Exhibit 10.2

 

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

 

THIS SUPPLY 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”).

 

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®, the uniquely modified
form of sulfobutylether b (beta) cyclodextrin, sodium salt;

 

WHEREAS, CyDex desires to supply and Company desires to purchase Captisol from
CyDex, under the terms and conditions set forth herein;

 

WHEREAS, CyDex and Company are contemporaneously entering into a License
Agreement (the “License Agreement”); and

 

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 definitions shall apply:

 

“Captisol” means sulfobutylether b (beta) cyclodextrin, sodium salt.  CyDex
supplies a uniquely modified form of such material under the Captisol® brand,
manufactured in accordance with the Specifications, which, for the sake of
clarity, includes Clinical Grade Captisol and Commercial Grade Captisol. For
avoidance of doubt:  the uniquely modified form of such material supplied by
CyDex under the Captisol® brand shall be deemed to be included among the
substances/products which are within the defined term “Captisol.”

 

“Clinical Grade Captisol” means Captisol® brand sulfobutylether b (beta)
cyclodextrin, sodium salt which (a) has been manufactured in accordance with the
Specifications under GMP conditions, (b) is intended for use in humans, and
(c) is intended for clinical trials for the Licensed Products.

 

“Commercial Grade Captisol” means Captisol® brand sulfobutylether b (beta)
cyclodextrin, sodium salt which (a) has been manufactured in accordance with the
Specifications under GMP conditions, (b) is intended for use in humans, and
(c) is intended for commercial sale of the Licensed Products.  For the sake of
clarity, engineering and regulatory qualification batches of Licensed Products
shall be deemed “Commercial Grade Captisol” batches.

 

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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.

 

“Commercial Grade Shortfall” shall have the meaning defined in Section 4.2.

 

“Defect” and “Defective” shall have the meanings defined in Section 3.6(b).

 

“Detailed Forecast” shall have the meaning defined in Section 3.2.

 

“First Commercial Order Date” shall have the meaning defined in Section 3.2.

 

“GMP” means requirements for the quality system under which drug products and
their ingredients are manufactured under conditions of current good
manufacturing practices for bulk excipients as pursuant to the Federal Food,
Drug, and Cosmetic Act and consistent with regulatory guidance, standards or
directives, as applicable and as set forth in U.S. Pharmacopeia <1078> as of the
Effective Date or any successor thereto.

 

“Latent Defect” shall have the meaning defined in Section 3.6(c).

 

“Minimum Remaining Shelf Life” means with respect to Captisol, a remaining shelf
life of at least two years.

 

“Permitted Purchaser Requirements” means the requirements during the Term of all
Permitted Purchasers for sulfobutylether b (beta) cyclodextrin, sodium salt in
connection with the Licensed Products.

 

“Permitted Purchasers” means, collectively:  (a) Company; (b) Affiliates of
Company; (c) Sublicensees of Company; and (d) all Contract Manufacturers for
Company, Affiliates of Company and Sublicensees permitted in accordance with the
License Agreement.

 

“Purchase Volume Limitations” shall have the meaning defined in Section 3.3.

 

“Q1”, “Q2”, “Q3” and “Q4 shall have the meanings defined in Section 3.2.

 

“Quality Agreement” means a formal agreement between CyDex and Company that sets
forth the quality expectations, responsibilities, rights (including, as
applicable and agreed upon, audit requirements) and quality measures and good
manufacturing practices relating to the manufacture and supply of Captisol to
assure drug quality, safety and efficacy consistent with FDA guidance or
equivalent foreign regulatory authority requirements for Quality Agreements. 
Any such agreement may be amended from time to time by written agreement between
the Parties.

 

“Specifications” means the specifications for Captisol set forth in Exhibit B
hereto, as such may be amended from time to time pursuant to Section 3.10.

 

“Term” shall have the meaning defined in Section 6.1.

 

“Testing Methods” shall have the meaning defined in Section 3.6(a).

 

“Third-Party Manufacturer” shall have the meaning defined in Section 2.3.

 

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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 addition, any capitalized terms not separately defined herein, including
“Affiliate”, “Application”, “Confidential Information”, “Contract Manufacturer”,
“DMF”, “FDA”, “Licensed Product”, “Major Market”, “Party”, “Sublicensee”,
“Study” and “Third Party” shall have the respective meanings defined in the
License Agreement.

 

2.                                      PURCHASE AND SUPPLY OF CAPTISOL.

 

2.1          Purchase Commitment.  Subject to the provisions of this Agreement
and during the Term of this Agreement, Company agrees that Company, on behalf of
itself and the other Permitted Purchasers, shall purchase from CyDex and CyDex
shall supply 100% of the Permitted Purchaser Requirements during the Term. 
Company and the other Permitted Purchasers shall not have the right to
manufacture (or have manufactured on their behalf) under any CyDex intellectual
property rights, Captisol, without CyDex’s prior written consent.

