Exhibit 10.108

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

EXCLUSIVE LICENSE AGREEMENT

This License Agreement is entered into as of the 4th day of June, 1996 (the
“Effective Date”) by and between Pfizer Inc., a Delaware corporation. having an
office at 235 East 42nd Street, New York, New York 10017 and its Affiliates
(“Pfizer”) and the University of Kansas, a state educational institution of the
State of Kansas with a place of business at Office of Research Support and
Grants Administration, Strong Hall, Lawrence, Kansas 66045 and its Affiliates
(“KU”) (each individually a “Party” and collectively the “Parties”).

WHEREAS, KU is the assignee and owner of U.S. Patent No. [***] and foreign
counterparts all of which claim [***] (“KUCD”); and

WHEREAS, Pfizer desires to obtain an exclusive license under such U.S. Patent so
that Pfizer can manufacture, use and sell certain [***] Products (as hereinafter
defined); and

WHEREAS, KU is willing to grant such license;

NOW, THEREFORE, in consideration of the mutual covenants and promises set forth
in this License, the Parties agree as follows:

 

1. Definitions

The following terms used in this License shall have the following meanings:

1.1 “Affiliate” means (a) in the case of Pfizer, any corporation or other legal
entity owning, directly or indirectly, fifty percent (50%) or more of the voting
capital shares or similar voting securities of Pfizer; any corporation or other
legal entity fifty percent (50%) or more of the voting capital shares or similar
voting rights of which is owned, directly or indirectly, by Pfizer, or any
corporation or other legal entity fifty percent (50%) or more of the voting
capital shares or similar voting rights of which is owned, directly or
indirectly, by a corporation or other legal entity which owns, directly or
indirectly, fifty percent (50%) or more of the voting capital shares or similar
voting securities of Pfizer; and (b) in the case of KU, any corporation or other
legal entity which is formed by KU or enters into a joint venture with KU to
perform any activities related to KUCD.

1.2 [***] Product” means any pharmaceutical preparation [***]

1.3 “Licensed [***] Products” means any [***] Product, the manufacture, use or
sale of which would infringe a Valid Claim within the Patent Rights in the
absence of a license.

1.4 “Major Market” means [***].

 

 

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1.5 “Net Sales” means the gross amount invoiced by Pfizer or any sublicensee of
Pfizer for sales to a third party or parties of [***] Products, less normal and
customary trade discounts actually allowed, rebates, returns, credits, taxes the
legal incidence of which is on the purchaser and separately shown on Pfizer’s or
any sublicensee of Pfizer’s invoices and transportation, insurance and postage
charges, if prepaid by Pfizer or any sublicensee of Pfizer and billed on
Pfizer’s or any sublicensee of Pfizer’s invoices as a separate item.

1.6 “Patent Rights” means:

(a) U.S. Patent No. [***], any division, continuation, continuation-in-part,
renewal, patent of addition, extension, reissue, and any foreign counterpart
thereof, and

(b) rights under all other composition-of-matter, method of use and process
patents and applications therefor, whether U.S. or foreign, claiming in each
case KUCD only, for use as [***] [***] only, including all continuations,
continuations-in-part, divisions, renewals and patents of addition, and
extensions, and reissues thereof. This definition does not include rights under
any patent claiming KUCD as an active ingredient, either alone or in combination
with other active ingredients or excipients.

1.7 “Territory” means all countries of the world in which Patent Rights subsist.

1.8 “Valid Claim” means a claim to a composition of matter claim and in the
United States only, a KUCD method of use claim within Patent Rights so long as
such claim shall not have been disclaimed by both KU or Pfizer or shall not have
been held invalid in a final decision rendered by a tribunal of competent
jurisdiction from which no appeal has been or can be taken. By way of further
explanation, a Valid Claim does not include KUCD process claims anywhere in the
world and KUCD method of use claims outside the United States.

