Document:

EX-10.28

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 
  

Exhibit 10.28 
 LICENSE
AGREEMENT 
 by and between 

Durect Corporation 
 and

 Santen Pharmaceutical Co., Ltd. 

Dated 

December 11, 2014 
  

 
  

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 TABLE OF CONTENTS 

 

							
	 	  	Page	 
	ARTICLE 1 DEFINITIONS	  	 	1	  
		
	ARTICLE 2 GOVERNANCE	  	 	10	  
	        2.1	 	Joint Development Committee	  	 	10	  
	        2.2	 	Meetings	  	 	11	  
	        2.3	 	Decision Making	  	 	11	  
	        2.4	 	Day-to-Day Responsibilities	  	 	11	  
		
	ARTICLE 3 LICENSES AND EXCLUSIVITY	  	 	12	  
	        3.1	 	License Grant	  	 	12	  
	        3.2	 	No Other Rights	  	 	13	  
	        3.3	 	[* * *]	  	 	13	  
	        3.4	 	[* * *]	  	 	13	  
		
	ARTICLE 4 DEVELOPMENT AND COMMERCIALIZATION OF PRODUCT	  	 	13	  
	        4.1	 	Know-How Transfer	  	 	13	  
	        4.2	 	Development	  	 	13	  
	        4.3	 	Commercialization	  	 	17	  
	        4.4	 	Regulatory Matters	  	 	18	  
	        4.5	 	Reporting	  	 	18	  
		
	ARTICLE 5 SUPPLY	  	 	18	  
	        5.1	 	Development Supply	  	 	18	  
	        5.2	 	Commercial Supply	  	 	20	  
	        5.3	 	Manufacture of Product by Santen or Third Party Supplier, Technology Transfer	  	 	20	  
		
	ARTICLE 6 PAYMENTS	  	 	21	  
	        6.1	 	Upfront License Fee	  	 	21	  
	        6.2	 	Milestone Payments	  	 	21	  
	        6.3	 	Royalty Payments	  	 	23	  
	        6.4	 	Payment Method	  	 	25	  
	        6.5	 	Taxes	  	 	25	  
	        6.6	 	Inspection of Records	  	 	26	  
	        6.7	 	Late Payment	  	 	26	  
	        6.8	 	Currency Conversion	  	 	26	  
		
	ARTICLE 7 INTELLECTUAL PROPERTY	  	 	27	  
	        7.1	 	General	  	 	27	  
	        7.2	 	Patent Prosecution	  	 	27	  

  
 -i- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

TABLE OF CONTENTS 

(Continued) 
  

							
		  	 	Page	  
	        7.3	 	Defense of Third Party Infringement Claims	  	19	 
	        7.4	 	Enforcement	  	 	20	  
	        7.5	 	Patent Marking	  	 	21	  
		
	ARTICLE 8 CONFIDENTIALITY	  	 	21	  
	        8.1	 	Confidentiality; Exceptions	  	 	21	  
	        8.2	 	Authorized Use and Disclosure	  	 	21	  
	        8.3	 	Prior Agreement	  	 	22	  
	        8.4	 	Scientific Publications	  	 	22	  
	        8.5	 	Publicity	  	 	23	  
		
	ARTICLE 9 REPRESENTATIONS, WARRANTIES AND COVENANTS; INDEMNIFICATION	  	 	24	  
	        9.1	 	Santen Representations and Warranties	  	 	24	  
	        9.2	 	Durect’s Warranties and Covenants	  	 	24	  
	        9.3	 	Disclaimer of Warranties	  	 	34	  
	        9.4	 	Indemnification	  	 	25	  
	        9.5	 	Insurance	  	 	25	  
	        9.6	 	LIMITATION OF LIABILITY	  	 	26	  
		
	ARTICLE 10 TERM AND TERMINATION	  	 	26	  
	        10.1	 	Term	  	 	26	  
	        10.2	 	Termination by Santen	  	 	26	  
	        10.3	 	Termination by Durect	  	 	27	  
	        10.4	 	Termination by either Party	  	 	27	  
	        10.5	 	General Effects of Expiration or Termination	  	 	27	  
	        10.6	 	Additional Effects of Certain Terminations due to cause by Santen	  	 	28	  
	        10.7	 	Additional Effects of Certain Terminations due to cause by Durect	  	 	28	  
	        10.8	 	Termination Press Releases	  	 	28	  
	        10.9	 	Additional Effects of Expiration of this Agreement	  	 	29	  
		