 

2.2          Supply Commitment.  CyDex agrees that CyDex shall produce (or have
produced for it as set forth in Section 2.3), sell, supply and deliver to
Company and the other Permitted Purchasers 100% of the Permitted Purchaser
Requirements during the Term, subject to the provisions of this Agreement. 
CyDex shall only be required to sell the Permitted Purchaser Requirements for
Captisol pursuant to this Agreement.  Company shall place orders for Captisol on
behalf of itself and/or the other Permitted Purchasers, and shall directly pay
to CyDex all amounts payable with respect thereto.  CyDex does not grant Company
or any other Permitted Purchaser the right to manufacture (or have manufactured
on their behalf) under any CyDex intellectual property rights, Captisol.

 

2.3          Third-Party Manufacturers.  Without limiting or relieving CyDex’s
responsibilities and/or obligations under this Agreement, CyDex may, upon
written notice to Company, satisfy its supply obligations to Company hereunder
either in whole or in part through arrangements with Third Parties engaged by
CyDex to perform services or supply facilities or goods in connection with the
manufacture or testing of Captisol (each, a “Third-Party Manufacturer”).  CyDex
shall and hereby does guarantee the performance of all Third-Party Manufacturers
and shall promptly notify Company of the name and other relevant information of
any Third-Party Manufacturer intended to be used by CyDex to satisfy its supply
obligations of Captisol to any Permitted Purchasers hereunder.  CyDex shall and
hereby does represent and warrant that such Captisol shall meet and satisfy all
of the obligations and requirements for supply of Captisol to Company pursuant
to this Agreement, including without limitation, meeting the Specifications as
set forth in Exhibit B and the Minimum Remaining Shelf Life and have been
manufactured in accordance with all applicable laws and regulations, including
under conditions of GMP and under the same DMF and manufacturing processes
properly referenced in Company’s Applications.  The Parties hereby agree that
The Hovione Group is an approved Third-Party Manufacturer as of the Effective
Date of this Agreement, and unless otherwise instructed by CyDex, Company shall
reference The Hovione Group’s manufacturing processes with respect to Captisol,
and no others, in Company’s Applications.

 

2.4          Restrictions.  Company covenants and agrees that:  (a) all Captisol
supplied by CyDex pursuant to this Agreement shall be used only in Licensed
Products, including, without limitation, the development, approval and
manufacture of Licensed Products (provided, however, that Company may separately
use Captisol for testing, product research, Study and pre-clinical or clinical
development of Licensed Products, for such purposes and/or requirements arising
under or in

 

3

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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.

 

regards to applicable law (including, without limitation, the Food, Drug and
Cosmetics Act, in each instance as may be required by Company, Permitted
Purchasers and/or the FDA or equivalent foreign regulatory authorities or
governmental agencies in connection with Licensed Products); (b) Company shall
obtain the written agreement (for the express benefit of CyDex) of each
Permitted Purchaser to, among other things, not resell Captisol as a standalone
product and only use Captisol in accordance with (a) above; (c) Company shall
not make or have made, and shall not permit any other Permitted Purchaser to
make or have made, Captisol; and (d) Company and its Affiliates shall not sell,
deliver or transfer to anyone any Captisol supplied by CyDex pursuant to this
Agreement, except to the extent it is incorporated into a Licensed Product or is
otherwise expressly permitted in this Section or elsewhere in this Agreement
and/or in the License Agreement.

 

3.                                      SUPPLY TERMS.

 

3.1          Long-Term Forecast.  Company shall use reasonable efforts to
provide to CyDex, at least one year before the date on which Company anticipates
issuing its first purchase order to CyDex for Commercial Grade Captisol (the
“First Commercial Order Date”), a non-binding forecast setting forth Company’s
estimate of the required quantities of Commercial Grade Captisol for each of the
following two years.  Such non-binding long-term forecast shall thereafter be
updated by Company at least once every 12 months.

 

3.2          Binding Detailed Forecast.  At least one calendar quarter before
the First Commercial Order Date, Company shall provide to CyDex a detailed
rolling forecast setting forth Company’s requirements (inclusive of all
Permitted Purchaser Requirements) and anticipated delivery schedules for
Commercial Grade Captisol for each calendar quarter during a 12 month period
(the “Detailed Forecast”) which includes the calendar quarter in which the First
Commercial Order Date is to occur and the three following calendar quarters. 
For purposes of this Agreement, a calendar quarter means the consecutive three
month period ending March 31, June 30, September 30, and December 31,
respectively.  The Detailed Forecast shall thereafter be updated by Company
quarterly on a rolling basis, no later than the first day of each calendar
quarter, so that in each calendar quarter CyDex shall have been provided with a
rolling Detailed Forecast for each calendar quarter during the 12 month period
commencing on the first day of the next calendar quarter following the date on
which such Detailed Forecast is submitted.  The Detailed Forecast shall be firm
and binding on Company, subject to the permissible variances set forth in
Section 3.3 below, with respect to the first, second and third calendar quarters
covered by such updated Detailed Forecast (“Q1”, “Q2”, “Q3”, respectively, and
where the fourth calendar quarter shall be “Q4”).  Q4 of such Detailed Forecast
shall not be binding and shall be provided for the sole purpose of planning;
provided, that if Company fails to provide any updated Detailed Forecast in
accordance with this Section 3.2, the Detailed Forecast last provided by Company
shall be deemed to be Company’s binding Detailed Forecast (in the subsequent
time period when no Detailed Forecast was provided), with the prior Q4
forecasted quantity and timing being the new Q3 forecasted quantity and timing,
the prior Q3 forecasted quantity and timing being the new Q2 forecasted quantity
and timing and the prior Q2 forecasted quantity and timing being the new Q1
forecasted quantity and timing, and with the same quantity and timing as had
been forecasted (or deemed to be forecasted) for the Q4 of the prior Detailed
Forecast being repeated as the forecasted quantity and timing for the new
Detailed Forecast’s Q4.

