Document:

Clinical Supply, Development and License Agreement

 EXHIBIT 10.7 
  

	[***]	CERTAIN INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED. 

 CLINICAL SUPPLY, DEVELOPMENT AND LICENSE AGREEMENT 
 This CLINICAL SUPPLY, DEVELOPMENT AND LICENSE AGREEMENT (this “Agreement”), is entered into as of 15 day of Jan., 2004 (“Effective
Date”) by and between 
 NeurogesX Inc., a California corporation with its principal place of business at San Carlos Business Park,
981 F 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 the Memorandum of Understanding dated May 29, 2001 (“MOU”), pursuant to which the Parties cooperated on the development of a Patch
containing capsaicin and wish to complete such development under this Agreement; 
 WHEREAS, NeurogesX desires to seek Marketing Approval for
the Patches in the Territory; 
 WHEREAS, NeurogesX desires to exclusively purchase from LTS, and LTS desires to exclusively supply to
NeurogesX, Clinical Samples of the Patches, all in accordance with the terms and conditions of this Agreement; 
 WHEREAS, the Parties desire
to restate all of their rights and obligations with respect to the Patches in this Agreement, and for this Agreement to supersede the MOU with respect to the Parties’ rights, obligations and activities from this point forward. 
 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 “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). 
 1.2 “Clinical Samples” means Patches supplied by LTS under this Agreement meeting the
Specifications, that are intended by NeurogesX to be used in human clinical trials for purposes of obtaining Marketing Approval for the Patches. 
 1.3 “Clinical Program Patents” means patents worldwide 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, or any method of
use of the Patches. 
 1.4 “Control” means the possession at any time during the term of this Agreement of the right or
power to grant licenses of or within the scope set forth herein without violating the terms of any agreements with non-Affiliate third parties. 
 1.5 “Current GMP,” or “cGMP” means then current Good Manufacturing Practices promulgated by the United States Food & Drug Administration (FDA) or its counterpart governmental agencies in the
Territory in the form of laws, regulations or guidance documents. 
 1.6 “Defect” or “Defective” when
applied to Clinical Samples means the failure of such Clinical Samples to meet the warranty set forth in Section 9.2. 
 1.7
“Development Costs” means those costs paid by NeurogesX to LTS for the development of the Patch, solely as set forth in the Development Plan, attached hereto as Exhibit D. 
 1.8 “Development Plan” means the development plan set forth in Exhibit D. 
 1.9 “Development Team” has the meaning as set forth in Article 4. 
 1.10 “Field” has the meaning as set forth in Section 7.2. 
 1.11 “Kit” means the ultimate commercial product in the form sold by NeurogesX, its Affiliates or Sublicensees of which the Patch(es) is
a component. 
  

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 1.12 “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. 
 1.13 “Net Sales” means the [***] of Kits 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) [***] and [***], (b) [***] and [***], including for [***], and [***], (c) [***] and other
[***] or [***] and [***], (d) if included in the [***] of the Kits, [***] or [***] (including any such [***] as a [***] or similar [***] or [***]), (e) if included in the [***] of Kits, [***] and [***] on [***] of Kits, and (f) [***]
determined in accordance with Generally Accepted Accounting Principles in the United States, consistently applied. 
 If mutually agreed in
writing by the Parties, some or all such items may be estimated and subsequently adjusted. 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 by NeurogesX to an Affiliate or Sublicensees for resale, Net Sales shall include the amounts invoiced by such entities to third parties on the resale (excluding (a) through (f) above), but
not the amounts invoiced by NeurogesX to such entities. Net Sales shall not include any sales of Kits as samples, for clinical trials, or for research and development efforts by or for NeurogesX. 
 1.14 “Patch” or “Patches” means any TTS containing VRl-Ligands of the same design as patches developed for or delivered
to NeurogesX under the MOU or this Agreement which meet any version of the Specifications. 
 1.15 “Patch Regulatory
Information” means any and all information in the possession of LTS relating to the Patches, as reasonably necessary for NeurogesX’s efforts to obtain Marketing Approval therefor 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 Clinical Samples, and (c) all data reasonably required to qualify a manufacturing facility for the Patches under Regulatory Requirements. 
 1.16 “Quality Assurance Agreement” means the quality assurance procedures then currently, mutually agreed upon in writing. The Quality
Assurance Agreement as of the Effective Date is attached as Exhibit C. 
 1.17 “Reasonable Commercial Efforts” means
those reasonable commercial efforts employed by a Party, equivalent to at least that level of attention and care that it devotes to its other businesses and products of similar commercial potential and at a similar stage of progress of development.

 1.18 “Regulatory Requirements” means all laws, regulations and other legal requirements applicable to the manufacture of
Patches or components thereof, including without limitation cGMP, 
  

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FDA regulations, any applicable local laws and regulations in the place of manufacture, storage and handling, and any requirements set forth in the IND, NDA,
Marketing Approval Application (MAA) and other regulatory filings or approvals for the Patches. 
 1.19 “Specifications”
means the specifications for the Patches and/or Clinical Samples as then currently, mutually agreed upon in writing under the MOU or this Agreement. The Specifications for the Patches at the time of execution of the MOU is set forth in
Exhibit B-l, and the Specifications for the Clinical Samples at the time of this Agreement is set forth in Exhibit B-2 of this Agreement. Unless indicated to apply to only a particular batch of Clinical Samples, the Specifications then
currently agreed upon for the Clinical Samples shall also be the Specifications men currently agreed upon for the Patches in general. 
 1.20
“Sublicensees” means non-Affiliate third party to whom NeurogesX has granted (i) the right to market and sell a Product purchased from LTS under this Agreement or the Supply Agreement, provided that such third party has primary
responsibility for and has the right to direct and control the marketing and promotion of such Product in its distribution territory and the right to record sales of such Product for its own account or (ii) the right to make (to the extent that
NeurogesX has the right to do so pursuant to Section 7.3 or the Supply Agreement) and sell a Product, with respect to Products that were manufactured and then sold by such third party, within the scope of the license from LTS hereunder. For the
avoidance of doubt, Sublicensee shall exclude retailers, wholesalers, distributors or specialty distributors, but shall include marketing partners of NeurogesX. 
 1.21 “Supply Agreement” has the meaning as set forth in Section 6.2. 
 1.22
“Territory” means the United States, European Union (in one or more countries therein selected by NeurogesX) and Japan (at NeurogesX’s option). In addition, the Territory may be extended by NeurogesX to include additional
countries and/or regulatory jurisdictions in accordance with Section 3.7. 
 1.23 “TTS” means [***] or other patch
products for delivering drugs [***]. 
 1.24 “VR1-Ligands” means compounds that bind to the vanilloid receptor
subtype 1, as further described in Exhibit A. The parties may amend Exhibit A from time to time upon mutual written agreement. 
 ARTICLE 2 
 SUPPLY OF CLINICAL SAMPLES 
 2.1 Supply of NeurogesX Requirements of Clinical Samples. Subject to the terms and conditions of this Agreement, LTS shall manufacture for and
supply NeurogesX’s requirements of Clinical Samples. However, LTS shall not be liable under this Section 2.1 for failure to meet such obligation to manufacture for and supply NeurogesX’s requirements of Clinical Samples so long as LTS
used its Reasonable Commercial Efforts to comply with its obligation stated in this Agreement. 
  

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 2.2 Purchase Orders. All supply of Clinical Samples hereunder shall be initiated by a purchase
order placed by NeurogesX. Purchase orders shall include the quantity of Clinical Samples ordered, requested delivery date(s), and shipping destination and/or instructions. LTS shall accept and fill all purchase orders for Clinical Samples placed by
NeurogesX hereunder, and shall deliver the Clinical Samples by the delivery dates requested therein, unless (a) a purchase order includes substantially higher volumes and/or provides for substantially shorter lead times than those purchase
orders previously placed by NeurogesX and accepted by LTS, and (b) LTS cannot fill such purchase order by using [***]. With respect to such purchase orders, LTS shall notify NeurogesX within [***] business days of receipt thereof, and NeurogesX
shall have the option, to be executed with [***] business days thereafter, to either (i) modify the purchase order based on the parties’ mutual discussion, or (ii) in case of LTS acceptance of such order (which shall not be
unreasonably withheld provided that LTS shall not be forced to breach any of its other obligations), NeurogesX shall [***] LTS for its [***] beyond those normally [***], if any, for LTS to meet such order. Such [***] shall be [***] and [***] prior
to acceptance of the order, and it is understood that LTS shall use [***] to [***] any such additional [***]. In the event LTS does not so notify NeurogesX within such [***] business days, NeurogesX’s purchase order shall be deemed accepted by
LTS, and Section 2.2(ii) above shall not apply thereto. 
 2.3 Delivery. All Clinical Samples for delivery will be placed at the
disposal of NeurogesX at the relevant LTS manufacturing facility. Title and risk of loss, delay or damage to the Clinical Samples in transit shall pass to NeurogesX upon delivery of the Clinical Samples to the carrier. Unless NeurogesX requests
otherwise, all Clinical Samples shall be packed for shipment and storage fit for the respective way of transportation using the packaging set forth in Exhibit E and any requirements set forth in the Quality Assurance Agreement. In the event
NeurogesX has any special freight packaging requirements, it shall notify LTS, and LTS will use Reasonable Commercial Efforts to comply with any such requirements. All costs associated with any special freight packaging requirement shall be borne by
NeurogesX. NeurogesX 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 the Clinical Samples hereunder.

 2.4 Quality Assurances. LTS shall comply with each requirement set forth in the Quality Assurance Agreement with respect to
manufacturing (and associated support functions including without limitation testing, release, stability studies), storage, handling and delivery of Clinical Samples to NeurogesX hereunder; provided, however, the provisions concerning LTS
responsibility and liability as set forth in this Agreement shall supersede any conflicting provisions in the Quality Assurance Agreement or any amendment thereof. 
 2.5 Manufacturing Facility. LTS’s manufacturing facilities for the Clinical Samples are and shall continue to be in compliance with cGMP and shall be available for governmental inspection if any competent
authority or governmental organization so requests. LTS shall promptly provide to NeurogesX any cGMP certificate issued by the competent authority/authorities. 
 2.6 Audits. NeurogesX 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 reasonable times and on reasonable notice and during regular business hours. 
  

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 2.7 Supply of Capsaicin. NeurogesX shall provide LTS with the necessary amounts of the active
principle capsaicin according to the specifications as set forth in Exhibit I (“Materials”), solely for LTS to fill NeurogesX’s purchase orders for Clinical Samples placed under this Article 2, and for performing the
activities described in the Development Plan under Article 3. LTS shall only perform identity testing of the Materials. NeurogesX shall retain all right, title and interest in the Materials. The Materials shall be (i) clearly marked as property
of NeurogesX, (ii) stored under conditions specified in Exhibit I, (iii) kept free of any liens and encumbrances, and (iv) subject to inspection by NeurogesX at any time during LTS’s business hours. LTS shall maintain an
accurate inventory of Materials and shall be responsible for any and all loss, damage, or theft of Materials. Upon termination or expiration of this Agreement (or an earlier request of NeurogesX), LTS will promptly deliver to NeurogesX or
NeurogesX’s designee all Materials F.O.B. NeurogesX’s address first set forth above. 
 2.8 Conflicting Terms and
Conditions. The supply of Clinical Samples by LTS to NeurogesX and of Materials 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. 
 ARTICLE 3 
 DEVELOPMENT 
 3.1 Continuing Development of the Patch. The Parties agree to cooperate on the continuation of the development of the Patch in accordance with
this Agreement. LTS shall use Reasonable Commercial Efforts to continue carrying out the activities set forth in the Development Plan in accordance with the schedules set forth therein and this Agreement, and NeurogesX shall use Reasonable
Commercial Efforts to continue to pursue obtaining Marketing Approval for the Patch in the Territory, and, if elected, any additional countries in accordance with Section 3.7 below. 
 3.2 Changes to the Specifications. Each Party shall be available to consult, and shall cooperate with the other Party with respect to any changes
to the Specifications NeurogesX requires to facilitate obtaining Marketing Approval for the Patches in the Territory. Without limiting the foregoing, neither Party shall unreasonably withhold its approval for any changes to the Specifications that
(a) NeurogesX reasonably determines are necessary for its efforts to obtain such Marketing Approval for the Patches in the Territory or (b) LTS reasonably determines are necessary to meet the CMC section of any HMD or NDA for the Patch (or
the equivalents thereof outside the United States). 
 The Party requesting such change shall be fully responsible for any reasonable delay,
complications and/or cost increases connected to such change. Changes to the Specification which are mutually agreed upon in writing shall apply to all Patches and/or Clinical Samples ordered after the date of such change, unless otherwise agreed
upon by the Parties. 
  

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 3.3 Patch Regulatory Information. LTS shall provide NeurogesX with Patch Regulatory Information
upon NeurogesX’s request. To the extent such Patch Regulatory Information constitutes LTS’s manufacturing or patch trade secrets, LTS may notify NeurogesX and provide a general description thereof, and if requested by NeurogesX, LTS may,
instead of providing the Patch Regulatory Information to NeurogesX, elect to directly provide such Patch Regulatory Information to the applicable regulatory authority. 
 3.4 Regulatory Issues. LTS will notify NeurogesX in due time (and no later than five (5) business 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. 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 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 reasonable efforts to incorporate therein NeurogesX’s comments as appropriate. 
 3.5 Changes by LTS to the Manufacturing Process. Notification of intent by LTS to change any aspect of manufacture, which to LTS’s best knowledge has the potential to substantially affect the Patch will be provided by LTS to
NeurogesX prior to implementation of the change, which change shall further be subject to the approval of NeurogesX. 
 3.6 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. 
 3.7 Additions to the [***]. NeurogesX shall have the right to elect from time to time to pursue [***] for the Patches in [***] or [***] other than
[***] upon written notice to LTS within a reasonable lead time. In the event NeurogesX’s decision to add any [***] or [***] to the [***] shall cause LTS to [***], as a result of specific [***] of such [***] or [***] (“ [***]”),
and/or impose requirements beyond LTS’s standard manufacturing practice, LTS shall in due time notify and discuss with NeurogesX such [***] and such additional requirements. Upon such mutual agreement of the [***] and ways of accommodating such
additional requirements, NeurogesX shall have the option to either (a) modify or limit such addition to the [***], or (b) include such [***] or [***] within the [***] and [***] LTS for the [***]. It is understood that LTS shall use [***]
to [***] any such [***] and accommodate such reasonable requirements. 
 3.8 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 Affiliates shall be bound by all of the terms and conditions set forth herein as if named as a Party, and provided further that LTS remains
responsible for the performance of such Affiliates under this Agreement or otherwise. 
  