	ARTICLE 11 DISPUTE RESOLUTION	  	 	29	  
	        11.1	 	Disputes	  	 	29	  
	        11.2	 	Arbitration	  	 	29	  
	        11.3	 	Injunctive Relief	  	 	29	  
		
	ARTICLE 12 MISCELLANEOUS	  	30	 
	        12.1	 	Governing Law	  	 	30	  

  
 -ii- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

TABLE OF CONTENTS 

(Continued) 
  

							
	 	  	Page	 
	        12.2	 	Assignment	  	 	30	  
	        12.3	 	Consequences of Bankruptcy	  	 	30	  
	        12.4	 	Notices	  	 	31	  
	        12.5	 	Waiver	  	 	31	  
	        12.6	 	Severability	  	 	32	  
	        12.7	 	Entire Agreement/Modification	  	 	32	  
	        12.8	 	Relationship of the Parties	  	 	32	  
	        12.9	 	Force Majeure	  	 	32	  
	        12.10	 	Compliance with Laws/Other	  	 	32	  
	        12.11	 	Counterparts	  	 	33	  

  
 -iii- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 CONFIDENTIAL 

LICENSE AGREEMENT 
 This
LICENSE AGREEMENT (the “Agreement”) is effective as of December 11, 2014 (the “Effective Date”) by and between Durect Corporation, a Delaware company having offices located at 10260 Bubb Road, Cupertino,
CA 95014, U.S.A. (“Durect”) and Santen Pharmaceutical Co., Ltd., a Japanese corporation having offices located at 4-20 Ofukacho, Kita-ku, Osaka 530-8552, Japan (“Santen”). Santen and Durect are each referred
to herein by name or, individually, as a “Party” or, collectively, as “Parties.” 
 BACKGROUND 

A. The Parties are parties to that certain Feasibility Evaluation Agreement entered into as of [* * *] (as amended, the “Feasibility
Evaluation Agreement”) pursuant to which the Parties conducted certain feasibility studies with respect to the Existing Product (as defined below) and Durect granted to Santen certain option rights with respect thereto, all as set forth
therein. 
 B. Durect owns and controls rights in and to certain technologies and compositions related to and comprising its proprietary
injectable, non-polymeric, high viscosity liquid carrier known as the SABER® formulation platform technology. 

C. Santen desires to obtain a license to develop and commercialize Product (as defined below), and Durect desires to grant Santen such a
license, all on the terms and conditions set forth herein below. 
 NOW, THEREFORE, in consideration of the mutual covenants and agreements
provided herein below and other consideration, the receipt and sufficiency of which is hereby acknowledged, Santen and Durect hereby agree as follows: 

ARTICLE 1 

DEFINITIONS 
 The following
capitalized terms shall have the meanings given in this Article 1 when used in this Agreement: 
 1.1 “Accounting
Standards” shall mean (i) with respect to Durect and calculations to be performed by Durect, the generally accepted accounting principles of the United States, and (ii) with respect to Santen and calculations to be performed by
Santen, the generally accepted accounting principles in Japan or the International Financial Reporting Standards, in each case (i) and (ii) as consistently applied by such Party throughout its enterprise. 

1.2 “Acquiring Entity” shall mean a (i) Third Party that merges or consolidates with or acquires a Party, or to which a
Party transfers all or substantially all of its assets to which this Agreement pertains (any such transaction is referred to herein below as a “Subject Transaction”) and (ii) any Affiliate of such Third Party other than those
Persons which become Affiliates as a result of the Subject Transaction. 

  
 -1- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 1.3 “Active Ingredient” shall mean [* * *]. 

1.4 “Affiliate” shall mean with respect to either Party, any Person who is controlling, controlled by or under common control
with such Party, for so long as such control exists. For purposes of this Section 1.4 only, “control” shall mean (i) direct or indirect ownership of more than fifty percent (50%) (or, if fifty percent (50%) or less, the
maximum ownership interest permitted by Applicable Law) of the stock or shares having the right to vote for the election of directors of such corporate entity or (ii) the direct or indirect possession, of the power to direct, or cause the
direction of, the management or policies of such entity, whether through the ownership of voting securities, by contract or otherwise. 

