Exhibit 10.1

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

LICENSE AGREEMENT

 

THIS LICENSE AGREEMENT (this “Agreement”) is made this 31st day of March, 2017
(the “Effective Date”) between CyDex Pharmaceuticals, Inc., a Delaware
corporation (“CyDex”), and Marinus Pharmaceuticals, Inc., a Delaware corporation
(“Company”).  CyDex and Company are hereinafter individually referred to as a
“Party” and collectively as the “Parties”.

 

RECITALS

 

WHEREAS, CyDex is engaged in the business of developing and commercializing
novel drug delivery technologies designed to enhance the solubility and
effectiveness of existing and development-stage drugs;

 

WHEREAS, CyDex is the exclusive supplier of Captisol®, a patented drug
formulation system designed to enhance the solubility and stability of drugs;

 

WHEREAS, Company desires to obtain an exclusive license to use the Captisol®
patented drug formulation system in connection with its development and
commercialization of one or more Licensed Products (defined below) and CyDex is
willing to grant such an exclusive license to Company under the terms and
conditions set forth herein; and

 

WHEREAS, CyDex desires to sell Captisol® sulfobutylether b (beta) cyclodextrin,
sodium salt to Company, and Company desires to purchase Captisol®
sulfobutylether b (beta) cyclodextrin, sodium salt from CyDex, in accordance
with the terms and conditions of that certain Supply Agreement between the
Parties of even date herewith (the “Supply Agreement”);

 

NOW, THEREFORE, in consideration of the following mutual promises and other good
and valuable consideration, the receipt and sufficiency of which are
acknowledged, the Parties, intending to be legally bound, agree as follows:

 

1.                                      DEFINITIONS.

 

For the purposes of this Agreement, the following terms shall have the meanings
as defined below:

 

“Adverse Event” means any side effect, injury, toxicity or sensitivity reaction,
or any unexpected incident, and the severity thereof, reasonably believed both
to be serious and associated with a Study, investigation, test, use and/or
marketing of Captisol® or the Licensed Product.

 

“Affiliate” means, with respect to any Party, any entity controlling, controlled
by, or under common control with such Party, during and for such time as such
control exists.  For these purposes, “control” shall refer to the ownership,
directly or indirectly, of at least 50% of the voting securities or other
ownership interest of the relevant entity or having the actual power, either
directly or indirectly through one or more intermediaries, to direct the
management and policies of the relevant entity (e.g.,

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

by contract or otherwise).

 

“Application” means a 505(b)(2) application, an abbreviated new drug application
or a new drug application, pursuant to and/or as defined in the United States
Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder,
or similar application filed with an equivalent regulatory body in another
country or multinational region.

 

“Captisol” means sulfobutylether b (beta) cyclodextrin, sodium salt.  CyDex
supplies a uniquely modified form of such material under the Captisol® brand. 
For avoidance of doubt:  the uniquely modified form of sulfobutylether b (beta)
cyclodextrin, sodium salt supplied by CyDex under the Captisol® brand shall be
deemed to be included among the substances/products which are within the defined
term “Captisol.”

 

“Captisol Data Package” means (a) all toxicology/safety and other relevant
scientific safety data owned, licensed or developed by CyDex and its Affiliates
relating to Captisol, including without limitation those provided in the DMF;
(b) all toxicology/safety and other relevant scientific data owned, licensed or
developed by the licensees or sublicensees of CyDex or its Affiliates or other
Third Parties (to the extent permitted in the applicable license or other
agreements between CyDex and/or its Affiliates and such licensees, sublicensees
or other Third Parties), including without limitation those provided in the DMF;
and (c) the open portion of the DMF for Captisol®, in each case to the extent
relating to Captisol® alone (and not in conjunction with a product formulation).

 

“Captisol Improvement” means any technology or improvement related to Captisol
alone, including without limitation any method of combining or formulating
Captisol with an active compound, whether or not patentable, that is developed
by Company or its Affiliates or Sublicensees, solely or jointly with a Third
Party during the Term; provided, that any such technology or improvement shall,
to the extent it involves combining or formulating Captisol with the Compound or
is related to the Compound and/or other non-Captisol components of the Licensed
Product, shall not to constitute a Captisol Improvement.

 

“Claim” has the meaning specified in Section 10.1.

 

“Company Indemnitees” has the meaning specified in Section 10.1.

 

“Competing Product” means any product, not covered by any license granted
hereunder, that incorporates the Compound as an active pharmaceutical ingredient
prepared or combined with or formulated using Captisol as a solubilizing agent
for ultimate use in humans within the Field.

 

“Compound” means ganaxolone (i.e., 3β-Methyl-3α-ol-5α-pregnan-20-one or
3α-Hydroxy-3β-methyl-5α-pregnan-20-one).

 

“Confidential Information” has the meaning specified in Section 8.1.

 

“Contract Manufacturer” has the meaning specified in Section 2.4.

 

“CyDex Indemnitees” has the meaning specified in Section 10.2.

 

“Designated Executives” means (a) for CyDex, Matthew Foehr, and (b) for Company,

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Christopher Cashman.

 

“Disclosing Party” has the meaning specified in Section 8.1.

 

“Discovery” has the meaning specified in Section 12.1(b).

 

“Dispute” has the meaning specified in Section 14.3(a).

 

“DMF” means a Drug Master File (or similar dossier filed with an equivalent
regulatory body in another country) for Captisol®, as filed as of the Effective
Date, or as hereafter updated from time to time during the Term, by CyDex with
the FDA (or equivalent regulatory body in another country).

 

“FDA” means the United States Food and Drug Administration, or any successor
thereto.

 

“Field” means any and all therapeutic uses in humans, with the exceptions of the
following ***.

 

“First Commercial Sale” means, with respect to a Licensed Product in any
country, the first commercial transfer or disposition for value of such Licensed
Product in such country to a Third Party by Company, an Affiliate of Company or
a Sublicensee of Company. For avoidance of doubt: “IND treatment sales,”
“compassionate use sales” or “named patient sales” in a country before Marketing
Approval in such country shall not be deemed to constitute a First Commercial
Sale in such country.

 

“Indemnified Party” has the meaning specified in Section 10.4.

 

“Indemnifying Party” has the meaning specified in Section 10.4.

 

“July 2014 Agreement” means the Captisol® Use Agreement dated July 2, 2014
between the Parties.

 

“Know-How” means all scientific and technical information and knowhow, trade
secrets, data and technology, including inventions (whether patentable or not),
discoveries, trade secrets, specifications, instructions, processes, formulae,
materials, expertise and other technology applicable to compounds, formulations,
compositions or products or to their manufacture, development, registration, use
or commercialization or methods of assaying or testing them or processes for
their manufacture, formulations containing them, compositions incorporating or
comprising them and including all biological, chemical, pharmacological,
biochemical, toxicological, pharmaceutical, physical and analytical, safety,
quality control, manufacturing, preclinical and clinical data, instructions,
processes, formulae, expertise and information, regulatory filings and copies
thereof, that are proprietary or confidential to CyDex and relate to or are
directed to Captisol or its manufacture and/or use.  Notwithstanding the
foregoing, the defined term Know-How (and derivative defined terms thereof)
shall not include Licensed Patents or inventions claimed thereby, nor any
portion of the DMF not within the definition of Captisol Data Package.

 

“Licensed Intellectual Property” means the Licensed Patents and the Licensed
Know-How Rights.

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

“Licensed Know-How Rights” means, collectively, all trade secret and Know-How
rights of CyDex at the Effective Date or during the term of this Agreement as
necessary or useful to practice the inventions described in Licensed Patents for
the purpose hereof, which relate to the preparation, combination and/or
formulation of the Compound with Captisol, including proprietary and
confidential information contained in the Captisol Data Package.

 

“Licensed Patents” means all patents and patent applications in the Territory
which include Valid Claims (or claims which upon patent issuance would include
Valid Claims) that cover Captisol and which now or at any time during the Term
are owned by or licensed to CyDex or any CyDex Affiliate with the right to
sublicense, including any and all extensions, renewals, continuations,
substitutions, continuations-in-part, divisionals, patents-of-addition,
reissues, reexaminations and/or supplementary protection certificates to any
such patents.  Set forth in Exhibit A attached hereto is a list of the Licensed
Patents as of the Effective Date. An updated version of Exhibit A, if
applicable, shall be communicated by CyDex to Company upon request, but no more
often than once per year.

 

“Licensed Product” means (a) the Compound prepared or combined with or
formulated using Captisol for ultimate therapeutic use in humans within the
Field, in any dosage form/formulation, or (b) a pharmaceutical preparation,
composition or formulation for ultimate therapeutic use in humans within the
Field, in any dosage form/formulation, that includes the Compound and that is
covered by or developed through the direct use of any of the Licensed
Intellectual Property. For avoidance of doubt:  the Licensed Products shall not
(without the express written consent of CyDex) include any product the
composition of which includes the Compound and any other active pharmaceutical
ingredient.

 

“Licensed Products Related Uses” has the meaning specified in Section 3.

 

“Losses” has the meaning specified in Section 10.1.

 

“Major Market” means any of (a) the United States, (b) Europe (meaning the
European Union or any one of France, Germany or the United Kingdom), (c) Japan,
or (d) the People’s Republic of China.

 

“Marketing Approval” means final approval of an Application by the FDA, or
comparable final approval of a comparable document filed with an equivalent
health regulatory authority in any other country or in the European Union (using
the centralized process, decentralized process or mutual recognition or member
state national authorization), without regard to any other marketing approvals
such as pricing and reimbursement approvals; provided, that if a First
Commercial Sale for use or consumption by a member of the general public of a
Licensed Product has occurred in any country in compliance with that country’s
applicable laws, it shall be conclusively deemed for purposes of this Agreement
that such approval in such country has been obtained.

 

“Net Sales” means the gross amount invoiced by Company or any Sublicensee
thereof to unrelated Third Parties, excluding to any Sublicensee for resale, for
the sale or other disposition of a Licensed Product, less the following
deductions to the extent actually allowed or incurred with respect to such
sales:

 

a.                                      Trade, cash and quantity discounts;

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

b.                                      Discounts, refunds, rebates actually
taken, chargebacks, retroactive price adjustments, and any other allowances
which effectively reduce the net selling price (other than such which have
already diminished the gross amount invoiced), including, without limitation,
Medicaid, institutional and governmental rebates (other than such which have
already diminished the gross amount invoiced);

 

c.                                       Credits or allowances granted on
returns of Licensed Product actually sold;

 

d.                                      Amounts invoiced for Licensed Product
sales but actually written off in good faith as uncollectible (net of any
recoveries on written-off debt);

 

e.                                       Shipping, handling, freight, postage,
insurance and transportation charges, but all only to the extent included as a
separate line item in the gross amount invoiced; and

 

f.                                       Any tax imposed on the production,
sale, delivery or use of the Licensed Product, including, without limitation,
import, export, sales, use, excise or value added taxes and customs, tariffs and
duties, but all only to the extent included as a separate line item (e.g.,
“taxes”) in the gross amount invoiced.

 

Such amounts shall be determined from the books and records of Company and its
Sublicensees, maintained in accordance with United States GAAP, consistently
applied, or, in the case of foreign Sublicensees, similar accounting principles,
consistently applied.  Company further agrees that in determining such amounts
with respect to sales and/or expenses not denominated in United States Dollars,
conversion from the applicable foreign currency in which such sales and/or
expenses were recorded to United States Dollars shall be performed at the
exchange rate reported in The Wall Street Journal, Eastern U.S. Edition, for the
last trading day of the applicable calendar quarter; based on the resulting Net
Sales in U.S. Dollars, the then applicable royalties shall be calculated.

