Exhibit 10.112

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Execution Copy

LICENSE AGREEMENT

 

This LICENSE AGREEMENT (“Agreement”) is made and entered into as of January 4,
2006, (“Effective Date”) by and between CyDex, Inc. (“CyDex” or “Licensor”), a
corporation with its principal place of business located at 10513 W. 84th
Terrace, Lenexa, Kansas 66214, and PRISM PHARMACEUTICALS, INC. (“Prism” or
“Licensee”), a Delaware corporation, with its principal place of business
located at 1150 First Ave, Suite 1050, King of Prussia, Pennsylvania, 19406,
each a “Party” and together the “Parties.”

WHEREAS, CyDex is the owner of certain patents and rights relating to
Captisol-enabled® Amiodarone and certain related compounds, as are further
defined below, and;

WHEREAS, Prism desires to obtain an exclusive worldwide license to develop,
market, make, have made, use, distribute, offer for sale, sell, import and
export products by practicing said patents, and;

WHEREAS, Prism desires to develop said products, without limitation, including
but not limited to process development, non-clinical development, clinical
development, and manufacture, and;

WHEREAS, CyDex is willing to grant to Prism said license under said patents,
subject to the terms and limitations set forth herein;

NOW, THEREFORE, in consideration of the mutual covenants contained in this
Agreement and other good and valuable consideration, the receipt and sufficiency
of which each Party acknowledges, the Parties hereto agree as follows:

 

1. DEFINITIONS.

1.1 “Approval” shall mean the first effective date on which sales of a new drug
may begin, in accordance with a new drug approval received from FDA.

1.2 “Captisol”® means the [***] -based solubility technology.

1.3 “Captisol”® Supply Agreement” shall have the meaning set forth in
Section 10.3.

 

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1.4 “CyDex” means CyDex, Inc. and any subsidiary or any other entity in which
CyDex, Inc., directly or indirectly, owns more than 50% of the voting
securities, partnership, or other ownership interest.

1.5 “Confidential Information” shall mean any proprietary, confidential
information (whether or not patentable or copyrightable), whether or not so
marked, that is not generally known to third parties and that has actual or
potential economic value by reason of not being generally known. Confidential
Information includes, without limitation, trade secrets, and nonpublic know-how,
data, processes, formulas, methods, technology, manufacturing techniques, cost
and pricing information, sales and marketing information, and information of
third parties held by a Party in confidence. Documents and things containing or
embodying Confidential Information are Confidential Information. Confidential
Information does not include information that:

 

  (a) was known to the receiving party, as evidenced by the receiving party’s
written records, before receipt from the disclosing party;

 

  (b) is disclosed to the receiving party by a third person who is under no
obligation of confidentiality to the disclosing party hereunder with respect to
such information and who otherwise has a right to make such disclosure;

 

  (c) is or becomes generally known to the public through no fault of the
receiving party;

 

  (d) is independently developed by the receiving party, as established by the
receiving party’s contemporaneous written records, without access to or reliance
on the other Party’s Confidential Information; or

 

  (e) is required to be disclosed by law, rule or regulation of any court or
regulatory authority of competent jurisdiction; provided, that a Party required
to disclose the other Party’s Confidential Information shall notify the other
Party as soon as possible and, if requested by the other Party, use reasonable
good faith efforts, at its own expense, to assist in seeking a protective order
(or equivalent protection) with respect to such disclosure or otherwise take
reasonable steps to avoid making such disclosure.

1.6 “Default” shall have the meaning set forth in Section 17.1.3(b).

1.7 “Effective Date” means the date first set forth above.

1.8 “Encumbrance” means any mortgage, charge, lien, security interest, easement,
right of way, pledge or encumbrance of any nature whatsoever.

1.9 “FDA” means the U.S. Food and Drug Administration.

1.10 “FDA Communication” shall mean any communication or inquiry to or from the
FDA related to the Product Intellectual Property or Licensed Products, including
but not limited to communications which are verbal, electronic, written, formal
submissions, chronological files and any other record of any communication.

1.11 “Fees” shall have the meaning set forth in Section 9.1.

 

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1.12 “Field of Use” or “Field” means all uses in humans and animals.

1.13 “Force Majeure Event” shall have the meaning set forth in Section 18.13.

1.14 “GAAP” means U.S. generally accepted accounting principles.

1.15 “Governmental Entity” or “Governmental Entities” means any (i) federal,
state, local, foreign or international government; (ii) court, arbitral or other
tribunal or governmental or quasi-governmental authority of any nature
(including any governmental agency, political subdivision, instrumentality,
branch, department, official or entity); or (iii) body exercising, or entitled
to exercise, any administrative, executive, judicial or legislative, police,
regulatory, or taxing authority or power of any nature pertaining to government.

1.16 “IND” means an investigational new drug application, as defined in the
United States Federal Food, Drug and Cosmetics Act and the regulations
promulgated thereunder, where such application is for a Licensed Product.

1.17 “Indemnified Party” shall have the meaning set forth in Section 15.2.1.

1.18 “Indemnifying Party” shall have the meaning set forth in Section 15.2.1.

1.19 “Knowledge” means actual knowledge.

1.20 “License” shall have the meaning set forth in Section 2.1.

1.21 “Licensed Products” means Captisol-enabled® Amiodarone [***]and all
formulations for all uses [***]. A product that is a Licensed Product in any
jurisdiction is a Licensed Product in all jurisdictions.

1.22 “Losses” shall have the meaning set forth in Section 15.1.

1.23 “Management Committee” shall have the meaning set forth in Section 3.1.

1.24 “NDA” means a new drug application, as defined in the United States Federal
Food, Drug and Cosmetics Act and the regulations promulgated thereunder, where
such application is for a Licensed Product.

1.25 “Net Sales” means, for any Royalty Payment Period, the sum of:

1.25.1 gross revenues invoiced by Prism or its authorized sublicensee during the
Royalty Payment Period on the first arm’s length sale for commercial use of
Licensed Products, whether by Prism or its authorized sublicensee, to an
unaffiliated third party (“Product Sales”), less only: (1) normal and customary
quantity, trade or cash allowances/discounts, credits or volume discounts given
in connection with the sale of Licensed Products; (2) credits actually

 

 

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allowed for returns of Licensed Products sold; (3) normal and customary
chargebacks, rebates and refunds actually granted and taken; (4) freight and
insurance to the extent separately identified on the invoice, (5) sales and
other excise taxes and duties related to or in connection with the sale,
transportation or delivery of the Licensed Products (taxes assessed against
Licensee’s income are not deductible in calculating Net Sales), and
(6) uncollectible accounts receivable not to exceed [***]% of gross revenues
invoiced during the prior [***] month period, provided that if there is less
than [***]month history of invoiced sales, then the multiplier shall be the
actual gross revenues invoiced commencing with the first commercial sale. The
deductions set forth in the previous subsections 1-6 shall be determined in
accordance with GAAP and itemized on the Quarterly Royalty Reports; and

1.25.2 milestones, fees and other consideration paid to Prism by any sublicensee
of Prism’s rights under the License during the Royalty Payment Period; provided,
however, that this Section 1.26.2 shall not include any amount that is
calculated based on Product Sales. By way of example and not limitation, Net
Sales shall not include any royalty paid to Prism based on a sublicensee’s
Product Sales if Prism also pays a Royalty on the same Product Sales made by
such sublicensee.