1.5 “Annual Net Sales” shall mean, with respect to a particular Santen Fiscal Year, all Net Sales of Product for the Field in
the Territory during such Santen Fiscal Year. 
 1.6 “Applicable Laws” shall mean any and all laws, ordinances, orders,
rules, rulings, directives and regulations of any kind whatsoever of any governmental or regulatory authority within the applicable jurisdiction applicable to the Parties’ activities under this Agreement. 

1.7 “Business Day” shall mean any day other than a Saturday, Sunday or any other day on which commercial banks in New York,
New York, United States or Tokyo, Japan are authorized or required by law to remain closed. 
 1.8 “Commercialization”
shall mean, with respect to a product, any and all processes and activities conducted to establish and maintain sales for such product (including with respect to reimbursement and patient access), including offering for sale, detailing, selling
(including launch), marketing (including education and advertising activities), promoting, storing, transporting, distributing, and importing such product, but shall exclude Development of such product. For clarity, Commercialization shall (in the
case of Product hereunder, subject to Article 5) include the manufacture of a product in support of the foregoing processes and activities, in each case with respect to such product. “Commercialize” and “Commercializing”
shall have their correlative meanings. 
 1.9 “Commercially Reasonable Efforts” shall mean, with respect to a Party, the
efforts and resources normally applied by [* * *]. 
 1.10 “Competing Product” shall mean [* * *] 

1.11 “Control” shall mean, with respect to any particular Know-How or a particular Patent, possession by the Party granting
the applicable right, license or sublicense to the other Party as provided herein of the power and authority, whether arising by ownership, license, or other authorization, to disclose and deliver the particular Know-How or the particular Patent to
the other Party, and to grant and authorize under such Know-How or Patent the right, license or sublicense, as applicable, of the scope granted to such other Party in this Agreement without giving rise to any

  
 -2- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 
payment obligation to any Third Party or any violation of the terms of any written agreement with any Third Party. “Controlled” and “Controlling” shall have
their correlative meanings. Notwithstanding anything to the contrary in this Agreement, the following shall not be deemed to be Controlled by Durect for purposes of this Agreement:  

 

	 	(i)	[* * *]; and 

  

	 	(ii)	[* * *]. 

 1.12 “Cover” shall mean, with respect to any subject matter, the
manufacture, use, sale, offering for sale, importation, exportation or other exploitation of such subject matter would infringe a claim of a Patent at the time thereof. “Covered” or “Covering” shall have their correlative
meanings. 
 1.13 “Development” shall mean, with respect to a product, any and all processes and activities conducted to
obtain Marketing Approvals for such product, including preclinical testing, test method development and stability testing, toxicology, formulation, process development, quality assurance/control development, statistical analysis, clinical studies
(including trials for additional indications for a product for which a Marketing Approval has been obtained), quality of life assessments, pharmacoeconomics, post-marketing studies, label expansion studies, regulatory affairs, and further activities
relating to development or preparation of such product for Commercialization. For clarity, Development shall (in the case of Product hereunder, subject to Article 5) include the manufacture of any product in support of the foregoing processes
and activities, including, to the extent applicable, any packaging, labeling and other finishing activities, quality control and assurance testing, formulation development and other activities performed in support of CMC (chemistry, manufacturing
and controls, or equivalent) section of any MAA, in each case with respect to such product. “Develop” and “Developing” shall have their correlative meanings. 

1.14 “Drug Master File” shall mean, with respect to [* * *], any and all submission(s) to any Regulatory Authority that may
be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs to support regulatory filings including but not limited to an IND, NDA,
an export application, or amendments and supplements to any of these. 
 1.15 “Durect Costs” shall mean [* * *]. 

1.16 “Durect Technology” shall mean the Durect Know-How and Durect Patents. For avoidance of doubt, [* * *]. 

1.17 “Durect Know-How” shall mean [* * *]. 

1.18 “Durect Patents” shall mean [* * *]. 

1.19 “Existing Product” shall mean [* * *]. 

