Document:

License Agreement

 Exhibit 10.1 
 CONFIDENTIAL 
 CERTAIN MATERIAL (INDICATED BY ASTERISKS) 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. 
 LICENSE AGREEMENT 
 BETWEEN 

CYDEX PHARMACEUTICALS, INC. 
 AND 
 MEI PHARMA, INC. 

DATED: September 28, 2012 

 TABLE OF CONTENTS 

 

							
	 Section
	 	 Title
	  	Page	 
			
	1.	 	DEFINITIONS	  	 	1	  
			
	2.	 	GRANT OF RIGHTS	  	 	6	  
			
	3.	 	MANUFACTURE AND SUPPLY OF CAPTISOL	  	 	9	  
			
	4.	 	COMPENSATION	  	 	9	  
			
	5.	 	RECORDS; REPORTS; AUDIT	  	 	12	  
			
	6.	 	DEVELOPMENT AND COMMERCIALIZATION BY COMPANY	  	 	13	  
			
	7.	 	REGULATORY MATTERS	  	 	14	  
			
	8.	 	CONFIDENTIALITY	  	 	15	  
			
	9.	 	REPRESENTATIONS AND WARRANTIES	  	 	18	  
			
	10.	 	INDEMNIFICATION	  	 	20	  
			
	11.	 	LIMITATION OF LIABILITY	  	 	21	  
			
	12.	 	MANAGEMENT OF INTELLECTUAL PROPERTY	  	 	22	  
			
	13.	 	TERM AND TERMINATION	  	 	24	  
			
	14.	 	GENERAL PROVISIONS	  	 	25	  

 TABLE OF EXHIBITS 

 

							
	 Exhibit
	 	 Title
	  	Page	 
			
	A.	 	 LICENSED PATENTS
	  	 	A-1	  

  
 i 

 LICENSE AGREEMENT 

THIS LICENSE AGREEMENT (this “Agreement”) is made this 28th day of
September, 2012 (the “Effective Date”) between: 
 CYDEX
PHARMACEUTICALS, INC., a Delaware corporation, with offices at 11119 North Torrey Pines Road, Suite 200, La Jolla, California 92037) (“CyDex”); and 

MEI PHARMA, INC., a Delaware corporation, with offices at 11975 El Camino Real, Suite 101, San Diego,
California 92130 (“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®, a patented drug formulation system designed to enhance the solubility and stability of drugs; 

WHEREAS, Company desires to obtain an exclusive license to use the Captisol® patented drug formulation system in connection with its development and commercialization of one or more Licensed
Products (defined below) and CyDex is willing to grant such an exclusive license to Company under the terms and conditions set forth herein; and 
 WHEREAS, CyDex desires to sell
Captisol® to Company, and Company desires to purchase
Captisol® from CyDex, in accordance with the terms and conditions of that certain Supply Agreement between the
parties of even date herewith (the “Supply Agreement”); 
 NOW, Therefore, in
consideration of the following mutual promises and other good and valuable consideration, the receipt and sufficiency of which are acknowledged, the parties, intending to be legally bound, agree as follows: 

1. DEFINITIONS. 
 For the purposes of this Agreement, the following terms shall have the meanings as defined below: 
 “Adverse Event” means any undesirable medical occurrence in a patient or clinical investigation subject administered Captisol or a Licensed Product (whether or not necessarily having a
causal relationship with Captisol or a Licensed Product). 
 “Affiliate” means, with respect to any party, any
entity controlling, controlled by, or under common control with such party, during and for such time as such control exists. For these purposes, “control” shall refer to the ownership, directly or indirectly, of at least 50% of the voting
securities or other ownership interest of the relevant entity. 

 “Captisol” means sulfobutylether ß(beta)
cyclodextrin, sodium salt. CyDex supplies such material under the Captisol® brand. 

“Captisol Improvement” means any technology or improvement specifically related to the physical properties of Captisol,
whether or not patentable, that is developed by Company or its Affiliates or Sublicensees, solely or jointly with a Third Party. 
 “Captisol Related Compound” means Captisol or any derivative, homolog analog of Captisol or any isomer, salt, hydrate, solvate, amide, ester, metabolite or product of any of the
foregoing, including without limitation sulfobutylether g(gamma) cyclodextrin sodium salt. 
 “Captisol Data Package” means (i) all toxicology/safety and other relevant scientific safety data owned, licensed or developed by CyDex and its Affiliates relating to Captisol;
(ii) all toxicology/safety and other relevant scientific data owned, licensed or developed by the licensees or sublicensees of CyDex or its Affiliates or other Third Parties (to the extent permitted in the applicable license or other agreements
between CyDex and/or its Affiliates and such licensees, sublicensees or other Third Parties); and (iii) the open portion of the DMF for Captisol, in each case relating to Captisol alone (and not in conjunction with a product formulation).

 “Claim” has the meaning specified in Section 10.1. 

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

“Competing Product” shall mean any product an active pharmaceutical ingredient of which is a Compound and which is not
marketed and sold by or under license from Company. 
 “Compound” means the proprietary Company
isoflavone-based drug compound known as ME-143 (also known as NV-143) or the proprietary Company mitochondrial inhibitor drug compound known as ME-344, or any derivative, homolog, or analog of ME-143 or ME-344 or any isomer, salt, hydrate, solvate,
amide, ester, metabolite, or prodrug of any of the foregoing. 
 “Confidential Information” has the meaning
specified in Section 8.1. 
 “Contract Manufacturer” has the meaning specified in
Section 2.4. 
 “CyDex Indemnitees” has the meaning specified in Section 10.2.

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

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

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

“Field” means the entire field of prevention, diagnosis and treatment of all human and animal diseases and disorders
with the exceptions of: (i) ocular treatment of any disease or condition with a 

  
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formulation including a hormone; (ii) topical ocular treatment of inflammatory conditions; (iii) treatment and prophylaxis of fungal infections in humans; and (iv) any ocular
treatment for retinal degeneration. 
 “First Commercial Sale” means the first sale for use or consumption by
the general public of a Licensed Product in a particular country following Marketing Approval. 
 “Generic
Captisol” [***] 
 “Generic Supplier” [***] 

“IND” means an Investigational New Drug application, as defined in the United States Federal Food, Drug and Cosmetic Act
and the regulations promulgated thereunder, or similar application filed with an equivalent regulatory body in another country. 

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

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

“Licensed Patents” means all patents and patent applications in the Territory which cover Captisol and which now or at
any time during the Term are owned by or licensed to CyDex or any CyDex Affiliate with the right to sublicense, including any and all extensions, renewals, continuations, substitutions, continuations-in-part, divisions, patents-of-addition,
reissues, reexaminations and/or supplementary protection certificates to any such patents. Set forth in Exhibit A attached hereto is a list of the Licensed Patents as of the Effective Date. Such Exhibit A shall be
updated by CyDex at least annually during the Term. CyDex shall designate for each Licensed Patent specified in Exhibit A whether such Licensed Patent is exclusively owned by CyDex, jointly owned by CyDex, or is licensed to CyDex by a
Third Party, and in each case whether CyDex has the right to grant an exclusive license to Company hereunder (i.e. with respect to itself and any Third Party). 
 “Licensed Product” means (a) a Compound combined with or formulated using Captisol for ultimate use in humans in a dosage form/formulation, or (b) a pharmaceutical composition
that includes a Compound and that is developed with the assistance of or incorporates any then-confidential component of the Captisol Data Package. 
 “Licensed Product Family” means one or more Licensed Products which are based on the same Compound(s) (or any isomers, salts, hydrates, solvates, amides, esters, metabolites, or prodrugs
of the foregoing), irrespective of whether such Licensed Products contain different dosage forms, proportions or formulations of such Compound(s), utilize different inactive ingredients and/or are marketed for different indications. Notwithstanding
the foregoing, a Licensed Product based on a Compound shall be deemed to be in a distinct Licensed Product Family from a Licensed Product based on the combination of the same relevant Compound with any other active pharmaceutical

  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 

  
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ingredient. As such, if Company develops one Licensed Product with ME-344 as the sole active ingredient with Captisol and also develops another Licensed Product with ME-344 in combination with
another active ingredient with Captisol, then two distinct sets of milestone payments shall be potentially due under this Agreement, one for each of such two distinct Licensed Products. 

“Losses” has the meaning set forth in Section 10.1. 

“Major Market” means each of Japan, France, Germany, Italy, Spain, the United Kingdom and the United States of America.

 “Marketing Approval” means final approval of an NDA by the FDA, or final approval of a comparable document
filed with an equivalent health regulatory authority in any other country or in the European Union (using the centralized process or mutual recognition), including all required marketing, pricing or reimbursement approvals; provided, that if a First
Commercial Sale has occurred in any country (or within any country within a region), it shall be conclusively deemed for purposes of this Agreement that all required marketing, pricing and reimbursement approvals in such country and in such (entire)
region have been obtained. 
 “NDA” means a New Drug Application, as defined in the United States Federal Food,
Drug and Cosmetic Act and the regulations promulgated thereunder, or similar application filed with an equivalent regulatory body in another country. 
 “Net Sales” means the gross amount invoiced by Company (including a Company Affiliate) or any Sublicensee thereof to unrelated Third Parties, excluding any Sublicensee, for a Licensed
Product, less: 
  

	 	(i)	Trade, quantity and cash discounts allowed; 

  

	 	(ii)	Discounts, refunds, rebates, chargebacks, retroactive price adjustments, and any other allowances which effectively reduce the net selling price (other than such which
have already diminished the gross amount invoiced); 

  

	 	(iii)	Licensed Product returns and allowances; 

  

	 	(iv)	Administrative fees paid to group purchasing organizations (e.g., Medicare); 

 

	 	(v)	[***] 

  

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

  

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

Such amounts shall be determined from the books and records of Company and its Affiliates and Sublicensees, maintained in accordance with U.S. GAAP or,
in the case of Sublicensees, similar 

  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 

  
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accounting principles, consistently applied. Company further agrees in determining such amounts, it shall use Company’s then current standard procedures and methodology, including
Company’s then current standard exchange rate methodology for the translation of foreign currency sales into U.S. Dollars or, in the case of Sublicensees, such similar methodology, consistently applied. 

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

“Phase II Clinical Trial” means any human clinical trial of a Licensed Product conducted for purposes of preliminary
determination of efficacy and/or preliminary establishment of appropriate dosage ranges for efficacy and safety in patients, as described under 21 C.F.R. §312.21(b) (as hereafter modified or amended) and any of its foreign equivalents.

 “Phase III Clinical Trial” means any human clinical trial to confirm with statistical significance the
efficacy and safety of a Licensed Product, as described under 21 C.F.R. §312.21(c) (as hereafter modified or amended) and any of its foreign equivalents. For avoidance of doubt: any pivotal trial shall be deemed to be a Phase III Clinical
Trial. 
 “Pfizer” has the meaning specified in Section 8.5. 

“Quality Agreement” means any document developed, approved, and updated between CyDex and Company that sets forth the
quality expectations, responsibilities, rights (including, as applicable and agreed upon, audit requirements) and requirements relating to the manufacture and supply of Captisol. Such agreement may be amended from time to time by written agreement
between the parties. 
 “Receiving Party” has the meaning specified in Section 8.1. 

“Safety Agreement” has the meaning specified in Section 7.4. 

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

“Study” has the meaning specified in Section 6.2. 

“Sublicensees” has the meaning specified in Section 2.3. 

“Term” has the meaning specified in Section 13.1. 

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

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

“Third Party Manufacturer” has the meaning specified in Section 2.3 of the Supply Agreement. 

“Upstream Licensor has the meaning specified in Section 2.6. 

  
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 “U.S. GAAP” means United States generally accepted accounting principles,
consistently applied. 
 “Valid Claim” means a claim which, but for the license granted hereunder, would be
infringed by Company’s use, manufacture or sale of a Licensed Product in a country in the Territory, and which is covered by an issued and unexpired patent in such country included within the Licensed Patents which has not been held invalid or
unenforceable by a decision of a court or governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid, canceled or unenforceable by
the owner through re-issue, re-examination or disclaimer, opposition procedure, nullity suit, or otherwise or is not enforceable by virtue of applicable law in such country. 
 2. GRANT OF RIGHTS. 
 2.1
License Grants from CyDex to Company. 
 (a) Licensed Patents. Subject to the terms and conditions of this Agreement,
including but not limited to payment of the amounts set forth in Section 4.1 below, CyDex hereby grants to Company an exclusive (even as against CyDex and its Affiliates), nontransferable (except with respect to the assignment provision
in Section 14.15) limited license during the Term under the Licensed Patents, solely to make, have made (pursuant to Section 2.4), use, sell, offer for sale and import the Licensed Products in the Territory in and for the
Field. (No license, exclusive or nonexclusive, is granted hereunder under the Licensed Patents, except to so make, have made, use, sell, offer for sale and import the Licensed Products in the Territory in and for the Field.) Notwithstanding the
foregoing, to the extent that any Licensed Patents are licensed to CyDex or its Affiliates by a Third Party on a non-exclusive basis, the license granted to Company in the foregoing sentence shall be exclusive as to CyDex and its Affiliates and
non-exclusive as to any Third Party. For clarity, as CyDex is unable to grant Company any rights that it does not have, in the event that CyDex obtains a non-exclusive license from a Third Party for intellectual property necessary for Company to
perform its obligations hereunder, then CyDex shall pass on such rights to Company hereunder via a license that grants rights that are non-exclusive with respect to Third Parties but that is exclusive with respect to CyDex and its Affiliates.
Company may not make, use, sell, offer for sale, or import the Licensed Products for any other purposes than those granted to it in this Agreement. Company may not sublicense the Licensed Patents, except as expressly set forth in
Sections 2.3 and 2.4 below. 
 (b) Captisol Data Package. Subject to the terms and conditions of this
Agreement, CyDex hereby grants to Company an exclusive (even as against CyDex and its Affiliates), nontransferable (except with respect to the assignment provision in Section 14.15) license during the Term under CyDex’s rights in
and to the Captisol Data Package, solely to make, have made, use, sell, offer for sale and import the Licensed Products in the Territory in and for the Field. CyDex shall make its personnel reasonably available to Company and its Contract
Manufacturers to respond to informational inquiries and provide technical assistance related to the Captisol Data Package. Company may sublicense its rights in and to the Captisol Data Package, as expressly set forth in Sections 2.3 and
2.4 below 
 (c) Scope of Licenses. CyDex grants no licenses or rights to use other than as expressly set forth
herein. Without limiting the generality of the foregoing, CyDex grants no rights 