1.26 “Party” means individually CyDex or Prism, as the context dictates, and
“Parties” means collectively, CyDex and Prism.

1.27 “Patent(s)” means any and all patents and patent applications filed in the
Territory as of the Effective Date which are owned by or licensed to CyDex with
the right to sublicense, and which claim the product known as Captisol-enabled®
Amiodarone (and all polymorphs and active metabolites of amiodarone known by
CyDex (or its agents) as of the Effective Date) for claimed uses in [***] and
the developing, marketing, commercializing, manufacturing, making, having made,
using, distributing, selling, offering for sale, importing or exporting thereof;
together with all patents that in the future issue therefrom in any country of
the Territory, including utility, model and design patents and certificates of
invention and all continuations, continuations-in-part, reissues,
re-examinations, renewals, extensions, substitutions, confirmations or additions
to any such patents and patent applications, extensions, divisionals,
improvements as of the Effective Date, ancestors, descendents and foreign
counterparts of any of the foregoing, whether or not pending on the Effective
Date, and including, without limitation, any other application (U.S. or foreign)
claiming priority from or through any of the foregoing. For the avoidance of
doubt, the Patents include, as of the Effective Date, but are not limited to,
the patents and patent applications set forth on Exhibit A.

1.28 “Person” means any individual, corporation, partnership, limited liability
company, joint venture, trust, business association, organization, governmental
entity, or other entity, including any successor or assigns (by merger or
otherwise) of any such entity.

 

 

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1.29 “Prism” means Prism, and any, subsidiary or any other entity in which Prism
owns, directly or indirectly, more than 50% of the voting securities,
partnership, or other ownership interest.

1.30 “Product Copyrights” means all registered and unregistered copyrights which
are owned by, controlled by or licensed to CyDex with the right to sublicense as
of the Effective Date or acquired by CyDex during the Term related to the
Licensed Products in the Field in the Territory, including both published works
and unpublished works.

1.31 “Product Intellectual Property” means the Product Technology, Patents, the
Product Trademarks, and the Product Copyrights.

1.32 “Product Medical Materials” means any of the following: (i) all adverse
event reports related to the Licensed Products, including any correspondence
with the FDA, reports or other documents relating thereto, (ii) all data,
information and files relating to the adverse· experiences relating to the
Licensed Products and (iii) all medical responses relating to the Licensed
Products, and written, telephone and personal contact inquiries relating to the
Licensed Products.

1.33 “Product Sales” shall have the meaning set forth in Section 1.26.

1.34 “Product Technology” means, in all cases which are owned by, controlled by
or licensed to CyDex with the right to sublicense as of the Effective Date or
acquired by CyDex during the Term, all inventions (patentable or unpatentable)
regardless of whether patent rights have yet been obtained or applied for,
Specifications, technical data, clinical data, know-how, research and
development information, knowledge and other information, whether in existence
on the Effective Date or in the future related to, or are desirable for, or are
necessary or useful for the development, manufacture, formulation,
reformulation, packaging, testing, marketing, use, distribution,
commercialization, offer for sale, sale, import and export of the Licensed
Products in the Field in the Territory, but excluding any common industry
practice, process or procedure.

1.35 “Product Trademarks” means all of CyDex’s trademarks (whether registered or
unregistered) in the Territory related to any Licensed Product that are owned
by, controlled by or licensed to CyDex with the right to sublicense as of the
Effective Date or acquired by CyDex during the Term, including but not limited
to those trademarks set forth on Exhibit B.

1.36 “Quarterly Royalty Reports” shall have the meaning set forth in
Section 9.4.2.

1.37 “Registrations” shall mean all the pending, withdrawn and/or approved
applications, including but not limited to INDs, NDAs and orphan drug
applications and designations, registrations and approvals for each of the
Licensed Products currently in the name of CyDex and filed with the FDA or any
other Regulatory Authority, including all information therein, each as more
particularly described in Exhibit C.

1.38 “Regulatory Authority” shall mean any Governmental Entity in any country of
the Territory competent to approve pharmaceutical products for manufacturing,
marketing, distribution and sale in any country of the Territory and/or to
approve the price for pharmaceutical products to be sold in any country of the
Territory.

 

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1.39 “Royalties” or “Royalty” shall have the meaning set forth in Section 9.2.

1.40 “Royalty Payment Period” shall have the meaning set forth in Section 9.4.1.

1.41 “Specifications” shall mean the specifications, formulations, recipes and
manufacturing instructions for Licensed Products as known at the Effective Date
and from time to time during the Term changed, altered, amended or repealed.

1.42 “Term” shall have the meaning set forth in Section 2.3 below.

1.43 “Termination Date” shall have the meaning set forth in Section 17.1.2.

1.44 “Territory” is worldwide.

1.45 “U.S.” means the United States of America.

 

2. LICENSE.

2.1 License Grant. Subject to the terms and limitations of this Agreement, CyDex
grants to Prism a sole and exclusive license, with the right to grant
sublicenses, under the Product Intellectual Property, to develop, market,
manufacture, make, have made, use, distribute, commercialize, sell, offer to
sell, import and export the Licensed Products (the “License”) in the Field of
Use and throughout the Territory.

2.2 Nature of Exclusivity. This license grant is exclusive even against CyDex,
except that CyDex remains free to practice the Patents in the course of
rendering goods or services to Prism or any of Prism’s successors, assigns,
licensees or customers in accordance with Prism exercising its rights under this
License.

2.3 Term. Unless terminated in accordance with this Agreement, this License
shall commence as of the Effective Date and shall remain in force and effect in
perpetuity (“Term”).

2.4 Right to Sublicense. Prism has the right to sublicense, in whole or in part,
its rights under the License; provided that each sublicense shall include terms
and provisions which protect CyDex’s rights and interests substantially to the
extent provided in Section 6.1, Article 8, Article 14, and Section 17.2.2(b) of
this Agreement.

 

3. MANAGEMENT COMMITTEE.

3.1 The Parties shall establish a committee of up to six (6) of members which
shall be designated and agreed upon in writing by each of Prism and CyDex and
each of whom shall be senior executives of or experienced professional counsel
to the appointing Party, provided that such professional counsel is (a) bound to
protect the confidentiality of the Confidential Information of the other Party
at least to the extent provided in Article 14 and (b) obligated to assign to the
appointing Party any intellectual property developed in the course of its
relationship with the appointing Party which shall be further assigned, if
necessary, and owned in accordance with Article 6 (the “Management Committee”).
The Parties shall work through the Management Committee to address issues
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Products. The initial Management Committee is set forth on Schedule 3.1. At any
time, a Party may replace one or more of its designees to the Management
Committee by written notice to the other Party. The Management Committee shall
meet quarterly (or more frequently as deemed necessary by the Management
Committee), in a location or by telephone as mutually agreed by the Parties, to
share information on the status of the development and commercialization of the
Products in the Field in the Territory. The location of the meetings shall take
place at Prism’s principal office location. The Management Committee shall also
discuss any requests by Prism for assistance from CyDex pursuant to this
Agreement.

