiration or termination), 6.2, 6.4, 6.5, 7.1, 7.2, 7.4 and Articles 1, 8 (with respect to Patches delivered by LTS under this Agreement), 9 (with
respect to Patches delivered by LTS under this Agreement), 10, 11 and 12 shall survive any expiration or termination of this Agreement. Except as set forth in this Section 11.5, all other sections of this Agreement shall terminate upon any
expiration or termination of this Agreement. (a) Accrued Liabilities. Termination of this Agreement for any reason shall not release
either Party hereto from any liability which at the time of such termination has already accrued to the other Party. (b) Backup
Manufacturing License. In the event of termination of this Agreement by NeurogesX under Section 11.4(a) or 11.2 or by LTS under Section 11.4(a) or 11.3 any time after NeurogesX has the right to exercise its Backup License the following
Sections shall survive (in addition to those described in Section 11.5 above), Sections 5.3 (as it relates to Section 6.4), 6.4, and 7.3 shall survive such termination. For clarity, an election to have this Agreement expire after a Failure
Event shall be treated as a termination of this Agreement under Section 11.4(a) by either or both Parties. In any other termination or expiration of this Agreement, Section 7.3 shall survive only with respect to infringement occurring
prior to such termination or expiration. (c) Pending Orders. In the event of any termination or expiration of this Agreement other than
termination under Section 11.2, 11.3 or 11.4(a), unless otherwise mutually agreed, all pending orders for the Patches shall be cancelled, and NeurogesX shall reimburse LTS for the
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cost of Raw Materials and works-in-progress of Patches that cannot be used by LTS in the manufacture of products for its other clients, and such Raw
Materials and works-in-progress shall be disposed of or transferred in accordance with NeurogesX''''''''''''''''s instruction at NeurogesX''''''''''''''''s expense. In the event of termination of this Agreement under Section 11.3 with respect to a country, unless
otherwise mutually agreed, all pending orders for Patches specifically for such country shall be cancelled. ARTICLE 12
MISCELLANEOUS 12.1 Dispute
Resolution. (a) Disputes. The Parties shall attempt in good faith to resolve promptly any dispute arising out of or relating to this
Agreement by negotiation. If the matter cannot be resolved in the normal course of business, any interested Party shall give to the other Party written notice of any such dispute not resolved, after which the dispute shall be referred to the
principal executive officers of both Parties or their designees who shall likewise attempt to resolve the dispute. If the dispute has not been resolved by negotiations within [***] days of such written notice, each Party may have the dispute
arbitrated in accordance with Section 12.1(b) below. (b) Arbitration. Any dispute or claim arising out of or in connection with this
Agreement or the performance, breach or termination thereof, shall be finally settled by binding arbitration under the rules of arbitration of the International Chamber of Commerce by [***] appointed in accordance with said rules, unless the Parties
have agreed to have only [***]. The decision and/or award rendered by the arbitrator(s) shall be written, final and non-appealable, and judgment on such decision and/or award may be entered in any court of competent jurisdiction. The arbitral
proceedings and all pleadings and evidence shall be in the English language. Any evidence originally in a language other than English shall be submitted with an English translation accompanied by an original or true copy thereof. The place of
arbitration shall be in [***]. The costs of any arbitration, including administrative fees and fees of the arbitrator(s), shall be shared equally by the Parties, unless otherwise determined by the arbitrator(s). Each Party shall bear the cost of its
own attorneys'''''''''''''''' and expert fees. (c) THE UNDERSIGNED PARTIES ACKNOWLEDGE THAT THE RIGHT TO TRIAL BY JURY IS A CONSTITUTIONAL ONE, BUT
THAT IT MAY BE WAIVED AND AFTER CONSULTING WITH COUNSEL, KNOWINGLY AND VOLUNTARILY WAIVE ANY RIGHT TO TRIAL BY JURY IN THE EVENT OF LITIGATION REGARDING THE PERFORMANCE OR ENFORCEMENT OF, OR IN ANY WAY RELATED TO, THIS AGREEMENT AND ANY AGREEMENT
CONNECTED THERETO. 12.2 Governing Law. This Agreement shall be governed by, and construed and interpreted in accordance with, the laws of
the [***], United States of America (including U.S. federal law), without regard to conflict of laws principles. 12.3 Assignment. Neither
Party shall have the right to assign this Agreement or its rights hereunder without a prior written consent of the other Party; provided, however, that no
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consent is required in connection with a sale or transfer of all or substantially all of the assets, securities or business of the assigning Party whether by
sale, merger, operation of law, reincorporation or otherwise. 12.4 Independent Contractors. The relationship of LTS and NeurogesX
established by this Agreement is that of independent contractors. Nothing in this Agreement shall be construed to create any other relationship between LTS and NeurogesX. Neither Party shall have any right, power or authority to assume, create or
incur any expense, liability or obligation, express or implied, on behalf of the other Parties. 12.5 English Language. This Agreement is
in the English language only, which language shall be controlling in all respects, and all versions of this Agreement in any other language shall not be binding on the Parties hereto. All communications and notices to be made or given pursuant to
this Agreement shall be in the English language. 12.6 Force Majeure. Neither Party shall be responsible or liable to the other Party for,
nor shall this Agreement be terminated as a result of, any failure to perform any of its obligations hereunder, if such failure results from circumstances beyond the control of such Party, including, without limitation, requisition by any government
authority, the effect of any statute, ordinance or governmental order or regulation, wars, strikes, lockouts, riots, epidemic, disease, an act of God, civil commotion, fire, earthquake, storm, failure of public utilities, common carriers or
supplies, or any other circumstances, whether or not similar to the above causes and whether or not foreseeable (each, a “Force Majeure”). The Parties shall use their Reasonable Commercial Efforts to avoid or remove any such cause and
shall resume performance under this Agreement as soon as feasible whenever such cause is removed; provided, however, that the foregoing shall not be construed to require either Party to settle any dispute with any third party, to commence, continue
or settle any litigation, or to incur any unusual or extraordinary expenses. 12.7 Notices. Any notice or other communication required by
this Agreement shall be made in writing and given by prepaid, first class, certified mail, return receipt requested, and shall be deemed to have been given on the date received by the addressee at the following address or such other address as may
from time to time be designated to the other Party in writing:
If to NeurogesX:
NeurogesX, Inc.
San Carlos Business Park,
981F Industrial Road,
San Carlos, CA 94070
United States of America
Attn: President
If to LTS:
LTS Lohmann Therapie-Systeme AG,
Lohmannstraße 2,
D-56626 Andernach,
Germany
Attn: General Counsel
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12.8 Compliance with Law. Each Party shall comply with all applicable national and local laws and
regulations in connection with its activities pursuant to this Agreement. 12.9 No Waiver. A waiver, express or implied, by either LTS or
NeurogesX of any right under this Agreement or of any failure to perform or breach hereof by the other Party hereto shall not constitute or be deemed to be a waiver of any other right hereunder or of any other failure to perform or breach hereof by
such other Party, whether of a similar or dissimilar nature thereto. 12.10 Severability. If any provision of this Agreement shall be found
by a court to be void, invalid or unenforceable, the same shall be reformed to comply with applicable law or stricken if not so conformable, so as not to affect the validity or enforceability of the remainder of this Agreement, and the remainder of
this Agreement shall remain in full force and effect. 12.11 Entire Agreement. This Agreement and the Clinical Supply Agreement, together
with their Exhibits, constitute the entire understanding and agreement between the Parties as of the Effective Date with respect to the subject matter hereof and supersedes any and all prior and contemporaneous negotiations, representations,
agreements, and understandings, written or oral, that the Parties may have reached with respect to the subject matter hereof. No agreements altering or supplementing the terms hereof may be made except by means of a written document signed by the
duly authorized representatives of each of the Parties hereto. Upon execution of this Agreement, the Secrecy Agreement dated January 23, 2001 executed between LTS Lohmann Therapy-Systems Corp. and NeurogesX and Sections 6.2, 7.3, 8.3, and 8.4
and Article 11 of the Clinical Supply Agreement shall be terminated and shall be of no further force and effect. Except as amended or qualified in this Agreement, and except as inconsistent with the provisions of this Agreement, the Clinical Supply
Agreement shall remain in full force and effect in accordance with its terms. 12.12 Article and Section Headings, Language and
Construction. The article and section headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement. All references in this Agreement to “Articles,”
“Sections” and “Exhibits” refer to the articles, sections and exhibits of this Agreement. The words “hereof,” “herein” and “hereunder” and other words of similar import refer to this Agreement as a
whole and not to any subdivision contained in this Agreement. The words “include” and “including” when used herein are not exclusive and mean “include, without limitation” and “including, without limitation,”
respectively. This Agreement has been negotiated by the Parties and their respective counsel. Accordingly, this Agreement will be interpreted fairly in accordance with its terms and without any strict construction in favor of or against either
Party. 12.13 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but both of which
together shall constitute one and the same instrument. IN WITNESS WHEREOF, the Parties have caused their duly authorized representatives
to execute this Agreement on the dates set forth below.
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NeurogesX, Inc.