  
 -3- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 1.20 “FDA” shall mean the United States Food and Drug Administration, or any
successor agency thereto. 
 1.21 “Field” shall mean the treatment, mitigation or preventions of diseases, disorders or
conditions of the eye. 
 1.22 “Generic Product” shall mean, [* * *]. 

1.23 “IND” shall mean an Investigational New Drug Application, as described in the FDA regulations, 21 CFR §312.23,
including all amendments and supplements thereto, or similar applications (i.e., a filing that must be made prior to commencing clinical testing of a pharmaceutical product in human subjects) filed with a Regulatory Authority in any other
jurisdiction. 
 1.24 “Joint Patent” shall mean [* * *]. 

1.25 “Know-How” shall mean any and all information and materials, which is not generally known, comprising (i) ideas,
discoveries, inventions (including Patent and legal data or descriptions (to the extent that disclosure thereof would not result in loss or waiver of privilege or similar protection)), improvements or trade secrets, (ii) research and
development data, such as medicinal chemistry data, preclinical data, pharmacology data, chemistry data (including analytical, product characterization, manufacturing, and stability data), toxicology data, clinical data (including investigator
reports (both preliminary and final), statistical analyses, expert opinions and reports, safety and other electronic databases), analytical and quality control data and stability data, in each case together with supporting data,
(iii) databases, practices, methods, techniques, specifications, formulations, formulae, knowledge, (iv) techniques, processes, manufacturing information, and (v) research materials, reagents and compositions of matter. 

1.26 “MAA” (Marketing Approval Application) shall mean a new drug application filed with the FDA as more fully defined in 21
C.F.R. §314.50 et. seq., or similar application or submission filed with or submitted to any Regulatory Authority to obtain permission to commence marketing and sales of a product in any particular jurisdiction. 

1.27 “Major Market” shall mean [* * *]. 

1.28 “Market Launch” shall mean, with respect to a particular country, the date on which [* * *]. For the avoidance of doubt,
[* * *]. 
 1.29 “Marketing Approval” shall mean, with respect to a product in a particular jurisdiction, approval or
other permission by the applicable Regulatory Authority sufficient to initiate marketing and sales of such product in such jurisdiction. “Marketing Approval” includes pricing approval where such pricing approval is (i) required to
initiate marketing and sales of such product in such jurisdiction, or (ii) typically obtained by pharmaceutical companies prior to Market Launch. For clarity, Marketing Approval with respect to the United States shall not include pricing
approval. 

  
 -4- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 1.30 “NDA” shall mean a new drug application, including all amendments and
supplements thereto, filed with the Regulatory Authority in Japan to obtain Marketing Approval of a Product in Japan, or the equivalent application filed with any other Regulatory Authorities in any other countries or legal jurisdictions in the
Territory to obtain Marketing Approval for a Product in such country or other legal jurisdiction. 
 1.31 “Net Sales” shall
mean gross sales of Santen, its Affiliates and Sublicensees (each, a “Selling Party”) of Product to Third Parties less the following: 

(i) actual bad debts related to Product; 

(ii) normal and customary trade, quantity and cash discounts and any other adjustments, including granted on account of price adjustments,
billing errors, rejected goods, damaged or defective goods, recalls, returns, rebates, chargeback rebates, reimbursements or similar payments granted or given to wholesalers or distributors, buying groups, health care insurance carriers or other
institutions, adjustments arising from consumer discount programs, in each case actually allowed and taken by a Third Party with respect to sales of Product; 

(iii) any payment in respect of sales of Product to any government (including any agency or department thereof) or with respect to any
government-subsidized program or managed care organization; 
 (iv) sales taxes or similar taxes, including duties or other governmental
charges imposed on the sale of the Product to a Third Party (including value added taxes or other governmental charges otherwise measured by the billing amount, but excluding any taxes imposed on or measured by the net income or profits of the
Selling Party), not reimbursable, refundable or creditable to the Selling Party; and 
 (v) prepaid freight, insurance and handling fees
actually invoiced (to the extent that the Selling Party actually incurs the cost of freight, insurance and handling fees for Product and are not reimbursable, refundable or creditable to the Selling Party), 

in each case as determined from books and records of the Selling Party maintained in accordance with the applicable Accounting Standards. Sales of Product
between or among Santen, its Affiliates and Sublicensees shall be excluded from the computation of Net Sales if such sales are not intended for end use. If a sale, transfer or other disposition with respect to the Product involves consideration
other than cash or is not at arm’s length, then the Net Sales from such sale, transfer or other disposition shall be the arm’s length fair market value, which generally will mean the Selling Party’s average sales price for the
calendar quarter in the country where such sale took place. 
 For purposes of this definition of “Net Sales”, [* * *]. 