 

4. DATA DELIVERY AND TRANSFER OF SPONSORSHIP.

4.1 Data Delivery. CyDex shall deliver to Prism no later than [***] days after
the Effective Date a copy of all books and records, then in CyDex’s possession,
control or use, related to the Product Medical Materials, the Product
Intellectual Property and FDA Communication, including but not limited to, back
up files and materials, relating to regulatory filing and compliance, and the
research, development, pre-clinical and clinical studies (including pending,
completed and discontinued studies), testing, analysis, marketing, use,
off-label use, sale or distribution of the Licensed Products. Such books and
records shall be catalogued and identified appropriately by CyDex and delivered
to Prism in a complete and orderly fashion, accompanied by a master list
identifying the name and contents of each individual file.

4.2 Transfer of Sponsorship. Cydex shall promptly after the Effective Date send
written notice as reasonably requested by Prism to the FDA transferring the
sponsorship of the Registrations to Prism and Prism shall promptly after the
Effective Date send written notice, as reasonably requested by CyDex or at its
own discretion, to the FDA assuming all obligations thereunder, and such notices
shall have an effective date that is approximately [***] days after the
Effective Date (or such other date as may be agreed to by the Parties). CyDex
shall reasonably assist Prism with the preparation and filing of all amendments
to INDs, NDAs and orphan drug designations related to the Licensed Products. The
Parties shall coordinate with one another and shall send such notices
simultaneously, and each Party shall deliver a copy of its FDA notice to the
other Party. CyDex shall promptly furnish to Prism the Registrations, to the
extent not previously transferred, and the books and records relating thereto.

 

5. PRISM’S RESPONSIBILITIES; CYDEX ASSISTANCE; MANUFACTURING AGREEMENT.

5.1 Prism’s Responsibilities.

5.1.1 Prism shall be solely responsible for, exercising commercially reasonable
discretion, the developing, marketing, offering for sale, sale, advertising,
promotion, distribution, making, having made, manufacturing, exporting,
importing, and all other exploitation of the Licensed Products in the Territory.

 

 

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5.1.2 Prism shall have the sole and absolute discretion to develop the Licensed
Products for purposes of obtaining regulatory approvals and commercializing and
selling the Licensed Products in the Field in the Territory, subject to
commercially reasonable efforts and compliance with the terms and conditions of
this Agreement and applicable Laws, rules and regulations. Except as otherwise
set forth in this Agreement, Prism shall bear all expenses it incurs with
respect to its development of the Licensed Products after the Effective Date.

5.1.3 Prism shall be responsible for obtaining, at its own expense, all
applicable legal and regulatory approvals for the Licensed Products, including
but not limited to all FDA and other Regulatory Authority permits and approvals,
in all jurisdictions in which Prism seeks to make, use or sell the Licensed
Products.

5.1.4 During the Term, Prism will be responsible for ongoing safety monitoring
of the Licensed Products and for regulatory compliance of the Licensed Products,
the NDA and the IND.

5.2 CyDex Assistance. If Prism reasonably requests (through the Management
Committee or otherwise) that CyDex provide assistance to Prism’s preparation and
filing of any document or other information with the FDA or any other Regulatory
Authority of filings required to be filed by Prism for the development,
commercialization, manufacture, marketing, distribution, offer for sale, sale,
import or export of the Licensed Products, then CyDex shall provide such
assistance to Prism. CyDex will assist Prism throughout the Term with FDA
submissions and information regarding the Licensed Products to the medical
community, customers, manufacturers and as otherwise necessary for Prism to
develop, commercialize, manufacture, market, distribute, offer for sale, sell,
import, export and/or sublicense the Licensed Products. Such assistance shall
include CyDex’s providing Prism with CyDex’s expertise and reasonable access to
CyDex’s employees, consultants and agents, subject to their availability which
shall be reasonably provided.

5.3 Manufacturing Agreement. Prism will be responsible for the identification
and selection of one or more manufacturers for the Licensed Products. CyDex will
use its commercially reasonable efforts to assist Prism in the transfer to the
selected manufacturer(s) of the process and other Product Intellectual Property
necessary to manufacture the Licensed Products. The ultimate selection of any
manufacturer and the negotiation of any manufacturing supply agreement with such
manufacturer shall be in the sole right and discretion of Prism.

 

6. PATENT MANAGEMENT.

6.1 Marking. Prism shall ensure that the Licensed Products, and all packaging
and labeling therefor, as well as all promotional, marketing, and advertising
material associated with the Licensed Products, as applicable, bear forms of
patent notice and marking meeting the requirements of the applicable
jurisdiction(s) and reasonably acceptable to CyDex. Prism shall provide samples
of the foregoing to CyDex upon request

6.2 Prosecution and Maintenance of Patents as of the Effective Date. CyDex shall
retain ownership of all Patents, subject to this License, that CyDex owns on the
Effective Date and CyDex shall continue prosecution of all patent applications
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Products that are pending as of the Effective Date and shall pay all costs
associated therewith. CyDex shall promptly inform Prism of any actions regarding
the prosecution of all such patent applications. [***] and [***] by [***] the
[***] of [***], [***] have [***] with respect to [***].

6.3 Maintenance of Patents after the Effective Date.

6.3.1 [***] be [***] for and [***] and [***] with the [***] of the [***] the
[***]. During the Term, CyDex shall not abandon any of the Patents without first
providing prior written notice to Prism of such intention to abandon (which
notice shall, in any event, be given no later than [***] days prior to the next
deadline for any action that may be taken with respect to the Patent in the
relevant patent office) and such Patent shall be assigned by CyDex to Prism, at
Prism’s option.

6.3.2 During the Term, Prism shall have the right, in its sole and absolute
discretion with respect to any determination, to secure patent protection for
any intellectual property, arising out of the License, invented or created by
Prism or on its behalf (and assigned or assignable to it).

6.3.3 With respect to any patent application filed after the Effective Date,
Prism shall be responsible for and pay the costs of prosecution and maintenance
of all such Patents. Prism may elect, in its sole and absolute discretion, to
discontinue or forgo the prosecution or maintenance of any Patent. Should Prism
so elect, Prism shall give written notice in advance of Prism taking any such
action (which notice shall, in any event, be given no later than [***] days
prior to the next deadline for any action that may be taken with respect to the
Patent in the relevant patent office) to CyDex. CyDex shall then have the right,
in its sole and absolute discretion, to maintain or prosecute such Patent.

6.4 Intellectual Property Ownership. Any inventions relating to the Licensed
Products made during the Term shall be owned by the inventor and joint
inventions shall be owned equally by all inventors, in each case determined by
rules of inventorship under United States patent law, or as is otherwise
determined by the Parties’ written agreement. All such inventions arising from
any activity conducted by the Parties under this Agreement and associated
intellectual property shall be assigned to Prism, at its option, by CyDex (or
its agents). The parties agree to obtain such assignments of these inventions
from the inventors as are necessary to satisfy their respective obligations
under this Section 6.4.

 

7. ENFORCEMENT AND DEFENSE OF PATENTS.

7.1 Notification. Each Party agrees to promptly notify the other Party of their
knowledge of any actual or suspected third-party infringement or violation of
any of the Patents

 

 

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or other Product Intellectual Property, as well as of any claim, demand,
invitation to license or other third-party challenge to the Patents or other
Product Intellectual Property.

