Document:

exv10w4

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 [**] 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-

 

			
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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

 
 

			
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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

 

			
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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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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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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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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.

 

 

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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 [**].

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.

 

			
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     (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 [**], 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.

 

			
	**	 	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

     (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.

 

			
	**	 	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

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
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

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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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

3

 

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 [**]

 

			
	**	 	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.

4

 

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.

[**]

 

			
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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

5

 

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.

6

 

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

 

			
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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

7

 

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

[**].

 

			
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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 [**] 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, [**].

 

			
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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.

 

			
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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.

 
 

			
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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

 

[**]

 

			
	**	 	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.comexv10w5

Exhibit 10.5

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.

LICENSE AGREEMENT

     THIS LICENSE AGREEMENT (this “Agreement”), effective as of September 23, 2009 (the
“Effective Date”), is entered into between SURMODICS PHARMACEUTICALS, INC., a Delaware
corporation (“SMP”), having a place of business at 750 Lakeshore Parkway, Birmingham,
Alabama 35211, U.S.A., and NUPATHE, INC., a Delaware corporation (“NUPATHE”), having a
place of business at 227 Washington Street, Suite 200, Conshohocken, Pennsylvania 19428, U.S.A.
with respect to the following facts:

     WHEREAS, SMP is the owner or exclusive licensee of certain technology, patent rights and
know-how rights related to the SMP Technology (as defined below);

     WHEREAS, NUPATHE is the owner or exclusive licensee of certain technology, patent rights and
know-how rights related to compositions and methods of the NUPATHE Technology (as defined below) in
conjunction with the Active Agent (as defined below);

     WHEREAS, NUPATHE desires to obtain from SMP and SMP desires to grant to NUPATHE, a license
under the SMP IP Rights (as defined below) upon the terms and conditions of this Agreement.

     NOW, THEREFORE, in consideration of the foregoing and the mutual covenants herein contained,
the parties hereby agree as follows:

     1. DEFINITIONS. Capitalized terms used in this Agreement and not otherwise defined
herein, shall have the meanings assigned to such terms in the Development Agreement.

          1.1 “Active Agent” shall mean the non-ergoline dopamine agonist known as ropinirole
(including the hydrochloride salt and free base).

          1.2 “Affiliate” shall mean, with respect to a party, any entity that controls or is
controlled by such party, or is under common control with such party. For purposes of this
definition, an entity shall be deemed to control another entity if it owns or controls, directly or
indirectly, at least fifty percent (50%) of the voting equity of another entity (or other
comparable interest for an entity other than a corporation).

          1.3 “Commercially Reasonable Efforts” shall mean those efforts and resources
consistent with the exercise of prudent scientific and business judgment, as applied to other
pharmaceutical products of similar market potential and market size and at a similar stage in the
development or life of such product and which are consistent with the general level of efforts and
resources in the pharmaceutical industry for a company similar in size and scope.

          1.4 “Confidential Information” shall mean all information and data that (a) is
provided by one party to the other party under this Agreement, and (b) if disclosed in writing or
other tangible medium is marked or identified as confidential at the time of disclosure to the
recipient, is acknowledged at the time of disclosure to be confidential, or otherwise should
reasonably be deemed to be confidential. Notwithstanding the foregoing, Confidential Information
of a party shall not include that portion of such information and data which, and only to the
extent, the recipient can establish by written documentation: (i) is known to the

1

 

recipient as evidenced by its written records before receipt thereof from the disclosing
party, (ii) is disclosed to the recipient free of confidentiality obligations by a third person who
has the right to make such disclosure, (iii) is or becomes part of the public domain through no
fault of the recipient, or (iv) the recipient can reasonably establish is independently developed
by persons on behalf of recipient without access to or use of the information disclosed by the
disclosing party (each, a “Confidentiality Exception”).

     1.5 “Delivery Matrix” shall mean the controlled delivery system comprising a
biodegradable matrix composed of [**] developed or optimized pursuant to the Development Program
for use by NUPATHE to deliver the Active Agent.

     1.6 “Development Agreement” shall mean that certain Feasibility Evaluation Agreement
between the parties dated March 19, 2007, as may be amended or restated from time to time by the
mutual written agreement of the parties.

     1.7 “Development Program” shall mean the development program conducted by the parties
pursuant to the Development Agreement.

     1.8 “Field” shall mean [**].

     1.9 “First Commercial Sale” shall mean the first sale of the Product by NUPATHE, its
sublicensee or their respective Affiliates to customers who are not Affiliates in any country after
all applicable marketing approvals (if any) have been granted by the applicable governing health
authority.

     1.10 “IND” shall mean an Investigational New Drug application or similar application
required to commence human clinical testing of a product submitted to the FDA or its foreign
equivalent.

     1.11 “Joint Research Inventions” shall mean those Research Inventions set forth in
Section 6(e) of the Development Agreement.

     1.12 “Joint Research IP Rights” shall mean, collectively, the Joint Research
Inventions and the Joint Research Patent Rights.

     1.13 “Joint Research Patent Rights” shall mean any Patent Rights that claim or cover
the Joint Research Inventions. Joint Research Patent Rights existing as of the Effective date are
set forth in Schedule 1.12 attached hereto, as may be amended from time to time.

     1.14 “Know-How” shall mean any and all proprietary technical information,
formulations, processes, data, specifications, characterization methods, characterization results,
and other proprietary information, excluding any Patent Rights with respect thereto.

     1.15 “Major European Country” shall mean any one of [**].

 

			
	**	 	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

 

          1.16 “NDA” shall mean a New Drug Application or similar application for marketing
approval of a product submitted to the FDA or its foreign equivalent.

          1.17 “Net Sales” shall mean [**].

          1.18 “NUPATHE IP Rights” shall mean, collectively, the NUPATHE Patent Rights and the
NUPATHE Know-How Rights.

          1.19 “NUPATHE Know-How Rights” shall mean all Know-How owned and controlled by
NUPATHE, existing as of the Effective Date, that relates to the NUPATHE Technology and that is
reasonably necessary or useful to develop, obtain regulatory approval for, manufacture, use, or
otherwise commercially exploit the Active Agent or the Product in the Field. All NUPATHE Know-How
Rights that do not fall within the scope of a Confidentiality Exception shall be the Confidential
Information of NUPATHE.

          1.20 “NUPATHE Patent Rights” shall mean, collectively, all Patent Rights owned or
controlled by NUPATHE that claim or cover the NUPATHE Technology.

          1.21 “NUPATHE Research Inventions” shall mean those Research Inventions set forth in
Section 6(c) of the Development Agreement.

          1.22 “NUPATHE Research IP Rights” shall mean shall mean collectively the NUPATHE
Research Inventions and the NUPATHE Research Patent Rights.