  
 6 

 
to Company to manufacture, import, sell or offer for sale bulk Captisol; provided, however, that Company may provide Captisol to bona fide collaborators in order to help Company to
make, have made (pursuant to Section 2.4), use, sell, offer for sale or import the Licensed Products in the Territory in the Field. Licensee acknowledges that not all rights of CyDex related to Captisol are included within the rights
licensed hereunder, given that CyDex shall supply Company’s requirements of Captisol for the Licensed Products. Company shall not attempt to reverse engineer, deconstruct or in any way determine the structure or composition of Captisol except
as and to the extent reasonably required to determine an optimal formulation of the Licensed Product, and such structure and composition of Captisol (as and if so determined) shall be considered Confidential Information of CyDex; [***] CyDex shall
not be liable to Company for violation of Company’s exclusive rights hereunder by parties which are not Affiliates or licensees of CyDex except to the extent CyDex has contributed to such violation. Company acknowledges and agrees that except
as is expressly set forth in this Agreement (i) CyDex shall not be required to obtain or maintain patent rights in the Territory for the Licensed Patents, (ii) CyDex shall not be restricted in making sales of Captisol or, except as
provided herein for the Licensed Products and/or Competing Products, licensing rights to other parties, and (iii) CyDex does not warrant or indemnify Licensee or its Affiliates and Sublicensees against the Licensed Products infringing Third
Party rights. 
 2.2 Grant of License from Company to CyDex. Company hereby grants to CyDex a nonexclusive, transferable,
perpetual, worldwide and royalty-free license, with the right to grant sublicenses (through multiple tiers of sublicensees), under Company’s and its Affiliates’ and Sublicensees’ rights in and to Captisol Improvements to develop,
make, have made, use, market, distribute, import, sell and offer for sale Captisol, any Captisol Improvement and products formulated with Captisol or any Captisol Improvement (other than the Licensed Products in the Field). If during the Term any of
(a) Company, (b) Affiliates to whom Company has provided rights under the licenses granted to Company by CyDex pursuant to Section 2.1, or (c) Sublicensees pursuant to the practice of their respective sublicenses from
Company under Section 2.3, file any patent application claiming any Captisol Improvement anywhere in the world, CyDex shall be deemed automatically to have a nonexclusive, transferable, perpetual, worldwide and royalty-free license, with
the right to grant sublicenses (through multiple tiers of sublicensees), under the claims relating specifically to any Captisol Improvement to make, have made, use, market, distribute, import, sell, and offer for sale Captisol. Company shall provide
prompt notice of any Captisol Improvement. 
 2.3 Sublicensing. Company shall have the right to grant sublicenses
(through one or more tiers of sublicenses) to its Affiliates and licensees of the Licensed Products (collectively “Sublicensees”) under the licenses granted to Company pursuant to Section 2.1; provided,
however, Company warrants and shall procure, as a condition precedent thereto, that each such Sublicensee shall first be advised of the restrictions set forth in this Agreement with respect to the transfer of the rights sublicensed to such
Sublicensee and such Sublicensee shall enter into an agreement with Company (with CyDex named as an intended third-party beneficiary) pursuant to which such Sublicensee shall acknowledge and agree to observe and be bound by the applicable
restrictions set forth in this Agreement. Other than as specifically provided in this Section 2.3 and Section 2.4, Company shall not have the right to grant sublicenses to any Third Party under the licenses granted pursuant
to Section 2.1. Company shall ensure that all of its Sublicensees shall comply with the 

  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 

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

2.5 Bankruptcy Code. All rights and licenses granted under or pursuant to this Agreement by CyDex to Company are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the Bankruptcy Code. The parties agree that Company, as a licensee of
such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. All rights and licenses granted under or pursuant to this Agreement by Company to CyDex are, and shall otherwise be
deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101 of the Bankruptcy Code. The parties agree that, as a licensee of such rights under
this Agreement, CyDex shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code. 
 2.6
Compliance with Upstream Licenses. CyDex shall be solely responsible for paying directly to any and all Third Parties having rights in any of the Licensed Patents and/or Captisol Data Package (each an “Upstream Licensor”) any
royalties or other amounts due to such Upstream Licensors as a result of Company exercising its rights hereunder. In addition, CyDex represents and warrants that it is not in breach of any of its obligations to such Upstream Licensors and covenants
that it shall maintain its rights under and shall comply with the terms of its agreements with such Upstream Licensors throughout the Term. Furthermore, CyDex represents and warrants that it shall not amend, modify or supplement the terms of, or
waive any rights under any such agreements if the same would have the effect of limiting or further restricting Company’s rights or expanding Company’s obligations hereunder. 

2.7 Negative Covenants by CyDex. 
 (a) During the Term (on a country-by-country basis), neither CyDex nor any of its Affiliates shall directly themselves, nor provide any Third Party any assistance whatsoever, nor grant any Third
Party any right or license under any of the Licensed Patents to, research, develop, 

  
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modify, make, have made, import, export, use, promote, market, distribute, package, offer for sale, sell, or otherwise commercially exploit Licensed Products or any Competing Products.

 (b) During the Term (on a country-by-country basis), neither CyDex nor any of its Affiliates shall supply Captisol or
a Captisol Related Compound to any Third Party (other than a Company designee) which it knows or should know will use it for a Licensed Product or a Competing Product. If during the Term (on a country-by-country basis), any such Third Party, or any
other Third Party that acquires any Captisol Related Compound, utilizes such Captisol Related Compound in a Licensed Product or Competing Product, CyDex shall immediately cease and cause its Affiliates and any other Third Party to immediately cease
supplying any Captisol Related Products to the offending Third Party for the duration of the Term or until (if sooner) assurances reasonably satisfactory to Company that the infringing use has ended and will not resume have been obtained.

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

 The provisions of the Supply Agreement and any related Quality Agreement shall govern the manufacture and supply of
Captisol for use in the formulation of the Licensed Products. Company acknowledges and agrees that, pursuant to the Supply Agreement, CyDex is the exclusive manufacturer of Captisol for Company and its Affiliates and Sublicensees and nothing set
forth herein shall be deemed to grant Company or its Affiliates or Sublicensees the right to manufacture Captisol nor the right to contract the manufacture of Captisol to a Third Party except as provided in Section 3.8(d) of the Supply
Agreement. 
 4. COMPENSATION. 
 4.1 Payments and Royalties for Licenses. 
 (a) One-Time Fee. Company
shall forthwith pay to CyDex a [***] one-time fee of [***] in partial consideration of the rights granted to Company under this Agreement which shall be due fifteen (15) days after the Effective Date. [***] 

(b) Milestone Payments. Within 14 days following the occurrence of each and any of the milestone events listed below, Company
shall provide written notice to CyDex of the achievement of such milestone event, and within 21 days of the occurrence of such milestone event, pay to CyDex the applicable non-refundable milestone fee listed next to such event in further
consideration of the rights granted Company hereunder. If for any respective Licensed Product 

  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 

  
 9 

 
Family, milestone (iv), (vi) or (viii) is achieved before any or all of milestones (i), (ii) and (iii) have been actually achieved, then any and all of milestones (i),
(ii) and (iii) which were not previously actually achieved for such Licensed Product Family shall be deemed to have thereby been achieved for such Licensed Product Family, and the milestone payments for such deemed-achieved milestones
shall also be payable within such 21 days. 
  

							
	 	  	 MILESTONE
	  	MILESTONE
PAYMENT	 
	 (i)
	  	Upon dosing of the first patient in the first [***] Clinical Trial by Company or under rights from Company for a Licensed Product in a Licensed Product Family*	  	 	[	***] 
	 (ii)
	  	Upon dosing of the first patient in the first [***] Clinical Trial by Company or under rights from Company for a Licensed Product in a Licensed Product Family*	  	 	[	***] 
	 (iii)
	  	Upon submission of a NDA to the FDA for a Licensed Product in a Licensed Product Family*	  	 	[	***] 
	 (iv)
	  	Upon receipt of Marketing Approval from the FDA for the first indication of a Licensed Product in a Licensed Product Family*	  	 	[	***] 
	 (v)
	  	Upon receipt of Marketing Approval from the FDA for each additional indication of a Licensed Product in a Licensed Product Family	  	 	[	***] 
	 (vi)
	  	Upon receipt of Marketing Approval in the EU for the first indication of a Licensed Product in a Licensed Product Family*	  	 	[	***] 
	 (vii)
	  	Upon receipt of Marketing Approval in the EU for each additional indication of a Licensed Product in a Licensed Product Family	  	 	[	***] 
	 (viii)
	  	Upon receipt of Marketing Approval in Japan for the first indication of a Licensed Product in a Licensed Product Family*	  	 	[	***] 
	 (ix)
	  	Upon receipt of Marketing Approval in Japan for each additional indication of a Licensed Product in a Licensed Product Family	  	 	[	***] 

  

	*	such milestone shall only be payable once per Licensed Product Family. 

 (c) Royalties. 
 (i) In addition to amounts payable pursuant to
Sections 4.1(a) and 4.1(b) above, Company shall make royalty payments to CyDex on a calendar quarterly basis in an amount equal to [***] of the applicable Net Sales during such quarter, as determined for each Licensed Product.
Provided that for the duration of any period in the Term in which (a) [***] 

  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 

  
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 (ii) The royalty shall be reduced with respect to Net Sales in a particular country
by deducting (a) 50% of any and all royalties paid by Company, its Affiliates and/or Sublicensees to any Third Party for any additional solubility technology that is incorporated in a Licensed Product in such country, up to a maximum reduction
of 50% in the aggregate of the royalty owing for Net Sales in such country; (b) 100% of any and all royalties paid for any license that the parties mutually determine in good faith would be prudent to obtain given the potential to resolve or
avoid any claims that Captisol, or specifically the Captisol element of a Licensed Product infringes or misappropriates the intellectual property rights of any Third Party in such country; and (c) any final, unappealed judgment awarded against
Company, its Affiliates or Sublicensees for damages for infringement of Third Party intellectual property rights with respect to making, having made, using, selling, offering for sale or importing Captisol, or specifically the Captisol element of a
Licensed Product in such country. Company shall use commercially reasonable efforts to minimize any such royalties or other payments to Third Parties on account of sales of Licensed Products hereunder. 

(iii) In the event that a Licensed Product is commercialized in combination with one or more products which are themselves not
Licensed Products under this Agreement for a single price, the Net Sales for such Licensed Product shall be calculated by multiplying the sales price of such combination sale by the fraction A/(A+B) where A is the fair market value of the Product
and B is the fair market value of the other product(s) in the combination sale. If the fair market value for any product sold in combination with a Licensed Product cannot be reasonably determined, the price attributed to such product shall be based
on the relative cost of goods for such product, as determined in accordance with U.S. GAAP. 
 (iv) All royalties payable
to CyDex pursuant to Section 4.1(c) shall be due and payable within [***] after the conclusion of each calendar quarter, provided that within [***] after the conclusion of each Company fiscal year Company may provide notice to
CyDex of any adjustments necessary to account for any royalties which were overpaid or underpaid for such prior fiscal year’s calendar quarters (as determined from Company’s end of fiscal year external audit), and the parties shall
promptly true-up for any such adjustments which are mutually determined to be correct. 
 In establishing the royalty structure hereunder, the
parties recognize, and Company acknowledges, the substantial value of the various obligations being undertaken by CyDex under this Agreement, in addition to the grant of the licenses under the Captisol Data Package as well as under the Licensed
Patents, to enable the rapid and effective market introduction of the Licensed Products. The parties have agreed to the payment structure set forth herein as a convenient and fair mechanism to compensate CyDex for these obligations. 

4.2 Taxes. All amounts due hereunder exclude all applicable withholding, sales, use, and other taxes and duties, and Company shall
be responsible for payment of all such taxes (other than taxes based on CyDex’s income) and duties and any related penalties and interest, arising from the payment of amounts due under this Agreement. The parties agree to cooperate with one
another and use commercially reasonable efforts to avoid or reduce tax withholding or similar obligations in respect of royalties, milestone payments, and other payments made by Company to CyDex under this Agreement. To the extent Company is
required to withhold taxes on any payment to CyDex, 

  

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portions. 

  
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Company shall pay the amounts of such taxes to the proper governmental authority in a timely manner and promptly transmit to CyDex official receipts issued by the appropriate taxing authority
and/or an official tax certificate, or such other evidence as CyDex may reasonably request, to establish that such taxes have been paid. CyDex shall provide Company any tax forms that may be reasonably necessary in order for Company to not withhold
tax or to withhold tax at a reduced rate under an applicable bilateral income tax treaty. CyDex shall use commercially reasonable efforts to provide any such tax forms to Company at least 45 days before the due date for any payment for which CyDex
desires that Company apply a reduced withholding rate. Each party shall provide the other with reasonable assistance to enable the recovery, as permitted by applicable law, of withholding taxes, value added taxes, or similar obligations resulting
from payments made under this Agreement, such recovery to be for the benefit of the party bearing such withholding tax or value added tax. CyDex shall indemnify and hold Company harmless from and against any penalties, interest or other tax
liability arising from any failure by Company (at the express request of CyDex) to withhold or by Company reduction (at the express request of CyDex) in its withholding. 
 4.3 Payments. Payments that are not made when due hereunder shall accrue interest, from due date until paid, at an annual interest rate equal to the prime rate, as reported in The Wall Street
Journal, Eastern U.S. Edition, on the date such payment is due, plus an additional 200 basis points (2%). All amounts due hereunder are stated in, and shall be paid in, U.S. Dollars. 
 5. RECORDS; REPORTS; AUDIT. 

5.1 Records. During the Term and for a period of three years thereafter, Company shall, and shall require its Affiliates and
Sublicensees to, maintain accurate records relating to Net Sales of the Licensed Products and clinical study subject enrollment for Studies. 
 5.2 Reports. 
 (a) Quarterly Financial Reports. Within 45 days
following the conclusion of each calendar quarter during the Term, Company shall provide CyDex with a written report with respect to such calendar quarter that sets forth sales of the Licensed Products in the Territory during such calendar
quarter. Such report shall include Net Sales and royalties due for each Licensed Product. Within 90 days after the conclusion of each Company fiscal year Company may provide notice to CyDex of any adjustments necessary to such reports and any
royalties which were overpaid or underpaid for such prior fiscal year’s calendar quarters (as determined from Company’s end of fiscal year external audit) shall be adjusted in accordance with Section 4.1(c)(iv). 

(b) Annual Milestone Reports. By November 1st of each calendar year during the Term, Company shall provide CyDex with written
reports that describe in reasonable detail Company’s progress made toward achievement of the milestones specified in Section 4.1(b) above during such calendar year and set forth such other information regarding Captisol as mutually
agreed upon by the parties. Company shall also provide quarterly updates regarding any significant changes to the expected completion of any such milestones outlined in the annual report. 