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 ARTICLE 4 
 COORDINATION 
 4.1 Development Team. Promptly after the Effective Date, the Parties will form
a team (the “Development Team”) to facilitate communications and decision making by the Parties regarding the activities to be carried out pursuant to this Agreement including, but not limited to, facilitating the transfer of
information between the Parties relating to NeurogesX’s applications for Marketing Approval, discussing capacity constraints and other supply issues, discussing additions to the Territory, establishing, supplementing and modifying the Patch
development or the Specifications, discussing intellectual property issues relating to the Patch in conjunction with a competent patent counsel of NeurogesX and/or LTS as appropriate. 
 4.2 Composition. The Development Team shall consist of [***] representatives from [***], 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 Development Team. In the event that a member of the Development 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 Development Team will conduct formal meetings via teleconference or in person on at least a [***] basis, and will issue minutes of those meetings within [***] days to the management of
each respective company. 
 4.4 Decisions. All decisions made by the Development Team shall be based on the mutual 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 liability, In case the Project Leaders do not agree, the
principal executive officers 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 Development Team shall vary the terms
and conditions of this Agreement, nor the rights and obligations of the Parties hereunder. 
 ARTICLE 5 
 PAYMENT 
 5.1 Payment: Rates. In
accordance with this Article 5, NeurogesX shall compensate LTS, at a rate of: 
 (a) [***] per person hour, and 
 (b) [***] per machine hour for work performed on the large scale TTS production equipment; 
 each plus [***], if applicable, for all hours actually expended by LTS on activities set forth in the Development Plan performed in accordance with this Agreement
(“LTS Activities”), such as for example, the supply of Clinical Samples to NeurogesX under Article 2 and continuing development 
  

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activities under Article 3. It is understood that the amounts to be paid by NeurogesX under this Section 5.1 are in lieu of any purchase price to
be paid by NeurogesX for the supply of Clinical Samples, and LTS shall not charge NeurogesX any amounts for the supply of Clinical Samples or its other activities hereunder except as expressly set forth in this Agreement. 
 5.2 Advance Payments. [***] days prior to the beginning of each calendar quarter during the term of this Agreement, LTS shall provide the
Development Team for its approval an estimate of the hours it expects to spend on activities under the Development Plan in such quarter, broken down by category of activity (as approved, the “Estimated Hours”). Within
[***] days thereafter, NeurogesX shall pay LTS an advance payment (“Advance Payment”) equal to the amount calculated under Section 5.1 for [***] of the Estimated Hours. LTS shall verify and document the person hours
and machine hours actually expended on the LTS Activities each quarter, and will submit such documentation to NeurogesX along with an invoice at the end of each calendar quarter. If the amount actually owed under Section 5.1 for LTS Activities
is less than the Advance Payment, then the difference will be credited against the amounts due in the succeeding calendar quarters, including without limitation any future Advance Payments. If the amount actually owed under Section 5.1 for LTS
Activities is greater than the balance of the Advance Payment, then NeurogesX shall pay such difference within [***] days after receipt of the invoice. All payments hereunder shall be in Euros. Upon termination or expiration of this Agreement
for any reason, (a) LTS shall promptly refund to NeurogesX any unused Advance Payments or (b) in case the amount actually owed under Section 5.1 for LTS Activities is greater than the balance of the Advance Payment, then NeurogesX
shall promptly pay such difference. 
 5.3 Audits. At NeurogesX’s request, NeurogesX shall have the right through an independent
auditor, acting in confidence, to audit LTS’s allocation of person-hours and machine-hours for the LTS Activities. 
 5.4 No Setoff
nor Suspension of Performance. 
 (a) 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 and 5.2 of this Agreement, unless the Parties otherwise agree or until NeurogesX has obtained a final and non-appealable judgment against LTS in
the amount asserted by NeurogesX. 
 (b) LTS shall not have the right to suspend performance (including without limitation refusing or
withholding delivery of Clinical Samples) under this Agreement unless and until LTS has obtained a final and non-appealable judgment against NeurogesX holding that NeurogesX has materially failed to perform its obligations under this Agreement
relating thereto. 
 ARTICLE 6 
 OTHER ASPECTS OF THE BUSINESS RELATIONSHIP 
 6.1 Memorandum of Understanding. The MOU shall continue to be in effect
only with respect to rights and obligations of the Parties prior to the Effective Date arising from activities prior to the Effective Date, notwithstanding any survival provisions set forth in the MOU. With respect to 
  

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(a) activities of the Parties after the Effective Date, and/or (b) rights and obligations of Parties after the Effective Date (including those
arising from activities under the MOU prior to the Effective Date), this Agreement shall supersede the MOU and the MOU shall be of no further effect. For purposes of determining the rights and obligations of the Parties after the Effective Date
arising from the MOU, all activities by the Parties under the MOU shall be deemed to have been activities under Article 3 of this Agreement. 
 6.2 Supply Agreement. In case NeurogesX is interested in continuing to commercialize the Patches, LTS will be NeurogesX’s exclusive (to be defined in the Supply Agreement) partner for manufacturing and supply of the Patch, and
NeurogesX will be LTS’s exclusive (as defined in Section 7.2 below) partner for sale and distribution of the Patches; subject to terms and conditions, including but not limited to [***], as well as [***], to be negotiated between the
Parties in good faith (the “Supply Agreement”). Notwithstanding the foregoing, in the event the Parties cannot in good faith agree on the terms and conditions of the Supply Agreement within [***] after such negotiation has
commenced, which shall not be later than [***] after the Effective Date (“Failure to Agree”), NeurogesX shall be free to negotiate and enter into any manufacturing and supply agreement(s) with any third party(ies) and its rights set
forth in Section 7.3 below shall become active. 
 (a) Milestone Payment. It is the Parties’ intent that the Supply Agreement
would provide for a one time payment by NeurogesX in the amount of [***] within [***] days of first receipt by NeurogesX of Marketing Approval of a Patch in the first launch country. 
 (b) Royalties. It is the Parties’ intent that the Supply Agreement would provide for a royalty rate of [***] on the Net Sales of Kits sold by
NeurogesX, its Affiliates or Sublicensees, containing Patch(es) purchased from LTS under the Supply Agreement. Royalties shall be paid according to Section 7.3(e). 
 (c) Transfer Price. It is the Parties’ intent that the transfer price for the Patches shall be negotiated at the time of the negotiation of the Supply Agreement based on the non-binding price offer for the
Patch provided by LTS in its letter dated June 13, 2001, attached hereto as Exhibit H, and the email dated August 29, 2002 from [***] to [***] amending the non-binding price offer based on discussions between the Parties regarding
insurance and liability issues, which states that the non-binding price offer for the Patch shall be increased by not more man [***] per [***] Patches. 
 (d) Other Terms. To the extent the rationale behind the provisions set forth in this Agreement are applicable to like provisions of the Supply Agreement, the Parties shall endeavor not to vary the terms and
conditions of such provisions when negotiating the Supply Agreement. 
  

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 ARTICLE 7 LICENSES 
 7.1 Clinical Program License to NeurogesX. LTS hereby grants NeurogesX a worldwide, [***], [***] right and license under the Clinical Program
Patents and the Patch Regulatory Information to use said patents and information, for purposes of obtaining Marketing Approval for the Patches, including without limitation for designing and conducting clinical trials, toxicological, pharmacological
and other studies, inclusion in the CMC documentation and other regulatory filings, and preparing documentation regarding the preparation, manufacturing and/or use of the Patches or the delivery of services relating thereto. The license set form in
this Section 7.1 shall be exclusive, for purposes of obtaining Market Approval for TTS in the Field. 
 7.2 Limited Exclusivity.

 (a) LTS shall for the duration of this Agreement and any future Supply Agreement not develop for, sell or license to, any third parties any
TTS with capsaicin with an [***] (such TTS, the “Field”). 
 (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 Section 7.2, 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 VRl-Ligands. 
 7.3 Backup Commercialization License. 
 (a) Definitions. For the purpose of this
Section 7.3, the following terms will have the meanings set forth below. 
 (i) “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 MOU and the Secrecy Agreement. 
 (ii) “LTS Technology” means LTS Know-how and any and all patents or other 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. 
 (b) Delivery of Technology. In the event of a Failure to Agree (as defined in Section 6.2), in order to permit NeurogesX to manufacture or have manufactured and commercialize the Patch, LTS shall, upon NeurogesX’s request,
deliver to NeurogesX at no additional cost, [***] 
  

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[***]. EXCEPT AS SET FORTH IN THIS SECTION 7.3(B), LTS SHALL IN NO CASE BE OBLIGED TO PROVIDE ITS PROPRIETARY KNOW-HOW WITH REGARD TO GENERAL TTS
MANUFACTURING METHODS, BUT SHALL IF REQUESTED BY NEUROGESX AND AT NEUROGESX’S COSTS [***]. 
 (c) License. LTS hereby grants
NeurogesX a world-wide right and license, with 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, and to [***]; provided that NeurogesX shall not exercise any rights set forth in this Section 7.3 except in the event of a Failure to Agree (as defined
in Section 6.2). NeurogesX shall not disclose any LTS Know-how to any third party except in connection with exercising the rights set forth in this Section 7.3(c), and subject to reasonable confidentiality obligations on the part of such
third party. [***] 
 (d) Royalties. In consideration of the license set forth in this Section 7.3, NeurogesX shall pay LTS a
[***] running royalty on the Net Sales of Kits by NeurogesX, its Affiliates or Sublicensees, in the event NeurogesX exercises the rights set forth in this Section 7.3 for such Kits after a Failure to Agree. 
 (e) Computation of Royalties. The royalties set forth in Section 6.2(b) and 7.3(d) shall be computed for each applicable [***] period
([***]), and shall be due and payable within [***] days after such [***] period. For purposes of computing royalties, the Patch 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 Sections 6.2 or 7.3 accruing during such [***] period. NeurogesX shall keep
records in sufficient detail to enable the royalties’ payable under the Section 6.2 or this Section 7.3 to be determined. The records of NeurogesX shall be available during reasonable business hours for inspection not more than once
every [***] month period, by an independent Certified Public Accountant reasonably acceptable to NeurogesX acting in confidence and retained by LTS at LTS’s 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 costs connected with the verification. 
 7.4 Sublicensing. In the event NeurogesX desires to grant a sublicense to any third party under the licenses set forth in Section 7.1 and/or 7.3, [***], provided that 
 (a) LTS is informed of [***] (as it relates to the scope of such sublicense); and 
  

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 (b) those Sublicensees shall be obligated to indemnify LTS regarding product liability to the extent
NeurogesX is so obligated under Sections 10.2 and 10.3(b). 
 ARTICLE 8 
 INTELLECTUAL PROPERTY 
 8.1
Inventions from the LTS Development of the Patch. 
 (a) LTS Owned. All inventions developed by the Parties under this Agreement
solely relating to LTS’s existing TTS technology, including but not limited to [***] of TTS, shall be the property of LTS (“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 under this Agreement [***] uses of VRl-Ligands 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. [***] inventions developed by the Parties under this Agreement shall be the joint property of the Parties (“Joint
IP”), provided that it does not belong to [***]. 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 [***] have the right to [***] applications and products. 
 8.2 Prosecution of Patents Covering the Patch. 
 (a) As used in this Sections 8.2 and 8.4, “prosecute” means the procedure(s) involved in securing patent rights in patent offices worldwide. 
 (b) LTS shall have the right, but not the obligation, to file, prosecute and/or maintain any patent or patent application solely owned by LTS covering
the Patches. 
 (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 [***] prior to the due date for action or payment. NeurogesX shall then have the right, to file, prosecute and/or maintain any such patent or patent application. 
  

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 (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 non-exclusive (except as set forth in this Section 8.2(e)), transferable, sublicensable, royalty free, perpetual license under such patents or
patent applications to make, use, sell, offer for sale, export, practice and otherwise exploit the subject matter thereof. 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 8.3 below. 
 8.3 Third Party
Infringement in the Field. Each Party agrees to promptly notify the other Party if it becomes aware of any third party’s TTS in the Field that infringes LTS’s patents covering the Patch (an “Infringement”). LTS shall
have the first right, but not the obligation, to enforce its patents against any Infringement. LTS shall solely control any such enforcement action. LTS shall keep NeurogesX informed of the proceeding of such enforcement. In case NeurogesX believes
LTS is not diligently pursuing the enforcement, NeurogesX shall have the right to consult 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 Section 6.2 or Article 7 of this Agreement or the Supply Agreement. LTS shall not settle any Infringement action
without the prior written approval of NeurogesX. In the event LTS notifies NeurogesX within 120 days after notice of an alleged Infringement by either party that it intends not to file suit against any alleged Infringement, or does not give any
notification whether it intends to file suit within one hundred and twenty (120) 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’s 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 8.3, at
NeurogesX’s cost and expense. If LTS decides to enforce its patents against Infringement and NeurogesX permits LTS to claim NeurogesX damages, then any proceeds recovered from any such Infringement action shall be divided [***] between
NeurogesX and LTS after first subtracting all legal and attorney fees and expenses. In the event NeurogesX is given the right to enforce LTS’s patents against Infringement and LTS permits NGX to claim LTS’s damages, then again any proceeds
recovered from any such Infringement action shall be divided [***] between NeurogesX and LTS after first subtracting all legal and attorney fees and expenses. 
 8.4 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 the other Party including without limitation participating in enforcement actions, 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. 
 8.5 IP Review by LTS. LTS shall review on a regular basis the intellectual property rights relevant for
LTS’s work LTS shall give NeurogesX a confirmation in writing [***] a year (on or about [***] of each year) that, to the best of its actual knowledge, [***] with respect to the Patches. 
  

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 ARTICLE 9 
 REPRESENTATIONS AND WARRANTIES; DISCLAIMER; LIMITATION OF 
 LIABILITY 
 9.1 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. 
 9.2 Clinical Samples. Subject to the limited liability provisions set forth in this Agreement, LTS represents and warrants that the Clinical
Samples delivered to NeurogesX shall be in conformity with the Specifications, shall be manufactured in accordance with Current GMP and the Quality Assurance Agreement, and shall comply with all Regulatory Requirements. 
 (a) Rejection of Defective Clinical Samples. NeurogesX may reject Defective Clinical Samples (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) by delivering to LTS written notice of rejection, and if practical, specifying the nature of the Defect and the Clinical
Samples lot number, within [***] days after receipt by NeurogesX of the applicable shipment. In the case of Clinical Samples with Defects that are not reasonably discoverable upon NeurogesX’s customary incoming quality control testing
(“Latent Defects”), NeurogesX may reject such Clinical Samples within [***] days after discovery of the Latent Defects. 
 (b) Replacement of Defective Clinical Samples. During the [***] period commencing on the date the Clinical Samples are delivered to NeurogesX, LTS shall promptly (and in any event within [***] of receipt of notice of rejection)
deliver to NeurogesX, at LTS’s own cost and risk, including shipping costs, replacements for any rejected Defective Clinical Samples, up to the maximum of units contained in the applicable lot; but provided that NeurogesX can prove by
sufficient evidence mat such Defect is not due to the mishandling or incorrect or inappropriate storage (i.e., not in accordance with the Specifications) of the Clinical Samples by NeurogesX and or any third party who has had access thereto.

 LTS shall have the right to examine any Clinical Samples rejected by NeurogesX, provided such examination shall not delay the shipping of replacement
Clinical Samples. In the case LTS disagrees that the rejected Clinical Samples are subject to this Section 9.2, 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. The determination of such laboratory shall be final and binding upon the Parties. The Party against whom the determination is made shall be
responsible for the fees and expenses of such determination, as well as the costs of the replacements for the rejected Clinical Samples at issue, including shipping costs. 
  