          1.23 “NUPATHE Research Patent Rights” shall mean all Patent Rights that claim or cover
the NUPATHE Research Inventions.

          1.24 “NUPATHE Technology” shall mean, collectively, all compositions, formulations,
methods, processes, uses, technology, data and information, owned and controlled by NUPATHE and
existing as of the Effective Date, that comprise, are responsible for, derive or

result from
or relate to [**]; provided, however, that NUPATHE Technology shall exclude the Product and all
uses thereof. All NUPATHE Technology that does not fall within the scope of a Confidentiality
Exception shall be the Confidential Information of NUPATHE.

          1.25 “Patent Rights” shall mean any of the following, whether existing now or in the
future anywhere in the world (i) any issued patent, including inventor’s certificates,
substitutions, extensions, supplemental protection certificates, confirmations, reissues,
reexaminations, renewals, or any like governmental grant for protection of inventions and (ii) any
pending applications for any of the foregoing, including any continuation, divisional,
substitution, continuations-in-part, provisional and converted provisional applications.

          1.26 “Phase III Clinical Trial” shall mean a pivotal human clinical trial in any
country the results of which could be used to establish safety and efficacy of a product as a basis
for an NDA or that would otherwise satisfy requirements of 21 CFR 312.21(c).

 

			
	**	 	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

 

          1.27 “Product” shall mean a biodegradable, preformed, macroscopic implant device
consisting of the Active Agent, as the sole active pharmaceutical ingredient, incorporated into the
Delivery Matrix.

          1.28 “Research Inventions” shall mean collectively all inventions, Know-How, trade
secrets, discoveries, development, methods, techniques, formulae, processes and compositions of
matter, whether or not patentable, resulting or derived from or directly relating to SMP’s and/or
NUPATHE’ s activities under the Development Agreement.

          1.29 “Royalty Term” shall mean, on a country-by-country basis, the period equal to the
longer of: (a) the date on which the Product ceases to be covered by a Valid Claim in such country
or (b) [**] from the date of the First Commercial Sale of the Product in such country.

          1.30 “SMP IP Rights” shall mean, collectively, the SMP Know-How Rights and the SMP
Patent Rights.

          1.31 “SMP Know-How Rights” shall mean all Know-How owned and controlled by SMP,
existing as of the Effective Date, that relates to the SMP Technology and that is reasonably
necessary or useful to develop, obtain regulatory approval for, manufacture, use, or otherwise
commercially exploit the Product in the Field. All SMP Know-How Rights that does not fall within
the scope of a Confidentiality Exception shall be the Confidential Information of SMP.

          1.32 “SMP Patent Rights” shall mean, collectively, the Patent Rights that claim or
cover the SMP Technology. The SMP Patent Rights existing as of the Effective Date and covered by
this Agreement are set forth on Schedule 1.32 attached hereto, as may be amended from time to time.

          1.33 “SMP Research Inventions” shall mean those Research Inventions set forth in
Sections 6(d) of the Development Agreement.

          1.34 “SMP Research IP Rights” shall mean collectively (a) the SMP Research Inventions,
and (b) the SMP Research Patent Rights.

          1.35 “SMP Research Patent Rights” shall mean all Patent Rights that claim or cover the
SMP Research Inventions.

          1.36 “SMP Technology” shall mean, collectively, all compositions, formulations,
methods, processes, uses, technology, data and information, owned and controlled by SMP and
existing as of the Effective Date, that comprise, are responsible for, derive or result from or
relate to [**]; provided, however, that SMP Technology shall exclude the Product and all uses
thereof. All SMP Technology that does not fall within the scope of a Confidentiality Exception
shall be the Confidential Information of SMP.

          1.37 “Sublicense” shall mean any license granted by NUPATHE (including its Affiliates or
sublicensees) of the rights granted under Section 3.1.1 (including without limitation

 

			
	**	 	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.

4

 

any promotion, marketing, distribution, joint venture or other arrangement conferring such rights
and intending to provide for the commercialization of products, including the Product) to a third
party.

          1.38 “Territory” shall mean all the countries in the world.

          1.39 “Valid Claim” shall mean either (a) a claim of an issued and unexpired patent
included within the SMP Patent Rights or SMP Research Patent Rights, which has not been held
permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which
has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, or
(b) a claim of a pending patent application included within the SMP Patent Rights or SMP Research
Patent Rights, which claim was filed in good faith and has not been abandoned or finally disallowed
without the possibility of appeal or refiling of such application.

     2. REPRESENTATIONS AND WARRANTIES; COVENANTS.

          2.1 Mutual Representations and Warranties. Each party represents and warrants to the
other party as follows:

               2.1.1 Organization. Such party is duly organized, validly existing and in good
standing under the laws of the jurisdiction in which it is organized.

               2.1.2 Authorization and Enforcement of Obligations. Such party (a) has the requisite
power and authority and the legal right to enter into this Agreement and to perform its obligations
hereunder; and (b) has taken all requisite action on its part to authorize the execution and
delivery of this Agreement and the performance of its obligations hereunder. This Agreement has
been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding
obligation, enforceable against such party in accordance with its terms.

               2.1.3 Consents. All necessary consents, approvals and authorizations of all
governmental authorities and other persons or entities required to be obtained by such party in
connection with this Agreement have been obtained.

               2.1.4 No Conflict. The execution and delivery of this Agreement and the performance
of such party’s obligations hereunder (a) do not conflict with or violate any requirement of
applicable laws, regulations or orders of governmental bodies; and (b) do not conflict with, or
constitute a default under, any contractual obligation of such party.

          2.2 NUPATHE Representations and Warranties. NUPATHE represents and warrants to SMP
that, as of the Effective Date:

               2.2.1 To the best of NUPATHE’S knowledge and belief NUPATHE has, sufficient and/or beneficial
title under the NUPATHE IP Rights to enable SMP to perform the activities contemplated under the
Development Program. To NUPATHE’s actual knowledge,

5

 

NUPATHE has not received any notice, claim or assertion from any third party that the use of
the NUPATHE IP Rights (including with respect to the Active Agent) in a manner contemplated under
the Development Program would constitute infringement or misappropriation of the intellectual
property rights of any third party.

          2.3 SMP Representations and Warranties: SMP represents and warrants to NUPATHE that,
as of the Effective Date:

               2.3.1 SMP is the owner of the SMP Patent Rights listed on Exhibit 1.32 and of the
items included in the SMP Know-How Rights and, as of the Effective Date, the Patent Rights listed
on Exhibit 1.32 are the only Patent Rights owned or controlled by SMP, or in which SMP has
any rights, that are directed to the SMP Technology or the Product in the Field.