 

In the event that a Licensed Product is commercialized in combination with one
or more services and/or with one or more products which are themselves not
Licensed Products for a mutually related price (e.g., buy one and get a discount
on or a coupon for the other) or for a single price, the Net Sales for such
Licensed Product shall be calculated by multiplying the gross amount invoiced
for such combination sale by the fraction A/(A+B) where A is the fair market
value of the Licensed Product and B is the fair market value of the other
product(s) and/or service(s) in the combination sale, and allocating applicable
“Net Sales” deductions in the same proportion.  In the case of sale of a product
combining (with the express written consent of CyDex) both of the Compound and
another active pharmaceutical ingredient(s) prepared or combined with or
formulated using Captisol, the Net Sales with respect to such
multiple-ingredient product shall be calculated by multiplying the gross amount
invoiced for such multiple-ingredient product sale by the fraction A/(A+B) where
A is the fair market value of a (Compound-only) Licensed Product of such dosage
and B is the fair market value of the multiple-ingredient product; provided,
that it is understood that CyDex is entitled to withhold or condition such
express written consent in its sole and absolute discretion, and that CyDex
expressly reserves the right to condition the giving of any such express written
consent on an agreement to vary the foregoing formula.

 

Resales of Licensed Products between Company, its Affiliates or Sublicensees
shall not be included in the calculation for Net Sales.

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

“Notice of Termination” has the meaning specified in Section 13.3.

 

“Pfizer” has the meaning specified in Section 8.4.

 

“Pivotal Trial” means a clinical trial of a Licensed Product in human patients,
which trial is designed (a) to establish that the Licensed Product is safe and
efficacious for its intended use; (b) to define warnings, precautions and
adverse reactions that are associated with the Licensed Product in the dosage
range to be prescribed; (c) to be, either by itself or together with one or more
other clinical trials having a comparable design and size, the final human
clinical trial in support of Marketing Approval of the Licensed Product, and
(d) consistent with 21 CFR § 312.21(c) (as hereafter modified or amended) and
any of its foreign equivalents.  Provided that, and for avoidance of doubt:  any
pivotal trial, which could be or is used as one of the adequate and
well-controlled trials for registration in any jurisdiction, whether or not
formally denominated as a Phase III trial, shall be deemed to be a Pivotal
Trial.  Further for avoidance of doubt: if a clinical trial of a Licensed
Product in human patients is not initially designed or presented as a Pivotal
Trial but is later re-designed, re-presented or identified as or converted into
a trial which could be or is used as one of the adequate and well-controlled
trials for registration in any jurisdiction, it shall be deemed to be a Pivotal
Trial as of the date of such
re-design/re-presentation/identification/conversion, and if the first patient in
such trial was dosed before the date of such
re-design/re-presentation/identification/conversion, the
Section 4.1(b)(B) milestone payment shall be payable upon such
re-design/re-presentation/identification/conversion.

 

“Receiving Party” has the meaning specified in Section 8.1.

 

“SEC” means the United States Securities and Exchange Commission.

 

“Study” has the meaning specified in Section 6.3.

 

“Sublicense” has the meaning specified in Section 2.3.

 

“Sublicensee” means the sublicensee party to a Sublicense.

 

“Supply Agreement” means that certain Supply Agreement between the Parties of
even date herewith, as mentioned in the Recitals.

 

“Term” has the meaning specified in Section 13.1.

 

“Territory” means the entire world.

 

“Third Party” means any person or entity or authority other than CyDex or
Company or an Affiliate of either of them.

 

“Third Party Infringement” has the meaning specified in Section 12.3.

 

“Upstream Licensor” has the meaning specified in Section 2.6.

 

“Valid Claim” means a claim which, but for the license granted hereunder, would
be infringed by Company’s use, manufacture or sale of a Licensed Product in a
country in the Territory, and which is covered by an issued and unexpired patent
in such country included within the Licensed Patents

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

which has not lapsed or been revoked, abandoned or held unenforceable or invalid
by a final decision of a court or governmental authority of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal, and
which has not been disclaimed, denied or admitted to be invalid, canceled or
unenforceable by the owner through re-issue, re-examination or disclaimer,
opposition procedure, nullity suit, or otherwise.

 

2.                                      GRANT OF RIGHTS.

 

2.1                               License Grants from CyDex to Company.

 

(a)                                 Licensed Intellectual Property.  Subject to
the terms and conditions of this Agreement, including but not limited to payment
of the amounts set forth in Section 4.1 below, CyDex hereby grants to Company an
exclusive, nontransferable (except with respect to the assignment provision in
Section 14.13) license during the Term under the Licensed Intellectual Property,
solely to develop, make, have made (pursuant to Section 2.4), use, sell, offer
for sale, import and otherwise commercially exploit the Licensed Products in the
Territory in and for the Field.  (No license, exclusive or non-exclusive, is
granted hereunder under the Licensed Intellectual Property, except to so
develop, make, have made, use, sell, offer for sale, import or otherwise
commercially exploit the Licensed Products in the Territory in and for the
Field.)  Notwithstanding the foregoing, to the extent that any Licensed
Intellectual Property is licensed to CyDex or its Affiliates by a Third Party on
a non-exclusive basis, the license granted to Company in the foregoing sentence
shall be non-exclusive.  For clarity, as CyDex is unable to grant Company any
rights that it does not have, in the event that CyDex obtains a non-exclusive
license from a Third Party (including without limitation being potentially
non-exclusive as a result of rights inhering in the United States Government
under Chapter 18, Title 35 of the United States Code and regulations thereunder
(or otherwise) by virtue of the fact that the licensed invention was funded by
the United States Government) for intellectual property within the Licensed
Intellectual Property, then CyDex shall pass on such rights to Company hereunder
via a license that grants rights that are to such extent non-exclusive.  It is
understood that all references in this Agreement to “licenses” from CyDex to
Company (and other forms of the word “license”) include applicable sublicenses
from CyDex (as sublicensor) to Company (as sublicensee).  Company may not
develop, make, have made, use, sell, offer for sale, import or otherwise
commercially exploit either the Licensed Intellectual Property or the Licensed
Products for any other purposes than those specified in this Agreement.  Company
may not sublicense the Licensed Intellectual Property, except as expressly set
forth in Sections 2.3 and 2.4 below.

 

(b)                                 Scope of Licenses.  CyDex grants no licenses
or rights to use the Licensed Intellectual Property or any other intellectual
property other than as expressly set forth herein or as may be expressly set
forth in the Supply Agreement.  CyDex grants no rights to Company to
manufacture, have manufactured, import, sell or offer for sale bulk Captisol;
provided, however, that Company may provide Captisol to bona fide collaborators
in order to help Company to develop, make, have made (pursuant to Section 2.4),
use, sell, offer for sale, import or otherwise commercially exploit the Licensed
Products in the Territory in the Field.  Without prejudice to the provisions of
subsection (a) above, Company acknowledges that not all rights of CyDex related
to Captisol are included within the rights licensed hereunder, given that CyDex
shall supply Company’s requirements of Captisol for the Licensed Products. 
Company shall not attempt to reverse engineer, deconstruct or in any way
determine the structure or composition of Captisol except as and to the extent
reasonably required to determine an optimal formulation of the Licensed Product,
and such structure and composition of

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Captisol (as and if so determined) shall be considered a Captisol Improvement. 
CyDex shall not be liable to Company for violation of Company’s exclusive rights
hereunder by Third Parties which are not Affiliates or licensees of CyDex except
to the extent CyDex has contributed to such violation.  Company acknowledges and
agrees that except as is expressly set forth in this Agreement (i)  CyDex shall
not be restricted in making sales of Captisol or licensing intellectual property
rights to other persons and/or entities to the extent not expressly inconsistent
with the licenses granted to Company under this Agreement and/or the covenants
of CyDex in this Agreement, and (ii) CyDex does not warrant or indemnify Company
or its Affiliates and Sublicensees against the Licensed Products infringing
Third Party rights, except in cases where such infringement results from the
incorporation of Captisol in said Licensed Products.

 

2.2                               Grant of License from Company to CyDex. 
Company hereby grants to CyDex a non-exclusive, transferable, perpetual,
worldwide and royalty-free license, with the right to grant sublicenses (through
multiple tiers of sublicensees), under Company’s and its Affiliates’ and
Sublicensees’ rights in and to Captisol Improvements to develop, make, have
made, use, market, distribute, import, sell and offer for sale Captisol, any
Captisol Improvement and products formulated with Captisol or any Captisol
Improvement (other than the Licensed Products in the Field or Competing Products
during the Term).  If during the Term any of (a) Company, (b) Affiliates to whom
Company has provided sublicense rights under the licenses granted to Company by
CyDex pursuant to Section 2.1, or (c) other Sublicensees pursuant to the
practice of their respective sublicenses from Company under Section 2.3, file
any patent application claiming any Captisol Improvement anywhere in the world
or are issued any patent thereupon, CyDex shall be deemed automatically to have
a non-exclusive, transferable, perpetual, worldwide and royalty-free license,
with the right to grant sublicenses (through multiple tiers of sublicensees),
under the claims relating specifically to any Captisol Improvement to develop,
make, have made, use, market, distribute, import, sell, offer for sale and
otherwise commercialize Captisol and all products formulated with Captisol
(other than the Licensed Products in the Field or Competing Products during the
Term).  Company shall provide prompt notice of any Captisol Improvement.

 

2.3                               Sublicensing.  Company shall have the right to
grant sublicenses with terms consistent with those of this Agreement
(collectively “Sublicenses”) under the licenses granted to Company pursuant to
Section 2.1; provided, however, that the granting by Company of a Sublicense
shall not relieve Company of any of its obligations hereunder. Any Sublicense
shall automatically terminate upon the termination or expiration of this
Agreement ***.  Company shall ensure that all of its Sublicensees shall comply
with the terms and conditions of this Agreement and the Supply Agreement, and
Company shall be and remain fully responsible to CyDex for the compliance by
such Sublicensees with the terms and conditions of this Agreement and the Supply
Agreement as if such Sublicensees were Company hereunder and thereunder;
provided, it is not required that a Sublicense include provisions for the
Sublicensee to pay royalties or make milestone payments or other payments
directly to Licensor or to provide royalty reports directly to Licensor. 
Company acknowledges that it has no right to, and agrees not to purport to,
grant to anyone a sublicense under the Licensed Intellectual Property, other
than Sublicenses compliant with the requirements of this Agreement for
Sublicenses.

 

2.4                               Contracting.  To the extent necessary to
engage any one or more Third Party

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

manufacturers (collectively “Contract Manufacturers”) for a Licensed Product,
Company shall be permitted under this Agreement to grant any such Contract
Manufacturer a sublicense under the licenses granted to Company pursuant to
Section 2.1 solely for such purposes; provided, however, Company warrants and
shall procure, as a condition precedent thereto, that (a) any such Contract
Manufacturer shall first be advised of the restrictions set forth in this
Agreement with respect to the transfer of the rights licensed to Company and its
Sublicensees hereunder and (b) any such Contract Manufacturer shall enter into
an agreement with Company with terms consistent with those of this Agreement. 
Company shall ensure that all of its Contract Manufacturers shall comply with
the terms and conditions of this Agreement and shall remain fully responsible to
CyDex for the compliance by such Contract Manufacturers with the terms and
conditions of this Agreement as if such Contract Manufacturers were Company
hereunder.  Company shall not manufacture bulk Captisol (or contract the
manufacture of bulk Captisol with a Contract Manufacturer).

 

2.5                               Bankruptcy Code.  All rights and licenses
granted under or pursuant to this Agreement by CyDex to Company are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy
Code, licenses of rights to “intellectual property” as defined under Section 101
of the Bankruptcy Code.  The Parties agree that Company, as a licensee of such
rights under this Agreement, shall retain and may fully exercise all of its
rights and elections under the Bankruptcy Code.  All rights and licenses granted
under or pursuant to this Agreement by Company to CyDex are, and shall otherwise
be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses
of rights to “intellectual property” as defined under Section 101 of the
Bankruptcy Code.  The Parties agree that, as a licensee of such rights under
this Agreement, CyDex shall retain and may fully exercise all of its rights and
elections under the Bankruptcy Code.

 

2.6                               Compliance with Upstream Licenses.  CyDex
shall be solely responsible for paying directly to any and all Third Parties
having rights in any of the Licensed Intellectual Property (each an “Upstream
Licensor”) any royalties or other amounts due to such Upstream Licensors as a
result of Company exercising its rights hereunder.  In addition, CyDex
represents and warrants that it is not in breach of any of its obligations to
such Upstream Licensors and covenants that it shall comply with the terms of its
agreements with such Upstream Licensors throughout the Term.  Furthermore, CyDex
covenants and warrants that it shall not amend, modify or supplement the terms
of, or waive any rights under any such agreements if the same would have the
effect of limiting or further restricting Company’s rights or expanding
Company’s obligations hereunder.