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 9.3 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, CLINICAL SAMPLES AND CAPSAICIN 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. 
 9.4 Limitation of
Liability. EXCEPT WITH RESPECT TO ARTICLE 10 AS RELATED TO THIRD PARTIES AND ARTICLE 11, 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 10 
 INDEMNIFICATION 
 10.1 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 and Clinical Samples which, at the time of delivery, do not conform to the Specifications (“Product Claims”). NOTWITHSTANDING THE
FOREGOING, LTS’S AGGREGATE LIABILITY UNDER THIS SECTION 10.1 IN EACH CALENDAR YEAR FOR PRODUCT CLAIMS THAT DO NOT RESULT FROM LTS’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, SHALL NOT EXCEED THE LIMITS OF [***]. 
 10.2 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’s development, manufacturing, sale and using the Patches for or to NeurogesX, which IP Claims are caused by LTS’s use of any technology or intellectual property owned or supplied by
NeurogesX. 
 (b) LTS Caused. With respect to any third party IP Claims arising from the development, manufacture, sale and use of the
Patches or Clinical Samples 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 7.3(a)(ii)) (an “LTS Infringement”), the following shall apply: 
  

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 (i) If either Party is sued for an alleged [***], [***] is liable up to an amount of [***] for all costs
and expenses (including reasonable attorney’s fees and disbursements) incurred by [***] in connection with the defense of such IP Claims. For all costs and expenses incurred by [***] in defense of such IP Claims in excess of [***], [***] is
liable and shall indemnify and hold harmless [***]. In the event [***] is the Party sued for an alleged [***], and [***] desires indemnification from [***], [***] shall promptly notify [***] of the alleged [***], permit [***] sole control of the
defense and/or settlement of the alleged [***] as requested (but [***] may participate in such defense and/or settlement with counsel of its choice and its own expense), and cooperate with [***] with respect to such defense and settlement.

 (ii) [***] agrees to automatically [***] under this Agreement and any future Supply Agreement by the [***] a court may require [***] to
pay to a third party claiming a [***] in satisfaction of a judgment against [***], or by the [***] owed by [***] in any settlement of the [***]; provided that the [***] under this Agreement or future Supply Agreement shall not fall below [***].

 (iii) In case of a court judgment which prohibits [***] from [***] as a result of an [***], [***] shall reimburse [***] for [***] of the
[***]. This obligation shall only be valid during the term of this Agreement and future Supply Agreement. 
 (c) Sole Remedy for IP
Claims. Notwithstanding any other provision of this Agreement, this Section 10.2 shall 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. 
 10.3 Other
Indemnification. 
 (a) LTS. Without regard to LTS insurance, LTS shall indemnify and hold NeurogesX harmless from any claims,
damages, losses, costs and expenses (including attorney’s fees) (“Claims”) that arise from LTS’s gross negligence or willful misconduct in connection with the use, development, manufacturing, sale, distribution or
application of the Patch. 
 (b) NeurogesX. Other than to the extent that LTS is obligated to indemnify NeurogesX pursuant to this
Article 10 or otherwise arising from LTS’s gross negligence or willful misconduct, NeurogesX shall indemnify and hold LTS harmless from any Claims that arise from the [***] which shall include claims under Article 10.1 to the extent that they
exceed [***], and not falling within Section 10.3(a) above or those claims addressed in Section 10.2, provided that (i) LTS promptly 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. 
  

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 10.4 Insurance. 
 (a) NeurogesX. NeurogesX shall obtain sufficient clinical trial insurance coverage of an amount reasonable and customary in the pharmaceutical industry considering the nature and extent of the clinical trials
in question, 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, if such coverage is available at terms and conditions not substantially more unfavorable than
LTS’s 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 11 
 CONFIDENTIALITY 
 11.1 Confidential Information. The parties agree that
the Secrecy Agreement dated January 23, 2001 executed between LTS Lohmann Therapy-Systems Corp. and NeurogesX and herein attached as Exhibit G (“Secrecy Agreement”) shall govern the confidential information disclosed by
each party under this Agreement; provided that the “Purpose” set forth therein shall mean performing obligations and/or exercising rights under this Agreement, and the term of the confidentiality obligations thereunder shall be for the
term of this Agreement plus [***], and that the provisions in this Agreement regarding choice of law venue and liability shall supersede the corresponding provisions in the Secrecy Agreement. 
 11.2 Confidential Terms/Publicity. Except as expressly provided herein, 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 (i) as required by securities or other applicable laws, in which case the disclosing party shall seek confidential treatment to the extent available, or (ii) to
advisors, investors and others on a need-to-know basis under circumstances that reasonably ensure the confidentiality thereof, or (iii) to the extent required by law. 
 ARTICLE 12 
 TERM AND TERMINATION 
 12.1 Term. Unless terminated in accordance with this Article 12, this Agreement shall be in effect until the earlier of (a) NeurogesX
obtaining (or notifying LTS in writing that it has abandoned its efforts to obtain) Marketing Approval for the Patches in each regulatory jurisdiction in the Territory, or (b) June 30, 2006. NeurogesX shall have the option (exercisable
multiple times, each time for an additional two (2) years) to extend the date set forth in clause (b) above upon written notice at least thirty (30) days prior to such date; provided that at the time of such date NeurogesX is
continuing to use Reasonable Commercial Efforts to obtain Marketing Approval for the Patches in one or more regulatory jurisdictions in the Territory or as expanded in Section 3.7. 
  

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 12.2 Termination for Breach. Each Party shall have the right to terminate this Agreement upon
written notice, in the event of the other Party’s material breach hereof which is not cured within thirty (30) days after notice specifying such breach. 
 12.3 Termination upon Failure to Agree. Either Party shall have the right to terminate this Agreement in the event of a Failure to Agree (as defined in Section 6.2). 
 12.4 Survival. Articles and Sections 1, 2.7 (last sentence), 3.3, 3.6, 5.2 (last two sentences), 6, 7 (except 7.2(a)), 8, 9, 10, 11, 12 and
13 shall also survive any expiration or termination of this Agreement. 
 ARTICLE 13 
 MISCELLANEOUS 
 13.1 Dispute
Resolution. 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 forty-five (45) days of such written notice, each party shall have full access to personal jurisdiction and service of process in any venue or in any court at the seat of the defendant. Both Parties
waive any right to demand a trial by jury. 
 13.2 Governing Law. In case LTS is the defendant, this Agreement is subject to German
law, regardless of the laws that might otherwise govern under applicable principles of conflicts of law thereof. In no event in such case shall choice of law analysis lead to the application of other than German law. In case NeurogesX is the
defendant, this Agreement is subject to the law of the State of California, the United States of America (including U.S. federal law), regardless of the laws that might otherwise govern under applicable principles of conflicts of law thereof. In no
event in such case shall choice of law analysis lead to the application of other than the law of the State of California. 
 13.3
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 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 or otherwise. 
 13.4 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. 
 13.5 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. 
  

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 13.6 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. 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. 
 13.7 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 & CEO

		
	 If to LTS:
	 	LTS Lohmann Therapie-Systeme AG,
		 	 Lohmannstraße 2,
 D-56626
Andernach,
 Germany
 Attn: Legal Department

	 
	 
	 

 13.8 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. 
 13.9 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. 
 13.10 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 
  

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 13.11 Entire Agreement. This Agreement together with the Exhibits attached hereto constitutes 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. 
 13.12 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. 
 13.13 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. 
  

									
	NeurogesX, Inc.	 		 	LTS Lohmann Therapie-Systeme AG
					
	 By:
	 	 /s/ Anthony DiTonno
	 		 	By:	 	 /s/ F.
Becher                     /s/ K. Haczkiewicz

	 Name:
	 	Anthony DiTonno	 		 	Name:	 	F. Becher                          K. Haczkiewicz
	 Title:
	 	President and Chief Operating Officer	 		 	Title:	 	General Counsel               Manager Strategic Business Development
	 Date:
	 	1-21-04	 		 	Date:	 	15 Jan. 2004

  

	
	 Exhibits

	Exhibit A: VRl-Ligands
	Exhibit B-1: Specifications as of execution of the MOU
	Exhibit B-2: Specifications as of the Effective Date
	Exhibit C: Quality Assurance Agreement
	Exhibit D: Development Plan
	Exhibit E: Packaging of Clinical Samples
	Exhibit F: LTS Liability Insurance
	Exhibit G: Secrecy Agreement
	Exhibit H: Prior Correspondence Re: Transfer Price of the Patches
	Exhibit I: Specifications for Materials

  

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 EXHIBIT A 
 VR-1 LIGANDS 
 VR-1 Ligand is a vanilloid or related molecule selected from the group
consisting of capsaicin, [***] such as [***] such as [***] such as [***] . 
  

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 EXHIBIT B-l 
 SPECIFICATIONS AT THE TIME OF THE MOU 

 Confidential 
 NeurogesX 
 Annex 2: Required Properties of TransdolorTM Pain Treatment System Patches

 Patch properties: 
 [***] 
  

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 [***] 
  

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 EXHIBIT B-2 
 SPECIFICATIONS AS OF THE EFFECTIVE DATE 

 EXHIBIT C 
 QUALITY ASSURANCE AGREEMENT 

 Addendum 
 Reference to the Memorandum of Understanding 
 Due to the fact that in the mean time an agreement of clinical supply
and development has been finished in reference to the no. 1.2 of chapter 1 the following clause shall be supplemented to the agreement: 
 This Agreement is
entered into pursuant to and is supplemental to the Memorandum of Understanding dated, May 29, 2001. In the event of any conflict between the provision of this Quality Agreement and the provisions of the Memorandum of Understanding, then the
provisions of the Memorandum of Understanding or other subsequent agreements as for clinical supply and development shall prevail. 

	I.	INTRODUCTION AND SCOPE 

  

	1.1	The purpose of this Quality Agreement is to define and establish the obligations and responsibilities of Lohmann Therapie-Systeme AG (LTS) and NeurogesX, Inc. (NGX) as they
relate to the development, manufacture and supply of drug product to NGX by LTS. All manufacture and supply of drug product will be performed in accordance with current Good Manufacturing Practices. 

  

	1.2	This Agreement is entered into pursuant to and is supplemental to the Memorandum of Understanding dated, May 29, 2001. In the event of any conflict between the provision
of this Quality Agreement and the provisions of the Memorandum of Understanding, then the provisions of the Memorandum of Understanding shall prevail. 

  

	1.3	NGX and LTS are responsible for the steps involved in manufacture, control, packaging and final release of drug product as specified in the Appendices contained herein.

  

	1.4	This Agreement and appendices will be accessible to competent Regulatory Agencies as required. 

  

	1.5	Both the NGX and LTS Quality Assurance Units are responsible for keeping this document current, and changes as such will be submitted through the NGX Quality Assurance Unit,
who shall be responsible for maintaining this Quality Agreement and its revision control. Modifications will be agreed between the parties and reflected in written addenda. This Agreement may be revised independently from the Memorandum of
Understanding. 

							
	Section	  	 	  	 Revision
	  	 Date

	I	  	Definitions	  	00	  	Dec 20, 2002
				
	II	  	Overview of Functions and Responsibilities	  	00	  	Dec 20, 2002
				
	III	  	Description of Functions and Responsibilities	  	00	  	Dec 20, 2002
				
	IV	  	Batch Accompanying Documents	  	00	  	Dec 20, 2002
				
	V	  	Conditions for Storage, Packaging, and Shipment	  	00	  	Dec 20, 2002
				
	VI	  	Persons to Contact	  	00	  	Dec 20, 2002
				
	VII	  	Supplementary Agreements and Attachments	  	00	  	Dec 20, 2002

 Section I 
 Definitions 
 cGMP – current Good Manufacturing Practices, which shall include all applicable standards relating to
manufacturing practices for intermediates, bulk products, or finished pharmaceutical products (i) in the form of laws or regulations, or (ii) in the form of guidance documents (including, but not limited to, advisory opinions, compliance
policy guides and guidelines) which guidance documents are being implemented within the pharmaceutical manufacturing industry for like products; in each case, which are promulgated by the FDA or its counterpart foreign governmental agencies or
entities, as applicable. 
 FDA – United States Food and Drug Administration, or any successor agency. 
 SOP – Standard Operating Procedures. 
 C of A – Certificate of
Analysis. 
 OOS – a test result that is outside of the preestablished specification and is investigated and documented per Standard Operating
Procedures for such results. 
 Significant Event – a planned or unplanned deviation from the specifications, quality control procedures or
manufacturing processes known to, or reasonably likely to have an impact on the quality, stability, shelf life or other characteristics of drug product, or that would require the parties to make additional regulatory filings, including, to the
Investigation^ New Drug (IND) Application. 
 Significant Change – a proposed change to a raw material, packaging or labeling component, equipment,
manufacturing method or procedure, product or material specification or requirement, sampling method, test method or release requirements or procedures of any kind known to, or reasonably likely to have an impact on the quality, stability, shelf
life or other characteristics of drug product, or that would require the parties to make additional regulatory filings, including to the Investigational New Drug (IND) Application. 
 Production demonstration – also known as validation batches. 
 Stability – the ability of the drug product to
remain within its established specifications throughout its retest or expiration period, as appropriate. 
 Quality Unit – an independent unit within
organization responsible for duties associated with assuring the quality of the product. 
 Batch (or Lot) – a specific quantity of drug product or
other material that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacture order during the same cycle of manufacture. 

 Master Production Record – a set of specific and detailed instructions required to manufacture a batch of drug
product. 
 Final Product Specification – the combination of physical, chemical, biological, and microbiological tests and acceptance criteria that a
drug product should meet throughout its shelf life. 
 Reference Standard – substances selected for their purity, critical characteristics, and
suitability for use in assays for quantification and identity. 
 Third Party Service Provider – an independent service contracted for any aspect of
manufacturing or testing. 
 Supplier – Any third party who provides materials that will be used in products or as primary packaging or labeling
components for NeurogesX products. 
  