               2.3.2 To SMP’s actual knowledge, SMP has not received any notice, claim or assertion from any
third party that the SMP IP Rights as incorporated into the Product would infringe or
misappropriate any intellectual property rights of any third party.

          2.4 DISCLAIMER OF WARRANTIES-SMP. EXCEPT AS EXPRESSELY SET FORTH IN THIS SECTION 2,
SMP MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE SMP IP RIGHTS,
INCLUDING WITHOUT LIMITATION, ANY REPRESENTATION OR WARRANTY REGARDING VALIDITY, ENFORCEABILITY,
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT. THE SMP IP RIGHTS ARE
PROVIDED “AS IS.”

          2.5 DISCALIMER OF WARRANTIES-NUPATHE. EXCEPT AS EXPRESSELY SET FORTH IN THIS SECTION 2,
NUPATHE MAKES NO REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, REGARDING THE NUPATHE IP
RIGHTS, INCLUDING WITHOUT LIMITATION, ANY REPRESENTATION OR WARRANTY REGARDING VALIDITY,
ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT. THE NUPATHE
IP RIGHTS ARE PROVIDED “AS IS.”

          2.6 NUPATHE Covenant. NUPATHE shall at all times during the term of this Agreement
comply and use Commercially Reasonable Efforts to cause its sublicensees and Affiliates to comply
with all laws that may control or apply to the research, testing, development, distribution or
marketing of the Product or any other activity undertaken pursuant to this Agreement.

     3. LICENSE GRANT.

          3.1 License Grant to NUPATHE.

               3.1.1 On the terms and conditions of this Agreement, SMP hereby grants to NUPATHE an exclusive,
even as to SMP, worldwide, royalty-bearing license under the SMP IP Rights, SMP Research IP Rights,
and SMP’s rights under the Joint Research IP Rights to

 

			
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develop, make, have made, use, offer for sale, sell, have sold, export and import the Product for
use in the Field.

               3.1.2 NUPATHE shall have the right to grant Sublicenses (a) to third parties, other than
Affiliates, for the purpose of developing or commercializing the Product in each case jointly with,
or for the benefit of, NUPATHE, or (b) to Affiliates. NUPATHE shall remain responsible for all
payments due to SMP hereunder, and shall require that each of its sublicensees be bound by the
applicable terms of this Agreement. Without limiting the foregoing, any Sublicense agreement must
require that the sublicensee comply with the limitations of the license set forth in Section 3.1.1,
and confidentiality and non-use obligations (with respect to Confidential Information of SMP) that
are no less stringent than those set forth in Section 7, and must include an obligation of the
sublicensee to account for and report its Net Sales to NUPATHE on the same basis as if such Net
Sales were made by NUPATHE. Upon the written request of SMP, but no more frequently than once per
calendar quarter, NUPATHE shall provide to SMP a list of the third parties to which NUPATHE has
granted any Sublicense.

          3.2 License Grant to SMP.

               3.2.1 NUPATHE hereby grants to SMP an exclusive, worldwide, royalty free perpetual license
under NUPATHE’s rights in the Joint Research IP Rights for any and all uses that do not relate to
the Product or include NUPATHE Know-How Rights.

          3.3 Manufacturing Rights to SMP.

               3.3.1 NUPATHE hereby grants to SMP a right of first negotiation to manufacture supplies of the
Product for use in human clinical studies. NUPATHE will provide SMP with written notice of
NUPATHE’S intention to procure such clinical supplies and the proposed terms and conditions for the
manufacture, including but not limited to NUPATHE’S requirements for price, timeliness, Product
quality and Product quantity. SMP and NUPATHE will then negotiate for a period of up to [**] in an
effort to mutually agree to such terms and conditions for the manufacture of clinical supplies of
the Product. Should NUPATHE and SMP enter into a manufacturing agreement regarding clinical
supplies of the Product, SMP shall have a right of first negotiation to manufacture commercial
supplies of the Product. NUPATHE will provide SMP with written notice of NUPATHE’S intention to
procure such commercial supplies and the proposed terms and conditions for the manufacture,
including but not limited to NUPATHE’S requirements for price, timeliness, Product quality and
Product quantity. SMP and NUPATHE will then negotiate for a period of up to [**] in an effort to
mutually agree to such terms and conditions for the manufacture of commercial supplies of the
Product.

               3.3.2 In connection with any manufacturing agreement entered into between the Parties pursuant
to Section 3.3.1 above, NUPATHE will grant to SMP, for the term of such agreement, [**],
irrevocable, nonexclusive, worldwide license (with the right to grant sublicenses upon notice to
and the prior written consent of NUPATHE) as may be necessary to fulfill any manufacturing
obligations for the clinical or commercial supply of the Product under the NUPATHE IP Rights,
NUPATHE Research IP Rights and NUPATHE’S rights under the Joint Research IP Rights to make and have
made the Product solely for sale to NUPATHE, its sublicensees and their respective Affiliates.

 

			
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          3.4 No Implied Licenses; Reservation of Rights. Only licenses and rights expressly
granted herein shall be of legal force and effect. No license or other right shall be created
hereunder by implication, estoppel or otherwise. NUPATHE acknowledges that SMP’s business involves
the application of the SMP IP Rights to numerous drugs and other products and that SMP retains the
right (expressly subject to SMP’s obligations under this Agreement or under any other agreement
between the Parties) to apply its technology to drugs or products owned by SMP or any third party
and to make, use or sell drugs or products owned by SMP or any third party. For the avoidance of
doubt, no license is conferred to NUPATHE under the SMP IP Rights, SMP Research IP Rights or SMP’s
rights under the Joint Research IP Rights to research, develop, make, have made, use, offer to
sell, sell, have sold, import, export or otherwise deal in or with any product, item, device or
technology other than the Product in the Field, and SMP retains and reserves all rights that are
not explicitly granted to NUPATHE herein including the sole and exclusive right to use and exploit
SMP IP Rights, SMP Research IP Rights and SMP’s rights under the Joint Research IP Rights to
research, develop, make, have made, use, offer to sell, sell, have sold, import, export or
otherwise deal in any product, process, item, device, machine or other apparatus that is not the
Product.

          3.5 Restriction. During the Term, SMP and its Affiliates (a) may not grant a license
under the SMP IP Rights, SMP Research IP Rights, or SMP’s rights under the Joint Research IP Rights
to any third party for the development, manufacture, use, sale, import or export of a Product; and
(b) may not, for its or their own account or for any third party, directly or indirectly develop,
manufacture, use, sell, import or export a Product that is covered by the SMP IP Rights, SMP
Research IP Rights, or SMP’s rights under the Joint Research IP Rights.

