Development and License Agreement Between NuPathe Inc. and LTS Lohmann Therapie-Systeme AG

Exhibit 10.2

Development and License Agreement

Between

NuPathe Inc.

and

LTS ▇▇▇▇▇▇▇ 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.

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

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

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

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

DEVELOPMENT AND LICENSE AGREEMENT

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

AND

NuPathe Inc., a corporation organized under the laws of Delaware having a principal place of business at ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇ (“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:

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.

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

		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.

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

		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.

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

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.

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.

		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

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.

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

			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

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;

	(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.

		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

		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

		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

		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

		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.

(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.

		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”).

	(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

			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”.

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

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 ▇▇▇▇▇▇▇ 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.

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

			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.

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).

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.

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.

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

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,

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

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

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.

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 ▇▇▇▇▇▇▇ Therapie-Systeme AG		NuPathe Inc.
/s/ ▇▇▇▇▇▇		/s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇▇▇
Name: ▇▇▇▇▇▇		Name: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇
Title: General Counsel		Title: CEO
Place, Date: Andernach, 12.09.2007		Place, Date: Conshohocken, PA 14-09-2007
/s/ ppa. ▇▇▇▇ ▇▇▇▇▇▇		/s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇▇▇
Name: ▇▇▇▇ ▇▇▇▇▇▇		Name: ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇
Title: Head of Sales and Marketing		Title: CEO
Place, Date: Andernach, 12.09.2007		Place, Date: Conshohocken, PA 14-09-2007

ANNEX A Active Principle Specifications

LTS ▇▇▇▇▇▇▇ 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		▇▇. ▇▇▇▇▇▇ PhE 2/1		2 jährlich
Empfangs-Berechtigte(r)/authorized recipient(s)				Genehmigt/approved
Name,Datum,Unterschrift/name,date,signature
				F + E
▇▇▇▇ ▇▇. ▇▇▇▇▇▇				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 ▇▇		▇▇▇▇ ▇▇. ▇▇▇▇▇▇ ▇▇▇▇ ▇▇. ▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇. ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇. ▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇. ▇▇▇▇▇ Frau ▇▇▇▇▇ ▇▇▇▇ Brathuhn

Querverweis/cross-reference

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

Schlüssel-Wörter/key-words

LTS ▇▇▇▇▇▇▇ 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
		[**]

LTS ▇▇▇▇▇▇▇ 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
[**]		[**]		[**]
[**]		[**]		[**]
[**]		[**]		[**]
[**]		[**]		[**]
[**]		[**]
[**]				[**]
[**]				[**]
[**]				[**]
[**]				[**]
[**]				[**]
[**]				[**]
[**]		[**]		[**]

LTS ▇▇▇▇▇▇▇ 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
		[**]		[**]

LTS ▇▇▇▇▇▇▇ 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

[**]

LTS ▇▇▇▇▇▇▇ 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
		[**]

LTS ▇▇▇▇▇▇▇ 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

[**]

LTS ▇▇▇▇▇▇▇ 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

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.]

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 ▇▇▇▇▇▇▇ Therapy Systems Corp. in West ▇▇▇▇▇▇▇▇, 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 ▇▇▇▇▇▇▇▇ Facility, to have the Product manufactured by a third party. In this event LTS shall

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.

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).

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.

ANNEX D     Specifications

0700504

LTS ▇▇▇▇▇▇▇ 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 ▇▇. ▇▇▇▇▇▇		jährlich

Empfangs-Berechtigte(r)/authorized recipients(s)		Genehmigt/approved
Name,Datum,Unterschrift/name,date,signature
		QAO       [ILLEGIBLE]
PhE 2/1 ▇. ▇▇▇▇▇▇
Analagen/enclosure(s)		F + E       [ILLEGIBLE]
		QK-Leitung       [ILLEGIBLE]
		RA       [ILLEGIBLE]

Verteiler/distribution		Empfänger/recipient(s)		Datum, Unterschrift/
				date, signature
PhE 2/1		▇▇▇▇ ▇▇. ▇▇▇▇▇▇
QAO		▇▇▇▇ ▇▇. ▇▇▇▇▇▇
RA		Hr. ▇▇. ▇▇▇▇▇▇
B		▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
QK-Archiv		Frau ▇▇▇▇▇
LL		▇▇▇▇ ▇▇▇▇▇
		[ILLEGIBLE]
QK II		▇▇▇▇ ▇▇▇▇▇
PhA4		Frau ▇▇. ▇▇▇▇▇▇
PhA2		▇▇▇▇ ▇▇. ▇▇▇▇▇▇▇▇
QK I		▇▇▇▇ ▇▇. ▇▇▇▇▇▇
QS-SDK		▇▇▇▇ Grzembke

Querverweis/cross-reference

Schlüssel-Wörter/key-words
[**]

LTS ▇▇▇▇▇▇▇ 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		[**]		[**]		[**]

LTS ▇▇▇▇▇▇▇ 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

0700505

LTS ▇▇▇▇▇▇▇ 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 ▇▇. ▇▇▇▇▇▇		jährlich

Empfangs-Berechtigte(r)/authorized recipients(s)		Genehmigt/approved
Name,Datum,Unterschrift/name,date,signature
		QAO       [ILLEGIBLE]
PhE 2/1 ▇. ▇▇▇▇▇▇
Analagen/enclosure(s)		F + E       [ILLEGIBLE]
		QK-Leitung       [ILLEGIBLE]
		RA       [ILLEGIBLE]

Verteiler/distribution		Empfänger/recipient(s)		Datum, Unterschrift/
				date, signature
PhE 2/1		▇▇▇▇ ▇▇. ▇▇▇▇▇▇
QAO		▇▇▇▇ ▇▇. ▇▇▇▇▇▇
RA		Hr. ▇▇. ▇▇▇▇▇▇
B		▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
QK-Archiv		Frau ▇▇▇▇▇
LL		▇▇▇▇ ▇▇▇▇▇
		[ILLEGIBLE]
QK II		▇▇▇▇ ▇▇▇▇▇
PhA4		Frau ▇▇. ▇▇▇▇▇▇
PhA2		▇▇▇▇ ▇▇. ▇▇▇▇▇▇▇▇
QK I		▇▇▇▇ ▇▇. ▇▇▇▇▇▇
QS-SDK		▇▇▇▇ Grzembke

Querverweis/cross-reference

Schlüssel-Wörter/key-words

LTS ▇▇▇▇▇▇▇ 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		[**]		[**]		[**]

LTS ▇▇▇▇▇▇▇ 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

ANNEX E Active Principle Data

		Material Safety Data Sheet
		▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇		Telephone calls: (▇▇▇) ▇▇▇-▇▇▇▇ 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.

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

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