 

2.7                               Negative Covenants by CyDex.

 

(a)                                 During the Term, neither CyDex nor any of
its Affiliates shall directly themselves, nor provide any Third Party any
assistance whatsoever, nor grant any Third Party any title, right, claim,
interest or license under, in or to any of the Licensed Intellectual Property
to, research, develop, modify, make, have made, import, export, use, promote,
market, distribute, package, offer for sale, sell, or otherwise commercially
exploit Licensed Products or any Competing Products.

 

(b)                                 During the Term, neither CyDex nor any of
its Affiliates shall (other than at Company’s express written request) supply
Captisol to any Third Party which it knows or should know will use it for a
Licensed Product or a Competing Product.  If during the Term, any such Third
Party utilizes such Captisol (supplied by CyDex or any of its Affiliates) in a
Licensed Product or Competing Product, CyDex shall immediately cease and cause
its Affiliates and any other Third Party to

 

9

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

immediately cease supplying Captisol to the offending Third Party for the
duration of the Term or until (if sooner) assurances reasonably satisfactory to
Company that the infringing use has ended and will not resume have been
obtained.

 

(c)                                  During the Term, neither CyDex nor any of
its Affiliates shall sue or threaten to sue, or take any similar action against,
or aid, abet or enable any Third Party to sue, threaten to sue or take any
similar action against, Company, or any Sublicensees, or any of their respective
Affiliates, or any customers or end-users of any Licensed Products, claiming
that the development, manufacture, use, sale, offer for sale or importation of
any Licensed Product infringes any Captisol-related patents or patent
applications owned, licensed, sublicensed or otherwise controlled by, now or in
the future, CyDex or any of its Affiliates.

 

3.                                      MANUFACTURE AND SUPPLY OF CAPTISOL.

 

The provisions of the Supply Agreement shall govern the manufacture and supply
of Captisol® sulfobutylether b (beta) cyclodextrin, sodium salt for use in
Company’s (and its Affiliates’ and their Sublicensees’) preparation, formulation
and production of the Licensed Products, both before and after Marketing
Approval (the “Licensed Products Related Uses”). Company acknowledges and agrees
that CyDex is, during the term of the Supply Agreement, the exclusive
manufacturer of sulfobutylether b (beta) cyclodextrin, sodium salt for Company
and its Affiliates and Sublicensees for the aforementioned Licensed Products
Related Uses.  Nothing set forth herein shall be deemed to grant Company or its
Affiliates or Sublicensees the right to manufacture Captisol nor the right to
contract the manufacture of Captisol to a Third Party, except pursuant to any
express provisions of the Supply Agreement.  It is understood that it shall be
Company’s and its Affiliates’ responsibility to obtain, at Company’s and its
Affiliates’ sole expense and from sources other than CyDex, all materials
(including all quantities of the Compound, but excluding sulfobutylether b
(beta) cyclodextrin, sodium salt) needed by Company and its Affiliates for the
Licensed Products Related Uses — it being further understood, of course, that
Company is to obtain at Company’s sole expense and solely from CyDex (pursuant
to the Supply Agreement) all sulfobutylether b (beta) cyclodextrin, sodium salt
needed by Company and its Affiliates and Sublicensees for the Licensed Products
Related Uses.    It is of the essence that the only Captisol used in or for any
Licensed Product shall be Captisol supplied by CyDex under the Supply Agreement
or previously supplied by CyDex under the July 2014 Agreement, and Company
hereby covenants and agrees that Company and its Affiliates and Sublicensees
shall not use in or for any Licensed Product any other Captisol other than
Captisol® and further covenants and agrees that Company and its Affiliates and
Sublicensees shall not use in or for any Licensed Product any Captisol® obtained
other than directly from CyDex under the Supply Agreement or previously under
the July 2014 Agreement.

 

4.                                      COMPENSATION.

 

4.1                               Payments and Royalties for Licenses.

 

(a)                                 One-Time Fee.  Company shall forthwith (but
in no event later than 10 days after delivery of the corresponding invoice sent
by CyDex after the Effective Date) pay to CyDex a non-refundable,
non-creditable, one-time cash fee of $*** in partial consideration of the rights
granted to Company under this Agreement.

 

10

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(b)                                 Milestone Payments. Within 30 days following
the achievement of each and any milestone event listed below, Company shall, in
further consideration of the rights granted Company hereunder, provide written
notice to CyDex of the achievement of such milestone event, accompanied by
payment to CyDex of the applicable non-refundable cash milestone fee listed next
to such event.

 

 

 

MILESTONE

 

MILESTONE
PAYMENT

 

(A)

 

***

 

$

***

 

(B)

 

***

 

$

***

 

(C)

 

***

 

$

***

 

(D)

 

***

 

$

***

 

 

Upon achievement of Milestone (B), (C) or (D) with regard to a Licensed Product,
the Milestone (A) shall be deemed to be thereby achieved and if such Milestone
(A) milestone payment has not previously been paid, it shall thereupon also be
paid, forthwith.  For clarity, each Milestone shall be paid only once.

 

(c)                                  Royalties.

 

(i)                                    In addition to the amounts payable
pursuant to Section 4.1(a) and Section 4.1(b) above, Company shall for all Net
Sales within the Term pay to CyDex, on a calendar quarterly basis, ***%
royalties on the first $*** of worldwide annual Net Sales, and ***% royalties on
the portion of worldwide annual Net Sales which exceeds $***. Notwithstanding
the foregoing, as a royalty-rate step-down, for Net Sales (in a country), during
the Term, of a Licensed Product which are made after expiry of the
last-to-expire Licensed Patent containing a Valid Claim that would in the
absence of the license granted herein be infringed by the use, manufacture or
sale of such Licensed Product in such country or by the importation of such
Licensed Product into such country, Company shall instead pay to CyDex, on a
calendar quarterly basis, ***% royalties on the first $*** of worldwide annual
Net Sales, and ***% royalties on the portion of worldwide annual Net Sales which
exceeds $***.

 

(ii)                                Unless this Agreement is earlier terminated
pursuant to Section 13, royalties shall be payable, on a Licensed
Product-by-Licensed Product and country-by-country basis, during the period from
the First Commercial Sale of a given Licensed Product in a given country until
the later of (a) expiry of the last-to-expire Licensed Patent containing a Valid
Claim in such country that would in the absence of the license granted herein be
infringed by the use, manufacture or sale of such Licensed Product in such
country or by the importation of such Licensed Product into such country; or
(b) the 10th anniversary of the First Commercial Sale of such Licensed Product
in such country.

 

(iii)                            All royalties payable to CyDex pursuant to
Section 4.1(c) shall be paid on a quarterly basis.  These royalties shall be
paid together with and in strict compliance with the amounts defined in the
final written royalty report sent by Company for the preceding calendar quarter,
as set forth in Section 5.2 below. Within 75 calendar days after the conclusion
of its fiscal year, Company may provide notice to CyDex of any adjustments
necessary to account for any royalties which were overpaid or underpaid for such
prior fiscal year’s calendar quarters (as determined from Company’s end of
fiscal year external audit), and the Parties shall promptly true-up for any such
adjustments which are mutually determined in good faith to be correct; provided
however, the lapse of

 

11

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

such 75-day period shall not impact the right of a Party to credit or recover
any overpayments or underpayments discovered during an audit under Section 5.3.

 

(iv)                             In establishing the royalty structure
hereunder, the Parties recognize, and Company acknowledges, the substantial
value of the various obligations being undertaken by CyDex under this Agreement,
in addition to the grant of the license under the Licensed Intellectual
Property, to enable the rapid and effective market introduction of the Licensed
Products.  The Parties have agreed to the payment structure set forth herein as
a convenient and fair mechanism to compensate CyDex for these obligations.

 

4.2                               Taxes.  All amounts due hereunder and under
the Supply Agreement exclude and shall, as far as is legally possible, be paid
in full to CyDex without reduction for all applicable sales, use, and other
taxes and duties, and Company shall be responsible for payment of all such taxes
(other than taxes based on CyDex’s income) and duties and any related penalties
and interest, arising from the payment of amounts due under this Agreement and
under the Supply Agreement.  The Parties agree to cooperate with one another and
use reasonable efforts to avoid or reduce tax withholding or similar obligations
in respect of royalties, milestone payments and other payments made by Company
to CyDex under this Agreement and under the Supply Agreement.  To the extent
Company is required to withhold taxes on any payment to CyDex under this
Agreement or under the Supply Agreement, Company shall pay the amounts of such
taxes to the proper governmental authority in a timely manner and promptly
transmit to CyDex official receipts issued by the appropriate taxing authority
and/or an official tax certificate, or such other evidence as CyDex may
reasonably request, to establish that such taxes have been paid.  CyDex shall in
due time  provide Company any tax forms that may be reasonably necessary in
order for Company to not withhold tax or to withhold tax at a reduced rate under
an applicable bilateral income tax treaty, and Company shall utilize such forms
to such effect.  Each Party shall provide the other with reasonable assistance
to enable the recovery, as permitted by applicable law, of withholding taxes,
value added taxes, or similar obligations resulting from payments made under
this Agreement and under the Supply Agreement, such recovery to be for the
benefit of the Party bearing such withholding tax or value added tax.  CyDex
shall indemnify and hold Company harmless from and against any penalties,
interest or other tax liability arising from any failure by Company (at the
express request of CyDex) to withhold or from any Company reduction (at the
express request of CyDex) in its withholding.

 

4.3                               Payments.  Accrual and payment of interest
shall not be deemed to excuse or cure breaches of contract arising from late
payment or nonpayment.  Cumulative with and not exclusive of any and all other
available remedies, payments that are not made when due hereunder, and which are
not otherwise subject to a good faith dispute, shall accrue interest, from due
date until paid, at an annual rate equal to the prime rate, as reported in The
Wall Street Journal, Eastern United States Edition, on the date such payment is
due, plus an additional 200 basis points (2%).  All amounts due hereunder are
stated in and shall be paid in United States Dollars.

 

5.                                      RECORDS; REPORTS; AUDIT.

 

5.1                               Records.  During the Term and until the end of
the third calendar year after the calendar year during which the Term ends,
Company shall, and shall require its Affiliates and Sublicensees to, maintain
accurate books and records relating to Net Sales.  Without limitation, for three
years after the calendar year in which each respective sale of a Licensed
Product (whether covered by a Valid Claim

 

12

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

or not) occurs, Company shall keep (and shall ensure that its Affiliates and
Sublicensees shall keep) complete and accurate records of such sale in
sufficient detail to confirm the accuracy of the royalty calculations hereunder.

 

5.2                               Royalty Reports.  Within 25 calendar days
after the conclusion of each calendar quarter after a First Commercial Sale and
after the conclusion of each successive calendar quarter until the end of the
first full calendar quarter after the end of the Term, Company shall deliver to
CyDex a verbal or written, non-binding initial estimate of Net Sales and
royalties due to CyDex, followed by (within 45 calendar days following the
conclusion of each calendar quarter after the First Commercial Sale of the
relevant Licensed Product in any country and after the conclusion of each
successive calendar quarter until the end of the first full calendar quarter
after the end of the Term) a final written royalty report.  Each final written
royalty report shall provide, on a Licensed Product-by-Licensed Product (and
specifying whether covered by a Valid Claim or not, as applicable) and
country-by-country basis, (a) gross invoiced (or otherwise charged) amounts of
sales, by Company and its Affiliates and Sublicensees, of Licensed Products
subject to royalty payments for such calendar quarter, (b) amounts deducted by
category (following the definition of Net Sales) from such gross invoiced
amounts to calculate Net Sales, (c) Net Sales subject to royalty payments for
such calendar quarter and calendar year to date, (d) exclusions pursuant to
Section 4.1(c)(i), and (e) the corresponding royalty amount due hereunder.  Such
reports shall be deemed “Confidential Information” of Company and shall be
subject to the obligations of Section 8 of this Agreement.