     4. FINANCIAL TERMS.

          4.1 Milestone Payments.

               4.1.1 In consideration for the rights granted hereunder, upon the terms and conditions
contained herein, NUPATHE shall pay to SMP the following milestone payments within thirty (30) days
of the first achievement by NUPATHE, its Affiliates or sublicensees of each of the corresponding
events (each a “Milestone Event”):

	 	 	 	 	 
	Milestone Event	 	Payment
	[**]
	 	 	 	 
	TOTAL
	 	$	4,750,000	 

               4.1.2 In addition to the milestones set forth above, following the achievement of the
Milestone Event set forth in Section 4.1.1(iv), NUPATHE shall also pay SMP (a) USD $[**] upon
approval of the Product for commercial sale for Restless Leg Syndrome (except in the event that
Restless Leg Syndrome was the first approved indication) or any other second indication and (b) USD
$[**] upon the approval of the Product for commercial sale for each additional separate and
distinct clinical indication.

          4.2 Royalties.

 

			
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               4.2.1 Within [**] following the First Commercial Sale of the Product in each country, NUPATHE
shall give written notice to SMP thereof.

               4.2.2 In addition to the payments set forth in Section 4.1 above, and subject to the terms and
conditions of this Agreement, during the applicable Royalty Term, NUPATHE shall pay to SMP with
respect to each Product covered by a Valid Claim, a royalty of [**] ([**]%) percent of annual Net
Sales of the Product.

               4.2.3 If NUPATHE elects not to have SMP manufacture its needs for commercial supplies of the
Product, the royalty rate set forth in Section 4.2.2 above shall be increased to [**] ([**]%)
percent of annual Net Sales of the Product.

               4.2.4 If, during any calendar quarter during the applicable Royalty Term, the manufacture,
use, offer for sale, sale or import of the Product in the country in which manufactured, used,
offered for sale, sold or imported would not infringe a Valid Claim (if such Valid Claim were in an
issued patent) in such country, then the applicable royalty rate under Section 4.2.2 or 4.2.3 in
such country for such calendar quarter shall be [**].

          4.3 Royalty Reports.

               4.3.1 Within [**] after the end of each calendar quarter
following the First Commercial Sale of the Product by NUPATHE, its sublicensees or their respective
Affiliates, NUPATHE shall furnish to SMP a written report showing in reasonably specific detail, on
a country-by-country basis, (a) the gross sales of the Product sold by NUPATHE, its sublicensees
and their respective Affiliates during such calendar quarter and the calculation of Net Sales from
such gross sales; (b) the calculation of the royalties, if any, which shall have accrued based upon
such Net Sales; (c) the withholding taxes, if any, required by law to be deducted from such
royalties; and (d) the exchange rates, if any, used in determining the amount of United States
dollars.

               4.3.2 With respect to sales of the Product invoiced in United States dollars, all such amounts
shall be expressed in United States dollars. With respect to sales of the Product invoiced in a
currency other than United States dollars, all such amounts shall be expressed both in the currency
in which the sale is invoiced and in the United States dollar equivalent. The United States dollar
equivalent shall be calculated at a quarterly conversion rate for each foreign currency calculated
for the relevant quarter as the daily average of the noon buying rate in New York City for cable
transfers in foreign currencies as certified for customs purposes by the Federal Reserve Bank in
New York as these exchange rates are published at www.federalreserw.gov/releases/H10/hist. All
royalties payable hereunder shall be calculated based on Net Sales expressed in United States
dollars.

               4.3.3 NUPATHE shall keep complete and accurate records in sufficient detail to properly
reflect all gross sales and Net Sales and to enable the royalties payable to be determined.

 

			
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               4.3.4 All royalties shown to have accrued by each royalty report provided under this Section
4.3 shall be payable on the date such royalty report is due. Payment of royalties in whole or in
part may be made in advance of such due date.

          4.4 Audits.

               4.4.1 Upon the written request of SMP and not more than once in each calendar year, NUPATHE
shall permit an independent certified public accounting firm of nationally recognized standing,
selected by SMP and reasonably acceptable to NUPATHE, at SMP’s expense, to have access during
normal business hours to such records of NUPATHE as may be reasonably necessary to verify the
accuracy of the royalty reports hereunder for any year ending not more than [**] prior to the date
of such request. The accounting firm shall disclose to SMP only whether the reports are correct or
not and the specific details concerning any discrepancies. No other information shall be shared.

               4.4.2 If such accounting firm concludes that additional royalties were owed during the audited
period, NUPATHE shall pay such additional royalties within [**] of the date SMP delivers to NUPATHE
such accounting firm’s written report so concluding. The fees charged by such accounting firm
shall be paid by SMP; provided, however, if the audit discloses that the royalties payable by
NUPATHE for such period are more than [**] of the royalties actually paid for such period, then
NUPATHE shall pay the reasonable fees and expenses charged by such accounting firm.

               4.4.3 SMP shall treat all financial information subject to review under this Section 4.4 as
confidential, and shall cause its accounting firm to retain all such financial information in
confidence.

               4.4.4 Withholding Taxes. NUPATHE shall be entitled to deduct from the royalty
payments otherwise due to SMP hereunder the amount of any withholding taxes, value-added taxes or
other taxes, levies or charges with respect to such royalty payments that are required to be
withheld by NUPATHE, to the extent NUPATHE pays to the appropriate governmental authority on behalf
of SMP such taxes, levies or charges. NUPATHE promptly shall deliver to SMP proof of payment of
all such taxes, levies and other charges, together with copies of all communications from or with
such governmental authority with respect thereto.

          4.5 Payment Method. All payments by NUPATHE to SMP hereunder shall be in United
States Dollars in immediately available funds and shall be made by wire transfer from a United
States bank located in the United States to such bank account as designated from time to time by
SMP to NUPATHE.

          4.6 Interest. NUPATHE additionally shall pay SMP interest on all amounts due
hereunder which are not paid on or before the due date therefor (except amounts determined in
connection with an audit pursuant to Sections 4.4.1 and 4.4.2), calculated at a rate equal to the
lesser of one percent (1.0%) per month, or the maximum rate permitted by law, whichever is lower,
calculated on the number of days such payment is past due, compounded monthly.

     5. DEVELOPMENT PROGRAM.

 

			
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          5.1 Conduct. The parties shall perform their respective obligations under the
Development Agreement. Each party shall use its Commercially Reasonable Efforts to perform its
obligations under the Development Agreement within the proposed time schedules set forth therein.
Any intellectual property rights (including any know-how or patent rights) developed or conceived
by either party shall be governed in accordance with the terms of the Development Agreement.

          5.2 Term. The Development Program shall terminate upon the completion of the
activities described in the Development Agreement, or such other date as the parties mutually agree
in writing.