7.2 Enforcement.

7.2.1 Prism is solely responsible, in its sole and absolute discretion, and at
its sole expense, for the enforcement and defense of any patent or intellectual
property rights that it owns, including but not limited to patent and other
intellectual property interests created by it or on its behalf (and assigned or
assignable to it) pursuant to this Agreement.

7.2.2 With respect to the Product Intellectual Property licensed to Prism
hereunder, except as is provided herein to the contrary, Prism shall be solely
responsible for the enforcement and defense of such Product Intellectual
Property, at its sole expense, during the Term. Notwithstanding the foregoing:
(a) CyDex agrees to be joined as a party plaintiff, at Prism’s request and as is
reasonably required to pursue an enforcement action; (b) counsel selected by
Prism shall be reasonably acceptable to CyDex; (c) Prism shall give CyDex prompt
notice that an infringement or other action has been commenced concerning any of
the Product Intellectual Property, an opportunity to review and approve in
advance any demand, cease and desist letter or invitation to license, and if
commercially practical, at least [***] days prior written notice of its intent
to commence an enforcement action; (d) Prism shall give CyOcx prompt written
notice of its decision not to enforce or defend any of the Product Intellectual
Property; and (e) Prism shall not enter into any settlement agreement or consent
judgment, nor shall it make any material admission relating to validity or
enforceability of any of the Product Intellectual Property or with respect to
CyDex which would materially adversely effect CyDex without the prior written
consent and approval of CyDex, which shall not be unreasonably withheld. In the
event CyDex joins or is named as a party in any enforcement or defense action,
CyDex shall have the right but not the obligation to retain separate counsel at
its own expense. Any recovery of damages in any enforcement action by Prism
involving the Product Intellectual Property shall be allocated as follows:
(i) first, to the payment of attorney’s fees and other costs and expenses of the
litigation; (ii) second, the amount that Prism is responsible for making any
required payments to its sublicensees; (iii) third, the remainder to be divided
between Prism and CyDex, with CyDex receiving an amount equal to the remainder
multiplied by the Royalty rate applicable to Prism’s Net Sales in the most
recent Royalty Payment Period. In the event [***] to [***] or [***] of the [***]
or the [***], [***] the [***] the [***] to [***] or [***] at [***] , as the
[***] be, and in the [***] to [***] or [***] and [***] to [***].

7.3 Procedure. Each Party, regardless of whether it joins in a legal action,
agrees to reasonably cooperate with the other to assist in the prosecution or
defense of any actions described in this Article 7. In addition to any other
obligation set forth in this Agreement, each Party shall keep the other
regularly informed on developments in any such action in which it

 

 

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participates or obtains information, if the other Party is not involved. With
respect to the foregoing actions, each Party shall cooperate with each other in
such a manner as to preserve in full (to the extent possible) the
confidentiality of any of the other Party’s Confidential Information and the
attorney-client and work-product privileges. In connection therewith, each Party
agrees that: (i) the provisions of Article 14 shall apply to the production of
Confidential Information, and (ii) all communications between any Party hereto
and counsel responsible for participating in the defense of any third-party
claim or with respect to any action regarding the Product Intellectual Property
to the extent such action involves or impacts Prism’s right to develop,
commercialize, market, manufacture, distribute, sell, offer for sale, import
and/or export the Products in the Field in the Territory, shall, to the extent
possible, be made so as to preserve any applicable attorney-client or
work-product privilege.

 

8. TRADEMARKS.

8.1 Licensee agrees to comply with any requirements established by Licensor
concerning the style, design, display and use of the Licensed Trademarks; to use
the registered trademark symbol ® with every use of the mark; and to submit in
advance of its use advertising copy, labels, stickers or packaging to Licensor
for approval, which shall not be unreasonably withheld.

8.2 When requested, Licensee agrees to send samples of advertising and
promotional materials, as well as promotional and advertising materials bearing
or sold under the Product Trademarks and any other documents which may permit
Licensor to determine whether the services and trademark uses meet the
standards, specifications and directions approved by Licensor.

8.3 Licensee agrees that ownership of the Product Trademarks and the goodwill
relating thereto shall remain vested in Licensor both during the period of this
Agreement and thereafter, and Licensee further agrees never to challenge,
contest or question the validity of Licensor’s ownership of the Product
Trademarks or any registrations thereof by Licensor.

8.4 Licensee agrees to inform Licensor of the use of any marks similar to the
Product Trademarks and any potential infringements of Licensor’s mark which come
to its attention.

8.5 Prism may use its own trademark(s), service marks, logos and trade dress for
the marketing and sale of the Licensed Products, and it shall be solely
responsible for the registration, maintenance, enforcement and defense of any
such marks.

 

9. FEES AND ROYALTIES.

9.1 In consideration of the rights and license granted pursuant to this
Agreement, Prism shall pay to CyDex the following fees (“Fees”) upon the
attainment of the milestones set forth in the table below:

 

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a. A one-time Fee upon the [***]

   [***]

b. A one-time Fee upon the [***]

   [***]

c. A one-time Fee upon the [***]

   [***]

d. A one-time Fee upon the [***]

   [***]

e. A one-time Fee upon [***]

   [***]

9.2 In addition to its payments of Fees pursuant to Section 9.1, Prism shall pay
to CyDex royalties on Net Sales (“Royalty” or “Royalties”) commencing with the
first commercial sale of a Licensed Product as follows:

 

a. Subject to the reduction set forth in (c) below, Royalty on annual Net Sales
of the Licensed Products on the first [***], in total, paid to Prism during any
calendar year:    [***]% b. Subject to the reduction set forth in (c) below,
Royalty on annual Net Sales of the Licensed Products totaling more than
[***]paid to Prism during any calendar year:    [***]% c. Notwithstanding
anything to the contrary herein, at the time that there is no longer regulatory
exclusivity in the United States, the Royalty on Net sales of the License
Products shall be reduced [***].   

9.3 Calculation of Royalties. All Royalties payable shall be calculated first in
the currency of the jurisdiction in which payment was made, and then converted
into U.S. dollars. The exchange rate for such conversion shall be the rate
quoted in The Wall Street Journal on the last business day of the applicable
Royalty Payment Period.

9.4 Royalty Payment Periods and Reports.

9.4.1 Prism shall pay Royalties to CyDex on a quarterly basis, measured by each
calendar quarter, beginning with the [***] in [***] of [***] (“Royalty Payment
Period(s)”). Prism shall pay Royalties in full within [***]days after the end
each Royalty Payment Period. All Royalties and Fees shall be paid in U.S.
dollars and directed to such addresses and payees as CyDex may designate in
writing from time to time.

9.4.2 Whether or not Royalties are payable at the end of a Royalty Payment
Period, Prism shall provide to CyDex within [***]days after the end of such
Royalty Payment Period a written report (“Quarterly Royalty Report(s)”)
summarizing the volume of sales of the Licensed Products in each jurisdiction,
gross revenue paid to Prism on sale of the Licensed Products or other sublicense
fees as set forth in Section 1.26.2, deductions to determine Net Sales thereof,
Net Sales, and Royalties payable.

 

 

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9.5 Late Payments. Unpaid balances shall accrue interest, from the due date
until paid, at a rate equal to the lesser of (i) the prime rate, as reported in
The Wall Street Journal, on the date such payment is due, plus an additional
[***] percent ([***]%) or (ii) the maximum rate permitted under applicable law.