1.32 “Non-Product Patent” shall mean any Durect Patent that is not a Product-Patent. 

  
 -5- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 1.33 “Patent” shall mean any of the following, whether existing now or in
the future anywhere in the world: (i) any issued patent, including inventor’s certificates, substitutions, extensions, confirmations, reissues, reexamination, renewal or any like governmental grant for protection of inventions; and
(ii) any pending application for any of the foregoing, including any continuation, divisional, substitution, continuations-in-part, provisional and converted provisional applications. 

1.34 “Person” shall mean any individual, corporation, partnership, association, joint-stock company, trust, unincorporated
organization or government or political subdivision thereof. 
 1.35 “Phase 1 Clinical Trial” shall mean any human
clinical trial conducted in any country that generally provides for the first introduction into humans of a pharmaceutical product with the primary purpose of which is preliminary determination of safety, metabolism and pharmacokinetic properties
and clinical pharmacology of such pharmaceutical product in healthy patients, or otherwise generally consistent with 21 C.F.R. §312.21(a). 

1.36 “Phase 2 Clinical Trial” shall mean any human clinical trial conducted in any country that is designed (i) to
establish the safety and biological activity of a pharmaceutical product for its intended use, (ii) to define warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed,
or (iii) to support a Phase 3 Clinical Trial, or otherwise generally consistent with U.S. 21 C.F.R. §312.21(b). 
 1.37
“Phase 3 Clinical Trial” shall mean any human clinical trial conducted in any country that is designed that, if the defined end-points are met, is intended to establish efficacy of a pharmaceutical product in patients with the
indication being studied for purposes of filing a MAA or otherwise be a pivotal trial for obtaining a Marketing Approval or label expansion for such pharmaceutical product, or otherwise generally consistent with 21 C.F.R. §312.21(c). 

1.38 “Product” shall mean: 

(i) any pharmaceutical product incorporating (A) [* * *] and (B) the SABER®
Formulation Platform; or 
 (ii) any Existing Product, 

[* * *] 
 1.39 “Prosecution and
Maintenance” shall mean, with respect to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well as re-examinations, reissues, requests for term extensions and the like
with respect to such Patent, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to the particular Patent; and “Prosecute and Maintain” shall have the correlative
meaning. 
 1.40 “Regulatory Authority” shall mean any federal, national, multinational, state, provincial or local
regulatory agency, department, bureau or other governmental entity with authority over the Development, Commercialization or other use or exploitation (including the granting of Marketing Approvals) of Product in any jurisdiction, including the FDA,
European Medicines Agency, and the Ministry of Health, Labor and Welfare in Japan. 

  
 -6- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 1.41 “Regulatory Filing” shall mean any filing or application with any
Regulatory Authority, including INDs, MAAs and authorization, approvals or clearances arising from the foregoing, including Marketing Approvals and any related pricing approvals, and all correspondence with the FDA or other relevant Regulatory
Authority, as well as minutes of any material meetings, telephone conferences or discussions with the FDA or other relevant Regulatory Authority, in each case with respect to Product. 

1.42 “SABER® Formulation Platform” shall mean, Durect’s or its
Affiliate’s proprietary [* * *] injectable non-polymeric, high viscosity liquid carrier system [* * *] for imparting controlled release to active ingredients. 

1.43 “Santen Fiscal Year” shall mean each successive twelve (12) months period commencing on April 1 and ending on
March 31. 
 1.44 “Santen Technology” shall mean any and all (i) Patents listed on Exhibit 1.45, and
(ii) Know-How, owned or controlled by Santen or its Affiliates or Sublicensees that relates to the Active Ingredient. 
 1.45
“Sublicensee” shall mean any entity to whom Santen has directly or indirectly through Santen’s Affiliate granted the right to (i) make and sell Product or (ii) sell Product, [* * *]. [* * *] 

1.46 “Territory” shall mean all of the countries and territories in the world. 