5.3 Audit. Upon at least 14 days advance written notice by CyDex, Company shall permit CyDex’s independent, Third Party
certified public accountant, reasonably acceptable to Company, to have access during normal business hours to such of the records of Company as may be reasonably necessary to verify the royalty reports under Section 5.2(a) in respect of
any calendar 

  
 12 

 
year ending not more than 36 months before the date of such request. Except as described in the next paragraph, all such audits shall be conducted at the expense of CyDex and not more than once
in each calendar year and not more than once for each audited period. In the event such accountant concludes that additional payments of any kind as required by this Agreement were owed to CyDex during such period, the additional amounts shall be
paid within 30 days of the date CyDex delivers to Company such accountant’s written report so concluding unless Company disputes the results of such audit in accordance with Section 14.3. The fees charged by such accountant shall be
paid by CyDex, unless the audit discloses that the amounts payable by Company for the audited period are more than [***] of the amounts actually paid for such period and more than [***] in which case Company shall pay the reasonable fees and
expenses charged by the accountant (pending the results of any dispute initiated by either party pursuant to Section 14.3 with respect to the same). In the event such accountant concludes that there was an overpayment by Company to CyDex
during such period, at Company’s option, the overpayment shall be (i) credited against future amounts due from Company, or (ii) paid by CyDex to Company within 30 days of the date of the written report. The independent certified
public accountant shall keep confidential any information obtained during such inspection in accordance with the provisions set forth in Section 8 hereof and shall report to CyDex and Company only the amounts of Net Sales and royalties
due and payable. The parties agree that all information subject to review under this Section 5.3 or under any sublicense agreement is the Confidential Information of Company and that CyDex shall cause its accountant to retain all such
information in confidence. 
 6. DEVELOPMENT AND COMMERCIALIZATION BY
COMPANY. 
 6.1 Costs and Expenses. Company shall be solely responsible for all costs and expenses
related to its development and commercialization of the Licensed Products, including without limitation costs and expenses associated with all preclinical activities and clinical trials, and all regulatory filings and proceedings relating to the
Licensed Products. 
 6.2 In Vivo Studies. If Company wishes to conduct any in vivo study (preclinical or clinical, in
animals or in humans, each a “Study”) of a Licensed Product utilizing Captisol, the following provisions shall apply: 
 (a) Dosing. Company shall not exceed the maximum allowable dosing levels of Captisol specified in CyDex’s then-current clinical dosing matrix (which shall be provided by CyDex to Company from
time to time) without the written consent of CyDex. 
 (b) Compliance with Laws. Company represents and warrants that
each Study shall be performed in accordance with all applicable laws, regulations and requirements. Company shall provide or cause to be provided all appropriate warnings to participants enrolled in each Study and obtain or cause to be obtained
appropriate documentation of informed consent from all participants in each such Study. 
 (c) Adverse Events. Company
agrees to immediately inform CyDex if any adverse effects are observed and ascribed to Captisol in any Study in accordance with Section 7.3 hereof. To accurately track adverse events and preserve the validity of each Study preceding the
First Commercial Launch of the applicable Licensed Product, subject to Company’s additional rights under the Supply Agreement, Company shall only use Captisol supplied by CyDex for each such Study preceding the First Commercial Launch of the
applicable Licensed Product conducted under 

  

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portions. 

  
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the scope of this Agreement, and, subject to Company’s additional rights under the Supply Agreement, shall not use any other cyclodextrin product supplied by a Third Party. 

(d) Reporting and Study Data. Within three months after receipt of the final Study report for a Study, Company shall provide to
CyDex a summary of the data and results of each Study that pertain solely to Captisol, and subject to Section 8, Company hereby grants to CyDex a non-exclusive, royalty-free license (with the right to sublicense) to use and disclose such
data solely as necessary for regulatory purposes, including without limitation to update the DMF for Captisol. 
 (e)
Responsibility. Company has the freedom to formulate and design each Study, and (as between Company and CyDex) Company is solely responsible for executing each Study; and so it is reasonable that, and the parties agree that, Company shall be
solely responsible therefor and for any effects or consequences of the formulation, design and execution of each Study. 

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

6.4 Access to Company’s Data. CyDex shall have the right to reference and utilize all toxicology/safety and other relevant
scientific data developed on Captisol alone (and not in conjunction with a Licensed Product) by Company, its Sublicensees or Affiliates, at no cost to CyDex. Upon request by CyDex, Company shall either provide CyDex, at CyDex’s sole expense,
with a copy of all such data or shall make such data accessible to CyDex at times and locations reasonably agreeable to CyDex and Company subject to the provisions of Section 8. 
 7. REGULATORY MATTERS. 
 7.1 Captisol
Information Submitted for Regulatory Review. Except as otherwise set forth herein, Company shall be solely responsible for all communications with regulatory agencies in connection with the Licensed Products, provided CyDex shall reasonably
cooperate with Company with respect to any interactions with regulatory authorities concerning Captisol. Company shall provide CyDex with copies of the portions of all regulatory submissions containing Captisol data alone (and not in conjunction
with any Licensed Product) 14 days before submission and shall allow CyDex to review and comment upon said submissions. The contents of each such submission shall be deemed to be Confidential Information of Company, subject to the terms and
provisions of Section 8 below. Company shall promptly inform CyDex of meetings with the FDA (or other regulatory agencies in the Territory) regarding Captisol. If Company submits written responses to the FDA that include data on Captisol
alone, CyDex shall be permitted to review such written materials 14 days before submission. If CyDex reasonably objects to the contents of such written responses relating to Captisol, the parties agree to cooperate in working toward a reasonable and
mutually agreeable response; provided, however, that Company shall be entitled to in good faith make the final determination as to the contents of any such materials. 
 7.2 Material Safety. CyDex shall provide Company, in writing, from time to time, with (a) relevant material information currently known to it regarding handling precautions, toxicity and
hazards with respect to Captisol, and (b) the then-current material safety data sheet for Captisol. Notwithstanding the foregoing or anything in this Agreement to the contrary, Company is solely

  
 14 

 
responsible for (i) use of all documentation provided by CyDex, including without limitation, use in any regulatory submission to the FDA or any other regulatory agency in the Territory,
(ii) document control and retention, and (iii) determining the suitability of any documentation provided by CyDex hereunder for use in any regulatory submission. 
 7.3 Adverse Event Reporting. Company shall adhere, and shall require that its Affiliates, Sublicensees, co-marketers and distributors adhere, to all requirements of applicable law and regulations
that relate to the reporting and investigation of any adverse event, including without limitation an unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease, whether or not considered
Captisol or Licensed Product-related, which occurs or worsens following administration of Captisol or Licensed Product. Each party shall provide the other with copies of all reports it obtains (either directly or through any Sublicensee or licensee)
of any adverse event which is serious (e.g., any such adverse event involving Captisol or the Licensed Product that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in disability, congenital anomaly or
is medically important (i.e., may require other medical or surgical intervention to prevent other serious criteria from occurring)) which such party has reason to believe are associated with Captisol within 14 days following (i) submission of
any such report to any regulatory agency, or (ii) receipt from such party’s Sublicensee, licensee, co-marketer or distributor of any such report to any regulatory agency. Company shall also advise CyDex regarding any proposed labeling or
registration dossier changes affecting Captisol. Reports from Company shall be delivered to the attention of Chief Scientific Officer, CyDex, with a copy to Chief Executive Officer, CyDex, at the address set forth in Section 14.7. The
parties shall mutually cooperate with regard to investigation of any such serious adverse event, whether experienced by Company, CyDex or any other Affiliate, Sublicensee, sublicensee, co-marketer or distributor of CyDex or Company. 

7.4 Safety Agreement. Upon request by Company, CyDex shall negotiate in good faith a separate safety agreement (the
“Safety Agreement”), for each proposed Licensed Product, at least 120 days before submission of an IND related to such proposed Licensed Product (or, for any proposed Licensed Products for which the IND was submitted before the
Effective Date, then as soon as practicable after the Effective Date). The Safety Agreement would be anticipated to provide details related to the management of serious Adverse Events that occur during clinical trials, including safety issues rising
from pre-clinical research and other safety and reporting practices and procedures, detailing obligations related to the development and commercialization of the Licensed Product in compliance with all applicable laws, rules, and regulations.

 8. CONFIDENTIALITY. 
 8.1 Definition. Company and CyDex each recognizes that during the Term, it may be necessary for a party (the “Disclosing Party”) to provide Confidential Information (as defined
herein) to the other party (the “Receiving Party”) that is highly valuable, the disclosure of which would be highly prejudicial to such party. The disclosure and use of Confidential Information shall be governed by the provisions of
this Section 8. Neither Company nor CyDex nor their Affiliates shall use the other’s Confidential Information except as expressly permitted in this Agreement. For purposes of this Agreement, “Confidential
Information” means all information disclosed by the Disclosing Party to the Receiving Party and which reasonably ought to have been understood to be confidential and/or non-public information at the time disclosed to the Receiving Party, or
which is designated in writing by the Disclosing Party as “Confidential” (or equivalent), or which when 

  
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disclosed orally to the Receiving Party is declared to be confidential by the Disclosing Party and is so confirmed in a writing delivered to the Receiving Party within 30 days of such oral
disclosure, including but not limited to product specifications, data, know-how, formulations, product concepts, sample materials, business and technical information, financial data, batch records, trade secrets, processes, techniques, algorithms,
programs, designs, drawings, and any other information related to a party’s present or future products, sales, suppliers, customers, employees, investors or business. Without limiting the generality of the foregoing, CyDex’s Confidential
Information includes all materials provided as part of the Captisol Data Package. 
 8.2 Obligation. CyDex and Company
agree that they will disclose the other party’s Confidential Information to its own (or its 100% stockholder’s, or with respect to Company, its Sublicensees’) officers, employees, consultants and agents only if and to the extent
necessary to carry out their respective responsibilities under this Agreement or in accordance with the exercise of their rights under this Agreement, and such disclosure shall be limited to the maximum extent possible consistent with such
responsibilities and rights. Except as set forth in the foregoing sentence, neither party shall disclose Confidential Information of the other to any Third Party without the other’s prior written consent; provided, however, consent shall
not be required to the extent such Confidential Information is disclosed for diligence purposes to Company’s potential Sublicensees, sources of funding or acquirers of any or all of the Company’s assets to which this Agreement relates. In
all events, however, any and all disclosure to a Third Party shall be pursuant to the terms of a non-disclosure/nonuse agreement no less restrictive than this Section 8. The party which disclosed Confidential Information of the other to
any Third Party or Affiliate shall be responsible and liable for any disclosure or use by such Third Party or Affiliate (or its disclosees) which would have violated this Agreement if committed by the party itself. Neither party shall use
Confidential Information of the other except as expressly allowed by and for the purposes of this Agreement. Each party shall take such action to preserve the confidentiality of each other’s Confidential Information as it would customarily take
to preserve the confidentiality of its own Confidential Information (but in no event less than a reasonable standard of care). Upon expiration or termination of this Agreement, each party, upon the other’s request, shall return or destroy (at
disclosing party’s discretion) all the Confidential Information disclosed to the other party pursuant to this Agreement, including all copies and extracts of documents, within 60 days of the request, except for one copy which may be retained in
its confidential files for archive purposes. 
 8.3 Exceptions. The use and non-disclosure obligations set forth in this
Section 8 shall not apply to any Confidential Information, or portion thereof, that the Receiving Party can demonstrate by competent evidence: 
 (a) at the time of disclosure is in the public domain; 
 (b) after
disclosure, becomes part of the public domain, by publication or otherwise, through no fault of the Receiving Party or its disclosees; 
 (c) at the time of disclosure is already in the Receiving Party’s possession, and such prior possession can be properly demonstrated by the Receiving Party, with the exception of Confidential
Information exchanged between parties before the execution of this Agreement; 
 (d) is made available to the Receiving
Party by an independent Third Party without obligation of confidentiality; provided, however, that to the Receiving Party’s knowledge, 

  
 16 

 
such information was not obtained by said Third Party, directly or indirectly, from the Disclosing Party hereunder; or 
 (e) is independently developed by an employee of the Receiving Party not accessing or utilizing the Disclosing Party’s information. 

In addition, the Receiving Party may disclose information that is required to be disclosed by law, by a valid order of a court or by
order or regulation of a governmental agency including but not limited to, regulations of the SEC or in the course of arbitration or litigation; provided, however, that in all cases the Receiving Party shall give the other party prompt notice
of the pending disclosure and use commercially reasonable efforts to obtain, or to assist the Disclosing Party in obtaining, a protective order or confidential-treatment order preventing or limiting (to the greatest possible extent and for the
longest possible period) the disclosure and/or requiring that the Confidential Information so disclosed be used only for the purposes for which the law or regulation required, or for which the order was issued. 

8.4 Injunction. Each party agrees that should it breach or threaten to breach any provisions of this Section 8, the
Disclosing Party will suffer irreparable damages and its remedy at law will be inadequate. Upon any breach or threatened breach by the Receiving Party of this Section 8, the Disclosing Party shall be entitled to seek temporary,
preliminary and/or permanent injunctive relief in addition to any other remedy which it may have, without need to post any bond or security, in addition to any and all other legal and equitable rights and remedies available to the Disclosing Party.

 8.5 Third Party Information. 
 (a) Company acknowledges that CyDex’s Confidential Information and DMF include information developed by Pfizer, Inc. (“Pfizer”) that is confidential to both CyDex and Pfizer.
Only to the extent that confidential information of Pfizer is disclosed to Company hereunder, and only as required by CyDex’s pre-existing contractual obligations to Pfizer, then Pfizer is a limited third party beneficiary of only this
Section 8 of this Agreement and may seek remedies pursuant to it, but only in accordance with its terms. 
 (b)
Both parties agree not to disclose to the other party any Confidential Information of a Third Party which is in the possession of such party, unless the other party has given an express prior written consent (which specifies the owner of such
Confidential Information) to receive such particular Confidential Information. 
 8.6 Public Announcements. The parties
shall mutually agree on any press release to be issued upon execution of this Agreement. Neither party shall make any subsequent public announcement concerning this Agreement or the terms hereof not previously made public without the prior written
approval of the other party with regard to the form, content, and precise timing of such announcement, except as may be required to be made by either party in order to comply with applicable law, regulations, court orders, or tax, securities
filings, financing arrangements, acquisitions, or sublicenses. Such consent shall not be unreasonably withheld or delayed by such other party. Before any such public announcement, the party wishing to make the announcement shall submit a draft of
the proposed announcement to the other party in sufficient time to enable such other party to consider and comment thereon. In addition, Company shall not, without at least 14 

  
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days’ prior written notice to CyDex (except to the extent such a notice period would not be allowed due to an affirmative requirement of applicable law for immediate disclosure to
governmental authorities), state or suggest orally or in writing to any governmental authorities, physicians or other Third Parties that Captisol (sulfobutylether ß cyclodextrin) has any safety or efficacy issues or that any Adverse Event was
due to Captisol. Upon providing such notice, Company shall not be required to provide any additional notices to CyDex for any subsequent statements (oral or written) concerning the same issue. Similarly, CyDex shall not, without at least 14
days’ prior written notice to Company (except to the extent such a notice period would not be allowed due to an affirmative requirement of applicable law for immediate disclosure to governmental authorities), state or suggest orally or in
writing to any governmental authorities, physicians or other Third Parties that a Compound or Licensed Product has any safety or efficacy issues or that any Adverse Event was due to a Compound or a Licensed Product. Upon providing such notice, CyDex
shall not be required to provide any additional notices to Company for any subsequent statements (oral or written) concerning the same issue. 