 

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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.

 

3.3          Detailed Forecast Variances.  Each updated Detailed Forecast may
modify the amount of Commercial Grade Captisol estimated in the previous
Detailed Forecast in accordance with the following limitations (the “Purchase
Volume Limitations”):

(a)           for the Q1 covered by such updated Detailed Forecast, no change in
excess of a ***% volume increase or decrease may be made to the forecast
provided for the Q2 in the immediately preceding Detailed Forecast without the
prior express written consent of CyDex;

 

(b)           for the Q2 covered by such updated Detailed Forecast, no change in
excess of a ***% volume increase or decrease may be made to the forecast
provided for the Q3 in the immediately preceding Detailed Forecast without the
prior express written consent of CyDex; and

 

(c)           for the Q3 covered by such updated Detailed Forecast, no change in
excess of a ***% volume increase or decrease may be made to the forecast
provided for the Q4 in the immediately preceding Detailed Forecast without the
prior express written consent of CyDex.

 

3.4          Supply.

 

(a)           Purchase Orders.  Together with each Detailed Forecast provided
under Section 3.2, Company shall place a firm purchase order with CyDex, for
Company’s order of Commercial Grade Captisol for Q1 of the concurrent Detailed
Forecast for delivery consistent with the Detailed Forecast.  Each purchase
order, for all grades of Captisol, shall specify:  (i) the grade of Captisol
ordered (i.e., Commercial Grade Captisol or Clinical Grade Captisol);
(ii) quantities; (iii) delivery dates; and (iv) reasonable shipping instructions
and packaging requirements.  Any firm purchase order for Captisol, to the extent
it does not request more or less than the Purchase Volume Limitations (in the
case of Commercial Grade Captisol ordered) nor request a delivery date less than
60 nor more than 100 days after the date of such purchase order (in the case of
any grade of Captisol ordered), shall be deemed accepted by CyDex upon receipt
by CyDex.  With respect to quantities of Commercial Grade Captisol ordered
pursuant to such purchase order that exceed the Purchase Volume Limitations,
CyDex shall not be obligated to accept the excess portion of such purchase order
but nevertheless shall use commercially reasonable efforts to fill such orders
for such excess quantities.  If CyDex, despite the use of commercially
reasonable efforts, is unable to supply as requested such quantities that exceed
the Purchase Volume Limitations for Commercial Grade Captisol, such inability to
supply shall not be deemed for any purpose to be a breach of this Agreement by
CyDex or an inability by CyDex to supply.  If CyDex does supply any or all of
the excess requested quantity, Company shall be required to take and pay for the
entire quantity so supplied.  CyDex shall use commercially reasonable Efforts to
notify Company as soon as possible, but no less than within 14 days, after its
receipt of a purchase order of its expectation regarding its ability to fill any
amounts of such order that are in excess of the Purchase Volume Limitation for
Commercial Grade Captisol.  If any purchase order or other document submitted by
a Party hereunder or any other document passing between the Parties contains
terms or conditions in addition to or inconsistent with the terms of this
Agreement, the terms of this Agreement shall control and prevail and the Parties
hereby agree that such additional or inconsistent terms shall simply be ignored
and deemed not to exist, unless they are expressly identified as being
additional to or inconsistent with this Section 3.4 and are signed by officers
of both Parties.

 

5

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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)           Safety Stock.  CyDex ***.  CyDex shall keep Company reasonably
informed of the level of inventory identified as the safety stock and shall
notify Company in the event any deliveries to Company deplete safety stock
levels.

 

3.5          Delivery.  Subject to Section 3.4(a), CyDex shall deliver (or have
delivered by any Third-Party Manufacturers approved pursuant to the provisions
of Section 2.3 above) the quantities of Captisol defined in any accepted
purchase order. Unless otherwise agreed in writing by the Parties, Captisol
shall be delivered CPT (Incoterms 2010) CyDex’s production point or storage
facilities.  Title and risk of loss and/or damage to Captisol shall pass to
Company upon delivery of Captisol to Company at CyDex’s production point or
storage facilities.  Company acknowledges the inherent risk that a batch of
Captisol may be lost in production or shipment, and Company shall use
commercially reasonable efforts to maintain a sufficient inventory of Captisol
in the event of late delivery by CyDex.  Quantities actually delivered to
Company pursuant to an accepted purchase order may vary from the quantities
reflected in such purchase order by up to 5% and still be deemed to be in
compliance with such purchase order; provided, however, that Company shall only
be invoiced and required to pay for the quantities of Captisol that Company
actually ordered and CyDex actually delivered to Company.  CyDex shall, if
requested by Company, include in the next shipment of Captisol to Company, any
quantities ordered pursuant to an accepted purchase order but not previously
delivered.