 

5.3                               Audit.  Upon at least 30 days’ advance written
notice by CyDex, Company shall permit, shall cause its Affiliates and
Sublicensees to permit, an independent certified public accounting firm of
nationally recognized standing selected by CyDex (who has not been engaged by
CyDex to provide services in any other capacity at any time during the
three-year period before such selection), and reasonably acceptable to Company
or such Affiliate or Sublicensee, to have access to and to review, during normal
business hours on business days upon reasonable prior written notice, the
applicable records of Company and its Affiliates or Sublicensees to verify the
accuracy of the royalty payments under this Section 5. Such review may cover:
(a) the records for sales made in any calendar year ending not more than three
years before the date of such request, and (b) only those periods that have not
been subject to a prior audit. Except as described hereafter, all such audits
shall be conducted at the expense of CyDex.   Such audits shall be conducted not
more than once in each calendar year and not more than once for each audited
period.    In the event such accountant concludes that additional payments of
any kind as required by this Agreement were owed to CyDex during such period,
the additional amounts shall be paid within 30 days after the date of the
corresponding invoice sent by CyDex and delivered to Company with copy of the
aforementioned accountant’s written report so concluding, unless Company
disputes the results of such audit in accordance with Section 14.3.  The fees
charged by such accountant shall be paid by CyDex, unless the audit discloses
that the amounts payable by Company for the audited period are more than *** of
the amounts actually paid for such period, in which case Company shall pay the
reasonable fees and expenses charged by the accountant for such audit (upon
resolution of any dispute initiated by either Party pursuant to Section 14.3
with respect to the same).  In the event such accountant concludes that there
was an overpayment by Company to CyDex during such period, at Company’s option,
the overpayment shall be paid by CyDex to Company within 30 days after the date
of the of the corresponding invoice sent by Company to CyDex, unless CyDex
disputes the results of such audit in accordance with Section 14.3.  CyDex shall
cause the independent certified public accountant to keep confidential any
information obtained during such inspection in accordance with the provisions
set forth in Section 8 hereof and shall report to

 

13

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

CyDex only the amounts of (y) Net Sales that give rise to royalties and
(z) royalties payments due and payable.  The Parties agree that all information
subject to review under this Section 5.3 or under any Sublicense agreement is
the Confidential Information of Company.

 

5.4                               Annual Progress Reports.  By November 1 of
each calendar year during the Term, Company shall provide CyDex with written
reports that describe in reasonable detail Company’s progress made toward
achievement of the milestones specified in Section 4.1(b) above during such
calendar year and summarize Company’s activities, progress and outlook in
developing Licensed Products.  Company shall also provide updates regarding any
material changes to the expected completion of any such milestones outlined in
the annual report or any change that may materially affect the Supply Agreement
or orders placed thereunder during such calendar year. The Parties agree that
the aforementioned written report is the Confidential Information of Company and
shall be subject to the obligations of Section 8 of this Agreement.

 

6.                                      DEVELOPMENT AND COMMERCIALIZATION BY
COMPANY.

 

6.1                               Development.  As between CyDex and Company,
from and after the Effective Date Company shall be responsible for all
non-clinical and clinical development of the Licensed Products, all
commercialization of the Licensed Products, and all storage, handling and use of
physical quantities of the Compound and/or the Compound prepared, combined
and/or formulated with Captisol.

 

6.2                               Costs and Expenses.  Company shall be solely
responsible for all decision-making, compliance with law, costs and expenses
related to its development, manufacturing and commercialization of the Licensed
Products, including without limitation costs and expenses associated with all
preclinical activities and clinical trials, and all regulatory filings and
proceedings relating to the Licensed Products, and all commercialization of
Licensed Products.

 

6.3                               In Vivo Studies.  If Company wishes to conduct
any in vivo study (preclinical or clinical, in animals or in humans, each a
“Study”) of a Licensed Product, the following provisions shall apply:

 

(a)                                 Dosing.  Company shall not without the
written consent of CyDex exceed the allowable dosing levels of Captisol
specified in CyDex’s then-current clinical dosing matrix (which shall be
provided by CyDex to Company from time to time).

 

(b)                                 Compliance with Laws.  Company represents,
warrants and covenants that each Study shall be performed in material compliance
with all applicable laws, regulations and requirements.  Company shall provide
or cause to be provided all appropriate warnings to participants enrolled in
each Study and obtain or cause to be obtained appropriate documentation of
informed consent from all participants in each such Study.

 

(c)                                  Adverse Events.  Company agrees to promptly
inform CyDex if any Adverse Events are observed and ascribed to Captisol in any
Study in accordance with Section 7.4 hereof.  Company agrees that, for so long
as and to the extent that CyDex is providing supply pursuant to the Supply
Agreement, it shall use for each such Study conducted under the scope of this
Agreement only Captisol supplied by CyDex under the Supply Agreement or
previously supplied by CyDex under the July 2014 Agreement, and shall not use
any other Captisol supplied by a Third Party or any Captisol® obtained other
than directly from CyDex under the Supply Agreement or previously under the July

 

14

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

2014 Agreement.

 

(d)                                 Reporting and Study Data.  Within three
months after receipt of the final Study report for a Study, Company shall
provide to CyDex a summary of the data and results of each Study that pertain
solely to Captisol, and Company hereby grants to CyDex a non-exclusive,
royalty-free license (with the right to sublicense) to use and disclose such
data solely as necessary for regulatory purposes, including without limitation
to update the DMF for Captisol®.

 

(e)                                  Responsibility.  Company has the freedom to
formulate and design each Study, and (as between Company and CyDex) Company is
solely responsible for executing each Study; and so it is reasonable that, and
the Parties agree that, Company shall be solely responsible therefor and for any
effects or consequences of the formulation, design and execution of each Study.

 

(f)                                   Review of Regulatory Filings and
Publications.  At least 14 days before a submission of any proposed written
publication material or regulatory submission reporting results of a Study where
such publication material refers to Captisol (which shall be subject to the
restrictions of Section 8 hereof), Company shall provide to CyDex for CyDex’s
review and comment a copy of any proposed written publication, material or
regulatory submission.  Company shall give due consideration to and reasonably
incorporate any input that CyDex provides regarding Captisol.

 

6.4                               Global Safety Database.  Company shall set up,
hold, and maintain (at Company’s sole cost and expense) the global safety
database for the Licensed Products

 

6.5                               Access to Company’s Data.  CyDex shall have
the right to reference and utilize all toxicology/safety and other relevant
scientific data that exclusively relate to Captisol and are developed by
Company, its Sublicensees or Affiliates, at no cost to CyDex.  Upon request by
CyDex, Company shall either provide CyDex, at CyDex’s sole expense, with a copy
of all such data or shall make such data accessible to CyDex at times and
locations reasonably agreeable to CyDex and Company.

 

6.6                               Insurance. During the Term and for three years
thereafter, both Parties shall obtain and maintain, at their respective cost and
expense, commercial general liability insurance and product liability insurance
in amounts that are appropriate with respect to its indemnification obligations
hereunder. It is understood and agreed that this insurance shall not be
construed to limit each Party’s liability with respect to its indemnification
obligations hereunder. Each Party shall provide upon request the other Party
with a certificate evidencing the insurance it is required to obtain and keep in
force under this Section 6.6, and shall provide the other Party at least 30
days’ prior written notice of any cancellation or material modification of such
insurance.

 

6.7                               Patent Marking. Company agrees that with
respect to each unit or package of Licensed Products sold in a given country,
Company shall comply with the customary patent marking laws and practices of
such country as to the applicable Licensed Patents.

 

6.8                               Trademarks. As between CyDex and Company,
Company shall have the sole authority to select trademarks for Licensed Products
and shall own all such trademarks.  CyDex does not grant Company the right to
use any trademarks of CyDex or its Affiliates.

 

6.9                               No Guaranty of Favorable Outcomes.  CyDex does
not warrant that Company’s preclinical studies and evaluation and/or Company’s
clinical studies (if any) will produce any

 

15

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

particular results or any favorable results, or that Licensed Products can ever
receive Marketing Approval or can ever be successfully or profitably
commercialized.

 

7.                                      REGULATORY MATTERS.

 

7.1                               Right of Reference.  Company shall have the
right to reference the DMF solely in connection with Company’s regulatory
filings (including Applications) submitted in connection with obtaining
Marketing Approval for a Licensed Product.  CyDex shall use commercially
reasonable efforts to keep its DMF in good standing throughout the Term.

 

7.2                               Captisol Information Submitted for Regulatory
Review.  Except as otherwise set forth herein, Company shall be solely
responsible for all communications with regulatory agencies in connection with
the Licensed Products, provided CyDex shall reasonably cooperate with Company
with respect to any interactions with regulatory authorities concerning
Captisol.  Company shall provide CyDex with copies of the portions of all
regulatory submissions containing Captisol data alone (and not in conjunction
with any Licensed Product) 14 days before submission and shall allow CyDex to
review and comment upon said submissions.  The contents of each such submission
shall be deemed to be Confidential Information of Company, subject to the terms
and provisions of Section 8 below.  Company shall promptly inform CyDex of
meetings with the FDA (or other regulatory agencies in the Territory) regarding
Captisol.  If Company submits written responses to the FDA that include data on
Captisol alone, CyDex shall be permitted to review the portions of such written
materials relating to Captisol 14 days before submission.  If CyDex reasonably
objects to the contents of such proposed submissions or written responses
relating to Captisol, the Parties agree to cooperate in working toward a
reasonable and mutually agreeable submission or response; provided, however,
that Company shall be entitled to in good faith make the final determination as
to the contents of any such materials.

 

7.3                               Material Safety.  CyDex shall provide Company,
in writing, from time to time, with (a) all relevant material information
currently known to it regarding handling precautions, toxicity and hazards with
respect to Captisol®, and (b) the then-current material safety data sheet for
Captisol®.  Notwithstanding the foregoing or anything in this Agreement to the
contrary, Company is solely responsible for (x) use of all documentation
provided by CyDex, including without limitation, use in any regulatory
submission to the FDA or any other regulatory authority in the Territory,
(y) document control and retention, and (z) determining the suitability of any
documentation provided by CyDex hereunder for use in any regulatory submission.

 

7.4                               Adverse Event Reporting.  Company shall
adhere, and shall require that its Affiliates, Sublicensees, co-marketers and
distributors adhere, to all requirements of applicable law and regulations that
relate to the reporting and investigation of any Adverse Event, including
without limitation an unfavorable and unintended diagnosis, symptom, sign
(including an abnormal laboratory finding), syndrome or disease, whether or not
considered Captisol or Licensed Product-related, which occurs or worsens
following administration of Captisol or Licensed Product.  Each Party shall
provide the other with copies of all reports it obtains (either directly or
through any Sublicensee or licensee) of any Adverse Event which such Party has
reason to believe are associated with Captisol within 14 days following
(a) submission of any such report to any regulatory authority, or (b) receipt
from such Party’s Sublicensee, licensee, co-marketer or distributor of any such
report to any regulatory authority.  Each Party shall also advise the other
Party promptly regarding any proposed labeling or registration dossier changes,
of which it becomes aware, which relate specifically to both the Licensed
Product and

 

16

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Captisol.  Reports from Company shall be delivered to the attention of Chief
Scientific Officer, CyDex, with a copy to Chief Executive Officer, CyDex, at the
address set forth in Section 14.7.  Reports from CyDex shall be delivered to the
attention of Chief Scientific Officer, Company, at the address set forth in
Section 14.7.  The Parties shall mutually cooperate with regard to investigation
of any such serious adverse event, whether experienced by Company, CyDex or any
Affiliate, Sublicensee, sublicensee, co-marketer or distributor of CyDex or
Company.

 

7.5                               Certification under Drug Price Competition and
Patent Restoration Act. Each Party shall immediately give written notice to the
other Party of any certification of which it becomes aware filed pursuant to 21
U.S.C. Section 355(b)(2)(A) (or any amendment or successor statute thereto)
claiming that any Licensed Patents covering the Compound or a Licensed Product,
or the manufacture or use of each of the foregoing, are invalid or
unenforceable, or that infringement will not arise from the manufacture, use or
sale in the United States of a Licensed Product or Competing Product by a Third
Party.