9.6 Taxes. All amounts due under this Agreement are exclusive of any applicable
taxes, including without limitation, sales, use, value-added, and withholding
taxes, and Prism shall pay or withhold all such taxes as required by law.
Notwithstanding the foregoing, any and all withholding taxes or similar charges
assessable to Prism on Royalties or other amounts payable hereunder for sales in
the Territory outside of the United States will be deducted from such amount
due, will be paid by the payer to the proper taxing authority, and Prism shall
use commercially reasonable efforts to obtain proof of payment of said tax, as
well as any other documents or confirmations reasonably required by CyDex to
recover any such withholding taxes or parts thereof from the proper tax
authorities, and sent to CyDex as evidence of such payment.

9.7 Audit Rights. Licensee shall make and maintain for a period of at least
[***] years records of its sales of Licensed Products, gross revenues paid to
Prism on the sale of Licensed Products and deductions in calculating Net Sales.
Licensor, at its expense, shall have the right to inspect, copy and audit
(itself or through its representative, subject to a confidentiality agreement
reasonably acceptable to Licensee) such books and records at the premises of
Licensee during normal business hours, within [***]business days of notice to
Prism of its request to conduct such an inspection or audit. CyDex may not
exercise this right more than [***] in any [***] month period during the Term,
and only [***] [***] within the [***] month period after this Agreement expires
or is terminated. Prism shall provide reasonable cooperation in the conduct of
any inspection or audit. In the event the audit shows an underpayment of more
than [***] percent ([***]%) for any applicable Royalty Payment Period, Licensee
shall pay Licensor the amounts underpaid. In addition, in the event the audit
shows an underpayment of more than [***] percent ([***]%) for any applicable
Royalty Payment Period, Licensee shall pay Licensor, in addition to the amounts
underpaid, the reasonable third party costs of such audit. In the event the
audit shows an overpayment of more than [***] percent ([***]%) for any
applicable Royalty Payment Period, Licensor shall pay Licensee the amount of
such overpayment less the reasonable third party costs of such audit (not to
exceed the amount of the overpayment). Any amount discovered to be due under an
audit shall not give rise to a right to terminate this Agreement for failure to
make Royalty Payments if such deficiency is paid within [***]days of the audit
report; provided, however, that if Licensee is not in agreement with the audit
report, then the Parties shall resolve such dispute in accordance with
Section 18.8 and this Agreement may not be terminable by Licensor for reasons of
underpayment until the resolution of such dispute in Licensor’s favor.

 

 

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10.

PURCHASE AND SUPPLY OF CAPTISOL®.

10.1 Purchase of the Captisol®. During the Term, CyDex shall sell to Prism
and/or its designee the [***].

10.2 Quality Control. CyDex shall perform routine quality control tests with
respect to all Captisol® as required by the FDA, as requested in writing by
Prism, or otherwise as CyDex deems necessary in accordance with its applicable
policies, and [***]. CyDex shall permit Prism reasonable access to the copies of
the records of such quality control tests performed on each lot or batch of
Captisol®.

10.3 Captisol® Supply Agreement. The parties agree to negotiate in good faith a
Supply Agreement for Captisol® (“Captisol® Supply Agreement”) which shall
include terms addressing pricing, safety stock, supply failure procedures,
rights and obligations and other normal and customary terms. The parties agree
to enter into a definitive Captisol® Supply Agreement no later than [***].

 

11. NOTICE OF SAFETY OR EFFICACY CONDITIONS:

11.1 Each Party shall promptly notify the other Party of its Knowledge of any
fact, circumstance, condition or knowledge that bears on (i) the safety or
efficacy of Captisol® or the Licensed Products or (ii) the safety of any of the
Licensed Products. Each Party may use and disclose such information to the
extent necessary to comply with law.

 

12. WARRANTIES; DISCLAIMERS.

12.1 Representation and Warranties of Both Parties. Each Party represents, and
warrants to the other Party that:

 

  (a) it is a corporation duly organized and validly existing under the laws of
the state or country of its incorporation;

 

  (b) the execution and delivery of this Agreement and the performance of the
transactions contemplated hereby have been duly authorized by all necessary
corporate action of such Party;

 

  (c) the execution and delivery of this Agreement and the performance by such
Party of any of its obligations under this Agreement do not and will not:

 

  (i)

conflict with, or constitute a breach or violation of, any other contractual
obligation to which it is a party, any judgment of any court or governmental
body applicable to such Party or its properties, or, to such Party’s Knowledge,
any statute, decree,

 

 

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order, rule or regulation of any court or governmental agency or body applicable
to such Party or its properties, and

 

  (ii) require any consent or approval of any governmental authority or other
person;

 

  (d) it will, to the best of its knowledge without undertaking a special
investigation, disclose to the other Party any material adverse proceedings,
claims or actions that arise that would materially interfere with that Party’s
performance of its obligations under this Agreement.

12.1.1 Representations and Warranties of CyDex. CyDex, as an inducement to Prism
to enter into this Agreement, represents, warrants or covenants to Prism, as
applicable, as follows:

 

  (a) Right to License. CyDex owns or controls the Product Intellectual property
and has full right, power and authority, free of any Encumbrance, to grant the
License. As of the Effective Date, CyDex is not aware of any fact or
circumstances that the Licensed Products are, in or with respect to the
Territory, subject to any restrictions, covenants, licenses other than this
Agreement, or judicial and administrative orders of any kind, which detract in
any material respect from the value of the Licensed Products or the Product
Intellectual Property, or which could interfere with the use thereof by Prism in
the Territory as contemplated by this Agreement.

 

  (b) No Inability to Receive Approval. As of the Effective Date, CyDex is aware
of no facts that would lead it to conclude that any of the Licensed Products
will be unable to receive Approval or approval from any other Regulatory
Authority; provided that clinical development and other regulatory requirements
are completed in accordance with all applicable Laws, rules and regulations.

 

  (c) Clear Rights. As of the Effective Date, CyDex has not received any notice
and has no Knowledge that (i) the rights to the Product Intellectual Property or
the Licensed Products have been challenged or that there exists any reasonable
basis for such a challenge in any judicial or administrative proceeding, or
(ii) any person, entity or product has infringed or that any person or entity
intends to infringe any patent rights encompassed by the Licensed Products or
the Product Intellectual Property and applicable to the Licensed Products, or
(iii) any patent rights or other intellectual property rights, including but not
limited to rights of trademark, trade dress and copyright, have been infringed
by CyDex in connection with the Licensed Products or will be infringed by Prism
by virtue of exercising the License granted by this Agreement.

 

  (d) Intellectual Property Rights.

 

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  (i) As of the Effective Date, Exhibit A contains a true and correct list of
the Patents. The omission of any Patent from this definition shall not prejudice
Prism’s right to such intellectual property pursuant to the License.

 

  (ii) Exhibit B contains a true and correct list of the Product Trademarks. The
omission of any trademark from Exhibit B shall not prejudice Prism’s right to
such trademark pursuant to the License. All of the Product Trademarks listed on
Exhibit B as registered or filed have been duly registered in the Territory in
the name of CyDex with the appropriate Governmental Entities and are in full
force and effect.