          5.3 No Warranty. SMP does not represent, warrant, or guarantee that the results or
outcome of the Development Program (or any portion thereof), or any products produced therefrom are
merchantable or satisfactory for any particular purpose, and there are no warranties, express or
implied, to such effect. NUPATHE bears the sole risk of acceptance, reliance on or use of the
results provided to NUPATHE by SMP under the Development Program.

     6. DEVELOPMENT AND COMMERCIALIZATION BY NUPATHE

          6.1 Responsibility.

               6.1.1 Except as otherwise set forth in the Development
Program and this Section 6.1, NUPATHE shall be solely responsible, at its sole cost, for conducting
the development, regulatory approval and commercialization of the Product, and shall own all
regulatory applications, filings, approvals and licenses for the Product.

          6.2 Diligence.

               6.2.1 NUPATHE shall use Commercially Reasonable Efforts to actively develop and obtain
regulatory approvals to market the Product in major markets throughout the world. Without limiting
the generality of the foregoing, NUPATHE shall achieve the following milestones within the
applicable period commencing on the Effective Date:

          [**]

          6.3 Development and Commercialization Reports. NUPATHE shall keep complete and
accurate records of its activities conducted under this Agreement and the results thereof.
Following the conclusion of the Development Program and until the First Commercial Sale in the
United States and the first Major European Country of the Product, within thirty (30) days after
the end of each June and December, NUPATHE shall prepare and provide SMP with a reasonably detailed
written report of the activities conducted under this Agreement, and the results thereof, through
such date of such report to develop and obtain regulatory approvals to market the Product in major
markets throughout the world.

 

			
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          6.4 Regulatory Communications.

          6.5 If the FDA or the governing health authorities of any country initiates any oral
communication with NUPATHE directly regarding the Delivery Matrix, NUPATHE shall have the right to
respond to such communication to the extent reasonably necessary or appropriate under the
circumstances; provided, however, that promptly thereafter, NUPATHE shall provide SMP with written
notice thereof in reasonably specific detail describing the communications regarding the Delivery
Matrix; and (c) NUPATHE promptly shall provide SMP with copies of all minutes and other materials
resulting therefrom.

          6.6 NUPATHE promptly shall provide SMP with copies of all (a) written communications from the
FDA or the governing health authorities of any country directly regarding the Delivery Matrix and
(b) filings, communications or other submission with the FDA or the governing health authorities of
any country directly regarding the Delivery Matrix.

          6.7 Adverse Event Reporting. Each party shall promptly notify the other party immediately
of any information that comes to such party’s attention concerning any serious or unexpected side
effect, injury, toxicity or sensitivity reaction, or any unexpected incidence, and

the severity thereof, associated with the clinical uses, studies, investigations, tests and marketing
of the Product. For purposes of this Section 6.7, “serious” shall mean an experience which (a)
results in the death, permanent or substantial disability, in-patient hospitalization or
prolongation of hospitalization, or (b) is a congenital anomaly, cancer, the result of an overdose
or life threatening (only if unrelated to primary disease); and “unexpected” shall mean (x) for a
nonmarketed product, an experience that is not identified in nature, severity or frequency in the
current clinical investigator’s confidential information brochure, and (y) for a marketed product,
an event which is not listed in the current labeling for such product, and includes an event that
may be symptomatically and pathophysiologically related to an experience listed in the labeling but
differs from the event because of increased frequency or greater severity or specificity. Each
party further shall promptly notify the other party of any information received regarding any
threatened or pending action by an agency that may affect the safety and efficacy claims of a
Product. Upon receipt of any such information, the parties shall consult with each other in an
effort to arrive at a mutually acceptable procedure for taking appropriate action; provided,
however, that nothing contained herein shall restrict either party’s right to make a timely report
of such matter to any government agency or take other action that it deems to be appropriate or
required by applicable law, regulation or court order.

     7. CONFIDENTIALITY.

          7.1 Confidentiality. During the term of this Agreement and for a period of [**]
following the expiration or earlier termination hereof, each party shall maintain in confidence the
Confidential Information of the other party, shall not use or grant the use of the Confidential
Information of the other party except as expressly permitted hereby, and shall not disclose the
Confidential Information of the other party except on a need-to-know basis to such party’s
Affiliates, directors, officers, employees, sublicensees, and consultants, to the extent such
disclosure is reasonably necessary in connection with such party’s activities as expressly
authorized by this Agreement. To the extent that disclosure to any person is authorized by this

 

			
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Agreement, prior to disclosure, a party shall obtain written agreement of such person to hold
in confidence and not disclose, use or grant the use of the Confidential Information of the other
party except as expressly permitted under this Agreement. Each party shall notify the other party
promptly upon discovery of any unauthorized use or disclosure of the other party’s Confidential
Information.

          7.2 Additional Permitted Disclosures. Neither party shall disclose any terms or
conditions of this Agreement to any third party without the prior consent of the other party;
provided, however, that a party may disclose the terms or conditions of this Agreement, (a) on a
need-to-know basis to its legal and financial advisors to the extent such disclosure is reasonably
necessary, and (b) to a third party in connection with (i) an equity investment in such party, (ii)
a merger, consolidation or similar transaction by such party, or (iii) the sale of all or
substantially all of the assets of such party. Notwithstanding the foregoing, prior to execution
of this Agreement, the parties have agreed upon the substance of information that can be used to
describe the terms and conditions of this transaction, and each party may disclose such
information, as modified by mutual written agreement of the parties, without the consent of the
other party.

          7.3 Exceptions. The confidentiality obligations under this Section 7 shall not apply
to the extent that a party is required to disclose information by applicable law, regulation or
order of a governmental agency or a court of competent jurisdiction; provided, however, that such
party shall provide written notice thereof to the other party, consult with the other party with
respect to such disclosure and provide the other party sufficient opportunity to object to any such
disclosure or to request confidential treatment thereof

     8. INDEMNIFICATION AND INSURANCE.

          8.1 By NUPATHE. NUPATHE shall indemnify and hold harmless SMP, and its directors,
officers, employees and agents, from and against all losses, liabilities, damages and expenses,
including reasonable attorneys’ fees and costs (collectively, “Liabilities”), resulting from any
claims, demands, actions or other proceedings by any third party to the extent resulting from (a)
the breach of any representation, warranty or covenant by NUPATHE under this Agreement; (b) the
manufacture, use, sale, handling or storage of the Product by or on behalf of NUPATHE, its
sublicensees or their respective Affiliates, customers or end-users (including with respect to the
infringement or misappropriation of intellectual property rights of third parties); or (c) the use
of the Confidential Information of SMP by NUPATHE, its sublicensees or their respective Affiliates.
NUPATHE’s indemnity obligation under this Section 8.1 will not apply where the basis for the
Liabilities is the negligence or willful malfeasance of SMP or SMP’s breach of its representations,
warranties and agreements contained herein.