 -2- 

 Section II  
 Overview of Functions and Responsibilities 
  

					
	 NeurogesX, Inc.
 San Carlos Business Park
 981F Industrial Road
 San Carlos, CA 94070-4117
 USA
	 	 LTS
 Lohmann Therapie-Systeme AG
Lohmannstraße 2
 56626 Andernach
 Germany
	 	Third Party
N/A

  

							
	 Responsibilities:
	  	NeurogesX	 	LTS	 	T.P.
	 Sponsor
	  	[***]	 	[***]	 	
	 STARTING MATERIALS
	  		 		 	
	 Active ingredients
	  		 		 	
	 Purchasing
	  	[***]	 	[***]	 	
	 Quality Control testing
	  	[***]	 	[***]	 	
	 Specification + methods
	  	[***]	 	[***]	 	
	 Reserve samples
	  	[***]	 	[***]	 	
	 Inactive ingredients
	  		 		 	
	 Purchasing
	  	[***]	 	[***]	 	
	 Quality Control Testing
	  	[***]	 	[***]	 	
	 Specification + methods
	  	[***]	 	[***]	 	
	 Reserve samples
	  	[***]	 	[***]	 	
	 Packaging materials
	  		 		 	
	 Purchasing
	  	[***]	 	[***]	 	
	 Quality Control Testing
	  	[***]	 	[***]	 	
	 Specification + methods
	  	[***]	 	[***]	 	
	 Reserve samples
	  	[***]	 	[***]	 	
	 PRODUCTION
	  		 		 	
	 Current production formula
	  	[***]	 	[***]	 	
	 - Manufacturing of the bulk, product and in- process controls
	  	[***]	 	[***]	 	
	 - Primary packaging (incl. in-process-controls)
	  	[***]	 	[***]	 	
	 - Cleaning Confirmation
	  	[***]	 	[***]	 	
	 - Secondary packaging (incl. in-process-controls)
	  	[***]	 	[***]	 	
	 Labeling for clinical supplies
	  	[***]	 	[***]	 	
				
	 QUALITY CONTROL
	  		 		 	
	 Release of raw materials
	  	[***]	 	[***]	 	
	 Testing of the final product
	  	[***]	 	[***]	 	
	 Release of clinical trial supplies
	  	[***]	 	[***]	 	

  

	***	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.

  

 -3- 

							
	 Responsibilities:
	  	NeurogesX	 	LTS	 	T.P.
	 Reserve samples final product
	  	[***]	 	[***]	 	
	Stability	  		 		 	
	 Stability protocol development
	  	[***]	 	[***]	 	
	 Stability protocol review and approval
	  	[***]	 	[***]	 	
	 Stability testing of clinical trial supplies Starting with phase I
	  	[***]	 	[***]	 	
	 Stability report generation
	  	[***]	 	[***]	 	
	 Establishing retest date
	  	[***]	 	[***]	 	
	 Analytical method development
	  	[***]	 	[***]	 	
	THIRD PARTY QUALIFICATIONS	  		 		 	
	 Third party manufacturers qualification
	  	[***]	 	[***]	 	
				
	INVESTIGATIONS	  		 		 	
	 Deviation investigation
	  	[***]	 	[***]	 	
	 Deviation approval (significant)
	  	[***]	 	[***]	 	
	 Out of specification results investigations
	  	[***]	 	[***]	 	
				
	VALIDATION	  		 		 	
	 Facility / utility / equipment validation plans
	  	[***]	 	[***]	 	
	 Facility / utility / equipment validation execution
	  	[***]	 	[***]	 	
	 Cleaning validation
	  	[***]	 	[***]	 	
	 Computer validation
	  	[***]	 	[***]	 	
	 Analytical method validation execution
	  	[***]	 	[***]	 	
	 Process validation plan
	  	[***]	 	[***]	 	
	 Process validation
	  	[***]	 	[***]	 	
	 Process validation report
	  	[***]	 	[***]	 	
	 Development reports
	  	[***]	 	[***]	 	
				
	CHANGE CONTROL	  		 		 	
	 Process and Formulation
	  	[***]	 	[***]	 	
	 Equipment
	  	[***]	 	[***]	 	
				
	COMPLAINTS AND RECALLS	  		 		 	
	 Complaints and Recalls
	  	[***]	 	[***]	 	

 X in both columns – [***] 
 X* – to be available for review by NGX prior to finalization 
  

	***	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.

  

 -4- 

 Section III 
 Description of Functions and Responsibilities 
 Production of product 
 LTS shall manufacture and test NGX’s drug product in accordance with LTS’s SOPs, cGMPs, applicable laws and regulations, including all
applicable FDA regulations, any applicable local laws and regulations in the place of manufacture, and any IND, NDA, MAA and other regulatory filings or approvals for the drug product (collectively, the “Regulatory Requirements”), and
applicable contracts between LTS and NGX, including the parties’ Memorandum Of Understanding, as amended on May 29, 2002. The manufactured product shall adhere to the specification supplied by NGX or as mutually agreed upon and in
compliance with all cGMPs and any other applicable Regulatory Requirements. LTS will prepare for each batch of product manufactured for NGX, the complete production record documentation (see section IV, Batch Accompanying Documentation). This
completed documentation will be retained by LTS in accordance with its document retention policy and Regulatory Requirements, and in no event less than 10 years. The documentation will be readily accessible for review and inspection by NGX and
regulatory authorities, and true copies of these records will be sent to NGX by LTS for each batch of product produced. 
 Control of Suppliers

 LTS shall maintain an approved supplier’s list in accordance with LTS’s procedures. NGX’s approval will be required
for any supplier change for materials used in NGX’s products. LTS shall notify NGX of intended change in suppliers at least 6 months in advance of implementing the change. LTS will provide the Material Name, Supplier Name and Manufacturing
Location to NGX upon request. The initial approved supplier’s list shall be subject to NGX’s written approval. 
 Third Party Service
Providers 
 Should LTS employ a third party service provider (TPSP) for any manufacture, testing or performance of any ancillary
function related to NGX’s product, NGX and LTS and the TPSP will agree on the following: 
  

	 	1.	LTS will not use any TPSP without a written consent by NGX. 

  

	 	2.	LTS will be the primary contact with the TPSP. 

  

	 	3.	LTS will adequately qualify the supplier according to LTS policies and procedures and this Quality Assurance Agreement. 

  

	 	4.	LTS will be responsible for release and review of any one part or all parts of the process performed by TPSP, and shall be responsible for any actions performed by the TPSP with
respect to NGX’s product as if performed by LTS itself. 

  

	 	5.	LTS will perform appropriate process transfer according to their internal procedures and applicable regulations. 

  

 -5- 

	 	6.	NGX retains the right to review or obtain copies of documents created by TPSPs and retained by LTS. 

  

	 	7.	The Quality Assurance Agreement with TSPS shall not have discrepancies to this Quality Assurance Agreement or other agreements between LTS and NGX. 

  

	 	8.	NGX will not give analytical methods or procedures of LTS to TSPS without written consent of LTS. 

 Printed Materials 
 NGX will be responsible for, and provide LTS with, all copy content and
artwork for all printed materials associated with the product, e.g. labels, etc. NGX will be responsible for compliance with all necessary laws and regulations concerning such materials. The products supplied to NGX hereunder shall be packaged and
labeled in accordance with instructions from NGX. 
 Drug Product Specifications 
 The referenced drug product(s) must be manufactured, packaged, labeled (if necessary) and handled according to the written specifications and procedures
as outlined in this agreement. Changes to the specifications shall be mutually agreed upon and approved by both parties. 
 In testing drug
product(s) NGX and LTS will agree upon the analytical methods requiring validation. For those methods which appear in the current compendia or other recognized standard references, a statement indicating the reference shall suffice. For those
analytical methods developed by LTS, documentation supporting the validation of the analytical method shall be supplied upon request, to NGX. 
 Each lot of drug product will be sampled and tested in accordance with the agreed upon LTS procedures, cGMPs and must meet the specifications as outlined in this agreement. 
 Reserve samples 
 LTS shall keep retention samples of raw materials as required by LTS’s
SOPs and Regulatory Requirements. LTS shall commit itself to keep reserve samples of drug product for regulatory purposes for each batch of drug product produced. 
 If batches are reworked and/or reprocessed additional retention samples will be collected and retained by LTS. The quantity of critical intermediate and drug product retained should be at least three times the amount
to be able to perform all physical and chemical tests according to the Certificate of Analysis. 
 Deviations, OOS and Non-Conformances (Significant
Events) 
 All deviations from approved, product–specific procedures or specifications, Out-Of-Specification test results of any
kind, and any non–conformances to specifications will be considered Significant Events and will be investigated and resolved, as applicable, by LTS in consultation with 

  

 -6- 

 
NGX, provided that such Significant Event occurs during the manufacture of NeurogesX product and have, to the best of the knowledge of LTS, the potential to
substantially impact the NeurogesX product. Reprocessing or reworking of drug product or intermediates will always be considered a Significant Event. LTS must notify NGX within 5 working days of each Significant Event, and within within reasonable
time of the completion and results of the investigation concerning such Significant Event. The documentation of the occurrence of the Significant Event, the investigation and any necessary actions required for resolution will be retained as part of
the batch document for the batch(es) affected and a copy thereof provided to NGX. On mutual agreement additional and more in-depth investigation of the Significant Event will be performed by LTS. NGX shall review the documentation for each
Significant Event and provide the required approval in writing for each Significant Event as soon as reasonably possible after the deviation has occurred, but in no event later than release of the relevant batch(es). 
 All actions investigating non-conformances and justifying the release of the batch of material must be fully documented to best of the knowledge of each
party. The non-conformance documents relating to drug product or drug substance will be subject to approval by both LTS and NGX. 
 Release and
Shipment of Product 
 LTS has the responsibility to release finished drug product to NGX. LTS will not ship any of NGX’s product
to any destination other than NGX until NGX has released the product and authorized shipment or unless prior approval has been received from NGX to perform such shipments. 
 A Certificate of Analysis (CofA) or applicable documentation, as well as a Certificate of Production Compliance, shall be provided to NGX by LTS for each
batch of drug product produced. The CofA, or equivalent, will be generated upon completion of all testing requirements and will contain the items tested, corresponding acceptance criteria, and test results. NGX is responsible for the approval and
final release of all finished drug product after review of LTS’ CofA and other required documentation. Upon approval, NGX will notify LTS of such approval by forwarding to LTS the NGX completed and approved batch release checklist. 

Reprocessing and Rework 
 Reprocessing and
rework activity can only be performed per agreement between both LTS and NGX. Reprocessing and rework directions must be established to define the process. Reprocessing and/or rework of material or product must be documented to state reason and
justification for processing. A reprocessing or rework Batch Record will be written and issued following standard procedures. 
 Change Control

 All changes to this Quality Agreement must be documented as an addendum and reviewed and approved by authorized QAU representatives
of LTS and NGX. 
  

 -7- 

 Changes to raw materials, packaging materials, equipment, utilities, facilities, manufacturing methods
and procedures, product and material specifications and requirements, sampling, test methods, and release requirements will be implemented according the LTS’s change control procedures and, in cases of Significant Changes, will require
NGX’s approvals. Changes to the approved Master Production Records and Final Product Specifications will always require LTS’s and NGX’s approvals. 
 LTS and NGX will jointly determine the most efficient route for handling change notifications. LTS will notify NGX of significant proposed changes at least 10 working days prior to the date of proposed implementation.
LTS will not implement any changes without NGX’s written approval, which will be given or withheld by written notice within 5 working days after NGX receives LTS’s notice. 
 Audits and Inspections of Facilities and Products 
 LTS and TPSP’s will notify NGX (and in
advance if possible) of any inspections or actions by regulatory agencies or other enforcement bodies in due time, of LTS’s or any TPSP’s facilities and/or processes which will directly impact NGX’s products. Where reasonably
possible, LTS and TPSP’s shall afford NGX the opportunity to be present at such inspections. 
 NGX reserves the right to audit
LTS’s facilities, systems, documents and processes (including validation, investigation and qualification processes) as they relate to the manufacture and control of NGX’s products or otherwise relating to LTS’s performance of this
Agreement. These audits will be performed on an annual basis or as mutually agreed upon by LTS and NGX and at times convenient to NGX and LTS under such conditions as LTS may reasonable require in order to protect the confidentiality of it’s
and other customer’s proprietary and confidential information. 
 NGX also reserves the right to audit TPSPs (e.g. contract
laboratories, third party manufacturers, etc.) if utilized by LTS for NGX’s product. NGX reserves the right to be on site at LTS during manufacture of NGX’s products and/or during and regulatory inspection specific to NGX’s products
with adequate notice to LTS. LTS will respond to, and forward all responses to observations, generated during NGX’s audit within 30 days of issuance. 
 Storage of Products 
 LTS agrees to store NGX’s products under appropriate product label storage conditions and
in a secure area, to ensure they comply with all the quality specifications, attributes and in compliance with all applicable regulations. If special storage conditions are necessary for special purposes, the conditions, timeframes and material
requirements will be supplied in writing by NGX. 
 Stability Activities 
 The responsibility for writing of stability protocols, stability testing, data interpretation and reporting will belong to LTS and will be conducted in
accordance with ICH guidelines and in consultation with NGX. Stability protocols will be approved by NGX prior to initiation of the stability study. Stability protocols and reports will be subject to approval by NGX. Stability reports 

  

 -8- 

 
will be provided to NGX by LTS at regular intervals and stability milestones. Updating of stability information to regulatory documents for the product is
the responsibility of NGX. All stability related activities under the responsibility of LTS will be completed in a timely manner according to the agreed-upon stability protocols and applicable regulations. NGX will notify LTS to terminate stability
programs at the end of clinical trial or when the lot on stability is no longer relevant. 
 Investigational Product Complaints 
 Each party shall provide any information regarding product complaints to the other party. LTS will assist NGX with any investigations required in regards
to such complaints as a highest priority under this agreement. The results of the investigation will be documented in writing and be provided to NGX as soon as feasible in a timeframe to be agreed upon by LTS and NGX. NGX will communicate with the
customers and/or regulatory authorities the results of the investigation, if necessary. 
  

 -9- 

 Section IV 
 Batch Accompanying Documentation 
 LTS will give a copy of the batch records to NeurogesX for
clinical and PD batches (Production Demonstration). The following documents shall be forwarded to NeurogesX with each delivery of the product: 
  

	 	•	 	 Certificate of Production Compliance 

  

	 	•	 	 Certificate of Analysis 

  

	 	•	 	 List of raw materials used, date raw materials were released and retest or expiration date 

  

	 	•	 	 Manufacturing record for lots released by LTS 

  

	 	•	 	 Packaging record (if applicable) 

  

	 	•	 	 Labeling record (if applicable) 

  

	 	•	 	 Translation of comments made on records 

  

	 	•	 	 Deviations, including investigation/resolution documentation 

  

	 	•	 	 Out of Specification test results including investigation/resolution documentation for lots released by LTS* 

  

	 	•	 	 Analytical testing results for in-process and finished product testing 

  

	 	•	 	 Lot production tree (i.e. a list of all the lots (post raw material lots) used toward production of the final lot of drug product) 

  

	 	•	 	 Certificate of Batch Review by Quality 

  

	 	•	 	 Batch Record Document Inventory Checklist (list of documents sent to NGX for each batch) 

  

	 	•	 	 Copy of any clinical labels applied to drug product 

  

	 	•	 	 Copy of the shipping labels 

	*	If an OOS result is confirmed, the batch will be rejected by QC. This batch will not be shipped to NGX or other destination and therefore NGX will not receive batch documentation

 Section V 
 Conditions for Storage, Packaging and Shipment 
 See 
 • May 29, 2001 Memorandum of Understanding 
  

 -10- 

 Section VI 
  

			
	NeurogesX, Inc. (NGX)
	 [***]
	 	 VP, Regulatory Affairs
 [***]
 [***]

		
	 [***]
	 	 VP, Pharmaceutical Science
 [***]
 [***]

		
	 [***]
	 	 Sr. Manager, Quality Assurance
 [***]
 [***]

	
	LTS LOHMANN Therapie-Systeme AG (LTS)
	 [***]
	 	 Head of Quality Control
 [***]
 [***]

		
	 [***]
	 	 Head of Production
 [***]
 [***]

		
	 [***]
	 	 Acting Head of Quality Assurance
 [***]
 [***]

		
	 [***]
	 	 Head of Regulatory Affairs
 [***]
 [***]

  

	***	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.

  

 -11- 

 Section VII 
 Supplementary Agreements 
 Attachment 1 – NeurogesX: Example of an order for Clinical Batches 
 Attachment 2 – Example of the Shipping Confirmation 
 Attachment 3 –
Example of the Batch Record Document Inventory Checklist 
  

 -12- 

 Example for Formula Assignment for Clinical Trials 
 Manufacturing Order (Attachment 1) 
 Address of
Sponsor: 
 NeurogesX, Inc., 981F San Carlos, CA 94070-4117, USA 
 According to the existing Memorandum of Understanding for clinical Samples, dated May 29, 2001 the following joint project decision has been taken: 
  

	1.	The following formula(e) of the patch, developed by LTS, will be used in a clinical study: 

 (in case of more than one formula, every one has to be listed separately) 
  

							
	 Formulation
	  	Capsaicin patch, active, composition as batch no.: XXXXXXX	  	IND XXXX
	 Shelf life: [***] after mass preparation, stability-data are available ([***], [***] °C/[***]% RH,
[***]°C/[***]% RH and [***]°C/[***]% RH)

	 Batch size: Not less than XXXX patches
	  	Size: XXX cm2, XX x XX cm2
	 Current manufacturing instruction LTS:
	  	XXXXX

  

			
	 Imprint on cardboard boxes:
  
  
  
 (e.g.: (Drug)- xxx cm2, potency: xx mg xxx/, batch no., material no., for clinical trials only, for skin application only, 1 box contains xxx, address of
LTS,)
	  	 NeurogesX, Inc. San Carlos, CA 24670
 Capsaicin
Dermal Patch
  
 Strength: xx mg/cm2
 Quantity per Pouch: One patch, xxx cm2
 Lot No. 811xxxxx
 Instructions: Apply as Directed in Protocol
 For Dermal Use Only
 Store At Controlled Room Temperature
 20-25°C (68-77°F)
  
 CAUTION: New Drug – Limited by Federal Law to Investigational Use

	 Storage conditions before shipment to CRO: 
 (humidity, temperature, others)
	  	20-25°C
	 Storage conditions during shipment to CRO: 
 (humidity, temperature, others)
	  	nmt 30°C
	 Storage conditions at CRQ site:
 (humidity, temperature, others)
	  	20-25°C
		
	 No. of samples to be shipped:
  
 Shipping date:
	  	

  

	***	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.

  

 -13- 

 This construction and the currently established process have been developed to establish a reasonable basis for further
development. The study results will according to current knowledge lead to significant progress (e.g. formulation refinement or decision of alternatives). The ingredients selected are regarded to be acceptable for human use. 
  