LTS Lohmann Therapie-Systeme AG
By:
/s/ Anthony DiTonno
By:
/s/ Marc Deuker
Name:
Anthony DiTonno
Name:
Marc Deuker
Title:
President and Chief Executive Officer
Title:
Head of Sales and Marketing
Date: 1-28-2207
Date: January 19th, 2007
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Exhibits
Exhibit A:
Transfer Price
Exhibit B:
VR1-Ligands
Exhibit C:
Patch Specifications
Exhibit D:
Active Ingredient Specifications
Exhibit E:
Quality Assurance Agreement
Exhibit F:
LTS Liability Insurance
Exhibit G:
Maximum Capacity
Exhibit H:
List of Patents/Patent Applications
Exhibit I:
Stability Testing
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EXHIBIT A TRANSFER PRICE The prices represent delivery in bulk, printing on front side of the pouch in [***]
colours and lacquer and backside as random print in one colour. Above [***] patches [***] : [***] / Patch Above [***] patches [***] : [***] / Patch Above [***] patches [***] : [***] / Patch Above [***] patches [***] : [***] / Patch Above [***] patches [***] : [***] / Patch All prices are Ex Works Andernach plus prospective legal taxes. The minimum quantity per label version is [***] pieces each.
Annual minimum volume: [***] Patches Product description: Patch Size: [***] Consisting of: [***] Coated with: [***] Covered by: [***] Punched: [***]
Packed in: [***] Theoretical Batch size: [***] Patches based on mass preparation of [***]
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EXHIBIT B VR1-LIGANDS [***]
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has been requested with respect to the omitted portions.
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EXHIBIT C PATCH SPECIFICATIONS [Information in the Patch Specifications will be updated with information
from final marketing approval including packaging information. Specifications will also include compliance with GMP and all applicable laws and regulations]
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EXHIBIT D ACTIVE INGREDIENT SPECIFICATIONS [to be attached]
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EXHIBIT E QUALITY ASSURANCE AGREEMENT [to be attached]
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EXHIBIT F LTS LIABILITY INSURANCE
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Versicherungsbestätigung
Confirmation of Insurance
Art der Versicherung Betriebs-Haftpflichtversicherung inkl. Produkthaftpflicht (Grundvertrag)
Type of Cover General Liability, including products liability (Primary)
Summen-Anschlußversicherungen
Excess-Layers
Versicherungsschein Nr. [***]
Policy No.
[***]
Versicherungenehmer
Named insured
LTS Lohmann Therapie-Systeme AGLohmannstr. 2 56623
Andernach
Versicherungsbeginn [***]
Inception
[***]
Versicherungsablauf [***] Uhr MEZ Der Verträge verlängern sich still-schweigend um ein Jahr, sofem diese nicht
unter Einhaltung einer drei-monatigen Kon-digungsfrist vor dem Ablauf von einem der Vertragspartelen schriftlich gekündigt werden.
Expiry [***] The policies will be automatically renewed for a further year, unless one of the contracting
parties gives written notice three months before the date of expiration
Örtlicher Geltungsbereich [***]
Policy Territory [***]
Deckungssummen [***]
Limits of Indemnity [***]
Betriebshaftpflicht EUR 10.000.000,00 [***]
General Liability [***]
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Rechts - und Gerichtsstand [***]
Governing Law and Jurisdiction . [***]
Hinweis [***]
Annotation [***]
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-123-
Bestätigung der Versicherer: [***]
Confirmation of Insurer: [***]
XL Insurance Company Ltd. Direction of Germany München
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-124-
Bestätigung der Versicherer: [***]
Confirmation of Insurer: [***]
Gerling Allgemeine Versicherungs-AG
Düsseldorf
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-125-
EXHIBIT G MAXIMUM CAPACITY The maximum capacity is [***] Patches per year.
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-126-
EXHIBIT H LIST OF PATENTS/PATENT APPLICATIONS Mikroreservoirsystem Familie: 19930340
Country
EP
WO
File-No
Priority date
Patent-No
granted
Status
AR P
[***]
[***]
[***]
applied
AT P
EP
WO
[***]
[***]
[***]
12.03.03
granted
AU P
WO
[***]
[***]
[***]
11.11.04
granted
BE P
EP
WO
[***]
[***]
[***]
12.03.03
granted
BR P
WO
[***]
[***]
[***]
applied
CA P
WO
[***]
[***]
[***]
applied
CH P
EP
WO
[***]
[***]
[***]
12.03.03
granted
CN P
WO
[***]
[***]
[***]
applied
CZ P
WO
[***]
[***]
[***]
applied
DE P
EP
WO
[***]
[***]
[***]
12.03.03
granted
DK P
EP
WO
[***]
[***]
[***]
12.03.03
granted
EP P
WO
[***]
[***]
[***]
12.03.03
granted
ES P
EP
WO
[***]
[***]
[***]
12.03.03
granted
FI P
EP
WO
[***]
[***]
[***]
12.03.03
granted
FR P
EP
WO
[***]
[***]
[***]
12.03.03
granted
GB P
EP
WO
[***]
[***]
[***]
12.03.03
granted
GR P
EP
WO
[***]
[***]
[***]
12.03.03
granted
HK P
WO
[***]
[***]
[***]
applied
HU P
WO
[***]
[***]
[***]
applied
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-127-
IE P
EP
WO
[***]
[***]
[***]
12.03.03
granted
IL P
WO
[***]
[***]
[***]
applied
IN P
WO
[***]
[***]
[***]
applied
IT P
EP
WO
[***]
[***]
[***]
12.03.03
granted
JP P
WO
[***]
[***]
[***]
applied
KR P
WO
[***]
[***]
[***]
applied
LU P
EP
WO
[***]
[***]
[***]
12.03.03
granted
MX P
WO
[***]
[***]
[***]
applied
NL P
EP
WO
[***]
[***]
[***]
12.03.03
granted
NZ P
WO
[***]
[***]
[***]
06.10.03
granted
PH P
[***]
[***]
[***]
applied
PL P
WO
[***]
[***]
[***]
applied
PT P
EP
WO
[***]
[***]
[***]
12.03.03
granted
RU P
WO
[***]
[***]
[***]
applied
SE P
EP
WO
[***]
[***]
[***]
12.03.03
granted
TR P
WO
[***]
[***]
[***]
22.07.02
granted
TW P
[***]
[***]
[***]
applied
ZA P
WO
[***]
[***]
[***]
24.12.02
granted
DE P
[***]
[***]
[***]
13.06.02
granted
TW P
[***]
[***]
[***]
applied
US P
WO
[***]
[***]
[***]
applied
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-128-
Capsaicinpflaster Familie: 2003/103
Country
EP
WO
File-No
Priority date
Patent-No
granted
Status
WO P
[***]
[***]
[***]
applied
US P
[***]
[***]
[***]
applied
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-129-
EXHIBIT I STABILITY TESTING PROGRAM [To be completed and attached]
-130-
CONFIDENTIAL June 5, 2009 LTS LOHMANN Therapie-Systeme AG Lohmannstrasse 2 D-56626, Andernach, Germany Attn:
Klaudia Haczkiewicz
Re:
Amendment 1 to the Commercial Supply and License Agreement Dear Klaudia: The following sets forth certain amendments to the Commercial Supply and License Agreement entered into by LTS LOHMANN
Therapie-Systeme AG (“LTS”) and NeurogesX, Inc. (“NeurogesX”) of January 28, 2007 (the “Agreement”), as agreed to by the Parties as of the date set forth in the signature line below. Unless otherwise defined in
this letter, all terms shall have the meaning given to such terms in the Agreement.
•
LTS and NeurogesX hereby agree to extend the term of the Agreement until the expiration of the last patent within the Commercialization Patents covering the Patch.
Accordingly, Section 11.1 of the Agreement shall be amended to read as follows: “11.1 Unless terminated in
accordance with this Article 11, this Agreement shall continue in effect on a country-by-country basis until the expiration, revocation or invalidation of the last patent within the Commercialization Patents that covers the Patch in such
country. The term shall be automatically renewed for additional two (2) year terms, unless terminated by either Party with two (2) years prior written notice.”
•
LTS and NeurogesX hereby agree to amend the Agreement to permit the survival of sublicenses granted by NeurogesX to its Sublicensees. Accordingly, The following
shall be added to the Agreement as Section 11.5(d): “11.5(d) Survival of Sublicenses. Upon termination
of this Agreement for any reason, any sublicense granted by NeurogesX to a Sublicensee in accordance with Section 6.5 shall survive, and such Sublicensee shall be entitled to continue to purchase Patches from LTS under the terms of the
Agreement, provided that upon request by LTS, each Sublicensee shall promptly agree in writing to be bound by the applicable terms of this Agreement.
Unless otherwise specifically amended herein, all terms of the Agreement shall remain as set forth in the Agreement.
Please sign below to indicate LTS'''''''''''''''' agreement with the foregoing.
