Document:

exv10w2

Exhibit 10.2

Development and License Agreement

Between

NuPathe Inc.

and

LTS Lohmann Therapie-Systeme AG

Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 230.406. The
confidential portions of this exhibit have been omitted and are marked accordingly. The
confidential portions have been filed separately with the Securities and Exchange Commission
pursuant to the Confidential Treatment Request.

1

 

TABLE OF CONTENTS

(continued)

	 	 	 	 	 
	 	 	Page	 
	Article I. Definitions
	 	 	7	 
	 
	 	 	 	 
	1.01 Introduction
	 	 	7	 
	 
	 	 	 	 
	1.02 “Active Principle”
	 	 	7	 
	 
	 	 	 	 
	1.03 “Active Principle Specifications”
	 	 	7	 
	 
	 	 	 	 
	1.04 “Affiliate”
	 	 	7	 
	 
	 	 	 	 
	1.05 “Agreement”
	 	 	7	 
	 
	 	 	 	 
	1.06 “Annex”
	 	 	8	 
	 
	 	 	 	 
	1.07 “cGMP”
	 	 	8	 
	 
	 	 	 	 
	1.08 “Clinical Samples”
	 	 	8	 
	 
	 	 	 	 
	1.09 “Commercially Reasonable Efforts”
	 	 	8	 
	 
	 	 	 	 
	1.10 “Defective”
	 	 	8	 
	 
	 	 	 	 
	1.11 “Development Committee”
	 	 	9	 
	 
	 	 	 	 
	1.12 “Development Work”
	 	 	9	 
	 
	 	 	 	 
	1.13 “Development Plan”
	 	 	9	 
	 
	 	 	 	 
	1.14 “FDA”
	 	 	9	 
	 
	 	 	 	 
	1.15 “Iontophoretic Components”
	 	 	9	 
	 
	 	 	 	 
	1.16 “LTS Know How”
	 	 	10	 
	 
	 	 	 	 
	1.17 “LTS Intellectual Property”
	 	 	10	 
	 
	 	 	 	 
	1.18 “LTS Patents”
	 	 	10	 
	 
	 	 	 	 
	1.19 “Major Market Country”
	 	 	10	 
	 
	 	 	 	 
	1.20 “Manufacturing Agreement”
	 	 	10	 
	 
	 	 	 	 
	1.21 “NuPathe Know How”
	 	 	10	 
	 
	 	 	 	 
	1.22 “NuPathe Intellectual Property”
	 	 	10	 
	 
	 	 	 	 
	1.23 “Patents”
	 	 	11	 
	 
	 	 	 	 
	1.24 “Product”
	 	 	11	 
	 
	 	 	 	 
	1.25 “Party”
	 	 	11	 
	 
	 	 	 	 
	1.26 “Project”
	 	 	11	 
	 
	 	 	 	 
	1.27 “Quality Agreement”
	 	 	11	 
	 
	 	 	 	 
	1.28 “Report”
	 	 	11	 

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TABLE OF CONTENTS

(continued)

	 	 	 	 	 
	 	 	Page	 
	1.29 “Specifications”
	 	 	12	 
	 
	 	 	 	 
	1.30 “Sublicensee”
	 	 	12	 
	 
	 	 	 	 
	1.31 “Territory”
	 	 	12	 
	 
	 	 	 	 
	1.32 Interpretation
	 	 	12	 
	 
	 	 	 	 
	Article II. Contribution of LTS
	 	 	13	 
	 
	 	 	 	 
	2.01 LTS Contribution
	 	 	13	 
	 
	 	 	 	 
	2.02 Report
	 	 	13	 
	 
	 	 	 	 
	2.03 Clinical Samples
	 	 	13	 
	 
	 	 	 	 
	2.04 Timelines
	 	 	14	 
	 
	 	 	 	 
	2.05 Implementation of the Project
	 	 	14	 
	 
	 	 	 	 
	2.06 LTS’ Support of Registration
	 	 	14	 
	 
	 	 	 	 
	2.07 Audit at LTS
	 	 	15	 
	 
	 	 	 	 
	2.08 Establishment Registration/Device Listing
	 	 	15	 
	 
	 	 	 	 
	Article III. Contributions of NuPathe
	 	 	15	 
	 
	 	 	 	 
	3.01 NuPathe Cooperation
	 	 	15	 
	 
	 	 	 	 
	3.02 Active Principle Supply
	 	 	15	 
	 
	 	 	 	 
	3.03 Active Principle Data
	 	 	16	 
	 
	 	 	 	 
	3.04 Evaluating Results
	 	 	16	 
	 
	 	 	 	 
	3.05 Iontophoresis Components
	 	 	17	 
	 
	 	 	 	 
	3.06 Clinical Trials
	 	 	17	 
	 
	 	 	 	 
	3.07 Registration of Products
	 	 	17	 
	 
	 	 	 	 
	3.08 Upgrade to the LTS’ facility
	 	 	17	 
	 
	 	 	 	 
	Article IV. Involvement of Third Parties
	 	 	18	 
	 
	 	 	 	 
	4.01 Involvement of Third Parties — General
	 	 	18	 
	 
	 	 	 	 
	4.02 Involvement of Third Parties by LTS
	 	 	18	 
	 
	 	 	 	 
	4.03 Involvement of Third Parties by NuPathe
	 	 	19	 
	 
	 	 	 	 
	Article V. Development Committee
	 	 	20	 
	 
	 	 	 	 
	5.01 Development Committee
	 	 	20	 
	 
	 	 	 	 
	5.02 Control over Project
	 	 	21	 

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TABLE OF CONTENTS

(continued)

	 	 	 	 	 
	 	 	Page	 
	5.03 Meetings
	 	 	21	 
	 
	 	 	 	 
	5.04 Patent Search
	 	 	21	 
	 
	 	 	 	 
	5.05 Solving of Disputes
	 	 	22	 
	 
	 	 	 	 
	Article VI. Funding of Development Work
	 	 	22	 
	 
	 	 	 	 
	6.01 Payment Schedule
	 	 	22	 
	 
	 	 	 	 
	6.02 Payment Schedule, Invoices
	 	 	23	 
	 
	 	 	 	 
	6.03 Overdue payments
	 	 	23	 
	 
	 	 	 	 
	6.04 No Setoff
	 	 	24	 
	 
	 	 	 	 
	6.05 Expenses
	 	 	24	 
	 
	 	 	 	 
	Article VII. Commercialization
	 	 	24	 
	 
	 	 	 	 
	Article VIII. License Grants
	 	 	24	 
	 
	 	 	 	 
	8.01 NuPathe Grants
	 	 	24	 
	 
	 	 	 	 
	8.02 LTS Grants
	 	 	25	 
	 
	 	 	 	 
	8.03 Specific LTS Manufacturing Know How
	 	 	25	 
	 
	 	 	 	 
	Article IX. Inventions and Data
	 	 	26	 
	 
	 	 	 	 
	9.01 Inventions
	 	 	26	 
	 
	 	 	 	 
	9.02 NuPathe Inventions
	 	 	26	 
	 
	 	 	 	 
	9.03 LTS Inventions
	 	 	27	 
	 
	 	 	 	 
	9.04 Joint Inventions
	 	 	27	 
	 
	 	 	 	 
	9.05 Transfer
	 	 	30	 
	 
	 	 	 	 
	9.06 Use of Inventions
	 	 	30	 
	 
	 	 	 	 
	9.07 Data
	 	 	30	 
	 
	 	 	 	 
	Article X. Confidentiality
	 	 	31	 
	 
	 	 	 	 
	Article XI. Patent Infringements
	 	 	31	 
	 
	 	 	 	 
	11.01 Notices
	 	 	31	 
	 
	 	 	 	 
	11.02 Joint Patents
	 	 	32	 
	 
	 	 	 	 
	11.03 Literature Research on Patents
	 	 	33	 
	 
	 	 	 	 
	11.04 No Warranty
	 	 	33	 
	 
	 	 	 	 
	11.05 Patent Infringement
	 	 	34	 

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TABLE OF CONTENTS

(continued)

	 	 	 	 	 
	 	 	Page	 
	11.06 Assistance
	 	 	34	 
	 
	 	 	 	 
	Article XII. Liability and Indemnification
	 	 	35	 
	 
	 	 	 	 
	12.01 No warranty
	 	 	35	 
	 
	 	 	 	 
	12.02 Product Liability
	 	 	35	 
	 
	 	 	 	 
	12.03 Burden of proof
	 	 	37	 
	 
	 	 	 	 
	12.04 Insurance
	 	 	37	 
	 
	 	 	 	 
	Article XIII. Term and Termination
	 	 	37	 
	 
	 	 	 	 
	13.01 Term
	 	 	37	 
	 
	 	 	 	 
	13.02 Termination by either Party
	 	 	37	 
	 
	 	 	 	 
	13.03 Termination by NuPathe
	 	 	37	 
	 
	 	 	 	 
	13.04 Termination for Default
	 	 	38	 
	 
	 	 	 	 
	13.05 Termination by Either Party
	 	 	38	 
	 
	 	 	 	 
	13.06 Surviving Rights
	 	 	38	 
	 
	 	 	 	 
	13.07 Effect of Termination
	 	 	38	 
	 
	 	 	 	 
	Article XIV. Miscellaneous Provisions
	 	 	39	 
	 
	 	 	 	 
	14.01 No Guarantee
	 	 	39	 
	 
	 	 	 	 
	14.02 No Agency
	 	 	39	 
	 
	 	 	 	 
	14.03 No License
	 	 	39	 
	 
	 	 	 	 
	14.04 Force Majeure
	 	 	40	 
	 
	 	 	 	 
	14.05 No Indirect, Punitive or Exemplary Damages
	 	 	40	 
	 
	 	 	 	 
	14.06 Settlement of Disputes
	 	 	41	 
	 
	 	 	 	 
	14.07 Choice of Law and Jurisdiction
	 	 	41	 
	 
	 	 	 	 
	14.08 No Jury Trial
	 	 	41	 
	 
	 	 	 	 
	14.09 Notices
	 	 	42	 
	 
	 	 	 	 
	14.10 Official Language
	 	 	42	 
	 
	 	 	 	 
	14.11 Severability
	 	 	42	 
	 
	 	 	 	 
	14.12 Titles
	 	 	43	 
	 
	 	 	 	 
	14.13 Amendment
	 	 	43	 
	 
	 	 	 	 
	14.14 Entire Agreement
	 	 	43	 

ANNEX A Active Principle Specifications

ANNEX B Development Plan

ANNEX C LTS Outlines of Principles for Manufacturing Agreements

ANNEX D Specifications

ANNEX E Active Principle Data

ANNEX F Investment Costs for manufacture of clinical samples

ANNEX G LTS Product Liability Insurance

ANNEX H Quality Agreement

5

 

DEVELOPMENT AND LICENSE AGREEMENT

THIS AGREEMENT, effective as of September 14, 2007 (“Effective Date”) by and among LTS Lohmann
Therapie-Systeme AG, a company organized under the laws of Germany having a principal place of
business at Lohmannstraße 2, 56626 Andernach, Federal Republic of Germany (“LTS”);

AND

NuPathe Inc., a corporation organized under the laws of Delaware having a principal place of
business at 375 East Elm Street, Suit 110, Conshohocken, PA 19428, USA (“NuPathe”)

WITNESSETH

     WHEREAS, NuPathe is engaged in the research and development of new products including Active
Principle and Active Principle compositions for use in the health care field.

     WHEREAS, NuPathe has acquired rights to an iontophoretic transdermal technology for the use
with the Active Principle.

     WHEREAS, LTS is engaged and experienced in developing and manufacturing transdermal
therapeutic systems for the delivery of pharmaceutical ingredients through the skin (“TTS”).

     WHEREAS, NuPathe is interested in a cooperation concerning Product.

     WHEREAS, the parties intend to collaborate in the commercialization of such Product resulting
from the development work under this agreement, during which, subject, however to the terms and
conditions of this agreement NuPathe would market, distribute, sell and/or have marketed,
distributed or sold such Product and LTS would exclusively manufacture and supply NuPathe’s
requirements therefore.

     NOW THEREFORE, in consideration of the premises and mutual covenants and conditions set forth
herein, the Parties agree as follows:

6

 

Article I. Definitions

	1.01	 	Introduction
	 
	 	 	When used in this Agreement, each of the following terms shall have the meanings set out in
this Article I.
	 
	1.02	 	“Active Principle”
	 
	 	 	shall mean the active pharmaceutical ingredient Sumatriptan Succinate ready to be used for
the development of the Product (as hereinafter defined) and for the manufacturing of
Clinical Samples (as hereinafter defined) and the Product.
	 
	1.03	 	“Active Principle Specifications”

means the specifications of the Active Principle, set forth in Annex A.
	 
	1.04	 	“Affiliate”
	 
	 	 	means any person or business entity which directly or indirectly controls, is controlled by,
or is under common control with a Party to this Agreement. A business entity shall be deemed
to “control” another business entity, if it owns directly or indirectly, more than fifty
percent (50%) of the outstanding voting securities, capital stock, or other comparable
equity or ownership interest of such business entity, or exercises equivalent influence over
such entity. If the laws of the jurisdiction in which such entity operates prohibit
ownership by a Party of more than fifty percent (50%), “control” shall be deemed to exist at
the maximum level of ownership allowed by such jurisdiction.
	 
	1.05	 	“Agreement”
	 
	 	 	shall mean this agreement and the annexes thereto.

7

 

	1.06	 	“Annex”
	 
	 	 	means an exhibit to this Agreement which sets out details of the Agreement and shall be
binding only if signed by legal representatives of the parties.
	 
	1.07	 	“cGMP”
	 
	 	 	means current good manufacturing practices, as applicable, as described in (i) Parts 210,
211 and 820 of Title 21 of the United States’ Code of Federal Regulations, (ii) Division 2
of Part C of the Food and Drug Regulations (Canada), (iii) EC Directive 91/356/EEC and (iv)
the latest Health Canada, FDA and European Medicine Evaluation Agency guidance documents
pertaining to manufacturing and quality control practice, as updated, amended and revised
from time to time and as applicable under the particular circumstances.
	 
	1.08	 	“Clinical Samples”
	 
	 	 	mean samples of the Product complying with the Specifications manufactured by LTS according
to cGMP and the Quality Agreement and supplied to NuPathe for purposes of evaluation by
NuPathe in one or more clinical studies.
	 
	1.09	 	“Commercially Reasonable Efforts”
	 
	 	 	means those efforts employed by the Parties, equivalent to that level of attention and care
that they devote to their other businesses and products of similar commercial potential and
at a similar stage of progress of development.
	 
	1.10	 	“Defective”
	 
	 	 	means in connection with the term “Product” or “Clinical Samples” any Product or Clinical
Samples which does not meet the Specifications and / or is not manufactured

8

 

	 	 	according to cGMP and according to applicable laws and regulations. Defect shall be
construed accordingly.
	 
	1.11	 	“Development Committee”
	 
	 	 	means a group composed of one or more representative(s) from NuPathe and representatives
from LTS, which shall be responsible for planning and monitoring the Project to ensure
diligent completion thereof.
	 
	1.12	 	“Development Work”

means the activities set forth in the Development Plan, attached hereto.
	 
	1.13	 	“Development Plan”
	 
	 	 	means the plan attached hereto as Annex B, which sets forth the activities to be performed
and the timelines for such activities. The Development Plan may be amended by the mutual
written agreement of the parties.
	 
	1.14	 	“FDA”
	 
	 	 	means the United States Food and Drug Administration and any successor agency thereto.
	 
	1.15	 	“Iontophoretic Components”
	 
	 	 	means all materials related to the iontophoretic operation of the Product, including but not
limited to assembled iontophoretic circuits, power sources, electrodes, batteries, and other
components necessary for operation of the Product.

9

 

	1.16	 	“LTS Know How”
	 
	 	 	means proprietary information of LTS regarding the general development and manufacture of
TTS and related technologies.
	 
	1.17	 	“LTS Intellectual Property”
	 
	 	 	means all right, title and interest to LTS Know-How, including but not limited to LTS’
Patents.
	 
	1.18	 	“LTS Patents”
	 
	 	 	means any patent or application owned or controlled by LTS covering general development and
manufacture of TTS and related technologies
	 
	1.19	 	“Major Market Country”
	 
	 	 	shall mean the United States and each country of the European Union.
	 
	1.20	 	“Manufacturing Agreement”
	 
	 	 	shall mean the manufacturing and supply agreement to be concluded between the Parties for
the commercial manufacture and supply of the Product consistent with LTS’ Outlines of
Principles for Manufacturing Agreements, which are attached hereto as Annex C.
	 
	1.21	 	“NuPathe Know How”
	 
	 	 	means proprietary information of NuPathe concerning iontophoresis, the Iontophoretic
Components, the Active Principle.
	 
	1.22	 	“NuPathe Intellectual Property”
	 
	 	 	means all right, title and interest in and to all proprietary information of NuPathe
regarding the SmartReliefTM iontophoretic patch technology including, without

10

 

	 	 	limitation, design, specifications, engineering, drug formulation and technology, including
Patents related thereto and NuPathe Know-How.
	 
	1.23	 	“Patents”
	 
	 	 	shall mean any patents or patent applications and any continuations, continuations-in-part,
divisions, provisionals, substitutions, patents of addition, reissues, reexamination,
renewals or extensions thereof (including any supplemental patent certificates) and any
confirmation patent or registration patent and all foreign counterparts of any of the
foregoing.
	 
	1.24	 	“Product”
	 
	 	 	means a TTS containing Active Principle, combined with the Iontophoretic Components.
	 
	1.25	 	“Party”

shall mean a Party to this Agreement.
	 
	1.26	 	“Project”
	 
	 	 	means collaboration of the Parties under this Agreement with the objective to develop and
commercialize the Product.
	 
	1.27	 	“Quality Agreement”
	 
	 	 	means the Quality Agreement attached hereto as Annex___and executed simultaneously with this
Agreement
	 
	1.28	 	“Report”
	 
	 	 	means the final report to NuPathe containing LTS’s results of LTS’ activities under this
agreement to develop a Product.

11

 

	1.29	 	“Specifications”
	 
	 	 	means the written specifications developed in accordance with the Quality Agreement for the
manufacturing and quality control of the Product, and any and all additions and amendments
to the same made by the written agreement of the Parties during the term of this Agreement.
	 
	 	 	The Specifications will be attached to and made a part of this Agreement as Annex D.
	 
	1.30	 	“Sublicensee”
	 
	 	 	means a Party whom NuPathe has sublicensed its license(s) granted hereunder in accordance
with Section 4.03 subsection (b) of this agreement.
	 
	1.31	 	“Territory”
	 
	 	 	means worldwide.
	 
	1.32	 	Interpretation
	 
	 	 	Unless the context of this Agreement requires otherwise,

	 	(i)	 	words of any gender include each other gender,
	 
	 	(ii)	 	words using the singular or plural number also include the plural or singular
number, respectively,
	 
	 	(iii)	 	the terms “hereof”, “herein”, “hereunder”, “hereby” and derivative or similar
words refer to this entire Agreement,
	 
	 	(iv)	 	the terms “Article” or “Section” refer to the specified Article or Section of
this Agreement, and

12

 

Article II. Contribution of LTS

	2.01	 	LTS Contribution.
	 
	 	 	LTS shall use its Commercially Reasonable Efforts to perform the Development Work and to
perform the Development Work in accordance with the Quality agreement and all applicable
laws and regulations, including standards of cGMP.
	 
	2.02	 	Report.
	 
	 	 	The Development Work shall culminate in a Report summarizing and documenting the Development
Work.
	 
	 	 	LTS shall use Commercially Reasonable Efforts to present the Report to NuPathe within sixty
(60) days after completion of the Development Work.
	 
	 	 	NuPathe may request reasonable modifications to such Report within thirty (30) days after
receiving the Report and LTS shall make such reasonable modifications within thirty (30)
days after receipt of NuPathe’s written request. In the event NuPathe does not comment on
the draft within such thirty (30) days period, then the Report shall be deemed accepted.
	 
	2.03	 	Clinical Samples.
	 
	 	 	LTS shall use its Commercially Reasonable Efforts to manufacture and supply to NuPathe
Clinical Samples. It is being understood that NuPathe shall pay no other compensation for
the delivery of Clinical Samples, other than the compensation as provided for in Article VI.

13

 

	2.04	 	Timelines.
	 
	 	 	LTS shall use its Commercially Reasonable Efforts to perform the Development Work within the
timelines set forth in the Development Plan, however NuPathe acknowledges that due to the
developmental nature of such work LTS is unable to warrant or guarantee the completion of
the Project within those time limits. In the event LTS becomes aware that it will not be
able to comply with the timelines set forth in the Development Plan, it shall inform NuPathe
in due time.
	 
	2.05	 	Implementation of the Project.
	 
	 	 	LTS shall have sole control over the implementation of the LTS activities as established by
the decisions and recommendations of the Development Committee and / or the Development
Plan.
	 
	2.06	 	LTS’ Support of Registration.
	 
	 	 	LTS shall provide to NuPathe in a timely manner the information which concerns the design
and manufacture of the Product necessary for preparing the applicable regulatory documents
for NuPathe’s regulatory filings and shall use its Commercially Reasonable Efforts to
provide NuPathe support reasonably required for such filing for one Major Market Country.
Subject to regulatory requirements, in the event that this requires disclosure of LTS
Know-How or confidential information of LTS customers, LTS shall have the right to
communicate such information directly to the health authorities, without disclosing same to
NuPathe. All INDs, NDAs and other regulatory filings made or filed by NuPathe with respect
to any Products shall be in the name of, and be owned solely by NuPathe.

14

 

	 	 	In the event NuPathe wishes additional support from LTS for the registration in other
countries, any activities shall be subject to the terms and conditions of this agreement,
provided, however, that such support from LTS shall be subject to a written agreement
including LTS’ compensation and the timelines for such support.
	 
	2.07	 	Audit at LTS.
	 
	 	 	In addition to any audit and/or inspection rights set forth in the Quality Agreement, LTS
will permit an authorized representative of NuPathe or its Affiliates to inspect at all
reasonable times the process of manufacture and storage of the Clinical Samples under such
conditions as LTS may reasonably require in order to protect the confidentiality of its and
its other customer’s proprietary and confidential information.
	 
	2.08	 	Establishment Registration/Device Listing
	 
	 	 	If necessary, LTS shall use its Commercial Reasonable Efforts to file a Registration of
Device Establishment and Medical Device Listing pursuant to 21 CFR 807. NuPathe shall pay
all costs related thereto.

Article III. Contributions of NuPathe

	3.01	 	NuPathe Cooperation.
	 
	 	 	NuPathe shall use its Commercially Reasonable Efforts to duly cooperate during the entire
course of the Project.
	 
	3.02	 	Active Principle Supply.
	 
	 	 	NuPathe shall supply LTS with such quantities of Active Principle at such times as LTS reasonably,
at its discretion, needs for the Project [**] and will ship the Active Principle DDP (Incoterms
2000). All Active Principle supplied hereunder shall be utilized by LTS

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND
WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL
TREATMENT REQUEST.

15

 

	 	 	solely for conducting work on the Project and any unused quantities shall be returned
to NuPathe at NuPathe’s cost.

	 	(1)	 	NuPathe’s Compliance with Active Principle Specifications. NuPathe
represents and warrants that Active Principle delivered under this Agreement conforms
to the Active Principle Specifications as the Parties have agreed upon and has been
manufactured according to cGMP and all other applicable statutes, laws and regulations.
LTS shall check for identity only all such supplies within ten (10) days of receipt
thereof.
	 
	 	(2)	 	Audit at Supplier of Active Principle. If it is required by law,
NuPathe shall enable authorized representative of LTS or its Affiliates upon written
reasonable advance notice to inspect at all reasonable times the process of manufacture
and storage of the Active Principle supplies, under such conditions as NuPathe or any
supplier of the Active Principle may reasonably require in order to protect the
confidentiality of its and its other customer’s proprietary and confidential
information.

	3.03	 	Active Principle Data.
	 
	 	 	NuPathe shall supply LTS with relevant data related to the Active Principle including safety
data sheet and all other information LTS might additionally require in pursuance of the
Project.
	 
	3.04	 	Evaluating Results.
	 
	 	 	NuPathe shall duly evaluate the results in any
interim report and the Report in order to promote
the Project as much as practical.

16

 

	3.05	 	Iontophoresis Components
	 
	 	 	NuPathe shall supply LTS with sufficient quantities of Iontophoretic Components, as LTS
reasonably requires for the Project [**]. All Iontophoretic Components supplied hereunder
shall conform to the Specifications and shall be utilized by LTS solely for conducting work
on the Project.
	 
	3.06	 	Clinical Trials.
	 
	 	 	NuPathe shall be responsible for planning and carrying out all clinical trials of Products.
NuPathe shall perform such clinical trials in accordance with all applicable laws and
regulations.
	 
	3.07	 	Registration of Products.
	 
	 	 	NuPathe shall be responsible for preparing in a timely manner the applicable regulatory
documents and filing for registration and approval of Products in the Territory. Any
sections of the filing for registration relevant for LTS shall be subject to LTS’ prior
approval which shall not be unreasonably withheld.
	 
	3.08	 	Upgrade to the LTS’ facility
	 
	 	 	NuPathe shall reimburse LTS for investment costs specified in Annex F and all other
investment costs which are directly related to specific tools and equipment necessary for
manufacturing the clinical samples of Product, which are currently not available for the
manufacture of the clinical samples of Product at LTS.

	 	(a)	 	NuPathe shall pay the costs within thirty (30) days of submission by LTS to
NuPathe of the respective invoice. LTS may invoice NuPathe, once it has entered into a
firm commitment to purchase tools or equipment. LTS will fulfill its

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

17

 

	 	 	 	obligation to pay the third party vendor(s). NuPathe shall have the right to audit
invoices received by LTS for the purchase of such equipment and/or tools in LTS’
rooms in Andernach, Germany at a time mutually convenient to both parties.
	 
	 	(b)	 	LTS does not guarantee or assumes any liability that such specific tools and
equipment are suitable for manufacture of commercial quantities; however LTS shall use
its Commercially Reasonable Efforts to make such equipment useable for the commercial
manufacture of the Product.

Article IV. Involvement of Third Parties

	4.01	 	Involvement of Third Parties — General.
	 
	 	 	Except as set forth herein, this Agreement and the licenses granted are personal to the
Parties and cannot be assigned by a Party without the prior written authorization of the
other Party, such authorization not to be unreasonably withheld. Such an authorization shall
not be required for assignments by a Party to one of its Affiliates or in connection with
the transfer or sale of all or substantially all of its assets, stock or business or its
merger, consolidation or combination with or into another entity, provided however, that
this exception does not apply in case of NuPathe assignment to an entity who’s primary
business is the manufacturing of transdermal patches. Subject to the foregoing, this
Agreement shall be binding upon, inure to the benefit of and be enforceable by the
respective heirs, administrators, successors and permitted assigns of the parties.
	 