          8.2 By SMP. SMP shall indemnify and hold harmless NUPATHE, and its directors, officers,
employees and agents, from and against all Liabilities resulting from any claims, demands, actions
or other proceedings by any third party to the extent resulting from (a) the breach of any
representation, warranty or covenant by SMP under this Agreement; or (b) the use by SMP of the
Confidential Information of NUPATHE. SMP’s indemnity obligation under this Section 8.2 will not
apply where the basis for the Liabilities is the negligence or willful

13

 

malfeasance of NUPATHE or NUPATHE’s breach of its representations, warranties and agreements
contained herein.

          8.3 Procedure. If a party (the “Indemnitee”) intends to claim indemnification
under this Section 8, it shall promptly notify the other party (the “Indemnitor”) in
writing of any claim, demand, action or other proceeding for which the Indemnitee intends to claim
such indemnification, and the Indemnitor shall have the right to participate in, and, to the extent
the Indemnitor so desires, to assume the defense thereof with counsel mutually satisfactory to the
parties; provided, however, that an Indemnitee shall have the right to retain its own counsel, with
the reasonable fees and expenses to be paid by the Indemnitor, if representation of such Indemnitee
by the counsel retained by the Indemnitor would be inappropriate due to actual or potential
differing interests between the Indemnitee and any other party represented by such counsel in such
proceeding. The obligations of this Section 8 shall not apply to amounts paid in settlement of any
claim, demand, action or other proceeding if such settlement is effected without the consent of the
Indemnitor, which consent shall not be withheld or delayed unreasonably. The failure to deliver
written notice to the Indemnitor within a reasonable time after the commencement of any such
action, if prejudicial to its ability to defend such action, shall relieve the Indemnitor of any
obligation to the Indemnitee under this Section 8. The Indemnitee, its employees and agents, shall
reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any
claim, demand, action or other proceeding covered by this Section 8.

          8.4 Insurance. Each party shall maintain insurance, including product liability and
general liability insurance, with respect to its activities under this Agreement regarding the
Product in such amount as such party customarily maintains with respect to similar activities for
its other products, but not less than such amount as is reasonable and customary in the industry
for companies of comparable size and activities. Each party shall maintain such insurance for so
long as it continues its activities under this Agreement, and thereafter for so long as such party
customarily maintains insurance for itself covering similar activities for its other products.

     9. PATENTS AND INFRINGEMENT.

          9.1 Prosecution of SMP Patent Rights and SMP Research Patent Rights.

               9.1.1 SMP shall have the sole and absolute right, at its sole expense, to exercise control
over the SMP IP Rights and the SMP Research IP Rights, including but not limited to, responsibility
for prosecuting, maintaining, abandoning and obtaining Patent Rights and other similar
registrations related to the SMP Patent Rights or the SMP Research Patent Rights. SMP shall (a)
consider in good faith the interests of NUPATHE in so doing, (b) keep NUPATHE reasonably informed
with respect to such activities, including providing to NUPATHE complete copies of all patents and
patent applications that claim or cover the Product; and (c) consult in good faith with NUPATHE
regarding such matters, including the modification or abandonment of any claims thereof covering a
Product for use in the Field.

               9.1.2 In the event SMP wishes to abandon any patent, patent application or claim within the SMP
Patent Rights or SMP Research Patent Rights that claims or covers the Product, SMP will offer to
assign, free of charge, any such patent to NUPATHE prior to

14

 

effectuating the abandonment. Should NUPATHE elect to become an assignee of such SMP Patent Rights
or SMP Research Patent Rights, NUPATHE will bear the costs connected to any assignment hereunder
and shall have the right to prosecute and maintain such patent, patent application or claim at its
sole expense.

          9.2 Prosecution of Joint Research Patents.

               9.2.1 With respect to all Joint Research Inventions, the parties shall determine which party
shall be responsible for filing, prosecuting, maintaining and defending Joint Research Patent
Rights 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.

               9.2.2 At least [**] prior to the contemplated filing of any patent applications related to
Joint Research Inventions, the Responsible Party shall submit a substantially completed draft
application to the other party for its approval, which shall not be unreasonably withheld or
delayed. The other party shall also execute such documents and perform such acts as may be
reasonably necessary to prepare, file, prosecute or maintain any such Joint Research Patent Rights.

               9.2.3 Except as set forth below, the parties shall share equally the costs of the
preparation, filing, prosecution and maintenance of all Joint Research Patent Rights. If the
Responsible Party does not wish to file, prosecute or maintain any Joint Research Patent Rights in
a particular country, it shall grant the other party any necessary authority to file, prosecute or
maintain such Joint Research Patent Rights. If either party elects not to pay its portion of any
shared costs in connection with the filing, prosecution, or maintenance of any particular Joint
Research Patent Rights, the other party may file, prosecute, or maintain such Joint Research Patent
Rights 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 Joint Research Patent
Rights to the other party.

          9.3 Enforcement.

               9.3.1 Notice. At any time during the term of this Agreement, SMP and NUPATHE shall
each promptly notify the other in writing upon learning of any Infringing Product. As used herein,
“Infringing Product” shall mean any product sold by a third party in the Field that (a) is
formulated as a biodegradable, preformed, macroscopic implant device composed of [**]; (b) contains
the Active Agent; and (c) infringes or is alleged to infringe any of the SMP IP Rights or the Joint
Research IP Rights licensed to NUPATHE hereunder covering a Product.

               9.3.2 SMP IP Rights. SMP shall have the sole right, at its discretion and expense, to
enforce the SMP IP Rights and any SMP Research IP Rights against an Infringing Product to the
extent such enforcement relates to the SMP Technology. Upon receipt of a written notice from
NUPATHE requesting that SMP initiate legal proceedings against an Infringing Product, SMP agrees
that it shall use its Commercially Reasonable Efforts to evaluate (a) whether it believes that such
Infringing Product infringes the SMP Patent Rights or the SMP

 

			
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Research IP Rights, and (b) the merits of any and all appropriate legal actions that may be
brought against such third party to enforce the SMP Patent Rights or the SMP Research IP Rights,
taking into consideration such factors as the likelihood of success on the merits of any such
action, the likelihood that any such action might impair or otherwise affect the scope of such
Patent Rights, the likelihood that failure to initiate legal proceedings might impair or otherwise
negatively affect NUPATHE’s ability to commercialize Product and other similar factors. In the
event that SMP initiates an enforcement action, NUPATHE shall assist SMP in connection with any
such action, upon request and at SMP’s sole expense, and to the extent commercially reasonable; and
in any event, SMP shall keep NUPATHE reasonably informed of the progress of any such enforcement
action. Any settlement or recovery shall be distributed in the following order: (i) to SMP for
reimbursement of expenses related to such claim, including but not limited to attorneys’ fees and
expenses associated with the legal proceedings; and (ii) [**] percent ([**]%) to NuPathe and [**]
([**]%) to SMP for damages related to the infringement, including lost profits. SMP shall not make
any settlement or compromise that adversely affects the interests of NUPATHE in respect of the
Product in the Territory without the prior consent of NUPATHE.