Very truly yours,
/s/ Stephen F. Ghiglieri
Stephen F. Ghiglieri Chief Financial
Officer
LTS LOHMANN THERAPIE-SYSTEME AG
By:
/s/ U. Sielaff
By:
/s/ K. Haczkiewicz
U. Sielaff, General Counsel
K. Kaczkiewicz, Head of Business Development
Date:
June 05, 2009
Date:
June 05, 2009
EXHIBIT 1.40 PATENT RIGHTS [***]:
Title
Region/Country
Status
ApplicationNumber
FileDate
PatentNumber
GrantDate
DesignatedCountries
Inventors
Owner
[***]
[***]
[***]
[***]
[***]
[***]
[***]
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[***]
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[***]
[***]
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[***]
[***]
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[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
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[***]
[***]
[***]
[***]
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[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
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[***]
[***]
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[***]
[***]
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[***]
[***]
[***]
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
Title
Region/Country
Status
ApplicationNumber
FileDate
PatentNumber
GrantDate
DesignatedCountries
Inventors
Owner
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
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[***]
[***]
[***]
[***]
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[***]
[***]
[***]
[***]
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[***]
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[***]
[***]
[***]
[***]
[***]:
[***]
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[***]
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[***]
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[***]
[***]
[***]
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-134-
EXHIBIT 1.44 PRODUCT TRADEMARK AND ALTERNATIVE TRADEMARK
MarkSerial NumberRegistration NumberApplicant
Country
Status
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
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[***]
[***]
*
European Community Trademark Countries: [***].
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
EXHIBIT 1.48 TERRITORY
A.
European Region European Union (present and future member states):
Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland
Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Romania Slovakia Slovenia Spain Sweden United Kingdom Norway
Iceland Liechtenstein Switzerland Andorra Monaco San Marino Vatican City
B.
SATR Region South Africa Turkey Russia
C.
Rest of Territory Region Armenia Azerbaijan Belarus Georgia Kazakhstan Kyrgyzstan Moldova Tajikistan Turkmenistan Ukraine Uzbekistan Albania Bosnia & Herzegovina Croatia Kosovo Macedonia Montenegro Serbia
Republic Srpska Bahrain Gaza Strip [***] Iraq Israel Jordan Kuwait Lebanon
Oman Qatar Saudi Arabia [***] United Arab Emirates West Bank (Palestine) Yemen Algeria Egypt Libya Morocco
Tunisia Benin Cameroon Chad Ivory Coast Guinea Mali
Mauritania Niger Senegal Togo Angola Burkina Faso Mozambique Botswana Central African Republic
Congo Democratic Republic of Congo Ethiopia Gabon Ghana Kenya Lesotho
Liberia Madagascar Mauritius Namibia Nigeria Somalia
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-137-
[***] Swaziland
Tanzania Zambia Zimbabwe
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-138-
EXHIBIT 1.51 UC LICENSE AGREEMENT
EXCLUSIVE LICENSE AGREEMENT between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA and NEUROGESX, INC. for HIGH DOSE CAPSAICIN FOR NEUROPATHIC PAIN
UCSF Case No. SF00-056
UC Case No. SF00-056 EXCLUSIVE LICENSE AGREEMENT For HIGH DOSE CAPSAICIN FOR NEUROPATHIC PAIN This license agreement (the “Agreement”) is made
effective November 1, 2000 (the “Effective Date”) between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California 94607-5200,
(“The Regents”), and acting through its Office of Technology Management, University of California San Francisco, 1294 Ninth Avenue – Suite 1, Box 1209, San Francisco, CA 94143-1209 (“UCSF”), and NEUROGESX, INC., a
Delaware corporation having a principal place of business at 2215 Bridgepointe Parkway, Suite 200, San Mateo, California, (the “Licensee”). BACKGROUND A. Certain inventions, generally characterized as “High Dose Capsaicin Relieves
Neuropathic Pain” (collectively the “Invention”), were made in the course of research at the University of California San Francisco by Wendye R. Robbins as described in UCSF Case Number SF00-056, and are covered by Regents''''''''''''''''
Patent Rights as defined below; B. The Licensee has evaluated the Invention under a Secrecy Agreement with The Regents effective
August 20, 1999 (U.C.Control No. 2000-20-0104); E. The Licensee and The Regents have executed a Letter of Intent dated
June 1, 2000 (U.C.Control No. 2000-30-0050) for the purpose of negotiating a license to Regents'''''''''''''''' Patent Rights; F. The
Licensee wishes to obtain rights from The Regents for the commercial development, use, and sale of products from the Invention, and The Regents is willing to grant those rights so that the Invention may be developed to its fullest and the benefits
enjoyed by the general public; and G. The Licensee is a “small business firm” as defined in 15 U.S.C. §632; H. Licensee recognizes and agrees that royalties due under this Agreement will be paid on both pending patent applications and issued patents;
In view of the foregoing, the parties agree: 1. DEFINITIONS 1.1 “Regents'''''''''''''''' Patent Rights” means the Regents'''''''''''''''' interest in any subject matter claimed in or
covered by any of the following: Pending U.S. Patent Application Serial No. 08/746,207 entitled “Therapeutic Method with Capsaicin and Capsaicin Analogs” filed November 6, 1996, the
continuation-in-part U.S. Patent Application Serial No. 08/990,633 entitled “Transdermal Therapeutic Device and Method with Capsaicin and Capsaicin
Analogs” filed December 15, 1997 and assigned to The Regents; and continuing applications thereof including divisions, substitutions, continuation-in-part applications (but only to the extent however, that claims in the
continuation-in-part applications are entitled to the priority filing date of the foregoing applications); any patents issuing on said applications including reissues, reexaminations and extensions; and any corresponding foreign applications or
patents based on said applications. 1.2 “Licensed Product” means any material for which the manufacture, use, sale, or import
would constitute an infringement of a Valid Claim within the Regents'''''''''''''''' Patent Rights if not for the license granted to the Licensee under this Agreement. 1.3 “Licensed Method” means any method for which the use or sale would constitute an infringement of a Valid Claim within the Regents'''''''''''''''' Patent Rights if not for the license granted to the Licensee under
this Agreement. 1.4 “Net Sales” means the total of the gross invoice prices of Licensed Products sold or Licensed Methods
performed by the Licensee, an Affiliate, or a Sublicensee, less the sum of the following actual and customary deductions where applicable: cash, trade, or quantity discounts; sales, use, tariff, import/export duties or other excise taxes imposed on
particular sales; transportation charges and allowances (including insurance); or credits to customers because of rejections, returns, or expired goods. For purposes of calculating Net Sales, transfers to an Affiliate or Sublicensee for end use by
the Affiliate or Sublicensee will be treated as sales to an independent third party for purposes of calculating earned royalties (as specified in Article 7) 1.5 “Affiliate” means any corporation or other business entity in which the Licensee owns or controls, directly or indirectly, at least fifty percent (50%) of the outstanding stock or other voting
rights entitled to elect directors, or in which the Licensee is owned or controlled directly or indirectly by at least fifty percent (50%) of the outstanding stock or other voting rights entitled to elect directors; but in any country where the
local law does not permit foreign equity participation of at least fifty percent (50%), then an “Affiliate” includes any company in which the Licensee owns or controls or is owned or controlled by, directly or indirectly, the maximum
percentage of outstanding stock or voting rights permitted by local law. 1.6 “Field of Use” means all fields and uses.
1.7 “Commercial Sale” means with respect to each Licensed Product in each country, a bona fide commercial sale of such Licensed
Product following marketing approval by the regulatory authority in such country; provided that where such a first commercial sale has occurred in a country for which government pricing or government reimbursement approval is needed for widespread
commercial sale (for clarification, the parties acknowledge that no such approval is required in the United States) then a sale shall not be deemed a Commercial Sale until such pricing or reimbursement approval has been obtained.
-142-
1.8 “IND” means an Investigational New Drug Application, as defined in the U.S. Federal Food,
Drug and Cosmetic Act and the regulations promulgated thereunder, or comparable filing in a foreign jurisdiction, in each case with respect to a Licensed Product. 1.9 “NDA” means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, and all subsequent supplements to that NDA, as well as any equivalent
foreign application, registration or certification in the relevant country, such as a Marketing Approval Application (“MAA”) in Europe, in each case with respect to a Licensed Product. 1.10 “Phase I” means a clinical trial involving the initial introduction of a Licensed Product into humans and which is designed to determine
the metabolism and pharmacologic actions of the Licensed Product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. 1.11 “Phase III” means human clinical trials of a Licensed Product performed after obtaining preliminary evidence suggesting effectiveness of
the drug, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug, to provide an adequate basis for physician labeling, and to form the basis
for approval to market such Licensed Product. 1.12 “Valid Claim” means a claim of an issued and unexpired patent or a claim of a
pending patent application within the Regents'''''''''''''''' Patent Rights which has not been held invalid or unenforceable by a court or other government agency of competent jurisdiction from which no appeal can be or has been taken, and has not been
admitted to be invalid or unenforceable through re-examination, disclaimer or otherwise; provided that if a claim of a pending application has not issued as a claim of an issued patent within the Regents'''''''''''''''' Patent Rights within ten
(10) years after the filing date from which such claim takes priority, such pending claim shall not be a Valid Claim for purposes of this Agreement until such time as such claim issues. 1.13 “Sublicensee” means, with respect to a particular Licensed Product, a third party to whom Licensee has granted a right or license to both
make and sell such Licensed Product or practice the Licensed Method. As used in this Agreement, “Sublicensee” shall also include a non-Affiliate third party to whom Licensee has granted a right to distribute such Licensed Product, provided
that such third party is responsible for some or all of the marketing and promotion of such Licensed Product within the territorial region in which it has such sublicensed rights. 2. LIFE OF PATENT EXCLUSIVE GRANT 2.1 Subject to the limitations set forth in this Agreement, The Regents
grants to the Licensee a world-wide license under Regents'''''''''''''''' Patent Rights to make, have made, use, sell, offer to sell, import and have imported Licensed Products, to practice Licensed Methods, and to otherwise exploit the Regents'''''''''''''''' Patent
Rights, and to have each of the foregoing performed by a third party on Licensee''''''''''''''''s behalf.