 

3.6          Quality Control; Acceptance and Rejection.

 

(a)           Quality Control.  The Parties shall, within 180 days after the
Effective Date, negotiate in good faith and execute a mutually agreeable Quality
Agreement.  It is anticipated that the Quality Agreement would clearly describe
and set forth the roles and responsibilities of the Parties with respect to
quality activities, which shall be consistent with this Agreement.  CyDex shall
conduct or have conducted quality control testing of Captisol before shipment in
accordance with the Quality Agreement, if any, the Specifications, all
applicable laws and regulations, including without limitation, GMP and other
CyDex-approved quality control testing procedures set forth in the DMF (the
“Testing Methods”).  CyDex shall retain or have retained accurate and complete
records pertaining to such testing.  Each shipment of Captisol hereunder shall
be accompanied by a certificate of analysis for the relevant lots of Captisol
signed and dated by the authorized responsible quality control official of CyDex
or its Third-Party Manufacturer.

 

(b)           Acceptance Testing.  Company shall have a period of *** days from
the date of receipt to test or cause to be tested Captisol supplied under this
Agreement, with an eye to possible rejection of the shipment.  Company or its
designee shall have the right to reject by notice to CyDex any shipment of
Captisol that does not conform in all material respects with the Specifications,
DMF, the Minimum Remaining Shelf Life, applicable laws and regulations,
including GMP or is otherwise materially defective or materially not in
compliance with the applicable purchase order (including any

 

6

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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.

 

packaging instructions set forth therein) or the terms of this Agreement at the
time of delivery pursuant to Section 3.5 when tested in accordance with the
Testing Methods (such Captisol thereby having a “Defect” and upon proper
rejection, deemed “Defective”).  All shipments of Captisol shall be deemed
accepted by Company unless CyDex receives written notice of rejection from
Company within such *** day period describing the reasons for the rejection in
reasonable detail.  Once a delivery of Captisol is accepted or deemed accepted
hereunder, Company shall have no recourse against CyDex in the event Captisol is
subsequently deemed unsuitable for use for any reason, except as provided in
Section 10.1 of the License Agreement or except in circumstances where the
Defect is deemed a Latent Defect.  In the case of a Latent Defect in a shipment
of Captisol, Company shall not be permitted to revoke any prior actual or deemed
acceptance of such shipment but shall have the other rights and remedies as set
forth in this Agreement.  It is understood that the terms “Defect” and
“Defective” include matters observed before actual or deemed acceptance and all
Latent Defects, but do not include matters falling outside the definition of
Latent Defect because, e.g., they arise on or after the 180th day after actual
or deemed acceptance.

 

(c)           Latent Defects.  As soon as either Party becomes aware of any
Defect in any Captisol lot which either (i) existed at the time of actual or
deemed acceptance but was not discovered after a reasonable inspection or
(ii) arose, before the 180th day after actual or deemed acceptance, by no fault
of any Permitted Purchasers (each such Defect, a “Latent Defect”), it shall
promptly notify the other Party of such event (including reasonable details and
the lot involved).  If Captisol accepted by Company becomes non-conforming by
virtue of the Latent Defect, Company may place the lot on quality assurance hold
pending the further cooperative investigation by CyDex and Company and a final
resolution of the claimed Latent Defect.  In the event that such Captisol is
found to contain a Latent Defect, such Captisol shall be deemed rejected as of
the date of the notice, and the rights and obligations of the Parties with
respect to the rejected Captisol shall thereafter be governed by the same
process as governs acceptance testing set forth below.

 

(d)           Confirmation.  After its receipt of a notice of rejection or of
Latent Defect from Company pursuant to Section 3.6(b) or (c) above, CyDex shall
notify Company as soon as reasonably practical, and in no event later than 10
days after CyDex’s receipt of Company’s notice of rejection or of Latent Defect,
whether it accepts Company’s basis for rejection or Latent Defect and Company
and CyDex shall cooperate in any further investigation of the rejected or
questioned Captisol.  If the Parties are unable to agree as to whether a
shipment of Captisol supplied by CyDex or its Third-Party Manufacturer hereunder
is Defective, such question shall be resolved in accordance with Section 3.6(f).

 

(e)           Return or Destruction of Defective Shipments.  Company may not
return or destroy any batch of Captisol until it receives written notification
from CyDex that CyDex does not dispute that the batch or portion thereof is
Defective, or independent testing pursuant to Section 3.6(f) confirms the
Defective Captisol.  CyDex shall indicate in its notice either that Company is
authorized to destroy the rejected/Latent Defect batch of Captisol or that CyDex
requires return of the rejected/Latent Defect Captisol.  Upon written
authorization from CyDex to do so, Company shall promptly destroy the
rejected/Latent Defect batch of Captisol and provide CyDex with written
certification of such destruction, or, if the request so states, Company shall
promptly return the rejected/Latent Defect batch of Captisol to CyDex.  In each
case, CyDex shall reimburse Company for the documented, reasonable costs
associated with the rejected/Latent Defect Captisol, including without
limitation, storage, transport, destruction or return of the rejected/Latent
Defect Captisol.

 

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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.