	4.02	 	Involvement of Third Parties by LTS.
	 
	 	 	LTS may have certain of its tasks or duties performed by one of its Affiliates, or, after
written authorization of NuPathe, which shall not be withheld unreasonably, by a third

18 

 

	 	 	party under obligation of confidentiality, if same is necessary for the timely performance
of the Development Work, however, LTS shall remain solely responsible for the performance of
the Development Work in accordance with the terms hereof. If LTS chooses to have certain of
its tasks or duties performed by one of its Affiliates or a third party according to the
foregoing or if the Parties determine that the Product shall be manufactured in the
facilities of LTS’ Affiliates, then all licenses in favor of LTS hereunder shall be deemed
to be granted to such LTS’ Affiliate or such third party for the period during which it is
performing LTS’ tasks or duties or is manufacturing the Product and such Affiliates or third
parties shall:

	 	(a)	 	assume the obligations to indemnify NuPathe according to this Agreement and the
Manufacturing Agreement; and
	 
	 	(b)	 	provide a sufficient product liability insurance coverage equal to the
coverage, which LTS is obliged to provide according to this Agreement and the
Manufacturing Agreement.

	4.03	 	Involvement of Third Parties by NuPathe.
	 
	 	 	The grant of licenses to NuPathe by LTS may be sublicensed by NuPathe to those of NuPathe’s
third party sublicensees that require such license rights for the use, sale, importation,
distribution or marketing of the Products, provided, that.

	 	(a)	 	LTS is informed of the identity of the potential sublicense and the scope of
rights that are being granted;

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	 	(b)	 	those sublicensees additionally assume the obligations to indemnify LTS
according to this Agreement and the Manufacturing Agreement; and
	 
	 	(c)	 	those sublicensees provide a sufficient product liability insurance coverage
equal to the coverage, which NuPathe is obliged to provide according to this Agreement
and the Manufacturing Agreement.

Article V. Development Committee

	5.01	 	Development Committee.
	 
	 	 	Within thirty (30) days after execution of this Agreement LTS and NuPathe will create a
Development Committee which shall be responsible for

	 	(a)	 	the control over the Project;
	 
	 	(b)	 	the review and approval of the Specifications subject to the Quality Agreement;
	 
	 	(c)	 	the co-ordination of all joint activities of the Parties under the Development
Plan;
	 
	 	(d)	 	the exchange of information between the Parties;
	 
	 	(e)	 	analysis of the intellectual property aspects of the Product;
	 
	 	(f)	 	the evaluation of new research projects relating to the Project;
	 
	 	(g)	 	modifying the Development Plan;
	 
	 	(h)	 	resolving any unexpected issues that may arise in the performance of this
Agreement.

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	 	 	LTS and NuPathe shall inform each other within thirty (30) business-days of the execution
hereof of the identities of other persons and its deputies it has designated to the
Development Committee. Each Party shall appoint at least one representative. The Parties
shall be entitled to replace such representatives from time to time. NuPathe and LTS shall
have equal voting rights in the Development Committee regardless of the number of
representatives designated by NuPathe and LTS respectively. Decision of the Development
Committee shall be made by unanimous written agreement of the Parties.
	 
	5.02	 	Control over Project.
	 
	 	 	The Development Committee shall have the primary control over the direction and the course
of the Development Work. The Development Committee shall modify the Development Plan as
appropriate.
	 
	5.03	 	Meetings.
	 
	 	 	The Development Committee shall meet at least quarterly, as appropriate also by
teleconference or videoconference, to review the progress of the Development Work, to
establish the program for the next quarter and to review if modifications to the Development
Plan and on the time schedule are required; if any
	 
	5.04	 	Patent Search.
	 
	 	 	The Development Committee shall work with competent patent counsel of both of LTS and
NuPathe to search frequently the patent literature in order to avoid that the Product
infringes any third party’s patent, or to take appropriate action if any such patent exists.
Such patent search and its results shall be reported orally to members of the Development
Committee and to the legal departments of either Party. For the avoidance of doubt, this

21 

 

	 	 	clause does not apply to patents held independently of the Project by either Party including
but not limited to patents relating to the Active Principle, NuPathe Intellectual Property,
NuPathe Know-how. LTS Intellectual Property or LTS Know-how.
	 
	5.05	 	Solving of Disputes.
	 
	 	 	If an unanimous decision cannot be reached within the Development Committee, each Party has
the right to ask for discussions of the problem on the management level. In this case the
appropriate management level of the Parties shall enter into good faith negotiations on the
problem without undue delay. If such individuals cannot resolve such dispute, then NuPathe
shall have the deciding vote; provided, however, that notwithstanding the foregoing, LTS
shall not be obligated, as a result of such a deciding vote by NuPathe, to violate any
obligation or agreement it may have with any third party and provided further that subject
to Sections 12.02 and 14.05, NuPathe shall indemnify and hold LTS harmless from such damages
resulting from such decision.

Article VI. Funding of Development Work

	6.01	 	Payment Schedule.

	 	(1)	 	NuPathe shall compensate LTS for all man—hours actually expended by LTS on the
Project according to the Development Plan for development activities, for production
testing, scale-up activities and — as applicable — to validation activities, and
registration activities at the rate of € [**],-per man-hour [**].
	 
	 	(2)	 	During the term of this Agreement, LTS may increase the man-hour rate set forth
above at the end of each calendar year (with such increase to take effect at the
beginning of the next calendar year), provided, however, that such increase shall

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

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	 	 	not exceed [**] percent ([**] %) of the man-hour rate for the previous year, or [**]
percent ([**] %) in two (2) consecutive years.
	 
	(3)	 	LTS will take reasonable steps to verify and document the time devoted by LTS’
employees to the Project, and will monthly submit an accounting to NuPathe. LTS will
allocate man-hours consistently with its historical allocation practice and will
provide NuPathe with a sufficiently detailed explanation of such practice, upon
request, so as allow an independent Certified Public Accountant or chartered accountant
appointed by NuPathe and reasonably acceptable to LTS to audit same.

	6.02	 	Payment Schedule, Invoices.
	 
	 	 	LTS may monthly send out invoices to NuPathe. NuPathe shall make all payments within thirty
(30) days of date of invoice by LTS, detailing value added tax separately, to a bank account
designated by LTS. A copy of the invoice shall be sent by fax parallel to mailing the
invoice; however, no payment shall be due within said thirty (30) days until an original
invoice has been received by NuPathe.
	 
	6.03	 	Overdue payments.
	 
	 	 	Overdue payments shall accrue interest at the rate of 4 (four) per cent above EURIBOR —
EURO Interbank Offered Rate (three months) — as reported in the Handelsblatt, Frankfurt on
the first business day that any payments becomes overdue, until made.
	 
	6.04	 	No Setoff.
	 
	 	 	NuPathe shall not be entitled to exercise any right of setoff, net-out or deduction, take
any credit, or assert any other defense arising out of any transaction unless and until

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

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	 	 	NuPathe has obtained a final and non-appealable judgment against LTS in the amount asserted
by NuPathe.
	 
	6.05	 	Expenses.
	 
	 	 	Each Party shall bear all of the expenses of its own participation or related to its
contribution or the performance of its obligations under this Agreement unless provided for
in this Agreement. In the event of unforeseen or extraordinary expenses the Parties shall be
entitled to request an equitable allocation.

Article VII. Commercialization

	 	 	Should the Product be successfully developed, NuPathe shall have the exclusive right to
import, market, sell or distribute or have imported, marketed, sold or distributed the
Product in the Territory and LTS shall have the exclusive right to manufacture or have
manufactured Product in the Territory. Such rights are subject to the execution of a
Manufacturing Agreement on mutually agreed terms. The Parties will meet and discuss in good
faith the Manufacturing Agreement, which shall be consistent with LTS’ Outlines as set forth
in Annex C and the terms of this Agreement.

Article VIII. License Grants

	8.01	 	NuPathe Grants.
	 
	 	 	NuPathe hereby grants to LTS a non-exclusive, royalty-free license under NuPathe
Intellectual Property and all NuPathe Know-How for the sole purpose of conducting the
Development Work, and if NuPathe elects to market a Product, such license shall include

24 

 

	 	 	the right to manufacture and supply Product to NuPathe under the Manufacturing Agreement in
the Territory.
	 
	8.02	 	LTS Grants.
	 
	 	 	LTS hereby grants to NuPathe a non-exclusive, royalty-free license in the Territory under
LTS Intellectual Property and all LTS Know How for the sole purpose of conducting the
Development Work pursuant to this Agreement and, provided that the parties cooperate in the
development of Product in connection with pre-clinical, non-clinical and clinical drug
development activities reasonably necessary to the development and submission of regulatory
data to a regulatory authority for the purpose of achieving regulatory approval for the
Product. In addition, if the Parties enter into a Manufacturing Agreement for the Product,
NuPathe shall have the exclusive, royalty free right to use, import, sell, market and
distribute or have imported, sold, marketed or distributed the Products in the Territory
under the Manufacturing Agreement.
	 
	8.03	 	Specific LTS Manufacturing Know How.

	 	(1)	 	In no case shall NuPathe be entitled to request any of LTS’ information
concerning specific manufacturing LTS Know How, unless required for patent filing,
prosecution or maintenance or regulatory registration or regulatory approval purposes.
Subject to regulatory requirements, LTS will be entitled to communicate such
information directly to regulatory authorities without disclosing it to NuPathe.

25 

 

	 	(2)	 	Nothing in this Agreement shall be construed as an obligation for LTS to
provide or transfer general know-how and/or proprietary information necessary or useful
for establishing a production of transdermal or other coating products.

Article IX. Inventions and Data

	9.01	 	Inventions.
	 
	 	 	Each party shall continue to own its existing patents, trademarks, copyrights, trade
secrets, know how and other intellectual property, without conferring any interests therein
on the other party. Without limiting the generality of the preceding sentence, NuPathe shall
retain all right, title and interest in and to NuPathe Intellectual Property and LTS shall
retain all right, title and interest to LTS Intellectual Property. In the course of the
performance of the Development Work under this Agreement, LTS and NuPathe will collaborate
in the development of the Product and such collaboration may generate inventions as such
term is defined under United States patent law (“Inventions”). Ownership of such inventions
is as set forth in Articles 9.02 through 9.04 below.
	 
	9.02	 	NuPathe Inventions.
	 
	 	 	Any Inventions that are conceived, reduced to practice or created solely by LTS or in
conjunction with NuPathe as a result of LTS’ performance of the Development Work under this
Agreement which relate solely to NuPathe Intellectual Property shall be owned by NuPathe
(“NuPathe Inventions”). NuPathe may file patent applications for such Inventions at its
cost. Any compensation to an inventor under provisions of labor law shall be paid by the
employer of that inventor.

26 

 

	 	 	LTS hereby assigns to NuPathe without further compensation, all of LTS’ right with respect
to NuPathe Inventions. To ensure NuPathe’s ownership of such Inventions, LTS shall promptly
disclose each such Invention to NuPathe (or any persons designated by it), and without
disclosing the same to others, communicate to NuPathe all available information relating to
such Inventions.
	 
	9.03	 	LTS Inventions.
	 
	 	 	Any Inventions that are conceived, reduced to practice or created solely by LTS or in
conjunction with NuPathe as a result of LTS’ performance of the Development work under this
Agreement which relate solely to LTS Intellectual Property shall be owned by LTS (“LTS
Inventions”). LTS may file patent applications for such Inventions at its cost. Any
compensation to an inventor under provisions of labor law shall be paid by the employer of
that inventor.
	 
	 	 	NuPathe hereby assigns to LTS without further compensation, all of NuPathe’s rights with
respect to LTS Inventions. To ensure LTS’ ownership of such Inventions, NuPathe shall
promptly: disclose each such Invention to LTS (or any persons designated by it), and without
disclosing the same to others, communicate to LTS all available information relating to such
Inventions.
	 
	9.04	 	Joint Inventions.

	 	(1)	 	Any Inventions that are conceived, reduced to practice or created under this
Agreement that are not NuPathe Inventions or LTS Inventions shall be jointly owned by
the Parties (‘Joint Inventions”).

27 

 

	 	(2)	 	Each of LTS and NuPathe will promptly disclose to the other in writing any
Invention that might, under the applicable patent laws, be patentable and constitute a
Joint Invention that would be owned by, or jointly owned with, the other party pursuant
to this Section 9.03.
	 
	 	 	 	With respect to all patent applications (including amendments, continuations or
continuations in part) related to Joint Inventions (the “Joint Patent
Applications”), the Parties shall determine which Party shall be responsible for
filing, prosecuting, maintaining and defending patent applications and patents on
behalf of both Parties (the “Responsible Party”) based on a good faith determination
of the relative contributions of the Parties to the invention and the relative level
of interest of the Parties in the Invention.
	 
	 	 	 	At least twenty (20) days prior to the contemplated filing of such patent
application, the Responsible Party shall submit a substantially completed draft of
the Joint Patent Applications to the other Party and provide such Party with a
reasonable opportunity to review and comment on any such documents prior to filing.
	 
	 	 	 	The Responsible Party shall also promptly provide the other Party with copies of any
substantive prosecution correspondence received directly or indirectly from a patent
office or from local patent counsel assisting with patent prosecution of such
applications and the other Party shall have an opportunity to review and comment on
any response thereto. The Responsible Party will consider in good faith the other
Party’s comments and suggestions with respect to Joint Patent Applications

28 

 

	 	 	 	and/or substantive prosecution correspondence and shall use its Commercially
Reasonable Efforts to prepare, file, prosecute and maintain Joint Patents, in the
Territory that provide the broadest possible coverage for the Product and shall not
take any actions that would lessen or minimize coverage without the other Party’s
prior written approval.
	 
	 	(3)	 	Any Joint Patent Applications shall be filed and registered in the name of LTS
and NuPathe. Except as set forth below, the Parties shall share equally the costs of
the preparation, filing, prosecution and maintenance of all Joint Patent Applications.
	 
	 	(4)	 	If the Responsible Party does not wish to file, prosecute or maintain any Joint
Patent Application or maintain or defend such a patent in a particular country, it
shall grant the other Party any necessary authority to file, prosecute and maintain
such a patent application or maintain or defend such a patent in the name of both
Parties.
	 
	 	(5)	 	If either Party elects not to pay its portion of any shared costs for a Joint
Patent Application or patent issuing therefrom, the other Party may proceed with such
Joint Patent Application in its own name and at its sole expense, in which case the
Party electing not to pay its share of costs shall assign its entire right, title and
interest in and to such Joint Patent Application to the other Party and such invention
shall be treated as a sole Invention of the assignee.
	 
	 	 	 	Once a patent or other intellectual property rights are granted resulting from a
Joint Patent Application, such patent shall be defined as a “Joint Patent Right”.

29 

 

	9.05	 	Transfer.
	 
	 	 	Either Party shall have the right to license Joint Inventions to a third party , provided,
however, in the event LTS exclusively manufactures the Product on behalf of NuPathe using a
Joint Invention, LTS may not grant any license to such Joint Invention to any third party
for use in connection with the manufacture, sale, marketing, importation or distribution of
any iontophoretic patch containing sumatriptan succinate.
	 
	9.06	 	Use of Inventions.

	 	(1)	 	NuPathe shall have the right to use LTS Inventions consistent with its
contractual rights and obligations set forth in this Agreement, including those set
forth Section 8.02 hereof, or the Manufacturing Agreement for the purpose of
commercializing the Product.
	 
	 	 	 	LTS shall have the right to use NuPathe Inventions consistent with its contractual
rights and obligations set forth in this Agreement, including those set forth in
Section 8.01 hereof, or the Manufacturing Agreement.
	 
	 	(2)	 	Each Party may license patents that it owns and/or sublicense its license to
the other party’s patents as explicitly granted hereunder to any sublicensee and/or
Affiliates consistent with this Agreement or the Manufacturing Agreement, provided that
such sublicensee or Affiliate additionally assumes the rights and obligations of such
party.

	9.07	 	Data
	 
	 	 	NuPathe will own all data, information and results and technical, chemical, safety and
scientific data and information obtained or generated in connection with clinical trials of

30 

 

	 	 	the Product and non- clinical testing of the Product . Ownership of all other data and
information generated in the course of the collaboration shall be determined according to
the principles for Inventions as set forth in Sections 9.02 to 9.04.

Article X. Confidentiality

	 	 	The information of the parties generated or exchanged during the performance of activities
under this Agreement shall be treated in accordance with the terms of the Confidentiality
Agreement concluded between NuPathe Inc. and LTS Lohmann Therapy Systems Corp. dated May
31st, 2006; provided, however, that with respect to information generated or
exchanged in connection with the performance of this Agreement, all rights and obligations
of the parties with respect to nondisclosure and non use of Confidential Information shall
survive for a period of five (5) years from the expiration or termination of this Agreement.

	 	 	For purposes of clarity, each party’s intellectual property as defined herein shall be
deemed to be Confidential Information of the party owning such intellectual property. Any
disclosure of information by one party to the other under the provisions of Article X of
this Agreement shall be treated as the disclosing party’s Confidential Information under the
Confidentiality Agreement.

Article XI. Patent Infringements

	11.01	 	Notices.

	 	 	LTS and NuPathe shall each promptly
notify the other upon learning of any
infringement of any Patents covering
NuPathe Inventions, LTS Inventions or
Joint Inventions.

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	11.02	 	Joint Patents.

	 	(1)	 	In the event that a patent resulting from a Joint Patent Application should be
the subject of a re-examination, interference or challenge before any court, the
Parties shall jointly defend such action. Either Party may abandon such action, by
conveying its interest in such patent to the other Party at no additional cost, in
which case the license provided for in Section 8.01 and 8.02 shall not apply to such
patent.
	 
	 	(2)	 	In the event that a Party becomes aware of any infringement or possible
infringement of any Joint Patent Rights, such Party shall promptly notify the other
Party in writing regarding such infringing activity.
	 
	 	 	 	Each Party shall have the right and authority, but not the obligation, to bring or
defend an action involving claims or counterclaims for such infringing activity on
its own upon at least thirty (30) days advance written notice to the other Party.
	 
	 	 	 	However, if both Parties wish to participate in such action, the action shall be
brought jointly by both Parties. Any action in which the Parties participate jointly
shall be jointly controlled and each Party shall bear its own expenses and be
entitled to any recoveries gained for its own damages; all other recoveries shall be
[**]. Both Parties shall have a duty to cooperate reasonably with each other with
regard to a joint action.
	 
	 	(3)	 	In the event one Party chooses not to participate jointly in an action or
similar legal recourse involving Joint Patent Rights, the other Party (the “Acting
Party”) may do so at its own expense in its own name. Any recoveries gained by the

 

			
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	 	 	 	Acting Party in such action or similar legal recourse shall first be used to
reimburse each Party for all costs and expenses incurred in connection with pursuing
the action and then Acting Party shall keep those recoveries gained for its own
damages. The remainder, if any, shall be [**].
	 
	 	(4)	 	Upon request of the Acting Party and at the expense of the Acting Party, the
other Party (“Non-Acting Party”) shall have a duty to cooperate reasonably with the
Acting Party in any action involving Joint Patent Rights that is brought by the Acting
Party. The Acting Party shall provide the Non-Acting Party with the opportunity to
comment and keep the Non-Acting Party informed of all developments in the action.
	 
	 	(5)	 	Neither Party shall settle any action or similar legal recourse involving Joint
Patent Rights without the prior written consent of the other Party, including but not
limited to the grant of a license to a third party during any action.

	11.03	 	Literature Research on Patents.

	 	 	As set forth in Section 5.01, the Parties agree that the Development Committee, working in
conjunction with competent patent counsel of LTS and/or NuPathe, shall cooperate in order to
analyze all intellectual property aspects of the Product.

	11.04	 	No Warranty.

	 	 	LTS and NuPathe make no representation or warranty that any application for any patent is or
will be sufficient for the issuance of a patent, nor that the manufacture or use of Product
or Active Principle does not infringe any patent owned by a third party.

 

			
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	11.05	 	Patent Infringement.

	 	 	In the event of a suit against one or more Parties for patent infringement relating to the
Product relating to [**], the Parties shall share the out-of-pocket expenses resulting from
such situation (such out-of-pocket expenses shall be considered to include royalties and
damages, as well as legal expenses and settlement payments) in the ratio of [**] % for
NuPathe and [**] % for LTS, except that LTS share of such costs shall not exceed [**] % of
the payments made by NuPathe during the preceding 12 months period, and that such sharing
shall be the sole extent of their responsibility to each another in connection with such
suit, claim or license. NuPathe shall [**], for which LTS [**].

	11.06	 	Assistance.

	 	 	The Parties shall assist each other with information, evidence, and fact witnesses as may be
reasonably requested in the defense of or negotiations related to claims made against either
one of the Parties.

Article XII. Liability and Indemnification

	12.01	 	No warranty.

	 	 	LTS does not make and shall not be deemed to make any representation or warranty, express or
implied, as to the infringement of any third party’s rights to such intellectual property,
including but not limited to, patents relating to the system, patentability, quality,
merchantability, fitness for a particular use or performance of any licensed Product or that
a party will successfully design (and develop a commercially marketable licensed Product).

 

			
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	12.02	     	Product Liability.

LTS will replace Defective Product and Defective Clinical Samples at no additional costs for
NuPathe claimed to be defective within twelve (12) months after delivery, subject to NuPathe
providing sufficient evidence of appropriate and correct storage at all times, after such
Product or Clinical Sample has been delivered by LTS.

In addition LTS shall hold NuPathe harmless within the scope and to the extent of its
product liability insurance coverage from any claim, cost, expense and damage arising out of
the use of Defective Product or Defective Clinical Samples supplied by LTS to NuPathe for
clinical trials to the extent that:

	(a)	 	NuPathe (and/or its designated clinical research organization) acts in
accordance with applicable laws and standards, such as GCP and the Helsinki
Declaration;
	 
	(b)	 	the afore-mentioned claim, expense, damage or injury is not caused by the
Active Principle supplied by NuPathe to LTS for the manufacture of Product or Clinical
Samples according to Section 2.03.
	 
	 	 	NuPathe shall bear all of the risk, cost and expenses related to the use of Product
or Clinical Samples and shall be fully liable and shall indemnify and hold harmless
LTS from any damage, claims, costs and expenses (including reasonable attorney’s
fees) arising out of claims resulting from damage or injury to itself and its
employees and any third party, for which LTS is according to the foregoing not
liable, including but not limited to the claims exceeding the scope and extent of
the product liability insurance of LTS.

The restrictions on LTS’ liability and NuPathe’s obligation to indemnify shall not
apply in the event of LTS’ willful misconduct.

LTS shall use its
Commercially Reasonable Efforts to maintain product liability
insurance coverage of an amount substantially similar to its product liability
insurance coverage set forth in Annex C. A certificate of LTS’ current product
liability insurance is attached hereto as Annex G.

The parties
acknowledge that currently some re-insurance companies do not provide
insurance coverage for the Active Principle and thus LTS might not — despite its
Commercially Reasonable Efforts — be able to maintain product liability insurance
covering the Product or such coverage would only be available for a substantially
higher premium. In the latter case the parties agree to discuss in good faith the
bearing of such additional premium.

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	12.03	 	Burden of proof.

	 	 	NuPathe shall have the burden of proof in the event NuPathe makes any claims on negligence
and/or willful misconduct.

	12.04	 	Insurance

	 	 	NuPathe shall maintain 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 for any clinical trial conducted by NuPathe with the Product.

Article XIII. Term and Termination

	13.01	 	Term.

	 	 	This Agreement shall remain in effect until terminated in accordance with Section this
Article 13, or the Manufacturing Agreement is executed by the Parties.

	13.02	 	Termination by either Party.

	 	 	If the Development Committee, in good faith, determines that it is not feasible to jointly
develop a Product either Party may terminate this Agreement on sixty (60) days
notice.
	 
	13.03	 	Termination by NuPathe.

	 	 	NuPathe shall be entitled to terminate this Agreement upon sixty (60) days written notice to
LTS thereof. In such an event, NuPathe shall reimburse LTS for all costs incurred or
irrevocably obligated by LTS prior to the date of termination; provided, however, any
installment payments made by NuPathe that are in excess of LTS’ accumulated charges shall be
returned to NuPathe.

 

			
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	13.04	 	Termination for Default.

	 	 	If either Party shall be in default of any of its material obligations under this Agreement,
the non-defaulting Party shall give the defaulting Party written notice of such default,
upon which the defaulting Party shall have sixty (60) days to cure such default or establish
that no default has occurred. In the event such default is incapable of being cured within
such sixty (60) days period, the non-defaulting party shall have the right to terminate the
agreement only, if the defaulting party did not initiate appropriate action within such
period to cure such default. In the event that a default remains uncured after sixty (60)
days have elapsed, the non-defaulting Party may declare this Agreement terminated, by
written notice to the defaulting Party.

	13.05	 	Termination by Either Party.

	 	 	If the Parties despite good faith negotiations fail to execute a Manufacturing Agreement
either Party may terminate this Agreement on thirty (30) days written notice

	13.06	 	Surviving Rights.

	 	 	Neither cancellation or termination of this Agreement nor the execution of a Manufacturing
Agreement shall relieve the Parties of their obligations of confidentiality under Article
10, their obligations as to Inventions under Article 9, their obligations regarding patent
infringements under Article 11 or their obligations regarding product liability and
indemnification under Article 12.

	13.07	 	Effect of Termination.

	 	 	Should a Party elect to terminate this Agreement pursuant to the provisions of this
Agreement, neither Party shall thereafter have any rights to the use the Intellectual

37

 

	 	 	Property, including Inventions, Patents or know-how, in so far owned by the other Party
except as provided otherwise herein.

Article XIV. Miscellaneous Provisions

	14.01	 	No Guarantee.

	 	 	EACH OF THE PARTIES ACKNOWLEDGES THAT THE WORK TO BE PERFORMED HEREUNDER IN CONNECTION WITH
THE DEVELOPMENT PROJECT IS DEVELOPMENTAL AND THAT NOTHING IN THIS AGREEMENT MAY OR SHALL BE
CONSTRUED AS A GUARANTEE OR A REPRESENTATION THAT THE PRODUCTS WILL, WITHIN A CERTAIN PERIOD
OF TIME, BE SUCCESSFULLY DEVELOPED WITH REGARD TO FITNESS FOR A PARTICULAR USE, FEASIBILITY
OF MANUFACTURING, MARKETABILITY AND ALL TECHNICAL, LEGAL AND COMMERCIAL ASPECTS RELATED
THERETO.

	14.02	 	No Agency.

	 	 	Nothing in this Agreement shall be construed as an authorization for a Party to act as an
agent for another. Furthermore, NuPathe shall incur no liability for any act or failure to
act by employees of LTS and LTS shall incur no liability for any act or failure to act by
employees of NuPathe.