 

  (e) CyDex has taken commercially reasonable precautions to protect the secrecy
and confidentiality of the Product Intellectual Property, other than the
Patents, Product Copyrights and Product Trademarks to the extent publicly known.

12.1.2 Litigation. As of the Effective Date, there is no suit, claim, action,
investigation or proceeding pending or, to the Knowledge of CyDex, threatened
against CyDex that relates to the Licensed Products or Product Intellectual
Property, or challenges or seeks to prevent or enjoin the License. CyDex has no
Knowledge of any settlements, court decisions or agreements involving any third
party and existing on the Effective Date that would have a material adverse
effect on the Licensed Products.

12.2 No Brokers. CyDex has not entered into any agreement, arrangement or
understanding with any Person or firm which will result in the obligation of
Prism to pay any finder’s fee, brokerage commission or similar payment in
connection with the transactions contemplated hereby.

12.3 Disclaimer. EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS ARTICLE 12,
NEITHER PARTY MAKES ANY REPRESENTATIONS OR GRANT ANY WARRANTIES, EXPRESS OR
IMPLIED, AND EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER WARRANTIES, WHETHER
WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

13. LIMITATION OF LIABILITY.

NOTWITHSTANDING ANYTHING ELSE IN THIS AGREEMENT OR OTHERWISE, AND EXCEPT FOR THE
PARTIES’ OBLIGATIONS TO INDEMNIFY AS SET OUT HEREIN AND EXCEPT FOR INFRINGEMENT
OR VIOLATION OF THE OTHER PARTY’S PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS
OR A PARTY’S BREACH OF ITS CONFIDENTIALITY OBLIGATIONS HEREUNDER, NEITHER PARTY
SHALL BE LIABLE TO THE OTHER PARTY WITH RESPECT TO ANY SUBJECT MATTER OF THIS
AGREEMENT, UNDER ANY EQUITY, COMMON LAW, TORT, CONTRACT, ESTOPPEL, NEGLIGENCE,
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THEORY, FOR ANY INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY, INDIRECT OR
CONSEQUENTIAL DAMAGES (INCLUDING BUT NOT LIMITED TO DAMAGES RESULTING FROM LOSS
OF SALE, BUSINESS, PROFITS, OPPORTUNITY OR GOODWILL), EVEN IF A PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF ANY OF THE FOREGOING DAMAGES.

 

14. CONFIDENTIALITY.

14.1 The Parties anticipate that, in the course of their relationship in
connection with this Agreement, they are likely to exchange Confidential
Information. Each Party agrees to use the other’s Confidential Information only
to exercise its rights and perform its duties pursuant to this Agreement.

14.2 Each Party agrees not to disclose the other’s Confidential Information to
third parties without the other’s express prior, written consent, except that
each may disclose the other’s Confidential Information:

14.2.1 to those of its employees, representatives and agents that it reasonably
requires to have access to same in order to perform its obligations and/or
exercise its rights under this Agreement, provided such employees,
representatives or agents are bound by obligations of confidentiality comparable
to those set forth in this Section 14; and

14.2.2 to the extent such disclosure is reasonably necessary in filing or
prosecuting patent applications or complying with orders of any court, other
Governmental Entity or arbitral body or with applicable laws or governmental
regulations, provided that if a Party intends to make any such disclosure, it
shall use reasonable efforts to give reasonable advance written notice to the
other Party of such intended disclosure to permit such other Party to seek such
protective orders or other similar relief as may be available in the
circumstances.

14.3 Each Party agrees to safeguard the other’s Confidential Information against
unauthorized use and disclosure with means at least as stringent as it employs
to safeguard its own Confidential Information, and in no event with less than
reasonable means.

14.4 The obligations of confidentiality in this Section 14 are in addition to
and not in lieu of any confidentiality obligations the Parties may owe each
other as a matter of underlying law, and the obligations herein shall survive
the termination or expiration of this Agreement for so long as the information
at issue continues to meet the definition of Confidential Information set forth
in Section 1.6.

 

15. INDEMNIFICATION AND INSURANCE.

15.1 Indemnification.

 

  (a) Indemnification by Licensor. Licensor shall indemnify and hold Licensee
and its affiliates, officers, directors, employees, and agents harmless from and
against any and all liability, damage, loss, cost (including reasonable
attorneys’ fees) and expenses related to any third-party claims (“Losses”) to
the extent arising from or in connection with:

 

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  (i) Licensor’s breach of any representation, warranty, covenant or agreement
contained in this Agreement; or (ii) any infringement or alleged infringement of
intellectual property rights resulting from Licensee’s authorized use of the
Product Intellectual Property; provided, however, that excluded from this
Section 15.1(a) is any claim that is a result of willful misconduct or grossly
negligent act of Licensee or breach by Licensee of this Agreement to the extent
covered in Section 15.l(b)(i) below.

 

  (b) Indemnification by Licensee. Licensee, to the extent not caused by,
related to or in any way connected with the acts of Licensor, shall indemnify
and hold Licensor and its affiliates, officers, directors, employees, and agents
harmless from and against any and all liability, damage, loss, cost (including
reasonable attorneys’ fees) and expenses to the extent arising from or in
connection with any third-party claims: (i) Licensee’s breach of any
representation, warranty, covenant or agreement contained in this Agreement, or
(ii) the development, manufacturing, use, handling advertising, promotion,
marketing or sale of Licensed Products by Licensee or any sublicensee of its
rights under this Agreement; provided, however, that excluded from this
Section 15.1(b) is any claim that is a result of willful misconduct or grossly
negligent act of Licensor or breach by Licensor of this Agreement to the extent
covered in Section 15.l(a)(i) above and excluded from Licensee’s indemnification
obligations under Section 15.l(b)(ii) are all matters to the extent covered by
Licensor’s indemnities under Section 15.1(a).

15.2 Procedure.

15.2.1 In order for an indemnified party under this Article 15 (an “Indemnified
Party”) to be entitled to any indemnification provided for under this Agreement,
such Indemnified Party will, promptly following the discovery of the matters
giving rise to any Loss, notify the indemnifying party under this Article 15
(the “Indemnifying Party”) in writing of its claim for indemnification of such
Loss, specifying in reasonable detail the nature of such Loss and the amount of
the liability estimated to accrue therefrom; provided, however, that failure to
give such prompt notification will not affect the indemnification provided
hereunder except to the extent the Indemnifying Party will have been actually
prejudiced as a result of such failure. Thereafter, the Indemnified Party shall
promptly deliver to the Indemnifying Party, at the Indemnifying Party’s expense,
all information and documentation reasonably requested by the Indemnifying Party
with respect to such Loss and the Indemnified Party shall cooperate fully with
the Indemnifying Party, at the Indemnifying Party’s expense, in the defense of
such claim.