9. REPRESENTATIONS AND WARRANTIES. 

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

 (a) it is a corporation duly organized and validly existing under the laws of the state or country of its
incorporation; 
 (b) it has the full power and right to enter into this Agreement and to perform its obligations
hereunder; 
 (c) this Agreement has been duly authorized, executed and delivered by such party and constitutes a legal,
valid and binding obligation of such party enforceable against such party in accordance with its terms except as enforceability may be limited by applicable bankruptcy, insolvency, reorganization, receivership, moratorium, fraudulent transfer, or
other similar laws affecting the rights and remedies of creditors generally and by general principles of equity; 
 (d)
the execution, delivery and performance of this Agreement by such party do not conflict with any agreement, instrument or understanding, oral or written, to which such party is a party or by which such party may be bound, nor violate any law or
regulation of any court, governmental body or administrative or other agency having authority over such party; 
 (e) all
consents, approvals and authorizations from all governmental authorities or other Third Parties required to be obtained by such party in connection with the execution and delivery of this Agreement have been obtained; 

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

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

  
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 9.2 CyDex Representations and Warranties. CyDex hereby represents and warrants to
Company as follows: 
 (a) that it has no knowledge of any unsettled past or current, and has not received notice of any
threatened, patent, trade secret or other intellectual property dispute with any Third Party that actually or is reasonably likely to have a material adverse effect on the Licensed Patents or Captisol Data Package; 

(b) the Licensed Patents are not subject to any outstanding injunction, judgment order, ruling or charge and CyDex knows of no
pending or threatened claim or action which challenges the validity, legality, enforceability or use of the Licensed Patents or Captisol Data Package; 
 (c) CyDex has the full right, power and authority to grant all of the licenses granted to Company under this Agreement; 
 (d) as of the Effective Date, CyDex has not granted to any Third Party any license to any of the Licensed Patents or Captisol Data Package which conflicts with the exclusive license hereunder;

 (e) through the Effective Date CyDex has filed and maintained with the appropriate regulatory authorities in the
Territory all permits, licenses, regulatory filings (including the DMF) and approvals related to Captisol and the manufacture and sale thereof, necessary for CyDex to carry out its obligations and for Company to exercise its rights under this
Agreement and the Supply Agreement, except where the failure to so file and maintain 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 and/or
(ii) Company and/or its ability to obtain Captisol and/or exploit Licensed Products; 
 (f) all information provided
pursuant to Section 7.2, in Exhibit A hereof and Exhibit B of the Supply Agreement and as a part of the Captisol Data Package shall to CyDex’s knowledge be complete and accurate; and 

(g) CyDex shall notify Company promptly if it becomes aware of any material facts or circumstances occurring after the Effective
Date which it has reason to believe would have made the aforementioned representations and warranties untrue had they been given after the Effective Date. 
 9.3 Disclaimer. The warranties set forth in this Section 9 above are provided in lieu of, and each party hereby disclaims, all other warranties, express and implied, relating to the
subject matter of this Agreement, Captisol, the Licensed Patents, the Captisol Data Package, the Compounds, the Licensed Products, the Captisol Improvements, any Study Data or Results provided hereunder and/or any toxicology and/or scientific data
provided hereunder including but not limited to the implied warranties of merchantability and fitness for a particular purpose, title and non-infringement of third party rights. Each party’s warranties under this Agreement are solely for the
benefit of the other party and may be asserted only by the other party and not by any Affiliate, Sublicensee or any customer of the other party, its Affiliates or Sublicensees. Each party, its Affiliates and Sublicensees shall be solely responsible
for all representations and warranties that it, its Affiliates or Sublicensees make to any customer of such party, its Affiliates or Sublicensees. 

  
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 10. INDEMNIFICATION. 

10.1 By CyDex. CyDex shall defend, indemnify and hold Company and its Affiliates and Sublicensees, and each of their respective
directors, officers, agents and employees (collectively, the “Company Indemnitees”), harmless from and against any and all losses, judgments, damages, liabilities, settlements, penalties, fines, costs and expenses of attorneys and
other professionals) (collectively, “Losses”) incurred by the Company Indemnitees as a result of any claim, demand, action or other proceeding (each, a “Claim”) by a Third Party, to the extent such Losses arise out
of (i) CyDex’s breach of this Agreement or the Supply Agreement, including without limitation any of its representations and warranties set forth herein or therein; (ii) the research, development, manufacture, use, handling,
promotion, marketing, distribution, importation, sale or offering for sale of Captisol by CyDex, its Affiliates, distributors, licensees or agents (for clarity, such terms shall not include Company in any event); (iii) [***]
(iv) interactions and communications by CyDex, its Affiliates, manufacturers, distributors or agents with governmental authorities, physicians or other Third Parties relating to Captisol, including the Captisol Data Package; (v) use or
reliance by CyDex upon the Captisol Improvements, any Study data or results provided to CyDex pursuant to Section 6.2(d) and/or any toxicology and/or scientific data provided to CyDex pursuant to Section 6.4; (vi) the
supply, sale, distribution or, consumption of any defective Captisol and any recall resulting therefrom (whether or not rejected by Company under the Supply Agreement); (vii) any enforcement action by a regulatory authority relating to
Captisol; or (viii) the grossly negligent or willful misconduct of CyDex or its Affiliates or any of their respective distributors, officers, directors, employees or agents; all except to the extent that such Losses are primarily caused by a
Company Indemnitee’s gross negligence or willful misconduct. 
 10.2 By Company. Company shall defend, indemnify and
hold CyDex and its Affiliates, and each of their respective directors, officers, agents and employees (collectively, the “CyDex Indemnitees”), harmless from and against any and all Losses incurred by the CyDex Indemnitees as a
result of any Claim by a Third Party, to the extent such Losses arise out of: (i) Company’s breach of this Agreement or the Supply Agreement, including without limitation any of its representations and warranties herein or therein;
(ii) any Study conducted by or on behalf of Company (whether before or after the Effective Date); (iii) the research, development, manufacture, use, handling, promotion, marketing, distribution, importation, sale or offering for sale of
Licensed Products by Company, its Affiliates, Sublicensees, Contract Manufacturers, distributors or agents (for clarity, such terms shall not include CyDex in any event); (iv) infringement of a Third Party’s intellectual property rights in
the making, having made (other than by CyDex or its designee), using, selling, offering for sale and importing of Licensed Products (other than intellectual property rights claiming Captisol per se or its manufacture or use);
(v) interactions and communications by Company, its Affiliates, Sublicensees, distributors or agents with governmental authorities, physicians or other Third Parties relating to Licensed Products; or (vi) the grossly negligent or willful
misconduct of Company or its Affiliates, Sublicensees, Contract Manufacturers, distributors or agents or any of their respective officers, directors, managers, employees or agents; all except to the extent that such Losses are primarily caused by a
CyDex Indemnitee’s gross negligence or willful misconduct. 
 10.3 Expenses. As the parties intend complete
indemnification, all costs and expenses of enforcing any provision of this Section 10 shall also be reimbursed by the Indemnifying Party. 

  

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 10.4 Procedure. The party intending to claim indemnification under this
Section 10 (an “Indemnified Party”) shall promptly notify the other party (the “Indemnifying Party”) of any Claim in respect of which the Indemnified Party intends to claim such indemnification, and the
Indemnifying Party shall assume the defense thereof whether or not such Claim is rightfully brought; provided, however, that an Indemnified Party shall have the right to retain its own counsel, with the fees and expenses to be paid by the
Indemnified Party, unless Indemnifying Party does not assume the defense, in which case the reasonable fees and expenses of counsel retained by the Indemnified Party shall be paid by the Indemnifying Party. The Indemnified Party, and its employees
and agents, shall cooperate fully with the Indemnifying Party and its legal representatives in the investigations of any Claim. Indemnifying Party shall not be liable for the indemnification of any Claim settled (or resolved by consent to the entry
of judgment) without the written consent of the Indemnifying Party. Also, if the Indemnifying Party shall control the defense of any such Claim, the Indemnifying Party shall have the right to settle such Claim; provided, that the Indemnifying
Party shall obtain the prior written consent (which shall not be unreasonably withheld or delayed) of the Indemnified Party before entering into any settlement of (or resolving by consent to the entry of judgment upon) such Claim unless
(A) there is no finding or admission of any violation of law or any violation of the rights of any Person by an Indemnified Party, no requirement that the Indemnified Party admit fault or culpability, and no adverse effect on any other claims
that may be made by or against the Indemnified Party and (B) the sole relief provided is monetary damages that are paid in full by the Indemnifying Party and such settlement does not require the Indemnified Party to take (or refrain from
taking) any action. 
 Regardless of who controls the defense, the other party hereto shall reasonably cooperate in the defense as may be
requested. Without limitation, the Indemnified Party, and its directors, officers, advisers, agents and employees, shall cooperate fully with the Indemnifying Party and its legal representatives in the investigations of any Claim. 

11. LIMITATION OF LIABILITY. 
 EXCEPT FOR DAMAGES FOR WHICH A PARTY IS RESPONSIBLE
PURSUANT TO ITS INDEMNIFICATION OBLIGATIONS SET FORTH IN SECTION 10 OR
AS OTHERWISE EXPRESSLY STATED HEREIN (E.G., VIA AN EXPRESS REFERENCE
TO “INCIDENTAL” COSTS), EACH PARTY SPECIFICALLY DISCLAIMS ALL LIABILITY FOR
AND SHALL IN NO EVENT BE LIABLE FOR ANY INCIDENTAL, SPECIAL, INDIRECT
OR CONSEQUENTIAL DAMAGES, EXPENSES, LOST PROFITS, LOST SAVINGS, INTERRUPTIONS OF
BUSINESS OR OTHER DAMAGES OF ANY KIND OR CHARACTER WHATSOEVER ARISING
OUT OF OR RELATED TO THIS AGREEMENT OR RESULTING FROM THE
MANUFACTURE, HANDLING, MARKETING, SALE, DISTRIBUTION OR USE OF LICENSED PRODUCTS,
THE LICENSED PATENTS OR CAPTISOL DATA PACKAGE, REGARDLESS OF THE FORM
OF ACTION, WHETHER IN CONTRACT, TORT, STRICT LIABILITY OR OTHERWISE, EVEN
IF SUCH PARTY WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. SUBJECT
TO THE FOREGOING, EACH PARTY SHALL BE ENTITLED TO ALL REMEDIES
AVAILABLE TO IT IN CONTRACT LAW OR IN EQUITY (OTHER THAN REMEDIES
IN EQUITY WHICH REQUIRE THE PAYMENT OF MONEY). EXCEPT WITH RESPECT TO
THE INDEMNIFICATION SPECIFICALLY PROVIDED IN SECTION 10, A PARTY’S RECALL
OBLIGATIONS UNDER SECTION 3.9 OF THE SUPPLY AGREEMENT, A BREACH OF
SECTION 2.7 OR CLAIMS FOR NON-PAYMENT OF MILESTONES OR ROYALTIES DUE
HEREUNDER, IN NO EVENT SHALL A PARTY’S TOTAL AGGREGATE LIABILITY
FOR ALL CLAIMS ARISING OUT OF OR RELATED TO THIS AGREEMENT EXCEED
THE AMOUNTS PAID BY COMPANY TO CYDEX PURSUANT TO SECTION 4
OF THIS AGREEMENT DURING THE 12 MONTH PERIOD IMMEDIATELY PRECEDING THE EVENT
GIVING RISE TO LIABILITY. NO ACTION, REGARDLESS OF FORM, ARISING OUT
OF 

  
 21 

 
OR RELATED TO THIS AGREEMENT MAY BE BROUGHT BY
EITHER PARTY MORE THAN TWO YEARS AFTER SUCH PARTY HAS KNOWLEDGE OF
THE OCCURRENCE THAT GAVE RISE TO THE CAUSE OF ACTION OR AFTER
EXPIRATION OF THE APPLICABLE STATUTORY LIMITATIONS PERIOD, WHICHEVER IS SOONER. 

12. MANAGEMENT OF INTELLECTUAL PROPERTY. 

12.1 Ownership. 
 (a) Existing and Acquired Rights. Each party shall maintain its ownership and other rights with respect to intellectual property owned or controlled by such party before the Effective Date. Each
party shall own any intellectual property acquired by such party outside of this Agreement after the Effective Date. 
 (b)
New Rights. The ownership of discoveries, inventions, improvements and other technology, whether or not patentable, made by Company’s and/or CyDex’s personnel and related to the subject matter of this Agreement (but expressly excluding
Company IP) (“New Rights”) shall be determined in accordance with US patent law and state intellectual-property law, as applicable. 
 (c) Company IP. Notwithstanding anything to the contrary in this Agreement, any technology or improvement, whether or not patentable, that claims the Compound or the Compound with Captisol (but
excluding any claims to Captisol alone), shall be owned solely by Company (collectively, “Company IP”). If such Company IP was developed under the Agreement solely by or jointly with CyDex, its Affiliates, or their employees or
contractors, CyDex hereby assigns and will assign and cause such Affiliates, employees or contractors to assign all rights in such Company IP to Company or its designated Affiliate. 

12.2 Prosecution and Maintenance. 
 (a) Existing Rights (Licensed Patents). During the Term CyDex shall use commercially reasonable efforts to prosecute and maintain, at its sole cost and expense, the Licensed Patents. CyDex shall
have the sole right to control the prosecution and maintenance of patent applications and the selection of countries where patent applications are filed related to the Licensed Patents, subject to the following sentence. In the event that CyDex
decides not to prosecute and maintain the Licensed Patents in a country in the Territory, CyDex shall provide not less than 30 days’ prior written notice of such decision to Company, and Company shall have the right, but not the obligation, to
take over such prosecution and maintenance in such country on CyDex’s behalf at Company’s sole and unreimbursable expense. Each party shall reasonably cooperate with the prosecuting party in connection with its prosecution and maintenance
activities at the prosecuting party’s request and expense, including by making scientists and scientific records reasonably available to the prosecuting party. 
 (b) New Rights. The parties shall cooperate to take whatever, if any, action they mutually agree upon in writing and in their respective discretion to prosecute patent applications and maintain
patents covering rights which are jointly owned in accordance with Section 12.1(b). Such agreement shall include actions to be taken by each party and the allocation of expenses related to such action. Neither party shall seek patent
protection covering such rights without such agreement. 