 

8.                                      CONFIDENTIALITY.

 

8.1                               Definition.  Company and CyDex each recognizes
that during the Term, it may be necessary or advisable for a Party (the
“Disclosing Party”) to provide Confidential Information (as defined herein) to
the other Party (the “Receiving Party”).  Neither Company nor CyDex shall
disclose or use the other’s Confidential Information except as expressly
permitted in this Agreement.  For purposes of this Agreement, “Confidential
Information” means all information disclosed by the Disclosing Party to the
Receiving Party and which reasonably ought to have been understood to be
confidential and/or non-public information at the time disclosed to the
Receiving Party, or which is designated in writing by the Disclosing Party as
“Confidential” (or equivalent), or which when disclosed orally to the Receiving
Party is declared to be confidential by the Disclosing Party and is so confirmed
in a writing delivered to the Receiving Party within 30 days after such oral
disclosure, including but not limited to product specifications, data, know-how,
formulations, product concepts, sample materials, study results, analyses,
protocols, business and technical information, financial data, batch records,
inventions, works of authorship, Know-How, trade secrets, processes, techniques,
algorithms, programs, designs, drawings, and any other information related to a
Party’s present or future products, technology, sales, suppliers, customers,
employees, investors or business.  Without limiting the generality of the
foregoing, CyDex’s Confidential Information includes all materials provided as
part of the Captisol Data Package.

 

8.2                               Obligation.  CyDex and Company agree that they
will disclose the other Party’s Confidential Information to its own (or its
Sublicensees’ and/or Affiliates’) officers, employees, consultants, attorneys,
accountants, bankers, Contract Manufacturers, lenders and agents only if and to
the extent necessary to carry out their respective responsibilities under this
Agreement or the Supply Agreement, or in accordance with the exercise of their
rights under this Agreement or the Supply Agreement, and such disclosure shall
be limited to the maximum extent possible consistent with such responsibilities
and rights and provided that such persons or entities are under a written
obligation of confidentiality at least as restrictive as this Section 8.  Except
as set forth in the foregoing sentence, neither Party shall disclose
Confidential Information of the other to any person or entity without the
other’s prior written consent.  In all events, however, any and all disclosure
to any such persons or entities shall also be pursuant to the terms of a
non-disclosure/nonuse agreement no less restrictive than this Section 8 (or, in
the case of attorneys, to a duty and obligation of nondisclosure/nonuse

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

pursuant to the applicable rules of the profession).  The Party which disclosed
Confidential Information of the other to any such team member or Third Party (or
to any such Affiliate or Sublicensee) shall be responsible and liable for any
disclosure or use by such team member or Third Party, Affiliate or Sublicensee
(or its disclosees) which would have violated this Agreement if committed by the
Party itself.  Neither Party shall use Confidential Information of the other
except as expressly allowed by and for the purposes of this Agreement.  Each
Party shall take such action to preserve the confidentiality of each other’s
Confidential Information as it would customarily take to preserve the
confidentiality of its own Confidential Information (but in no event less than a
reasonable standard of care).  Upon expiration or termination of this Agreement,
each Party, upon the other’s request, shall promptly return or destroy (at
Disclosing Party’s discretion) all the Confidential Information disclosed to the
other Party pursuant to this Agreement, including all copies, embodiments,
reflections, analyses and extracts of documents, except for (a) one archival
copy (and such electronic copies that exist as part of the Party’s computer
systems, network storage systems and electronic backup systems) of such
materials solely to be able to monitor its obligations that survive under this
Agreement and (b) any archival copy that this Party is required to keep by
applicable regulations.

 

8.3                               Exceptions.  The non-use and non-disclosure
obligations set forth in this Section 8 shall survive the expiration or earlier
termination of this Agreement.   The non-use and non-disclosure obligations set
forth in this Section 8 shall not apply to any Confidential Information, or
portion thereof, that was first disclosed by the Disclosing Party to the
Receiving Party after the expiration or earlier termination of this Agreement or
that the Receiving Party can demonstrate by competent evidence:

 

(a)                                 at the time of disclosure is in the public
domain;

 

(b)                                 after disclosure, becomes part of the public
domain, by publication or otherwise, through no fault of and or without
violation of any duty of confidentiality of the Receiving Party or its
disclosees;

 

(c)                                  at the time of disclosure is already in the
Receiving Party’s possession with no duty of confidentiality;

 

(d)                                 is rightfully received by the Receiving
Party from an independent Third Party without obligation of confidentiality;
provided, however, that to the Receiving Party’s best knowledge, such
information was not obtained by said Third Party, directly or indirectly, from
the Disclosing Party; or

 

(e)                                  is independently developed by or expressly
for the Receiving Party, in either case solely by personnel without any access
to or use of the Disclosing Party’s information as shown by Receiving Party’s
competent, contemporaneous written evidence.

 

In addition, in the event that the Receiving Party or any of its Representatives
is required by law, rule, regulation, court order or in any regulatory, judicial
or governmental process having jurisdiction over the Receiving Party to disclose
the Confidential Information, the Receiving Party hereby agrees to notify the
Disclosing Party of the request or requirement immediately and to make a
reasonable effort to obtain, or to assist the Disclosing Party in obtaining,
confidential treatment or a protective order or any other reasonable measure
preventing or limiting the disclosure (to the greatest

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

possible extent and for the longest possible period), and/or requiring that the
Confidential Information so disclosed be used only for the purposes for which
the law or regulation required, or for which the order was issued, which the
Disclosing Party deems necessary to protect the confidentiality of the
Confidential Information (or as much as possible of the Confidential
Information).  In any event, should the Receiving Party be required by such
compulsion to in the end disclose Confidential Information to the requiring
authority (and, if so required thereby, to the public), (x) the Receiving Party
hereby agrees to take reasonable steps to seek such confidential treatment for
the Confidential Information (or as much as possible of the Confidential
Information); (y) the Receiving Party may provide the Confidential Information
to the appropriate requiring authority (and, if so required thereby, to the
public) as ultimately so compelled without such disclosure being deemed a
violation of this Agreement; and (z) such disclosure to the requiring authority
as ultimately so compelled shall not deprive the disclosed information of
Confidential Information status for any other purposes of this Agreement.

 

8.4                               Third Party Information.

 

(a)                                 Company is generally informed that CyDex’s
Confidential Information and DMF include information developed by Pfizer Inc.
(“Pfizer”) that is confidential to both CyDex and Pfizer.  Only to the extent
that confidential information of Pfizer is either included in the DMF or is
specifically identified in a prior written notice by CyDex to Company as being
part of CyDex’s Confidential Information disclosed to Company hereunder, Pfizer
is a limited third party beneficiary of only this Section 8 of this Agreement
and may seek remedies pursuant to it, but only in accordance with its terms.

 

(b)                                 The Parties acknowledge that the defined
term “Confidential Information” shall include not only a Disclosing Party’s own
Confidential Information but also Confidential Information of a Third Party or
the Disclosing Party’s Affiliates which is in the possession of the Disclosing
Party.  Both Parties agree not to disclose to the other Party any Confidential
Information of a Third Party which is in the possession of such Party, unless
the other Party has given an express prior written consent (which specifies the
owner of such Confidential Information) to receive such particular Confidential
Information.

 

8.5                               Public Announcements.  The Parties shall
mutually agree on any press release to be issued upon execution of this
Agreement; such release may include a high-level description of the royalty and
milestone payment obligations of this Agreement.  Neither Party shall make any
subsequent public announcement concerning this Agreement or the terms hereof not
previously made public without the prior written approval of the other Party
with regard to the form, content, and precise timing of such announcement,
except as may be required to be made by either Party in order to comply with
applicable law, regulations, court orders, or tax, securities filings, financing
arrangements, acquisitions, or sublicenses.  Such consent shall not be
unreasonably withheld, conditioned or delayed by such other Party.  Before any
such public announcement, the Party wishing to make the announcement shall
submit a draft of the proposed announcement to the other Party sufficiently in
advance of the scheduled disclosure to afford such other Party a reasonable
opportunity to review and comment upon the proposed text and the timing of such
disclosure, and shall consider all reasonable comments of the other Party
regarding such disclosure. (Provided, that neither Party shall use the trademark
or logo of the other Party, its Affiliates or their respective employee(s) in
any publicity, promotion, news release or public disclosure relating to this
Agreement or its subject matter, except as may be required by law or required by
the rules of an applicable US national securities exchange or except with the
prior

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

express written permission of such other Party, such permission not to be
unreasonably withheld, conditioned or delayed.)  Notwithstanding the above, once
a public disclosure has been made, either Party shall be free to disclose to
Third Parties any information contained in said public disclosure, without
further pre-review or pre-approval.

 

9.                                      REPRESENTATIONS AND WARRANTIES.

 

9.1                               Mutual Representations and Warranties.  Each
Party represents and warrants to the other that, as of the Effective Date:

 

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

 

(b)                                 it has the full power and right to enter
into this Agreement and to perform its obligations hereunder;

 

(c)                                  this Agreement has been duly authorized,
executed and delivered by such Party and constitutes a legal, valid and binding
obligation of such Party enforceable against such Party in accordance with its
terms, except as enforceability may be limited by applicable bankruptcy,
insolvency, reorganization, receivership, moratorium, fraudulent transfer, or
other similar laws affecting the rights and remedies of creditors generally and
by general principles of equity;

 

(d)                                 the execution, delivery and performance of
this Agreement by such Party does not and will not conflict with, breach or
create in any Third Party the right to accelerate, terminate or modify any
agreement or instrument to which such Party is a party or by which such Party is
bound;

 

(e)                                  all consents, approvals and authorizations
from all governmental authorities or other Third Parties required to be obtained
by such Party in connection with the execution and delivery of this Agreement
have been obtained; and the execution, delivery and performance of this
Agreement by such Party does not and will not violate any order, law or
regulation of any court, governmental body or administrative or other agency
having authority over such Party;

 

(f)                                   no person or entity has or will have, as a
result of the transactions contemplated by this Agreement, any right, interest
or valid claim against or upon such Party for any commission, fee or other
compensation as a finder or broker because of any act by such Party or its
Affiliates or agents, or in addition, with respect to Company, because of any
act by its Sublicensees; and

 

(g)                                 it has not entered and shall not enter into
any agreement with any Third Party that is in conflict with the rights granted
to the other Party pursuant to this Agreement.

 

9.2                               CyDex Additional Representations and
Warranties.  CyDex hereby represents and warrants to Company that, as of the
Effective Date:

 

(a)                                 CyDex has no knowledge of any unsettled past
or current, and has not received notice of any threatened, patent, trade secret
or other intellectual property dispute with any Third Party that actually or is
reasonably likely to have a material adverse effect on the Licensed Intellectual
Property;

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(b)           the Licensed Intellectual Property (i) is not subject to any
outstanding injunction, judgment, order or ruling, and (ii) to CyDex’s
knowledge, there is no pending or threatened claim or action, in each instance,
which challenges the validity, legality, enforceability or use of the Licensed
Intellectual Property;

 

(c)           CyDex has the full right, power and authority to grant all of the
licenses granted to Company under this Agreement;

 

(d)           as of the Effective Date, CyDex has not granted to any Third Party
any license to any of the Licensed Intellectual Property which conflicts with
the exclusive license hereunder and CyDex shall not grant any such license
during the Term;

 

(e)           the Licensed Intellectual Property constitutes all
Captisol-related rights owned or controlled by CyDex that pertain to Company’s
development, manufacture, use and commercialization of the Licensed Product as
contemplated by this Agreement;

 

(f)            CyDex and its Affiliates are not a debarred entity and have not
used and will not use in any capacity the services of any individual or entity
known by CyDex to be debarred under 21 U.S.C. §335(a) or (b) of the Federal
Food, Drug and Cosmetic Act in connection with its obligations hereunder; and

 

(g)           CyDex has filed and maintained with the appropriate regulatory
authorities in all Major Markets all permits, licenses, regulatory filings
(including the DMF) and approvals related to Captisol and the manufacture and
sale thereof, necessary for CyDex to carry out its obligations and for Company
to exercise its rights under this Agreement and the Supply Agreement.