	2.	A clinical trial with above test formula will be performed at: n.a. 

 Date: n.a. 
  

			
	 Clinical development phase
	  	
	
	Shelf life: [***] after mass preparation, stability data are available ([***], [***] °C/[***]% RH, [***]°C/[***]% RH and
[***]°C/[***]% RH
		
	 Study Design:
 (1-, 2-..armed, cross-over, no. of volunteers/patients)
	  	n.a.
		
	 Sampling:
 (type (blood, urine), possibly sampling times))
	  	n.a.
		
	 Studying objective:
 (e.g. preliminary pharmacokinetics of)
	  	n.a.
		
	 Application period:
 (e.g. 24 hours)
	  	n.a.
		
	 Reference Medication (if any):
 (e.g. IND, CTX, if applicable)
	  	IND XXXX
		
	There is a joint agreement that the study design is suitable to support further formula decisions in the development process	  	
		
	 For GMP responsibilities, contact:
	  	[***]
		
	NeurogesX, Inc. orders to manufacture the above mentioned clinical batch/batches by LTS	  	
		
	 (Project Manager LTS R&D)
	  	Project Manager/responsible Person Partner Company)

 Shipping Confirmation (Attachment 2) 
 SECTION 2: LOHMANN 
  

													
	 Date Request
Received:                                      
      
	  	
			
	 Ship as Requested? Yes   ̈    No   ̈
	  		  	
	
	 (If
no, explain)                                     
                                        
                                        
                           

	
	 Description of Units Shipped:

	 Material Description
	  	 Quantity
	  	 Lot Number

		  		  	
		  		  	
		  		  	
		  		  	
		  		  	
		  		  	

													
			
	Date Shipped:                                   
                             	 	Method of Shipment:                        	 	Tracking
No.:                        
		
	AUTHORIZED SIGNATURE:                                  
                                        
              	 	Date:                                     
   
	
	Immediately upon shipment of this order, complete section 2, and fax this form to:
		
	                                      
                                  , NeurogesX, Inc.	 	
	
	Tel no. 001-650-508-2116, fax no. 001-650-622-0998

  

	***	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.

  

 -44- 

 SECTION 3: MATERIAL RECIPIENT 
  

							
	 Recipient:
	  		 	
	
	 Date Received:                                   
                                      Received
by:                                       
         

			
	 Any Discrepancies Noted? Yes   ̈    No   ̈
	  		 	
	
	 Condition of Shipment & Comments                             
                                        
                                        
                                      
 

	
	 AUTHORIZED SIGNATURE:                                  
                                        
                              
Date:                            

	
	 Immediately upon receipt, check shipment, complete section 3, and fax this form to:

		
	                                       
                                        
                              , NeurogesX, Inc.
	  	
			
	 Tel no. (650) 508-2116, fax no. (650) 622-0998
	 		  	

  

 -15- 

 EXHIBIT D 
 DEVELOPMENT PLAN 
 [Parties need to revise dates on the Development Plan] 

 EXHIBIT E 
 PACKAGING OF CLINICAL SAMPLES 
 Clinical Samples shall be supplied as unlabeled patches,
within pouches without labeling or with labeling as specified by NeurogesX in the Quality Assurance Agreement. NeurogesX understands that some pouch marking such as a lot number will probably be required by LTS’ QA group. The patches
themselves, however, must have no marking that could trace to dosage strength. Patches in pouches will be bulk packaged in suitable containers and shippers for shipment to NeurogesX. 

 EXHIBIT F 
 LTS LIABILITY INSURANCE 

 EXHIBIT G 
 SECRECY AGREEMENT 

 SECRECY AGREEMENT 
 between 
 LTS LOHMANN Therapy Systems Corp., 21 Henderson Drive, West Caldwell, New Jersey 07006
(“LTS”) 
 and Neurogesx Inc., 969 C Industrial Road, San Carlos, CA 94070 (“PARTNER”) 
 with respect to: 
 a [***] analgesic patch
containing a natural product (“Information”) 
 the following Secrecy Agreement has been agreed upon herewith: 
 1.1 Insofar as a party provides such Information it will be referred to herein as the “DISCLOSING PARTY”; insofar as a party receives such
Information it will be referred to herein as the “RECIPIENT”. 
 1.2 RECIPIENT shall treat as confidential and secret all
Information including but not limited to data, know–how, formulas, processes, specifications, organization, mechanical equipment and/or trade secrets which have been or may hereafter be disclosed; directly or indirectly by DISCLOSING PARTY to
RECIPIENT, either orally or in writing, or through inspection, as well as samples (“Information”), which might be necessary for experiments and tests concerning effectiveness and importance for the market and shall use the Information only
for the purpose of evaluating its interest in making appropriate commercial arrangements (“Purpose”) with LTS. 
 1.3 Information
disclosed to RECIPIENT must be identified as being confidential and if disclosed orally be reduced to writing by DISCLOSING PARTY and sent to RECIPIENT within 30 (thirty) days from disclosure. 
 1.4 RECIPIENT shall not copy or disclose any Information, without express prior written agreement of DISCLOSING PARTY, save that LTS may disclose any of
the Information to any of its affiliated companies on the same terms as this Agreement. 
 1.5 RECIPIENT shall neither directly nor
indirectly through its employees, agents, affiliates or other persons or entities connected to RECIPIENT use or put into production Information, which has been received from DISCLOSING PARTY, except for Purpose of this Agreement. 
 1.6 RECIPIENT shall not forward any Information to third parties without express prior written consent of DISCLOSING PARTY, save as stated above.

 1.7 RECIPIENT shall limit access to the Confidential Information from the disclosing party to those of its officers and employees who need
to know such Confidential Information for the purpose of this Agreement and who will be advised of the conditions of this Agreement. 
  

	***	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.

 1.8 RECIPIENT shall not use Information to contest or challenge any protected rights or applications for
protection of rights concerning Information, and shall refrain from undertaking any action which, to its knowledge based on due diligence, could affect such protected rights or impede any applications by using Information. 
 1.9 RECIPIENT shall keep all Information in good condition and a safe place and return them on request, provided, however that the RECIPIENT may keep one
copy thereof for purpose of maintaining records of Information received hereunder. 
 2. This Secrecy Agreement shall not apply for
Information and know–how which RECIPIENT can show by competent proof that 
 (a) it was, at the time of disclosure, in the public
domain; 
 (b) it has, subsequent to disclosure, become part of the public domain through no fault, act, omission or violation by RECIPIENT
of the confidentially obligation; 
 (c) it was, at the time of disclosure, in the possession of the RECIPIENT and not otherwise acquired,
directly or indirectly, from the DISCLOSING PARTY; 
 (d) it has been developed independently by the RECIPIENT without access to the
Information; 
 (e) it has, subsequent to disclosure been obtained by RECIPIENT 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. 
 3. Any
information disclosed to the other party hereto which is a distinct use or evaluation of, or a distinct combination with non–proprietary information and/or with proprietary Information shall be deemed to be distinct proprietary Information
subject to this Agreement. 
 4. In case the disclosure of confidential Information is necessary to allow either LTS or PARTNER to defend
itself against litigation, or to file and prosecute health registration applications, patent applications or to comply with judicial decrees or government actions or regulations such disclosure shall not constitute a breach of the confidentiality
obligations set forth herein provided, however, that prior written consent by the DISCLOSING PARTY has been obtained, which shall not be unreasonably withheld and shall be rendered as soon as practical. 
 5. No right or license to any patent, trade secret or intellectual property to either party is granted by this Agreement. Nothing in this Agreement shall
be construed as an obligation to provide proprietary Information and/or as to grant any licensing agreement and/or any other agreement. 
 6.
The unenforceability of one or more provisions of this Agreement shall not affect the enforceability of the remainder of the Agreement. Any unenforceable provisions or void provisions shall be replaced with comparable provisions that are enforceable
and conform to the purpose and intention of this Agreement. 
  

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 7. This Agreement, and all rights and obligations of the parties under this Agreement, shall terminate
five (5) years after the date of the latest signature under this Agreement. 
 8. This Agreement shall be governed by and construed in
accordance with the laws of the State of New Jersey, regardless of the laws that might otherwise govern under applicable principles of conflicts of laws thereof. 
 The parties hereto unconditionally and irrevocably agree and consent to personal jurisdiction in any court that has jurisdiction within the state of New Jersey and waive any objection with respect thereto, for the
purpose of any action, suit or proceeding arising out of or relating to this Agreement and/or the respective business relationship and further agree not to commence any such action, suit or proceeding except in any such court. 
 9. In the event that any dispute or claim of any sort arising out of this Agreement concerning the Information and or any dispute or claim concerning
competent court and/or jurisdiction and/or execution of any award granted by a foreign court or arbitration panel should lie in a jurisdiction in which trial by jury is standard or may be demanded, each of the parties irrevocably waives any right to
demand or request a trial by jury, and agrees to take such further action as it is necessary to petition or apply for a trial without a jury. 
 10. Under no circumstances shall LTS be liable for damages not specified in this Agreement, whether direct, indirect, special or consequential, lost profits and/or punitive damages unless covered by the insurance it maintains, provided,
that this exclusion of liability does not apply if such agreement would be invalidated by stringent law as it may be the case of intentional misconduct or willful default. 
 11. PARTNER acknowledges that LTS has had prior experience with the Coating Foam/Tape technology and that in the event of any allegation by LTS of
PARTNER’S breach of this Confidentiality Agreement, and the establishment of PARTNER having communicated or used Confidential Information related to LTS technology, the burden of proof that such information is not Confidential Information shall
be borne by PARTNER. 
  

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 12. This Agreement embodies the entire understanding of the patties relating to the subject matter hereof
and supersedes all prior understandings and agreements. No modification or amendment of this Agreement shall be valid or binding unless such modification or amendment is in writing and is signed by each of the parties hereto. 
  

					
	 LTS LOHMANN Therapy–Systems Corp.
	 		 	Neurogesx Inc.
			
	 /s/ Patrick A. Walters
	 		 	 /s/ Gerard Pereira

	 Patrick A. Walters, CEO
	 		 	Gerard Pereira, VP Business Development
			
	 West Caldwell, ND 07006, 01-19-01
	 		 	 San Carlos, 01/23/01

	 Place, Date
	 		 	Place, Date

  

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 EXHIBIT H 
 TRANSFER PRICE OF THE PATCHES 
  

 -5- 

 EXHIBIT I 
 MATERIAL SPECIFICATIONS 
  

 -6-Manufacturing and Supply Agreement

 Exhibit 10.8 
 MANUFACTURING AND SUPPLY AGREEMENT 
 This MANUFACTURING AND SUPPLY AGREEMENT (this
“Agreement”), effective as of December 22, 2005 (the “Effective Date”), is made by and between NeurogesX Inc., a Delaware corporation having a principal place of business at San Carlos Business Park, 981F
Industrial Road, San Carlos, California 94070 U.S.A. (“NeurogesX”), and Contract Pharmaceuticals Limited Canada, an Ontario corporation having a principal place of business at 7600 Danbro Crescent, Mississauga, Ontario Canada, L5N
6L6 (“CPL”). NeurogesX and CPL may be referred to herein each, individually, as a “Party” or, collectively, as the “Parties”. 
 BACKGROUND 
 A. NeurogesX has developed a certain formulation and manufacturing
process for a cleansing gel for use in connection with NeurogesX’s capsaicin products. 
 B. CPL has the capability and know-how
necessary to manufacture and supply such cleansing gel in bulk and finished form, as well as to provide certain research, development and other services relating to such cleansing gel. 
 C. NeurogesX desires to engage CPL, and CPL desires to perform, the manufacturing and supply of such cleansing gel in bulk and finished form and related
services for NeurogesX, all on the terms and conditions set forth herein. 
 NOW THEREFORE, for and in consideration of the covenants,
conditions, and undertakings hereinafter set forth, it is agreed by and between the Parties as follows: 
 ARTICLE 1 

DEFINITIONS 
 As used in this
Agreement, the following capitalized terms shall have the meanings indicated below: 
 1.1 “Act” shall mean the United States
Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) and the regulations promulgated thereunder, as such may be amended from time to time. 
 1.2 “Approval” shall have the meaning as set forth in Section 7.1 below. 
 1.3
“Confidential Information” shall have the meaning as set forth in Section 10.1 below. 
 1.4 “CPL Background
Technology” shall mean all patent rights, know-how and other intellectual property rights developed by CPL outside the scope of this Agreement (including outside the scope of any Services) without use of or reference to NeurogesX’s
Confidential Information, or otherwise acquired or licensed by CPL, in each case to the extent controlled by CPL as of the Effective Date or at any time during the term of this Agreement. 

 1.5 “Deliverables” shall mean the information, materials, Product batches,
Documentation, and other identified items that CPL is obligated to provide to NeurogesX pursuant to a Proposal. 
 1.6
“Documentation” shall mean all written materials generated in connection with the Services, including the Master Production Record, test results, Certificate of Analysis (“CoA”), analytical test methods, reports, protocols
and any other documents related to the manufacturing process for the Product, as well as such other documents reasonably necessary for NeurogesX to complete its regulatory filings or technology transfer. 
 1.7 “Facility” shall mean CPL’s GMP manufacturing facility located at 7600 Danbro Crescent and/or testing laboratory (Innopharm) at
1 Valleywood Drive. 
 1.8 “FDA” shall mean the United States Food and Drug Administration, or any successor agency thereto.