  
 22 

 (c) For the avoidance of doubt, subject to Sections 12.2(a) and (b) each
party shall be solely responsible for all decisions and actions pertaining to the prosecution and maintenance of patents owned solely by such party. 
 12.3 Infringement by Third Parties. 
 (a) Each party shall promptly
notify the other party in writing of any actual or threatened infringement, misappropriation or other violation by a Third Party of any Licensed Patents in the Field and in the Territory (“Third Party Infringement”) of which it
becomes aware. 
 (b) Existing Rights. CyDex shall have the initial right (but not the obligation), at its own expense,
to initiate and control any action to enforce the Licensed Patents against any Third Party Infringement and may name Company as a party plaintiff solely to the extent required to maintain standing, providing CyDex shall reimburse Company for any
such costs incurred by Company therefor. If CyDex does not obtain agreement from the alleged infringer to desist or fails to initiate an infringement action within: (i) 60 days following receipt of notice of the alleged infringement (120 days
if CyDex is in active negotiations with such infringer), or (ii) 30 days before the expiration date for filing such actions, whichever comes first, Company shall have the right, at its sole discretion, to initiate and control an action to
enforce the Licensed Patents against such Third Party Infringement at its sole expense and may name CyDex as a party plaintiff solely to the extent required to maintain standing; provided, however, Company shall reimburse CyDex for any costs
incurred by CyDex therefor, provided, further, Company shall not enforce any Licensed Patents to the extent such Third Party Infringement is unrelated to the development, filing for regulatory approval for, manufacture, offer for sale, sale,
import or use of a Competing Product. Before commencing an action, the party bringing such action (the “Enforcing Party”) shall consult with the other party and give consideration to the other party’s recommendations regarding
the proposed action. The Enforcing Party shall give the other party timely notice of any proposed settlement of any such action instituted by the Enforcing Party and shall not, without the prior written consent of the other party, enter into any
settlement. Notwithstanding the foregoing, if CyDex is the Enforcing Party and such Third Party Infringement is unrelated to a Competing Product or Company is the Enforcing Party (and thus by default such Third Party Infringement is related to a
Competing Product), then in either such case the Enforcing Party shall not be required to obtain the other party’s prior written consent to settle an action so long as such settlement does not: (i) adversely affect the validity,
enforceability or scope of any of the Licensed Patents, (ii) give rise to liability of the other party or its Affiliates, (iii) admit non-infringement of any Licensed Patents, or (iv) otherwise impair the other party’s rights in
any Licensed Patents or under this Agreement. Any recoveries resulting from an action relating to a claim of Third Party Infringement of the Licensed Patents (including any recoveries resulting from settlement) shall first be applied against payment
of each party’s costs and expenses incurred in connection therewith. If CyDex was the Enforcing Party, then any remaining recoveries shall be retained by CyDex, provided that if such Third Party Infringement is related to the development,
filing for regulatory approval for, manufacture, offer for sale, sale, import or use of a Competing Product, then any remaining recoveries shall be split such that CyDex retains [***] and Company retains [***] of such remainder. If Company was the
Enforcing Party, then any remaining recoveries shall be retained solely by Company but shall be treated as Net Sales for purposes of determining royalties under Section 4.1(c). 

(c) New Rights. The parties shall cooperate to take whatever, if any, action they mutually agree upon in writing and in their
respective discretion against the alleged infringer of New 

  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 

  
 23 

 
Rights which are jointly owned in accordance with Section 12.1(b). Such agreement shall include actions to be taken by each party and the allocation of expenses and recoveries related
to such action. Neither party shall take any such action against the alleged infringer without the written consent of the other party. 
 (d) For the avoidance of doubt, subject to Sections 12.3(a), (b) and (c), each party shall be solely responsible for all decisions and actions pertaining to the enforcement of patents
owned solely by such party. 
 13. TERM AND TERMINATION. 

13.1 Term. The term of this Agreement (the “Term”) shall commence on the Effective Date and shall continue in
effect thereafter on a country-by-country basis until the later of (i) the fifth anniversary of the First Commercial Sale of a Licensed Product in the Territory (and irrespective of whether such First Commercial Sale occurred in the applicable
country or another country in the Territory) or (ii) the date that there no longer exists any Valid Claim in the applicable country. 
 13.2 Termination by Company for Convenience. 
 (a) Company may
terminate this Agreement, in its entirety, for convenience at its election, upon 90 days’ prior express written notice to CyDex. If the Agreement is terminated by Company pursuant to this Section 13.2(a), within 30 days after such
termination, Company shall pay to CyDex all payments owing at the date of termination. 
 (b) Company may terminate this
Agreement, solely with respect to any country(ies) in the Territory in which Generic Captisol is being manufactured or sold on a commercial basis, at its election, upon [***] prior express written notice to CyDex. If the Agreement is terminated by
Company with respect to any such country(ies) pursuant to this Section 13.2(b), within 30 days after such termination, Company shall pay to CyDex all royalty payments owing at the date of termination with respect to prior Net Sales in
such country. 
 13.3 Termination for Breach. If either party should violate or fail to perform any material term or
covenant of this Agreement, then the other party may give written notice of such default to such party. If such party should fail to cure such default within 60 days (or 10 days with respect to any payment obligation) after such notice, the other
party shall have the right to terminate this Agreement by a second written notice (a “Notice of Termination”) to such party. If Notice of Termination is sent to such party, this Agreement shall automatically terminate on the
effective date of such notice. In the event of a material breach by CyDex, if CyDex fails to cure such default within the applicable cure period under this Section 13.3 Company may elect to either (i) terminate this Agreement in
accordance with the provisions set forth in this Section 13.3 or (ii) without limiting any other legal or equitable remedies that Company may have, continue this Agreement in full force and effect, but with the milestones and
royalties otherwise due hereunder to be reduced by an amount to be mutually agreed upon by the parties. 
 13.4 Termination
for Bankruptcy. Either party may terminate this Agreement immediately upon written notice to the other party in the event that the other party has a petition in bankruptcy filed against it that is not dismissed within 60 days of such filing,
files a petition in bankruptcy, or makes an assignment for the benefit of creditors. 

  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 

  
 24 

 13.5 Termination of the Supply Agreement. If the Supply Agreement is terminated by
CyDex pursuant to Section 13.2 thereof for Company’s material breach of the Supply Agreement, then CyDex shall have the right to terminate this Agreement upon written notice to Company. If the Supply Agreement is terminated in accordance
with its terms (except for by CyDex for Company’s material breach), Company shall have the right to terminate this Agreement upon written notice to CyDex. 
 13.6 Effect of Termination. 
 (a) Following the termination by
Company under Section 13.2 or by CyDex for Company’s breach under Section 13.3, all rights granted to Company herein shall immediately terminate and each party shall promptly return all relevant records and materials in
its possession or control containing the other party’s Confidential Information with respect to which the former party does not retain rights hereunder; provided, however, that each party may retain one archival copy of such records and
materials solely to be able to monitor its obligations that survive under this Agreement. 
 (b) Upon the natural
expiration of the Term as to a country, the licenses granted in Section 2.1 shall become perpetual, fully paid-up and royalty-free as to such country. 
 (c) Upon any early termination of this Agreement and until the first anniversary of such early termination, Company shall have the right to sell its remaining inventory of Licensed Products so long
as Company has fully paid, and continues to fully pay when due, any and all payments owed to CyDex, and provides royalty reports as called for hereunder, and Company otherwise is not in continuing material breach of this Agreement. 

13.7 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. Such termination or expiration shall not relieve either party from obligations that are expressly indicated
or obviously intended to survive termination or expiration of this Agreement, nor shall any termination or expiration of this Agreement relieve Company of its obligation to pay CyDex, subject to the terms herein, (i) royalties for all Licensed
Products sold by Company, its Affiliates or Sublicensees before the effective date of such expiration or termination (or pursuant to Section 13.6(c)), or (ii) sums due in respect of Captisol shipped before termination or expiration
of this Agreement. Sections 2.2 (Grant of License from Company to CyDex), 4.2 (Taxes), 4.3 (Late Payments), 5 (Records; Reports; Audit), 6.2(d) (Reporting and Study Data), 6.4 (Access to Company’s
Data), 7.3 (Adverse Event Reporting), 8 (Confidentiality), 9.3 (Disclaimer), 10 (Indemnification), 11 (Limitation of Liability), 12 (Management of Intellectual Property), 13 (Term and Termination),
and 14 (General Provisions) shall survive termination or expiration of this Agreement. 
 14. GENERAL
PROVISIONS. 
 14.1 Relationship of Parties. Each of the parties hereto is an independent contractor
and nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee or joint venture relationship between the parties. No party shall have the right to, and each party agrees not to purport to, incur
any debts or make any commitments or contracts for the other. During the Term of this Agreement and for a period of one year thereafter, Company shall 

  
 25 

 
not solicit, induce, encourage or attempt to induce or encourage any employee of CyDex to terminate his or her employment with CyDex or to breach any other obligation to CyDex; provided,
that this sentence is not meant to encompass general solicitations such as may be found in newspaper advertisements and the like. 
 14.2 Compliance with Law. Company agrees that use of the Licensed Patents, Captisol and Captisol Data Package by it and its Affiliates and Sublicensees, and the manufacture, handling, marketing,
sale, distribution and use of Licensed Products, shall comply with all applicable international, federal, state and local laws, rules and regulations, including, but not limited to, import/export restrictions, laws, rules and regulations governing
use and patent, copyright and trade secret protection. CyDex agrees that its manufacture, handling, marketing, sale, distribution and use of Captisol hereunder shall comply with all applicable international, federal, state and local laws, rules and
regulations, including, but not limited to, import/export restrictions, laws, rules and regulations governing use and patent, copyright and trade secret protection. 
 14.3 Arbitration. 
 (a) Procedure. Any and all disputes or
controversies arising out of or relating to this Agreement shall be exclusively and finally resolved by binding arbitration in accordance with the commercial arbitration rules of the American Arbitration Association then in effect, in San Diego,
California. The arbitration shall be conducted by an arbitrator reasonably knowledgeable about the pharmaceutical industry and acceptable to CyDex and Company. If CyDex and Company cannot agree on a single arbitrator within 30 days after a demand
for arbitration has been made, CyDex shall appoint an arbitrator, Company shall appoint an arbitrator, the two (2) arbitrators shall appoint a third arbitrator, and the three arbitrators shall hear and decide the issue in controversy. If either
party fails to appoint an arbitrator within 45 days after service of the demand for arbitration, then the arbitrator appointed by the other party shall arbitrate any controversy in accordance with this Section 14.3(a). Except as to the
selection of arbitrators, the arbitration proceedings shall be conducted promptly and in accordance with the rules of the American Arbitration Association then in effect. The expenses of any arbitration, including the reasonable attorney fees of the
prevailing party, shall be borne by the party deemed to be at fault or on a pro-rata basis should the arbitration conclude in a finding of mutual fault. 
 (b) Confidentiality of Proceedings. All arbitration proceedings hereunder shall be confidential and the arbitrator(s) shall issue appropriate protective orders to safeguard each party’s
Confidential Information. Except as required by law, no party shall make (or instruct the arbitrator(s) to make) any public announcement with respect to the proceedings or decision of the arbitrator(s) without prior written consent of the other
party. 
 (c) Interim Equitable Relief. Each party shall, in addition to all other remedies accorded by law (or in
equity) and permitted by this Agreement, be entitled to equitable relief (including but not limited to interim injunctive relief) in any court having jurisdiction to protect its interests. Neither party shall commence any court proceeding or action
against the other to resolve any dispute, except (i) to enforce an arbitral award rendered pursuant to this Section 14.3, or (ii) for such interim injunctive relief. 

(d) Binding Effect. The provisions of this Section 14.3 shall survive any expiration or termination of this Agreement,
and shall be severable and binding on the parties hereto, 

  
 26 

 
notwithstanding that any other provision of this Agreement may be held or declared to be invalid, illegal or unenforceable. 

14.4 Costs and Expenses. Except as otherwise expressly provided in this Agreement, each party shall bear all costs and expenses
associated with the performance of such party’s obligations under this Agreement. 
 14.5 Further Assurances. The
parties hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge and deliver any and all such other documents and take any such other action as may be reasonably necessary or appropriate to carry out the
intent and purposes of this Agreement. 
 14.6 Force Majeure. Neither party shall be liable for failure to perform, or
delay in the performance of, its obligations under this Agreement (other than payment obligations) when such failure or delay is caused by an event of force majeure. For purposes of this Agreement, an event of force majeure means any
event or circumstance beyond the reasonable control of the affected party and not reasonably preventable using industry standard practices, including but not limited to, war, insurrection, riot, fire, flood or other unusual weather condition,
explosion, act of God, peril of the sea, sabotage, accident, embargo, act of governmental authority, compliance with governmental order on national defense requirements, or inability due to general industry wide shortages to obtain fuel, power, raw
materials, labor or transportation facilities. If, due to any event of force majeure, either party shall be unable to fulfill its obligations under this Agreement (other than payment obligations), the affected party shall immediately notify
the other party of such inability and of the period during which such inability is expected to continue, shall use commercially reasonable efforts to cure and remedy such non-performance and the time for performance shall be extended for a number of
days equal to the duration of the force majeure, and the parties shall meet promptly to determine an equitable solution to the effects of such event. If any event of force majeure continues in effect for a period of 90 days or more,
the party who is not claiming excuse from performance under such force majeure may terminate this Agreement by giving not less than 30 days’ notice to the other party on a country-by-country basis. 

14.7 Notices. Any notice, request, or communication under this Agreement shall be effective only if it is in writing and
personally delivered; sent by certified mail, postage pre-paid; or sent by nationally recognized overnight courier with signature required, addressed to the parties at the addresses stated below or such other persons and/or addresses as shall be
furnished in writing by any party in accordance with this Section 14.7. Unless otherwise provided, all notices shall be sent: 
  

			
	 If to CyDex, to:
  

CyDex Pharmaceuticals, Inc.
 c/o Ligand
Pharmaceuticals Incorporated
 11119 North Torrey Pines Road, Suite 200
 La Jolla, CA 92037
 Attention: President
	  	 If to Company, to:
  

MEI Pharma, Inc.
 11975 El Camino Real, Suite
101
 San Diego, CA 92130
 Attention:
Chief Executive Officer

  
 27 

	
	 With a copy to:
  

Ligand Pharmaceuticals Incorporated
 11119 North
Torrey Pines Road, Suite 200
 La Jolla, CA 92037
 Attention: General Counsel

 If sent by overnight courier, the next business day after the date of deposit with such courier shall be deemed to be the
date on which such notice, request or communication was given. If sent by certified mail, the third business day after the date of mailing shall be deemed the date on which such notice, request or communication was given. 

14.8 Use of Name. Neither party shall have any right, express or implied, to use in any manner the name or other designation of
the other party or any other trade name or trademark of the other party for any purpose, except as may be required by applicable law or regulation or with the written approval of the other party, such approval not to be unreasonably withheld.

 14.9 Public Announcements. No party shall use the name, trademark, trade name or logo of the other party, its
Affiliates or their respective employee(s) in any publicity, promotion, news release or public disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other party, such permission not to be
unreasonably withheld, except as may be required by law or required by the rules of an applicable US national securities exchange or as permitted by Section 14.8. The parties agree that a party may disclose this Agreement and its terms,
and material developments or material information generated under this Agreement, in (i) securities filings with the SEC (or equivalent foreign agency), or taxing authorities, to the extent required by law after complying with the procedure set
forth in this Section 14.9, or (ii) under conditions of confidentiality/nonuse in connection with investment and similar corporate transactions. 
 14.10 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of California (without giving effect to any conflicts of law principles that require
the application of the law of a different state). 
 14.11 Entire Agreement; Amendment. This Agreement and the Supply
Agreement and all Exhibits attached hereto or thereto contain the entire agreement of the parties relating to the subject matter hereof and thereof and supersede any and all prior or contemporaneous agreements, written or oral, between CyDex and
Company relating to the subject matter hereof and thereof, including without limitation the Limited Clinical Use Agreement between the parties dated November 11, 2010, as amended October 4, 2011. Without limiting the foregoing, CyDex
hereby acknowledges and agrees that Company owes no further payments under such prior agreements and to the extent there are any invoices that have yet to be paid or issued under such prior agreements, CyDex hereby releases Company and waives its
rights to any such payments or amounts owed. Subject to the foregoing, neither party shall be relieved from any liability for any past breach of any such prior written agreements, for any strict liability claims or tort
claims or from any indemnification obligation thereunder. In addition, any confidential information which was disclosed under such prior agreements shall remain confidential and shall be subject to the nondisclosure and nonuse provisions set
forth in Section 8 of this Agreement. This Agreement may not be amended unless agreed to in writing by both parties. 