 

2. Grant of License, Term, Rights and Obligations

2.1 License Granted to Pfizer under the Patent Rights

KU grants to Pfizer an exclusive license, including the right to grant
sublicenses, to manufacture, use and sell [***] Products in the Territory under
the Patent Rights (the “License”).

2.2 Term of License Grant

Unless terminated earlier as provided below, the License shall commence on the
Effective Date and shall terminate in each country in the Territory on the date
on which the last to expire of the Patent Rights expires.

2.3 Sublicensing Obligations

 

 

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If Pfizer grants a sublicense pursuant to Section 2, Pfizer shall guarantee that
any sublicensee fulfills all of Pfizer’s obligations under this License. Pfizer
further agrees to incorporate in all sublicenses granted hereunder provisions
similar to those contained herein at Section 3.5 (Records); Section 5
(Termination); and Section 9 (Non-Use of Names), and a confidentiality provision
no less stringent than that contained in Article 10 of the Option Agreement
dated December 3, 1993 between the Parties (the “Option Agreement”). Pfizer
further agrees to forward to KU a copy of each sublicense agreement entered into
hereunder, and a copy of all reports received by Pfizer from its sublicensees
during each l2-month period.

2.4 Technical Assistance

KU shall provide to Pfizer or any sublicensee of Pfizer, at Pfizer’s request and
expense, any technical assistance reasonably necessary to enable Pfizer or such
sublicensee to manufacture, use or sell [***] Products and to enjoy fully all
the rights granted to Pfizer pursuant to this License; provided, however, that
KU is reasonably capable of providing that assistance.

 

3. Royalties, Payments of Royalties, Accounting for Royalties, Records,
Milestone Payments

3.1 Patent Rights

Pfizer shall pay KU a royalty based on the Net Sales of Licensed [***]Products.
Such royalty shall be paid with respect to each country of the world from the
date of the [***](the date of the invoice of Pfizer or any sublicensee of Pfizer
with respect to such sale) of such Licensed [***]Product in each such country
until the expiration of the last Patent Right to expire with respect to each
such country and each such Licensed [***]Product. By way of explanation, Pfizer
shall pay royalties pursuant to Section 3.2.2. with respect to the manufacture
of Licensed [***]Products whose manufacture would infringe a Valid Claim if it
were done by an unlicensed third party, such royalties to be paid on the Net
Sales of such Licensed [***]Products even if the actual sale of such Licensed
[***]Products would not alone infringe a Valid Claim if such sales were made by
an unlicensed third party.

3.2 Royalty Rates

3.2.1 The Royalties payable under Section 3.1 above shall be at the rate set
forth in Section 3.2.2; provided, however, that the Royalty rate otherwise
applicable to Net Sales of [***]Products in the United States shall be reduced
by [***]percent ([***]%) until such time that KU obtains a license from the
National Institutes of Health to NIH’s U.S. Patent No. [***](“[***]Patent”) and
any foreign counterparts to make, use and sell [***]with the right to sublicense
to Pfizer.

 

 

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3.2.2 Pfizer shall pay a Royalty of [***] percent [***]%) of the [***] dollars
($[***] of Net Sales made in each calendar year in the United States and a
royalty of [***] percent [***]%) of Net Sales in excess of [***]and a royalty of
[***]%) of the [***] dollars [***] of Net Sales made in each calendar year
outside the United States and a royalty of [***] percent [***]%) of any such Net
Sales in excess of [***] dollars ($[***]).

3.3 Payment Dates

Royalties shall be paid by Pfizer on Net Sales within [***] days after the end
of each calendar quarter in which such Net Sales are made. Such payments shall
be accompanied by a statement showing the Net Sales of each [***] Product upon
which Royalties are payable by Pfizer or any sublicensee of Pfizer in each
country, the applicable Royalty rate for such [***] Product, and a calculation
of the amount of Royalty due.