	14.03	 	No License.

	 	 	Except as otherwise expressly provided herein, nothing contained in this Agreement shall be
construed or interpreted, either expressly or by implication, estoppel or otherwise, as: (i)
a grant, transfer or other conveyance by either Party to the other of any right, title,

38

 

	 	 	license or other interest of any kind in any of its Inventions or other intellectual
property, (ii) creating an obligation on the part of either Party to make any such grant,
transfer or other conveyance or (iii) requiring either party to participate with the other
Party in any cooperative development program or project of any kind or to continue with any
such program or project.

	14.04	 	Force Majeure.

	 	 	Neither Party shall be responsible or liable or shall be considered in default or liable to
the other Party for, nor shall this Agreement be terminated as a result of, any delay or
failure to perform any of its obligations hereunder, if such delay or failure results from
circumstances beyond the control of such Party, including requisition by any authority, the
effect of any statute, ordinance or governmental order or regulation, war, rebellion,
insurrection, civil commotion, riot, strike, lockout, labor disturbance, epidemic, disease,
act of God, civil commotion, explosion, fire, earthquake, storm, accident, failure of public
utilities, common carriers or suppliers or the like, or any other circumstances, whether or
not similar to the above causes and whether or not foreseeable. The Parties shall use
Commercially Reasonable 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 expense.

	14.05	 	No Indirect, Punitive or Exemplary Damages.

	 	 	Except for damages caused by or related to willful misconduct by a Party, neither Party
shall be liable to the other for any indirect, special or consequential damages, lost
profits

39

 

	 	 	and/or punitive damages, provided, that this exclusion of liability does not apply if such
agreement would be invalidated as a violation of law or public policy.

	14.06	 	Settlement of Disputes.

	 	 	The Development Committee shall attempt to amicably resolve any dispute concerning any
rights or obligations of either Party under this Agreement. If the Development Committee is
unable to resolve any such dispute, the matter shall be referred to the Chairman of the
Board of LTS and the President of NuPathe for resolution.

	14.07	 	Choice of Law and Jurisdiction.

	 	 	This Agreement shall be construed and the rights of the Parties determined in accordance
with the laws of Germany, regardless of the laws that might otherwise govern under
applicable principles of laws thereof.

	 	 	All disputes arising out of or in connection with the present agreement and any subsequent
agreement shall be finally settled under the Rules of Arbitration of the International
Chamber of Commerce by one or more arbitrators appointed in accordance with the said Rules.

	 	 	The Arbitration shall be held in Toronto, Canada or any other place that the parties may
agree upon. The arbitration shall be conducted in English. The award of arbitration shall be
final and binding upon both parties.

	14.08	 	No Jury Trial.

	 	 	In the event that any dispute or claim of any sort arising out of this Agreement or any
subsequent agreement concerning the subject matter and or any dispute or claim concerning
competent court and/or jurisdiction and/or execution of any award granted by

40

 

	 	 	a foreign court or arbitration panel should be filed, each of the Parties waives irrevocably
any right that such Party may have to demand or request a trial by jury.

	14.09	 	Notices.

	 	 	Any notice required or permitted to be given under this Agreement shall be in writing and
shall be deemed to have been sufficiently given for all purposes if mailed by first class
certified or registered mail, or commercial delivery service, postage prepaid. Unless
otherwise specified in writing, the mailing addresses of the Parties shall be as described
above.

	14.10	 	Official Language.

	 	 	This Agreement is written in the English language and English shall be the language employed
in all correspondence as well as in all communication and documentation by the Development
Committee.

	14.11	 	Severability.

	 	 	The provisions of this Agreement shall be deemed severable. Therefore, if any part of this
Agreement is rendered void, invalid or unenforceable, such rendering shall not affect the
validity or enforceability of the remainder of this Agreement and shall be replaced by
provisions that are economically similar; provided that if the part or parts which are void,
invalid or unenforceable as aforesaid shall substantially impair the value of the whole
Agreement to either Party, that Party may cancel and terminate this Agreement by giving
written notice to the other Party.

41

 

	14.12	 	Titles.

	 	 	The titles of the Articles and Sections of this Agreement are for general information and
reference only, and this Agreement shall not be construed by reference to the titles.

	14.13	 	Amendment.

	 	 	This Agreement may not be amended, supplemented or otherwise modified except by an
instrument in writing signed by both Parties.

	14.14	 	Entire Agreement.

	 	 	This Agreement, including the Appendices attached hereto, constitutes and contains the
complete, final and exclusive undertaking and agreement of LTS and NuPathe hereto, and
cancels and supersedes any and all prior negotiations, correspondence, understandings and
agreements whether oral or written, between the Parties respecting the subject matter
hereof.

     IN WITNESS WHEREOF, the Parties hereto have executed this Agreement by their respective
officers thereunto duly authorized.

	 	 	 	 	 
	 

	 	 	 	 
	LTS Lohmann Therapie-Systeme AG

	 	NuPathe Inc.	 	 
	 
	 	 	 	 
	/s/ Becher

	 	/s/ Jane H. Hollingsworth	 	 
	 

	 	 	 	 
	Name: Becher

	 	Name: Jane Hollingsworth	 	 
	Title: General Counsel

	 	Title: CEO	 	 
	Place, Date: Andernach, 12.09.2007

	 	Place, Date: Conshohocken, PA 14-09-2007	 	 
	 
	 	 	 	 
	/s/ ppa. Marc Denker

	 	/s/ Jane H. Hollingsworth	 	 
	 

	 	 	 	 
	Name: Marc Denker

	 	Name: Jane Hollingsworth	 	 
	Title: Head of Sales and Marketing

	 	Title: CEO	 	 
	Place, Date: Andernach, 12.09.2007

	 	Place, Date: Conshohocken, PA 14-09-2007	 	 

42

 

ANNEX A Active Principle Specifications

LTS LOHMANN Therapie-Systeme

	 	 	 	 	 	 	 	 	 	 	 
	SPEZIFIKATION	 	Nummer/number	 	Seite/page	 	von/of
	 	 	04-413-11-0-00083-01

	 	 	1	 	 	 	8	 

	 	 	 
	Titel/subject	 	ersetzt Nr./replaces no.
	 
	Sumatriptan Succinat

	 	04-413-11-0-00083-00
	Sumatriptan succinate

	 	gültig ab/valid from

	 	 	 	 	 

	Ersteilt am/issued on

	 	von/by
	 	Dtum nÜchste Überprüfung
	 

	 	 	 	date of next revision
	16.05.07

	 	Dr. Sameti PhE 2/1
	 	2 jährlich
	 
	Empfangs-Berechtigte(r)/authorized recipient(s)	 	Genehmigt/approved
	 
	Name,Datum,Unterschrift/name,date,signature	 	 
	 

	 	 	 	F + E
	Herr Dr. Sameti	 	PPK-RA
	Anlagen/enclosure(s)	 	B
	Monographien USP Sumatriptan and Ph. Eur.	 	QK 2
	Sumatriptan Succinate	 	QAO
	Monographs USP Sumatriptan and Ph. Eur.	 	 
	Sumatriptan Succinate	 	 

	 	 	 	 	 
	 	 	 	 	Datum, Unterschrift/
	Verteiler/distribution	 	Empfänger/recipient(s)	 	date, signature
	 
	 	 	 	 
	PhE 2/1

QAO

QK2

F

PPK/ RA

B

QK- WE 

QK- Archiv

SU

	 	Herr Dr. Sameti

Herr Dr. Meyer

Herr Kurka

Herr M. Hoffmann

Herr Dr. von Kleinsorgen

Herr Ch. Hoffmann

Herr E. Stein

Frau Fuchs

Herr Brathuhn	 	 

Querverweis/cross-reference

MFG 04-421-11-0-00083-...BA 04-440-00-0-00006-...

Schlüssel-Wörter/key-words

43

 

LTS LOHMANN Therapie-Systeme

	 	 	 	 	 	 	 	 	 	 	 
	SPEZIFIKATION	 	Nummer/number	 	Seite/page	 	von/of
	 	 	04-413-11-0-00083-01

	 	 	2	 	 	 	8	 

	 	 	 
	Titel/subject	 	ersetzt Nr./replaces no.
	 
	Sumatriptan Succinat

	 	04-413-11-0-00083-00
	Sumatriptan succinate

	 	gültig ab/valid from

	1.	 	Aligemeines / General

	 	1.1.	 	Bezeichnung / name
	 
	 	 	 	[**]
	 
	 	1.2.	 	Beschreibung / Description
	 
	 	 	 	[**]
	 
	 	1.3.	 	Verwendung / Application
	 	 	 	Pharmazeutischer Wirkstoff

Active ingredient for pharmaceuticals.

	2.	 	Qualität / Quality
	 
	 	 	[**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

44

 

LTS LOHMANN Therapie-Systeme

	 	 	 	 	 	 	 	 	 	 	 
	SPEZIFIKATION	 	Nummer/number	 	Seite/page	 	von/of
	 	 	04-413-11-0-00083-01

	 	 	3	 	 	 	8	 

	 	 	 
	Titel/subject	 	ersetzt Nr./replaces no.
	 
	Sumatriptan Succinat

	 	04-413-11-0-00083-00
	Sumatriptan succinate

	 	gültig ab/valid from

	 	 	 	 	 
	Prümerkmale/	 	Methode /	 	Spezifiziert /
	Parameters	 	Method	 	Specification
	2.1. Identit ät/ identity
	 	 	 	 
	 
	 	[**]	 	[**]
	[**]
	 	 	 	 
	 
	 	 	 	 
	2.2. Reinheit / Purity
	 	 	 	 
	[**]
	 	[**]	 	[**]
	[**]
	 	[**]	 	[**]
	[**]
	 	[**]	 	[**]
	[**]
	 	[**]	 	[**]
	[**]
	 	[**]	 	 
	[**]
	 	 	 	[**]
	[**]
	 	 	 	[**]
	[**]
	 	 	 	[**]
	[**]
	 	 	 	[**]
	[**]
	 	 	 	[**]
	[**]
	 	 	 	[**]
	[**]
	 	[**]	 	[**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

45

 

LTS LOHMANN Therapie-Systeme

	 	 	 	 	 	 	 	 	 	 	 
	SPEZIFIKATION	 	Nummer/number	 	Seite/page	 	von/of
	 	 	04-413-11-0-00083-01

	 	 	4	 	 	 	8	 

	 	 	 
	Titel/subject	 	ersetzt Nr./replaces no.
	 
	Sumatriptan Succinat

	 	04-413-11-0-00083-00
	Sumatriptan succinate

	 	gültig ab/valid from

	 	 	 	 	 
	Prümerkmale/	 	Methode /	 	Spezifiziert /
	Parameters	 	Method	 	Specification
	[**]
	 	[**]	 	[**]
	[**]
	 	[**]	 	 
	 
	 	 	 	 
	[**]
	 	 	 	[**]
	 
	 	 	 	 
	[**]
	 	 	 	[**]
	 
	 	 	 	 
	[**]
	 	 	 	[**]
	 
	 	 	 	 
	[**]
	 	 	 	[**]
	 
	 	 	 	 
	[**]
	 	 	 	[**]
	 
	 	 	 	 
	2.3. Gehalt/Assay
	 	 	 	 
	 
	 	[**]	 	[**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

46

 

LTS LOHMANN Therapie-Systeme

	 	 	 	 	 	 	 	 	 	 	 
	SPEZIFIKATION	 	Nummer/number	 	Seite/page	 	von/of
	 	 	04-413-11-0-00083-01

	 	 	5	 	 	 	8	 

	 	 	 
	Titel/subject	 	ersetzt Nr./replaces no.
	 
	Sumatriptan Succinat

	 	04-413-11-0-00083-00
	Sumatriptan succinate

	 	gültig ab/valid from

	3.	 	Lagerung / Haltbarkeit / Storage / Shelf life

	 	3.1.	 	Lagerungsbedingungen LTS / Storage conditions
	 
	 	 	 	[**]
	 
	 	3.2.	 	Verarbeitungsfrist / Nachprüfdatum / Shelf life / Retest date
	 
	 	 	 	[**]
	 
	 	3.3.	 	Parameter zur Nachprüfung / Retest parameters
	 
	 	 	 	[**]

	4.	 	Probenahmeplan LTS/ Sampling

	 	 	 	[**]

	5.	 	Referenzcharge/Referenzmuster/ Reference batch/ Reference sample

	 	 	 	[**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

47

 

LTS LOHMANN Therapie-Systeme

	 	 	 	 	 	 	 	 	 	 	 
	SPEZIFIKATION	 	Nummer/number	 	Seite/page	 	von/of
	 	 	04-413-11-0-00083-01

	 	 	6	 	 	 	8	 

	 	 	 
	Titel/subject	 	ersetzt Nr./replaces no.
	 
	Sumatriptan Succinat

	 	04-413-11-0-00083-00
	Sumatriptan succinate

	 	gültig ab/valid from

	6.	 	Angaben zur Lieferform/ Delivery form
	 
	 	 	[**]
	 
	7.	 	Sicherheitshinweise/ Safty requirements
	 
	 	 	[**]
	 
	8.	 	Sonstiges / miscellaneous
	 
	 	 	[**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

48

 

LTS LOHMANN Therapie-Systeme

	 	 	 	 	 	 	 	 	 	 	 
	SPEZIFIKATION	 	Nummer/number	 	Seite/page	 	von/of
	 	 	04-413-11-0-00083-01

	 	 	7	 	 	 	8	 

	 	 	 
	Titel/subject	 	ersetzt Nr./replaces no.
	 
	Sumatriptan Succinat

	 	04-413-11-0-00083-00
	Sumatriptan succinate

	 	gültig ab/valid from

	9.	 	BSE / TSE Bescheinigung / BSE / TSE declaration

[**]

	10.	 	Restlõsemittel / OVI Declaration / Residual solvents / OVl declaration

[**]

	11.	 	Änderungsindex / Alterations

[**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

49

 

LTS LOHMANN Therapie-Systeme

	 	 	 	 	 	 	 	 	 	 	 
	SPEZIFIKATION	 	Nummer/number	 	Seite/page	 	von/of
	 	 	04-413-11-0-00083-01

	 	 	8	 	 	 	8	 

	 	 	 
	Titel/subject	 	ersetzt Nr./replaces no.
	 
	Sumatriptan Succinat

	 	04-413-11-0-00083-00
	Sumatriptan succinate

	 	gültig ab/valid from

[**]

Ende der Spezifikation \ End of specification

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

50

 

ANNEX B Development Plan

     [**]
[A
total of two pages, including the remainder of this page, have been
redacted and filed separately with the Securities and Exchange
Commission.]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

51

 

ANNEX C LTS Outlines of Principles for Manufacturing Agreements

	1.	 	Manufacturing. LTS shall manufacture the Product in compliance with the agreed upon
Specifications and applicable current GMP. LTS shall be deemed to have fulfilled any of its
obligations arising out of this Agreement and any subsequent agreement by employing
commercially reasonable efforts.

	2.	 	Minimum Quantities. To be negotiated.

	3.	 	Forecast. NuPathe shall supply a forecast of orders for a [**] period which shall be
updated at the beginning of [**] (Rolling Forecast).

	4.	 	Firm orders. Firm orders will be made at the latest [**] in advance of the required
delivery date, during the first year of the agreement [**] in advance.

	5.	 	Delivery Terms and Conditions. To be negotiated.

	6.	 	Exclusivity. LTS shall be the exclusive manufacturer of the Product, subject to
certain exemptions, to be determined later on.

	7.	 	Second Source.

	 	 	Upon NuPathe’s request LTS shall qualify, as far as technical possible, the manufacturing
site at LTS Lohmann Therapy Systems Corp. in West Caldwell, New Jersey, USA as a second
source of supply, provided, however, that NuPathe shall bear all costs related thereto. In
addition NuPathe shall have the right, in case LTS Corp. and LTS is not able to supply
Product to NuPathe from the Andernach Facility and the West Caldwell Facility, to have the
Product manufactured by a third party. In this event LTS shall

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

53

 

	 	 	provide such know-how and assistance, a state of the art manufacturer of transdermal
therapeutic systems would reasonably require to manufacture Product.

	8.	 	Price and Payment Terms and Conditions. To be negotiated.

	9.	 	Specific Expenses. NuPathe shall

	 	a)	 	refund LTS for specific investment costs and expenses for establishing
manufacturing related to specific equipment necessary for manufacturing the Product,
and
	 
	 	b)	 	remunerate LTS for establishing manufacturing (scaling up, validation, waste,
etc.), based on a man hour rate of € [**].

	10.	 	Replacement. LTS will replace [**].

	

	11.	 	LTS Liability. LTS shall assume limited liability for any defective Product or sample
manufactured by LTS. Defective in this respect means any Product or sample that does not meet the
Specifications, the Quality Agreement or is not manufactured according to GMP, subject to NuPathe
providing sufficient evidence of appropriate and correct storage at all times according to the
storage specifications, after Product being delivered by LTS. Such liability by LTS shall be
subject to the extent covered by the product liability insurance of LTS.
	 
	 	 	LTS shall maintain product liability insurance and use its Commercially Reasonable Efforts to
maintain substantially similar coverage as the insurance coverage set forth in the certificate of
insurance provided to NuPathe.

	 
	 	 	The parties acknowledge that currently some re-insurance companies do not provide insurance
coverage for the Active Principle and thus LTS might not — despite its Commercially Reasonable
Efforts — be able to maintain product liability insurance covering the Product or such coverage
would only be available for a substantially higher premium. In the latter case the parties agree to
discuss in good faith the bearing of such additional premium.

	 
	 	 	The restrictions on liability and NuPathe’s obligation to indemnify LTS shall not apply in the
event of LTS’ wilful misconduct.
	

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

54

 

	

	12.	 	NuPathe Responsibility. NuPathe shall be fully responsible for the Specifications, the
availability of components and, (after consultation with LTS) the registration. NuPathe shall bear
all risks mentioned in this section.
	

	

	13.	 	Use of Product and Samples. NuPathe shall bear all responsibility and liability for damage
or injury to itself, its employees or any third party arising from the use of Product or samples
thereof. NuPathe shall indemnify and hold LTS harmless from any claim, expense or damage arising
out of or related to NuPathe’s receiving, holding or marketing samples or Product, including but
not limited to product liability claims such as risks connected to the safety of the Product, the
agent, the pharmaceutical preparation, information for users and physicians and after sales
surveillance and recall, as far as not covered by an LTS insurance.
	

	14.	 	Patents.

	 	a)	 	LTS shall have [**].
	 
	 	b)	 	In the event of a suit against one or more Parties for patent infringement
relating to [**], the Parties shall share the out-of-pocket expenses resulting from
such situation [**] (such out-of-pocket expenses shall be considered to include
royalties and damages, as well as legal expenses and settlement payments) in the ratio
of [**]% for NuPathe and [**]% for LTS, except that LTS share of such costs shall not
exceed [**] % of the payments made by NuPathe to LTS during the preceding 12 months and
that [**]. NuPathe shall [**].

	15.	 	No warranty. LTS does not make and shall not be deemed to make any representation or
warranty, express or implied, as to the infringement of any third party’s rights to such
intellectual property, including but not limited to, patents relating to the system,
patentability, quality, merchantability, fitness for a particular use or performance of any
licensed Product or that a party will successfully design (and develop a commercially
marketable licensed Product).

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

55

 

	16.	 	Sublicenses. NuPathe shall grant LTS and sublicensees a non-exclusive royalty-free
license with regard to any relevant own patent for the sole purpose of manufacturing. NuPathe
and LTS shall have the right to sublicense or delegate its obligations and rights to an
affiliate.

	

	17.	 	Term. The duration of the agreement shall be for a
period of 10 (ten) years from the first
launch of Product.
	

	 
	18.	 	Jurisdiction. Choice of law, place of venue and of
jurisdiction shall be at the place of business of LTS.

56

 

ANNEX D     Specifications

0700504

LTS LOHMANN Therapie-Systeme

	 	 	 	 	 	 	 

	ENPRODUKTSPEZIFIKATION

	 	Nummer/number
	 	Seite/page
	 	von/of
	 

	 	04-413-03-0-00093-01
	 	1 
	 	3 

	 	 	 

	Titel/subject

	 	ersetzt Nr./replaces no
	 
	 	 
	Final product specification

	 	04-413-03-0-00093-00 
	

	[**]

	 	gültig ab/valid from
	

	 

	 	13.NOV.2008

	 	 	 	 	 

	Erstellt am/issued on

	 	Von/by
	 	Datum nächste Überprüfung
	 

	 	[ILLEGIBLE]
	 	date of next revision
	24.10.2008

	 	PhE 2/1 Dr. Sameti
	 	jährlich

	 	 	 

	Empfangs-Berechtigte(r)/authorized recipients(s)

	 	Genehmigt/approved
	Name,Datum,Unterschrift/name,date,signature
	 	 
	 

	 	QAO       [ILLEGIBLE]
	PhE 2/1 H. Sameti
	 	 
	Analagen/enclosure(s)

	 	F + E       [ILLEGIBLE]
	 
	 	 
	 

	 	QK-Leitung       [ILLEGIBLE]
	 
	 	 
	 

	 	RA       [ILLEGIBLE]

	 	 	 	 	 

	Verteiler/distribution

	 	Empfänger/recipient(s)
	 	Datum, Unterschrift/
	 

	 	 	 	date, signature
	PhE 2/1	 	Herr Dr. Sameti
	QAO	 	Herr Dr. Holley
	RA	 	Hr. Dr. Strake
	B	 	Herr C. Hoffmann
	QK-Archiv	 	Frau Fuchs
	LL	 	Herr Lange
	 	 	[ILLEGIBLE]
	QK II	 	Herr Kurka
	PhA4	 	Frau Dr. Deubel
	PhA2	 	Herr Dr. Schnabel
	QK I	 	Herr Dr. Illich
	QS-SDK	 	Herr Grzembke

Querverweis/cross-reference

	 	 	 	 	 

	Schlüssel-Wörter/key-words
	 	 	 	 
	 
	 	 	 	 
	

	[**]	 	
	

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

57

 

			
	 	 	 
	LTS LOHMANN Therapie-Systeme	 	0700504

	 	 	 	 	 	 	 	 	 

	ENDPRODUKTSPEZIFIKATION

	 	Nummer/number
	 	Seite/page
	 	von/of
	 

	 	04-413-03-0-00093-01
	 	 	2	 	 	3 

	 	 	 

	Titel/subject

	 	ersetzt Nr./replaces no.
	Final product specification
[**]

	 	04-413-03-0-00093-00
	 	gültig ab/valid from
	 	13. NOV. 2008

1. Parameters:

	 	 	 	 	 	 	 
	 	 	LIMITS	 	ANALYTICAL
	TESTS	 	RELEASE	 	SHELF LIFE	 	PROCEDURE
	Appearance

	 	[**]	 	[**]	 	[**]
	Identification

	 	[**]	 	[**]	 	[**]
	Assay

	 	[**]	 	[**]	 	[**]
	Uniformity of dosage units
	 	[**]	 	[**]	 	[**]

 

			
	

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
	

58

 

			
	 	 	 
	LTS LOHMANN Therapie-Systeme	 	0700504

	 	 	 	 	 	 	 	 	 

	ENDPRODUKTSPEZIFIKATION
	 	Nummer/number	 	Seite/page	 	von/of
	 
	 	04-413-03-0-00093-01	 	 	3	 	 	3 

	 	 	 

	Titel/subject
	 	ersetzt Nr./replaces no.
	Final product specification
[**]
	 	04-413-03-0-00093-00
	 	gültig ab/valid from
	 	13. NOV. 2008

	 	 	 	 	 	 	 
	 	 	LIMITS	 	ANALYTICAL
	TESTS	 	RELEASE	 	SHELF LIFE	 	PROCEDURE
	[**]	 	Limits of mean values
[**]	 	Limit of mean value
[**]	 	[**]
	[**]	 	[**]	 	[**]	 	 
	[**]	 	[**]	 	[**]	 	 
	[**]	 	[**]	 	[**]	 	 
	[**]	 	[**]	 	[**]	 	 
	[**]	 	[**]	 	[**]	 	 
	[**]	 	[**]	 	[**]	 	 
	[**]	 	[**]	 	[**]	 	[**]
	[**]	 	[**]	 	[**]	 	[**]

 

			
	

	[**]	 	 
	

Abbreviations:

cv = current version

n.a. = not applicable

2. Change Index

[**]

-Update of distribution list and approval list

End of Specification

 

			
	

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
	

59

 

0700505

LTS LOHMANN Therapie-Systeme

	 	 	 	 	 	 	 

	ENPRODUKTSPEZIFIKATION

	 	Nummer/number
	 	Seite/page
	 	von/of
	 

	 	04-413-03-0-00092-01
	 	1 
	 	3 

	 	 	 

	Titel/subject

	 	ersetzt Nr./replaces no
	 
	 	 
	Final product specification

	 	04-413-02-0-00092-01 
	[**]

	 	gültig ab/valid from
	 

	 	13.NOV.2008

	 	 	 	 	 

	Erstellt am/issued on

	 	Von/by
	 	Datum nächste Überprüfung
	 

	 	[ILLEGIBLE]
	 	date of next revision
	24.10.2008

	 	PhE 2/1 Dr. Sameti
	 	jährlich

	 	 	 

	Empfangs-Berechtigte(r)/authorized recipients(s)

	 	Genehmigt/approved
	Name,Datum,Unterschrift/name,date,signature
	 	 
	 

	 	QAO       [ILLEGIBLE]
	PhE 2/1 H. Sameti
	 	 
	Analagen/enclosure(s)

	 	F + E       [ILLEGIBLE]
	 
	 	 
	 

	 	QK-Leitung       [ILLEGIBLE]
	 
	 	 
	 

	 	RA       [ILLEGIBLE]

	 	 	 	 	 

	Verteiler/distribution

	 	Empfänger/recipient(s)
	 	Datum, Unterschrift/
	 

	 	 	 	date, signature
	PhE 2/1	 	Herr Dr. Sameti
	QAO	 	Herr Dr. Holley
	RA	 	Hr. Dr. Strake
	B	 	Herr C. Hoffmann
	QK-Archiv	 	Frau Fuchs
	LL	 	Herr Lange
	 	 	[ILLEGIBLE]
	QK II	 	Herr Kurka
	PhA4	 	Frau Dr. Deubel
	PhA2	 	Herr Dr. Schnabel
	QK I	 	Herr Dr. Illich
	QS-SDK	 	Herr Grzembke

Querverweis/cross-reference

	 	 	 	 	 

	Schlüssel-Wörter/key-words	 	

 

			
	

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
	

60

 

			
	 	 	 
	LTS LOHMANN Therapie-Systeme
	 	0700505

	 	 	 	 	 	 	 	 	 

	ENDPRODUKTSPEZIFIKATION
	 	Nummer/number	 	Seite/page	 	von/of
	 
	 	04-413-03-0-00092-01	 	 	2	 	 	3 

	 	 	 

	Titel/subject
	 	ersetzt Nr./replaces no.
	Final product specification
[**]
	 	04-413-03-0-00092-00
	 	gültig ab/valid from
	 	13. NOV. 2008

1. Parameters:

	 	 	 	 	 	 	 
	 	 	LIMITS	 	ANALYTICAL
	TESTS	 	RELEASE	 	SHELF LIFE	 	PROCEDURE
	Appearance

	 	[**]	 	[**]	 	[**]
	Identification
	 	[**]	 	[**]	 	[**]
	Pouch Tightness
	 	[**]	 	[**]	 	[**]
	Microbial quality 1
	 	[**]	 	[**]	 	[**]

 

			
	

	1	 	[**]
	

		 	
	

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
	

61

 

			
	 	 	 
	LTS LOHMANN Therapie-Systeme
	 	0700505

	 	 	 	 	 	 	 	 	 

	ENDPRODUKTSPEZIFIKATION
	 	Nummer/number	 	Seite/page	 	von/of
	 
	 	04-413-03-0-00092-01	 	 	3	 	 	3 

	 	 	 

	Titel/subject
	 	ersetzt Nr./replaces no.
	Final product specification
[**]
	 	04-413-03-0-00092-00
	 	gültig ab/valid from
	 	13. NOV. 2008

Abbreviations:

cv = current version

n.a. = not applicable

2. Change Index

[**]

-Update of distribution list and approval list

End of Specification

 

			
	

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
	

62

 

ANNEX E Active Principle Data

	 	 	 	 	 

	 
	 	 	Material Safety Data Sheet
	

	 	12601 Twinbrook Parkway

Rockville, MD 20852 USA
	 	Telephone calls: (301) 881-0666

8:00am — 5:00pm EST Mon. — Fri.
	 	 	Responsible Party: Reference Standards Technical Services
	 

ATTENTION!

