Exclusive License Agreement



 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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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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