3.4 Accounting

The Net Sales used for computing the Royalties payable to KU by Pfizer shall be
computed in U.S. dollars, and such Royalties shall be paid in U.S. dollars by
check or other mutually acceptable means. For purposes of determining the amount
of Royalties due, the amount of Net Sales in any foreign currency shall be
computed by (a) converting such amount into dollars at the prevailing commercial
rate of exchange for purchasing dollars with such foreign currency as quoted by
Citibank in New York on the last business day of the calendar quarter for which
the relevant Royalty payment is to be made by Pfizer and (b) deducting the
amount of any governmental tax, duty, charge, or other fee actually paid in
respect of such conversion into, and remittance of dollars.

3.5 Records

Pfizer shall keep for [***] from the date of each payment of Royalties complete
and accurate records of sales by Pfizer and its sublicensees of each [***]
Product for which Royalties are payable in sufficient detail to allow the
accruing Royalties to be determined accurately. KU shall have the right for a
period of [***] after receiving any report or statement with respect to
Royalties due and payable to appoint at its expense an independent certified
public accountant reasonably acceptable to Pfizer to inspect the relevant
records of Pfizer to verify such report or statement. Pfizer shall make its
records available for inspection by such independent certified public accountant
during regular business hours at such place or places where such records are
customarily kept, upon reasonable notice from KU, to verify the accuracy of the
reports and payments. Such inspection right shall not be exercised more than
[***] in any calendar year nor more than [***] with respect to sales in any
given period. KU agrees to hold in strict confidence all information concerning
royalty payments and reports, and all information learned in the course of any
audit or inspection, except to the extent necessary for KU to reveal such
information in order to enforce its rights under this License or if disclosure
is required by law. The failure of KU to request verification of any report or
statement during said [***] period

 

 

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the Commission. Confidential treatment has been requested with respect to the
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shall be considered acceptance of the accuracy of such report, and Pfizer shall
have no obligation to maintain records pertaining to such report or statement
beyond said three-year period. The results of each inspection, if any, shall be
binding on both parties.

3.6 Additional Payments

Pfizer shall pay KU, within [***] [***] days of the completion of each event set
forth below (“Event”), the payment listed opposite that Event. Payments shall be
made in U.S. dollars by check or other mutually acceptable means. Pfizer shall
be obligated to make each payment only once with respect to each [***] Product
affected by an Event so that the occurrence of an Event with respect to
additional strengths, dosage forms or delivery modes of that [***] Product will
not require Pfizer to make an additional payment with respect to that [***]
Product.

 

1.    [***]    $[***] 2.    [***].    $[***]

 

4. Entire Agreement

The Option Agreement, the Exhibits thereto, the Confidentiality Agreements dated
March 24, 1992, May 7, 1992, and July 14, 1992 between the Parties, and this
License are the sole agreements with respect to the subject matter and supersede
all other agreements and understandings between the Parties with respect to
same. Section 2.5 and Articles 7, 8, 9, 10, 11, 12, 13, 14 and 18 of the Option
Agreement are hereby incorporated as if fully set forth herein.

 

5. Termination of this Agreement

5.1 Pfizer may terminate this Agreement, with or without cause, upon [***] days
notice to KU.

5.2 Either Party may terminate this Agreement upon material breach by the other
if such material breach remains unremedied [***] days after written notice of
same.

5.3 Termination of this Agreement pursuant to this Section shall not affect the
status of the Option Agreement (except that the Exclusive Option thereunder
shall no longer be exercisable) or the Nonexclusive License Agreement (if it is
in effect at the time of termination of this Agreement), and such Agreements
shall remain in full force and effect in accordance with their respective terms.

 

 

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5.4 All rights set forth in this Section shall be in addition to, and not in
limitation of, any right either Party may have with respect to the other at law
or in equity by virtue of any breach or default in the performance of the terms
and conditions of this License.

 

6. Indemnification; Insurance

6.1 Pfizer shall at all times during the term of this License and thereafter
indemnify, defend and hold KU and its trustees, officers, employees and
Affiliates harmless from and against any and all claims, proceedings, demands,
losses, damages, liabilities, costs and expenses of any nature whatsoever
(including without limitation reasonable attorneys fees) arising out of or
connected with the manufacture, marketing, promotion, distribution, use or sale
of the [***] Products or arising out of Pfizer’s failure to perform any
obligation hereunder.