USP Reference Standards are sold for chemical test and assay purposes only, and NOT for human
consumption. The information contained herein is applicable solely to the chemical substance when
used as a USP Reference Standard and does not necessarily relate to any other use of the substance
described, (i.e. at different concentrations, in drug dosage forms, or in bulk quantities). USP
Reference Standards are intended for use by persons having technical skill and at their own
discretion and risk. This information has been developed by USP staff from sources considered
reliable but has not been independently verified by the USP. Therefore, the USP Convention cannot
guarantee the accuracy of the information in these sources nor should the statements contained
herein be considered an official expression. NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED,
INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE is made with
respect to the information contained herein.

	 	 	 	 	 	 	 

	 
	SUMATRIPTAN SUCCINATE	 	 
	Catalog Number: 1642201

	 	Package Size: 1642201
	 	Revision Date:
	 	August 14, 2002
	 

SECTION 1 — IDENTIFICATION

	 	 	 	 	 	 	 

	Common Name:

	 	Sumatriptan Succinate
	 	Formula:
	 	C14H21N3O2S . C4H604
	Synonym:

	 	n/f	 	 	 	 
	Chemical Name:	 	1H-Indole-5-methanesulfonamide, 3-[2-(dimethylamino)ethyl]-N-methyl-, butanedioate (1:1)
	CAS Number:

	 	103628-48-4
	 	RTECS
	 	EJ9940000
	 

	 	 	 	Number:	 	 
	Chemical Family:

	 	n/f	 	 	 	 
	Therapeutic

	 	Antimigraine	 	 	 	 
	Category:
	 	 	 	 	 	 

SECTION 2 — INGREDIENT INFORMATION

	 	 	 	 	 

	Principle Components
	 	Percent
	 	Exposure Limits
	 
	 	 
	 	 
	Sumatriptan Succinate
	 	Pure Material
	 	n/f

SECTION 3 — HEALTH HAZARD INFORMATION

	 	 	 

	Usual Adult Dose:

	 	The usual oral adult dose of sumatriptan succinate is 25 to 100 mg (base)
as a single dose.

63

 

	 	 	 

	Adverse Effects:

	 	Adverse effects may include severe chest pain; difficulty swallowing;
heaviness, tightness, or pressure in chest or neck; nausea or vomiting;
atypical sensations; discomfort in jaw, mouth, throat, tongue. Nasal
cavity, or sinuses; dizziness; drowsiness; flushing; lightheadedness;
muscle aches, cramps, or stiffness; weakness; anxiety; general feeling of
illness or tiredness; and vision changes. Possible allergic reaction to
material if inhaled, ingested or in contact with skin.
	Overdose Effects:

	 	n/f
	Acute:

	 	Possible eye, skin, gastrointestinal and/or respiratory tract irritation.
	Chronic:

	 	Possible hypersensitization.
	Inhalation:

	 	May cause irritation. Remove to fresh air.
	Eye:

	 	May cause irritation. Flush with copious quantities of water.

	 	 	 	 	 	 	 

	 
	SUMATRIPTAN SUCCINATE	 	 
	Catalog Number: 1642201

	 	 Package Size: 1642201
	 	Revision Date:
	 	August 14, 2002
	 

	 	 	 

	Skin:

	 	May cause irritation. Flush with copious quantities of water.
	Ingestion:

	 	May cause irritation. Flush out mouth with water.
	 
	Medical Conditions 

Aggravated by 

Exposure:

	 	Hypersensitivity to material, coronary artery disease (or predisposition to),
uncontrolled hypertension, tachycardia, history of cerebrovascular accident, or
impaired liver function.
	Cross Sensivity:

	 	n/f
	Pregnancy Comments:

	 	Some studies in rats and rabbits have shown toxic effects and
abnormalities in fetuses of animals given high doses of
sumatriptan.
	Pregnancy Category:

	 	C

SECTION 4 — FIRST AID MEASURES

	 	 	 

	General:

	 	Remove from exposure. Remove contaminated clothing. Persons
developing serious hypersensitivity (anaphylactic) reactions must
receive immediate medical attention. If person is not breathing
give artificial respiration. If breathing is difficult give
oxygen. Obtain medical attention.
	Overdose Treatment:

	 	Overdose treatment should be symptomatic and supportive and may
include the following:
	 

	 	1. To decrease absorption if material was ingested, empty the
stomach by inducing vomiting or performing gastric lavage.

2. Monitor patient for at least 10 hours or while symptoms persist.

3. For patients with chest pain or other symptoms consistent with
angina pectoris, monitor electrocardiogram for evidence of
ischemia and administer appropriate treatment. [USP DI 2002]

SECTION 5 — TOXICOLOGICAL INFORMATION

	 	 	 

	Oral Rat:

	 	LD50: >2939 mg/kg
	Oral Mouse:

	 	LD50: n/f
	Irritancy Data:

	 	n/f

64

 

	 	 	 	 	 	 	 

	Target Organ(s):

	 	n/f	 	 	 	 
	Listed as a Carcinogen?

	 	NTP: No

Other: No
	 	IARC: No
	 	OSHA: No

SECTION 6 — FIREFIGHTING MEASURES

	 	 	 	 	 

	Flash Point:

	 	n/f
	 	Upper Flammable Limit: r
	Auto-Ignition Temperature:

	 	n/f
	 	Lower Flammable Limit: r

			
	Extinguisher Media:

	 	Water spray, dry chemical, carbon
dioxide or foam as appropriate for
surrounding fire and materials.
	Fire and Explosion Hazards:

	 	This material is assumed to be
combustible. As with all dry powders
it is advisable to ground mechanical
equipment in contact with dry
material to dissipate the potential
buildup of static electricity.
	Firefighting Procedures:

	 	As with all fires, evacuate
personnel to a safe area.
Firefighters should use
self-contained breathing equipment
and protective clothing.

	 	 	 	 	 	 	 

	 
	SUMATRIPTAN SUCCINATE	 	 
	Catalog Number: 1642201

	 	 Package Size: 1642201
	 	Revision Date:
	 	August 14, 2002
	 

SECTION 7 — PHYSICAL HAZARDS

	 	 	 

	Conditions to Avoid:

	 	Avoid exposure to light and heat.
	Incompatibilities:

	 	n/f
	Decomposition Products:

	 	When heated to decomposition material emits
toxic fumes of NOx and SOx. Emits toxic fumes
under fire conditions.
	Stable?

	 	Yes   Hazardous Polymerization? No

SECTION 8 — HANDLING / SPILL / DISPOSAL MEASURES

	 	 	 

	Handling:

	 	As a general rule, when handling USP Reference Standards avoid all contact and
inhalation of dust, mists, and/or vapors associated with the material. Wash
thoroughly after handling.
	 
	Storage:

	 	Store in tight, light-resistant container as defined in the USP-NF. This
material should be handled and stored per label instructions to ensure product
integrity. Store in a refrigerator.
	 
	Spill Response:

	 	Wear approved respiratory protection, chemically compatible gloves and
protective clothing. Wipe up spillage or collect spillage using a high
efficiency vacuum cleaner. Avoid breathing dust. Place spillage in appropriately
labelled container for disposal. Wash spill site.
	 
	Disposal:

	 	Dispose of waste in accordance with all applicable Federal, State and local laws.

SECTION 9 — EXPOSURE CONTROLS / PERSONAL PROTECTION

	 	 	 

	Respiratory Protection:

	 	When working with small quantities in a well-ventilated area, respiratory

65

 

	 	 	 

	 

	 	protection may not be required. The use of an approved dust mask is recommended.
	Ventilation:

	 	No special ventilation requirements.
	Gloves:

	 	Rubber
	Eye Protection:

	 	Safety Glasses
	Protective Clothing:

	 	Protect exposed skin.

SECTION 10 — PHYSICAL AND CHEMICAL PROPERTIES

NOTE: The data reported below is general information, and is not specific to the USP
Reference Standard Lot provided!

	 	 	 	 	 

	Appearance and Odor:

	 	White to off-white powder.	 	 
	Melting Point:

	 	165 — 166° C	 	 
	Solubility in Water:

	 	Soluble
	 	Vapor Density: n/f
	Boiling Point:

	 	n/f
	 	Evaporation Rate: n/f
	Specific Gravity:

	 	n/f
	 	Reactivity in Water: n/f
	Vapor Pressure:

	 	n/f
	 	%Volatile by Volume: n/f

66

 

ANNEX F Investment Costs for manufacture of clinical samples

	 	 	 	 	 	 	 
	Position	 	Work/Step	 	Amount, ca	 
	1.
	 	Tooling for [**]	 	 	[**] €	 
	2.
	 	Tooling for [**]	 	 	[**] €	 
	3.
	 	Assembling of final product	 	 	[**] €	 
	4.
	 	[**]	 	 	[**] €	 
	 
	 	   Sum	 	 	[**] €	 

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

67

 

ANNEX G LTS Product Liability Insurance

Aon Jauch & Hiibener

	 	 	 
	Versicherungsbestätigung	 	Confirmation of Insurance
	Art der Versicherung

	 	Type of Cover
	 
	 	 
	Betriebs-Haftpflichtversicherung inkl.

	 	General Liability, including products liability
	Produkthaftpflicht (Grundvertrag)

	 	(Primary)
	 
	Summen-Anschlußversicherungen

	 	Excess-Layers
	 
	 	 
	Versicherungsschein Nr.

	 	Policy No.

70-5385726, 70-5563377, 70-5563378, 70-5883228

	 	 	 

	Versicherungsnehmer

	 	Named Insured

LTS Lohmann Therapie-Systeme AG

Lohmannstr. 2

56623 Andernach

	 	 	 

	Versicherungsbeginn

	 	Inception
	 
	 	 
	01.01.2007, mittags 12.00 UHR MEZ

	 	01.01.2007, at noon CET
	 
	 	 
	Versicherungsablauf

	 	Expiry
	 
	 	 
	01.01.2008, mittags 12.00 Uhr MEZ

	 	01.01.2008, at noon CET
	Der Verträge verlängern sich still-
schweigend um ein Jahr, sofern diese nicht
unter Einhaltung einer drei-
monatigen Kündigungsfrist vor dem Ab-
lauf von einem der Vertragsparteien
schriftlich gekündigt werden.

	 	The policies will be
automatically renewed for a
further year, unless one of
the contracting parties gives
written notice three months
before the date of
expiration.
	 
	 	 
	Örtlicher Geltungsbereich

	 	Policy Territory
	 
	 	 
	Weltweit

	 	Worldwide

68

 

Aon Jauch & Hiibener

	 	 	 
	Versicherungsbestätigung	 	Confirmation of Insurance
	Deckungssummen

	 	Limits of Indemnity
	 
	Personen, Sach-und mitversichte Ver-mögensschäden (pauschal) 

Je Versicherungsfall und je Versiche-rungsjahr

	 	Bodily injury, property damage and insured pure
financial loss (combined single limit) 

Any one insured event and in the annual
Aggregate

	 	 	 	 	 

	Betriebshaftpflicht

	 	EUR 10.000.000,00
	 	General Liability
	1. Anschluss

	 	EUR 40.000.000,00
	 	1. Layer
	2. Anschluss

	 	EUR 50.000.000,00
	 	2. Layer
	3. Anschluss

	 	EUR 50.000.000,00
	 	3. Layer

	 	 	 

	Es bestehen Deckungssummenbegrenz-
ungen für besondere Deckungstat-
bestände 

Bei den in den USA-Territorien und Kana-da eintretenden Versicherungsfällen oder
geltend gemachten Ansprüchen werden
die Aufwendungen des Versicherers für Kosten als
Leistungen auf die Deckungssumme angerechnet.

	 	The limits of indemnity are limited in respect
of particular types of coverage. 

In respect of insured events in or claims made
in the United States of America, its
territories and possessions and Canada costs
are within the limits.
	 
	 	 
	Rechts- und Gerichtsstand

	 	Governing Law and Jurisdiction
	 
	 	 
	Hinsichtlich der Auslegung dieser Ver-sicherungsbestätigung und des betreffen-
den Versicherungsvertrages findet aus-schließlich deutsches Recht Anwendung.
Für die aus diesem Versicherungsver hältnis
entstehenden Rechtsstreitigkeiten ist
Gerichtsstand ausschließlich der Sitz des in der
Bundesrepublik Deutschland ansässigen
Versicherungsnehmers.

	 	German law shall apply exclusively to the
interpretation of this confirmation and the
policy to which it attaches. German courts
shall have both jurisdiction and venue of any
disputes arising out of this confirmation and
the policy to which it attaches.
	 
	 	 
	Hinweis

	 	Annotation
	 
	 	 
	Ausschließlich der deutsche Versicherungsvertrag
ist rechtsverbindlich.

	 	 Only the Germany policy is legally binding.

69

 

Aon Jauch & Hiibener

	 	 	 
	Versicherungsbestätigung	 	Confirmation of Insurance
	Unabhängig von jeglicher
Voraussetzung, Bedingung oder
anderen vertraglichen
Vereinbarungen, wegen derer diese
Versicherungsbestätigung
ausgestellt wurde oder auf die sie
sich bezieht, besteht
Versicherungsschutz nur im Rahmen
und Umfang des beschriebenen
Versicherungsvertrages. Die
aufgeführten Deckungssummen können
durch Schadenzahlungen reduziert
sein.

Die Versicherungsbestätigung wird
zu Informationszwecken ausgestellt
und überträgt keinerlei Rechte auf
den Empfänger. Die
Versicherungsbestätigung ändert
oder erweitert den Deckungsumfang
des beschriebenen
Versicherungsvertrages nicht.

	 	Notwithstanding any requirement,
term or condition of any contract or
other document with respect to which
this certificate may be issued or
may pertain, the insurance afforded
by the policy described herein is
subject to all terms, exclusions and
conditions of such policy. Limits
shown may have been reduced by paid
claims.

The certificate is issued as a
matter of information only and
confers no rights upon the
certificate holder. This
certificates does not amend, extend
or alter the coverage afforded by
policy described herein.
	 
	 	 
	Bestätigung der Versicherer:

	 	Confirmation of Insurer
	 
	 	 
	Siehe Anlagen

	 	Please compare the enclosure.

70

 

Aon Jauch & Hiibener

	 	 	 	 	 	 	 

	Bestätigung der Versicherer:	 	Confirmation of Insurer
	 
	 	 	 	 	 	 
	Versicherungsschein Nr.	 	Policy No.	 	 
	Betriebshaftpflicht

	 	70-5385726,
	 	General Liability
	 	70-5385726,
	1. Anschluss

	 	70-5563377
	 	1. Excess
	 	70-5563377
	2. Anschluss

	 	70-5563378
	 	2. Excess
	 	70-5563378
	3. Anschluss

	 	70-5883228
	 	3. Excess
	 	70-5883228
	 
	 	 	 	 	 	 
	Wir bestätigen für unseren 67% igen Anteil	 	We confirm for our share of 67%.

Gerling Allgemeine Versicherungs AG

Düsseldorf

GERLING-KONZERN

Allgemeine Versicherungs-Akiengesellschaft

Bevollmächtigte:

GERLING Vertrieb Deutschland GmbH

Regionalzentrum West

71

 

Aon Jauch & Hiibener

	 	 	 	 	 	 	 

	Versicherungsschein Nr.	 	Policy No.	 	 
	 
	 	 	 	 	 	 
	Betriebshaftpflicht

	 	70-5385726,
	 	General Liability
	 	70-5385726,
	1. Anschluss

	 	70-5563377
	 	1. Excess
	 	70-5563377
	2. Anschluss

	 	70-5563378,
	 	2. Excess
	 	70-5563378
	3. Anschluss

	 	70-5883228
	 	3. Excess
	 	70-5883228
	 
	 	 	 	 	 	 
	Wir bestätigen für unseren 33% igen Anteil	 	We confirm for our share of 33%.

XL Insurance Company Ltd.

Direction of Germany

München

72

 

ANNEX H QUALITY AGREEMENT

(to be attached after execution of the quality agreement)

73

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

	 	 	 

	Between:

	 	NuPathe Inc
	 

	 	375 E. Elm Street, Suite 110
	 

	 	Conshohocken, PA 19428, USA
	 
	 	 
	 

	 	- Receiving Party -
	 
	 	 
	 

	 	- hereinafter referred to as NuPathe-
	 
	 	 
	 

	 	and
	 
	 	 
	 

	 	LTS Lohmann Therapie-Systeme AG
	 

	 	Lohmannstr. 2
	 

	 	56626 Andernach, Germany
	 
	 	 
	 

	 	- Manufacturer -
	 
	 	 
	 

	 	- hereinafter referred to as LTS -
	 
	 	 
	- an agreement is made as follows:

 

 

	 	 	 	 	 
	CONTENT	 	 	 	 
	 
	PREAMBLE 3
	 	 	 	 
	§ 1  DEFINITIONS
	 	 	3	 
	§ 2  BASIS OF AGREEMENT
	 	 	4	 
	§ 3  SUBJECT MATTER OF AGREEMENT
	 	 	5	 
	§ 4  AUTHORIZATION DOCUMENTS
	 	 	5	 
	§ 5  STARTING MATERIALS
	 	 	5	 
	§ 6  ORDERING
	 	 	6	 
	§ 7  PRODUCTION
	 	 	7	 
	§ 8  QUALITY CONTROL
	 	 	7	 
	§ 9  BATCH PRODUCTION AND CONTROL RECORDS
	 	 	7	 
	§ 10  BATCH ACCOMPANYING DOCUMENTS
	 	 	8	 
	§ 11  REFERENCE AND RETENTION SAMPLES OF THE PRODUCTS
	 	 	8	 
	§ 12  RELEASE
	 	 	8	 
	§ 13  QUALIFICATIONS/TRAINING
	 	 	9	 
	§ 14  THIRD PARTIES
	 	 	9	 
	§ 15  INSPECTIONS
	 	 	9	 
	§ 16  QUALITY DEFECTS — PRODUCT COMPLAINTS
	 	 	10	 
	§ 17  DEVIATIONS — INVESTIGATIONS
	 	 	10	 
	§ 18  PERSONS TO CONTACT
	 	 	10	 
	§ 19  CONFIDENTIALITY
	 	 	10	 
	§ 20  FINAL PROVISIONS
	 	 	10	 
	LIST OF APPENDICES
	 	 	12	 

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

PREAMBLE

The purpose of this Agreement is to make sure that Manufacturer and Receiving Party are in
compliance with the applicable legal provisions relating to the manufacture of pharmaceutical
products, such as 2003/94/EC, Article 12 and related national laws, in particular AMWHV § 9, as
well as applicable U.S. federal regulations, including those promulgated by the FDA.

This Agreement shall make sure that quality functions as required by law are taken care in an
appropriate manner. It is not the intention of this Agreement to alter and/or amend any agreement,
included but not limited to the Legal Contract (as defined below) which is directly or indirectly
the basis for the supply of product to Receiving Party.

This Agreement shall be used only in order to comply with regulations applicable to the
responsibilities of pharmaceutical manufacturers and suppliers. Except to the extent set forth in
the Legal contract, nothing in this Agreement shall be construed to establish any financial or
other direct or indirect liability with regard to the other party or regarding the liability for
any third party claims related to the Product. The commercial basis of the relationship between
the parties as set forth in the Development Agreement shall continue to apply.

§ 1 DEFINITIONS

	 	(1)	 	Capitalized terms used herein and not otherwise defined herein, shall have
the meanings set forth in the Legal Contract.
	 
	 	(2)	 	“Authorities” shall mean the governmental authorities, which are responsible
for the approval of the Product in a certain jurisdiction and/or the surveillance of
the Product in such a jurisdiction.
	 
	 	(3)	 	“Legal Contract” shall mean the letter agreement concluded between NuPathe
and LTS as of October 26th, 2006.
	 
	 	(4)	 	“Master Manufacturing Instructions” shall mean the manufacturing instructions
for a Product, as set forth in the IMPD.
	 
	 	(5)	 	IMPD shall mean Investigational Medicinal Product Dossier
	 
	 	(6)	 	“Product” shall mean each of the products listed in Appendix I.
	 
	 	(7)	 	“Responsible” and/or “Responsibility” shall mean assignment of tasks and
shall not have any effect on the liability of the parties.

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

	 	(8)	 	“Specifications” shall mean the specifications of the Product mutually agreed
upon, as set forth in the Master Manufacturing Instructions.
	 
	 	(9)	 	“Starting Materials” shall mean:

	 	•	 	raw materials: active and inactive ingredients necessary for the production
of the Products;
	 
	 	•	 	materials that, although no longer contained in the Product, were used for
the manufacture of the Product (e.g. water, organic solvents); and
	 
	 	•	 	packaging materials.

	 	 	 	Those are listed in the Master Manufacturing Instructions.

	 	(10)	 	“Starting Materials Specifications” shall mean the specifications of the
Starting Materials laid down in the Master Manufacturing Instructions.
	 
	 	(11)	 	Iontophoretic Components in terms of this Quality Agreement is not defined as
starting material, but as an own class of components.
	 
	 	(12)	 	“Test Methods” shall mean the test methods listed in the Master Manufacturing
Instructions.

§ 2 BASIS OF AGREEMENT

	 	(1)	 	This Agreement is based on the Legal Contract. This Agreement is in general
appended to the Legal Contract between NuPathe and LTS which covers the commercial and
other aspects including the costs for special activities and secrecy agreements, and
does not amend, supply or otherwise modify the Legal Contract. In the event of
inconsistency between this Agreement and the Legal Contract, the Legal Contract shall
prevail.
	 
	 	(2)	 	LTS is a manufacturer of pharmaceutical products, having a manufacturing
authorization in accordance with the German Drug Law (AMG) §13 and being subject to
monitoring by the competent authorities.
	 
	 	 	 	LTS complies with all currently applicable rules regarding the manufacture of
pharmaceutical products, such as the “Good Manufacturing Practices, Medicinal
Products for Human and Veterinary Use” contained in Vol. IV of “the Rules Governing
Medicinal Products in the European Union”, including all relevant annexes; Good
Manufacturing

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

	 	 	 	Practices for Pharmaceutical Products, published by WHO and relevant
additional and supplementary guidelines, GMP rules published in 21 CFR Part 210 and
21 CFR Part 211.
	 
	 	(3)	 	NuPathe is a developer of pharmaceutical products, having authorization in
accordance with relevant pharmaceutical law and being subject to monitoring by the
competent authorities.
	 
	 	 	 	NuPathe complies with all currently applicable rules regarding the
development of pharmaceutical products such as “Good Manufacturing Practices,
Medicinal Products for Human and Veterinary Use” contained in Vol. IV of “the Rules
Governing Medicinal Products in the European Union”, including all relevant
annexes; Good Manufacturing Practices for Pharmaceutical products, published by WHO
and relevant additional and supplementary guidelines, GMP rules published in 21 CFR
Part 210 and 21 CFR Part 211.

§ 3 SUBJECT MATTER OF AGREEMENT

	 	 	LTS shall be Responsible for the manufacturing of the Products as set forth in Appendix I
“List of Products” for NuPathe
	 
	 	 	The functions and Responsibilities of the parties are as set forth in Appendix II
(“Overview of Functions and Responsibilities”).

§ 4 AUTHORIZATION DOCUMENTS

	 	 	NuPathe shall provide LTS with the IMPD or comparable documents. NuPathe shall immediately
inform LTS of any changes to the IMPD or comparable documents and provide LTS with a copy
of such changed IMPD or comparable documents.

§ 5 STARTING MATERIALS

	 	(1)	 	Purchase

	 	 	The Responsibility for the purchase of the Starting Materials is given in Appendix II.

	 	(2)	 	Quality control

	 	 	LTS shall be Responsible for the quality of the Starting Materials purchased by LTS and
will therefore analyze these Starting Materials with regard to the Starting Material
Specification.

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

	 	 	To the extent that NuPathe wishes additional analyses, NuPathe shall inform LTS. LTS will
provide NuPathe with an offer.
	 
	 	 	The quality of the Starting Materials made available by NuPathe shall be certified by
NuPathe in form of a Certificate of Analysis which shall accompany the shipment of each
batch of Starting Materials.
	 
	 	 	LTS’ Responsibility for the quality of the Starting Materials made available by NuPathe
shall include the verification — upon receipt of the Starting Materials — of at least the
following:

	 	i)	 	Intactness of the container and closure
	 
	 	ii)	 	Congruence of the labeling with the delivery notes
	 
	 	iii)	 	Identity testing of the content

	 	(3)	 	Storage
	 
	 	 	 	LTS shall be Responsible for the storage of all Starring Materials in such manner
that the quality of such Starting Material is not affected.
	 
	 	(4)	 	Reference and retention samples
	 
	 	 	 	LTS is Responsible for keeping reference and retention samples of each batch of
Starting Materials, other than solvents, gases or water, used for clinical samples
that LTS purchases. These samples shall be retained for at least two years after
the release of Product. The amount of reference and retention samples must be such
that it is possible to perform two (2) full quality control analyses (without
microbiological testing).
	 
	 	(5)	 	Suppliers
	 
	 	 	 	LTS will utilize only materials and components from only suppliers, which have been
approved by NuPathe. If the qualification of a new supplier is necessary, both LTS
and NuPathe are Responsible for the qualification activities.