 

(f)            Independent Testing.  If there is a dispute as to whether any
batch is Defective (including, as the case may be, whether it has a Latent
Defect) or has been properly rejected, then the Parties shall designate a
mutually acceptable Third Party laboratory to make a determination on such
matter from a sample obtained from the questioned batch.  The decision of the
Third Party laboratory shall be binding on all Parties hereto and all expenses
related to such Third Party investigation shall be borne by the Party found to
have been mistaken.  Should such Third Party laboratory confirm Company’s claim,
the batch shall be deemed to be Defective (including, as the case may be, that
it has a Latent Defect) and (if it had been rejected) to have been properly
rejected and may be returned or destroyed in accordance with CyDex’s
instructions.

 

(g)           Refund or Replacement.  Company shall not be required to pay any
invoice with respect to any shipment of Captisol properly rejected or determined
finally to have a Latent Defect pursuant to this Section 3.6.  Nor shall such
properly rejected/Latent Defect Captisol count against Company or Company
Affiliates or in any way comprise a failure of Company or Company Affiliates to
satisfy a Detailed Forecast, minimum purchase or other duties and obligations
under this Agreement, the License Agreement or otherwise.  Notwithstanding the
foregoing, Company shall be obligated to pay in full for any rejected shipment
of Captisol that is not subsequently determined to be Defective, irrespective of
whether Company has already paid CyDex for a replacement shipment.  If Company
pays in full for a shipment of Captisol and subsequently properly rejects such
shipment (or such shipment is determined finally to have a Latent Defect) in
accordance with this Section 3.6, Company shall be entitled, upon confirmation
that such shipment is Defective, at its election, either:  (i) to a refund or
credit equal to the purchase price, shipping costs and insurance paid with
respect to such rejected shipment; or (ii) to require CyDex to replace such
rejected/Latent Defect shipment with non-Defective Captisol at no additional
cost to Company. Company acknowledges and agrees that, except for the
indemnification obligations set forth in Section 10.1 of the License Agreement
(to the extent applicable), Company’s rights to a refund or credit for or to
receive replacement of properly rejected shipments of Captisol hereunder shall
be Company’s sole and exclusive remedy, and CyDex’s sole obligation, with
respect to Defective or non-conforming Captisol delivered hereunder.

 

(h)           Exceptions.  Company’s rights of rejection, return, refund and
replacement set forth in this Section 3.6 shall not apply to any Captisol that
is Defective due to damage (i) caused by Company, its Affiliates or Permitted
Purchasers or their respective employees or agents, including but not limited to
misuse, neglect, improper storage, improper transportation or use beyond any
dating provided or (ii) that occurs after delivery of such Captisol to the
carrier at the point of delivery, including but not limited to any damage caused
thereafter by accident, fire or other hazard; and CyDex shall have no liability
or responsibility to Company with respect thereto.

 

3.7          Facilities and Inspections.  CyDex shall permit, and shall use
reasonable commercial efforts to induce each Third-Party Manufacturer to permit,
a reasonable and limited number of Company’s authorized representatives, during
normal working hours and upon reasonable prior notice to CyDex but in no event
less than 30 days’ prior notice (subject to the Third-Party Manufacturer’s
consent to be reasonably sought by CyDex), to confidentially inspect for a
reasonable and limited number of days that portion of all CyDex facilities
utilized for the manufacture, preparation, processing, storage or quality
control of Captisol or such facilities of any Third-Party Manufacturer, no more
frequently than once per calendar year.  Company’s authorized representatives
shall be accompanied by CyDex personnel (and, if the Third-Party Manufacturer so
requests, Third-Party Manufacturer personnel) at all times, shall be qualified
to conduct such manufacturing audits, and shall

 

8

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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.

 

comply with all applicable rules and regulations relating to facility security,
health and safety.  Company shall ensure that its authorized representatives
conduct each manufacturing audit in such a manner as to not interfere with the
normal and ordinary operations of CyDex or its Third-Party Manufacturer.  Except
as expressly set forth in this Section 3.7, Company, Permitted Purchasers and
their respective employees or representatives shall not have access to CyDex’s
facilities or the facilities of any Third-Party Manufacturer.

 

3.8          Inability to Supply.

 

(a)           Additional Site.  CyDex may in its discretion seek to induce its
current Third-Party Manufacturer to undertake and complete validation,
qualification and regulatory approvals at its existing secondary site for the
manufacture of Captisol (which CyDex confirms is, as of the date of this
Agreement, validated and commercially manufacturing Captisol with a typical
batch size on the order of 2500 kg) utilizing the same DMF, Specifications and
manufacturing processes as utilized at its primary site.

 

(b)           Notice.  CyDex shall use commercially reasonable efforts to,
within 14 days after CyDex’s receipt of a purchase order from Company, notify
Company if CyDex then knows it will be unable to supply at the scheduled
delivery time any quantity of non-Defective Captisol ordered by Company.

 

(c)           Allocation.  If CyDex is unable to supply to Company and/or its
Permitted Purchasers the quantity of non-Defective Captisol that CyDex is
required to supply hereunder, CyDex shall (i)  first *** safety stock ***
(ii) allocate any remaining inventories of Captisol among Company and/or
Permitted Purchasers and any other purchasers of Captisol with which CyDex then
has an on-going contractual relationship, in proportion to the quantity of
Captisol for which each of them has orders pending at such time, (iii) require
its Third-Party Manufacturer to utilize both sites discussed in
Section 3.8(a) (if available) for the supply of any shortfall amounts of
Captisol and (iv) use commercially reasonable efforts to minimize supply delays.