 

9.3          Disclaimer.  Notwithstanding the representations and warranties set
forth in this Section 9, Company acknowledges and accepts the risks inherent in
attempting to develop and commercialize any pharmaceutical product. There is no
implied representation that any Licensed Products can be successfully developed
or commercialized. The express warranties set forth in this Section 9 and
elsewhere in this Agreement and the Supply Agreement are provided in lieu of,
and EACH PARTY HEREBY DISCLAIMS, all other warranties, express and implied,
relating to the subject matter of this Agreement, the subject matter of the
Supply Agreement, Captisol, the Licensed Intellectual Property, or the Licensed
Products, including but not limited to the implied warranties of merchantability
and of fitness for a particular purpose.  Each Party’s representations and/or
warranties under this Agreement are solely for the benefit of the other Party,
and may be asserted only by the other Party and not by any Affiliate,
Sublicensee, Permitted Purchaser or other Third Party (including without
limitation any customer of the other Party, its Affiliates or Sublicensees) -
other than a Company Indemnitee or CyDex Indemnitee with respect to an
indemnification claim.  Each Party, its Affiliates and Sublicensees shall be
solely responsible for all representations and warranties that it, its
Affiliates or Sublicensees make to any customer, Affiliates, Sublicensees or
other Third Party.

 

10.          INDEMNIFICATION.

 

10.1        By CyDex.  CyDex shall defend, indemnify and hold Company and its
Affiliates, and each of their respective directors, officers, managers,
employees and agents (collectively, the “Company Indemnitees”), harmless from
and against any and all judgments, damages, liabilities,

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

settlements, penalties, fines, costs and expenses (including the reasonable
costs and expenses of attorneys and other professionals) (collectively,
“Losses”; it being expressly understood, however, that incidental, special,
indirect and consequential damages and lost profits, lost savings and
interruptions of business are expressly excluded therefrom and from such defined
term) incurred by the Company Indemnitees as a result of any claim, demand,
action or other proceeding (each, a “Claim”) by a Third Party, to the extent
such Losses arise out of (a) CyDex’s breach of this Agreement or the Supply
Agreement, including without limitation any of its covenants, representations
and warranties set forth herein or therein; (b) any breach or violation of any
applicable law, regulation or court order by CyDex or its Affiliates or
contractors, or any of their respective directors, officers, managers, employees
or agents, in connection with the activities contemplated by this Agreement
including but not limited to those listed in subsections (c) and (d) below,
(c) the research, development, manufacture, use, handling, promotion, marketing,
distribution, importation, sale or offering for sale of Captisol by CyDex or its
Affiliates or agents (for clarity, such terms shall not include Company in any
event); (d) interactions and communications by CyDex, its Affiliates,
manufacturers or agents with governmental authorities, physicians or other Third
Parties relating to Captisol, including the Captisol Data Package; (e) the
grossly negligent or willful misconduct of CyDex or its Affiliates or any of
their respective directors, officers, managers, employees or agents; or
(f) infringement or unauthorized use by CyDex or its Affiliates or contractors,
or any of their respective directors, officers, managers, employees or agents,
of any Third Party patents or other intellectual property rights, including in
the granting of the rights listed in Section  2 above, but only to the extent
that any such infringement Claim is related to Captisol or the Licensed
Intellectual Property; and, for each of subsections (a)-(f), all except to the
extent that such Losses are primarily caused by a Company Indemnitee’s breach of
applicable law, this Agreement or the Supply Agreement, gross negligence or
willful misconduct.

 

10.2        By Company.  Company shall defend, indemnify and hold CyDex and its
Affiliates, and each of their respective directors, officers, managers,
employees and agents (collectively, the “CyDex Indemnitees”), harmless from and
against any and all Losses incurred by the CyDex Indemnitees as a result of any
Claim by a Third Party, to the extent such Losses arise out of: (a) Company’s
breach of this Agreement or the Supply Agreement, including without limitation
any of its covenants, representations and warranties herein or therein; (b) any
breach or violation of any applicable law, regulation or court order by Company,
its Affiliates, sublicensees or contractors, or any of their respective
directors, officers, managers, employees or agents, in connection with the
activities contemplated by this Agreement or the Supply Agreement including but
not limited to those listed in subsections (c), (d) and (e) below, (c) any Study
conducted by or on behalf of Company; (d) the research, development,
manufacture, use, handling, promotion, marketing, distribution, importation,
sale or offering for sale of Licensed Products by Company, its Affiliates,
Sublicensees, Contract Manufacturers, distributors or agents (for clarity, such
terms shall not include CyDex in any event); (e) interactions and communications
by Company, its Affiliates, Sublicensees, distributors or agents with
governmental authorities, physicians or other Third Parties relating to Licensed
Products and/or Captisol; (f) the grossly negligent or willful misconduct of
Company or its Affiliates, Sublicensees, Contract Manufacturers, distributors or
agents or any of their respective directors, officers, managers, employees or
agents; or (g) actual or alleged infringement of a Third Party’s intellectual
property rights in the making, having made, using, selling, offering for sale
and importing of Licensed Products, but only to the extent that any such
infringement Claim is unrelated to Captisol or the Licensed Intellectual
Property; and, for each of subsections (a)-(g), all except to the extent that
such Losses are primarily caused by a CyDex Indemnitee’s breach of applicable
law, this Agreement or the Supply Agreement, gross negligence or willful
misconduct.

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

10.3        Expenses.  The indemnification obligation of each Party under this
Section 10 shall include, where applicable, reasonable attorney costs and
expenses incurred by the other Party (or an applicable Company Indemnitee or
CyDex Indemnitee) to successfully enforce any provision of this Section 10.

 

10.4        Procedure.  The Party or other Indemnitee intending to claim
indemnification under this Section 10 (an “Indemnified Party”) shall promptly
notify the other Party (the “Indemnifying Party”) of any Claim in respect of
which the Indemnified Party intends to claim such indemnification (provided,
that no delay or deficiency on the part of the Indemnified Party in so notifying
the Indemnifying Party will relieve the Indemnifying Party of any liability or
obligation under this Agreement except to the extent the Indemnifying Party has
suffered actual prejudice directly caused by the delay or other deficiency), and
the Indemnifying Party shall assume the defense thereof (with counsel selected
by the Indemnifying Party and reasonably satisfactory to the Indemnified Party)
whether or not such Claim is rightfully brought; provided, however, that an
Indemnified Party shall have the right to retain its own counsel and to
participate in the defense thereof, with the fees and expenses to be paid by the
Indemnified Party, unless a representation of both the Indemnified Party and the
Indemnifying Party by the same counsel would be inappropriate due to the actual
or potential differing interests between them, in which case the Indemnifying
Party shall pay (as incurred and on demand) the reasonable fees and expenses of
counsel retained by the Indemnified Party and all other expenses of
investigation and litigation.  (Provided, that in no event shall the
Indemnifying Party be required to pay for more than one separate counsel no
matter the number or circumstances of all Indemnified Parties.)  If the
Indemnifying Party shall fail to timely assume the defense of and reasonably
defend such Claim, the Indemnified Party shall have the right to retain or
assume control of such defense and the Indemnifying Party shall pay (as incurred
and on demand) the reasonable fees and expenses of counsel retained by the
Indemnified Party and all other expenses of investigation and litigation. The
Indemnifying Party shall not be liable for the indemnification of any Claim
settled (or resolved by consent to the entry of judgment) without the written
consent of the Indemnifying Party.  Also, if the Indemnifying Party shall
control the defense of any such Claim, the Indemnifying Party shall have the
right to settle such Claim; provided, that the Indemnifying Party shall obtain
the prior written consent (which shall not be unreasonably withheld, conditioned
or delayed) of the Indemnified Party before entering into any settlement of (or
resolving by consent to the entry of judgment upon) such Claim unless (a) there
is no finding or admission of any violation of law or any violation of the
rights of any person or entity by an Indemnified Party, no requirement that the
Indemnified Party admit fault or culpability, and no adverse effect on any other
claims that may be made by or against the Indemnified Party and (b) the sole
relief provided is monetary damages that are paid in full by the Indemnifying
Party and such settlement does not require the Indemnified Party to take (or
refrain from taking) any action.

 

Regardless of who controls the defense, the other Party hereto shall reasonably
cooperate in the defense as may be requested.  Without limitation, the Party
hereto which is not the Indemnifying Party, and its directors, officers,
managers, employees, agents and advisers, and the Indemnified Party, and its
directors, officers, managers, employees, agents and advisers, shall cooperate
fully with the Indemnifying Party and its legal representatives in the
investigations of any Claim.

 

10.5        Other Scenarios.  Subject to Section 11, this Section 10 shall not
be construed to suggest that a Party has no remedy other than under this
Section 10 (or does not have any particular remedy) for Losses and diminutions
in value which arise from breaches of this Agreement or of the

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Supply Agreement but which are not incurred as a result of a Claim.

 

11.          LIMITATION OF LIABILITY.

 

EXCEPT FOR (a) INDEMNIFICATION OBLIGATIONS IN CONNECTION WITH THIRD PARTY CLAIMS
PURSUANT TO SECTION 10 HEREOF, AND/OR (b) (DAMAGES ARISING FROM OR IN CONNECTION
WITH A BREACH BY CYDEX OF ITS CONFIDENTIALITY OBLIGATIONS HEREUNDER, AND/OR
(c) INTENTIONAL MISCONDUCT OR WILLFUL AND KNOWING BREACH, AND/OR (d) PROVISIONS
OF THIS AGREEMENT AND THE SUPPLY AGREEMENT WHICH EXPRESSLY REQUIRE PAYMENTS, THE
TOTAL AGGREGATE LIABILITY OF CYDEX FOR DAMAGES UNDER THIS AGREEMENT AND THE
SUPPLY AGREEMENT (TOGETHER) IS LIMITED TO A MAXIMUM AMOUNT OF ***.

 

NO ACTION, REGARDLESS OF FORM, ARISING OUT OF OR RELATED TO THIS AGREEMENT OR
THE SUPPLY AGREEMENT MAY BE BROUGHT BY EITHER PARTY MORE THAN TWO YEARS AFTER
SUCH PARTY HAS KNOWLEDGE OF BOTH THE OCCURRENCE AND THE CONSEQUENCES OF SAID
OCCURRENCE THAT GAVE RISE TO THE CAUSE OF ACTION OR AFTER EXPIRATION OF THE
APPLICABLE STATUTORY LIMITATIONS PERIOD, WHICHEVER IS SOONER.

 

12.          MANAGEMENT OF INTELLECTUAL PROPERTY.

 

12.1        Ownership.

 

(a)           Existing and Acquired Rights.  Each Party shall remain the owner
of intellectual property rights owned or controlled by such Party before the
Effective Date.  Each Party shall own any intellectual property acquired by such
party outside of this Agreement after the Effective Date.

 

(b)           New Rights.  The ownership of discoveries, inventions,
improvements and other technology, whether or not patentable (each, a
“Discovery”), made by Company’s and/or CyDex’s personnel and related to the
subject matter of this Agreement, will be determined in accordance with United
States Patent laws and ownership shall follow inventorship. The Party other than
the owning Party agrees to cooperate fully in protecting the owning Party’s
rights and interests in to such Discovery.

 

12.2        Prosecution and Maintenance.

 

(a)           Existing Rights (Licensed Patents).  During the Term CyDex shall
conduct the maintenance, at its sole cost and expense and using reasonable
discretion, of the Licensed Patents.  CyDex shall have the sole right to control
the prosecution of patent applications and the selection of countries where
patent applications are filed related to the Licensed Patents.

 

(b)           New Rights.  The Parties shall cooperate to take whatever, if any,
actions they mutually agree upon in writing and in their respective discretion
to prosecute patent applications and maintain patents covering rights which are
jointly owned in accordance with Section 12.1(b).  Such

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

agreement shall include actions to be taken by each Party and the allocation of
expenses related to such action.  Neither Party shall seek patent protection
covering such rights without such agreement.

 

(c)           For the avoidance of doubt, subject to Sections 12.2(a) and
(b) each Party shall be solely responsible for all decisions and actions
pertaining to the prosecution and maintenance of patent applications and patents
owned solely by such Party.

 

12.3        Infringement by Third Parties.

 

(a)           Notification of Third Party Infringement.  Each Party shall
promptly notify the other Party in writing of any actual or threatened
infringement, misappropriation or other violation by a Third Party of any
Licensed Intellectual Property in the Field and in the Territory (“Third Party
Infringement”) of which it becomes aware.