§ 6 ORDERING

	 	 	NuPathe shall provide a specific order for each batch, specifying:

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

	 	a.	 	Current production formulae
	 
	 	b.	 	Master Manufacturing Instructions
	 
	 	c.	 	Storage conditions and packaging instructions for the
shipments of Products Such orders to be attached as Appendix III, “Formula
Assignment for Clinical Trials and Manufacturing Order”.

§ 7 PRODUCTION

	 	 	LTS shall be Responsible for the manufacturing of the Products according to the Master
Manufacturing Instructions.

§ 8 QUALITY CONTROL

	 	 	LTS shall be Responsible for compliance of the Products delivered by LTS with the
Specifications as defined by the IMPD.
	 
	 	 	For the judgement of compliance with the Specifications the results obtained with the Test
Methods are relevant. In case of contradictory results a mutual agreed external analytical
institute (Third Party) will be ordered for an investigation.

§ 9 BATCH PRODUCTION AND CONTROL RECORDS

	 	 	LTS shall be Responsible for retaining the batch documentation for the investigational
medicinal product for at least seven years after the release of Product at LTS. NuPathe
shall be Responsible for informing LTS if the completion or formal discontinuation of the
last clinical trial in which the batch was used extends beyond two years from the date of
release of Product at LTS. NuPathe shall be Responsible for ensuring that records are
retained as required for marketing authorisation in accordance with the Annex I to
Directive 2001/83/EC, if required for a subsequent marketing authorisation.

	 	 	The batch production and control record shall include, without limitation, the following:

	 	-	 	Name and form of Product;
	 
	 	-	 	Batch number of Product being manufactured;
	 
	 	-	 	Dates and times of commencements of significant intermediate stages and of the completion
of production;
	 
	 	-	 	Batch number or test number and amounts of each Starting Material used;

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

	 	-	 	Equipment used including cleaning confirmation;
	 
	 	-	 	Any relevant processing operation or event and its confirmation by signing
of the responsible operators;
	 
	 	-	 	Deviation reports and OOS investigations;
	 
	 	-	 	The theoretical and actual yields of major steps in the processing, detailed information
on deviations, exceptional occurrences, e.g. defects and their repairs, signed by an
authorized person;
	 
	 	-	 	Test reports of intermediates, bulk ware;
	 
	 	-	 	Results of in-process controls and laboratory testing and decisions following these
results;
	 
	 	-	 	Signature of the responsible production and quality control manager.
	 
	 	-	 	Signature of the Qualified Person

	 	 	Test reports of raw materials are separate archived in the Quality Control Lab.

§ 10 BATCH ACCOMPANYING DOCUMENTS

	 	 	LTS shall be Responsible for delivering with every batch a Certificate of Compliance
(Appendix IV) and other batch accompanying documents such as
Certificate of Production Compliance and Certificate of Analysis (both Appendix IV)
according to the Specifications.

§ 11 REFERENCE AND RETENTION SAMPLES OF THE PRODUCTS

	 	 	LTS is Responsible for keeping reference and retention samples of each batch of Product of
this Agreement. These samples shall be retained for at least four years after the release
of Product at LTS. NuPathe shall be Responsible for informing LTS if the completion or
formal discontinuation of the last clinical trial in which the batch was used, whichever
period is the longer, extends beyond two years from the date of release of Product at LTS.
The amount of reference and retention samples must be such that it is possible to perform
at least 2 full quality control analyses (without microbiological testing). LTS is also
Responsible for the keeping of samples which are mandatory by law.

§ 12 RELEASE

	 	 	The release of the bulk Product for shipment to NuPathe is in the Responsibility

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

		 	of LTS. Final release of the Product is in the Responsibility of NuPathe.

§ 13 QUALIFICATIONS/TRAINING

	 	 	LTS is Responsible for training all of its personnel involved in the Manufacture of Product
and the documentation of such training.

§ 14 THIRD PARTIES

	 	 	LTS may employ third parties with the execution of the tasks given to it by this Agreement.
The names of any such third parties and their duties delegated to them shall be listed in
the Overview of Functions and Responsibilities set forth in Appendix II. LTS is
Responsible for the quality of the Product and all legal requirements connected therewith
and such Responsibility cannot be transferred to a third party.

§ 15 INSPECTIONS

	 	 	LTS agrees that NuPathe has the right to audit the premises where the Products are
manufactured, including packaging, storage, quality control and distribution.
	 
	 	 	These audits will be scheduled at a time mutually convenient to both parties.
	 
	 	 	Audits by NuPathe during production of non NuPathe products are excluded with respect to
secrecy agreements with third parties. Mutually agreed upon corrective actions resulting
from the observations made during the inspection have to be performed as quickly as
reasonably practicable. LTS will report to NuPathe about its efforts in the carrying out
of the corrective actions within a time frame mutually agreed upon by the parties. LTS
shall use its commercially reasonable efforts to support NuPathe at the occasion of
inspections at NuPathe performed by drug monitoring authorities.
	 
	 	 	LTS shall be Responsible for the qualification and inspection of third parties if
necessary. They are also subject of inspections by NuPathe. The latter inspections shall
be performed only in the presence of LTS. The centralized control for these third-party
inspections shall be in the Responsibility of LTS. This encompasses the scheduling as well
as the surveillance concerning corrective actions. .NuPathe shall not contact the third
party directly without LTS’ written consent.
	 
	 	 	LTS will provide NuPathe with copies of any FDA 483 reports or any similar reports relating
to the Product.

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

§ 16 QUALITY DEFECTS — PRODUCT COMPLAINTS

	 	 	Both parties agree to contact each other immediately as soon as they become aware of
quality defects after shipment.
	 
	 	 	NuPathe will be Responsible for handling all complaints; regardless of source, will
coordinate all customer-related Activities involving complaints, and will maintain the
complete complaint database and complaint files. NuPathe will forward complaint
information to LTS when a technical investigation is required.

§ 17 DEVIATIONS — INVESTIGATIONS

	 	(1)	 	Deviations
	 
	 	 	 	LTS shall be Responsible to record in the Product batch file any deviation to the
manufacturing process and to inform NuPathe about all deviations which will have to
the best of the knowledge of LTS relevant influence on the quality of the Product
and do not result in a rejection by LTS itself. NuPathe shall be notified of such
deviations prior to LTS release of bulk Product. It is LTS’ Responsibility that
each deviation will be justified and approved by LTS’s Qualified Persons.
	 
	 	(2)	 	Investigations and solutions to problems
	 
	 	 	 	LTS is Responsible to conduct an investigation for each OOS result which may occur.
It is LTS’ Responsibility that each investigation will be assessed and approved by
LTS’s Qualified Person.

§ 18 PERSONS TO CONTACT

	 	 	The relevant persons who should be contacted in case of questions that may arise concerning
all pharmaceutical/technical matters which are subject of this Agreement are listed in
Appendix V (“Persons to Contact”).

§ 19 CONFIDENTIALITY

	 	 	LTS and NuPathe agree to keep proprietary information of each other, including but not
limited to know-how and Master Manufacturing Instructions confidential in accordance with §
11 of the Legal Contract.

§ 20 FINAL PROVISIONS

	 	(1)	 	This Agreement shall become effective upon its signature by the parties and
shall have a duration corresponding to the Legal Contract.

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

	 	(2)	 	This Agreement and any Appendices hereto may be amended or modified only by
written agreement executed by duly authorized officers of the parties hereto.
	 
	 	(3)	 	This Agreement and all appendices attached hereto contain the entire
understanding of the parties pertaining to the subject matter hereof.
	 
	 	(4)	 	Supplementary agreements are listed to the extent that they exist in Appendix
VI (“Supplementary Agreements”).
	 
	 	(5)	 	All appendices attached to this Agreement are incorporated by reference
herein and made a part hereof.
	 
	 	(6)	 	Upon the request of competent authorities, relevant parts of this Agreement
may be forwarded to the competent authorities. The party receiving such a request
shall notify the other party to this Agreement before complying with the information
request.
	 
	 	(7)	 	If any provision of this Agreement is held to be illegal, invalid or
unenforceable under any applicable present or future law, such provision shall be
fully severable and shall be replaced by a provision which comes as close to the
intended provision as is possible. The parties agree to inform and consult each other
if a party is in doubt regarding the validity of a provision of this Agreement and
shall not take any advantages of such doubts. Headings in this Agreement are included
for ease of reference only and have no legal effects.
	 
	 	(8)	 	This Agreement shall be governed by and construed in accordance with the laws
of the Federal Republic of Germany, regardless of the laws that might otherwise govern
under applicable principles of conflicts of laws thereof. In no event shall choice of
law analysis lead to the application of any other than German law.
	 
	 	(9)	 	As set forth in the Legal Contract, all disputes arising out of or in
connection with the present agreement and any subsequent agreement shall be finally
settled under the Rules of Arbitration of the International Chamber of Commerce by one or more arbitrators appointed in accordance with the
said Rules.
	 
	 	(10)	 	As set forth in the Legal Contract, the Arbitration shall be held in Toronto,
Canada or any other place that the parties may agree upon. The arbitration shall be
conducted in English. The award of arbitration shall be final and binding upon both
parties.

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

	 	(11)	 	In the event that any dispute or claim of any sort arising out of this
Agreement 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.

LIST OF APPENDICES

	 	 	 

	Appendix I

	 	List of Products
	Appendix II

	 	Overview of Functions and Responsibilities
	Appendix III

	 	Formula Assignment for Clinical Trials and Manufacturing Order
	Appendix IV

	 	Batch Accompanying Documents
	Appendix V

	 	Persons to Contact
	Appendix VI

	 	Supplementary Agreements

	 	 	 	 	 	 	 

	Conshohocken, PA USA

	 	 	 	Andernach, Germany	 	 
	 
	 	 	 	 	 	 
	July 10, 2007

	 	 	 	July 10 2007	 	 
	 
	 	 	 	 	 	 
	NuPathe

	 	 	 	LTS Lohmann Therapie-Systeme AG	 	 
	 
	 	 	 	 	 	 
	/s/ Terri B. Sebree
 

	 	 	 	/s/ K.-H. Meyer
 

	 	 
	Terri B. Sebree

	 	 	 	Dr. K.-H. Meyer	 	 
	President

	 	 	 	Qualified Person	 	 
	 
	 	 	 	 	 	 
	/s/ Suzanne M. Hanlon for
 

	 	 	 	12.07.07 /s/ Guido Müller
 

	 	 
	Amy Chandler-Skerkis

	 	 	 	Dr. Guido Müller	 	 
	VP, Quality Assurance

	 	 	 	Head of Quality Control	 	 

 

 

QUALITY ASSURANCE AGREEMENT

Between NuPathe Inc and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples

	 	 	 	 	 	 	 

	12 Jul. 2007 /s/ Michele Coulaloglou
 

	 	 	 	12.07.07 /s/ U. Riebe
 

	 	 
	Michele Coulaloglou

	 	 	 	Dr. U. Riebe	 	 
	Sr. Project Manager, CMC

	 	 	 	Head of Production — Clinical Samples	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	/s/ H.J. Holley
 

	 	 
	 

	 	 	 	Dr. H.J. Holley	 	 
	 

	 	 	 	Head of Quality Assurance	 	 

 

 

LIST OF APPENDICES pertaining to the QUALITY ASSURANCE AGREEMENT

between NuPathe and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples dated July 10, 2007

LIST OF APPENDICES

	 	 	 	 	 	 	 
	Appendix	 	 	 	Revision	 	Date
	I
	 	List of Products	 	00	 	 
	II
	 	Overview of Functions and Responsibilities	 	00	 	 
	III
	 	Formula Assignment for Clinical Trials	 	00	 	 
	 
	 	and Manufacturing Order	 	 	 	 
	IV
	 	Batch Accompanying Documents	 	00	 	 
	V
	 	Persons to Contact	 	00	 	 
	VI
	 	Supplementary Agreements	 	00	 	 

	 	 	 	 	 	 	 
	Approved by:	 	 	 	Revision: 00	 	 
	NuPathe (Date, Signature)

	 	 	 	LTS (Date, Signature)	 	 
	 
	 	 	 	 	 	 
	/s/ Terri B. Sebree
 

	 	 	 	12.07.2007 /s/ U. Riebe
 

	 	 
	Terri B. Sebree (President)

	 	 	 	Dr. U.
Riebe (Head of Manufacturing — Clinical

Samples)	 	 
	 
	 	 	 	 	 	 
	12.Jul. 2007 /s/ Michele Coulaloglou
 

	 	 	 	11.7.2007 /s/ K.-H. Meyer
 

	 	 
	Michele Coulaloglou (Sr. Project Manager, CMC)

	 	 	 	Dr. K.-H. Meyer (Qualified Person)	 	 
	 
	 	 	 	 	 	 
	/s/ Suzanne M. Hanlon for
 

	 	 	 	11.7.2007 /s/ H.J. Holley
 

	 	 
	Amy Chandler-Skerkis (VP, Quality Assurance)

	 	 	 	Dr. H.J. Holley (Head of Quality Assurance)	 	 

 

 

APPENDIX I pertaining to the QUALITY ASSURANCE AGREEMENT

between NuPathe and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples dated July 10, 2007

APPENDIX I

List of Products

Clinical samples of drug formulations ([**]) for use in iontophoretic patch.

 

	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

	 	 	 	 	 	 	 
	Approved by:	 	 	 	Revision: 00	 	 
	NuPathe (Date, Signature)

	 	 	 	LTS (Date, Signature)	 	 
	 
	 	 	 	 	 	 
	/s/ Suzanne M. Hanlon — for
 

	 	 	 	12.07.2007 /s/ U. Riebe
 

	 	 
	Amy Chandler-Skerkis (VP, Quality Assurance)

	 	 	 	Dr. U.
Riebe (Head of Manufacturing — Clinical

Samples)	 	 
	 
	 	 	 	 	 	 
	/s/ Terri B. Sebree
 

	 	 	 	11.7.2007 /s/ K.-H. Meyer
 

	 	 
	Terri B. Sebree (President)

	 	 	 	Dr. K.-H. Meyer (Qualified Person)	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	11.7.2007 /s/ H.J. Holley
 

	 	 
	 

	 	 	 	Dr. H.J. Holley (Head of Quality Assurance)	 	 

Page 1 of 1

 

APPENDIX II pertaining to the QUALITY ASSURANCE AGREEMENT

between NuPathe and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples dated July 5, 2007

APPENDIX II

Overview of Functions and Responsibilities

	 	 	 	 	 

	Company

	 	LTS
	 	Third Party
	 

	 	Lohmann Therapie-System AG	 	 
	 

	 	Lohmannstrasse 2	 	 
	 

	 	56626 Andernach	 	 
	 

	 	Germany	 	 
	 
	 	 	 	 
	Product:

	 	(see Appendix I)	 	 

	 	 	 	 	 	 	 
	Responsibilities	 	NuPathe	 	LTS	 	Third Party
	I. MATERIALS
	 	 	 	 	 	 
	1. STARTING MATERIALS (without active ingredients)
	 	 	 	 	 	 
	• Quality specifications, testing standards
	 	 	 	X	 	 
	• Purchase and shipment
	 	 	 	X	 	 
	• Testing and release of starting
materials supplied by agreed upon
suppliers
	 	 	 	X	 	 
	• Testing and release of starting
materials supplied by third parties
	 	 	 	X	 	 
	• Retention of batch documentation
	 	 	 	X	 	 
	• Reference and retention samples
	 	 	 	X	 	 
	 
	 	 	 	 	 	 
	2. ACTIVE PHARMACEUTICAL INGREDIENTS
	 	 	 	 	 	 
	• Quality specifications, testing standards
	 	 	 	X	 	 
	• Purchase
	 	X	 	 	 	 
	• Safety data sheet
	 	X	 	 	 	 
	• Testing and release of active
pharmaceutical ingredient(s) supplied by
	 	 	 	 	 	PPD
	• Identity test for correct arrival
	 	 	 	X	 	 
	• Retention of test documentation
	 	 	 	X	 	PPD
	• Reference and retention samples
	 	 	 	X	 	 
	• Shipment responsibilities
	 	X	 	 	 	 
	 
	 	 	 	 	 	 

Page 1 of 4

 

APPENDIX II pertaining to the QUALITY ASSURANCE AGREEMENT

between NuPathe and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples dated July 5, 2007

	 	 	 	 	 	 	 

	3. PRIMARY PACKAGING MATERIALS
	 	 	 	 	 	 
	• Quality specifications, testing standards
	 	 	 	X	 	 
	• Purchase
	 	 	 	X	 	 
	• Testing and release of primary packaging materials
	 	 	 	X	 	 
	• Approval of master for printed packaging materials
	 	 	 	X	 	 
	• Retention of batch documentation
	 	 	 	X	 	 
	• Reference and retention samples
	 	 	 	X	 	 
	• Shipment responsibilities
	 	 	 	X	 	 
	 
	 	 	 	 	 	 
	4. SECONDARY PACKAGING MATERIALS
	 	 	 	 	 	 
	• Quality specifications, testing standards
	 	 	 	X	 	 
	• Purchase of secondary packaging material
	 	 	 	X	 	 
	• Purchase of label material
	 	 	 	X	 	 
	• Testing and release of secondary packaging materials
	 	 	 	X	 	 
	• Approval of master for printed packaging materials
	 	 	 	X	 	 
	• Retention of batch documentation
	 	 	 	X	 	 
	• Reference and retention samples
	 	 	 	X	 	 
	• Shipment responsibility
	 	 	 	X	 	 
	 
	 	 	 	 	 	 
	5. INTERMEDIATE PRODUCTS — LAMINATE
	 	 	 	NA	 	 
	• IPC, testing standards
	 	 	 	 	 	 
	• Retention of batch documentation
	 	 	 	 	 	 
	• Storage conditions
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	6. PRIMARY PACKAGED PRODUCT
	 	 	 	 	 	 
	• Quality specifications, testing standard
	 	 	 	X	 	 
	• Testing and release of primary package product for
shipment to clinical site as defined in formula
assignment
	 	 	 	X	 	 
	• Purchase of label material
	 	 	 	X	 	 
	• Retention of batch documentation
	 	 	 	X	 	 
	• Reference and retention samples
	 	 	 	X	 	 
	• Retention of analytical samples for concurrent
stability testing
	 	 	 	X	 	 
	• Storage conditions
	 	 	 	X	 	 
	• Stability protocol
	 	 	 	X	 	 
	• Performance of stability study
	 	 	 	X	 	 
	• Stability Report
	 	 	 	X	 	 

Page 2 of 4

 

APPENDIX II pertaining to the QUALITY ASSURANCE AGREEMENT

between NuPathe and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples dated July 5, 2007

	 	 	 	 	 	 	 

	7. FINISHED PRODUCT
	 	 	 	 	 	 
	• Quality specifications, testing standard
	 	 	 	X	 	 
	• Retention of batch documentation
	 	 	 	X	 	 
	• Reference and retention samples
	 	 	 	X	 	 
	• Reference and retention samples mandatory by law
	 	 	 	X	 	 
	• Shipment responsibility
	 	X	 	X	 	 
	• Testing and release of finished product
	 	 	 	X	 	 
	• Certificate of Analysis for each batch
	 	 	 	X	 	—
	• Certificate of Compliance for each batch
	 	 	 	X	 	 
	• Stability protocol
	 	 	 	X	 	 
	• Performance of stability study
	 	 	 	X	 	 
	• Stability report
	 	 	 	X	 	 
	 
	 	 	 	 	 	 
	II. PROCESSES, PROCEDURES
	 	 	 	 	 	 
	8. PRODUCTION OF PRIMARY PACKAGED PRODUCT
	 	 	 	 	 	 
	• Validation/qualification of analytical
methods and equipment used including
documentation
	 	 	 	X	 	 
	• Manufacturing documentation
	 	 	 	X	 	 
	• Specifications of materials
	 	 	 	X	 	 
	• Processing instructions
	 	 	 	X	 	 
	• In-process controls
	 	 	 	X	 	 
	• Testing and release of primary packaged
product
	 	 	 	X	 	 
	• Certificate of Compliance for each batch
	 	 	 	X	 	 
	• Certificate of Analysis for each batch
	 	 	 	X	 	 
	• Retention of batch documentation
	 	 	 	X	 	 
	• Reference and retention samples
	 	 	 	X	 	 
	 
	 	 	 	 	 	 
	9. PACKAGING
	 	 	 	 	 	 
	• Specifications of materials
	 	 	 	X	 	 
	• Packaging instructions primary packaging
	 	 	 	X	 	 
	• Packaging instructions secondary packaging
	 	 	 	X	 	 
	• Labeling of primary packaged product including IPC
	 	 	 	X	 	 
	• Secondary packaging and labeling including IPC
	 	 	 	X	 	 
	• Retention of batch packaging records for
primary packaging
	 	 	 	X	 	 

Page 3 of 4

 

APPENDIX II pertaining to the QUALITY ASSURANCE AGREEMENT

between NuPathe and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples dated July 5, 2007

	 	 	 	 	 	 	 

	• Retention of batch packaging records for
secondary packaging
	 	 	 	X	 	 
	• Release and distribution of finished product for
clinical study
	 	X	 	X	 	 
	 
	 	 	 	 	 	 
	10. COMPLAINTS
	 	 	 	 	 	 
	• Registration of complaints from customer
	 	X	 	 	 	 
	• Investigation of complaints
	 	X	 	 	 	 
	• Corrective actions
	 	X	 	 	 	 
	• Answer to complaint to customer
	 	X	 	 	 	 
	• Documentation
	 	X	 	 	 	 

	 	 	 	 	 	 	 
	Approved by:	 	 	 	Revision: 00	 	 
	NuPathe (Date, Signature)

	 	 	 	LTS (Date, Signature)	 	 
	 
	 	 	 	 	 	 
	/s/ Suzanne M. Hanlon — for
 

	 	 	 	12.07.2007 /s/ U. Riebe
 

	 	 
	Amy Chandler-Skerkis (VP, Quality Assurance)

	 	 	 	Dr. U. Riebe (Head of Manufacturing — Clinical
Samples)	 	 
	 
	 	 	 	 	 	 
	12 Jul. 07/s/ Terri B. Sebree
 

	 	 	 	11.07.2007 /s/ K.-H. Meyer
 

	 	 
	Terri B. Sebree (President)

	 	 	 	Dr. K.-H. Meyer (Qualified Person)	 	 
	 
	 	 	 	 	 	 
	 

	 	 	 	11.7.2007 /s/ H.J. Holley
 

	 	 
	 

	 	 	 	Dr. H.J. Holley (Head of Quality Assurance)	 	 

Page 4 of 4

 

APPENDIX III pertaining to the QUALITY ASSURANCE AGREEMENT

between NuPathe and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples dated July 5, 2007

APPENDIX III

Formula Assignment for Clinical Trials and Manufacturing Order

(see Attachment)

	 	 	 	 	 

	Approved by:

	 	 	 	Revision: 00
	 
	 	 	 	 
	NuPathe (Date, Signature)

	 	 	 	LTS (Date, Signature)
	 
	 	 	 	 
	/s/ Michele Coulaloglou
 

Michele Coulaloglou (Sr. Project Manager, CMC)

	 	 	 	12.07.2007 /s/ U. Riebe
 
 Dr. U.
Riebe (Head of Manufacturing — Clinical Samples)
	 
	 	 	 	 
	12 Jul. 2007 /s/ Terri B. Sebree
 

Terri B. Sebree (President)

	 	 	 	11.7.2007 /s/ K.-H. Meyer
 
 Dr. K.-H.
Meyer (Qualified Person)
	 
	 	 	 	 
	 
 

	 	 	 	11.7.2007 /s/ H.J. Holley
 
 Dr. H.J.
Holley (Head of Quality Assurance)
	 
	 	 	 	 

Page 1of 1

 

APPENDIX IV pertaining to the QUALITY ASSURANCE AGREEMENT

between NuPathe and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples dated July 5, 2007

APPENDIX IV

Batch Accompanying Documentation

The following documents shall be forwarded to NuPathe with each delivery of the product

	 	1.	 	Certificate of Production Compliance
	 
	 	2.	 	Certificate of Analysis
	 
	 	3.	 	Certificate of Compliance
	 
	 	4.	 	Deviation Reports (if not “no risk” or “minor” classification)

	 	 	 	 	 

	Approved by:

	 	 	 	Revision: 00
	 
	 	 	 	 
	NuPathe (Date, Signature)

	 	 	 	LTS (Date, Signature)
	 
	 	 	 	 
	/s/ Suzanne M. Hanlon — for
 

Amy Chandler-Skerkis (VP, Quality Assurance)

	 	 	 	12.07.2007 /s/ U. Riebe
 
 Dr. U.
Riebe (Head of Manufacturing — Clinical Samples)
	 
	 	 	 	 
	12 Jul. 2007 /s/ Terri B. Sebree
 

Terri B. Sebree (President)

	 	 	 	11.7.2007 /s/ K.-H. Meyer
 
 Dr. K.-H.
Meyer (Qualified Person)
	 
	 	 	 	 
	 
 

	 	 	 	11.7.2007 /s/ H.J. Holley
 
 Dr. H.J.
Holley (Head of Quality Assurance)
	 
	 	 	 	 

Page 1of 1

 

APPENDIX V pertaining to the QUALITY ASSURANCE AGREEMENT

between NuPathe and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples dated July 5, 2007

APPENDIX V

Persons to Contact

LTS Lohmann Therapie-Systeme AG

	 	 	 
	Function	 	(Name, Telephone, Fax, e-mail)
	Projekt Manager

	 	[**]
	 

	 	[**]
	 

	 	[**]
	 

	 	[**]
	 
	 	 
	Head of Manufacturing Clinical samples

	 	Dr. U. Riebe
	 

	 	[**]
	 

	 	[**]
	 

	 	[**]
	 
	 	 
	Qualified Person

	 	Dr. K.-H. Meyer
	 

	 	[**]
	 

	 	[**]
	 

	 	[**]
	 
	 	 
	Head of Quality Assurance

	 	Dr. H.J. Holley
	 

	 	[**]
	 

	 	[**]
	 

	 	[**]
	 
	 	 
	Regulatory Affairs

	 	Dr. R. v. Kleinsorgen
	 

	 	+49 2632 99 2220
	 

	 	+49 2632 99 2393
	 

	 	Reinhard.vonKleinsorgen@ltslohmann.de
	 
	 	 
	Graduated Plan Officer

	 	[**]
	(Stufenplanbeauftragter)

	 	[**]

[**]
	 

	 	[**]
	 
	 	 
	Project Manager

	 	Michele Coulaloglou
	 

	 	484.567.0130 x1114
	 

	 	484.567.1336 (f)
	 

	 	[**]
	 
	 	 
	VP, Quality Assurance

	 	Amy Chandler-Skerkis
	 

	 	484.567.0130 x1113
	 

	 	484.567.0136 (f)
	 

	 	[**]
	 
	 	 
	President

	 	Terri . Sebree
	 

	 	484.567.0130 x1107
	 

	 	484.567.0136 (f)
	 

	 	[**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

	 	 	 	 	 

	NuPathe (Date, Signature)

	 	 	 	Revision: 00
	 
	 	 	 	 
	12 Jul. 2007 /s/ Michele Coulaloglou
 

Michele Coulaloglou (Sr. Project Manager, CMC)

	 	 	 	LTS (Date, Signature 
	 
	 	 	 	 
	12 Jul. 2007 /s/ Terri B. Sebree
 

Terri B. Sebree (President)

	 	 	 	12.07.2007 /s/ U. Riebe
 
 Dr. U.
Riebe (Head of Manufacturing — Clinical Samples)
	 
	 	 	 	 
	 

	 	 	 	11.7.2007 /s/ K.-H. Meyer
 
 Dr. K.-H.
Meyer (Qualified Person
	 
	 	 	 	 
	 

	 	 	 	11.7.2007 /s/ H.J. Holley
 
 Dr. H.J.
Holley (Head of Quality Assurance)

Page 1of 2

 

APPENDIX VI pertaining to the QUALITY ASSURANCE AGREEMENT

between NuPathe and LTS Lohmann Therapie-Systeme AG

on the manufacturing of clinical samples dated July 10, 2007

APPENDIX VI

Supplementary Agreements

Letter Agreement dated October 26, 2006.