 

3.9          Product Recalls.  If any CyDex-supplied Captisol should be alleged
or proven to be Defective, Company shall notify CyDex immediately, and both
Parties shall cooperate fully regarding the investigation and disposition of any
such matter.  If (a) Company recalls any Licensed Product, or (b) the FDA or any
equivalent Major Market regulatory body requires the recall of any Licensed
Product, and in either case such recall is primarily due to any act or omission
of CyDex in general or to the CyDex-supplied Captisol being Defective (either at
the time of delivery or due to a Latent Defect), then CyDex agrees, upon
substantiation thereof, to refund the purchase price for such Captisol and the
costs incurred by Company for such recall.  Company shall ensure that Permitted
Purchasers maintain records of all sales of Licensed Product sufficient to
adequately administer any such recall consistent with applicable laws and
regulations.

 

3.10        Regulatory Status and Specifications.

 

(a)           CyDex shall be solely responsible for maintaining the necessary
approvals and authorizations for Captisol from applicable regulatory agencies or
bodies, including updating and maintaining the DMF.

 

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.

 

(b)           CyDex shall promptly notify Company on becoming aware of any
matters that are likely to affect adversely the regulatory status of Captisol or
the ability of CyDex to supply Captisol in accordance with the terms of this
Agreement.

 

(c)           Except as set forth herein, CyDex may, at its sole cost and
expense, after at least two months’ prior written notice to Company, make
reasonable, non-material changes to the Specifications or the manufacturing
process for Captisol® without Company’s prior written consent, provided such
changes do not (i) require Company to conduct additional process validation or
stability testing, (ii) require Company to comply with additional clinical study
requirements from the FDA or any equivalent Major Market regulatory authority
that would be beyond that required for the Licensed Products formulated with
Captisol meeting the unmodified Specifications/ manufacturing process,
(iii) delay Company’s development or the FDA’s or equivalent foreign Major
Market regulatory authority’s approval of a Licensed Product, (iv) negatively
affect the solubility, stability, shelf life, safety, or efficacy of a Licensed
Product, or (v)  in any Major Market affect the regulatory status of any
Licensed Product or require any material additional regulatory filings and/or
approvals.  In addition, CyDex may, after at least *** months’ prior written
notice to Company, make changes to the Specifications or the manufacturing
process for Captisol® without Company’s prior written consent, even if such
changes (i) require Company to conduct additional process validation or
stability testing, (ii) require Company to comply with additional clinical study
requirements from the FDA or any equivalent Major Market regulatory authority
that would be beyond that required for the Licensed Products formulated with
Captisol meeting the unmodified Specifications/ manufacturing process,
(iii) delay Company’s development or regulatory approval of a Licensed Product,
(iv) negatively affect the solubility, stability, shelf life, safety, or
efficacy of a Licensed Product, and/or (v) affect the regulatory status of any
Licensed Product or any additional regulatory approvals.  CyDex shall provide
Company with an opportunity to evaluate and comment upon the reasonableness of
any proposed change to the Specifications or the manufacturing process for
Captisol®.  In the event of any permitted change to the Specifications or the
manufacturing process for Captisol® effected by CyDex hereunder, CyDex shall
nonetheless continue to provide Company with Captisol under the unmodified
Specifications and manufacturing process under the terms of this Agreement until
such time that Company has obtained any and all required approvals for the
Specification change or the manufacturing process, as applicable, for Captisol
by the FDA and other equivalent Major Market regulatory agencies or bodies (but
only for so long as Company has used commercially reasonable efforts to pursue
all required approvals for the Specification change or the manufacturing
process, as applicable, from the FDA and other applicable equivalent Major
Market regulatory agencies or bodies).

 

(d)           In the event that the FDA or another applicable equivalent Major
Market regulatory authority having jurisdiction requires Company to implement
any changes to the Specifications or the manufacturing process for Captisol,
CyDex shall make all such changes required by the FDA or other applicable Major
Market regulatory authority.  In the event Company desires to change (including
to narrow any ranges within) the Specifications or the manufacturing process for
Captisol® and CyDex elects in its sole discretion to accommodate such desire,
CyDex shall make all such changes requested by Company.  CyDex shall promptly
advise Company as to any lead-time changes or other terms that may result from a
change to the Specifications or the manufacturing process for Captisol.  (In
such a case, the Parties shall negotiate in good faith and mutually agree upon
amended lead-times and any other provisions which may require amendment as a
result of such change, as evidenced by an amendment to this Agreement.)  Company
shall bear the costs including the costs CyDex actually incurred for materials
already purchased expressly for Company, its Affiliates or

 

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.

 

Sublicensees which cannot be sold to a Third Party and are rendered unusable by
a change in Specifications or the manufacturing process for Captisol requested
by Company and agreed to by CyDex.