 1.9 “GMP” shall mean current good manufacturing practice and standards as provided for (and as amended from time to time)
in the Current Good Manufacturing Practice Regulations of the U.S. Code of Federal Regulations Title 21 (21 CFR §§ 210 and 211) and in European Community Directive 91/356/EEC (Principle and guidelines of good manufacturing practice for
medicinal products) in relation to the production of pharmaceutical products, as interpreted by the ICH Harmonized Tripartite Guideline, any U.S., European, or other applicable laws, regulations or respective guidance documents subsequently
established in the Territory, and any arrangements, additions or clarifications agreed from time to time between the Parties. 
 1.10
Master Production Record” shall mean that certain document approved by NeurogesX that defines the manufacturing methods and procedures, test methods, specifications, materials, and other procedures, directions and controls associated
with the manufacture and testing of Product. 
 1.11 “NeurogesX IP” shall have the meaning set forth in Section 6.1
below. 
 1.12 “Product” shall mean the Bulk Product or Finished Product, as applicable. 
 (a) “Bulk Product” shall mean the bulk cleansing gel product meeting the applicable Specifications. 
 (b) “Finished Product” shall mean the packaged cleansing gel product meeting the applicable Specifications. 
 1.13 “Quality Agreement” shall mean that certain Quality Assurance Agreement between the Parties dated March 25, 2003, which is
attached hereto as Exhibit A and as such may be modified pursuant to the terms set forth therein. 
 1.14 “Raw
Materials” shall mean all raw materials, supplies, components and packaging necessary to manufacture the Product in accordance with the Specifications. 
  

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 1.15 “Regulatory Requirements” shall mean (i) compliance with all applicable laws,
rules, guidelines, regulations and standards of governmental authorities, including GMP, and (ii) obtaining and maintaining all licenses and other authorizations required by regulatory authorities, that in each case are applicable to the
manufacturing, processing, and supply activities hereunder, the Facility, or any other facilities at which any of the manufacturing or process activities hereunder may be performed or are applicable in the Territory. 
 1.16 “Services” shall mean the development, validation, manufacturing and/or other services performed by CPL pursuant to a Proposal.

 1.17 “Specifications” shall mean (i) with respect to Bulk Product, the specifications set forth on Exhibit B
hereto, or (ii) with respect to Finished Product, the specifications set forth on Exhibit C hereto; in each case as such may be modified pursuant to Section 3.6 below. 
 1.18 “Proposal(s)” shall have the meaning set forth in Section 4.1 below, as such may be modified pursuant to Section 4.3
below. 
 1.19 “FTE” shall mean ‘full-time equivalent’ and provide the basis for charging CPL personnel to NeurogesX for
services performed. The charge out rate will be $100 USD per hour. 
 1.20 “Territory” shall mean Canada, United States and
European Union (EU) collectively. In addition, the Territory may be extended by NeurogesX to include countries and/or regulatory jurisdictions in accordance with Section 3.6(b) below. 
 ARTICLE 2 
 SUPPLY 
 2.1 Product Supply. Subject to the terms and conditions of this Agreement, CPL shall supply to NeurogesX all quantities of the Product ordered by
NeurogesX under this Agreement. 
 2.2 Raw Materials. CPL shall be responsible, at its expense, for procuring, inspecting and
releasing adequate Raw Materials from vendors approved by NeurogesX, which approval, shall not be unreasonably withheld or delayed, as necessary to meet NeurogesX’s purchase orders, unless otherwise agreed to by the Parties in writing. CPL
shall conduct tests on each Raw Material and shall provide NeurogesX with results of such tests. 
 2.3 Forecasts. At least one
hundred eighty (180) days before the commercial launch of the Product or a product incorporating the Product, NeurogesX shall provide CPL with an initial forecast of the quantities of Product estimated to be required from CPL during the four
(4) calendar quarter period following such launch. Thereafter, at least ninety (90) days prior to each calendar quarter (“Q1”), NeurogesX will provide CPL with a rolling forecast of the quantities of Product estimated to
be required during Q1 and the next three (3) calendar quarters (“Q2”, “Q3” and “Q4”, respectively). For clarity, all forecasts provided to CPL under this Section 2.3 are for advisory
purposes, with the exception of Q1 demand which will be binding on all required raw materials and packaging components to make the Product or a product incorporating the Product, and Q2 which will be binding on tubes only. Should orders for Product
or a product incorporating the Product for Q1 not materialize within the period for which CPL has purchased materials per this Agreement, NeurogesX will reimburse CPL for the cost of all materials (raw materials and packaging components) purchased
against the applicable forecast for Q1 and not used within six (6) months. 
  

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 2.4 Orders. NeurogesX’s orders for Product shall be made pursuant to a written purchase order
on its standard form specifying the desired quantity of Bulk Product and/or Finished Product, and will provide for shipment in accordance with reasonable delivery schedules and lead times as may be agreed upon from time to time by CPL and NeurogesX
so long as the maximum lead time shall not exceed ninety (90) days unless otherwise agreed to by the Parties. ANY ADDITIONAL OR INCONSISTENT TERMS OR CONDITIONS OF ANY PURCHASE ORDER, ACKNOWLEDGMENT OR SIMILAR STANDARDIZED FORM GIVEN OR
RECEIVED PURSUANT TO THIS AGREEMENT WILL HAVE NO EFFECT AND SUCH TERMS AND CONDITIONS ARE HEREBY EXCLUDED UNLESS THE PARTIES SPECIFICALLY AGREE IN WRITING FOR SUCH TERMS OR CONDITIONS TO SUPPLEMENT OR SUPERCEDE THE TERMS AND CONDITIONS OF THIS
AGREEMENT. 
 2.5 Packaging. Product shall be shipped packaged in containers in accordance with the applicable Specifications or as
otherwise agreed by the Parties in writing. Each such container will be individually labeled in accordance with any regulatory requirements which may include a description of its contents, including the manufacturer lot number, quantity of Product,
and expiration date. 
 2.6 Delivery. CPL shall deliver the quantities of Product ordered by NeurogesX on the dates specified in
NeurogesX’s purchase orders submitted in accordance with Section 2.4 above. All Product shall be delivered F.C.A point of shipment, CPL’s loading dock, Mississauga, Ontario. Upon CPL’s delivery of the Product F.C.A. point of
shipment, NeurogesX will bear all risk of loss, delay, or damage in transit. NeurogesX shall select the carrier. All Product delivered hereunder shall be suitably packed for shipment by CPL in accordance with good commercial practice, and
instructions provided to CPL by NeurogesX, with respect to protection of such Product during transportation and marked for shipment to NeurogesX’s specified receiving point. NeurogesX shall pay all shipping and insurance costs, as well as any
special packaging expenses identified in advance by CPL. 
 2.7 Cost Reduction. The Parties will participate in cost reduction
projects pertaining, but not limited to, the manufacture and supply of Product for NeurogesX. If a Party identifies a potential cost reduction measure, the identifying Party shall disclose the details to the other Party so that both Parties can
evaluate whether such measure should be implemented and agree upon the costs of implementing such measure and the resulting cost savings. In the event the Parties agree on implementing a cost saving measure, the Parties agree to come together and
discuss who will pay for the cost implementation and negotiate how to share the cost savings and the Parties shall adjust the price of the Product and revise Exhibit E accordingly. 
 2.8 Alternate Source(s). The Parties agree that this Agreement is not an exclusive supply agreement, and NeurogesX shall have the right to
manufacture itself or designate third party(ies) as alternate source(s) for the supply of the Product (each, an “Alternate Source”). Upon NeurogesX’s request at any time, CPL shall cooperate with NeurogesX and the Alternate
Source to fully transfer to such Alternate Source all manufacturing technology, know-how and information relating to the Product and its manufacture. CPL agrees to provide reasonable technical assistance to the Alternate 

  

 -4- 

 
Source for such purposes as requested by NeurogesX, including without limitation, assisting the Alternate Source to successfully manufacture three
(3) validation batches of Product conforming to the Specifications. NeurogesX shall pay to CPL reasonable FTE and out-of-pocket costs associated with such transfer and assistance in accordance with a budget approved in advance by NeurogesX;
provided, however, if either (i) the need for an Alternate Source arises from a material breach of this Agreement by CPL and/or (ii) subject to Article 13.5, CPL fails to deliver two successive batches of Product of at least eighty percent
(80%) of the quantities of Product specified in a purchase order submitted in accordance with this Agreement, to CPL hereunder within thirty (30) days after the delivery dates specified therein, then NeurogesX shall not be obligated to
make any such payments associated with the FTE costs of CPL and CPL shall bear the FTE costs associated with transfer and up to a maximum of 20 FTE days, of FTE costs associated with assistance. In any case, CPL shall not be responsible for any
costs associated with fee for service activities beyond the assistance described in this Section 2.8, performed on behalf of NeurogesX, for the Alternate Source nor any out-of-pocket costs (including, but not limited to, travel expenses)
associated with the transfer. Any additional assistance requested by NeurogesX above the 20 FTE days described in this Section 2.8 shall be at NeurogesX’s expense. 
 ARTICLE 3 
 QUALITY 
 3.1 Quality. All Product supplied by CPL shall meet the current Specifications and shall be manufactured, packaged, tested and stored at the
Facility in accordance with the Quality Agreement, all applicable Approvals and Regulatory Requirements, including GMP manufacturing and record keeping procedures. 
 3.2 Quality Control. Prior to each shipment of Product, CPL shall perform quality control testing procedures and inspections to verify that the Product to be shipped conforms fully to the Specifications, as set
forth in the Quality Agreement. Each shipment of Product shall be accompanied by a certificate of analysis (“COA”), in a form acceptable to NeurogesX, describing all current requirements of the Specifications, results of test
performed certifying that the Product supplied have been manufactured, controlled and released at the Facility in accordance with the Specifications, all Approvals and applicable Regulatory Requirements. 
 3.3 Acceptance. Acceptance by NeurogesX of Product delivered by CPL shall be subject to inspection and applicable testing by NeurogesX or its
designee. If on such inspection or testing NeurogesX or its designee discovers that any Product fails to conform with the Specifications or otherwise fails to conform to the warranties given by CPL in Section 8.1 below, NeurogesX or such
designee may reject such Product, which rejection will be accomplished by giving written notice to CPL that specifies the manner in which the Product fails to meet the foregoing requirements. Upon request from CPL, NeurogesX shall return the
rejected Product in accordance with CPL’s reasonable instructions at CPL’s expense, provided that such instructions comply with all applicable laws, regulations and Regulatory Requirements. In the event of a dispute between the parties
over the validity of a rejection, NeurogesX and CPL agree to submit a sample of the rejected Product to an independent test facility to be agreed by both parties, and to accept the results of the testing performed by that facility as binding with
regard to that lot of Product. The expense of such testing shall be borne by the losing party. CPL shall use reasonable commercial efforts to replace rejected Product within the shortest possible time within thirty (30) days after CPL’s
receipt of notice thereof 

  

 -5- 

 
provided materials are available, and in any event within ninety (90) days. The replacement of rejected Product shall have priority over the supply of
Product ordered for shipment not more than ninety (90) days before, or any time after, the rejection of such nonconforming Product. If a Product shipment or part thereof is rejected before the date on which payment is due therefor, NeurogesX
may withhold payment for such shipment or the rejected portion thereof. If a Product shipment or portion thereof is rejected after payment, NeurogesX may credit the amount paid therefor against other amounts due to CPL hereunder. If, subsequent to
investigation, a Product deemed by NeurogesX to be rejected is found to meet Specifications, than NeurgesX will not only pay for the originally shipped Product but also any replacement Product made, or in process, while the investigation was being
conducted. The warranties given by CPL in Section 8.1 below shall survive any failure to reject by NeurogesX under this Section 3.3. Subject to Section 3.4 and Article 8 below, Product shipments shall be deemed accepted if no
notice to the contrary is received by CPL within sixty (60) days of NeurogesX’s receipt of such Product. 
 3.4 Latent
Defects. As soon as either Party becomes aware of any defect in any Product that is not discoverable upon a reasonable inspection or quality control testing as set forth in the Specifications (“Latent Defect”), but in no case later
than thirty (30) days after reaching such awareness, it shall immediately notify the other Party and, at NeurogesX’s election, shall be deemed rejected as of the date of such notice. In the event of such rejection by NeurogesX, the
applicable provisions of Section 3.3 shall apply. Notwithstanding anything herein to the contrary, CPL will only be responsible for Latent Defects resulting from an act or omission of CPL, reasonably demonstrated, relative to its manufacturing,
packaging, and testing services responsibilities according to this Agreement. Any Latent Defect solely related to compatibility issues will not be the financial responsibility of CPL. The term “compatibility issues” as used in this
Section 3.4 shall mean a surprise chemical reaction between the Product’s chemical components and packaging. 
 3.5 Presence At
Facility. Upon at least fifteen (15) days’ prior written notice given by NeurogesX to CPL, NeurogesX shall have the right to assign a reasonable number of employees or consultants of NeurogesX (not to exceed three (3) persons) to
inspect and audit the Facility in order to verify CPL’s compliance with Regulatory Requirements and other agreed requirements. At all times, NeurgoesX personnel or consultants will be accompanied by CPL representatives and access will be
limited to areas and documentation applicable to NeurogesX Product or Proposals. 
 3.6 (a) Changes to the Specifications. NeurogesX
shall have the sole right to modify the Specifications with respect to all Bulk Products and Finished Products. All modifications shall be in writing and shall be signed by an authorized representative of NeurogesX and CPL, and shall be effective
for purchase orders for Product placed after the effective date of the changes. If the modifications result in a change in CPL’s manufacturing costs, the Parties shall agree upon an appropriate adjustment to the price of the Product under this
Agreement. If the modifications result in a delay in delivery, there shall be a reasonable extension of the affected lead times. If residual inventory of a raw material or packaging component results from a change to Specifications, NeurogesX shall
reimburse CPL at cost plus 15% (to cover CPL’s administrative, finance, and warehousing) for all residual inventory or restocking charges at suppliers, for materials that CPL cannot use elsewhere or returned without charge. 
 (b) Changes to the Territory. NeurogesX may expand the Territory upon written notice to CPL, with reasonable lead time. In the event,
NeurogesX’s decision to expand the territory 

  

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will cause CPL to incur additional costs, as a result of specific regulatory requirements of such country or regulatory jurisdiction
(“Territory-Specific Costs”), and/or impose requirements beyond CPL’s standard manufacturing practice, CPL shall immediately notify and discuss with NeurogesX such costs and ways of accommodating such additional requirements,
NeurgoesX shall have the option to either (1) modify or limit such addition to the Territory, or (2) include such country or regulatory jurisdiction within the Territory and reimburse CPL for the Territory-Specific Costs. It is understood
that CPL shall use reasonable efforts to mitigate any such Territory-Specific Costs and accommodate such reasonable requirements. 
 3.7
Lot Records; Samples. Subject to Article 7.6, CPL shall maintain lot records sufficient to trace the history of each lot, and representative samples from each batch of Product manufactured hereunder in sufficient quantity to perform ten
(10) tests each of, for record keeping, stability testing, and other regulatory purposes, including as may be required by the Specifications, Approvals or Regulatory Requirements, for as long as required by applicable law. Such samples will be
stored in cGMP storage facility at specified storage conditions up to two years after NDA approval, termination or discontinuation or one year beyond expiration date, whichever is later. Subject to the foregoing, CPL shall notify NeurogesX before
disposing of any of the foregoing, and NeurogesX shall have the option of having such records and samples delivered to NeurogesX or its designee. Upon the request of NeurogesX, CPL shall provide NeurogesX reasonable access to and copies of such
records and samples. 
 ARTICLE 4 
 SERVICES 
 4.1 Scope of Services. From time to time during the term of this Agreement,
NeurogesX may request and CPL may agree to perform certain services for NeurogesX relating to the Product or its manufacture (the “Services”), all as described in one or more mutually agreed workplans which shall be attached hereto as
Exhibit D (each, a “Proposal”). Each Proposal shall be numbered consecutively (for example, the initial Proposal would be Proposal #1 and set forth in detail the Services to be performed by CPL, including without
limitation, the timeline for delivery of reports and other Deliverables, the fees to be charged, and the like. The Parties may modify Exhibit D hereto to revise an existing Proposal pursuant to Section 4.3 below or otherwise add a new
Proposal, provided, that no Proposal, or any modification thereto, shall be attached to or made a part of this Agreement without first being executed by the Parties hereto in writing which specifically references this Agreement.