	 	 	 	 	 

	Approved by:

	 	 	 	Revision: 00
	 
	 	 	 	 
	NuPathe (Date, Signature)

	 	 	 	LTS (Date, Signature)
	 
	 	 	 	 
	12 Jul. 2007 /s/ Terri B. Sebree

	 	 	 	12.07.2007 /s/ U. Riebe
	 

	 	 	 	 
	Terri B. Sebree (President)

	 	 	 	Dr. U. Riebe (Head of Manufacturing -
Clinical Samples)
	 
	 	 	 	 
	 

	 	 	 	11.7.2007 /s/ K.-H. Meyer
	 

	 	 	 	 
	 

	 	 	 	Dr. K.-H. Meyer (Qualified Person)
	 
	 	 	 	 
	 

	 	 	 	11.7.2007 /s/ H.J. Holley
	 

	 	 	 	 
	 

	 	 	 	Dr. H.J. Holley (Head of Quality Assurance)

Page 1of 1

 

Amendment to Quality Assurance Agreement dated July 12th, 2007 (“QAA”)

between

NuPathe Inc., 375 East Elm Street, Suit 110, Conshohocken, PA 19428, USA (“NuPathe”)

and

LTS Lohmann Therapie-Systeme AG, Lohmannstr. 2, 56626 Andernach, Germany (“LTS”)

WHEREAS, the parties wish to amend the terms and conditions of the QAA for the manufacture of clinical samples by LTS.

Now, therefore, the parties agree as follows:

	1.	 	§ 3 of the QAA shall be amended as follows:
	 
	 	 	LTS shall be Responsible for the manufacturing of the Products as set forth in Appendix 1 “List of Products” for NuPathe.
	 
	 	 	The functions and Responsibilities of the parties are set forth in Appendix 2 (“Overview of functions and responsibilities”).
	 
	 	 	LTS shall be Responsible for the manufacturing of the Iontophoretic patch.
	 
	 	 	NuPathe shall be Responsible for the quality control and the release of the Iontophoretic patch.
	 
	2.	 	All other terms and conditions of the agreement shall remain unaffected.

	 	 	 	 	 

	Conshohocken, PA, USA

	 	 	 	Andernach, Germany
	Nov 6, 2007

	 	 	 	Nov 6, 2007
	NuPathe

	 	 	 	LTS Lohmann Therapie-Systeme AG
	 
	 	 	 	 
	/s/ Terri B. Sebree

	 	 	 	6.11.2007 /s/ . K.-H. Meyer
	 

	 	 	 	 
	Terri B. Sebree

	 	 	 	Dr. K.-H. Meyer
	President

	 	 	 	Qualified Person
	 
	 	 	 	 
	/s/ Amy Chandler-Skerkis 11-6-07

	 	 	 	06/11/2007 /s/ Guido Müeller
	 

	 	 	 	 
	Amy Chandler-Skerkis

	 	 	 	Dr. Guido Müeller
	VP, Quality Assurance

	 	 	 	Head of Quality Control
	 
	 	 	 	 
	/s/ Michele Coulaloglou 6 Nov. 2007

	 	 	 	06.11.2007 /s/ U. Riebe
	 

	 	 	 	 
	Michele Coulaloglou

	 	 	 	Dr. U. Riebe
	Sr. Project Manager, CMC

	 	 	 	Head of Production — Clinical Samples
	 
	 	 	 	 
	 

	 	 	 	06.11.07 /s/ H.J. Holley
	 

	 	 	 	 
	 

	 	 	 	Dr. H.J. Holley
	 

	 	 	 	Head of Quality Assurance

 

 

Amendment to the Development and License Agreement

between LTS LOHMANN Therapie-Systeme AG and NuPathe Inc.,

effective as of September 14th, 2007

This amendment, effective as of April 1st, 2008 (“Effective Date”) by and among LTS
LOHMANN Therapie-Systeme AG, a company organized under the laws of Germany having a principal place
of business at Lohmannstraße 2, 56626 Andernach, Federal Republic of Germany (“LTS”);

and

NuPathe Inc., a corporation organized under the laws of Delaware having a principal place of
business at 375 East Elm Street, Suit 110, Conshohocken, PA 19428, USA (“NuPathe”)

WHEREAS, LTS and NuPathe have concluded a Development and License Agreement effective as of
September 14th, 2007; and

WHEREAS, the parties now wish to amend the terms for the funding of the development work in order
to include a compensation for machine-hours.

NOW THEREFORE, in consideration of the premises and mutual covenants and conditions set forth
herein, the parties agree as follows:

	I.	 	Section 6.2.01 (1) shall be amended as follows:
	 
	 	 	“NuPathe shall compensate LTS for all man- and machine-hours
actually spent by LTS on the project according to the development
plan for development activities, for production testing, scale up
activities and — as applicable — to validation activities, and
registration activities at the rate of € [**] per man-hour, [**],
and € [**] per machine-hour, [**]. For the avoidance of doubt,
NuPathe shall not be obliged to compensate LTS for man-hours spent
on activities for which LTS receives a compensation by
machine-hour.”

	II.	 	All other terms and conditions of the agreement shall remain unaffected.

IN WITNESS WHEREOF, the Parties hereto have executed this Amendment.

	 	 	 	 	 	 	 	 	 

	LTS LOHMANN Therapie-Systeme AG	 	 	 	NuPathe Inc.
	 
	 	 	 	 	 	 	 	 
	/s/ ppa. K. Haczkiewicz	 	 	 	/s/ J. Hollingsworth
	 	 	 	 	   
	Name:

	 	K. Haczkiewicz
	 	 	 	Name:
	 	J. Hollingsworth
	Title: Head of Business Development
	 	 	 	Title: CEO
	Place, Date: Andernach, June 3, 2008
	 	 	 	Place, Date: June 11, 2008
	 
	 	 	 	 	 	 	 	 
	/s/ ppa. U. Sielaff	 	 	 	 	 	 
	   	 	 	 	 	 	 
	Name:

	 	U. Sielaff	 	 	 	 	 	 
	Title: General Counsel	 	 	 	 	 	 
	Place, Date: Andernach, June 4, 2008	 	 	 	 	 	 

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND
WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

 

Amendment No 2 to the Development and License Agreement

between LTS LHOMANN Therapie-Systeme AG and Nupathe Inc.

Effective as of September 14, 2007

This amendment, effective as of February 17, 2009 (“Effective Date”) by and among LTS LOHMANN
Therapie-Systeme AG, a company organized under the laws of Germany having a principal place of
business at Lohmannstraße 2, 56626 Andernach, Federal Republic of Germany (“LTS”)

and

NuPathe Inc., a corporation organized under the laws of Delaware having a principal place of
business at 227 Washington Street, Suite 200, Conshohocken, PA 19428 (“NuPathe”)

WHEREAS, LTS and NuPathe have concluded a Development and License Agreement effective as of
September 14, 2007 (the “Agreement”); and

WHEREAS, the parties amended the Agreement effective as of April 1, 2008 to include compensation to
LTS for machine hours; and

WHEREAS, the parties now wish to further amend the Agreement to specify delivery terms and shipment
responsibilities for Clinical Samples.

NOW THEREFORE, in consideration of the premises mutual covenants and conditions set forth herein,
the parties agree as follows:

	 	I.	 	Article II of the Agreement is hereby amended to add the following subsection
2.09:

	 	2.09	 	Clinical Samples Delivery Terms.
	 
	 	 	 	When a shipment of Clinical Samples is ready for delivery, LTS
shall notify NuPathe in writing of the expected delivery date
(including details of quantities, destination, date and time) to
enable delivery and receipt to be coordinated. LTS shall ship the
Clinical Samples to NuPathe ex works (INCOTERMS 2000), LTS
manufacturing facility Andernach, Germany, in accordance with
written shipping instructions provided by NuPathe as per the
Quality Agreement. NuPathe will bear all risk of loss, delay, or
damage in transit, and insurance for each shipment.

	 	II.	 	Capitalized terms used herein and not otherwise defined herein shall have the
meanings set forth in the Agreement.

 

 

	 	III.	 	Except as expressly provided to the contrary in this Amendment No. 2, all
other terms and conditions of the Agreement shall continue in full force and effect.

     IN WITNESS WHEREOF, the parties hereto have executed this Amendment No. 2 by their duly
authorized officers as of the date set forth below.

	 	 	 	 	 	 	 	 	 

	LTS LOHMANN Therapie-Systeme AG	 	 	 	NuPathe Inc.
	 
	 	 	 	 	 	 	 	 
	/s/ ppa. K. Haczkiewicz	 	 	 	/s/ Jane H. Hollingsworth
	 	 	 	 	   
	Name:

	 	K. Haczkiewicz
	 	 	 	Name:
	 	Jane H. Hollingsworth
	Title: Head of Business Development
	 	 	 	Title: CEO
	Place, Date: Andernach, March 16, 2009
	 	 	 	Place, Date:
	 
	 	 	 	 	 	 	 	 
	/s/ ppa. U. Sielaff	 	 	 	 	 	 
	 	 	 	 	 	 	 
	Name:

	 	U. Sielaff	 	 	 	 	 	 
	Title: General Counsel	 	 	 	 	 	 
	Place, Date: Andernach, March 16, 2009	 	 	 	 	 	 

 

 

Amendment No 3 to the Development and License Agreement

between LTS LOHMANN Therapie-Systeme AG and Nupathe Inc.

Effective as of Mai 10, 2010

This amendment, effective as of Mai 10, 2010 (“Effective Date”) by and among LTS LOHMANN
Therapie-Systeme AG, a company organized under the laws of Germany having a principal place of
business at Lohmannstrabe 2, 56626 Andernach, Federal Republic of Germany (“LTS”)

and

NuPathe Inc., a corporation organized under the laws of Delaware having a principal place of
business at 227 Washington Street, Suite 200, Conshohocken, PA 19428 (“NuPathe”)

WHEREAS, LTS and NuPathe have concluded a Development and License Agreement effective as of
September 14, 2007 (the “Agreement”); and

WHEREAS, the parties amended the Agreement effective as of April 1, 2008 to include compensation to
LTS for machine hours; and

WHEREAS, the parties amended the Agreement effective as of February 17, 2009 to specify delivery
terms and shipment responsibilities for Clinical Samples; and

WHEREAS, the parties now wish to further amend the Agreement concerning their respective
confidentiality obligations

NOW THEREFORE, in consideration of the premises mutual covenants and conditions set forth herein,
the parties agree as follows:

	 	I.	 	Article X of the Agreement is hereby amended to add the following language:
	 
	 	 	 	“Notwithstanding the foregoing, the following additional disclosures shall be permitted
without obtaining the prior written consent of the other party:

	 
	 	(a)   NuPathe may disclose Confidential Information of LTS Corp. to third parties in
connection with sublicenses, strategic collaborations, equity or debt financing, IPO,
merger, acquisition, changes of control or other similar transactions (“Transactions”),
for the sole purposes of enabling such third parties to conduct such Transactions
and/or any diligence in connection with such Transactions. In the case of Confidential
Information comprising batch records, manufacturing instructions, details of the
manufacturing process, specifications, supply price, quality audit reports and
regulatory filings detailing manufacturing know-how and LTS Corp. patent applications
prior to disclosing such Confidential Information of LTS Corp. to a third party,
NuPathe shall first obtain a written confidentiality agreement with such third party
that is reasonable and customary for such Transaction or diligence.

 

 

	 	(b)	 	Legal Requirements or Governmental Filings. In addition, each Party may use and
disclose Confidential Information of the other Party to the extent such use or
disclosure is necessary in prosecuting or defending litigation in accordance with this
Agreement, complying with applicable governmental laws or regulations, such as FDA or
SEC regulations, or court order or otherwise submitting information to tax or other
governmental authorities, in submissions to regulatory authorities, as a part of patent
applications filed on inventions made under this Agreement, or as a part of
applications for marketing approval; 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, except to the
extent inappropriate in the case of patent applications or the like, will use
reasonable commercial efforts to secure confidential treatment of such information.
Section 4 of the CDA concluded between Nupathe and LTS Lohmann Therapy Systems Corp.
dated May 31st, 2006 shall not apply to information of the parties generated
and exchanged during the performance of activities under this Agreement.”
	 
	 	II.	 	Capitalized terms used herein and not otherwise defined herein shall have the
meanings set forth in the Agreement.
	 
	 	III.	 	Except as expressly provided to the contrary in this Amendment No. 3, all other terms
and conditions of the Agreement shall continue in full force and effect.

                    IN WITNESS WHEREOF, the parties hereto have executed this Amendment No. 3 by their duly
authorized officers as of the date set forth below.

	 	 	 	 	 	 	 	 	 

	LTS LOHMANN Therapie-Systeme AG	 	 	 	NuPathe Inc.
	 
	 	 	 	 	 	 	 	 
	/s/ ppa. U. Sielaff	 	 	 	/s/ Suzanne M. Hanlon
	 	 	 	 	 
	Name:

	 	Ulrich Sielaff
	 	 	 	Name:	 	 
	Title: General Counsel
	 	 	 	Title: General Counsel
	Place, Date: Andernach, 10.05.2010
	 	 	 	Place, Date: Conshohocken, May 10, 2010
	 
	 	 	 	 	 	 	 	 
	/s/ ppa. K. Haczkiewicz	 	 	 	 	 	 
	 	 	 	 	 	 	 
	Name:

	 	Klaudia Haczkiewicz	 	 	 	 	 	 
	Title: Head of Business Development	 	 	 	 	 	 
	Place, Date: Andernach, 10.05.2010exv10w4

Exhibit 10.4

CONFIDENTIAL

FEASIBILITY EVALUATION AGREEMENT

(WITH OPTION TO LICENSE)

BETWEEN

BROOKWOOD PHARMACEUTICALS, INC.

AND

NUPATHE INC.

DATE: March 19, 2007

Confidential treatment requested under 17 C.F.R. §§ 200.80(b)(4) and 230.406. The
confidential portions of this exhibit have been omitted and are marked accordingly. The
confidential portions have been filed separately with the Securities and Exchange Commission
pursuant to the Confidential Treatment Request.

 

 

CONFIDENTIAL

FEASIBILITY EVALUATION AGREEMENT

(WITH OPTION TO LICENSE)

THIS FEASIBILITY EVALUATION (“AGREEMENT”) is made and entered into on March 19, 2007, by and
between BROOKWOOD PHARMACEUTICALS, INC., having an address at 756 Tom Martin Drive, Birmingham,
Alabama, 35211, United States of America (hereinafter “BROOKWOOD”), and NUPATHE INC., having an
address at 375 East Elm Street, Suite 110, Conshohocken, Pennsylvania 19428 (hereinafter “CLIENT”).

BACKGROUND

BROOKWOOD is corporation organized and operated for purpose of developing and manufacturing
controlled-release pharmaceutical formulations; and

CLIENT desires that BROOKWOOD conduct the research described in this AGREEMENT and BROOKWOOD’s
Proposal P06.107R1 (hereinafter the “Proposal”). A copy of the Proposal can be found in Exhibit C.

THEREFORE, in consideration of the premises and mutual promises and covenants herein contained,
BROOKWOOD and CLIENT agree as follows:

DEFINITIONS:

Active Agent – Ropinirole, including the hydrochloride salt and free base

Affiliate - Any entity or organization that controls, is controlled by or is
under common control with a party. For this purpose, “control” shall mean
the ownership (whether directly or indirectly) of fifty (50) percent or more
of the voting stock or other equity interest or the ability (whether
directly or indirectly) to determine the policy or actions of any entity on
account of contract or other relationships.

Product – Injectable, biodegradable implant (single preformed macroscopic
device) formulation of the Active Agent for the treatment of Parkinson’s
Disease and/or Restless Leg Syndrome in humans.

Research Invention - Means any and all inventions, trade secrets,
discoveries, developments, know-how, methods, techniques, formulae,
processes and compositions of matter, whether or not patentable, resulting
from or derived from or directly relating to BROOKWOOD’s and/or CLIENT’s
performance under this AGREEMENT.

BROOKWOOD’s Technology - Means any and all proprietary technical
information, formulations, processes, know-how, data, specifications,
characterization methods, characterization results, and other proprietary
information, whether or not patented or patentable, owned or used by
BROOKWOOD existing as of the Effective Date and relating to the process for
imparting controlled release or other performance-enhancing qualities to
products, including but not limited to the know how and patents (issued,
pending, or subsequently filed and including all divisionals, continuations,
continuations-

 

 

CONFIDENTIAL

in-part or other related United States and foreign applications) listed in
Exhibit A.

CLIENT’s Technology - Means any and all proprietary technical information,
formulations, processes, know-how, data, specifications, characterization
methods, characterization results, and other proprietary information,
whether or not patented or patentable, owned or used by CLIENT existing as
of the Effective Date and relating to injectable biodegradable implants for
the treatment of psychiatric and central nervous system disorders,
including, without limitation, Parkinson’s disease and/or the Active Agent,
including but not limited to the know how and patents (issued, pending, or
subsequently filed and including all divisionals, continuations,
continuations-in-part or other related United States and foreign
applications) listed in Exhibit B.

THE PROJECT

1. (a) CLIENT hereby establishes a research project with BROOKWOOD (hereinafter the
“Project”), the purpose of which is to develop the Product. The Project will be conducted in
accordance with the terms and conditions of this AGREEMENT, including without limitation the
Proposal, as it may be amended by agreement of the parties from time to time.

     (b) During the term of this AGREEMENT, BROOKWOOD will undertake the Project exclusively for
CLIENT. BROOKWOOD will commence the Project promptly following the execution if this AGREEMENT and
will use commercially reasonable efforts to carry out the Project in accordance with the schedule
set forth in the Proposal. BROOKWOOD agrees to conduct the Project in accordance with: (a) all
applicable laws and regulations; and (b) the standards and practices that are generally accepted in
the industry and exercised by other persons engaged in performing similar services.

     (c) BROOKWOOD grants to CLIENT an exclusive option to license BROOKWOOD’s interest in Research
Inventions and BROOKWOOD’S Technology necessary to make, have made, use and sell the Product
developed during the term of this AGREEMENT (hereinafter said term shall be referred to as the
“Option Period”). The purpose of such option to license is for CLIENT to evaluate its interest in
commercializing the Product. The payment for such option to license shall be in the amount and
shall occur pursuant to Paragraph 3(a) herein. CLIENT’s rights under this option to license are
described in Paragraph 8 herein.

     (d) Nothing contained herein shall be interpreted to preclude BROOKWOOD at any time from
undertaking efforts similar to those performed under this AGREEMENT for third parties or for
internal utilization, provided that such efforts do not involve the Product or use of Client’s
Technology or confidential information.

TERM/TERMINATION

2. (a) This AGREEMENT and the Option Period shall become effective on the date written above
and shall terminate [**] thereafter except as otherwise provided herein.

     (b) Paragraphs [**] shall survive the termination of this AGREEMENT.

     (c) CLIENT can terminate this AGREEMENT, which will also terminate the option to license, by giving
BROOKWOOD a written notice stating the desired termination date. This notice shall

 
 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

 

CONFIDENTIAL

be given at least two weeks in advance of the desired termination date. CLIENT shall pay to
BROOKWOOD in full for all of BROOKWOOD’s activities and other committed costs occurring in
accordance with this AGREEMENT through the date of termination.

     (d) The term of this AGREEMENT and the Option Period can be extended subject to mutual
agreement in writing between CLIENT and BROOKWOOD.

     (e) If this AGREEMENT is terminated prior to completion of the PROJECT for any reason, other
than material breach by CLIENT, BROOKWOOD shall deliver to CLIENT within thirty (30) days of such
termination and all documents or other tangible materials provided to BROOKWOOD by CLIENT in
connection with the AGREEMENT.

CHARGES AND INVOICING

3. (a) Upon signing of this AGREEMENT, CLIENT shall have at no charge the option to license
described in Paragraph 1(c) herein on terms set forth in the Option Term Sheet which is attached
hereto as Exhibit D. At CLIENT’s request, the Option Period can be extended subject to mutual
agreement in writing between CLIENT and BROOKWOOD provided, however, that some extensions of the
Option Period may require payment to BROOKWOOD of a mutually-agreeable amount for each month the
Option Period is extended. Such payments to extend the Option Period are non-refundable and are
non-creditable.

     (b) CLIENT’s liability for the payment of charges in carrying out the Project shall not exceed
[**] U.S. Dollars ($[**]) without the written consent of CLIENT. CLIENT shall pay to BROOKWOOD [**]
percent of this amount upon signing of this AGREEMENT. BROOKWOOD shall invoice CLIENT on a monthly
basis for charges incurred on the Project. The invoice will cover the actual amount of monthly
Project charges reduced by [**] percent.

     (c) BROOKWOOD shall send the invoices to Accounts Payable, NuPathe Inc, 375 E. Elm Street,
Suite 110, Conshohocken, PA 19428. CLIENT shall pay each invoice within 30 days of the invoice
date.

     (d) BROOKWOOD reserves the right to terminate this AGREEMENT and the option to license, if
CLIENT fails to pay any undisputed invoice within 60 days from the invoice date.

     (e) Upon receipt of CLIENT’s written notice to terminate this AGREEMENT pursuant to Paragraph
2(c), BROOKWOOD will promptly discontinue work on the Project and will invoice CLIENT for the sum
of any uninvoiced charges and committed costs incurred in accordance with this AGREEMENT prior to
CLIENT’s requested termination date.

SERVICES AND MATERIALS

4. (a) With respect to the Project, BROOKWOOD shall provide the services of such personnel,
laboratory facilities, equipment, chemicals, and other supplies as are required to conduct its
activities under this AGREEMENT.

     (b) CLIENT agrees to supply to BROOKWOOD, [**], such necessary quantities of Active Agent for the
Project at such times as BROOKWOOD may reasonably request in order to complete the Project. In
addition, CLIENT agrees to provide to BROOKWOOD complete and accurate instructions for

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

 

CONFIDENTIAL

the proper handling, safety procedures and storage of the Active Agent, including appropriate
warnings of any known toxicity with respect to the use and handling of the Active Agent.

     (c) BROOKWOOD will use the Active Agent only for the purpose of performing the Project. BROOKWOOD shall
not sell, transfer, disclose or otherwise provide access to the Active Agent provided by CLIENT to
any third party without the written consent of CLIENT. Upon termination of this AGREEMENT,
BROOKWOOD will return all unused Active Agent to CLIENT, if requested to do so within thirty (30)
days after termination, or otherwise will dispose of the Active Agent at CLIENT’S direction and
expense.

DELIVERABLES

5. (a) BROOKWOOD will furnish CLIENT timely progress updates summarizing the results of the
Project. These updates shall contain technical information generated on the Project, except the
details of the process to make the Product.

     (b) BROOKWOOD will provide research samples of the PRODUCT (“Research Samples”) to CLIENT for
evaluation as they become available. With the Research Samples, BROOKWOOD will provide CLIENT with
sufficient information to evaluate the Research Samples, but BROOKWOOD will not disclose to CLIENT
technical details of the process to make the Research Samples. The Research Samples shall be used
by CLIENT for research purposes only and CLIENT shall not distribute the Research Samples to a
third party, other than those of CLIENT’s contractors or consultants who are subject to
confidentiality obligations set forth in Section 10, without permission of BROOKWOOD. Information
generated by CLIENT from use of Research Samples will be shared in confidence with BROOKWOOD solely
for the purpose of performing the parties respective obligations under the Agreement.

     (c) It is understood and agreed that said Research Samples cannot be used in humans.

OWNERSHIP OF INVENTIONS AND DATA

6. (a) Each party must promptly notify the other party in writing of any and all Research
Inventions that might , under applicable patent laws be patentable and constitute a Research
Invention that would be owned by or jointly owned with the other party pursuant to this Section 6
and must provide the other party with full and complete information so as to enable the parties to
make a patent application or to seek other intellectual property protection for that Research
Invention.

     (b) Inventorship for patentable Research Inventions shall be determined in accordance with
U.S. patent laws. BROOKWOOD and CLIENT represent that each of its employees has entered into an
employment agreement that provides for assignment to BROOKWOOD or CLIENT, respectively, of all
inventions made by such employee during the course of his employment with BROOKWOOD or CLIENT.

     (c) Any Research Inventions made under this AGREEMENT by BROOKWOOD or CLIENT which are based
solely upon CLIENT’s Technology shall be exclusively owned by CLIENT. BROOKWOOD hereby assigns to
CLIENT such Research Inventions.

     (d) Any Research Inventions made under this AGREEMENT by BROOKWOOD or CLIENT which are based
solely upon BROOKWOOD’s Technology shall be exclusively owned by BROOKWOOD. CLIENT hereby assigns
to BROOKWOOD such Research Inventions.

 

 

CONFIDENTIAL

     (e) Any Research Inventions made under this AGREEMENT by BROOKWOOD or CLIENT which are based
on the combination of BROOKWOOD’S Technology and CLIENT’s Technology shall be jointly owned by
BROOKWOOD and CLIENT. With respect to jointly-owned Research Inventions, BROOKWOOD shall have the
right to practice for internal and commercial purposes aspects of such Research Inventions that do
not relate to the Product or use CLIENT’s Technology or confidential information.

     (f) Data generated in connection with testing or use of Research Samples shall be exclusively
owned by CLIENT.

     (g) Nothing contained herein shall be construed as granting to BROOKWOOD or implying any
rights to or in favor of BROOKWOOD under any CLIENT Technology or any right to or in favor of
BROOKWOOD to use any information, know-how or data covered thereby except as expressly provided for
in this Agreement for the performance of BROOKWOOD’s obligations under this Agreement.