15.2.2 If an Indemnified Party gives notice to the Indemnifying Party pursuant
to Section 15.2.1, the Indemnifying Party shall control the defense and
settlement of such third-party claim (unless the Indemnifying Party is also a
person against whom the third-party claim is made and the Indemnified Party
determines in good faith that joint representation would be inappropriate, in
which case the Indemnified Party shall have the right to select separate counsel
to participate in the defense of such action on its behalf, and the Indemnified
Party shall bear the

 

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cost and expense of such separate defense, unless and to the extent the Parties
otherwise agree or it is determined through arbitration hereunder that such
costs and expense are or were required to be indemnified by the Indemnifying
Party), with counsel selected by the Indemnifying Party that the Indemnified
Party consents to as reasonably satisfactory, which consent shall not be
unreasonably withheld. The Indemnifying Party shall not, so long as it
diligently conducts the defense of such third party claim be liable to the
Indemnified Party under this Article 15 for any fees of other counselor any
other expenses with respect to the defense of such third party claim. No
compromise or settlement of such third-party claim may be effected by either
Party in a way that prejudices or adversely impacts the other Party without the
other Party’s prior written consent, which consent shall not be unreasonably
withheld. Notwithstanding the assumption by the Indemnifying Party of the
defense of any third-party claim as provided in this Article 15, the Indemnified
Party will be permitted to join such defense and to employ counsel at its own
expense. If notice is given to an Indemnifying Party of the assertion of any
third-party claim and the Indemnifying Party does not, within [***] days after
the Indemnified Party’s notice is given, give notice to the Indemnified Party of
its assumption of the defense of such third-party claim, the Indemnifying Party
will be bound by any determination made in such third-party claim or any
reasonable compromise or settlement effected in good faith by the Indemnified
Party. Indemnified Party shall have the right to maintain the defense of such
claim or action and the Indemnifying Party shall provide reasonable assistance
to the Indemnified Party in the defense of such third party claim and to bear
the reasonable cost and expense of such defense (including attorney’s and
experts’ fees and expenses).

15.2.3 Notwithstanding the provisions of Section 18.8, the Parties each consent
to the nonexclusive jurisdiction of any court in which a proceeding in respect
of a third-party claim is brought by a third party either against Prism or CyDex
for purposes of defense of such third party claim and each Party agrees that
process may be served on it with respect to indemnification with respect to such
third party claim in accordance with Section 18.12.

15.2.4 This Article 15 sets forth the Parties’ complete and sole obligations to
indemnify one another for Losses arising from or connected with third party
claims.

15.3 Insurance. Licensee shall procure and maintain during the term of this
Agreement, commercial general liability insurance, in commercially reasonable
amounts, and with the insurance carriers licensed to do business in the
jurisdiction where Licensee is located; provided, however, that Licensee shall
not be required to maintain product liability coverage so long as Licensed
Products are not being sold or used with humans.

 

16. PUBLICATION.

16.1 The Parties will consult with each other before issuing any press release
or otherwise making any public statement or other disclosure with respect to
this Agreement. Neither Party will issue any such press release or make any such
public statement or other

 

 

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disclosure prior to receiving written approval from the other Party, unless
compelled to do so under a regulatory or legal obligation.

16.2 From time to time, Prism may desire to publish or otherwise publicly
announce the results of testing or from the research or development program
involving any Licensed Products orally or in writing. CyDex shall not
unreasonably withhold its consent to such publication or announcement.

 

17. TERMINATION.

17.1 Termination.

17.1.1 Termination by Prism. Prism may terminate this Agreement at any time,
without cause, by giving [***]days prior written notice thereof to CyDex.

17.1.2 Termination by CyDex. CyDex may terminate this Agreement if an NDA for
any of the Licensed Products has not been submitted to the FDA on or before the
[***] year anniversary of the Effective Date (the “Termination Date”); provided,
however, that CyDex must give Prism written notice of such termination within
[***]days after the Termination Date.

17.1.3 Termination by Either Party.

 

  (a) Either Party may terminate this Agreement upon a material or continuing
breach of this Agreement by the other Party by giving [***]days prior written
notice of termination, stating the claimed breach with specificity, and
termination shall be effective as of the end of such [***]-day notice period
unless the breach is then substantially cured or the breaching Party has
commenced such actions necessary to cure the breach.

 

  (b) Either Party may terminate this Agreement immediately by giving written
notice of termination in the event of a Default. Events of Default shall occur
if the other Party: (a) makes or attempts to make an assignment for the benefit
of creditors; (b) becomes the subject of voluntary or involuntary bankruptcy
proceedings, and such proceedings are not dismissed within [***]days, or if this
License or the rights hereunder are conveyed out of bankruptcy; or (c) is
convicted of any criminal offense in connection with the business associated
with the Licensed Products.

17.2 Effects of Termination or Expiration.

17.2.1 Upon termination or expiration, each Party shall return to the other all
of the other’s Confidential Information that is capable of being returned, and
destroy, in a manner that prevents undeletion, Confidential Information that is
not capable of being transported.

 

 

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Except as otherwise provided herein, neither Party may use the other’s
Confidential Information after termination or expiration of this Agreement.
Notwithstanding anything to the contrary, Prism may retain and use original
Confidential Information to the extent that it relates to or is connected with
any intellectual property owned by Prism.

17.2.2 If requested by CyDex within [***]days of the termination of this
Agreement pursuant to Section 17.1.1, Section 17.l.2, or by CyDex pursuant to
Section 17.1.3, Prism shall:

 

  (a) [***] to the [***] or [***] the [***] of the [***], the [***] and the
[***] ) to [***] and [***], as reasonably requested [***] , to the FDA or any
other applicable Regulatory Authority assuming all obligations thereunder and
such notices shall have an effective date that is [***]days after the date of
termination of this Agreement (or such other date as may be agreed to by the
Parties). The Parties shall coordinate with one another and shall send such
notices simultaneously, and each Party shall deliver a copy of its such notice
of the FDA or any other applicable Regulatory Authority to the other Party.

 

  (b) [***] to CyDex [***] and [***] including [***] and [***], relating to
[***] and [***], and the [***] and [***] studies (including [***] and [***] ),
[***] or [***] of the [***].

 

  (c) [***] to CyDex a [***] under [***] filed by Prism pursuant to
Section [***] above, to make, have made, use, sell, offer to sell or import the
Licensed Products.

 

  (d) at the option of CyDex, [***] to CyDex [***] as of the date of termination
to any or all of the patents abandoned by CyDex and [***] to [***] pursuant to
Section [***] above.

17.2.3 Upon termination of this Agreement, Prism shall have no further payment,
management, development obligations with respect to the Licensed Products.

 

18. MISCELLANEOUS.

18.1 Entire Agreement. This Agreement sets forth the entire agreement and
understanding of the Parties on the subject matter herein, and it supersedes all
prior agreements

 

 

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and understandings between the Parties with respect to its subject matter. No
amendment or modification to this Agreement shall be effective unless in writing
signed by an authorized representative of each Party.

18.2 Assignment. Neither Party may assign its rights or delegate its obligations
under this Agreement without the express prior written consent of the other
Party, except that either Party’s rights and obligations may succeed by
operation of law to the surviving entity in a merger or consolidation in which
it participates or to a successor of all or substantially all of either Party’s
assets or stock. Any unauthorized assignment or transfer of this Agreement shall
be void. Subject to the foregoing, the rights and liabilities of the Parties
will bind and inure to the benefit of their respective successors, permitted
assigns, insurers and reinsurers.

18.3 Relationship. The Parties are independent entities. Nothing contained in
this Agreement or the Parties’ conduct hereunder shall be construed to create a
relationship of partners, joint venturers, principal and agent or
employer/employee. Neither Party shall have any right, power or authority,
express or implied, to bind the other Party.