6.2 Pfizer agrees to insure all Products and Pfizer activities associated
therewith in the same manner in which it insures any other similar Pfizer [***]
products and such activities.

 

7. Governing Law

This License shall be governed by and construed in accordance with the laws of
the State of Kansas.

 

8. Notices

All notices shall be in writing mailed via certified mail, return receipt
requested, courier or facsimile transmission addressed as follows, or to such
other address as may be designated from time to time:

 

If to Pfizer:   

To Pfizer at its address as set forth at the beginning of this License.

Attention: President, Central Research, with copy to: Office of General Counsel

If to KU:   

To KU at its address as set forth at the beginning of this License.

Attention: Director

Notice shall be deemed given as of the date sent.

 

9. Non-Use of Names

Pfizer shall not use the name of KU or of any KU employee in any advertising,
promotional or sales literature without KU’s prior written consent, except that
Pfizer may state that it is licensed by KU under the Patent Rights.

 

 

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10. Miscellaneous

10.1 Binding Effect. This License shall be binding upon and inure to the benefit
of the Parties and their respective legal representatives successors and
permitted assigns.

10.2 Headings. Paragraph headings are inserted for convenience of reference only
and do not form a part of this License.

10.3 Counterparts. This License may be executed simultaneously in two or more
counterparts, each of which shall be deemed an original.

10.4 Amendment; Waiver. This License may be amended, modified, superseded or
canceled, and any of the terms may be waived, only by a written instrument
executed by each Party or, in the case of waiver, by the Party or Parties
waiving compliance. The delay or failure of either Party at any time or times to
require performance of any provisions shall in no manner affect the rights at a
later time to enforce the same. No waiver by either Party of any condition or of
the breach of any term contained in this License, whether by conduct or
otherwise in any one or more instances shall be deemed to be or considered as a
further or continuing waiver of any such condition or of the breach of such term
or any other term of this License.

10.5 No Third Party Beneficiaries. No third party including any employee of
either Party shall have or acquire any rights by reason of this License. Nothing
contained in this License shall be deemed to constitute the Parties partners
with each other or any third party.

10.6 Assignment and Successors. This License may not be assigned by either
Party, except that each Party may assign this License and the rights and
interests of such Party, in whole or in part, to any of its Affiliates.
Notwithstanding the foregoing, Pfizer may assign this License to any purchaser
of all or substantially all of its assets or to any successor corporation
resulting from any merger or consolidation of Pfizer with or into such
corporation, and KU may similarly assign this License to any successor entity.

10.7 Force Majeure. Neither Pfizer not KU shall be liable for failure of or
delay in performing obligations set forth in this License if such failure or
delay is due to natural disasters or any causes reasonably beyond the control of
the Party failing to perform (each a “Force Majeure Event”). Upon the occurrence
of any Force Majeure Event, the Party whose performance is affected thereby
shall promptly give written notice of such Force Majeure Event to the other
Party, and both Parties shall use all reasonable efforts to overcome such Force
Majeure Event.

10.8 Severability. If any provision of this License is or becomes invalid or is
ruled invalid by any court of competent jurisdiction or is deemed unenforceable,
it is the intention of the Parties that the remainder of the License shall not
be affected.

10.9 Kansas Open Records Act. This License is subject to the provisions of the
Kansas Open Records Act, K.S.A. 45-215 et seq.

IN WITNESS WHEREOF, the parties have caused this License to be executed by their
duly authorized representatives.

 

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PFIZER INC       CYDEX, L.C.

By:

 

/s/ [Illegible]

    By:  

/s/ [Illegible]

Title:

 

Vice President

    Title:  

President

Date:

 

22 May 1996

    Date:  

June 4, 1996

 

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