PATENT MATTERS

7. (a) BROOKWOOD shall have the sole right (but not the obligation), at its expense, to
prepare, file, prosecute and maintain patent applications or patents for Research Inventions which
are solely owned by BROOKWOOD. CLIENT shall execute such documents and perform such acts as may be
reasonably necessary for BROOKWOOD to prepare, file, prosecute or maintain such patent applications
or patents.

     (b) CLIENT shall have the sole right (but not the obligation), at its expense, to prepare,
file, prosecute and maintain patent applications or patents for Research Inventions which are
solely owned by CLIENT. BROOKWOOD shall execute such documents and perform such acts as may be
reasonably necessary for CLIENT to prepare, file, prosecute or maintain such patent applications or
patents.

     (c) [**].

     (d) If CLIENT or BROOKWOOD does not intend to participate in the filing for any Research
Invention patent or does not wish to continue preparation, prosecution or maintenance of a Research
Invention patent application or patent for a Research Invention pursuant to Paragraph (a) or (b)
above, then it shall give at least thirty (30) days advance notice, and in no event less than a
reasonable period of time, for the other party to act in its stead. Should either CLIENT or
BROOKWOOD elect to not participate:

	 	(i)	 	the other party may elect at its sole discretion to
continue preparation, filing and prosecution or maintenance of any such
patent application or patent at its sole expense,
	 
	 	(ii)	 	[**],
	 
	 	(iii)	 	the nonparticipating party shall execute such
documents and perform such acts as may be reasonably necessary to file
or to continue such prosecution or maintenance, and
	 
	 	(iv)	 	the nonparticipating party shall have the opportunity
for a timely textual review of patent filing and prosecution matters
related to such Research Invention applications.

 

			
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CONFIDENTIAL

PRODUCT COMMERCIALIZATION

8. (a) At any time during the Option Period, CLIENT may exercise the option granted herein by
providing written notice to BROOKWOOD. BROOKWOOD and CLIENT will then begin negotiation of a
license agreement, subject to the Option Term Sheet, granting CLIENT a license to BROOKWOOD’S
interest in Research Inventions and Brookwood’s Technology to the extent necessary to make, have
made, use and sell the Product. The license agreement will be royalty-bearing and contain terms and
conditions customary for products in the human pharmaceutical industry.

     (b) No product that would infringe or utilize BROOKWOOD’s Technology or BROOKWOOD’s interest
in Research Inventions, or their use shall be commercialized by CLIENT or any third party without
license from BROOKWOOD.

     (c) CLIENT shall provide BROOKWOOD with written notice that CLIENT wishes to pursue an agreement
for the manufacture of clinical supplies of Product. For a period of [**] from the date of such
notice, BROOKWOOD shall have the first right to negotiate with CLIENT regarding CLIENT’s
requirements for such clinical supplies. [**]. In the event the parties enter into a definitive
agreement for the manufacture of clinical supplies, CLIENT shall provide BROOKWOOD with written
notice that CLIENT wishes to pursue an agreement for the manufacture of supplies of the final
dosage form of the Product for commercial sale. For a period of [**] from the date of such notice,
BROOKWOOD shall have the first right to negotiate with CLIENT regarding CLIENT’s requirements for
such commercial supplies. [**].

PUBLICITY/PUBLICATIONS

9. (a) The Parties agree that except as otherwise expressly required by law, they will not
publicly announce or otherwise disclose any of the terms and conditions of this Agreement without
the express prior written consent of the other. Neither Party will use the names of the other or
any of its employees in any advertising, promotional or sales materials, except as required by law,
without the express prior written consent of the other.

     (b) During the term of this Agreement, CLIENT and BROOKWOOOD each acknowledge an interest in
publishing certain results to obtain recognition within the scientific community and to advance the
state of scientific knowledge. The parties also recognize their interest in obtaining valid patent
protection and protecting their business interests. Consequently, if either party, its employees or
consultants wish to make a publication (including any presentation or oral disclosure made without
obligation of confidentiality) relating to work performed as part of the Project, that party shall
transmit to the receiving party a copy of the proposed publication at least thirty (30) days prior
to submission for publication. The receiving party shall have the right (a) to propose
modifications to the publication for patent, confidentiality or other commercial reasons; and (b)
to request a reasonable delay in publication in order to protect patentable information. Upon the
expiration of thirty (30) days from transmission to the receiving party, the other party shall be
free to proceed with the publication, unless the receiving party has requested the delay described
above. The receiving party shall have the right to reasonably modify any publication, if in the
receiving party’s reasonable opinion such publication will jeopardize a patent application or
patent, or disclose Confidential Information of the receiving party.

CONFIDENTIALITY

 

			
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CONFIDENTIAL

10. (a) CLIENT and BROOKWOOD each agree that they will exert diligent efforts to ensure their
employees, agents, and consultants will not disclose or publish any proprietary information,
confidential technical information, or confidential business information (collectively hereinafter
referred to as “Information”) transmitted to one another for use in the performance of this Project
or new information developed by CLIENT or BROOKWOOD in connection with this Project. The
confidentiality obligations herein shall not apply to:

	 	i.	 	Information, that at the time of disclosure, is in the public domain;
or
	 
	 	ii.	 	Information, that after disclosure, becomes available to the public or
is lawfully made available to CLIENT or BROOKWOOD by a third party without
restrictions as to disclosure; or
	 
	 	iii.	 	Information that CLIENT or BROOKWOOD can establish by reasonable proof
was in their possession at the time of disclosure, or was subsequently and
independently developed by employees of CLIENT or BROOKWOOD who had no
knowledge of the Information disclosed; or
	 
	 	iv.	 	Information that CLIENT and BROOKWOOD mutually agree in writing to
release from the terms of this AGREEMENT; or
	 
	 	v.	 	Information required to be disclosed by order of a court or other
governmental body after consultation with the party who owns the Information.

     (b) CLIENT’s and BROOKWOOD’s obligation not to disclose, publish or use Information shall
continue for a period of [**] from the date of this AGREEMENT, at the end of such period the
obligation will terminate.

     (c) CLIENT and BROOKWOOD may, in their sole discretion, disclose necessary or appropriate
Information to its Affiliates, subcontractors, or consultants in order for CLIENT or BROOKWOOD to
perform its obligation under this AGREEMENT, provided, however, that such Affiliates,
subcontractors, and consultants shall be bound by the terms and conditions of this Paragraph 10
that are applicable to CLIENT and BROOKWOOD.

     (d) CLIENT and BROOKWOOD agree that Information disclosed by the other party will not be used
to provoke an interference with any patent application that the other party or its employees have
filed with respect to Information, and will not be used to amend any claim in any pending patent
application to expand the claim to read on, cover or dominate any invention (whether or not
patentable) disclosed as Information.

LIMITATION OF LIABILITY

11. Under this AGREEMENT, BROOKWOOD agrees to perform certain research and other work
incidental thereto, and to provide certain counseling, advice, conclusions, and/or recommendations.
BROOKWOOD will use its professional experience and diligent professional efforts in performing this
work. However, BROOKWOOD does not represent, warrant, or guarantee that its research results or any
products produced therefrom are merchantable or satisfactory for any particular purpose, and there
are no warranties, express or implied, to such effect. CLIENT hereby agrees to release, waive, and
forever discharge any demands, claims, suits, or actions of any character against BROOKWOOD arising
out of or in connection with CLIENT’s acceptance, reliance on, or use of such results. Acceptance,
reliance on, or use of such results shall be at the sole risk of CLIENT. In no event shall either
party be responsible or

 

			
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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

CONFIDENTIAL

liable to the other party in contract or in tort for any special, indirect, incidental, or
consequential damages such as, but not limited to, loss of product, profits or revenues, damage or
loss from operation or nonoperation of plant, or claims of third parties..

INDEMNIFICATION/WARRANTY

12. (a) CLIENT hereby agrees to indemnify, hold harmless, and defend BROOKWOOD and its
officers, directors, representatives, agents, and employees (each an “Indemnified Person”) from and
against any and all demands, claims, suits, or actions (“Claims”) of any character presented or
brought on account of any injuries, losses, or damages (including but not limited to court costs,
attorneys’ fees, costs of investigation and costs of defense) sustained by any person or property
in consequence of any act or omission of CLIENT or its agents, representatives, employees, or
subcontractors in the performance of the Project, the obligations imposed herein, and the, use, or
sale of any product resulting therefrom; provided, however, that the foregoing indemnity shall not
apply with respect to any Claim relating to or arising from the negligence or willful misconduct of
BROOKWOOD or any Indemnified Person..

     (b) BROOKWOOD hereby agrees to indemnify, hold harmless, and defend CLIENT and its officers,
directors, representatives, agents and employees from and against any and all Claims of any
character presented or brought on account of any injuries, losses, or damages sustained by any
person or property in consequence of, relating to, or arising from any negligent act or omission or
willful misconduct of BROOKWOOD or any Indemnified Party.

     (c) CLIENT represents and warrants to BROOKWOOD that, to CLIENT’S knowledge as of the effective
date of this AGREEMENT, it has sufficient rights to and/or beneficial title under intellectual
property rights in CLIENT’S Technology to allow BROOKWOOD to perform the Project and that to
CLIENT’s knowledge as of the effective date of this AGREEMENT, BROOKWOOD’S use of CLIENT’s
Technology in the performance of the Project will not constitute infringement or misappropriation
of the intellectual property rights of any third party. In the event that CLIENT becomes aware that
BROOKWOOD’s use of CLIENT’S Technology under this AGREEMENT may constitute infringement or
misappropriation of a third party’s intellectual property rights, CLIENT will promptly notify
BROOKWOOD.

DEBARRMENT

13. BROOKWOOD warrants and represents that it: (a) has not been, or is not currently, an
individual, corporation, partnership, association or entity that has been debarred by the U.S. Food
and Drug Administration (“FDA”) pursuant to 21 U.S.C. §335 (a) or (b); (b) has not been convicted
of or pled guilty or no contest to a crime; or (c) has not been sanctioned by a federal or state
law enforcement, regulatory or licensing agency. BROOKWOOD has no knowledge of any circumstances
which may affect the accuracy of the foregoing representations.

FDA AUDIT

14. In the event that BROOKWOOOD receives a Notice of Inspection (a “Notice”) from the FDA
which relates to this Agreement, BROOKWOOOD shall: (a) notify CLIENT promptly of such Notice; (b)
keep CLIENT informed of the progress of the inspection; and (c) provide to CLIENT a copy of any
documents produced to the FDA pursuant to such Notice. CLIENT acknowledges that it is BROOKWOOOD’s
obligation to respond to a Notice directed to BROOKWOOOD and BROOKWOOOD must respond to the Notice
without advice from, or consultation with CLIENT concerning the contents thereof.

 

 

CONFIDENTIAL

INSPECTION

15. During the term of this Agreement, CLIENT’s authorized representatives may visit
BROOKWOOOD’s site and facilities at reasonable times and with reasonable frequency during normal
business hours and upon reasonable advance written notice.

MISCELLANEOUS

16. (a) Assignment. This AGREEMENT and the benefits and obligations hereunder may not be
assigned or transferred by a party without the prior written consent of the other party, except

	 	i.	 	to an Affiliate or subsidiary, or
	 
	

	 	ii.	 	in connection with a merger or consolidation of the party in which such
party is not the surviving entity, or a sale or transfer of all or
substantially all of the assets of the party to which this AGREEMENT relates
provided that the successor or purchaser agrees to assume all of the
obligations of the party hereunder.
	

In the event of an assignment under Subsection (ii) of this Paragraph 13(a), the assigning party
shall notify the other party in writing of such assignment at least thirty (30) days in advance of
its occurrence.

     (b) Entire Agreement. This AGREEMENT, BROOKWOOD’s Proposal and the Option Term Sheet set forth and
constitute the entire agreement between the parties hereto with respect to the subject matter
hereof, and supersedes any and all prior agreements, requests for quotation, quotations, purchase
orders, letters of intent and understandings between the parties, and any and all promises,
statements, and representations made by either party to the other concerning the subject
matter hereof and the terms applicable hereto.

     (c) Parties Independent. In making and performing this AGREEMENT, the parties are acting and
shall act at all times as independent contractors and nothing contained in this AGREEMENT shall be
construed or implied to create an agency, partnership, or joint venture relationship between the
parties.

     (d) Waivers; Amendments.

	 	i.	 	The failure of either party to insist upon the performance of any of
the terms of this AGREEMENT or to exercise any right hereunder or at law or in
equity, or any delay by either party in the exercise of any such right, shall
not be construed as a waiver or relinquishment of any such performance or
right, the future performance of any such term or the future exercise of such
right or of the exercise, present or future of any other right, and any
effective waiver or relinquishment of any performance or right must be in
writing and signed by a duly authorized officer of the party waiving or
relinquishing such performance or right. No waiver or relinquishment of any
right granted by either party to the other shall be deemed to be a continuing
waiver of such right in the future unless otherwise provided in the waiver.
	 
	 	ii.	 	This AGREEMENT may not be released, discharged, amended, or modified in
any manner except by an instrument in writing that references this AGREEMENT
and is signed by a duly authorized officer of each party.

 

CONFIDENTIAL

     (e) Further Assurances. Each of the parties shall execute and deliver to, or cause to be
executed and delivered to, the other party, such further instruments, or take such other action as
may reasonably be requested of it to consummate more effectively the transactions contemplated
hereby.

     (f) Notice. Any notice or other written communication required or permitted to be made or
given hereunder may be made or given by either party to the other party by fax communication to the
fax number set forth below and such notice shall be followed up by depositing the same in the mail,
certified delivery, return receipt requested, postage prepaid, and addressed to the mailing address
set forth below:

     For BROOKWOOD:

Brookwood Pharmaceuticals, Inc.

756 Tom Martin Drive

Birmingham, Alabama 35211

FAX: 205-917-2205

Attention: President

     For CLIENT:

NuPathe Inc.

375 E. Elm Street, Suite 110

Conshohocken, PA 19428

Attn: President

cc: General Counsel

     (g) Applicable Law; Divisibility. This AGREEMENT is to be governed
by and construed in accordance with the laws of the State of Delaware, United States of America. If,
however, any provision hereof in any way contravenes the laws of any state or jurisdiction where
this AGREEMENT is to be performed, such provision shall be deemed to be deleted herefrom, and if
any term of this AGREEMENT shall be declared by a final adjudication to be illegal or contrary to
public policy, it shall not affect the validity of any other terms or provisions of this AGREEMENT.

     (h) Headings. Descriptive headings used herein are for convenience only and shall not affect
the meaning or construction of any provision hereof.

     (i) Translations. In the event of an inconsistency between any terms of this AGREEMENT and any
translations thereof into another language, the English language meaning shall control.

     (j) Force Majeure. The untimely performance of any obligation arising hereunder by either
party will be excused, and such delay of performance shall not constitute a breach or grounds for
termination or prejudice of any rights hereunder, provided that (a) the delay of performance is a
result of circumstances or occurrences beyond the reasonable control of the party whose performance
is excused hereunder (the “Delaying Event”), and (b) such party shall (i) immediately resume
performance after the Delaying Event is removed and (ii) be reasonably diligent during such
Delaying Event in avoiding further delay. Without limiting the generality of circumstances or
occurrences that shall constitute a Delaying Event, examples of Delaying Events include, but are
not limited to, strikes, shortages of power or other utility services, materials or transportation,
acts of government or of God, sabotage, insurrection and civil war. A party whose performance may
be affected by a Delaying Event promptly shall give notice to the other party of such Delaying
Event and the fact that it intends to rely upon such Delaying Event to excuse its performance under
this AGREEMENT.

 

CONFIDENTIAL

     (k) Agreement Under Seal. This AGREEMENT is intended to be under the seal of all parties
hereto and to have the effect of a sealed instrument in accordance with the law.

     (l) Counterparts. This AGREEMENT may be executed in one or more counterparts (including by
means of facsimile signature pages), all of which shall be considered one and the same agreement.

     IN WITNESS WHEREOF, the parties hereto have caused this AGREEMENT to be duly executed, on the
date written above.

	 	 	 

	BROOKWOOD PHARMACEUTICALS, INC.

	 	NUPATHE INC.
	 
	 	 
	By: /s/ F. Reese Frazer

	 	By: /s/ Terri Sebree
	 
	 	 
	Name: F. Reese Frazer

	 	Name: Terri Sebree
	 
	 	 
	Title: Executive Director Licensing & Strategic 

Affairs

	 	Title: President

 

CONFIDENTIAL

EXHIBIT A

BROOKWOOD’s Technology

A. Proprietary Know-How Owned or Controlled by BROOKWOOD Relating to:

[**]

B. BROOKWOOD Patent and Patent Applications

US Patent Application Serial No. 11/196,591 – Methods for Manufacturing delivery Systems and
Systems Thereof

AND ANY U.S. CONTINUATION(S), CONTINUATION(S) IN PART, OR DIVISIONALS

AND ANY FOREIGN COUNTERPART OF THE ABOVE.

 

			
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CONFIDENTIAL

EXHIBIT B

Client’s Technology

A. Proprietary Know-How Owned or Controlled by Client As Set Forth In:

[**]

B. Proprietary Know-How Owned or Controlled by CLIENT Relating To:

	•	 	[**]

C. CLIENT Patent and Patent Applications:

	 	 	 

	2002/0179096

	 	Polymer-Based Surgically Implantable Haloperidol Delivery
Systems and Methods for Their Production and use
	 
	 	 
	WO2005/070332

	 	Long-Term Delivery Formulations and Methods of Use Thereof
	(PCT.US05/00844)
	 	 
	 
	 	 
	US2006-0153895

	 	Drug Containing Implants and Methods of Use Thereof
	 
	 	 
	US2006-0159721

	 	Drug Containing Implants and Methods of Use Thereof
	 
	 	 
	PCT/US06/27894

	 	Drug Containing Implants and Methods of Use Thereof
	 
	 	 
	60/789,961

	 	Implants for Treatment of Dopamine Associated States

AND ANY U.S. CONTINUATION(S), CONTINUATION(S) IN PART, OR DIVISIONALS
AND ANY FOREIGN COUNTERPART OF THE ABOVE.

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
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3

 

CONFIDENTIAL

EXHIBIT C

PROPOSAL

 

Proposal To:

NuPathe, Inc.

Developmental Program for a Long-acting

Ropinirole Implant Formulation

Proposal P06.107R1

9 March 2007

 

This document is Brookwood Pharmaceutical’s revised Proposal P06.107R1. It contains

proprietary information belonging to Brookwood Pharmaceuticals. Its contents should be

handled according to the terms of the Confidential Disclosure Agreement between Brookwood

and

NuPathe, Inc. effective October 17, 2006.

 

 

SUMMARY

	 	 	 

	This is Brookwood Pharmaceuticals’
(Brookwood) revised proposal to
NuPathe, Inc. (NuPathe) to begin
development of a long-acting implant
formulation of Ropinirole. The
envisioned product will comprise a
biocompatible, resorbable implant
that releases Ropinirole for 1
month. The Ropinirole implants will
comprise Ropinirole dispersed within
a lactide/glycolide polymeric
cylindrical matrix. The implants
will be manufactured using [**].

	 	

Goal

Begin development of a long-acting
Ropinirole implant formulation

The proposed plan of work includes:

     [**]

The following is a list of target product specifications:

[**]

The Plan of Work section below describes the specific tasks involved in the proposed assessment
program. We assume [**]. The estimated duration of the proposed development program, [**]. The
estimated cost to complete the proposed development program is $[**] (USD).

 

			
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2

 

APPROACH

Ropinirole is an approved drug with a molecular weight of 260.4 daltons. It is a non-ergoline
dopamine agonist used in the treatment of Parkinson’s disease, and is also the only medication in
the United States with an FDA-approved indication for the treatment of restless legs syndrome.
Ropinirole’s water solubility is 133 mg/mL; its melting point is 243-250 °C.

Figure 1. Structure of Ropinirole

The first step in this proposed program will be to collaborate closely with NuPathe to identify
[**]. Also, analytical methods will be transferred to Brookwood at this time. A thorough and
complete sharing of technical information on the Ropinirole will help Brookwood design formulation
and process approaches.

Second, Brookwood will [**].

Brookwood drug delivery technology and formulation know-how

Brookwood Pharmaceuticals is uniquely positioned to develop drug-delivery products for its
pharmaceutical partners. Brookwood’s drug-delivery technologies have broad technical capabilities.
Therefore, we are developing drug-delivery products indicated for many therapeutic areas. In
particular, Brookwood specializes in long-acting parenteral delivery, like injectable implants and
microparticles. Brookwood’s implant platform is a proven delivery system for small molecules,
peptides, and some proteins. Depending on the indication and drug properties, active pharmaceutical
ingredients can be delivered at efficacious levels for days, weeks, or months following a single
administration.

Our formulation approach will be to formulate Ropinirole with biocompatible, resorbable polymer(s)
from the lactide/glycolide class of polymers (PLG polymers). This class of polymers has a long
safety record starting with its use in resorbable sutures in the early 1970s, followed by use in
many medical devices and drug-delivery products. including Decapeptyl LP, Lupron Depot®, Profact®
Depot, Supercur® MP, Sandostatin LAR®, Trelstar Depot, Zoladex®, Eligard®, Resiperidol®
ConstaTM, and Vivitrol.

 

			
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[**]
[A total of one page has been redacted and filed separately with the Securities and Exchange Commission.]

 

			
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4

 

Polymer selection

The PLG polymers are extremely useful in developing controlled-release implant and microparticle
formulations. This class of polymers contains hydrolytically labile ester bonds along the polymer
backbone. Upon exposure to aqueous environments, such as in the case of biological fluids, these
polymers degrade by random hydrolysis of these aliphatic-ester linkages. This random chain scission
process continues over time and resulting in a lowering of the polymer molecular weight. At some
point in time, the molecular weight drops to a sufficient extent causing the polymer formulation to
lose its mechanical integrity and begin breaking apart. Hydrolysis of the polymer continues until,
ultimately, only the individual monomeric constituents are left behind: namely, glycolic acid
and/or lactic acid (see Figure 2). Because these final breakdown products of the polymers are
naturally-occurring, endogenous entities, these polymers are considered biodegradable and
biocompatible. The actual degradation time is dependent on the polymer composition of glycolide and
lactide, end-group chemistries, molecular weight, extent of crystallinity, morphology of the
polymer crystallinity, physical geometry and the physicochemical environment.

PLG polymers offer several important advantages:

	 	1)	 	These polymers are biocompatible — they break down by hydrolysis to form
glycolic acid and lactic acid which in turn break down to carbon dioxide and water.
	 
	 	2)	 	[**]
	 
	 	3)	 	These polymers have been used in many products and are very well accepted by
the FDA for use in new products.

[**]

Active Pharmaceutical Ingredient Considerations

[**]

Release Modulation

[**]

In order to assess feasibility, we propose that [**].

Brookwood implant process technology

Brookwood has developed an implant processing technology that will be useful to meet the target
criteria for the desired Ropinirole formulation. This technology will support [**].

Ropinirole implants will be made by [**]

 

			
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5

 

[**]
[A total of one page has been redacted and filed separately with the Securities and Exchange Commission.]

 

			
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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

6

 

PLAN OF WORK

This plan of work comprises Brookwood’s development program with the objective being to identify
[**]. The tasks listed below describe the specific activities that Brookwood will be performing in
the execution of the development program. Some of these tasks will be performed in parallel.

[**]
[A
total of four pages, including the remainder of this page, have been redacted and filed separately with the Securities and Exchange

         Commission.]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

7

 

POTENTIAL FUTURE ACTIVITIES

[**]. A summary of the types of developmental activities that could be carried out by Brookwood are
listed below:

     [**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

11

 

BUSINESS SECTION

A. Time and Cost Estimates

The estimated cost to complete the proposed program is $[**] (USD). The estimated duration of the
proposed program is [**], depending on the timing of [**]. These are time and cost estimates only.
If we complete the tasks with less than the anticipated effort the cost will be less than the
estimated figure. On the other hand, if we encounter unforeseen difficulties we may not be able to
complete the tasks within the estimated time or budget. We will not exceed the approved budget
without approval from NuPathe.

The plan of work and scope of the proposed project may be changed by mutual consent of both
Brookwood and NuPathe. Any changes may affect (increase or decrease) the estimated cost.

B. Agreements

This proposal contains information that is proprietary to Brookwood. It should be handled according
to the terms of the Confidentiality Agreement between Brookwood and NuPathe.

C. Proposal Stipulations

The offers expressed or implied in this proposal will be valid until 30 April 2007. This document
is for the purpose of establishing a clear understanding of our potential relationship only. It
does not constitute a legal agreement. Until the appropriate project initiation document is
executed, no terms or conditions within this document should be construed as any firm offer or
commitment, nor should this document be construed as a constraint to preclude or limit concurrent
discussions with other parties regarding substantially identical, similar, or related subject
matter. If this proposal is agreeable, please contact [**] to arrange for preparation of the
appropriate Research Agreement.

Brookwood Proposal P06.107R1

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

12

 

CONFIDENTIAL

EXHIBIT D

OPTION TERM SHEET

 

TERM SHEET

Proposed Terms for Further Development and Commercialization of a

Biodegradable Implant for the Treatment of Parkinson’s Disease [**]

This term sheet is [**] and reflects their intent to negotiate a definitive License Agreement with
terms and conditions substantially equivalent to those in this term sheet.

Parties

NuPathe, Inc. (“NuPathe”)

Brookwood Pharmaceuticals, Inc. (“Brookwood”)

Objective

To conclude a definitive License Agreement (the “License Agreement”) between Brookwood and NuPathe
with respect to Brookwood’s interest in Research Inventions and Brookwood’s Technology related to
the Product. The Agreement while including the terms agreed upon in the Term Sheet will incorporate
additional and more detailed terms and conditions to be negotiated between parties.

Product

Injectable, biodegradable implant (single, preformed, macroscopic device) formulation of
Ropinirole.

Research Inventions

The definition set forth in the Feasibility Evaluation Agreement is incorporated herein by
reference.

Brookwood Technology

The definition set forth in the Feasibility Evaluation Agreement, including Exhibit A, is
incorporated herein by reference.

Field

[**].

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

Territory

Worldwide

License grant

Brookwood will grant to NuPathe an exclusive license to Brookwood’s interest in Research Inventions
and Brookwood’s Technology, including, without limitation, all know how and present and future
patents, patent applications, certificates of invention, or applications for certificates of
invention and any supplemental protection certificates together with any extensions, registrations,
confirmations, reissues, substitutions, divisions, continuations or continuations-in-part,
reexamination or renewals thereof to the extent necessary for NuPathe to make, have made, use,
import, sell, have sold and offer for sale the Product in the Field in the Territory. Brookwood
will further grant to NuPathe the right to sublicense, provided that consideration to Brookwood is
not altered by the sublicense.

Exclusivity

Upon grant of the license, Brookwood will not develop, commercialize or manufacture for its own
account, or for any third party, or license to any third party the rights to develop or
commercialize the Product.