18.4 Survival.

18.4.1 The representations and warranties contained in Article 12 shall survive
the execution and delivery of this Agreement and remain true during the Term,
except with respect to those representations and warranties which are limited to
the Effective Date or which otherwise are limited to a particular time or which
refer to past actions, which shall be true as of the Effective Date.

18.4.2 Each Party’s covenants and agreements under this Agreement shall remain
in effect only during the Term until performed by such Party, subject to any
conditions to performance, discharge of the duty to perform and similar
traditional contract interpretation principles.

18.4.3 Provisions of this Agreement that, by their nature, survive its
termination or expiration shall so survive, including without limitation
Sections 1 (Definitions), 17.2 (Effects of Termination or Expiration), 13
(Limitations), 14 (Confidentiality), 15.1-15.2 (Indemnity), and 18
(Miscellaneous Terms).

18.5 Severability. If any provision of this Agreement or portion thereof is
finally held by a court of competent jurisdiction to be unenforceable, void,
invalid, or otherwise contrary to law or equity, the Parties agree that such
provision or portion thereof shall be reformed automatically as necessary to
cure such defect, or if necessary to delete such provision or portion thereof,
and that the remainder of this Agreement shall continue in full force and effect

18.6 Waiver. The observance of any provision of this Agreement may be waived
(either generally or any particular instance and either retroactively or
prospectively) only in a writing signed by both Parties. The failure of either
Party to enforce its rights under this Agreement at any time for any period
shall not be construed as a waiver of such rights.

18.7 Fees and Expenses. Each Party will bear all fees, costs and expenses
incurred by it in respect of the negotiation, drafting and execution of this
Agreement and the consummation

 

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of the transactions contemplated thereby, including without limitation the fees
and disbursements of its legal, financial and other advisors and any and all
filing fees incurred by each of them in connection with obtaining all required
approvals from and submitting all required filing to, all governmental and other
regulatory agencies.

18.8 Arbitration. Any controversy, dispute or claim arising out of, in
connection with, or in relation to the interpretation, performance or breach of
this Agreement, or any amount due hereunder, including, without limitation, any
claim based on contract, tort or statute shall be settled as follows: The
Management Committee shall initially meet to attempt to resolve disputes. If the
Management Committee cannot resolve such disputes within [***]days after either
Party requests such a meeting, then either Party may request that the chief
executive officer of each Party meet to attempt to resolve such dispute. If the
chief executive officers cannot resolve such disputes within [***]days after
either Party requests such a meeting, then such controversy, dispute or claim
shall be settled, solely and exclusively, by arbitration. Any arbitration
pursuant to this Agreement shall be conducted in [***] before and in accordance
with the then existing Commercial Dispute Resolution Procedures through the
American Arbitration Association, using an arbitrator mutually selected by CyDex
and Prism from a list of those designated by the American Arbitration
Association or, if the Parties disagree, otherwise appointed by the American
Arbitration Association. At any time, a Party may seek or obtain preliminary,
interim or conservatory measures from the arbitrators or from a court. Any
arbitration shall be final and binding. The findings shall be delivered in a
written opinion with findings of facts based on the record. Any judgment upon
any interim or final award or order rendered by the arbitrator may be entered by
any State or Federal court having jurisdiction thereof. The Parties intend that
any agreement pursuant hereto to arbitrate be valid, enforceable and
irrevocable. Each Party in any arbitration proceeding commenced hereunder shall
bear such Party’s own costs and expenses (including expert witness and
attorneys’ fees) of investigating, preparing and pursuing such arbitration
claim. Notwithstanding the foregoing, neither Party shall be bound to follow the
dispute resolution process described in this Section 18.8 with respect to any
dispute for which interim equitable relief from a court is necessary to prevent
serious and irreparable injury to a Party.

18.9 Governing Law. This Agreement shall be governed and construed in accordance
with the laws of the state of Delaware, and without regard to its choice of law
rules.

18.10 Headings. The headings used in this Agreement are for convenience only and
are not to be used in interpreting the rights and obligations of the Parties
under this Agreement.

18.11 Counterparts; Facsimile. This Agreement shall be effective upon full
execution by facsimile or original, and a facsimile signature shall be deemed to
be and shall be as effective as an original signature. This Agreement may be
executed in any number of counterparts, each of which will be deemed an
original, but all of which taken together shall constitute one single agreement
between the Parties.

 

 

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18.12 Notices. Any notice or other communication required or permitted to be
given hereunder, shall be in writing and shall be deemed to be given when
delivered by hand or commercial overnight courier service with tracking
capabilities or sent by certified mail (return receipt requested), all of the
foregoing costs and postage prepaid, to the Parties at the addresses set forth
below, or such other address as a Party may specify for the other by written
notice;

 

For CyDex:

Attention: John M. Siebert Ph.D.

President and CEO

CyDex, Inc.

10513 W. 84th Terr.

Lenexa, Kansas 66214

 

For Prism:

Attention: Warren D. Cooper

President and CEO

Prism Pharmaceuticals, Inc

1150 First Ave., Suite 1050,

King of Prussia, PA, 19406

 

copy to:

Dinsmore & Shohl LLP

Attn: Paul R. Mattingly, Esq.

1900 Chemed Center

225 East Fifth Street

Cincinnati, Ohio 45202

18.13 Force Majeure. Neither Party hereto shall be held liable or responsible to
the other Party nor be deemed to have defaulted under or breached this Agreement
for failure or delay in fulfilling or performing any term of this Agreement when
such failure or delay is caused by or results from causes beyond the reasonable
control of the affected Party, which may include but not be limited to fire,
floods, embargos, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God, omissions or delays in acting by any Governmental
Entity (including the FDA and Regulatory Authorities) or the other Party hereto
(collectively, “Force Majeure Event”).

18.14 Drafting. Each Party and its counsel has reviewed and had the opportunity
to contribute to the drafting of this Agreement, and the rule of construction
providing that any ambiguities are to be resolved against the drafting Party
shall not be employed in the interpretation of this Agreement. This Agreement
shall be construed as drafted by both Parties.

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be signed
by their duly authorized representatives.

 

CYDEX, INC.     PRISM PHARMACEUTICALS, INC. By:  

/s/ John M. Siebert

    By:  

/s/ Warren D. Cooper

  John M. Siebert, Ph.D., President and CEO       Warren D. Cooper, President
and CEO Dated: 4 January, 2006     Dated: 1/4/2006

 

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SCHEDULE 3.1

Initial Management Committee

Prism’s designees to the Management Committee:

Kathleen DeLawrence

Dan Cushing

Robert Falconer

CyDex’s designees to the Management Committee:

Jose Rodriguez

Jerry Mosher

 

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EXHIBIT A

LICENSED PATENTS

EXHIBIT A

LICENSED PATENTS

 

Country

   Patent Number   Application Number [***]      [***] [***]      [***] [***]   
  [***] [***]      [***] [***]      [***] [***]      [***] [***]      [***]
[***]    [***]   [***] [***]    [***]   [***] [***]     

 

 

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omitted portions.

 

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EXHIBIT B

TRADEMARKS

[***]

 

 

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omitted portions.

 

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EXHIBIT C

REGISTRATIONS

[***]

 

 

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omitted portions.

 

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