-143-
2.2 Except as otherwise provided in this Agreement, the license granted in Paragraph 2.1 is
exclusive for the life of this Agreement. 2.3 The license granted in Paragraphs 2.1 and 2.2 is limited to methods and products that
are within the Field of Use. For other methods and products, the Licensee has no license under this Agreement. 2.4 To the extent it is
legally able, The Regents also grants Licensee a non-exclusive license to any proprietary know-how relating to Regents'''''''''''''''' Patent Rights that The Regents has an interest in and is reasonably needed by Licensee to practice and/or commercially
develop Licensed Products and/or Licensed Methods. 2.5 The Regents reserves the nontransferable right to use the Invention and associated
technology for its own bona fide non-commercial research and education purposes. 3. SUBLICENSES 3.1 The Regents also grants to the Licensee the worldwide right to issue sublicenses to third parties to make, have made, use, sell, offer to sell, import
and have imported Licensed Products, to practice Licensed Methods, and to otherwise exploit the Regents'''''''''''''''' Patent Rights, in each case as long as the Licensee has current exclusive rights thereto under this Agreement. Each sublicense shall be
subordinate to the terms and conditions of this Agreement (including, if applicable, those regarding the U.S. Government''''''''''''''''s and other sponsors'''''''''''''''' rights and the rights reserved by The Regents). 3.2 In addition, Licensee shall pay The Regents a percentage of all sublicense fees (as defined below). 3.2.1 For purposes of this Agreement, “sublicense fees” shall consist of amounts received in the form of up-front fees and milestone
payments as direct consideration for the grant of a sublicense for Licensed Products under the Regents'''''''''''''''' Patent Rights, but shall not include any amounts received as royalties on sales of Licensed Products, as support for research and
development activities, as a loan, as income derived from debt financing, for the purchase of an equity interest in the Licensee, as reimbursement for patent and patent related expenses, as earned royalties on net sales, or as consideration for the
grant of intellectual property rights and materials other than those claimed under Regents'''''''''''''''' Patent Rights. Licensee shall pay The Regents the following percentages of sublicense fees:
Percentage
Aggregate Sublicense Fees
25%
$2,000,000
-144-
3.2.2 For purposes of calculating the applicable percentage for the foregoing, “Aggregate Sublicense
Fees” shall be the cumulative amount of sublicense fees stated in each sublicense of Regents'''''''''''''''' Patent Rights entered into by Licensee and assuming that all milestone payments therein are made to Licensee. However, the actual
sublicensee fee payments due The Regents from Licensee shall be determined based on the actual amounts of sublicensee fees received by Licensee in each calendar year during the term of this Agreement. 3.3 The Licensee shall promptly provide The Regents with a copy of each sublicense issued; collect all payments due The Regents from Sublicensees; and
summarize and deliver all reports due The Regents from Sublicensees, provided that the Licensee may redact from such copy any terms which are not necessary to determine whether Licensee has complied with its obligations under this Agreement.
3.4 Upon termination of this Agreement for any reason, any sublicense granted by Licensee hereunder shall survive, provided that upon
request by The Regents, each Sublicensee promptly agrees in writing to be bound by the applicable terms of this Agreement.. 4. PAYMENT TERMS
4.1 Licensee shall pay to The Regents earned royalties (as specified in Section 7) on Net Sales of Licensed Products on a Licensed
Product-by-Licensed Product and country-by-country basis. The earned royalty due pursuant to this Section will continue on such basis until the manufacture, use or sale of a Licensed Product in such country does not infringe a Valid Claim
within the Regents'''''''''''''''' Patent Rights. 4.2 Licensee shall pay earned royalties quarterly on or before February 28,
May 31, August 31 and November 30 of each calendar year. Each payment will be for earned royalties accrued within the Licensee''''''''''''''''s most recently completed calendar quarter. 4.3 Licensee shall pay the applicable percentage of sublicense fees to The Regents on or before February 28 of each calendar year. Each
payment will be for sublicensee fees received by Licensee during the most recently completed calendar year. 4.4 [Intentionally left
blank] 4.5 All monies due The Regents are payable in United States dollars. When Licensed Products are sold for monies other than United
States dollars, the Licensee shall first determine the applicable earned royalty in the currency of the country in which Licensed Products were sold and then convert the amount into equivalent United States funds, using the exchange rate
quoted in the Wall Street Journal on the last business day of the reporting period. In no event shall the Licensee be required to pay The Regents more than twenty-five (25%) of its total annual revenue derived from Licensed Products.
4.6 Earned royalties earned on sales occurring in any country outside the United States may not be reduced by any taxes, fees, or
other charges imposed by the government of such country on the payment of royalty income. The Licensee is also responsible for all bank transfer charges. Notwithstanding this, all payments made by the Licensee in fulfillment of The Regents'''''''''''''''' tax
liability in any particular country will be credited against earned royalties or fees due The Regents for sales of Licensed Products in that country.
-145-
4.7 If at any time legal restrictions prevent the prompt remittance of earned royalties by the
Licensee from any country where a Licensed Product is sold, the Licensee shall deposit the amount owed in an interest-bearing account within that country until such time as the restrictions are lifted, at which time the Licensee shall promptly
convert the current balance of said account into United States funds and pay such amount to The Regents. 4.8 If any patent or Valid Claim
within Regents'''''''''''''''' Patent Rights is held invalid in a final decision by a court of competent jurisdiction and last resort and from which no appeal has or can be taken, all obligation to pay earned royalties based on that patent or Valid
Claim or any Valid Claim patentably indistinct therefrom will cease as of the date of final decision. The Licensee will not, however, be relieved from paying any earned royalties that accrued before the final decision or that are based on
another patent within Regents'''''''''''''''' Patent Right or Valid Claim not involved in the final decision. 4.9 If payments, rebillings or fees
are not received by The Regents when due, the Licensee shall pay to The Regents interest charges on the unpaid amount at a rate often percent (10%) per annum or the maximum permitted by law, whichever is less. Interest is calculated from the
date due until actually received by The Regents. 5. LICENSE-ISSUE FEE 5.1 Within sixty (60) days after the Effective Date, the Licensee shall pay to The Regents a license-issue fee equal to the total amount of out-of-pocket costs and expenses of patent prosecution of the
Regents'''''''''''''''' Patent Rights incurred by The Regents through the Effective Date. This fee is non-refundable, non-cancelable, and is not an advance against earned royalties. 6. LICENSE MAINTENANCE FEE 6.1 [Intentionally left blank] 7. EARNED ROYALTIES, MINIMUM ANNUAL ROYALTIES AND MILESTONE PAYMENTS 7.1 The Licensee shall also pay to The Regents an earned royalty of one-half percent (0.5%) of the Net Sales of Licensed Products worldwide, up to a maximum of one million dollars ($1,000,000) per year. 7.2 If it becomes necessary for Licensee to license intellectual property rights from an unaffiliated third party, and Licensee is required to pay a
royalty to that unaffiliated third party in order to practice Licensed Methods and make, use or sell Licensed Products, and the combined earned royalty due The Regents and unaffiliated third parties exceeds eleven percent (11%), then the
earned royalties to be paid to The Regents by Licensee shall be reduced by an amount equal to one-half (1/2) the excess over eleven percent (11%) of the royalty rate(s) due to the unaffiliated third party(ies). However, in no event
shall the amount paid to The Regents be reduced below fifty percent (50%) of the original earned royalty otherwise due The Regents.
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7.3 No cumulation of earned royalties shall be made in the event a Licensed Product is covered by
Valid Claims of more than one patent within Regents'''''''''''''''' Patent Rights. 7.4 No earned royalty shall be payable under this
Article 7 with respect to transfers of Licensed Product to Affiliates, Sublicensees, customers or prospective customers for use in research and/or development, in clinical trials or other regulatory purposes, as samples, or in any other
transfer that is not a Commercial Sale. 7.5 In the event that a Licensed Product is sold in combination with other products, components or
services (other than another Licensed Product having therapeutic activity) for which no amounts would be payable to The Regents if such other products, components or services having therapeutic activity were sold or performed separately, amounts
invoiced for such combination sales for purposes of calculating Net Sales of the Licensed Product in such combination shall be the Net Sales of the Licensed Product calculated by multiplying the Net Sales of the combination product by the fraction
A/B where A is the average price on a unit basis of Licensed Product containing a certain amount (by weight) of active ingredient, and B is the average unit price of the combination product containing the same amount of that active ingredient. In
the event that such average sale price cannot be determined for both the Licensed Product and the other product(s) in combination, Net Sales for purposes of determining royalty payment shall be mutually agreed by the parties based on relative value
contributed by each component, and such agreement shall not be unreasonably withheld. 7.6 [Intentionally left blank] 7.7 Licensee shall pay The Regents non-creditable milestone payments should either of the following occur while Commercial Sales or commercialization of
a Licensed Product by Licensee are continuing: (i) the closing of an Initial Public Offering (“IPO”) of the Licensee''''''''''''''''s common stock pursuant to a registration statement on Form S-1 filed with the U.S. Securities and Exchange
Commission; or (ii) the closing of (x) a consolidation or merger of the Licensee with any other entity, (y) sale of all or substantially all of the assets of Licensee, or (z) sale of all or substantially all of the outstanding
stock of the Licensee, pursuant to which the shareholders of the Licensee receive cash or publicly traded securities. Upon the occurrence of such event, the Licensee shall pay to The Regents total cash payments equal to X times P, where X is equal
to 16,400 stock equivalents (which number of stock equivalents shall be subject to adjustment from time to time for any stock split, stock dividends, recapitalizations a the like) and P is equal to either the IPO offering price per share of common
stock, or in the case of a merger, acquisition, or sale, the average price per share actually received by shareholders of the Licensee''''''''''''''''s common stock from the acquirer. Such payments shall be paid in three (3) installments, with one third
(1/3) of the total to be paid twelve (12) months after the closing date of such transaction, one third (1/3) to be paid twenty four (24) months after such closing date, and the remaining one third (1/3) to be paid thirty six
(36) months after such closing date. In the event that the transaction contemplated hereunder involves more than one closing date, the due date for payments owed to The Regents shall be measured from the date of the last closing.