  
 28 

 14.12 Binding Effect. This Agreement shall be binding upon, and the rights and
obligations hereof shall apply to CyDex and Company and any successor(s) and permitted assigns. The name of a party appearing herein shall be deemed to include the names of such party’s successors and permitted assigns to the extent necessary
to carry out the intent of this Agreement. 
 14.13 Waiver. The rights of either party under this Agreement may be
exercised from time to time, singularly or in combination, and the exercise of one or more such rights shall not be deemed to be a waiver of any one or more of the others. No waiver of any breach of a term, provision or condition of this Agreement
shall be deemed to have been made by either party unless such waiver is addressed in writing and signed by an authorized representative of that party. The failure of either party to insist upon the strict performance of any of the terms, provisions
or conditions of this Agreement, or to exercise any option contained in this Agreement, shall not be construed as a waiver or relinquishment for the future of any such term, provision, condition or option or the waiver or relinquishment of any other
term, provision, condition or option. 
 14.14 Severability. If any provision of this Agreement is determined by a final
and binding court or arbitration judgment to be invalid, illegal or unenforceable to any extent, such provision shall not be not affected or impaired up to the limits of such invalidity, illegality or unenforceability; the validity, legality and
enforceability of the remaining provisions of this Agreement shall not be affected or impaired in any way; and the parties agree to negotiate in good faith to replace such invalid, illegal and unenforceable provision (or portion of provision) with a
valid, legal and enforceable provision that achieves, to the greatest lawful extent under this Agreement, the economic, business and other purposes of such invalid, illegal or unenforceable provision (or portion of provision). Subject to
Section 13.1, this Agreement shall not be terminated or invalidated by any future determination that any or all of the Licensed Patents have expired or been invalidated. 

14.15 Assignment. Neither party may assign its rights or delegate its obligations under this Agreement, in whole or in part, by
operation of law or otherwise, to any Third Party without the prior written consent of the other party, which consent shall not be unreasonably withheld. Notwithstanding the foregoing, either party may assign in whole or in part its rights and/or
delegate in whole or in part its obligations under this Agreement to an Affiliate or to any Third Party successors (including with respect to Company, Third Party successors to one or more Licensed Products), whether by way of merger, sale of assets
to which this Agreement relates, sale of stock or otherwise, without prior written consent. As a condition to any permitted assignment hereunder, the assignee must expressly assume (for the express benefit of the party hereto which is not the
assignor) the performance of the terms and obligations of this Agreement by such assignee. Furthermore, notwithstanding anything to the contrary herein, CyDex shall not (i) assign any of the Licensed Patents to an Affiliate or Third Party
without assigning this Agreement in its entirety to such Third Party and (ii) assign this Agreement to any Affiliate or Third Party without assigning the Licensed Patents. Any assignment not in accordance with this Section 14.15
shall be void. 
 14.16 Third Party Beneficiaries. Except for the rights of Indemnified Parties pursuant to
Section 10 hereof, and subject to Pfizer’s rights under Section 8.5 hereof, the terms and provisions of this Agreement are intended solely for the benefit of each party hereto and their respective successors or permitted
assigns and it is not the intention of the parties to confer third-party beneficiary rights upon any other person, including without limitation Sublicensees. The enforcement of any obligation of CyDex under this Agreement shall only be pursued by
Company or a Company Indemnitee, and not Sublicensees (unless otherwise a Company Indemnitee). 

  
 29 

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

14.18 Interpretation. The language used in this Agreement is the language chosen by the parties to express their mutual intent,
and no provision of this Agreement shall be interpreted for or against any party because that party or its attorney drafted the provision. 
 14.19 Headings. The descriptive headings of this Agreement are for convenience only, and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement.

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

[Remainder of this page left blank intentionally] 

  
 30 

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

			
	CYDEX PHARMACEUTICALS, INC.
		
	By:	 	/s/ Charles Berkman
	Name:	 	Charles Berkman
	Title:	 	VP and Secretry

  

			
	MEI PHARMA, INC.
		
	By:	 	/s/ Daniel P. Gold
	Name:	 	Daniel P. Gold
	Title:	 	President & Chief Executive Officer

  
 31 

 EXHIBIT A 
 LICENSED CAPTISOL PATENTS 
 PATENT FAMILY 2: CIP of 5,134,127 –
“Derivatives of Cyclodextrins Exhibiting Enhanced Aqueous Solubility and the Use Thereof” 
  

									
	 Country
	  	Filing Date	  	Serial No.	  	Patent No.	  	Expiration Date
	 PCT
	  	07/26/93	  	PCT/US93/06880	  	WO94/02518	  	
	 Australia
	  	07/26/93	  	47799/93	  	672814	  	07/26/13
	EPO	  	07/26/93	  	93918302.6	  	620828	  	07/26/13
	 Austria
	  	07/26/93	  	93918302.6	  	E 217325	  	07/26/13
	 Belgium
	  	07/26/93	  	93918302.6	  	620828	  	07/26/13
	 Denmark
	  	07/26/03	  	93918302.6	  	620828	  	07/31/13
	 Djibouti
	  	05/08/02	  	93918302.6	  	620828	  	05/08/22
	 France
	  	07/26/93	  	93918302.6	  	620828	  	07/31/13
	 Germany
	  	07/26/93	  	69331900	  	69331900	  	07/31/13
	 Great Britain (UK)
	  	05/17/02	  	93918302.6	  	620828	  	07/26/13
	 Greece
	  	07/26/93	  	93918302.6	  	3040489	  	07/26/13
	 Ireland
	  	07/26/03	  	93918302.6	  	620828	  	07/31/13
	 Italy
	  	07/26/03	  	93918302.6	  	620828	  	07/26/13
	 Luxembourg
	  	07/26/03	  	93918302.6	  	620828	  	07/26/13
	 Monaco
	  	07/26/03	  	93918302.6	  	620828	  	07/26/13
	 Netherlands
	  	07/26/03	  	93918302.6	  	620828	  	07/26/13
	 Portugal
	  	07/26/93	  	93918302.6	  	620828	  	07/26/13
	 Spain
	  	07/26/93	  	93918302.6	  	620828	  	07/26/13
	 Sweden
	  	07/26/93	  	93918302.6	  	620828	  	07/26/13
	 Switzerland
	  	07/26/93	  	93918302.6	  	620828	  	07/26/13
	 Korea
	  	03/23/94	  	94-700951	  	279111	  	07/26/13
	 Canada
	  	07/26/93	  	2,119,154	  	2,119,154	  	07/26/13
	 Japan
	  	07/26/93	  	6-504678	  	3393253	  	07/26/13
	 Russia
	  	07/26/93	  	94028890/04	  	2113442	  	07/26/13
	 Georgia
	  	03/17/95	  	691/01-95	  	1649	  	07/26/13
	 Armenia
	  	07/26/93	  	96237	  	822	  	07/22/13
	 Kyrgyzstan
	  	08/09/96	  	960481.1	  	333	  	05/10/16
	 Moldova
	  	08/08/96	  	960306/PCT	  	1813	  	07/26/13
	 Tajikistan
	  	07/26/93	  	96000377	  	275	  	07/26/13
	 Turkmenistan
	  	08/08/96	  	393	  	430	  	07/26/13
	 Uzbekistan
	  	09/15/94	  	IHAP9400808.2	  	5799	  	04/28/19

 PATENT FAMILY 3: “Solid Pharmaceutical Formulations Containing A Physical Mixture of Sulfoalkyl Ether
Cyclodextrin and a Therapeutic Agent” 
  

									
	 Country
	  	Serial No.	  	Filing Date	  	Patent No.	  	Expiration Date
	 United States
	  	08/851,006	  	5/5/1997	  	5874418	  	5/5/2017
	 Australia
	  	71535/98	  	4/20/1998	  	729671	  	4/20/2018
	 Austria
	  	98918648.1	  	4/20/1998	  	980262	  	4/20/2018
	 Belgium
	  	98918648.1	  	4/20/1998	  	980262	  	4/20/2018
	 Canada
	  	2,289,202	  	4/20/1998	  	2289202	  	4/20/2018
	 European Union
	  	98918648.1	  	4/20/1998	  	980262	  	4/20/2018
	 France
	  	98918648.1	  	4/20/1998	  	980262	  	4/20/2018
	 Germany
	  	980262	  	4/20/1998	  	69812343.3-08	  	4/20/2018
	 Greece
	  	302627	  	4/20/1998	  	980262	  	4/20/2018
	 Italy
	  	21811BE/2003	  	4/20/1998	  	980262	  	4/20/2018
	 Japan
	  	548136/98	  	4/20/1998	  	3,745,382	  	4/20/2018
	 Korea
	  	10-1999-7010182	  	4/20/1998	  	378031	  	4/20/2018
	 Luxembourg
	  	98918648.1	  	4/20/1998	  	980262	  	4/20/2018
	 Netherlands
	  	98918648.1	  	4/20/1998	  	980262	  	4/20/2018
	 Russian Federation
	  	99125610	  	4/20/1998	  	2173172	  	4/20/2018
	 Spain
	  	98918648.1	  	4/20/1998	  	980262	  	4/20/2018
	 Sweden
	  	98918648.1	  	4/20/1998	  	980262	  	4/20/2018
	 Switzerland
	  	98918648.1	  	4/20/1998	  	980262	  	4/20/2018
	 United Kingdom
	  	98918648.1	  	4/20/1998	  	980262	  	4/20/2018

  
 2 

 PATENT FAMILY 4 (CIP of US 5,874,418): “Sulfoalkyl Ether Cyclodextrin Based Controlled Release Solid
Pharmaceutical Formulations” 
  

									
	 Country
	  	Serial No.	  	Filing Date	  	Patent No.	  	Expiration Date
	 United States
	  	09/229,513	  	1/13/1999	  	6046177	  	5/5/2017
	 Australia
	  	25011/00	  	1/11/2000	  	758376	  	1/11/2020
	 Austria
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020
	 Belgium
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020
	 Canada
	  	2,360,236	  	1/11/2000	  	2360236	  	1/11/2020
	 China
	  	802747.1	  	1/11/2000	  	ZL 00802747.1	  	1/11/2020
	 European Union
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020
	 France
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020
	 Germany
	  	60036534.4-08	  	1/11/2000	  	1140960	  	1/11/2020
	 Greece
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020
	 Hong Kong
	  	3101970.9	  	3/18/2003	  	HK1049797	  	1/11/2020
	 India
	  	00241/MUMNP/2005	  	1/11/2000	  	211311	  	1/11/2020
	 Israel
	  	143900	  	1/11/2000	  	143900	  	1/11/2020
	 Italy
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020
	 Korea
	  	10-2005-7015530	  	1/11/2000	  	712941	  	1/11/2020
	 Mexico
	  	PA/a/2001/007122	  	1/11/2000	  	221504	  	1/11/2020
	 Netherlands
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020
	 New Zealand
	  	512692	  	1/11/2000	  	512692	  	1/11/2020
	 Portugal
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020
	 Russian Federation
	  	2001119270	  	1/11/2000	  	2233176	  	1/11/2020
	 Spain
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020
	 Switzerland
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020
	 United Kingdom
	  	903234.3	  	1/11/2000	  	1140960	  	1/11/2020

  
 3 

 PATENT FAMILY 5: “Polar Drugs or Prodrug Compositions with Extended Shelf-life Storage and a Method of
Making Thereof” 
  

									
	 Country
	  	                Serial No. 
               	  	Filing Date	  	Patent No.	  	Expiration Date
	 United States
	  	09/096,747	  	6/12/1998	  	6133248	  	6/12/2018
	 Australia
	  	80591/98	  	6/12/1998	  	750207	  	6/12/2018
	 Austria
	  	98928901.2	  	6/12/1998	  	E253941          	  	6/12/2018
	 Belgium
	  	98928901.2	  	6/12/1998	  	986403	  	6/12/2018
	 European Union
	  	98928901.2	  	6/12/1998	  	986403	  	6/12/2018
	 France
	  	98928901.2	  	6/12/1998	  	986403	  	6/12/2018
	 Germany
	  	69819721.6-08	  	6/12/1998	  	986403	  	6/12/2018
	 Italy
	  	98928901.2	  	6/12/1998	  	986403	  	6/12/2018
	 Japan
	  	502895/10	  	6/12/1998	  	4439596	  	6/12/2018
	 Netherlands
	  	98928901.2	  	6/12/1998	  	986403	  	6/12/2018
	 Portugal
	  	98928901.2	  	6/12/1998	  	986403	  	6/12/2018
	 Spain
	  	98928901.2	  	6/12/1998	  	986403	  	6/12/2018
	 Sweden
	  	98928901.2	  	6/12/1998	  	986403	  	6/12/2018
	 Switzerland
	  	98928901.2	  	6/12/1998	  	986403	  	6/12/2018
	 United Kingdom
	  	98928901.2	  	6/12/1998	  	986403	  	6/12/2018

 PATENT FAMILY 9: “Capsules Containing Aqueous Fill Compositions Stabilized with Derivatized Cyclodextrin”

  

									
	 Country
	  	                Serial No. 
               	  	Filing Date	  	Patent No.	  	Expiration Date
	 United States
	  	11/076,072	  	9/12/2003	  	7,829,114	  	9/12/2023
	 Australia
	  	275329/03	  	9/12/2003	  	2003275329	  	9/12/2023
	 China
	  	3825141.8	  	9/12/2003	  	Zl03825141.8	  	9/12/2023
	 India
	  	954/DELNP/2005	  	9/12/2003	  	233167	  	9/12/2023
	 Russian Federation
	  	2005110945	  	9/12/2003	  	2359698	  	9/12/2023

  
 4 

 PATENT FAMILY LICENSED FROM PFIZER: “Process for Making a
Cyclodextrin”1 

 

									
	 Country
	  	Serial No.	  	Filing Date	  	Patent No.	  	Expiration Date
	 United States
	  	09/106,983	  	6/29/1998	  	6153746	  	06/29/2018
	 Austria
	  	98304785.3	  	6/17/1998	  	E323110	  	06/17/2018
	 Belgium
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Brazil
	  	P19802331-4	  	7/1/1998	  	9802331-4	  	07/1/2018
	 Canada
	  	2241774	  	6/29/1998	  	2241774	  	06/29/2018
	 Cyprus
	  	98304785.3	  	6/17/1998	  	CY1104797	  	06/17/2018
	 European Union
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Finland
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 France
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Germany
	  	98304785.3	  	6/17/1998	  	69834154.6-08	  	06/17/2018
	 Great Britain
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Greece
	  	98304785.3	  	6/17/1998	  	3057304	  	06/17/2018
	 Ireland
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Italy
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Japan
	  	178831/98	  	6/25/1998	  	3272669	  	06/25/2018
	 Luxembourg
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Mexico
	  	985383	  	7/1/1998	  	213259	  	07/1/2018
	 Netherlands
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Portugal
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Spain
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Sweden
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018
	 Switzerland
	  	98304785.3	  	6/17/1998	  	889056	  	06/17/2018

  

	1 	 Sublicense to this patent family is non-exclusive 

  
 5 

 PATENT FAMILY 15: “Sulfoalkyl Ether Cyclodextrin Compositions and Methods of Preparation Thereof.”