 

(b)           Existing Rights (Licensed Patents).  CyDex shall have the right
(but not the obligation), at its own expense, to initiate and control any action
to enforce the Licensed Patents against any Third Party Infringement and may
name Company as a party plaintiff solely to the extent required to maintain
standing; provided, that CyDex shall reimburse Company for any such costs
incurred by Company therefor.  Before commencing such an action, CyDex shall
consult with Company and give consideration to Company’s recommendations
regarding the proposed action.  Company shall provide to CyDex reasonable
assistance in such enforcement, at CyDex’s request and expense.  CyDex shall
control the direction of and any settlement of any such action.  Any recoveries
resulting from an action relating to a claim of Third Party Infringement of the
Licensed Patents (including any recoveries resulting from settlement) shall be
retained by CyDex.

 

(c)           New Rights.  The Parties shall cooperate to take whatever, if any,
actions they mutually agree upon in writing and in their respective discretion
against the alleged infringer of rights which are jointly owned in accordance
with Section 12.1(b).  Such agreement shall include actions to be taken by each
Party and the allocation of expenses and recoveries related to such action. 
Neither Party shall take any such action against the alleged infringer without
the written consent of the other Party.

 

(d)           Enforcement Decisions by Owner.  For the avoidance of doubt,
subject to Sections 12.3(a), (b) and (c), each Party shall be solely responsible
for all decisions and actions pertaining to the enforcement of patents owned
solely by such Party.

 

12.4        Alleged Infringement of Third Parties Rights.

 

(a)           Each Party shall promptly notify the other Party in writing of any
threat, allegation or claim of infringement received from a Third Party in
relation to any of that Third Party’s intellectual property rights, in relation
with the development, manufacture, use, sale, offer for sale, importation or
commercial exploitation of the Licensed Products in the Territory.

 

(b)           Company and/or any of its Affiliates shall control the defense of
any litigation mentioned in subsection (a) above, at their own expense and by
counsel of their own choice, and CyDex agrees that it will furnish to Company
and/or any of Company Affiliates, upon request, all evidence and information in
its possession relating to or reasonably necessary for such defense. Provided
that, to the extent the litigation concerns (in whole or in part) Captisol,
CyDex shall have the right, at its

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

own expense, to be represented in the legal proceedings by counsel of its own
choice, and Company and its Affiliates and their counsels will reasonably
cooperate with CyDex and its counsel in strategizing, preparing and presenting
the defense.

 

13.          TERM AND TERMINATION.

 

13.1        Term.  The term of this Agreement (the “Term”) shall commence on the
Effective Date and shall continue in effect thereafter on a country-by-country
basis until the later of (a) the final expiration of the last-to-expire of the
Licensed Patents that would in the absence of the license granted herein be
infringed by the use, manufacture or sale of any Licensed Product in the
applicable country or by the importation of such Licensed Product into such
country or (b) the 10th anniversary of the First Commercial Sale of any Licensed
Product, in each case in the applicable country. In a country (if any) where no
Licensed Patent containing a Valid Claim has ever existed nor ever exists, the
Term means the period from the First Commercial Sale of a Licensed Product in
such country until the 10th anniversary of such First Commercial Sale of a
Licensed Product in such country.  The Parties confirm that subject to this
Section 13.1, this Agreement shall not be terminated or invalidated by any
future determination that any or all of the Licensed Patents have expired or
been invalidated.

 

13.2        Termination of the Supply Agreement. If the Supply Agreement is
terminated in accordance with its terms (except a termination of the Supply
Agreement by CyDex for convenience or by Company for CyDex’s material breach),
CyDex shall have the right to terminate this Agreement with five days’ prior
written notice to Company.

 

13.3        Termination for Breach.  If either Party should materially breach or
violate or fail to perform any material term or covenant of this Agreement or
the Supply Agreement, then the other Party may give written notice of such
default to the first Party.  If such Party should fail to cure such default
within 60 days (or 15 days with respect to any payment obligation) of the date
of such notice, the other Party shall have the right to terminate this Agreement
by a second written notice (a “Notice of Termination”) to the first Party.  If
Notice of Termination is sent to such first Party, this Agreement shall
automatically terminate on the effective date of such notice.  The Parties agree
that any failure by Company to pay when due (subject to the 15-day cure period)
100% of any amount of money owing from Company to CyDex as is not disputed in
good faith by Company (or, if some portion of the amount of money owing from
Company to CyDex is not disputed in good faith by Company and the remaining
portion is disputed in good faith by Company, 100% of the portion which is not
disputed in good faith by Company) shall conclusively be deemed to constitute a
“material” breach.

 

13.4        Termination for Bankruptcy.  To the extent permitted under
applicable laws, either Party may terminate this Agreement in its entirety if,
at any time, the other Party: (a) files in any court or agency pursuant to any
statute or regulation of any state or country, a petition in bankruptcy or
insolvency or for reorganization or for an arrangement or for the appointment of
a receiver or trustee of such other Party or of its assets, (b) is served with
an involuntary petition against it, filed in any bankruptcy or insolvency
proceeding, and such petition is not dismissed within 45 days after the filing
thereof, (c) commences any dissolution or liquidation, or (d) makes a general
assignment for the benefit of its creditors.

 

13.5        Termination for Convenience.  Company may terminate this Agreement
at any time upon *** days’ prior written notice to CyDex.

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

13.6        Survival.  Notwithstanding any other provisions of this Agreement,
any liability or obligation of either Party to the other (or to the other’s
Indemnitees) for or arising from acts or omissions before the termination or
expiration of this Agreement shall survive the termination or expiration of this
Agreement.  Such termination or expiration shall not relieve either Party from
obligations that are expressly indicated or obviously intended to survive
termination or expiration of this Agreement, nor shall any termination or
expiration of this Agreement relieve Company of its obligation to pay CyDex,
subject to the terms herein, (a) royalties for all Licensed Products sold by
Company, its Affiliates or Sublicensees, (b) milestone payments for milestones
achieved, or (c) sums due in respect of Captisol shipped, in each case before
termination or expiration of this Agreement, or (d) the Section 4.1(a) ***
payment.  Sections 2.2 (Grant of License from Company to CyDex) [except that
this reference to Section 2.2 shall not apply where the Agreement is terminated
by Company pursuant to Section 13.3],  4.2 (Taxes), 4.3 (Late Payments), 5
(Records; Reports; Audit), 6.3(d) (Reporting and Study Data), 6.5 (Access to
Company’s Data), 7.4 (Adverse Event Reporting), 8 (Confidentiality), 9.3
(Disclaimer), 10 (Indemnification), 11 (Limitation of Liability), 12 (Management
of Intellectual Property), 13 (Term and Termination), and 14 (General
Provisions) and any other obligations that are expressly indicated or obviously
intended to survive shall survive termination or expiration of this Agreement.

 

13.7        Effect of Termination.

 

(a)           Following the termination by CyDex for Company’s breach under
Section 13.3, all rights granted to Company herein shall immediately terminate
and each Party shall promptly return all relevant records and materials in its
possession or control containing the other Party’s Confidential Information with
respect to which the former Party does not retain rights hereunder, except for
(i) one archival copy (and such electronic copies that exist as part of the
Receiving Party’s computer systems, network storage systems and electronic
backup systems) of such materials solely to be able to monitor its obligations
that survive under this Agreement and (ii) any archival copy that the Receiving
Party is required to keep by applicable law or regulations.

 

(b)           The licenses granted in Section 2.1 shall become perpetual, fully
paid-up and royalty-free as to all countries of the Territory if and when
(i) the Company terminates this Agreement under Section 13.3 for CyDex’s breach
and (ii) either (A) CyDex expressly acquiesces to such termination in writing or
(B) the rightfulness of such termination has been confirmed by a final judgment
of the appropriate federal or California state court pursuant to Section 14.3
and no further appeal from such court’s final judgment is possible, either
because the applicable time for filing any further appeal has expired or because
an appellate court of final jurisdiction has affirmed such final judgment.

 

(c)           Upon the natural expiration of the Term as to a country, the
licenses granted in Section 2.1 shall become perpetual, fully paid-up and
royalty-free as to such country.

 

14.          GENERAL PROVISIONS.

 

14.1        Relationship of Parties.  Each of the Parties hereto is an
independent contractor and nothing in this Agreement is intended or shall be
deemed to constitute a partnership, agency, employer-employee or joint venture
relationship between the Parties.  Neither Party shall have the right to, and
each Party agrees not to purport to, incur any debts or make any commitments or
contracts for the

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

other.  During the Term of this Agreement and for a period of one year
thereafter, Company shall not solicit, induce, encourage or attempt to induce or
encourage any employee of CyDex to terminate his or her employment with CyDex;
provided, that this sentence is not meant to encompass general solicitations
such as may be found in newspaper advertisements and the like.

 

14.2        Compliance with Law.  Company agrees that in the use of the Licensed
Intellectual Property and Captisol by it and its Affiliates and Sublicensees,
and the development, study, manufacture, handling, marketing, sale,
distribution, importation and use of Licensed Products, it and its Affiliates
and Sublicensees shall comply with all applicable international, federal, state
and local laws, rules and regulations, including, but not limited to,
import/export restrictions, laws, rules and regulations governing use and
patent, copyright and trade secret protection.  CyDex agrees that its
manufacture, handling, marketing, sale, distribution, importation and use of
Captisol under the Supply Agreement shall comply with all applicable
international, federal, state and local laws, rules and regulations, including,
but not limited to, import/export restrictions, laws, rules and regulations
governing use and patent, copyright and trade secret protection.

 

14.3        Dispute Resolution.

 

(a)           Elevation of Issues for Resolution. In the event of any dispute or
disagreement between the Parties in connection with this Agreement, the
construction hereof, or the rights, duties or liabilities of either Party
hereunder (each, a “Dispute”), the Parties shall endeavor to resolve such
Dispute in accordance with the terms of this Section 14.3(a). The Parties shall
promptly refer such matter to, as appropriate, the Parties’ respective
Designated Executives, who shall use good faith efforts to resolve such matter.
If agreement on a mutually acceptable resolution of such Dispute is not reached
by the Designated Executives within 15 business days after a Party gives written
notice to refer such Dispute to them, then such Dispute shall be subject to
resolution in accordance with Section 14.3(b).

 

(b)           Dispute Settlement. If any Dispute is not resolved by mutual
agreement of the Parties in accordance with Section 14.3(a) above within 15
business days of a Party giving notice to refer such Dispute to the Parties’
Designated Executives under Section 14.3(a), then either Party may submit such
Dispute (and any related claims or other disputes arising out of or relating
hereto or to the transactions contemplated hereby or to the inducement of any
Party to enter herein or therein, whether for breach of contract, tortious
conduct or otherwise and whether predicated on common law, statute or otherwise)
for final settlement by the competent federal or state court located in the
county of San Diego, California, notwithstanding plurality of defendants,
summary proceedings or impleader.  Each Party hereby irrevocably consents to the
personal jurisdiction of such federal or California state court and agrees that
venue is appropriate in such court, and agrees not to assert that such court is
an inconvenient forum.  The Parties agree that the jurisdiction of such court
located in the county of San Diego, California shall be exclusive.

 

(c)           Interim Equitable Relief.  Each Party shall, in addition to all
other remedies accorded by law (or in equity) and permitted by this Agreement,
be entitled to seek interim equitable relief.  Neither Party shall commence any
court proceeding or action against the other to resolve any dispute, except for
such interim injunctive relief or upon compliance with Section 14.3(a) and
Section 14.3(b).

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

14.4        Costs and Expenses.  Except as otherwise expressly provided in this
Agreement, each Party shall bear all costs and expenses associated with the
performance of such Party’s obligations under this Agreement.

 

14.5        Further Assurances.  The Parties hereby covenant and agree, without
the necessity of any further consideration, to execute, acknowledge and deliver
any and all such other documents and instruments and take any such other action
as may be reasonably necessary or appropriate to carry out the intent and
purposes of this Agreement.