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7.8 Notwithstanding the foregoing Section 7.7, no milestone payments shall be due from Licensee
under Section 7.7 in the event that: (i) a patent with a claim covering a Licensed Product has not issued under the Regents'''''''''''''''' Patent Rights at the time such milestone payment is due; and (ii) The Regents is no longer funding
active prosecution of the Regents'''''''''''''''' Patent rights in the United States patent office or a foreign equivalent; and (iii) the first Commercial Sale of a Licensed Product has already occurred. 8. DUE DILIGENCE 8.1 The Licensee, on execution of this
Agreement, shall use commercially reasonable efforts to develop, manufacture and sell Licensed Products, or cause a Sublicensee to do so, and shall use the same level of effort to market the same within a reasonable time after execution of this
Agreement. 8.2 The Licensee shall use commercially reasonable efforts to obtain all governmental approvals necessary for the manufacture,
use and sale of Licensed Products. 8.3 The Licensee shall commit to use commercially reasonable efforts (either itself or through a
Sublicensee) to develop and commercialize at least one Licensed Product, including achievement of the following milestones: (i) dosing of the first human patient with a Licensed Product in support of a Phase I clinical trials by the end of
the third year after the Effective Date; (ii) filing at least one NDA by November 1, 2009; and (iii) commencing the marketing of at least one Licensed Product in one country by November 1, 2011. 8.4 If the Licensee fails to complete any of the above provisions, and The Regents does not otherwise extend or waive such period of performance, then
The Regents has the right and option to terminate this Agreement pursuant to Paragraph 12.1 or, upon consent of Licensee, reduce the Licensee''''''''''''''''s exclusive license to a nonexclusive license. This right, if exercised by The Regents, supersedes the
rights granted in Article 2 (GRANT). 9. PROGRESS AND ROYALTY REPORTS 9.1 Beginning February 28, 2002 and semi-annually thereafter, the Licensee shall submit to The Regents a progress report covering the Licensee''''''''''''''''s (and any Affiliate or Sublicensee''''''''''''''''s) activities regarding
the development and testing of all Licensed Products and the obtaining of any governmental approvals necessary for marketing. Progress reports are required until the first Commercial Sale of the first Licensed Product occurs in the United States, at
which time the Licensee may discontinue such reports; provided that such reports may again be required by The Regents if Commercial Sales of such Licensed Product are suspended or discontinued. 9.2 Progress reports submitted under Paragraph 9.1 shall include, but are not limited to, the following topics, as they specifically refer to Licensed
Products:
•
summary of work completed
•
key scientific discoveries
•
summary of work in progress
•
current schedule of anticipated events or milestones
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•
market plans for introduction of Licensed Products, and
•
a summary of resources (dollar value) spent in the reporting period. 9.3 The Licensee has a continuing obligation to keep The Regents'''''''''''''''' informed of the large/small business entity status (as defined by the United
States Patent and Trademark Office) of itself and its Sublicensees and Affiliates. 9.4 The Licensee shall report to The Regents the date
of first Commercial Sale of a Licensed Product in each country in its immediately subsequent royalty report (as described below). 9.5
After the first Commercial Sale of a Licensed Product anywhere in the world, the Licensee shall make quarterly royalty reports to The Regents on or before each February 28, May 31, August 31 and November 30 of each year. Each
royalty report will cover the Licensee''''''''''''''''s most recently completed calendar quarter and will show (a) the gross sales and Net Sales of Licensed Products sold during the most recently completed calendar quarter; (b) the number of each
type of Licensed Product sold; (c) the earned royalties, in U.S. dollars, payable with respect to sales of Licensed Products; (d) the method used to calculate the earned royalties; and (e) the exchange rates used (if
applicable). 9.6 If no sales of Licensed Products have been made during any reporting period, Licensee shall provide a statement to this
effect. 10. BOOKS AND RECORDS 10.1 The
Licensee shall keep accurate books and records showing all Licensed Products manufactured, used, and/or sold under the terms of this Agreement. Books and records must be preserved for at least five (5) years from the date of the royalty payment
to which they pertain. 10.2 The Regents is entitled to have a mutually acceptable independent auditor under a duty of confidentiality
inspect these books and records during regular office hours for the purpose of verifying the payment of earned royalties and sublicense payments due hereunder with respect to Net Sales and sublicense fees received by Licensee not more
than five (5) years prior to the date of The Regents'''''''''''''''' request. The Regents may exercise its right to review Licensee''''''''''''''''s books and records not more than once per calendar year and must provide Licensee at least fourteen (14) days
advance written notice. The auditor shall only report to The Regents the amount of under or over payment of earned royalties and sublicense fees, if any. The Regents shall bear the fees and expenses of examination but if an error in
royalties of more than five percent (5%) of the total royalties due for any year is discovered in any examination then the Licensee shall bear the fees and expenses of that examination. The information learned by The Regents pursuant to this
Paragraph 10.2 or contained in reports provided to The Regents under Article 9 above shall be deemed Data of Licensee for purposes of Article 29 below. 11. LIFE OF THE AGREEMENT 11.1 Unless otherwise terminated by operation of law or by acts of the parties in accordance with the
terms of this Agreement, this Agreement will be in force from the Effective Date and shall expire on a country-by-country basis as to each Licensed Product on the date that
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neither the sale nor use of such Licensed Product would be covered by a Valid Claim in such country. This Agreement shall expire in its entirety, unless
otherwise terminated or otherwise provided herein, upon the last expiration date of a patent licensed under this Agreement; or until the last patent application licensed under this Agreement is abandoned and no patent in Regents'''''''''''''''' Patent Rights
ever issues. 11.2 Any termination of this Agreement will not affect the rights and obligations set forth in the following Articles:
Article 1
Definitions
Paragraph 3.4
Survival of Sublicenses
Article 10
Books and Records
Article 14
Disposition of Licensed Products on Hand on Termination
Article 15
Use of Names and Trademarks
Article 20
Indemnification
Article 24
Failure to Perform
Article 29
Secrecy
Article 30
Miscellaneous
12. TERMINATION BY THE REGENTS 12.1 If the Licensee fails to materially perform or materially violates any term of this Agreement, then The Regents may give written notice of default (“Notice of Default”) to the Licensee. If the Licensee
fails to repair the default within sixty (60) days of the effective date of Notice of Default, The Regents may terminate this Agreement and its licenses by a second written notice (Notice of Termination). However, if Licensee disputes the
alleged breach within the cure period, then The Regents shall not have the right to terminate this Agreement unless it has been determined by an arbitrator or court proceeding that this Agreement was materially breached, and Licensee fails to comply
with its obligations hereunder within sixty (60) days after that determination. If a properly given Notice of Termination is sent to the Licensee, this Agreement will automatically terminate on the effective date of such Notice. Termination
will not relieve the Licensee of its obligation to pay any fees owing at the time of termination and will not impair any accrued right of The Regents. These notices are subject to Article 21 (Notices). 13. TERMINATION BY LICENSEE 13.1 The Licensee has the right
at any time to terminate this Agreement in whole or as to any portion of Regents'''''''''''''''' Patent Rights by giving notice in writing to The Regents. Notice of termination will be subject to Article 21 (Notices) and termination of this Agreement will be
effective sixty (60) days from the effective date of notice. 13.2 Any termination under the above paragraph does not relieve the
Licensee of any obligation or liability accrued under this Agreement prior to termination or rescind any payment made to The Regents or anything done by Licensee prior to the time termination becomes effective. Termination does not affect in any
manner any rights of The Regents arising under this Agreement prior to termination.