 4.2 Standards of Performance. CPL will use reasonable commercial efforts to perform Services and deliver to NeurogesX the completed
Deliverables, all in accordance with the respective Proposal, including without limitation, the specifications and the timelines set forth therein. All Services shall be conducted in a good, scientific manner in compliance with all applicable
Regulatory Requirements, laws and regulations. 
 4.3 Changes to Proposals. NeurogesX may, at any time, submit to CPL a request for
changes to any Proposal. NeurogesX agrees to pay CPL the reasonable costs associated with such change, as mutually agreed in advance by the Parties in writing. CPL shall use its commercially reasonable efforts to make all changes requested by
NeurogesX, and to minimize the time and additional charges required as a result of such changes. Without limiting the foregoing, if CPL can 

  

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implement the requested changes without resulting in increases in CPL’s time or cost, and without affecting CPL’s ability to meet the Services
timeline as set forth in such Proposal, CPL shall implement such changes in accordance with such timeline at no additional cost to NeurogesX. 
 4.4 Acceptance of Deliverables under a Proposal. CPL shall timely deliver to NeurogesX or its designee each Deliverable resulting from the Services. Acceptance by NeurogesX of such Deliverables shall be subject to inspection and
other testing by NeurogesX or its designee. If on such inspection or testing NeurogesX or its designee discovers that the Deliverable fails to conform with the applicable specifications, NeurogesX or such designee may reject such Deliverable upon
written notice. Upon request from CPL, NeurogesX shall return the rejected Deliverable in accordance with CPL’s reasonable instructions at CPL’s expense, provided that such instructions comply with applicable laws, regulations and
Regulatory Requirements. If NeurogesX rejects a Deliverable, CPL shall promptly correct the failure(s) specified in the rejection notice and re-deliver to NeurogesX, at CPL’s cost and expense (including re-delivery costs), a replacement
Deliverable that meets the applicable specifications, for acceptance testing under this Section 4.4. If CPL disagrees with NeurogesX’s determination, the Parties agree proceed according to Section 3.3. above. 
 4.5 Reporting/Transfer of Results. 
 (a) In connection with the Services, CPL will provide NeurogesX with regular written reports, as part of the Proposal or as requested by NeurogesX, and a final written report upon completion of each Service, of all results and NeurogesX IP
developed or generated during the course of the Services. Upon request by NeurogesX from time to time and at NeurogesX’s expense, CPL shall provide reasonable assistance to NeurogesX in NeurogesX’s efforts to understand and use the
information contained in such reports. CPL agrees that the first time CPL provides any information in such reports that CPL believes to be CPL Background Technology or CPL Improvements, they shall be fully described in a separate section in such
report. 
 (b) CPL will also respond to NeurogesX’s reasonable inquiries, at CPL’s expense, regarding the status of the Services on
an ongoing basis, and CPL will endeavor to keep NeurogesX reasonably informed of interim results on an informal basis, including, if requested, periodic meetings at CPL’s facility to discuss results and progress of the Services, and CPL will
follow any reasonable instructions or direction of NeurogesX with regard to the Services. 
 ARTICLE 5 
 PAYMENTS 
 5.1 Product Orders.

 (a) Price. The price to be paid by NeurogesX per unit of Bulk Product and per unit of Finished Product ordered by NeurogesX shall be
as set forth on Exhibit E hereto. The parties agree that increases or decreases in the price may be made by mutual agreement of the parties on an annual basis (applicable to the ensuing 12-month calendar year) during the term of this Agreement
based on CPL’s increase in the cost of raw materials, packaging components, labor and allocable 

  

 -8- 

 
overhead in the last twelve (12) months; provided, however, that any increase will not exceed the United States Producer Price Index for Pharmaceutical
Preparations (“PPI”) measured at the beginning of such 12-month period. Further adjustments may be made to price to account for changes in the quantity of Product to be supplied or applicable run sizes provided such increases are agreed by
NeurogesX in advance. Also, price adjustments may occur upon modifications to the Specifications requested by either party to the extent of any increase or decrease in the cost of manufacturing or raw materials or packaging components resulting from
such changes in Specifications, consistent with Sections 2.7 and 3.6(a). 
 (b) Any special one-time increases in raw material or packaging
component costs, provided the impact to total cost of goods for that Product exceeds 3%, will be incorporated into the price upon ninety (90) days notice and NeurogesX’s confirmation of such increase in cost. It is understood that such
one-time increases in costs which are so incorporated in the price will not be taken in account when making the adjustment according to Section 5.1(a) above shall apply once only per year during the three (3) years of the terms of this
Agreement thereafter all other increases will be incorporated into the annual price evaluation according to Section 5.1(a) above. 
 (c)
Invoicing; Payment. CPL shall submit an invoice to NeurogesX upon shipment of Product ordered by NeurogesX under this Agreement. All invoices will be sent to the address specified in the applicable purchase order, and each invoice will state
the aggregate and unit price for Product in a given shipment, plus any taxes, or other costs incident to the purchase or shipment to be borne by NeurogesX under this Agreement. All payments under this Agreement shall be made in U.S. dollars within
thirty (30) days of NeurogesX’s receipt of the Product. 
 5.2 Services. In consideration for the Services performed by CPL,
NeurogesX agrees to pay to CPL by wire transfer the amounts set forth in the applicable Proposal in accordance with the terms and conditions set forth therein. 
 ARTICLE 6 
 OWNERSHIP AND LICENSES 
 6.1 NeurogesX IP. Subject to Section 6.2 below, NeurogesX shall own all Deliverables, as well as all Product specific information, inventions
(whether or not patentable), technology, data, documents, processes, protocols, methods, assays, techniques, Product specific operating procedures and materials created, reduced to practice or compiled by CPL in the course of performing activities
under this Agreement or that is based on NeurogesX’s Confidential Information, including without limitation, any Documentation, records, reports and other materials that CPL generates or provides to NeurogesX in the course of any Services, and
any modifications, additions or improvements to the Product or the manufacturing process for the Product created by CPL in the course of performing this Agreement, and all intellectual property rights in any of the foregoing (collectively, the
“NeurogesX IP”). CPL hereby assigns, and agrees to assign, to NeurogesX, all right, title and interest in and to the NeurogesX IP. CPL shall assist NeurogesX, or its designee, at NeurogesX’s expense, in every proper way to
secure NeurogesX’s rights in the NeurogesX IP and any patent rights relating thereto in any and all countries, including the disclosure to NeurogesX of all pertinent information and data with respect thereto, the execution of all applications,
specifications, oaths, assignments and all other instruments that NeurogesX deems necessary in order to apply for and obtain such rights and in order to assign and convey to NeurogesX the sole and exclusive right, title and interest in and to such
NeurogesX IP. 
  

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 6.2 CPL Technology. Subject to the terms of this Agreement, all CPL Background Technology that is
used, improved or modified by CPL in the course of performing its obligations hereunder, which improvements are of a general nature and unrelated to NeurogesX, NeurogesX’s products or Confidential Information, or the Product, including for
example, standard operating procedures, software or laboratory methodologies (the “CPL Improvements”) shall be and remain the sole and exclusive property of CPL. CPL hereby grants NeurogesX a non-exclusive, perpetual, irrevocable,
royalty-free, worldwide license, with the right to grant and authorize sublicenses, under the CPL Background Technology and CPL Improvements, solely as necessary or useful to make, have made, use, sell, have sold, import, and export the Product or
any derivatives or new versions thereof and to use and fully exploit the NeurogesX IP. Such CPL Background Technology and CPL Improvements cannot be used to develop and commercialize any other NeurogesX product without the approval, in writing, of
CPL. 
 ARTICLE 7 
 REGULATORY MATTERS 
 7.1 Regulatory Approvals. NeurogesX, itself or through its agents, shall have the sole right to
correspond with and submit regulatory applications and other filings to the FDA or other regulatory authorities to obtain approvals to import, export, sell, or otherwise commercialize the Product alone or with other products (each, an
“Approval” and collectively, “Approvals”) as NeurogesX deems useful or necessary. Accordingly, except as otherwise required by law, CPL shall not correspond directly with the FDA or any other regulatory agency
relating to the process of obtaining Approvals or any obtained Approval for the Product without NeurogesX’s prior consent. Notwithstanding the foregoing, CPL shall assist NeurogesX, as requested by NeurogesX and at NeurogesX’s expense, in
preparing, submitting, and maintaining applications for such Approvals. 
 7.2 Information. Without limiting Section 7.1 above,
CPL shall promptly provide NeurogesX all written and other information other than information developed for other CPL clients and subject to a confidentiality obligation, in CPL’s possession or control that is necessary or useful for NeurogesX
to apply for, obtain, and maintain Approvals for the Product, including without limitation, Documentation, information relating to the Facility, process, methodology, or components used in the manufacture, processing, or packaging of the Product or
other information required to be submitted to the FDA or other regulatory authorities in the form of a marketing application. In addition, CPL shall immediately inform NeurogesX when any such information is no longer current and reflective of
current manufacturing practices, procedures, or the Specifications and provide updated information to NeurogesX through agreed channels for managing change per the Quality Agreement attached hereto as Exhibit A. 
 7.3 Inspections. CPL shall permit the FDA and other regulatory authorities to conduct inspections of the Facility as the FDA or other regulatory
authorities may request, and shall cooperate with the FDA or other regulatory authorities with respect to the inspections and any related matters, in each case relating to the Product. CPL shall give NeurogesX prior notice, to the 

  

 -10- 

 
extent practicable, of any such inspections, and keep NeurogesX informed about the results and conclusions of each regulatory inspection, including actions
taken by CPL to remedy conditions cited in the inspections. In addition, CPL shall allow NeurogesX or its representative to assist in the preparation for and be present at the inspections to participate in discussion directly related to the Product
or its manufacture. CPL will provide NeurogesX with copies of any written inspection reports issued by the regulatory agency and all correspondence between CPL and the regulatory agency, including, but not limited to, FDA Form 483, Notice of
Observation, and all related correspondence, in each case relating to the Product or general manufacturing concerns (i.e., facility compliance or the like). NeurogesX and its regulatory consultants, agents, marketing partners, and other third
parties, under reasonable confidentiality requirements, shall have access to all regulatory and quality assurance and GMP audits of CPL to assess regulatory compliance and to the buildings, records, and areas of the Facility or other facilities
involved in the manufacture, testing, storage, and shipment of the Product. 
 7.4 Maintenance of Approvals. Notwithstanding anything
in the Agreement to the contrary, CPL shall not undertake any modifications to the Product manufacturing or testing processes or use any subcontractors or vendors in any way that could delay or otherwise impact the Approvals or other regulatory
submissions, including without limitation, regulatory product reviews, Investigational New Drug applications (INDs), New Drug Applications (NDAs), or any other compliance status without the prior written agreement of NeurogesX. 
 7.5 Reporting. Pursuant to the FDA’s and other applicable regulatory agency’s regulations and policies, NeurogesX may be required to
report information that reasonably suggests that a Product may have caused or contributed to the death or serious injury. Accordingly, CPL shall inform NeurogesX of any such information promptly after becoming aware of it so that NeurogesX can
comply with such reporting requirements. 
 7.6 Records. CPL shall maintain adequate and accurate records covering the manufacture,
stability programs, quality control testing and release of Product supplied hereunder and all other Services provided hereunder, in accordance with GMPs and all Regulatory Requirements, for as long as required under applicable laws and regulations,
for a period of ten (10) years thereafter. CPL will make such records available to NeurogesX, its designees and regulatory agencies as requested by NeurogesX, at no additional cost to NeurogesX. Subject to the foregoing maintenance requirement,
CPL shall notify NeurogesX before destroying any such records, and NeurogesX shall have the option of having such records delivered to NeurogesX or its designee at NeurogesX’s cost. 
 ARTICLE 8 
 PRODUCT WARRANTIES 
 8.1 Product Warranties. CPL represents and warrants that: 
 (a) Specifications. All Product supplied hereunder shall comply with the Specifications and shall conform with the information shown on the COA provided for the particular shipment pursuant to Section 3.2
above; 
  

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 (b) Regulatory Requirements. The Facility, the manufacturing and supply activities contemplated
herein and all Product supplied hereunder shall comply with the Regulatory Requirements and the Quality Agreement, and all Raw Materials used in the manufacture of Product hereunder shall comply with the applicable specifications, Regulatory
Requirements, and the Quality Agreement; 
 (c) Compliance with FFDCA. None of the Product supplied to NeurogesX under this Agreement
shall be adulterated or misbranded within the meaning of the Act; and 
 (d) No Encumbrance. Title to all Product supplied under this
Agreement shall pass as provided in this Agreement, free and clear of any security interest, lien, or other encumbrance. 
 (e) As of the
Effective Date, to its knowledge, CPL’s method of manufacturing the Product does not infringe any patent, trademark, trade secret, or other proprietary rights of third parties to the Product. 
 8.2 NeurogesX represents and warrants that: 
 (a) NeurogesX’s Specifications are the property of the NeurogesX organization and will, upon marketing authorization conform to all applicable regulatory and legal requirements and Approvals, and will continue to so conform during the
term of this Agreement; and 
 (b) As of the Effective Date, to its knowledge, NeurgoesX has the right to contract with CPL for the
manufacture of the Product using NeurogesX’s formula without infringing any patent, trade mark, trade secret or other proprietary rights of third parties to the Product or NeurogesX’s formula provided CPL has manufactured the Product in
strict compliance with NeurogesX’s formula. 
 8.3 Recalls. If NeurogesX is required by any regulatory agency to recall the
Product or if NeurogesX voluntarily initiates a recall of the Product and, in either case, if such recall is a result of a breach any of the warranties set forth in Sections 8.1(a) through 8.1(d) above, CPL shall bear the out-of-pocket costs of
such recall. The parties agree that CPL shall have no responsibility for any recall resulting from artwork or Specifications for Product provided by NeurogesX to CPL so long as Product complies with the Specifications and artwork provided by
NeurogesX to CPL. 
 ARTICLE 9 
 TERM AND TERMINATION 
 9.1 Term. The term of this Agreement shall commence on the
Effective Date and continue in full force until the fifth (5th) anniversary of the Effective Date, unless
terminated earlier in accordance with this Article 9 of this Agreement. This Agreement may be extended for additional two (2)-year periods at NeurogesX’s option upon written notice to CPL at least six (6) months prior to expiration of
the then-current term. 
 9.2 Termination for Breach. Either Party may terminate this Agreement upon written notice in the event that
the other Party shall have materially breached this Agreement, and such breach is not cured within sixty (60) days after receiving written notice of such breach. 