                    9.3.2.1 Notwithstanding the foregoing, in the event SMP chooses not to initiate an enforcement
action, NUPATHE shall have the right but not the obligation to initiate and prosecute such an
action at its cost and expense provided, however that SMP shall use its Commercially Reasonable
Efforts to cooperate with NUPATHE, at NUPATHE’s sole expense. The amount of any settlement or
recovery obtained in such enforcement action shall be retained by NUPATHE, except that SMP shall
receive a portion equivalent to the royalties it would have received in accordance with the terms
of this Agreement as if such amount were Net Sales of NUPATHE. NUPATHE shall not make any
settlement or compromise that adversely affects the interests of SMP without the prior consent of
SMP.

                    9.3.2.2 If neither party brings an enforcement action against an Infringing Product in any
country, royalty payments payable by NUPATHE pursuant to Section 4 of this Agreement shall be [**]
in such country.

               9.3.3 Joint Research IP Rights.

                    9.3.3.1 NUPATHE shall have the right, at its discretion and expense to enforce Joint IP Rights
against an Infringing Product to the extent such enforcement relates to the Product for use in the
Field. If both parties wish to participate in such action, the action shall be brought jointly by
both parties and they will jointly select counsel and equally share any expenses. The parties
shall use their Commercially Reasonable Efforts to cooperate with each other in connection with any
such action to enforce Joint IP Rights.

                    9.3.3.2 Any settlement or recovery shall be distributed in the following order: (i) to NUPATHE
(or pro rata to each party if the parties proceed jointly) for reimbursement of expenses related to
such claim, including but not limited to attorneys’ fees and expenses associated with the legal
proceedings; (ii) to NUPATHE for any damages related to the license rights granted to it, including
lost profits related to sales of Product in the Field; provided, however, that any such amounts
(after relevant adjustment to convert to Net Sales of Products)

 

			
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16

 

shall be subject to the royalty obligations under this Agreement; and (iii) to the extent any
settlement or recovery remains, [**].

                    9.3.3.4 No settlement, consent judgment or other voluntary final disposition of a suit under
this Section 9.3.3 may be undertaken without the prior consent of the other party if such
settlement would require the other party to be subject to an injunction or to make a monetary
payment or would otherwise adversely affect the other party’s rights under this Agreement or the
validity of the Joint Research IP Rights.

                    9.3.3.5 SMP Costs. In any action brought by NUPATHE pursuant to this Section 9.3.3 (other
than an action brought jointly by the Parties) in which SMP is named or becomes involuntarily
involved (including, for example, as a result of a counterclaim by NUPATHE, or is required to
respond to a subpoena), NUPATHE shall indemnify and hold SMP harmless from any damages,
liabilities, costs or expenses resulting from any such action, and in such event, SMP may be
represented by counsel of its own choice, and NUPATHE shall promptly reimburse SMP for its costs of
retaining counsel.

          9.4 Infringement of Third Party Rights.

               9.4.1 In the event that a party becomes aware of any claim that the development, manufacture, use,
sale, offer for sale, export or import of the Product in the

Territory infringes the
intellectual property rights of a third party, such party will promptly notify the other party.

               9.4.2 NUPATHE shall be responsible for defending the parties against any claim by a third
party that the development, manufacture, use, sale, offer for sale, export or import of a Product
in the Territory infringes third party intellectual property rights. NUPATHE shall indemnify and
hold SMP harmless in accordance with Section 8, above. SMP shall assist NUPATHE in connection with
any such action to the extent commercially reasonable and at NUPATHE’s sole expense.

     10. TERM AND TERMINATION.

          10.1 Term. This Agreement shall commence on the Effective Date and, unless earlier
terminated pursuant to this Section 10, shall continue in effect until the expiration of NUPATHE’s
obligation to pay royalties hereunder after which time, the licenses granted to NUPATHE with
respect to the Product in the applicable country, subject to applicable patent laws, shall become a
perpetual, exclusive license deemed fully paid-up.

          10.2 Termination by SMP. If NUPATHE has breached its obligations under Section 6.2,
and such breach shall continue for [**] after written notice of such breach was provided, then as
its sole remedy for such breach, SMP shall have the right at its option either (a) to terminate
this Agreement, or (b) to convert the license granted to NUPATHE to non-exclusive, in either case
effective upon written notice to NUPATHE.

 

			
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17

 

          10.3 Termination by NUPATHE. NUPATHE may terminate this Agreement at any time upon
ninety (90) days prior written notice to SMP.

          10.4 Termination by SMP or NUPATHE.

               10.4.1 Upon the occurrence of any of the events set forth below, SMP shall have the right to
terminate this Agreement by giving written notice of termination, such termination effective with
the giving of such notice:

                    10.4.1.1 In the event of nonpayment of any material amount payable to SMP, which nonpayment is
continuing [**] after SMP gives NUPATHE written notice of such non-payment;

                    10.4.1.2 In the event that NUPATHE is adjudged bankrupt, files or has filed against it any
petition under any bankruptcy, insolvency or similar law, has a receiver appointed for its business
or property, or makes a general assignment for the benefit of its creditors (each a “Bankruptcy
Event”) provided, however, that so long as SMP continues to receive all royalty
payments from NUPATHE under this Agreement, a Bankruptcy Event shall not, in and of itself, be a
basis for termination of this Agreement by SMP;

               10.4.2 Upon the occurrence of any of the events set forth below, NUPATHE shall have the right
to terminate this Agreement by giving written notice of termination, such termination effective
with the giving of such notice:

                    10.4.2.1 Breach by SMP of any covenant or any representation or warranty contained in this
Agreement that is continuing [**] after NUPATHE gives written notice of such breach;

                    10.4.2.2 Material breach or default by SMP with respect to any term or provision contained in
this Agreement that is continuing [**] after NUPATHE gives written notice of said breach or
default;

                    10.4.2.3 SMP becomes subject to a Bankruptcy Event; or

                    10.4.2.4 The dissolution or cessation of operations by SMP.

               10.4.3 Except as set forth in Section 10.2, above, no exercise by SMP or NUPATHE of any right
of termination shall constitute a waiver of any right of SMP or NUPATHE for recovery of any monies
then due to it hereunder or any other right or remedy SMP or NUPATHE may have at law or under this
Agreement.