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14. DISPOSITION OF LICENSED PRODUCTS ON HAND UPON TERMINATION 14.1 Upon termination of this Agreement the Licensee is entitled to dispose of all previously made or partially made Licensed Products, but no more,
within a period of one hundred and eighty (180) days provided that the sale of those Licensed Products is subject to the terms of this Agreement, including but not limited to the rendering of reports and payment of royalties required under this
Agreement 15. USE OF NAMES AND TRADEMARKS 15.1 Nothing contained in this Agreement confers any right to use in advertising, publicity, or other promotional activities any name, trade name, trademark, or other designation of either party hereto (including contraction, abbreviation
or simulation of any of the foregoing). Unless required by law, the use by the Licensee of the name “The Regents of the University of California” or the name of any campus of the University of California is prohibited. 16. LIMITED WARRANTY 16.1 The Regents, as represented by
the actual knowledge of the undersigned on behalf of the Regents as of the Effective Date, warrants to the Licensee that that it owns all right, title, and interest in and to the Regents'''''''''''''''' Patent Rights, and that it has the lawful right to grant
this license. 16.2 This license and the associated Invention are provided WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. THE REGENTS MAKES NO REPRESENTATION OR WARRANTY THAT THE LICENSED PRODUCTS OR LICENSED METHODS WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT OF A THIRD PARTY. 16.3 IN NO EVENT WELL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THIS LICENSE OR
THE USE OF THE INVENTION OR LICENSED PRODUCTS. 16.4 This Agreement does not: 16.4.1 express or imply a warranty or representation as to the validity or scope of any of Regents'''''''''''''''' Patent Rights; 16.4.2 express or imply a warranty or representation that anything made, used, sold, offered for sale or imported or otherwise disposed of under any
license granted in this Agreement is or will be free from infringement of patents of third parties; 16.4.3 obligate The Regents to bring
or prosecute actions or suits against third parties for patent infringement except as provided in Article 19; 16.4.4 confer by
implication, estoppel or otherwise any license or rights under any patents of The Regents other than Regents'''''''''''''''' Patent Rights as defined in this Agreement, regardless of whether those patents are dominant or subordinate to Regent''''''''''''''''s Patent
Rights; or
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16.4.5 obligate The Regents to furnish any know-how not provided in Regents'''''''''''''''' Patent Rights.
17. PATENT PROSECUTION AND MAINTENANCE 17.1
As long as the Licensee has paid patent costs as provided for in this Article, The Regents shall diligently prosecute and maintain the United States and foreign patents comprising Regents'''''''''''''''' Patent Rights using counsel of its choice, reasonably
acceptable to Licensee. If Licensee objects to the choice of patent counsel, then The Regents shall appoint an alternative choice of patent counsel with Licensee''''''''''''''''s approval. The Regents shall provide the Licensee with copies of all relevant
documentation and correspondence so that the Licensee may be informed of the continuing prosecution and submit timely comments and guidance for consideration by patent counsel. The Licensee agrees to keep such correspondence and documentation
confidential. The Regents agrees to allow Licensee to submit advice, counsel, and guidance regarding patent prosecution to The Regents'''''''''''''''' counsel, although such counsel will take instructions only from The Regents. All patents and patent
applications under this Agreement which are based solely on research performed at UCSF and filed prior to the Execution Date will be assigned solely to The Regents, subject to the grant of exclusive rights hereunder. 17.2 The Regents shall use best efforts to amend any patent application to include claims reasonably requested by the Licensee to protect the products
contemplated to be sold under this Agreement and shall ensure that the Licensee is kept apprised of patent-related activities so that it may provide such requests in a timely manner. 17.3 The Licensee shall, if appropriate in Licensee''''''''''''''''s business judgment, apply for an extension of the term of any patent included within
Regents'''''''''''''''' Patent Rights under the Drug Price Competition and Patent Term Restoration Act of 1984 and/or European, Japanese and other foreign counterparts of this Law. If Licensee elects to apply for such extension, Licensee shall prepare all
documents, and The Regents agrees to execute the documents and to take additional action as the Licensee reasonably requests in connection therewith. 17.4 If either party (in the case of the Regents, the actual knowledge of the Licensing Officer responsible for administration of this Agreement) receives notice from a third party pursuant to 21 CFR §314.95(a)
stating that one or more patents within the Regents'''''''''''''''' Patent Rights is invalid, unenforceable or not infringed by the manufacture, use or sale of a drug product for which such third party has submitted an ANDA under 21 CFR
§§314.92–314.99 (or an equivalent notice with respect to a drug product for which such third party has submitted a marketing application under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act), then that party shall
notify the other party within ten (10) days after receipt of notice of infringement. 17.5 The Regents shall bear the costs of
preparing, filing, prosecuting and maintaining all United States and foreign patent applications contemplated by this Agreement incurred after the Effective Date, and as required under Article 5 and Section 17.6. 17.6 The Licensee may request The Regents to obtain patent protection on the Invention in foreign countries if available and if it so desires. The
Licensee shall notify The Regents of its
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decision to obtain or maintain foreign patents not less than sixty (60) days prior to the deadline for any payment, filing, or action to be taken in
connection therewith. This notice concerning foreign filing must be in writing and must identify the countries desired. The absence of such a notice from the Licensee to The Regents will be considered an election not to obtain or maintain foreign
rights. 17.7 Licensee may terminate its obligations with respect to any given patent application or patent upon three (3) months
written notice to The Regents. If such notice is received from the Licensee, The Regents may continue to prosecute and maintain such application(s) or patent(s) at its sole discretion and expense, but the Licensee will have no further right or
licenses thereunder. If Licensee does not provide such a notice of termination as to any given patent application or patent within The Regents'''''''''''''''' patent Rights, then The Regents'''''''''''''''' obligation to underwrite and to pay patent prosecution costs
will continue for so long as this Agreement remains in effect. 17.8 [Intentionally left blank] 18. PATENT MARKING 18.1 The Licensee shall mark all
Licensed Products made, used or sold under the terms of this Agreement, or their containers, in accordance with the applicable patent marking laws. 19.
PATENT INFRINGEMENT 19.1 If The Regents (to the extent of the actual knowledge of the licensing professional responsible for the
administration of this Agreement) or the Licensee learns of the substantial infringement of any patent licensed under this Agreement, the knowledgeable party will provide the other (i) with written notice of such infringement and (ii) with
any evidence of such infringement available to it (the “Infringement Notice”). Neither party will notify a third party of the infringement of any of Regents'''''''''''''''' Patent Rights without first obtaining consent of the other party, which
consent will not be unreasonably denied or delayed. Both parties shall use their best efforts in cooperation with each other to terminate infringement without litigation. 19.2 If the infringing activity has not been abated within ninety (90) days following the date the Infringement Notice takes effect, then the Licensee or its designee may institute suit for patent infringement
against the infringer. The Regents may voluntarily join such suit at its own expense, but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of the Licensee''''''''''''''''s suit or any judgment rendered
in the suit. The Licensee may not join The Regents in a suit initiated by Licensee without The Regents'''''''''''''''' prior written consent. If, in a suit initiated by the Licensee, The Regents is involuntarily joined other than by the Licensee, then the
Licensee will pay any out-of-pocket costs incurred by The Regents arising out of such suit, including but not limited to, legal fees of counsel that The Regents selects and retains to represent it in the suit. The Regents will join as a party to any
suit initiated by Licensee if found to be a necessary party by a court of law. 19.3 If, within a hundred and eighty (180) days
following a request by The Regents that Licensee take action to abate the infringing activity, the infringing activity of potential commercial significance by the infringer has not been abated and the Licensee or it designee has not brought suit
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against the infringer or begun negotiations regarding the terms under which Licensee would grant a sublicense to the infringer, then The Regents may
institute such suit for patent infringement against the infringer. If The Regents institutes such suit, then the Licensee may not join such suit without The Regents'''''''''''''''' consent and may not thereafter commence suit against the infringer for acts of
infringement that are subject to The Regents'''''''''''''''' suit or any judgment rendered in that suit. The Regents may not join Licensee in a suit initiated by The Regents without Licensee''''''''''''''''s prior written consent. 19.4 Legal action as is decided on will be at the expense of the party bringing suit, but legal action brought jointly by The Regents and the Licensee
and fully participated in by both will be at the joint expense of the parties. Any recovery or settlement received in connection with any suit will be applied as follows: (i) first to reimburse the controlling party for its out-of-pocket costs
and expenses (including attorneys'''''''''''''''' and court costs and expenses and amounts reimbursed to the other party); (ii) next to reimburse the out-of-pocket costs and expenses of the other party; and (iii) any remainder after reimbursing the
amounts set forth in clause (i) and (ii) shall be retained by the controlling party; provided that if Licensee is the controlling party (or in the event that the action is jointly controlled), Licensee, while being entitled to retain any
remainder of such recovery, agrees to pay The Regents fifteen percent (15%) of such remainder, or to the extent of enhanced damages twenty five percent (25%) of such remainder. 19.5 Each party shall cooperate with the other in litigation proceedings instituted hereunder but at the expense of the party bringing suit. Litigation
will be controlled by the party bringing the suit. 20. INDEMNIFICATION 20.1 The Licensee shall indemnify, hold harmless and defend The Regents, its officers, employees, and agents; the sponsors of the research that led to the invention; and the inventors of the patents and patent
applications in Regents'''''''''''''''' Patent Rights and their employers against any and all claims, suits, losses, liabilities, damages, costs, fees, and expenses asserted by third parties (“Claims”) resulting from or arising out of exercise of
this license or any voluntary sublicense, except to the extent resulting from a breach of this Agreement by The Regents; provided that Licensee shall have no obligations with respect to any Claims unless the person or entity claiming under this
Paragraph 20.1 (i) promptly notifies Licensee in writing of such Claims, (ii) gives Licensee sole control of the defense and settlement thereof (provided that Licensee shall not admit to wrongdoing or liability on the part of The Regents
without the prior written consent of The Regents), and (iii) provides Licensee, at Licensee''''''''''''''''s expense, with reasonable assistance and full information with respect to such Claims. This indemnification includes, but is not limited to, any
product liability. Notwithstanding the foregoing, the Licensee shall have no obligations for any claim if the person (as listed above) seeking indemnification makes any admission or settlement regarding such claim without the prior written consent
of the Licensee, which consent shall not be unreasonably withheld. 20.2 The Licensee, at its sole cost and expense, shall insure its
activities in connection with the work under this Agreement and obtain (not later than the start of Phase I clinical trials of a product intended for Commercial Sale), keep in force and maintain insurance as follows, or an equivalent program of
self insurance.