 

14.6        Force Majeure.  Neither Party shall be liable or in breach for
failure to perform, or delay in the performance of, its obligations under this
Agreement (other than payment obligations) when such failure or delay is caused
by an event of force majeure.  The corresponding obligations of the other Party
shall be suspended to the same extent. For purposes of this Agreement, an event
of force majeure means any event or circumstance beyond the reasonable control
of the affected Party and not reasonably preventable using industry standard
practices, including but not limited to, war, insurrection, riot, fire, flood or
other unusual weather condition, explosion, act of God, peril of the sea,
sabotage, embargo, act of governmental authority, compliance with governmental
order on national defense requirements, or inability due to general industry
wide shortages to obtain fuel, power, raw materials, labor or transportation
facilities.  If, due to any event of force majeure, either Party shall be unable
to fulfill its obligations under this Agreement (other than payment
obligations), the affected Party shall immediately notify the other Party of
such inability and of the period during which such inability is expected to
continue, shall use reasonable commercial efforts to cure and remedy such
non-performance and the time for performance shall be extended for a number of
days equal to the duration of the force majeure, and the Parties shall meet
promptly to determine an equitable solution to the effects of such event.

 

14.7        Notices.  Any notice, request, approval or consent required or
permitted to be given under this Agreement or the Supply Agreement shall be in
writing and shall be deemed to have been sufficiently given if and only if
delivered in person, by email or by internationally recognized overnight courier
service to the Party to which it is directed at its physical or email address
shown below or such other physical or email address as such Party shall have
last given by such written notice to the other Party in accordance with this
Section 14.7:

 

If to CyDex, to:

CyDex Pharmaceuticals, Inc.
c/o Ligand Pharmaceuticals Incorporated
3911 Sorrento Valley Boulevard, Suite 110
San Diego, California 92121
Attention: Vice President and Secretary
Email: cberkman@ligand.com

 

If to Company, to:

Marinus Pharmaceuticals, Inc.
170 N. Radnor Chester Road, Suite 250
Radnor, Pennsylvania 19087-5279
Attention: Christopher Cashman
Email: ccashman@marinuspharma.com

With a copy to:

Ligand Pharmaceuticals Incorporated
3911 Sorrento Valley Boulevard, Suite 110
San Diego, California 92121
Attention: General Counsel

 

 

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 Email: cberkman@ligand.com

 

If sent by email, the date on which such notice, request, approval or consent
shall be deemed delivered is the date of transmission, if such notice, request,
approval or consent is sent via email to such email address before 5:00 p.m. at
the location of receipt on a business day, or the first business day after the
date of transmission, if such notice, request, approval or consent is sent via
email to such email address at or after 5:00 p.m. at the location of receipt on
a business day or on a day that is not a business day. If sent by
internationally recognized overnight courier, the date on which such notice,
request, approval or consent shall be deemed delivered is the next business day
after the date of deposit with such courier (by the courier’s stated time for
enabling next-business-day delivery), and if delivered after such stated time
shall be deemed to be the second business day after the date of deposit.

 

14.8        Governing Law.  This Agreement shall be governed by and construed in
accordance with the laws of the State of California (without giving effect to
any conflicts of law principles that require the application of the law of a
different state or country).  The Parties agree that the United Nations
Convention on Contracts for the International Sale of Goods shall be
inapplicable to this Agreement and the Supply Agreement and transactions
hereunder and thereunder.

 

14.9        Entire Agreement.  This Agreement and the Supply Agreement and all
Exhibits attached hereto or thereto contain the entire agreement of the Parties
relating to the subject matter hereof and thereof and supersede any and all
prior or contemporaneous agreements, written or oral, between CyDex and Company
relating to the subject matter hereof and thereof.  Notwithstanding the
foregoing, it is understood and agreed that neither Party shall be relieved from
any liability for any past breach of any previous written agreements.  In
addition, any confidential information which was disclosed under such previous
written agreements shall remain confidential and shall be subject to the
nondisclosure and nonuse provisions set forth in Section 8 of this Agreement. 
Neither Party has made any promises, representations, warranties, covenants, or
undertakings, other than those expressly set forth herein and in the Supply
Agreement, to induce the other Party to execute and deliver this Agreement and
the Supply Agreement, and each Party acknowledges that it has not executed or
delivered this Agreement and the Supply Agreement in reliance upon any such
promise, representation, or warranty, covenant or undertaking not contained
herein or in the Supply Agreement.

 

(Specifically with regard to the July 2014 Agreement (which the parties hereby
terminate with immediate effect), it is further agreed that any Confidential
Information disclosed thereunder shall be deemed to have been disclosed under
and shall be governed by this Agreement, the performance of any Studies
contemplated thereby shall hereafter be subject to and governed by this
Agreement, and any Captisol purchased thereunder shall be deemed to have been
purchased and delivered under and shall be governed by this Agreement  and the
Supply Agreement (except that the price paid for any Captisol ordered thereunder
before 2017 shall not be retroactively adjusted).  In addition, the Parties
agree that all Confidential Information heretofore disclosed under the Mutual
Non-Disclosure Agreement entered into in 2014 by Company and CyDex’s parent
company Ligand Pharmaceuticals Incorporated shall be deemed to have been
disclosed (by or on behalf of CyDex, or to CyDex or to a person or entity on
behalf of CyDex) under and shall be governed by this Agreement, and all
Confidential Information hereafter disclosed shall be deemed to be disclosed
under and shall be governed by this Agreement rather than under and by such
Mutual Non-Disclosure Agreement.)

 

14.10      Amendment.  This Agreement may not be amended unless agreed to in
writing by

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

both Parties.

 

14.11      Waiver.  No waiver of any breach of a term, provision or condition of
this Agreement shall be deemed to have been made by either Party unless such
waiver is in writing and signed by an authorized representative of that Party. 
The failure of either Party to insist upon the strict performance of any of the
terms, provisions or conditions of this Agreement, or to exercise any option
contained in this Agreement, shall not be construed as a waiver or
relinquishment for the future of any such term, provision, condition or option
or the waiver or relinquishment of any other term, provision, condition or
option.  The rights of either Party under this Agreement may be exercised from
time to time, singularly or in combination, and the exercise of one or more such
rights shall not be deemed to be a waiver of any one or more of the others.

 

14.12      Severability.  This Agreement is severable. When possible, each
provision of this Agreement will be interpreted in such manner as to be
effective and valid under applicable law; but if any provision of this Agreement
is determined by a final and binding court or arbitration judgment to be
invalid, illegal or unenforceable to any extent, such provision shall not be not
affected or impaired up to the limits of such invalidity, illegality or
unenforceability; the validity, legality and enforceability of the remaining
provisions of this Agreement shall not be affected or impaired in any way; and
the Parties agree to make a good faith effort to replace such invalid, illegal
and unenforceable provision (or portion of provision) with a valid, legal and
enforceable provision that achieves, to the greatest lawful extent under this
Agreement, the economic, business and other purposes of such invalid, illegal or
unenforceable provision (or portion of provision).

 

14.13      Assignment.  Either Party may assign in whole or in part its rights
and/or delegate in whole or in part its obligations under this Agreement to an
Affiliate or to any Third Party successors, whether by way of merger,
exclusive-license or sale of all or substantially all the assets to which this
Agreement relates, sale of stock or otherwise, without prior written consent. 
Provided, however, that as a condition to any such permitted assignment
hereunder, the assignor must guarantee the performance of the terms and
obligations of this Agreement by any assignee, and the assignee must expressly
assume (for the express benefit of the Party hereto which is not the assignor)
the performance of the terms and obligations of this Agreement by such assignee.
Except as provided herein, neither Party may assign its rights or delegate its
obligations under this Agreement, in whole or in part, by operation of law or
otherwise, to any Third Party without the prior written consent of the other
Party, which consent shall not be unreasonably withheld, conditioned or delayed.
Any assignment not in accordance with this Section 14.13 shall be void.

 

14.14      Binding Effect.  This Agreement shall be binding upon, and the rights
and obligations hereof shall apply to CyDex and Company and any successor(s) and
permitted assigns.  The name of a Party appearing herein shall be deemed to
include the names of such Party’s successors and permitted assigns to the extent
necessary to carry out the intent of this Agreement.

 

14.15      No Implied License. No right or license is granted to either Party
hereunder by implication, estoppel, or otherwise to any Know-How, patent or
other intellectual property right now or hereafter owned or controlled by such
Party or its Affiliates, except by an express license granted hereunder.

 

14.16      Third-Party Beneficiaries.  Except for the rights of Indemnified
Parties pursuant to

 

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Section 10 hereof, and subject to Pfizer’s rights under Section 8.4 hereof, the
terms and provisions of this Agreement are intended solely for the benefit of
each Party hereto and their respective successors or permitted assigns and it is
not the intention of the Parties to confer third-party beneficiary rights upon
any other person, including without limitation Sublicensees.  The enforcement of
any obligation of CyDex under this Agreement shall only be pursued by Company or
a Company Indemnitee, and not by Sublicensees (unless otherwise a Company
Indemnitee).

 

14.17      Remedies Cumulative; Right of Set-Off.  Except as provided in
Section 11, any enumeration of a Party’s rights and remedies in this Agreement
is not intended to be exclusive, and a Party’s rights and remedies are intended
to be cumulative to the extent permitted by law and include any rights and
remedies authorized in law or in equity.  Notwithstanding anything to the
contrary in this Agreement or in the Supply Agreement, Company shall not have a
right to set-off any royalties, milestone payments or other amounts due to CyDex
under this Agreement and/or the Supply Agreement against any damages incurred by
Company for a breach by CyDex of this Agreement and/or the Supply Agreement.

 

14.18      Equitable Relief. Each Party recognizes that the covenants and
agreements herein and their continued performance as set forth in this Agreement
are necessary and critical to protect the legitimate interests of the other
Party, that the other Party would not have entered into this Agreement in the
absence of such covenants and agreements and the assurance of continued
performance as set forth in this Agreement, and that a Party’s breach or
threatened breach of such covenants and agreements may cause the opposed Party
irreparable harm and significant injury, the amount of which will be extremely
difficult to estimate and ascertain, thus potentially making any remedy at law
or in damages inadequate. Therefore, each Party agrees that an opposed Party
shall be entitled to seek specific performance, an order restraining any breach
or threatened breach of Section 8 and any or all other provisions of this
Agreement, and any other equitable relief (including but not limited to
temporary, preliminary and/or permanent injunctive relief), all without need to
post any bond or security, and (except as provided in Section 11) in addition to
and not exclusive of any other remedy available to such other Party at law or in
equity.

 

14.19      Interpretation.  The language used in this Agreement is the language
chosen by the Parties to express their mutual intent, and no provision of this
Agreement shall be interpreted for or against any Party because that Party or
its attorney drafted the provision.

 

14.20      Headings.  The descriptive headings of this Agreement are for
convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.

 

14.21      Construction.  Any reference in this Agreement to an Article,
Section, subsection, paragraph, clause or Exhibit shall be deemed to be a
reference to an Article, Section, subsection, paragraph, clause or Exhibit of or
to, as the case may be, this Agreement, unless otherwise indicated.  Unless the
context of this Agreement otherwise requires, (a) words of any gender include
each other gender, (b) words such as “herein”, “hereof”, and “hereunder” refer
to this Agreement as a whole and not merely to the particular provision in which
such words appear, (c) words using the singular shall include the plural, and
vice versa, and (d) the words “include,” “includes” and “including” shall be
deemed to be followed by the phrase “but not limited to”, “without limitation”,
“inter alia” or words of similar import.

 

32

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

14.22      Counterparts.  This Agreement may be executed and delivered in
counterparts (portable document format (.pdf)/electronic transmission included),
each of which shall constitute an original document, but both of which shall
constitute one and the same instrument.

 

[Remainder of this page left blank intentionally]

 

33

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

IN WITNESS WHEREOF, the Parties have executed this License Agreement as of the
Effective Date.

 

CYDEX PHARMACEUTICALS, INC.

 

 

 

 

 

By:

/s/ Matthew W. Foehr

 

 

 

 

Name:

Matthew W. Foehr

 

 

 

 

Title:

President and Chief Operating Officer

 

 

 

 

 

MARINUS PHARMACEUTICALS, INC.

 

 

 

 

 

By:

/s/ Christopher M. Cashman

 

 

 

 

Name:

Christopher M. Cashman

 

 

 

 

Title:

Chief Executive Officer

 

 

34

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CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH
“[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION
REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXHIBIT A

 

LICENSED PATENTS (13 pages)

 

[... *** ...]

 

A-1

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