1.47 “Third Party” shall mean any Person other than Santen, Durect or their respective Affiliates. 

1.48 “Third Party Supplier” shall mean a contract manufacturer engaged for manufacturing Product by a Party under the
approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed. 
 1.49 “Valid
Claim” shall mean a claim of any issued and unexpired patent, [* * *]. 
 1.50 Additional Definitions. Each of the following
definitions shall have the meanings defined in the corresponding sections of this Agreement indicated below: 

 

			
	 Definitions
	 	Section
	 Agreement
	 	Preamble
	 Agreement Wind-Down Period
	 	10.6.1
	 Bankruptcy Laws
	 	12.3
	 Basic Royalty Rate
	 	6.3
	 Chairperson
	 	2.1.3
	 Challenge
	 	10.3.1
	 Commercialization Milestone Event
	 	6.2.2
	 Commercialization Milestone Payment
	 	6.2.2
	 Commercialize or Commercializing
	 	1.8
	 [* * *]
	 	[* * *]
	 Confidential Information
	 	8.1
	 [* * *]
	 	[* * *]
	 Controlled or Controlling
	 	1.11
	 Covered or Covering
	 	1.12
	 CRO
	 	8.2
	 Defending Party
	 	7.3
	 Develop or Developing
	 	1.13
	 Development Milestone Event
	 	6.2.1
	 Development Milestone Payment
	 	6.2.1
	 Development Plan
	 	4.2.1(a)
	 Dollars or $
	 	6.4
	 Durect
	 	Preamble
	 Durect Development Responsibilities
	 	4.2.3
	 Durect Indemnitees
	 	9.4.2
	 [* * *]
	 	[* * *]
	 Durect Trademark
	 	4.3.2(b)

			
	 Definitions
	 	Section
	 Durect’s Other Licensees
	 	4.2.4
	 Effective Date
	 	Preamble
	 Enforcement Action
	 	7.4.2
	 Enforcing Party
	 	7.4.4
	 Feasibility Evaluation Agreement
	 	Background
	 ICC
	 	11.2
	 Indemnify
	 	9.4.1
	 JDC
	 	2.1.1
	 [* * *]
	 	[* * *]
	 Losses
	 	9.4.1
	 Net Licensing Fees
	 	4.2.4
	 Original Payment
	 	6.5
	 out of pocket costs and expenses
	 	4.2.4
	 Party or Parties
	 	Preamble
	 Product Trademark
	 	4.3.2(a)
	 Prosecute and Maintain
	 	1.39
	 Royalty Term
	 	6.3.2
	 Santen
	 	Preamble
	 Santen Indemnitees
	 	9.4.1
	 [* * *]
	 	[* * *]
	 Selling Party
	 	1.31
	 Specific Affiliate
	 	4.2.4
	 Subject Transaction
	 	1.2
	 Term
	 	10.1
	 Third-Party Claim
	 	9.4.1

 
 

  
 -7- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 1.51 Interpretation. The captions and headings to this Agreement are for convenience
only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement. Unless specified to the contrary, references to Articles, Sections or Exhibits mean the particular Articles, Sections or Exhibits to
this Agreement and references to this Agreement include all Exhibits hereto. Unless context otherwise clearly requires, whenever used in this Agreement: (i) the words “include” or “including” shall be construed as
incorporating, also, “but not limited to” or “without limitation;” (ii) the word “day” or “year” shall mean a calendar day or year unless otherwise specified; (iii) the word “notice” shall
mean notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement; (iv) the words “hereof,” “herein,”
“hereby” and derivative or similar words refer to this Agreement (including any Exhibits; (v) provisions that require that a Party, the Parties or the JDC “agree,” “consent” or “approve” or the like shall
require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise; (vi) words of any gender include the other gender; (vii) words using the singular or plural
number also include the plural or singular number, respectively; (viii) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any
replacement law, rule or regulation thereof; and (ix) neither Party or its Affiliates shall be deemed to be acting “on behalf of” the other Party hereunder. 