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20.3 Comprehensive or commercial form general liability insurance (contractual liability included) with
limits as follows:
•
Each Occurrence $1,000,000
•
Products/Completed Operations Aggregate $5,000,000
•
Personal and Advertising Injury $1,000,000
•
General Aggregate (commercial form only) $5,000,000 The coverage and limits referred to under the above do not in any way limit the liability of the Licensee. The Licensee shall furnish The Regents with certificates of insurance showing compliance with all requirements. Certificates must:
•
Provide for thirty (30) days'''''''''''''''' advance written notice to The Regents of any modification.
•
Indicate that The Regents has been endorsed as an additional Insured under the coverage referred to under the above.
•
Include a provision that the coverage will be primary and will not participate with nor will be excess over any valid and collectable insurance or program of
self-insurance carried or maintained by The Regents. 20.4 The Regents shall notify the Licensee in writing of any claim
or suit brought against The Regents in respect of which The Regents intends to invoke the provisions of this Article. The Licensee shall keep The Regents informed on a current basis of its defense of any claims under this Article. 21. NOTICES 21.1 Any notice or payment required to be given
to either party is properly given and effective (a) on the date of delivery if delivered in person or (b) five (5) days after mailing if mailed by first-class certified mail, postage paid, to the respective addresses given below, or
to another address as is designated by written notice given to the other party.
In the case of the Licensee:
NeurogesX, Inc. 2215 Bridgepointe Parkway, Suite 200 San Mateo, CA 94404 Attn: CEO
In the case of The Regents:
Office of Technology Management University of California San Francisco 1294 Ninth Avenue - Box 1209 San Francisco, CA 94143-1209 Attention: Director Referring to: UCSF Case No. SF00-056
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22. ASSIGNABILITY 22.1 This Agreement may be assigned by The Regents, but is personal to the Licensee and assignable by the Licensee only with the written consent of The Regents, which consent will not be unreasonably withheld; provided that the Licensee may
assign this Agreement without The Regents'''''''''''''''' consent to an entity that acquires substantially all of the business or assets of the Licensee (or that portion thereof to which this Agreement relates), in each case whether by merger, acquisition, or
otherwise the acquiring party assumes this Agreement in writing or by operation of law. 23. NO WAIVER 23.1 No waiver by either party of any default of this Agreement may be deemed a waiver of any subsequent or similar default. 24. FAILURE TO PERFORM 24.1 If either party finds it
necessary to undertake legal action against the other on account of failure of performance due under this Agreement, then the prevailing party is entitled to reasonable attorney''''''''''''''''s fees in addition to costs and necessary disbursements.
25. GOVERNING LAWS 25.1 THIS AGREEMENT WILL
BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF CALIFORNIA, but the scope and validity of any patent or patent application will be governed by the applicable laws of the country of the patent or patent application.
26. PREFERENCE FOR UNITED STATES INDUSTRY 26.1 [Intentionally left blank] 27. GOVERNMENT APPROVAL OR REGISTRATION 27.1 Licensee shall notify The Regents if it becomes aware that this Agreement is subject to any U.S. or foreign government reporting or approval
requirement. Licensee shall make all necessary filings and pay all costs including fees, penalties, and all other out-of-pocket costs associated with such reporting or approval process. 28. EXPORT CONTROL LAWS 28.1 The Licensee shall observe all applicable United States and foreign laws with
respect to the transfer of Licensed Products and related technical data to foreign countries, including, without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations.
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29. SECRECY 29.1 If either party discloses confidential information (“Data”) to the other party, the disclosing party will designate this information as confidential by appropriate legend or instruction, e.g. “Confidential”
or “Proprietary”, and the receiving party will: 29.1.1 not to use the Data except for the sole purpose of accomplishing the
objectives of this Agreement; 29.1.2 to safeguard Data against disclosure to others with the same degree of care as it exercises with its
own data of a similar nature, but in no event less than reasonable care; 29.1.3 not to disclose Data to others (except to its employees,
agents, consultants, distributors, sublicensees, potential and actual investors and others who have a need to know and who are bound to the Licensee by a like obligation of confidentiality) without the express written permission of The Regents,
29.1.4 Neither party will have any confidentiality obligation with respect to Data belonging to or disclosed by the other party that:
(i) the receiving party can demonstrate by written records was previously known to it; (ii) is now, or becomes in the future, public knowledge other than through acts or omissions of the receiving party; (iii) is lawfully obtained by the receiving party from sources independent of the disclosing party; (iv) is independently developed by the receiving party without use of the Data of the disclosing party; and 29.1.5 that the secrecy obligations of the parties with respect to Data will continue for a period ending five (5) years from the termination date
of this Agreement. 29.1.6 The non-disclosure obligations contained in Article 29 shall not apply to particular Data that a receiving
party received from the other party to the extent that such receiving party is required to disclose such Data by law, order or regulation of a governmental agency (including the California Public Records Act or governmental audit requirement) or a
court of competent jurisdiction, provided that such receiving party first gives reasonable notice of such requirement to the disclosing party, removes the then actual trade secrets of the disclosing party upon request and as directed by the
disclosing party to the extent permitted by law, and cooperates with the disclosing party in the event the disclosing party challenges the requirement and/or scope of such disclosure.
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30. MISCELLANEOUS 30.1 The headings of the several sections are inserted for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement. 30.2 This Agreement is not binding on the parties until it has been signed below on behalf of each party. It is then effective as of the Effective Date.
30.3 No amendment or modification of this Agreement is valid or binding on the parties unless made in writing and signed on behalf of each
party. 30.4 For the purposes of this Agreement and all services to be provided hereunder, the parties shall be, and shall be deemed to be,
independent contractors and not agents or employees of either of the other parties. No party shall have authority to make any statements, representations or commitments of any kind, or to take any action which shall be binding on either of the other
parties, except as may be expressly provided for herein or authorized in writing. 30.5 This Agreement embodies the entire understanding of
the parties and supersedes all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter hereof. The Secrecy Agreement effective August 20, 1999 (U.C. Control
No. 2000-20-0104) is hereby terminated. 30.6 In case any of the provisions contained in this Agreement is held to be invalid,
illegal, or unenforceable in any respect, that invalidity, illegality or unenforceability will not affect any other provisions of this Agreement, and this Agreement will be construed as if the invalid, illegal, or unenforceable provisions had never
been contained in it. 30.7 In the event that, within one (1) year after the Amendment Date, Licensee agrees, at its sole discretion,
to accept an assignment or license of rights to US Patent Application Serial No. 08/746,207 from Messrs. Staats and Pappagallo (or their executors, successors, or assigns), named inventors on such Application, such that Licensee has exclusive
rights under such Application, The Regents and Licensee agree that the paragraphs 1-8, 10-12 of [Amendment Number One] shall be rescinded as of the date such assignment or license is perfected, and the original terms of the Agreement shall apply
thereafter. In addition, Licensee shall be entitled to deduct its costs and expenses incurred with respect to such assignment or license, as well as any on-going royalty obligations, from any amounts due The Regents hereunder after the date such
assignment or license is perfected. [Signature Page Follows]
-158-
IN WITNESS WHEREOF, both The Regents and the Licensee have executed this Agreement, in duplicate
originals, by their respective and duly authorized officers on the day and year written.
LICENSEE
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
By:
/s/ Tony DiTonno
By:
/s/ Joel B. Kirschbaum
(Signature)
(Signature)
Name:
Tony DiTonno
Name:
Joel B. Kirschbaum
(Please Print)
(Please Print)
Title:
CEO
Title:
Director - OTM
Date:
10/6/08
Date:
10/6/08
-159-
EXHIBIT 2.2.1 COOPERATION TERMS [***]
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
EXHIBIT 2.3.4 [***] AND PRINCIPLES OF LF DEVELOPMENT PLAN [***] [***]
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
EXHIBIT 2.3.7 [***] AND PRINCIPLES OF LF DEVELOPMENT PLAN [***] [***]
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
EXHIBIT 5.9 DOCUMENTATION TO BE PROVIDED BY NGX [***]
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
EXHIBIT 6.3.4 [***]
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
EXHIBIT 7.1.1 CHMP COMMITMENT
NeurogesX UK Limited Granta Park Great Abington, Cambridge CB1 6GQ, UK Artr: Helen Bull
Date: 09 March 2009
Dr. Eric Abadie European Medicines Agency 7 Westferry Circus Canary
Wharf London E14 4HB United Kingdom Dear Dr. Abadie,
RE:
EMEA/H/C/000909 (Qutenza 179 mg cutaneous patch,
NeurogesX UK Ltd) NeurogesX UK Ltd agrees to undertake the following Post-Authorisation Commitments requested by the CHMP and commit to submit the data
listed below within the specified timeframe. We also agree to submit any variation application resulting from the assessment of the below mentioned data.