 

(e)           The Parties shall use commercially reasonable efforts to cooperate
with each other in order to carry out the intent and purposes of this
Section 3.10.  In addition to the rights set forth above, before any change in
any of the Specifications or the manufacturing process for Captisol (other than
a change required by the FDA or another applicable regulatory authority having
jurisdiction), Company shall have the right to make a one-time bulk purchase of
Captisol (in addition to any amounts previously forecast) pursuant to a
separately issued purchase order and CyDex shall use commercially reasonable
efforts to accommodate and deliver the same in a reasonably timely manner.

 

3.11        Regulatory Authority Inspections.  CyDex agrees to reasonably
cooperate with all requests by the FDA and any other relevant regulatory
authority to conduct inspections of any and all facilities related to the
manufacture of Captisol, which the FDA and any other relevant regulatory
authority requires and CyDex agrees to reasonably cooperate with the FDA and any
other relevant regulatory authority in connection with such inspections.

 

3.12        Orders of Clinical Grade Captisol.  During or before Company’s
clinical development of any Licensed Product: (a) Company may provide CyDex with
purchase orders from time to time as needed for Clinical Grade Captisol, and
(b) CyDex shall accept and fulfill all such purchase orders for Clinical Grade
Captisol, provided that such purchase order is consistent with the terms of
Section 3.4(a).  Sections 3.4, 3.5 and 3.6 shall apply to such order.

 

4.                                      COMPENSATION.

 

4.1          Pricing.  The purchase prices for Captisol pursuant to this
Agreement are as specified in Exhibit A.  CyDex reserves the right to increase
such purchase prices set forth in Exhibit A on each January 1 during the Term,
upon not less than 30 days’ prior written notice to Company, by a percentage
equal to the aggregate percentage increase, if any, in the Producer Price Index,
Pharmaceutical Preparation Mfg - pcu325412325412 PCU as reported by the Bureau
of Labor Statistics, U.S. Department of Labor, for the 12 month period ending
October 31 of the prior year, subject to an annual cap of three percent (3%).
 In addition, CyDex reserves the right to, upon not less than five days’ prior
written notice to Company, decrease such purchase prices at any time to any
lower price selected by CyDex, provided that if CyDex does so it shall also have
the right to at any time, upon not less than 30 days’ prior written notice to
Company, increase such purchase prices back to the original prices from which
the decrease occurred, or to any in-between prices; and in the event of such an
increase pursuant to this sentence, CyDex shall have the right to make annual
increases thereafter (from such increased price point) pursuant to the preceding
sentence.

 

4.2          Shortfall Reimbursement (Take or Pay).  If Company fails to order
(pursuant to and in compliance with Article 3) for the Q1 of any Detailed
Forecast a quantity of Commercial Grade Captisol to be delivered during such Q1
(or within 100 days after the firm purchase order is placed) that is equal to or
greater than the quantity of Commercial Grade Captisol Company is obligated to
purchase pursuant to the applicable Detailed Forecast (the difference between
the quantity of Commercial Grade Captisol Company is obligated to purchase in Q1
pursuant to the applicable

 

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.

 

Detailed Forecast and the amount of Commercial Grade Captisol that Company
actually orders for delivery in Q1 (or within 60 days after the firm purchase
order is placed), the “Commercial Grade Shortfall”), then Company shall, at its
option upon notice to CyDex, either (a) pay CyDex 60% of the purchase price
hereunder for the Commercial Grade Shortfall amount and in such case shall not
be entitled to receive delivery of such Commercial Grade Shortfall amount or
(b) pay CyDex 100% of the purchase price hereunder for the Commercial Grade
Shortfall amount and in such case shall be entitled to receive delivery of such
Commercial Grade Shortfall amount upon request during the Term (but such
delivery shall not count toward satisfying the Purchase Volume Limitations
minimum quantity applicable, at the time of actual delivery, for such subsequent
quarter).  In either event, such payment must be made within 20 days after the
end of the Q1.  This Section 4.2 is based on the time stated for delivery in the
original order, as opposed to the time delivery is actually made.

 

4.3          Payments; Taxes.  All amounts due hereunder are stated in, and
shall be paid in, U.S. Dollars.  Payment of CyDex’s invoices shall be made,
except to the extent disputed in good faith, within 30 days after Company’s
receipt of such invoices.  The purchase prices for Captisol® specified in
Exhibit A exclude and shall, as far as legally possible, be paid in full to
CyDex without reduction for all applicable sales, use, and other taxes and
duties applicable to Company and/or in respect of the transactions contemplated
by this Agreement, and Company shall be responsible for payment of all such
taxes (other than taxes based on CyDex’s income), fees, duties, and charges, and
any related penalties and interest, arising from the payment of amounts due
hereunder.  If any amount due hereunder and not subject to a reasonable,
good-faith dispute by Company remains outstanding for more than 30 days after
its due date, CyDex may, in addition to any other rights or remedies it may
have, refuse to ship Captisol hereunder except upon payment by Company in
advance.