  

									
	 Country
	  	Filing Date	  	Serial No.	  	Patent No.	  	Expiration Date
	 United States
	  	4/23/2008	  	12/108,228	  	8,049,003	  	12/19/2026
	 United States
	  	04/23/2008	  	12/363,719	  	7,629,331	  	10/26/2025
	 PCT
	  	10/26/2005	  	PCT/US2005/038933	  		  	
	 Australia
	  	10/26/2005	  	2005337613	  		  	
	EPO	  	10/26/2005	  	05856927.8	  	1945228	  	
	 Belgium
	  	05/26/2008	  	5856927.8-1216	  		  	
	 Denmark
	  	05/26/2008	  	5856927.8-1216	  		  	
	 Djibouti
	  	05/26/2008	  	5856927.8-1216	  		  	
	 France
	  	05/26/2008	  	5856927.8-1216	  		  	
	 Germany
	  	05/26/2008	  	5856927.8-1216	  		  	
	 Great Britain (UK)
	  	05/26/2008	  	5856927.8-1216	  		  	
	 Greece
	  	05/26/2008	  	5856927.8-1216	  		  	
	 Ireland
	  	05/26/2008	  	5856927.8-1216	  		  	
	 Italy
	  	05/26/2008	  	5856927.8-1216	  		  	
	 Luxembourg
	  	05/26/2008	  	5856927.8-1216	  		  	
	 EPO Divisional
	  	04/05/2011	  	11161125.7	  		  	
	 Brazil
	  	04/28/2008	  	PI0520654-5	  		  	
	 Canada
	  	04/28/2008	  	2632211	  		  	
	 China
	  	06/26/2008	  	200580052421.8	  		  	
	 Austria
	  	04/29/2008	  	337613/05	  		  	
	 India
	  	04/25/2008	  	3462/DELNP/2008	  		  	
	 Israel
	  	04/27/2008	  	191081	  		  	
	 Japan
	  	10/26/2005	  	537669/08	  		  	
	 Korea
	  	05/26/2008	  	10-2008-7012541	  		  	
	 Mexico
	  	04/25/2008	  	MX/a/2008/005397	  		  	
	 Russian Federation
	  	05/23/2008	  	2008120659	  		  	

  
 6 

 PATENT FAMILY 20: “Sulfoalkyl Ether Cyclodextrin Compositions.” 

 

									
	 Country
	  	Filing Date	  	Serial No.	  	Patent No.	  	Expiration Date
	 United States
	  	03/13/2009	  	12/404,174	  	7,635,773	  	03/13/2029
	 United States CON
	  	11/5/2009	  	12/613,103	  		  	
	 PCT
	  	4/28/2009	  	PCT/US09/02572	  		  	
	 Australia
	  	4/28/2009	  	2009241858	  		  	
	EPO	  	01/20/2010	  	09739150.2	  		  	
	 Austria
	  	01/20/2010	  	application	  		  	
	 Belgium
	  	01/20/2010	  	application	  		  	
	 France
	  	01/20/2010	  	application	  		  	
	 Germany
	  	01/20/2010	  	application	  		  	
	 Great Britain (UK)
	  	01/20/2010	  	application	  		  	
	 Greece
	  	01/20/2010	  	application	  		  	
	 Italy
	  	01/20/2010	  	application	  		  	
	 Luxembourg
	  	01/20/2010	  	application	  		  	
	 Netherlands
	  	01/20/2010	  	application	  		  	
	 Sweden
	  	01/20/2010	  	application	  		  	
	 Switzerland
	  	01/20/2010	  	application	  		  	
	 Canada
	  	04/13/2010	  	2702603	  		  	
	 China
	  	07/10/2010	  	application	  		  	
	 Japan
	  	03/16/2010	  	application	  		  	
	 Brazil
	  	05/13/2010	  	application	  		  	
	 Mexico
	  	05/03/2010	  	application	  		  	
	 Korea
	  	4/28/2009	  	102107026534	  		  	
	Eurasia	  	04/01/2010	  	application	  		  	
	 Turkmenistan
	  	04/01/2010	  	application	  		  	
	 Republic of Belarus
	  	04/01/2010	  	application	  		  	
	 Republic of Tajikistan
	  	04/01/2010	  	application	  		  	
	 Russia
	  	04/01/2010	  	application	  		  	
	 Azerbaijan Republic
	  	04/01/2010	  	application	  		  	
	 Republic of Kazakhstan
	  	04/01/2010	  	application	  		  	
	 Kyrgyzstan
	  	04/01/2010	  	application	  		  	
	 Republic of Armenia
	  	04/01/2010	  	application	  		  	
	 Republic of Moldova
	  	04/01/2010	  	application	  		  	

  
 7 

 PATENT FAMILY 13: “DPI Formulation Containing Sulfoalkyl Ether Cyclodextrin.” 

 

									
	 Country
	  	Filing Date	  	Serial No.	  	Patent No.	  	Expiration Date
	 PCT
	  	04/22/2005	  	PCT/US05/14010	  		  	
	 United States
	  	10/19/2006	  	11/550,976	  		  	
	 EPC
	  		  		  		  	
					
	 Designated States: Austria, Belgium, Bulgaria, Switzerland and Liechtenstein, Cyprus, Czech Republic, Germany, Denmark, Estonia,
Spain, Finland, France, United Kingdom, Greece, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Monaco, Netherlands, Poland, Portugal, Romania, Sweden, Slovakia, and Turkey
	  	10/17/2006	  	05743067.0-2112	  		  	
	 Australia DIV
	  	06/16/2010	  	202503/10	  		  	
	 Brazil
	  	10/23/2006	  	PI0510119-0	  		  	
	 China
	  	04/22/2005	  	200580021269	  		  	
	 Israel
	  	04/22/2005	  	178728	  		  	
	 Japan
	  	10/20/2006	  	509706/07	  		  	
	 Korea
	  	11/14/2006	  	10-2006-7023802	  		  	
	 Mexico
	  	10/23/2006	  	PA/a/2006/012240	  		  	
	 New Zealand
	  	11/23/2006	  	550593	  		  	

  
 8Supply Agreement

 Exhibit 10.2 
 CONFIDENTIAL 
 CERTAIN MATERIAL (INDICATED BY ASTERISKS) 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. 
 SUPPLY AGREEMENT 
 BETWEEN 

CYDEX PHARMACEUTICALS, INC. 
 AND 
 MEI PHARMA, INC. 

DATED: September 28, 2012 

 TABLE OF CONTENTS 

 

							
	 Section
	 	 Title
	  	Page	 
	1.	 	 DEFINITIONS
	  	 	1	  
			
	2.	 	 PURCHASE AND SUPPLY OF CAPTISOL
	  	 	3	  
			
	3.	 	 SUPPLY TERMS
	  	 	4	  
			
	4.	 	 COMPENSATION
	  	 	12	  
			
	5.	 	 REPRESENTATIONS AND WARRANTIES
	  	 	13	  
			
	6.	 	 TERM AND TERMINATION
	  	 	14	  
			
	7.	 	 GENERAL PROVISIONS
	  	 	15	  

 TABLE OF EXHIBITS 

 

							
	 Exhibit
	 	 Title
	  	Page	 
	A.	 	 PURCHASE PRICES FOR CAPTISOL
	  	 	A-1	  
			
	B.	 	 SPECIFICATIONS
	  	 	B-1	  

  
 i 

 SUPPLY AGREEMENT 

THIS SUPPLY AGREEMENT (this “Agreement”) is made this
28th day of September, 2012 (the “Effective Date”) between: 
 CYDEX
PHARMACEUTICALS, INC., a Delaware corporation, with offices at 11119 North Torrey Pines Road, Suite 200, La Jolla, California 92037) (“CyDex”); and 

MEI PHARMA, INC., a Delaware corporation, with offices at 11975 El Camino Real, Suite 101, San Diego,
California 92130 (“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®, a drug formulation system designed to enhance the solubility and stability of drugs; 

WHEREAS, CyDex desires to supply and Company desires to purchase Captisol from CyDex, under the terms and
conditions set forth herein; and 
 WHEREAS, CyDex and Company are contemporaneously
entering into a License Agreement (the “License Agreement”); 
 NOW, Therefore, in
consideration of the following mutual promises and other good and valuable consideration, the receipt and sufficiency of which are acknowledged, the parties, intending to be legally bound, agree as follows: 

1. DEFINITIONS. 
 For the purposes of this Agreement, the following definitions shall apply: 
 “Captisol” means sulfobutylether ß(beta) cyclodextrin, sodium salt. CyDex supplies such material under the Captisol® brand, manufactured in accordance with the Specifications and the applicable DMF. 
 “Clinical Grade Captisol” means Captisol which (i) has been manufactured under GMP conditions, (ii) is intended for use in humans, and (iii) is intended for clinical trials
for the Licensed Products. 
 “Commercial Grade Captisol” means Captisol which (i) has been manufactured
under GMP conditions, (ii) is intended for use in humans, and (iii) is intended for commercial sale of the Licensed Products. 
 “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 3.1. 
 “Generic Captisol” [***] 

“Generic Supplier” [***] 
 “GMP” means manufactured under conditions of current good manufacturing practices for bulk excipients 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 not less than the longer of
(i) four years or (ii) the period that is 80% of the duration of stability reasonably confirmed by CyDex in the ordinary course of its stability testing program. 
 “Notice” shall have the meaning defined in Section 4.1. 
 “Notice of Termination” shall have the meaning defined in Section 6.2. 
 “Permitted Purchaser Requirements” means the requirements during the Term of all Permitted Purchasers for Captisol for sale or use in the Territory. 

“Permitted Purchasers” means, collectively: (i) Company; (ii) Affiliates of Company; (iii) Sublicensees
of Company; and (iv) all Contract Manufacturers for Company, Affiliates of Company and Sublicensees and assignees 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. 

“Significant Market Event” shall have the meaning defined in Section 3.2. 

“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. 
 “Supply Interruption” shall have the meaning
defined in Section 3.8(d). 
 “Term” shall have the meaning defined in Section 6.1.

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

  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 

  
 2 

 “Third-Party Manufacturer” shall have the meaning defined in
Section 2.3. 
 In addition, any capitalized terms not separately defined herein, including
“Affiliate”, “Claim”, “Compound”, “Confidential Information”, “Contract Manufacturer”, “DMF”, “FDA”, “IND”, “Licensed
Product”, “Major Market”, “NDA”, “Quality Agreement”, “Sublicensee”, “Territory”, “Third Party” and “Valid Claim” 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
so long as CyDex is not in breach of any material term under this Agreement, Company agrees that Company and the other Permitted Purchasers shall purchase and CyDex shall supply 100% of the Permitted Purchaser Requirements for Captisol during the
Term. Except as provided in Section 3.8(d), this Agreement and the License Agreement do not grant Company or any other Permitted Purchaser the right to manufacture (or have manufactured on their behalf) under Licensed Patents, Captisol,
without CyDex’s prior written consent except as otherwise set forth in this Agreement. 
 2.2 Supply Commitment.
CyDex agrees that CyDex shall produce (or have produced for it as set forth in Section 2.3), sell and deliver to Company and the other Permitted Purchasers 100% of the Permitted Purchaser Requirements, subject to the provisions of this
Agreement. CyDex shall only be required to sell Captisol pursuant to this Agreement. Company shall place orders for Captisol on behalf of itself and the other Permitted Purchasers, and shall guarantee payment to CyDex of all amounts payable with
respect thereto. 
 2.3 Third-Party Manufacturers. Without limiting CyDex’s responsibility under this Agreement,
CyDex shall have the right, subject to Section 3.10 and upon written notice to Company, to 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 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 warrant that such Captisol shall, at a
minimum, meet 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 referenced in Company’s IND or NDA. The parties hereby agree that The Hovione Group is a Third-Party Manufacturer as of the Effective Date of this Agreement. Unless otherwise instructed by CyDex, Company shall
reference The Hovione Group’s manufacturing processes, and no others, in Company’s INDs and NDAs in each country that the Supply Agreement has not been terminated, except (i) [***] or (ii) in the event CyDex notifies Company that
it is using a different Third Party Manufacturer. If CyDex decides to change or add a Third Party Manufacturer, or if the facilities of a Third Party Manufacturer used to supply Captisol are changed, CyDex shall use commercially reasonable efforts
to continue to supply Company from the original manufacturing site listed in the Company’s regulatory filings until Company has obtained any required amendment or other modification of the regulatory approvals for Licensed Products. 

  

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 2.4 Restrictions. Company covenants and agrees that: (i) all Captisol supplied
by CyDex pursuant to this Agreement shall be for use only in Licensed Products (except for testing, etc., required by Company, Permitted Purchasers and/or regulatory authorities, in relation to Licensed Products); (ii) Company shall obtain the
written agreement of each Permitted Purchaser to not resell Captisol as a standalone product and only use Captisol in accordance with (i) above; and (iii) [***] 
 3. SUPPLY TERMS. 
 3.1 Long-Term
Forecast. Company will use commercially 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 occurs and the next three 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. Following the six (6) month anniversary of the First Commercial Order Date, 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 for the next succeeding 12 month period, and with the same quantity and timing as had been forecasted (or deemed
to be forecasted) for the fourth quarter of the prior Detailed Forecast being repeated as the forecasted quantity and timing for the new Detailed Forecast’s fourth quarter. 

Notwithstanding the foregoing, if following the six (6) month anniversary of the First Commercial Order Date either (1) a
Generic Supplier enters the market, (2) a significant Licensed Product or Captisol has any significant efficacy or safety concerns, or (3) any regulatory approvals for Captisol and/or a significant Licensed Product are suspended or revoked
in a country in the Territory, and Company reasonably believes that such occurrence will have a significant effect upon its Detailed Forecasts (such occurrence, a “Significant Market Event”), then only Q1 of the Detailed Forecast
provided to CyDex immediately before such Significant Market Event shall be 

  

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 4 

 
firm and binding, while Q2, Q3 and Q4 shall not be binding and shall be provided for the sole purpose of planning. 
 3.3 Detailed Forecast Variances. Following the six (6) month anniversary of the First Commercial Order Date and absent a Significant Market Event, 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”): 

(i) for the Q1 covered by such updated Detailed Forecast, no change in excess of a 25% 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; 
 (ii) for the Q2 covered by such updated Detailed Forecast, no change in excess of a 50% 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 
 (iii) for the Q3 covered by such updated Detailed Forecast,
no change in excess of a 75% 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 the first calendar quarter of the 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 good faith efforts to fill such orders for such excess quantities from available supplies other than safety stock. If CyDex, despite the use of good faith efforts, is unable to supply such quantities
that exceed the Purchase Volume Limitations for Commercial Grade Captisol, such inability to supply shall not be deemed to be a breach of this Agreement by CyDex or a failure by CyDex to supply for any purpose. 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 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 Company 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 handwritten and expressly identified as being additional to or inconsistent
with this Section 3.4 and are signed by officers of both parties next to the handwriting. 