          10.5 Effect of Expiration or Termination.

               10.5.1 Expiration or termination of this Agreement shall be without prejudice to any rights
which shall have accrued to the benefit of a party prior to such expiration or termination.
Without limiting the foregoing, [**] shall survive any expiration or termination of this Agreement.

 

			
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18

 

               10.5.2 Except as otherwise expressly set forth in this Agreement, promptly upon the expiration
or earlier termination of this Agreement, (a) NUPATHE promptly shall prepare and provide SMP with a
final royalty report through the date of expiration or termination, and shall pay to SMP all
royalties owing through such date, and (b) each party shall return to the other party all tangible
items regarding the Confidential Information of the other party and all copies thereof; provided,
however, that each party shall have the right to retain one (1) copy for its legal files for the
sole purpose of determining its obligations hereunder.

     11. MISCELLANEOUS.

          11.1 Governing Law. This Agreement shall be governed by, interpreted and construed in
accordance with the laws of the State of [**], without regard to the conflicts of law principles
thereof.

          11.2 Waiver. No waiver by a party hereto of any breach or default of any of the
covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or
similar breach or default.

          11.3 Assignment. Neither this Agreement nor any right or obligation hereunder may be
assigned or delegated, in whole or part, by either party without the prior express written consent
of the other; provided, however, that either party may, without the written consent of the other,
assign this Agreement and its rights and delegate its obligations hereunder in connection with the
transfer or sale of all or substantially all of its business, or in the event of its merger,
consolidation, change in control or similar transaction. Any permitted assignee shall assume all
obligations of its assignor under this Agreement. Any purported assignment in violation of this
Section 11.3 shall be void.

          11.4 Independent Contractors. The relationship of the parties hereto is that of
independent contractors. The parties hereto are not deemed to be agents, partners or joint
venturers of the others for any purpose as a result of this Agreement or the transactions
contemplated thereby.

          11.5 Further Actions. Each party shall execute, acknowledge and deliver such further
documents and instruments and to perform all such other acts as may be necessary or appropriate in
order to carry out the purposes and intent of this Agreement.

          11.6 Notices. All requests and notices required or permitted to be given to the
parties hereto shall be given in writing, shall expressly reference the section(s) of this
Agreement to which they pertain, and shall be delivered to the other party, effective on receipt,
at the appropriate address as set forth below or to such other addresses as may be designated in
writing by the parties from time to time during the term of this Agreement.

	 	 	 	 	 

	     If to SMP:

	 	SurModics Pharmaceuticals Inc.

750 Lakeshore Parkway

Birmingham, Alabama 35211

U.S.A.

Attn: President

 

			
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19

 

	 	 	 	 	 

	 

	 	with a copy to:
	 	SurModics, Inc

9924 West 74th Street

Eden Prairie, Minnesota 55344

U.S.A.

Attention: General Counsel

	 
	 	 	 	 
	 

	 	If to NUPATHE:
	 	NUPATHE Inc.

227 Washington Street, Suite 200

Conshohocken, PA 19428

U.S.A.

Attn: Chief Executive Officer
	 
	 	 	 	 
	 

	 	With a copy to:
	 	NUPATHE Inc.

227 Washington Street, Suite 200

Conshohocken, PA 19428

U.S.A.

Attn: General Counsel

          11.7 Force Majeure. Nonperformance of a party (other than for the payment of money)
shall be excused to the extent that performance is rendered impossible by strike, fire, earthquake,
flood, governmental acts or orders or restrictions, failure of suppliers, or any other reason where
failure to perform is beyond the reasonable control and not caused by the negligence, intentional
conduct or misconduct of the nonperforming party; provided, however, that the nonperforming party
shall use Commercially Reasonable Efforts to resume performance as soon as reasonably practicable.

          11.8 No Consequential Damages. IN NO EVENT SHALL A PARTY BE LIABLE FOR SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS
HEREUNDER, INCLUDING WITHOUT LIMITATION LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS
AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 11.8 IS INTENDED TO
LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER SECTION 8 ABOVE.

          11.9 Complete Agreement. This Agreement constitutes the entire agreement between the
parties regarding the subject matter hereof, and all prior representations, understandings and
agreements regarding the subject matter hereof, either written or oral, expressed or implied, are
superseded and shall be and of no effect.

          11.10 Counterparts. This Agreement may be executed in counterparts, each of which
shall be deemed to be an original and together shall be deemed to be one and the same agreement.

          11.11 Headings. The captions to the several sections hereof are not a part of this
Agreement, but are included merely for convenience of reference only and shall not affect its
meaning or interpretation.

20

 

     IN WITNESS WHEREOF, the parties hereto have each caused this Agreement to be executed by their
duly-authorized representatives as of the Effective Date.

	 	 	 	 	 	 	 

	 	 	SURMODICS PHARMACEUTICALS, INC.	 	 
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ Arthur J. Tipton
 

	 	 
	 

	 	Name:
	 	Arthur J. Tipton, Ph.D.	 	 
	 

	 	Title:
	 	President	 	 
	 
	 	 	 	 	 	 
	 	 	NUPATHE, INC.	 	 
	 
	 	 	 	 	 	 
	 

	 	By:
	 	/s/ Keith A. Goldan
 

	 	 
	 

	 	Name:
	 	Keith A. Goldan	 	 
	 

	 	Title:
	 	 Vice President & CFO	 	 

21

 

     SCHEDULES TO BE ATTACHED

22

 

CONFIDENTIAL INFORMATION

Joint Research IP Rights

Schedule 1.12

	 	 	 	 	 	 	 
	Patent/Appl No.	 	Title	 	Inventors	 	Brief Description
	[**]

	 	[**]
	 	[**]
	 	[**]

 

			
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CONFIDENTIAL INFORMATION

SurModics Pharmaceuticals Patent Rights

Schedule 1.32

	 	 	 	 	 	 	 
	Patent/Appl No.	 	Title	 	Inventors	 	Brief Description
	11/196,591

	 	Methods for
manufacturing

delivery systems
and 
systems thereof
	 	Jay K. Staas

Thomas R. Tice

Bruce W. Hudson

Arthur J. Tipton
	 	Use of solevnt to

modify the implant

surface and modify

drug release

profile
	 
	 	 	 	 	 	 
	[**]

	 	[**]
	 	[**] 	 	[**]
	[**]

	 	[**]
	 	[**] 	 	[**]
	[**]

	 	[**]
	 	[**] 	 	[**]

 

			
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SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

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