 

5.                                      REPRESENTATIONS AND WARRANTIES.

 

5.1          Limited Warranty.  CyDex covenants and warrants solely to Company
that:

 

(a)           All Captisol sold to Company pursuant to this Agreement shall
conform to the respective Specifications (as applicable for Clinical Grade
Captisol or Commercial Grade Captisol), the DMF, the Minimum Remaining Shelf
Life and all applicable laws, including GMP, at the time of delivery and shall
not, before the 180th day after actual or deemed acceptance, be subject to any
Latent Defects;

 

(b)           All Captisol sold to Company pursuant to this Agreement shall, to
CyDex’s knowledge, not infringe any patent or other proprietary right of any
Third Party;

 

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

 

(d)           To CyDex’s knowledge, CyDex, its Affiliates and its Third-Party
Manufacturers hold, and are operating in material compliance with, all permits,
licenses, franchises, authorizations and clearances of the FDA and/or any other
Major Market regulatory authority (including without limitation all applicable
health, safety and environmental permits) 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 License
Agreement, except where the

 

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.

 

failure to so hold or be so operating does not have and would not reasonably be
expected to have a material adverse effect on (i) CyDex and/or its ability to
supply Captisol to Company hereunder and/or (ii) Company and/or its ability to
obtain Captisol hereunder and/or exploit Licensed Products; and

 

(e)           CyDex does not know of any actual or threatened enforcement
actions relating to the manufacture and/or supply of Captisol against CyDex, its
Affiliates or its Third-Party Manufacturers by the FDA or any other federal,
state or Major Market regulatory authority.

 

5.2          Representations to the Other Party.  The provisions of Section 9.1
(Mutual Representations and Warranties) of the License Agreement are
incorporated herein by reference as if fully set forth herein, with references
therein to “this Agreement” being understood to refer to this Supply Agreement
rather than to the License Agreement.

 

5.3          Representations to Other Persons.  Company shall be solely
responsible for all representations and warranties that Company or its
Affiliates make to any Permitted Purchaser or to any direct or indirect customer
of Licensed Products.

 

6.                                      TERM AND TERMINATION.

 

6.1          Term.  The term of this Agreement (the “Term”) shall commence on
the Effective Date and, unless terminated earlier as set forth herein, shall
continue until the earlier of (a) termination or expiration of the License
Agreement; or (b) if CyDex decides to stop the manufacture of Captisol, after
CyDex provides one year prior written notice to Company of its intent to
terminate this Agreement because it has decided to stop the manufacture of
Captisol.  In the event of a termination under Section 6.1(b), CyDex shall use
good faith efforts in cooperation with Company to enable an alternative supplier
of Captisol for the Permitted Purchasers.

 

6.2          Effect of Termination.  Upon the termination of this Agreement,
(a) Company shall no longer have any rights to order Captisol from CyDex; and
(b) 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; provided,
however, that each Party may retain (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 this Party is required to keep by applicable regulations.

 

6.3          Survival.  Notwithstanding any other provisions of this Agreement,
any liability or obligation of either Party to the other for acts or omissions
before the termination or expiration of this Agreement shall survive the
termination or expiration of this Agreement.  Sections 1 (Definitions) 2.4
(Restrictions), 3.5 (Delivery), 3.6 (Quality Control; Acceptance and Rejection),
3.7 (Facilities and Inspections), 3.9 (Product Recalls), 4.3 (Payments; Taxes),
5.2 (Representations, Warranties), 5.3 (Disclaimer), 6.2 (Effect of
Termination), 6.3 (Survival), 6.4 (Accrued Obligations) and 7 (General
Provisions) shall survive termination or expiration of this Agreement.  In the
event that termination of this Agreement is as a result of nonpayment by Company
of an obligation owing to CyDex, CyDex shall have the option, in its discretion,
either to cancel all outstanding Captisol orders properly made before and
pending at the time of termination or to honor and enforce all outstanding
Captisol orders properly made before and pending at the time of termination.

 

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.

 

6.4          Accrued Obligations.  Termination of this Agreement shall not
relieve either Party of any liability which has accrued before the effective
date of such termination (e.g., sums due in respect of Captisol supply), nor
prejudice either Party’s right to obtain performance of any obligations that are
expressly indicated or obviously intended to survive termination.

 

7.                                      GENERAL PROVISIONS.

 

The following Sections of the License Agreement are incorporated into this
Agreement by this reference as if fully set forth herein, with references
therein to “this Agreement” being understood to refer to this Supply Agreement
rather than to the License Agreement:  4.2 (Taxes), 4.3 (Payments), 7.3
(Material Safety), 7.4 (Adverse Event Reporting), 8 (Confidentiality), 9.3
(Disclaimer), 10 (Indemnification), 11 (Limitation of Liability), 12 (Management
of Intellectual Property), 13.3 (Termination for Breach), 13.4 (Termination for
Bankruptcy) and 14 (General Provisions).

 

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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.

 

IN WITNESS WHEREOF, the Parties have executed this Supply 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

 

1

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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

 

PURCHASE PRICES FOR CAPTISOL

 

All prices are CPT (Incoterms 2010) CyDex’s production point or storage
facilities.

 

All prices exclude shipping and insurance.

 

Grade of Captisol

 

Price per Kg

 

***

 

$

***

 

***

 

$

***

 

 

Such prices are subject to adjustment pursuant to Section 4.1.

 

All orders are subject to a minimum order size of 20 kg.

 

* * * * *

 

1

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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 B:  SPECIFICATIONS

 

[... *** ...]

 

B-1

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