  
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 (b) Safety Stock. CyDex shall establish and maintain, solely for the benefit of the
Permitted Purchasers, a safety stock of Captisol equivalent to the amounts forecasted by Company in Q2 of each Detailed Forecast. 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. [***] 

3.6 Quality Control; Acceptance and Rejection. 
 (a) Quality Control. The Parties shall negotiate in good faith a mutually agreeable Quality Agreement. It is anticipated that the Quality Agreement would clearly describe audit rights and
procedures, 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, Specifications, all applicable laws and regulations,
including GMP and other CyDex-approved quality control testing procedures (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 each lot of Captisol therein signed by the responsible quality control official of CyDex. Such certificate must include the results (whether numerical or otherwise) for each test performed that
verifies that the Captisol is in compliance with the Specifications, as well as a statement that the subject lot was manufactured under conditions of GMP and in accordance with the appropriate DMF and all applicable laws and regulations. 

(b) Acceptance Testing. Company shall have a period of 30 days from the date of receipt to test or cause to be tested Captisol
supplied under this Agreement. 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 defective or not in compliance with the applicable purchase order (including any 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 30 day period describing the reasons for the rejection in reasonable detail. Once a delivery of Captisol is accepted or deemed accepted

  

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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. 
 (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 acceptance but was not discovered after a reasonable inspection or (ii) arose, before the first anniversary of actual or deemed
acceptance, by no fault of any Permitted Purchasers (each such Defect, a “Latent Defect”), it will 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 CyDex’s investigation and a final resolution of the claimed Latent Defect. In the event that such Captisol is found to contain a
Latent Defect, such Captisol will be deemed rejected as of the date of the notice, and the rights and obligations of the parties with respect to the rejected Captisol will thereafter be governed by the same process as governs acceptance testing set
forth below. 
 (d) Confirmation. After its receipt of a notice of rejection from Company pursuant to
Section 3.6(b) or (c) above, CyDex shall notify Company as soon as reasonably practical whether it accepts Company’s basis for rejection and Company shall cooperate with CyDex in determining whether such rejection was
necessary or justified. 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 submitted to an independent quality control laboratory
mutually agreed upon by the parties. The findings of such independent laboratory shall be binding upon the parties. The cost of the independent quality control laboratory shall be borne by the party whose results are shown by such laboratory to have
been incorrect. 
 (e) Return or Destruction of Rejected 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 material portion thereof is Defective. CyDex will indicate in its notice either that Company is authorized to destroy the rejected batch of
Captisol or that CyDex requires return of the rejected Captisol. Upon written authorization from CyDex to do so (which authorization shall be deemed an admission that the batch was properly rejected by Company), Company shall promptly destroy the
rejected batch of Captisol and provide CyDex with written certification of such destruction, or, if the request so states, Company shall promptly return the rejected batch of Captisol to CyDex. In each case, CyDex will reimburse Company for the
documented, reasonable costs associated with the destruction or return of the rejected Captisol. 
 (f) Independent
Testing. If there is a dispute as to whether any batch is Defective 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 rejected 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 will be deemed to be Defective and 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 pursuant to this Section 3.6. Notwithstanding the foregoing, Company shall be obligated to pay in full for any rejected shipment 

  
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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 in accordance with this Section 3.6, Company shall be entitled in addition to any other rights or remedies Company may have under this Agreement, upon confirmation that such
shipment or material portion thereof is Defective, at its election, either: (i) to a refund or credit equal to the purchase price, shipping, insurance and other incidental expenses paid with respect to such rejected shipment; or (ii) to
require CyDex to replace such rejected 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, 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, 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 commercially reasonable 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 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; provided, however, if a defect in Licensed Product is attributed to Defective Captisol, there are pending Licensed Product recall decisions, or significant regulatory actions, such
as warning letters, then a for-cause audit may be performed by Company upon shorter notice and as frequently as necessary. In addition, Company may, upon prior written notice which is reasonable as to timing and availability, request the ability to
conduct additional not for cause audits more frequently than once per year for purposes of due diligence by Company’s existing or prospective partners, Sublicensees, collaborators, acquirers or investors, provided that any such party would
assume for CyDex’s benefit similar obligations of confidentiality as those set forth in this Agreement. All costs and expenses associated with the conduct of such not for cause audit, to the extent occurring more frequently than once per year,
would be reimbursed by Company to CyDex. Company’s authorized representatives shall be accompanied by CyDex personnel at all times, shall be qualified to conduct such manufacturing audits, shall 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. 

  
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 (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 for a secondary site for the manufacture of Captisol utilizing the same DMF, Specifications and manufacturing processes as its initial
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 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 utilize the safety stock it was required to maintain pursuant to Section 3.4(b) solely for the benefit of the Permitted Purchasers, (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 the additional site discussed in Section 3.8(a) (if any such additional site has been established) for the supply of any shortfall amounts of Captisol and
(iv) take all reasonable steps necessary to minimize supply delays. 
 (d) Alternate Suppliers.  

(i) [***] 

  

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 (ii) [***] 
 3.9 Product Recalls. If any 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 (i) Company recalls any Licensed Product, or (ii) the FDA 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 the
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 including any
incidental expenses related thereto. 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 authorities, including updating and maintaining the DMF.

 (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. CyDex shall promptly furnish to Company copies of all reports or correspondence issued by such governmental authority related to the
Captisol in connection with such inquiry, notification or inspection and copies of any and all proposed responses or explanations relating to items set forth above. Before submission of any response or explanation to such governmental agency, CyDex
shall discuss with Company all such proposed responses or explanations and shall reasonably consider in good faith, in the preparation of final responses or explanations, all comments made by Company that reasonably relate to Captisol. 

  

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 (c) Except as set forth herein, CyDex may, after [***] prior written notice to Company, make
reasonable, non-material changes to the Specifications and/or the DMF and/or the manufacturing process for Captisol without Company’s prior written consent, provided such changes do not, in Company’s reasonable opinion (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 other Major Market regulatory agencies that would be beyond that required for the
Licensed Products formulated with Captisol meeting the unmodified Specifications, DMF and/or the 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, or (v) affect in any Major Market the regulatory status of any Licensed Product or any additional regulatory approvals. In the event of any permitted change to the
Specifications, the DMF or the manufacturing process for Captisol effected by CyDex under this Section 3.10(c), CyDex will nonetheless continue to provide Company with Captisol under the unmodified Specifications and manufacturing
process under the terms of this Agreement until the sooner of such time that Company has obtained any required approvals for the Specification change or the manufacturing process, as applicable, for Captisol by the FDA and other applicable
regulatory agencies, or the third anniversary of such permitted change to the Specifications. 
 (d) In addition, CyDex may,
after [***] prior written notice to Company, offer a different or improved Captisol product for use by third parties (or for use by Company if requested by Company in writing) which requires material changes (including changes not otherwise
permitted in subsection (c) above) to the Specifications for Captisol, the DMF for Captisol or the manufacturing process for Captisol, provided that CyDex will nonetheless continue to manufacture and provide to Company Captisol manufactured
under the unmodified Specifications, DMF and manufacturing processes for the duration of the Term or as long (but not longer than the duration of the Term) as so requested by Company. 

(e) During such [***] periods described in Sections 3.10(c) and 3.10(d) above, Company shall have the opportunity to
evaluate and comment upon the reasonableness of any proposed change to the Specifications or the manufacturing process for Captisol. CyDex shall use commercially reasonable efforts to cooperate with Company to, if necessary, have any change approved
by the FDA and other regulatory agencies having jurisdiction. 
 (f) In the event that the FDA or another applicable Major
Market regulatory agency 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 such other applicable Major Market regulatory agency; and in
the event that Company desires to make any non-mandatory changes to 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 such a change to the Specifications or the manufacturing process for Captisol. (In such a case, the lead-times specified in
Section 3.10(c) shall be inapplicable.) CyDex shall reimburse Company for any Captisol purchased hereunder which is rendered unusable by any change in Specifications or the manufacturing process for Captisol required by the FDA or such
other applicable Major Market regulatory agency. 
 (g) 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 a change in any of the Specifications or the manufacturing process for Captisol

  

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(other than a change required by the FDA or another applicable regulatory agency having jurisdiction), Company shall have the right 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 Orders of Clinical Grade Captisol. During Company’s clinical development of any Licensed Product, (a) Company or a
Permitted Purchaser shall 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, 3.6 and 3.8 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 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%). Notwithstanding the foregoing, in the event Generic Captisol is available by a Generic Supplier for use in a country in the Territory, Company may give CyDex
written notice of its desire to discuss modifying the purchase price with respect to any Captisol intended for use in Licensed Products in such country in order to make it competitive with a price being offered by a Generic Supplier
(“Notice”). This notice may be provided each time such Generic Supplier lowers the price of its Generic Captisol. Within 14 days after receipt of a Notice, the parties shall agree to a mutually acceptable time to discuss, consult
and negotiate with each other in good faith a revised supply price satisfactory to CyDex and Company for such quantities of Captisol in respect of such countries. If a revised purchase price satisfactory to Company is not reached within 30 days of
the day a Notice is received by CyDex, Company shall have the right to terminate its obligation to purchase exclusively from CyDex any quantities of Captisol intended for Licensed Products to be sold in such country in which Generic Captisol is
available. 
 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 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 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. 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. 

  
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 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 of Company’s receipt of such invoices. The purchase prices for Captisol specified in Exhibit A exclude
all applicable sales, use, and other taxes, and Company will 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. Unpaid and undisputed balances shall accrue interest, from due date until paid, at an annual interest rate equal to the prime rate, as reported in The Wall Street Journal, Eastern U.S. Edition, on the date such payment is due
(or the last previous publication date if such date is not a publication date), plus an additional 200 basis points (2%). 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 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 first anniversary of actual or deemed acceptance, be subject to any Latent Defects; 
 (b) 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; 
 (c) 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 regulatory authority required in connection with the
manufacture and supply of Captisol, except where the 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 and/or
(ii) Company and/or its ability to obtain Captisol and/or exploit Licensed Products; 
 (d) there are no actual or
threatened enforcement actions relating to the manufacture and/or supply of Captisol against CyDex or its Affiliates by the FDA or any other federal, state or foreign regulatory authority. Further, CyDex does not know of any actual or threatened
enforcement actions relating to the manufacture and/or supply of Captisol against any Third Party Manufacturers by the FDA or any other federal, state or foreign regulatory authority; and 

(e) CyDex shall notify Company promptly if it becomes aware of any material facts or circumstances occurring after the Effective Date
which it has reason to believe would have made the aforementioned representations and warranties untrue had they been given after the Effective Date. 
 5.2 Representations, Warranties. The provisions of Section 9.1 (Mutual Representations and Warranties) of the License Agreement are incorporated herein by reference as if

  
 13 

 
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 Disclaimer. The warranties set forth in this Section 5 are provided in lieu of, and each party hereby disclaims,
all other warranties, express and implied, relating to the subject matter of this agreement or Captisol, including but not limited to the implied warranties of merchantability, non-infringement and fitness for a particular purpose. CyDex’s
warranties under this Agreement are solely for the benefit of Company and may be asserted only by Company and not any Affiliate, Permitted Purchaser or other Third Party (other than a Company Indemnitee with respect to an indemnification claim).
Company shall be solely responsible for all representations and warranties that Company or its Affiliates make to any Permitted Purchaser. 

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 of the License Agreement in its entirety or (b) 90 days after Company provides written notice to CyDex of its intent to terminate this Agreement for convenience. In any event, termination for convenience shall have no
effect on outstanding purchase orders or Detailed Forecasts and the binding nature thereof. Notwithstanding the foregoing, Company shall have the right to terminate the Agreement with immediate effect in its entirety in the event a significant
Licensed Product or Captisol has any significant efficacy or safety concerns, or to terminate the Agreement with immediate effect on a country-by-country basis if any regulatory approvals for Captisol and/or a significant Licensed Product are
suspended or revoked in a country in the Territory, and Company reasonably believes that such occurrence will have a significant effect upon its Detailed Forecasts. In addition, if Company terminates the License Agreement as to any particular
country pursuant to Section 13.2(b) or Section 14.6 thereof or terminates this Agreement pursuant to the foregoing sentence as to any particular country, the definition of “Territory” for purposes of this Agreement
shall thereupon automatically and immediately be deemed amended to exclude such country, and CyDex shall have no further obligation to supply Captisol to Company for use or sale in such country. 

6.2 Termination for Breach. If either party should violate or fail to perform any term or covenant of this Agreement, then the
other party may give written notice of such default to the first party. If such party should fail to cure such default within 60 days (or 10 days with respect to any payment obligation) of the date of such notice, the other party shall have the
right to terminate this Agreement by a second written notice (a “Notice of Termination”) to the first party. If Notice of Termination is sent to such first party, this Agreement shall automatically terminate on the effective date of
such notice. 
 6.3 Termination for Bankruptcy. Either party may terminate this Agreement immediately upon written notice
to the other party in the event that the first party has a petition in bankruptcy filed against it that is not dismissed within 60 days of such filing, files a petition in bankruptcy or makes an assignment for the benefit of creditors. 

6.4 Effect of Termination. Upon the termination of this Agreement by CyDex under Section 6.2, (a) Company shall
no longer have any rights to purchase Captisol, 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 

  
 14 

 
hereunder; provided, however, that each party may retain one archival copy of such records and materials solely to be able to monitor its obligations that survive under this Agreement.
Upon the termination of this Agreement by Company under Section 6.2, (i) a permanent Supply Interruption will be deemed to have occurred and Section 3.8(d) shall survive in perpetuity, including CyDex’s obligations
under such subsection and Company’s right and license to manufacture and/or have manufactured Captisol. 
 6.5
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. Such termination or expiration shall not relieve either party from obligations that are expressly indicated to survive termination or expiration of this Agreement, nor shall any termination or expiration of this Agreement relieve
Company of its obligation to pay CyDex sums due in respect of Captisol shipped before termination or expiration of this Agreement. Sections 2.4 (Restrictions), 3.5 (Delivery), 3.6 (Quality Control; Acceptance and Rejection), 3.7
(Facilities and Inspections), 3.8(d) (Alternate Suppliers; to the extent set forth in Section 6.4), 3.9 (Product Recalls), 4.3 (Payments; Taxes), 5.2 (Representations, Warranties), 5.3 (Disclaimer), 6.4 (Effect of Termination), 6.5 (Survival)
and 7 (General Provisions) shall survive termination or expiration of this Agreement. 
 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), 7.2 (Material Safety), 7.3 (Adverse Event Reporting),
8 (Confidentiality), 10 (Indemnification), 11 (Limitation of Liability), 12 (Management of Intellectual Property), and 14 (General Provisions). 

[Remainder of this page left blank intentionally] 

  
 15 

 IN WITNESS WHEREOF, the parties have executed this Supply Agreement as of the
Effective Date. 
  

			
	CYDEX PHARMACEUTICALS, INC.
		
	By:	 	/s/ Charles Berkman
		 	  

	Name:	 	Charles Berkman
	Title:	 	VP and Secretary
	
	MEI PHARMA, INC.
		
	By:	 	/s/ Daniel P. Gold
		 	  

	Name:	 	Daniel P. Gold
	Title:	 	President & Chief Executive Officer

  
 16 

 EXHIBIT A 
 PURCHASE PRICES FOR CAPTISOL 
 [***] 

  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 

 A-1 

 EXHIBIT B: SPECIFICATIONS 

[***] 

  

	***	Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted
portions. 

 B-1

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