  

 -12- 

 
Notwithstanding the foregoing, if during such sixty (60) day period, the allegedly breaching Party disputes that it has materially breached this
Agreement, then the other Party shall not have the right to terminate this Agreement until it has been finally determined in accordance with Section 13.2 below that the allegedly breaching Party has materially breached this Agreement, and such
Party fails to comply herewith within sixty (60) days thereafter. 
 9.3 Permissive Termination. 
 (a) Services. NeurogesX may terminate the Services, or any part thereof, without charge or penalty upon written notice to CPL; provided that if
such termination occurs after CPL has initiated work on a particular task within the Services, NeurogesX will reimburse CPL for actual, reasonable out-of-pocket expenses incurred by CPL that are directly allocated to such task to the extent such
obligations cannot reasonably be mitigated. 
 (b) Agreement. NeurogesX may terminate this Agreement upon one hundred eighty
(180) days’ prior written notice to CPL. In the event of a termination by NeurogesX, NeurogesX will continue to be obligated under this Agreement for all open purchase orders and continue to be obligated under Section 2.3 for any
residual inventory. 
 CPL may terminate this Agreement upon twenty four (24) months prior written notice to NeurogesX. 
 9.4 Effect of Expiration or Termination. 
 (a) Rights and Obligations. Termination or expiration of this Agreement shall not relieve a Party from any liability that, at the time of such termination or expiration, has already accrued to the other Party. Upon expiration or
termination of this Agreement: CPL shall, as promptly as practicable (i) cease all work on the Services, and (ii) turn over to NeurogesX all Deliverables, Documentation and NeurogesX IP (whether in written or electronic form, including any
work in progress) which are then in CPL’s possession or control. CPL shall have the right to retain a copy of all relevant Product related documentation for legal purposes. 
 (b) Survival. The provisions of Sections 1, 2.8, 3.7, 6, 7.2, 7.3, 7.5, 7.6, 8, 9, 10, 11, 12, and 13 of this Agreement shall survive the
termination or expiration of this Agreement for any reason. Section 3.3, 3.4, 4.4, 4.5 shall survive any termination or expiration of this Agreement with respect to Products or Deliverables delivered pursuant to this Agreement. 
 ARTICLE 10 
 CONFIDENTIALITY

 10.1 Confidential Information. The Parties may from time to time disclose to each other Confidential Information.
“Confidential Information” means any information disclosed by one Party to the other Party that, if disclosed in tangible form, is marked “confidential” or with other similar designation to indicate its confidential or
proprietary nature or, if disclosed orally, is indicated orally to be confidential or proprietary by the Party disclosing the information at the time of the disclosure and is confirmed in writing as confidential or proprietary by the disclosing
Party within forty-five (45) days after such disclosure. For avoidance of doubt, all Deliverables and NeurogesX IP shall be 

  

 -13- 

 
deemed the Confidential Information of NeurogesX. Notwithstanding the foregoing or anything herein to the contrary, Confidential Information shall not
include any information that, in each case as demonstrated by written documentation: (a) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure; (b) was generally available to
the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; (c) 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; or (d) was subsequently lawfully disclosed to the receiving Party by a person other than the disclosing Party. 
 10.2 Confidentiality. Each Party shall hold and maintain in strict confidence all Confidential Information of the other Party. Without limiting
the foregoing, neither Party shall use or disclose the Confidential Information of the other Party, except as otherwise permitted by this Agreement or as may be necessary or useful to exercise its rights (including in the case of NeurogesX, its
rights to NeurogesX IP) or perform its obligations under this Agreement. Nothing contained in this Article 10 of this Agreement shall prevent either Party from disclosing any Confidential Information of the other Party to the extent reasonable
necessary in prosecuting or defending litigation, 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, or as a part of patent applications filed on inventions made under this Agreement; provided that if a Party is required by 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 its reasonable efforts to secure confidential treatment of such information. 

10.3 Confidential Terms. Each Party shall treat the terms of this Agreement as the Confidential Information of the other Party. Notwithstanding
anything to the contrary, however, each Party may disclose the terms of this Agreement (a) to advisors, actual or potential investors, lenders and potential lenders, acquisition partners, sublicensees, and others on a need to know basis under
circumstances that reasonably ensure the confidentiality thereof, or (b) as required by securities or other applicable laws or regulations, such as SEC regulations. 
 ARTICLE 11 
 REPRESENTATIONS AND WARRANTIES 
 11.1 CPL. CPL represents and warrants that: (a) it has full power to enter into this Agreement and to grant to NeurogesX the rights granted
to NeurogesX under this Agreement; (b) it has the corporate authority to enter into and execute the Agreement; (c) CPL shall fully comply with the requirements of any and all applicable federal, state, local and foreign laws, regulations,
rules, and orders of any governmental body having jurisdiction over the activities contemplated by this Agreement or having jurisdiction over the Territory and to the extent applicable to CPL, including all Regulatory Requirements; (d) it shall
perform all Services in a professional manner in accordance with industry standards; and (e) it has not been debarred under the Generic Drug Enforcement Act of 1992 and that it will not employ any person or entity that has been so debarred to
perform any activities under this Agreement. 
  

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 11.2 NeurogesX. NeurogesX represents and warrants that: (a) it has full power to enter into
the Agreement; (b) it has obtained all necessary corporate approvals to enter and execute into this Agreement; and (c) NeurogesX shall fully comply with the requirements of any and all applicable federal, state, local and foreign laws,
regulations, rules and orders of any governmental body having jurisdiction over the activities contemplated by this Agreement and to the extent applicable to NeurogesX. 
 11.3 Disclaimer. EXCEPT AS PROVIDED IN THIS ARTICLE 11 AND SECTION 8.1 ABOVE, NEITHER PARTY MAKES ANY REPRESENTATIONS, WARRANTIES OR CONDITIONS (EXPRESS, IMPLIED, STATUTORY OR OTHERWISE) WITH RESPECT TO
THE SUBJECT MATTER HEREOF AND EACH PARTY EXPRESSLY DISCLAIMS ANY SUCH ADDITIONAL WARRANTIES. 
 ARTICLE 12 
 INDEMNIFICATION 
 12.1
NeurogesX. NeurogesX shall indemnify, defend, and hold harmless CPL, its directors, officers, employees, agents, successors and assigns from and against any liabilities, expenses, or costs (including reasonable attorneys’ fees and court
costs) arising out of any claim, complaint, suit, proceeding, or cause of action brought against any of them by a third party resulting from: (a) the negligent or intentionally wrongful acts or omissions of NeurogesX; and (b) breach by
NeurogesX of any of its representations and warranties under this Agreement, in each case subject to the requirements set forth in Section 12.3 below. Notwithstanding the foregoing, NeurogesX shall have no obligations under this
Section 12.1 for any liabilities, expenses, or costs to the extent arising out of or relating to claims covered under Section 12.2 below. NeurogesX shall indemnify and hold harmless CPL 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 CPL’s manufacturing, sale and using the Product for or to NeurogesX, which IP Claims are caused by
CPL’s use of any technology or intellectual property owned or supplied by NeurogesX. 
 12.2 CPL. CPL shall indemnify, defend,
and hold harmless NeurogesX, its directors, officers, employees, agents, successors and assigns from and against all liabilities, expenses, and costs (including reasonable attorneys’ fees and court costs) arising out of any claim, complaint,
suit, proceeding, or cause of action brought against any of them by a third party resulting from: (a) the negligent or intentionally wrongful acts or omissions of CPL; and (b) breach by CPL of any of its representations and warranties
under this Agreement, in each case subject to the requirements set forth in Section 12.3. Notwithstanding the foregoing, CPL shall have no obligations under this Section 12.2 for any liabilities, expenses, or costs to the extent arising
out of or relating to claims covered under Section 12.1 above. CPL shall indemnify and hold harmless NeurogesX from any tIP Claims arising from the manufacturing, sale and use of the Product under this Agreement by or for NeurogesX, which IP
Claims are caused by use of any technology or intellectual property owned or supplied by NeurogesX. 
 12.3 Indemnification Procedure.
A Party that intends to claim indemnification (“Indemnitee”) under this Article 12 shall promptly notify the indemnifying Party (“Indemnitor”) in writing of any third party claim, suit, or proceeding included
within the indemnification described in this Article 12 (each a “Claim”) with respect to which the Indemnitee intends to claim such 

  

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indemnification, and the Indemnitor shall have sole control of the defense and settlement of the Claim. The Indemnitee shall have the right to participate,
at its own expense, with counsel of its own choosing in the defense or settlement of the Claim. The indemnification obligations under this Article 12 shall not apply to amounts paid in settlement of any Claim if such settlement is effected
without the consent of the Indemnitor. The Indemnitee and its employees, at the Indemnitor’s request and expense, shall provide full information and reasonable assistance to Indemnitor and its legal representatives with respect to Claims.

 ARTICLE 13 
 GENERAL 
 13.1 Governing Law. This Agreement shall be governed by, and construed and interpreted in accordance with,
the laws of the United States and the State of California, without reference to conflict of laws principles and excluding the 1980 U.N. Convention on Contracts for the International Sale of Goods. 
 13.2 Disputes. In the event of any dispute or claim arising out of or in connection with this Agreement, or the performance, breach or termination
thereof, either CPL or NeurogesX may, by written notice to the other Party, have such dispute referred to the Chief Executive Officers (or equivalent) of CPL and NeurogesX, for attempted resolution by good faith negotiations within thirty
(30) days after such notice is received by such other Party. 
 13.3 English Language. This Agreement shall be made in the
English language, which language shall be controlling in all respects, and all versions hereof in any other language shall not be binding upon the Parties. All communications and notices to be made pursuant to this Agreement shall be in the English
language. 
 13.4 Implied Obligations. This Agreement sets forth all of the rights and obligations of the Parties with respect to the
subject matter hereof. 
 13.5 Force Majeure. Nonperformance of any Party shall be excused to the extent that performance is rendered
impossible by strike, fire, earthquake, terrorism, blackout, flood, governmental acts, orders, or restrictions, failure of suppliers, or any other reason where failure to perform is beyond the reasonable control of the nonperforming Party excluding
any monetary default, provided that the services or goods for which the money is being paid has been performed or delivered. 
 13.6
Assignment. The rights and obligations of each Party under this Agreement may not be assigned or otherwise transferred to a third party without the prior written consent of the other Party. Any assignment in violation of this
Section 13.6 shall be null and void. Notwithstanding the foregoing, either Party may transfer or assign its rights and obligations under this Agreement, without the consent of the other Party, to a successor to all or substantially all of its
business or assets relating to this Agreement whether by sale, merger, operation of law or otherwise if the assignee or transferee has agreed to be bound by the terms and conditions of this Agreement. 
 13.7 Subcontractors. CPL agrees not to subcontract its performance of any activities under this Agreement, including the Services and the supply
of Product to NeurogesX pursuant to Article 

  

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2, without NeurogesX’s prior written approval, such approval not to be unreasonably withheld or delayed. Innopharm, CPL’s analytical laboratory, is
a wholly owned entity of CPL. CPL shall ensure that Innopharm is bound by all the terms and conditions of this Agreement, including Articles 6 and 10 as if named in place of CPL. Subject to the foregoing, Innopharm is a permitted subcontractor of
CPL. 
 13.8 Notices. Any notice or report required or permitted to be given or made under this Agreement by either Party shall be in
writing and delivered to the other Party at its address indicated in this Agreement (or to such other address as a Party may specify by notice under this Agreement) by courier or by registered or certified airmail, postage prepaid, courier service,
or by facsimile, which facsimile is promptly confirmed, in writing, by registered or certified airmail, postage prepaid. All notices shall be effective as of the date received by the addressee. 
  

			
	If to CPL:	  	 7600 Danbro Crescent,
 Mississauga, Ontario,
Canada,
 L5N 6L6
 Attn: CEO Fax:
(905) 821-7602

		
	If to NeurogesX:	  	 San Carlos Business Park
 981F Industrial
Road
 San Carlos, California, 94070
 U.S.A.
 Attn: President
 Fax: (650) 649-1798

 13.9 Limitation of Liability. EXCEPT TO THE EXTENT SUCH PARTY MAY BE REQUIRED TO INDEMNIFY
THE OTHER PARTY UNDER ARTICLE 12 ABOVE OR IN THE CASE OF WILLFUL BREACH OF THIS AGREEMENT, NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR ANY SPECIAL, CONSEQUENTIAL, 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 AN AUTHORIZED REPRESENTATIVE OF SUCH PARTY IS
ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME. 
 13.10 Headings. Headings included herein are for convenience only, do not form a
part of this Agreement, and shall not be used in any way to construe or interpret this Agreement. 
 13.11 Non-Waiver. Any waiver of
the terms and conditions hereof must be explicitly in writing. The waiver by either of the Parties of any breach of any provision hereof by the other shall not be construed to be a waiver of any succeeding breach of such provision or a waiver of the
provision itself. 
 13.12 Severability. Should any section, or portion thereof, of this Agreement be held invalid by reason of any
law, statute, or regulation existing now or in the future in any jurisdiction by 

  

 -17- 

 
any court of competent authority or by a legally enforceable directive of any governmental body, such section or portion thereof will be validly reformed so
as to approximate the intent of the Parties as nearly as possible and, if unreformable, will be deemed divisible and deleted with respect to such jurisdiction, but the Agreement will not otherwise be affected. 
 13.13 Independent Contractors. The relationship of NeurogesX and CPL established by this Agreement is that of independent contractors. Nothing in
this Agreement shall be construed to create any other relationship between NeurogesX and CPL. 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. 
 13.14 Entire Agreement. This Agreement, together with the Exhibits hereto, constitutes and contains the entire
understanding and agreement of the Parties respecting the subject matter hereof and cancels and supersedes any and all prior and contemporaneous negotiations, correspondence, understandings and agreements between the Parties, whether oral or
written, regarding such subject matter. Notwithstanding the foregoing, to the extent the terms and conditions of the body of this Agreement conflict with the terms and conditions of any Exhibit hereto (including without limitation, the Quality
Agreement and any Workplan), the terms and conditions of the body of this Agreement shall govern. No agreement or understanding varying or extending this Agreement shall be binding upon either Party, unless set forth in a writing which specifically
refers to the Agreement that is signed by duly authorized officers or representatives of the respective Parties, and the provisions of the Agreement not specifically amended thereby shall remain in full force and effect. 
 13.15 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but which together shall constitute
one and the same instrument. 
 IN WITNESS WHEREOF, the Parties have caused their duly authorized representatives to execute this Agreement.

  

									
	 NEUROGESX INC.
	 		 	CONTRACT PHARMACEUTICALS LIMITED CANADA
					
	By:	 	 /s/ Stephen Ghiglieri
	 		 	By:	 	 /s/ Paul Pickles

					
	Name:	 	 Stephen Ghiglieri
	 		 	Name:	 	 Paul Pickles

					
	Title:	 	 Chief Financial Officer
	 		 	Title:	 	 Chief Executive Officer

  

 -18- 

 EXHIBIT A 
 QUALITY ASSURANCE AGREEMENT 

 EXHIBIT B 
 BULK PRODUCT SPECIFICATIONS 
  

 -2- 

 EXHIBIT C 
 FINISHED PRODUCT SPECIFICATIONS 
  

 -3- 

 EXHIBIT D 
 WORKPLAN 1 
  

 -4- 

 EXHIBIT E 
 PRICES 
  

 -5-

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