  
 -8- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 ARTICLE 2 

GOVERNANCE 
 2.1 Joint
Development Committee. 
 2.1.1 Establishment. [* * *] after the Effective Date, Santen and Durect shall establish a joint
development committee (the “JDC”) to oversee, review and coordinate the activities of the Parties with respect to the material Development of Product for the Field in the Territory and serve as a forum for the exchange and
discussion of information with respect thereto. 
 2.1.2 Responsibilities. The JDC shall be responsible for: (i) overseeing,
reviewing and monitoring the Parties’ activities under this Agreement; (ii) facilitating access to and the exchange of information between the Parties related to the Development of Product; (iii) establishing, reviewing and commenting
on the Development Plan and any amendment thereto (including as provided in Section 4.2.1(a)); and (iv) undertaking or approving such other matters as are specifically provided for the JDC under this Agreement. 

2.1.3 Membership. The JDC shall be comprised of an equal number of representatives from each of Durect and Santen and unless otherwise
agreed such number shall be three (3) employees from each Durect and Santen. Either Party may replace its respective JDC representatives at any time with prior notice to the other Party, provided that such replacement is of comparable
authority and scope of functional responsibility within that Party’s organization as the individual he or she is replacing. [* * *]as the Chairperson for the JDC (the “Chairperson”), and [* * *]. The Chairperson of the JDC shall be
responsible for calling meetings, preparing and circulating an agenda in advance of each meeting (any such agenda will include every matter requested by either Party), and preparing minutes of each meeting within thirty (30) days thereafter.

 2.1.4 Termination. During the Term, Durect shall have the right to terminate the JDC by providing thirty (30) days prior
written notice to Santen. During such thirty (30) day period, the Parties will discuss and agree on a mechanism for handling matters that were previously within the scope of the JDC’s responsibilities. Santen shall have the right to
terminate the JDC by providing thirty (30) days prior written notice to Durect [* * *]. 
 2.2 Meetings. The details of JDC
activities, including frequency of JDC meetings, shall be discussed and agreed between the Parties in good faith on an ongoing basis as the Development activities with respect to Product progress. However, unless the Parties agree otherwise, the JDC
shall hold meetings (either in person or by teleconference) at least [* * *] prior to the initiation of [* * *], and thereafter, the JDC shall meet at least [* * *]. Each Party shall bear its own costs associated with its representatives attending
such meetings. As appropriate, other employees of the Parties may attend JDC meetings as observers, but no Third Party personnel may attend unless otherwise agreed by the Parties, in which case such personnel shall be subject to written
confidentiality obligations consistent with Article 8. Each Party may also call for special meetings to resolve particular matters requested by such Party. 

  
 -9- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 2.3 Decision Making. Decisions of the JDC shall be made by consensus of the
members present in person or by other means (e.g., teleconference) at any meeting, with at least one (1) representative from each Party participating in making each such decision and each Party will ensure that its member(s) participating in
any such meeting may effectuate any decisions. The members of the JDC shall at all times use good faith efforts to reach consensus on matters properly before to the JDC; however, in the event that the JDC is unable to reach consensus with respect to
a particular matter despite such good faith efforts, then either Party may, by written notice to the other, refer the matter to the senior officers of the Parties for resolution by good faith discussions for a period of at least [* * *]. In the
event that the senior officers of the Parties are unable to reach agreement with respect to such matter within such [* * *], then either Party may, by written notice to the other, refer the matter to the chief executive officers (or their executive
level designees) of the Parties for resolution by good faith discussions for a period of at least [* * *] [* * *]. In the event that the chief executive officers (or such designees) of the Parties are unable to reach agreement with respect to such
matter within such [* * *], then Santen shall have the final decision-making authority, [* * *]. Notwithstanding anything herein to the contrary, the JDC shall not have any authority to amend, modify or waive compliance with any term or condition of
this Agreement or require that Durect incurs any expense or perform any activity not specifically provided in this Agreement. 
 2.4
Day-to-Day Responsibilities. Each Party shall: (i) be responsible for day-to-day implementation and operation of the activities hereunder for which it has or is otherwise assigned responsibility under this Agreement, provided that
such implementation is not inconsistent with the express terms of this Agreement or the decisions of the JDC within the scope of their authority specified herein; and (ii) keep the other Party informed as to the progress of such activities as
reasonably requested by the other Party and as otherwise determined by the JDC. 
 ARTICLE 3 