Commercialization diligence

[**].

License Fees and Milestones

NuPathe will pay milestone payments to Brookwood based on the first occurrence of following events
in a country in the Territory:

[**]

Royalties

NuPathe shall pay Brookwood a royalty of [**]% of annual Net Sales of the Product in the Territory.

Royalties shall commence with first commercial sale of the Product and shall be payable on a
country by country basis until the later of ten (10) years from the date of the first commercial sale of the
Product or the expiration or invalidation of the last enforceable licensed patent related to the
Product which provides marketing exclusivity in applicable country.

Net Sales” shall mean, [**].

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

2

 

NuPathe Representatives shall mean any person or entity who is a party to a sublicense, license,
distribution, joint venture, sales or other agreement with NuPathe to sell, market, or distribute
the Product.

Manufacturing

Brookwood shall have the first right to negotiate with NuPathe regarding NuPathe’s (i) supplies of
the Product for clinical studies and (ii) supplies of the final dosage form of the Product for
commercial sale as set forth in Section 8 in the Feasibility Evaluation Agreement. The parties will
use good faith efforts to negotiate a mutually acceptable arrangement.

If Brookwood does not manufacture commercial supplies of the Product, an additional [**]% royalty
will be paid by NuPathe provided, however that such additional royalty shall not be due in the
event Brookwood is unable to manufacture all or a portion of NuPathe’s commercial requirements for
the Product.

Intellectual Property

Ownership of Research Inventions and data shall be as set forth in Section 6 the Feasibility
Evaluation Agreement to be negotiated between the parties.

Patent prosecution responsibilities with respect to Research Inventions shall be as set forth in
Section 7 of the Feasibility Evaluation Agreement to be negotiated between the parties.

Term and Termination

The term of the License Agreement shall be as long as NuPathe is obligated to pay royalties to
Brookwood, after which NuPathe shall have a fully paid up license consistent with the terms of the
License Agreement. NuPathe may terminate the license upon 90 days written notice to Brookwood.

Press Release

Upon execution of the License Agreement, Brookwood my issue a press release, with language mutually
agreed upon by the parties, announcing the agreement.

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

3

 

ADDENDUM NUMBER ONE

TO THE

FEASIBILITY EVALUATION AGREEMENT

BETWEEN

BROOKWOOD PHARMACEUTICALS, INC.

AND

NUPATHE, INC.

BACKGROUND

This ADDENDUM NUMBER ONE is issued pursuant to Paragraph 13(d) of the FEASIBILITY EVALUATION
AGREEMENT (“AGREEMENT”) between BROOKWOOD PHARMACEUTICALS, INC. (“BROOKWOOD”) and NUPATHE, INC.
(“NUPATHE”) that became effective on March 19, 2007.

Now, therefore, in consideration of the mutual promises and covenants herein contained, NUPATHE and
BROOKWOOD hereby agree to amend the AGREEMENT as follows:

Paragraph 3(b)

Intent: To increase the budget for the Project to include the work described in Proposal Number
P08.022.

Paragraph 3(b) is amended to include the following additional language:

CLIENT’s liability for payment of charges in carrying out the activities performed by BROOKWOOD as
described in Proposal Number P08.022 shall not exceed [**] U.S. Dollars ($[**]) without the written
consent of CLIENT. CLIENT shall pay to BROOKWOOD [**] of this amount upon signing of this ADDENDUM
NUMBER ONE. BROOKWOOD shall invoice CLIENT on a monthly basis for charges incurred on the Project.
The invoice will cover the actual amount of monthly Project charges reduced by [**].

Exhibit C

Intent: To incorporate Proposal Number P08.022 into Exhibit C.

Proposal P08.022 is hereby made part of Exhibit C.

Except as hereby amended in accordance with Paragraph 13(d) of the AGREEMENT, all other terms and
conditions remain in full force and effect. This ADDENDUM NUMBER ONE is made effective as of the
date of the last signature below and is hereby incorporated and made a part of the AGREEMENT.

 
 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

Accepted, acknowledged, and agreed to:

	 	 	 	 	 	 	 

	BROOKWOOD PHARMACEUTICALS, INC.	 	NUPATHE, INC.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Arthur J. Tipton
	 	By:
	 	/s/ Terri Sebree
	 

	 	 
	 	 	 	 
	Name:

	 	Arthur J. Tipton
	 	Name:
	 	Terri Sebree
	Title:

	 	President
	 	Title:
	 	President
	 
	 	 	 	 	 	 
	Date:

	 	17 Dec. 2007
	 	Date:
	 	December 14, 2007

 

EXHIBIT C

PROPOSAL

 

Quotation P08.022

Work Plan [**]

	 	 	 

	FOR:

	 	[**]
	 
	 	 
	CLIENT:

	 	NuPathe, Inc.
	 
	 	 
	DATE:

	 	December 6, 2007

BUDGET INCREASE:           $[**]

SUMMARY

Brookwood has prepared the following quotation, including work plan and cost estimates through the
end of [**], in response to a request from NuPathe. [**].

The Brookwood/NuPathe project team has recently discussed the planning of additional activities and
the associated costs for [**].

We estimate a budget of approximately $[**] will be required to complete this plan of work. We have
approximately $[**] remaining in the currently approved budget. Therefore, we are requesting a
budget increase of $[**] to cover the additional tasks outlined in the plan of work. The tasks
listed under each month can be moved to allow for earlier characterization results, if necessary,
without increasing the total cost.

PLAN OF WORK

[**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

BUSINESS SECTION

The cost values are estimates only. The actual charges will depend on the effort and time our staff
members spend on the project. If it requires less than the anticipated effort to prepare and
analyze the samples, the cost will be less than the estimated figure. On the other hand, if we
encounter unexpected difficulties, we may not be able to complete these tasks within the estimated
time or cost. In no instance will we exceed the estimated cost without written authorization from
NuPathe.

The plan of work and scope of the proposed tasks may be changed by mutual consent of both Brookwood
Pharmaceuticals and NuPathe. Any changes may affect (increase or decrease) the estimated cost. Any
changes to the project will be undertaken in accordance with the procedures described in the
Feasibility Evaluation Agreement.

Agreements

If this proposal is agreeable to NuPathe, please contact [**]. We will work with NuPathe to quickly
establish the appropriate document to approve the budget increase and initiate the work plan
described above.

Proposal Stipulations

The offer expressed or implied in this proposal will be valid until 21 December 2007. This document
is for the purpose of establishing a clear understanding of the work requested by NuPathe.

It is anticipated that the work described in this proposal will be performed under the terms of the
Feasibility Evaluation Agreement.

Proposal P08.022

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

756 Tom Martin Drive • Birmingham, AL 35211 •
Phone: 205 917 2200 • Facsimile: 205 917 2205 • www.brookwoodpharma.com

2

 

ADDENDUM NUMBER TWO

TO THE

FEASIBILITY EVALUATION AGREEMENT

BETWEEN

BROOKWOOD PHARMACEUTICALS, INC.

AND

NUPATHE, INC.

BACKGROUND

This ADDENDUM NUMBER TWO is issued pursuant to Paragraph 13(d) of the FEASIBILITY EVALUATION
AGREEMENT (“AGREEMENT”) between BROOKWOOD PHARMACEUTICALS, INC. (“BROOKWOOD”) and NUPATHE, INC.
(“NUPATHE”) that became effective on March 19, 2007.

Now, therefore, in consideration of the mutual promises and covenants herein contained, NUPATHE and
BROOKWOOD hereby agree to amend the AGREEMENT as follows:

Paragraph 3(b)

Intent: To increase the budget for the Project to include the work described in Proposal Number
P08.042.

Paragraph 3(b) is amended to include the following additional language:

CLIENT’s liability for payment of charges in carrying out the activities performed by BROOKWOOD as
described in Proposal Number P08.042 shall not exceed [**] U.S. Dollars ($[**]) without the written
consent of CLIENT. BROOKWOOD shall invoice CLIENT on a monthly basis for charges incurred on the
Project.

Exhibit C

Intent: To incorporate Proposal Number P08.042 into Exhibit C.

Proposal P08.042 is hereby made part of Exhibit C.

Except as hereby amended in accordance with Paragraph 13(d) of the AGREEMENT, all other terms and
conditions remain in full force and effect. This ADDENDUM NUMBER TWO is made effective as of the
date of the last signature below and is hereby incorporated and made a part of the AGREEMENT.

	 	 	 	 	 	 	 

	Accepted, acknowledged, and agreed to:	 	 	 	 
	 
	 	 	 	 	 	 
	BROOKWOOD PHARMACEUTICALS, INC.	 	NUPATHE, INC.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Arthur J. Tipton 	 	By:	 	/s/ Jane H. Hollingsworth
	 

	 	 
	 	 	 	 
	 
	 	 	 	 	 	 
	Name:

	 	Arthur J. Tipton
	 	Name:	 	Jane H. Hollingsworth
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Title:

	 	President
	 	Title:	 	CEO
	 

	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	Date:

	 	7 April 2008	 	Date:	 	3/20/08
	 

	 	 
	 	 	 	 

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

 

EXHIBIT C

PROPOSAL P08.042

 

 

Quotation P08.042

Work Plan [**]

	 	 	 

	FOR:

	 	[**]
	 
	 	 
	CLIENT:

	 	NuPathe, Inc.
	 
	 	 
	DATE:

	 	March 11, 2008

BUDGET INCREASE:           $[**]

SUMMARY

Brookwood has prepared the following quotation for the scope of work to be performed during
the [**]. The primary activities consist of [**]. In the plan of work we have listed the specific
activities for each of the tasks with an estimate for labor hours and total cost.

PLAN OF WORK

[**]

BUSINESS SECTION

The cost values are estimates only. The actual charges will depend on the effort and time our
staff members spend on the project. In no instance will we exceed the estimated cost without
written authorization from NuPathe.

The plan of work and scope of the proposed tasks may be changed by mutual consent of both Brookwood
Pharmaceuticals and NuPathe. Any changes may affect (increase or decrease) the estimated cost. Any
changes to the project will be undertaken in accordance with the procedures described in the
Feasibility Evaluation Agreement.

Agreements

If this proposal is agreeable to NuPathe, please contact [**]. We will work with NuPathe to
quickly establish the appropriate document to approve the budget increase and initiate the work
plan described above.

Proposal Stipulations

The offer expressed or implied in this proposal will be valid until 31 March 2008. This
document is for the purpose of establishing a clear understanding of the work requested by NuPathe.

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

756 Tom Martin Drive • Birmingham, AL 35211 •
Phone: 205 917 2200 • Facsimile: 205 917 2205 • www.brookwoodpharma.com

1

 

It is anticipated that the work described in this proposal will be performed under the terms of the
Feasibility Evaluation Agreement.

Proposal P08.042

756 Tom Martin Drive • Birmingham, AL 35211 •
Phone: 205 917 2200 • Facsimile: 205 917 2205 • www.brookwoodpharma.com

2

 

ADDENDUM NUMBER THREE

TO THE

FEASIBILITY EVALUATION AGREEMENT

BETWEEN

BROOKWOOD PHARMACEUTICALS, INC.

AND

NUPATHE, INC.

BACKGROUND

This ADDENDUM NUMBER THREE is issued pursuant to Paragraph 13(d) of the FEASIBILITY EVALUATION
AGREEMENT (“AGREEMENT”) between BROOKWOOD PHARMACEUTICALS, INC. (“BROOKWOOD”) and NUPATHE, INC.
(“NUPATHE”) that became effective on March 19, 2007.

Now, therefore, in consideration of the mutual promises and covenants herein contained, NUPATHE and
BROOKWOOD hereby agree to amend the AGREEMENT as follows:

Paragraph 3(b)

Intent: To increase the budget for the Project to include the work described in Proposal Number
P08.065R1.

Paragraph 3(b) is amended to include the following additional language:

CLIENT’s liability for payment of charges in carrying out the activities performed by BROOKWOOD as
described in Proposal Number P08.065R1 shall not exceed [**] U.S. Dollars ($[**]) without the
written consent of CLIENT. BROOKWOOD shall invoice CLIENT on a monthly basis for charges incurred
on the Project.

Exhibit C

Intent: To incorporate Proposal Number P08.065R1 into Exhibit C.

Proposal P08.065R1 is hereby made part of Exhibit C.

Except as hereby amended in accordance with Paragraph 13(d) of the AGREEMENT, all other terms and
conditions remain in full force and effect. This ADDENDUM NUMBER THREE is made effective as of the
date of the last signature below and is hereby incorporated and made a part of the AGREEMENT.

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

 

	 	 	 	 	 	 	 

	Accepted, acknowledged, and agreed to:	 	 	 	 
	 
	 	 	 	 	 	 
	BROOKWOOD PHARMACEUTICALS, INC.	 	NUPATHE INC.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Arthur J. Tipton, Ph.D.
	 	By:
	 	/s/ Terri Sebree
	 

	 	 
	 	 	 	 
	Name:

	 	Arthur J. Tipton, Ph.D.
	 	Name:
	 	Terri Sebree
	Title:

	 	President
	 	Title:
	 	President
	 
	 	 	 	 	 	 
	Date:

	 	09 July 2008
	 	Date:
	 	07/08/08

 

 

EXHIBIT C

PROPOSAL P08.065R1

 

 

Quotation P08.065R1

	 	 	 

	FOR:

	 	[**]
	 
	 	 
	CLIENT:

	 	NuPathe, Inc.
	 
	 	 
	DATE:

	 	June 10, 2008
	 
	 	 
	COST:

	 	$[**]

PLAN OF WORK

[**]

BUSINESS SECTION

The cost values are estimates only. The actual charges will depend on the effort and time our staff
members spend on the project. In no instance will we exceed the estimated cost without written
authorization from NuPathe.

The plan of work and scope of the proposed tasks may be changed by mutual consent of both Brookwood
Pharmaceuticals and NuPathe. Any changes may affect (increase or decrease) the estimated cost. Any
changes to the project will be undertaken in accordance with the procedures described in the
Feasibility Evaluation Agreement.

Agreements

If this proposal is agreeable to NuPathe, please contact [**]. We will work with NuPathe to quickly
establish the appropriate document to approve the budget increase and initiate the work plan
described above.

Proposal Stipulations

The offer expressed or implied in this proposal will be valid until June 30, 2008. This document is
for the purpose of establishing a clear understanding of the work requested by NuPathe. It is
anticipated that the work described in this proposal will be performed under the terms of the
Feasibility Evaluation Agreement.

Proposal P08.065R1

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

756 Tom Martin Drive • Birmingham, AL 35211 •
Phone: 205 917 2200 • Facsimile: 205 917 2205 • www.brookwoodpharma.com

1

 

ADDENDUM NUMBER FOUR

TO THE

FEASIBILITY EVALUATION AGREEMENT

BETWEEN

BROOKWOOD PHARMACEUTICALS, INC.

AND

NUPATHE, INC.

BACKGROUND

This ADDENDUM NUMBER FOUR is issued pursuant to Paragraph 13(d) of the FEASIBILITY EVALUATION
AGREEMENT (“AGREEMENT”) between BROOKWOOD PHARMACEUTICALS, INC. (“BROOKWOOD”) and NUPATHE, INC.
(“NUPATHE”) that became effective on March 19, 2007.

Now, therefore, in consideration of the mutual promises and covenants herein contained, NUPATHE and
BROOKWOOD hereby agree to amend the AGREEMENT as follows:

Paragraph 3(b)

Intent: To increase the budget for the Project to include the work described in Proposal Number
P08.108R1.

Paragraph 3(b) is amended to include the following additional language:

CLIENT’s liability for payment of charges in carrying out the activities performed by BROOKWOOD as
described in Proposal Number P08.108R1 shall not exceed [**] U.S. Dollars ($[**]) without the
written consent of CLIENT. BROOKWOOD shall invoice CLIENT on a monthly basis for charges incurred
on the Project.

Exhibit C

Intent: To incorporate Proposal Number P08.108R1 into Exhibit C.

Proposal P08.108R1 is hereby made part of Exhibit C.

Except as hereby amended in accordance with Paragraph 13(d) of the AGREEMENT, all other terms and
conditions remain in full force and effect. This ADDENDUM NUMBER FOUR is made effective as of the
date of the last signature below and is hereby incorporated and made a part of the AGREEMENT.

	 	 	 	 	 	 	 

	Accepted, acknowledged, and agreed to:	 	 	 	 
	 
	 	 	 	 	 	 
	BROOKWOOD PHARMACEUTICALS, INC.	 	NUPATHE, INC.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Arthur J. Tipton, Ph.D.
	 	By:
	 	/s/ Terri Sebree
	 

	 	 
	 	 	 	 
	 
	 	 	 	 	 	 
	Name:

	 	Arthur J. Tipton
	 	Name:
	 	Terri Sebree
	 
	 	 	 	 	 	 
	Title:

	 	President
	 	Title:
	 	President
	 
	 	 	 	 	 	 
	Date:

	 	10-17-08
	 	Date:
	 	9-21-08

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

EXHIBIT C

PROPOSAL P08.108R1

 

Quotation P08.108R1

[**]

	 	 	 

	CLIENT:

	 	NuPathe, Inc.
	 
	 	 
	DATE:

	 	September 16, 2008
	 
	 	 
	COST:

	 	$[**]

SUMMARY

Brookwood has prepared the following revised quotation for activities to be performed in support of
[**]. In the plan of work we have listed the specific activities for each of the tasks with an
estimate for labor hours and total cost.

PLAN OF WORK

[**]

BUSINESS SECTION

The cost and time values are estimates only. The actual charges will depend on the effort and time
our staff members spend on the project. In no instance will we exceed the estimated cost without
written authorization from NuPathe.

The plan of work and scope of the proposed tasks may be changed by mutual consent of both Brookwood
Pharmaceuticals and NuPathe. Any changes may affect (increase or decrease) the estimated cost. Any
changes to the project will be undertaken in accordance with the procedures described in the
Feasibility Evaluation Agreement.

Agreements

If this proposal is agreeable to NuPathe please contact [**]. We will work with NuPathe to quickly
establish the appropriate document to approve the budget increase and initiate the work plan
described above.

Proposal Stipulations

The offer expressed or implied in this proposal will be valid until 30 September 2008. This
document is for the purpose of establishing a clear understanding of the work requested by NuPathe.

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

756 Tom Martin Drive • Birmingham, AL 35211 •
Phone: 205 917 2200 • Facsimile: 205 917 2205 • www.brookwoodpharma.com

1

 

It is anticipated that the work described in this proposal will be performed under the terms of the
Feasibility Evaluation Agreement.

Proposal P08.108R1

756 Tom Martin Drive • Birmingham, AL 35211 •
Phone: 205 917 2200 • Facsimile: 205 917 2205 • www.brookwoodpharma.com

2

 

ADDENDUM NUMBER FIVE

TO THE

FEASIBILITY EVALUATION AGREEMENT

BETWEEN

BROOKWOOD PHARMACEUTICALS, INC.

AND

NUPATHE INC.

BACKGROUND

This ADDENDUM NUMBER FIVE is issued pursuant to Paragraphs 2(d) and 16(d) of the FEASIBILITY
EVALUATION AGREEMENT (“AGREEMENT”) between BROOKWOOD PHARMACEUTICALS, INC. (“BROOKWOOD”) and
NUPATHE INC. (“NUPATHE”) that became effective on March 19, 2007. BROOKWOOD is now doing business
as SURMODICS PHARMACEUTICALS, INC. (“SURMODICS”).

Now, therefore, in consideration of the mutual promises and covenants contained herein, AND
INTENDING TO BE LEGALLY BOUND, NUPATHE and SURMODICS hereby agree to amend the AGREEMENT as
follows:

Paragraph 2(a)

[**]

Paragraph 8(a)

Intent: To clarify negotiation of the license agreement

The first sentence of Paragraph 8(a) is hereby deleted and replaced with the following language:

At any time during the Option Period, CLIENT may exercise the option granted herein by providing
written notice to SURMODICS; provided, however, that the parties agree to begin negotiation of a
license agreement no later than June 15, 2009 and shall use commercially reasonable efforts to
execute the license agreement by September 19, 2009.

Except as hereby amended in accordance with Paragraphs 2(a) and l6(d) of the AGREEMENT, all other
terms and conditions of the AGREEMENT shall remain in full force and effect. Capitalized terms used
herein and not otherwise defined herein shall have the meanings set forth in the AGREEMENT. This
ADDENDUM NUMBER FIVE is made effective as of the date of the last signature below and is
incorporated into and made a part of the AGREEMENT.

(SIGNATURE PAGE FOLLOWS)

 
 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

 

Accepted, acknowledged, and agreed to:

	 	 	 	 	 	 	 

	SURMODICS PHARMACEUTICALS, INC.	 	NUPATHE INC.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Arthur J. Tipton
	 	By:
	 	/s/ Jane H. Hollingsworth
	 

	 	 
	 	 	 	 
	 
	 	 	 	 	 	 
	Name:

	 	Arthur J. Tipton
	 	Name:
	 	Jane Hollingsworth
	 
	 	 	 	 	 	 
	Title:

	 	President
	 	Title:
	 	CEO
	 
	 	 	 	 	 	 
	Date:

	 	3-18-09
	 	Date:
	 	March, 10, 2009

 

 

ADDENDUM NUMBER SIX

TO THE

FEASIBILITY EVALUATION AGREEMENT

BETWEEN

SURMODICS PHARMACEUTICALS, INC.

AND

NUPATHE, INC.

BACKGROUND

This ADDENDUM NUMBER SIX is issued pursuant to Paragraph 13(d) of the FEASIBILITY EVALUATION
AGREEMENT (“AGREEMENT”) between SURMODICS PHARMACEUTICALS, INC. (“SURMODICS”) and NUPATHE, INC.
(“NUPATHE”) that became effective on March 19, 2007.

Now, therefore, in consideration of the mutual promises and covenants herein contained, NUPATHE and
SURMODICS hereby agree to amend the AGREEMENT as follows:

Paragraph 2(a)

Intent: To extend the term of the AGREEMENT.

Paragraph 2(a) is hereby deleted and replaced with the following language:

“This AGREEMENT shall become effective on the date written above and shall terminate as mutually
agreed by the parties, except as otherwise provided herein.”

Paragraph 3(b)

Intent: To increase the budget for the Project to include the work described in Proposal
Number P10.019R2.

Paragraph 3(b) is amended to include the following additional language:

CLIENT’s liability for payment of charges in carrying out the activities performed by SURMODICS as
described in Proposal Number P10.019R2 shall not exceed [**] U.S. Dollars ($[**]) without the
written consent of CLIENT. SURMODICS shall invoice CLIENT on a monthly basis for charges incurred
on the Project.

Exhibit C

Intent: To incorporate Proposal Number P10.019R2 into Exhibit C.

Proposal P10.019R2 is hereby made part of Exhibit C.

Except as hereby amended in accordance with Paragraph 13(d) of the AGREEMENT, all other terms and
conditions remain in full force and effect. Capitalized terms used herein but not defined shall
have the meanings ascribed to them in the AGREEMENT. This ADDENDUM NUMBER SIX is made effective as
of the date of the last signature below and is hereby incorporated and made a part of the
AGREEMENT.

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

 

Accepted, acknowledged, and agreed to:

	 	 	 	 	 	 	 

	SURMODICS PHARMACEUTICALS, INC.	 	NUPATHE INC.
	 
	 	 	 	 	 	 
	By:

	 	Arthur J. Tipton, Ph.D.
	 	By:
	 	Terri Sebree
	 

	 	 
	 	 	 	 
	 
	 	 	 	 	 	 
	Name:

	 	Arthur J. Tipton
	 	Name:
	 	Terri Sebree
	 
	 	 	 	 	 	 
	Title:

	 	President
	 	Title:
	 	President
	 
	 	 	 	 	 	 
	Date:

	 	21 May 2010
	 	Date:
	 	May 18, 2010

 

EXHIBIT C

PROPOSAL P10.019R2

 

Proposal To:

NuPathe, Inc.

Development and Production of Ropinirole

Implants for Clinical Evaluation

Proposal P10.019R2

14 May 2010

 

 

This document is SurModics Pharmaceuticals’ Proposal P10.019R2. It contains proprietary information belonging

to SurModics Pharmaceuticals. Its contents should be handled according to the terms of the Feasibility Evaluation

Agreement between SurModics Pharmaceuticals and Nupathe, Inc.

 

SUMMARY

This is SurModics Pharmaceuticals’ proposal to NuPathe, Inc. to continue the development and
production of Ropinirole implants suitable for [**]. The proposed plan and scope include [**].

The plan of work described assumes that [**]. In addition, the plan includes all the documentation
required for the GMP batches.

PLAN OF WORK

[**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

756 Tom Martin Drive • Birmingham, AL 35211 •
Phone: 205 917 2200 • Facsimile: 205 917 2205 • www.brookwoodpharma.com

 

[**]
[A total of four pages have been redacted and filed separately
with the Securities and Exchange Commission.]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

756 Tom Martin Drive • Birmingham, AL 35211 •
Phone: 205 917 2200 • Facsimile: 205 917 2205 • www.brookwoodpharma.com

 

BUSINESS SECTION

A. Time and Cost Estimates

The estimated time to complete the program is [**]. The estimated cost of the proposed program is
$[**].

The time and cost values are estimates only. The actual charges will depend on the effort and time
our staff members spend on the project. If it requires less than the anticipated effort to complete
the plan of work, the cost will be less than the estimated figure. On the other hand, if we
encounter unexpected difficulties, we may not be able to complete this project within the estimated
time or cost.

The plan of work and scope of the proposed project may be changed by mutual consent of both
SurModics Pharmaceuticals and NuPathe. Any changes may affect (increase or decrease) the estimated
cost.

B. Agreements

If this proposal is agreeable to NuPathe, please contact [**].

C. Proposal Stipulations

The offers expressed or implied in this proposal will be valid until [**]. This document is for the
purpose of establishing a clear understanding of our potential relationship only. It does not
constitute a legal agreement. Until the appropriate project initiation document is executed, no
terms or conditions within this document should be construed as any firm offer or commitment, nor
should this document be construed as a constraint to preclude or limit concurrent discussions with
other parties regarding substantially identical, similar, or related subject matter. If this
proposal is agreeable, please contact [**] to initiate the proper agreement.

This proposal contains information that is proprietary to SurModics Pharmaceuticals. It should be
handled according to the terms of the current feasibility evaluation agreement between SurModics
Pharmaceuticals and NuPathe.

SurModics Pharmaceuticals Proposal P10.019R2

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

756 Tom Martin Drive • Birmingham, AL 35211 •
Phone: 205 917 2200 • Facsimile: 205 917 2205 • www.brookwoodpharma.com

 

[**]

 

			
	**	 	CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

756 Tom Martin Drive • Birmingham, AL 35211 •
Phone: 205 917 2200 • Facsimile: 205 917 2205 • www.brookwoodpharma.com

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