Follow-up Measures: [***]
Your Sincerely,
/s/ Anthony A. DiTonno
Anthony A. DiTonno
President and Chief Executive Officer
NeurogesX UK Ltd 265
Strand London WC2R 1BH United Kingdom
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
-166-
EXHIBIT 8.4 SAFETY AGREEMENT
EXHIBIT 12.8 DOMAIN NAMES NETWORKSOLUTIONS.COM
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EXHIBIT 14.2.21 SAEs [***]
EXHIBIT 14.2.38 [***]
***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment
has been requested with respect to the omitted portions.
Index of QA Change Controls (Approved) Since May 21, 2009 to Present
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EXHIBIT 20.9 PRESS RELEASE
NeurogesX, Inc. Stephen
Ghiglieri Chief Financial Officer (650)
358-3310
The Ruth Group Sara Pellegrino (investors)
(646) 536-7002 spellegrino@theruthgroup.com
Astellas Pharma Europe Mindy Dooa Corporate Communications Director +44 (0)7826 912 339 mindy.dooa@eu.astellas.com
Jason Rando (media)/Janine McCargo (646)
536-7025/7033 jrando@theruthgroup.com jmccargo@theruthgroup.com
NeurogesX and Astellas Enter Commercialization Agreement for Qutenza™ Conference Call Today at 9:00am ET Covers Europe, Middle East and Africa Includes Licensing Option and Development Funding for NGX-1998 San Mateo, Calif. and Staines, U.K. (June 22, 2009) – NeurogesX, Inc. (NASDAQ: NGSX) and Astellas Pharma Europe Ltd., (Astellas), the European subsidiary of Tokyo based Astellas Pharma Inc. announced today
that the companies have entered into an exclusive Distribution, Marketing and License agreement for the commercialization of Qutenza™ in the European Economic Area (EEA) including the 27 countries of the European Union, Iceland, Norway, and
Liechtenstein as well as Switzerland, certain countries in Eastern Europe, the Middle East and Africa. The agreement closely follows the European Commission''''''''''''''''s approval received in May 2009, of Qutenza (capsaicin 179 mg) cutaneous patch for the
treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal pain products. Under terms of the
agreement, Astellas will commercialize Qutenza in the above-mentioned territories and perform certain development of Qutenza including post-marketing commitments, to support Qutenza in the EU market. NeurogesX will receive EUR 30 million
(approximately $42 million) for Qutenza commercialization rights, and EUR 5 million (approximately $7 million) for a license option of NGX-1998, the next-generation liquid formulation which uses the same active ingredient as Qutenza.
Astellas has an established and strong product portfolio with franchises in the therapeutic areas of urology, transplantation, dermatology and infectious
disease. Commenting on
the agreement, Masao Yoshida, President and CEO of Astellas Pharma Europe Ltd., said, “We are very pleased to
enter into this agreement with NeurogesX. Astellas is dedicated to developing a specialty focused franchise and Qutenza''''''''''''''''s launch in the European Union fits with our strategy. We are confident in the market potential for Qutenza given its safety
and efficacy to provide site-specific pain management for up to 12 weeks. Leveraging our foothold in these territories with our strong sales and marketing teams and Qutenza''''''''''''''''s product profile, we are positioning for a successful commercial
launch that will introduce an important new product to patients with neuropathic pain.” Anthony DiTonno, CEO of NeurogesX, commented, “Securing
an agreement with Astellas for the commercialization of Qutenza in Europe and additional territories is a significant milestone achievement for NeurogesX. Selecting the right partner was especially important to us since the European Union represents
the first approval and the initial launch market for Qutenza. Astellas brings a tremendous amount of sales experience and presence across Europe and we are confident in our partner''''''''''''''''s ability and commitment to launch Qutenza with the motivation
required for commercial success. Having secured a commercial partnership in Europe, we are now turning our full attention to the remaining steps involved for the potential U.S. approval and commercialization of Qutenza.” Collaboration Arrangements Under the Distribution, Marketing and
License Agreement, NeurogesX will receive two upfront payments from Astellas, EUR 30 million (approximately $42 million) for Qutenza commercialization rights and EUR 5 million (approximately $7 million) for a co-development and
commercialization option of NGX-1998. NeurogesX is eligible for additional sales-based milestone payments and additional option payments related to the
liquid formulation totaling approximately EUR 70 million ($97 million) and royalties based on a double-digit percentage of net sales for Qutenza. Astellas has committed investment for additional studies to support the marketing and promotion of Qutenza and to fulfill post-marketing commitments outlined in the European Commission''''''''''''''''s approval. These post-marketing commitments
include a long-term safety study of Qutenza in on-label indications. The option payment to license NGX-1998 includes an initial upfront payment as
mentioned previously as well as further option payments as development progresses. These payments are intended, in part, to accelerate NGX-1998 into Phase 2 clinical evaluation. In the event that Astellas exercises its option for NGX-1998, the
companies expect to collaborate in Phase 3 development. All payments to NeurogesX are expressed in euros and the dollar equivalents expressed in this
press release are stated at current exchange rates. Actual conversion rates will vary depending on exchange rates in effect at the time payments are due.
Conference Call Details NeurogesX will hold a teleconference today at 9:00 a.m. ET (6:00 a.m. PT) to discuss the distribution and licensing agreement with Astellas Pharma Europe Ltd. To participate, please dial 1-877-407-0789 (USA) or 1-201-689-8562 (International). To access the live web cast please visit the Investor Relations section on the corporate web site at http://www.neurogesx.com.
A replay of the conference call will be available beginning June 22, 2009 at 12:00 p.m. ET (9:00 a.m. PT) and ending on July 2, 2009 by dialing
1-877-660-6853 (USA) or 1-201-612-7415 (International), Account Number: 3055, Conference ID Number: 326456. A replay of the webcast will also be available on the corporate website for one month, through July 22, 2009. About NeurogesX, Inc. NeurogesX (NASDAQ: NGSX) is a
biopharmaceutical company focused on developing and commercializing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy
(HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX'''''''''''''''' late stage product portfolio is led by its product candidate Qutenza, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions. Qutenza is
currently approved in the European Union for the treatment of neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. NeurogesX submitted a new drug application (NDA) for Qutenza to the U.S.
Food and Drug Administration (FDA) which was accepted for filing by the FDA in December 2008 and was given a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009. NeurogesX'''''''''''''''' second most advanced product candidate, NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain
conditions. NGX-1998 has completed three Phase 1 studies and NeurogesX is currently evaluating the timing of entering Phase 2 development. NeurogesX''''''''''''''''
early stage product pipeline includes pre-clinical compounds, which are prodrugs of acetaminophen and various opioids. The company has evaluated these compounds in vitro and in vivo and is currently seeking development partners for
these programs. About Astellas Pharma Europe Ltd., Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of
innovative and reliable pharmaceutical products. The organization is committed to becoming a global company by combining outstanding R&D and marketing capabilities and continuing to grow in the
world pharmaceutical market. Astellas Pharma Europe is responsible for 20 affiliate offices located across Europe, the Middle East and Africa, an R&D
site and three manufacturing plants with approximately 3,400 staff. For more information about Astellas Pharma Europe Ltd., please visit our website at www.astellas.com. Safe Harbor Statement This press release contains forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995 (the “Act”). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples
of such statements include, but are not limited to, expectations with respect to the successful commercial launch and market potential of Qutenza; expectations with respect to the activities of NeurogesX and Astellas under the Distribution,
Marketing and License Agreement (the Agreement); the potential receipt of post-execution payments under the Agreement; potential uses of proceeds from the Agreement; expectations regarding additional studies, including a safety study to be carried
out by Astellas under the Agreement; the timing of regulatory decisions with respect to the NDA for Qutenza with the FDA, including the PDUFA date for the NDA; plans for entry into a U.S. commercialization partnership for NeurogesX pre-clinical
compounds; and plans for clinical development of NGX-1998. Such statements are based on management''''''''''''''''s current expectations, but actual results may
differ materially due to various risks and uncertainties, including, but not limited to; NeurogesX'''''''''''''''' product candidates may have unexpected adverse side effects or inadequate therapeutic efficacy; Astellas may not devote sufficient resources or
personnel to the commercialization of Qutenza; adoption of Qutenza by physicians may be longer than anticipated; discussions with governmental or administrative entities may not result in adequate reimbursement or pricing to support
commercialization efforts for Qutenza; Astellas may not elect to make option related payments or co-develop NGX-1998; positive results in Qutenza clinical trials may not be sufficient to obtain FDA approval; the FDA may request additional clinical
trials or other information prior to granting approval for Qutenza; and other difficulties or delays in the successful commercialization of Qutenza, carrying out activities or obtaining payments under the Agreement and in clinical development of,
and obtaining regulatory approval for, NeurogesX'''''''''''''''' product candidates. For further information regarding these and other risks related to NeurogesX'''''''''''''''' business, investors should consult NeurogesX'''''''''''''''' filings with the Securities and Exchange
Commission. |
Contract Category: 5
Industry: 23
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Agreement Type: License Agreement
Date Created: 9/10/2009
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