LICENSES AND EXCLUSIVITY 

3.1 License Grant.
 3.1.1
License to Product. Subject to the terms and conditions of this Agreement (including Article 5), Durect hereby grants to Santen, an exclusive license (even as to Durect) under the Durect Technology to research, Develop, have Developed,
make, have made, use, have used, market, distribute, import, export, lease, sell and offer for sale, promote, sell and have sold Product, in each case for use in the Field in the Territory. Santen shall have the right to exercise such license
through its Affiliates, provided that Santen shall be responsible for the failure by its Affiliates to comply with, and Santen guarantees the compliance by each such Affiliate with, the terms of this Agreement including all relevant
restrictions, limitations and obligations. 
 3.1.2 Sublicenses. The license under Section 3.1.1 includes the right to grant
sublicenses within the scope thereof to Third Parties on a country-by-country basis, [* * *] subject to the following: 
 (a) Durect’s
prior written approval, not to be unreasonably withheld, conditioned or delayed, provided that no such approval shall be required for a sublicense to an Affiliate. For clarity, [* * *]; 

  
 -10- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 (b) any sublicense granted under Section 3.1.2 shall expressly exclude the right for
any non-Affiliate Sublicensee to grant any further sublicenses, including to its Affiliates, without prior written consent of Durect; [* * *]; 

(c) Santen shall promptly notify Durect of the grant of each sublicense and provide Durect a copy of the final executed sublicense agreement,
redacted for information that is not necessary to disclose to ensure compliance with this Agreement; and 
 (d) Santen shall be responsible
for the failure by its Sublicensees (including such Sublicensees’ Affiliates to which further sublicense was granted by such Sublicensee) and distributors, wholesalers and resellers with which Santen has direct contractual privity to comply
with, and Santen guarantees the compliance by each of its Sublicensees(including such Sublicensees’ Affiliates to which further sublicense was granted by such Sublicensee) and distributors, wholesalers and resellers with which Santen has direct
contractual privity with, the terms of this Agreement including all relevant restrictions, limitations and obligations. 
 3.1.3 Retained
Rights. Notwithstanding anything herein to the contrary, Durect hereby retains all rights and licenses under the Durect Technology to conduct such activities assigned to it under this Agreement or that it otherwise has the right to conduct under
this Agreement including the Durect Development Responsibilities and those manufacturing activities conducted pursuant to Article 5. 

3.2 No Other Rights. Each Party acknowledges that the rights and licenses granted under this Article 3 and elsewhere in this
Agreement are limited to the scope expressly granted. Accordingly, except for the rights expressly granted under this Agreement, no right, title, or interest of any nature whatsoever is granted, whether by implication, estoppel, reliance, or
otherwise, by either Party to the other Party. All rights with respect to Know-How, Patent or other intellectual property rights that are not specifically granted herein are reserved to the owner thereof. 

3.3 [* * *].
 3.4 [* *
*]. [* * *]. 
 ARTICLE 4 

DEVELOPMENT AND COMMERCIALIZATION OF PRODUCT 

4.1 Know-How Transfer. Promptly after the execution of this Agreement, Durect shall transfer [* * *] copies of Durect Know-How to
Santen. [* * *] 
 4.2 Development.

4.2.1 General. Santen, directly or through its Affiliates or Sublicensees, shall use Commercially Reasonable Efforts to Develop and
Commercialize Product [* * *] in the Territory. Except for the Durect Development Responsibilities, Santen shall take the lead and be responsible for conducting the Development activities, including clinical trials, as may be reasonably necessary to
expeditiously obtain Marketing Approvals for Product for the Field in the Territory, all in accordance with the Development Plan. It is understood and agreed that, as between the Parties, all Development efforts for Product for the Field in the
Territory shall be [* * *] unless otherwise agreed in writing by the Parties. 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 (a) Development Plan. A high-level development plan is attached hereto as
Exhibit 4.2.1 setting forth the general activities to be conducted under this Agreement to obtain Marketing Approvals for the Product [* * *] (such Development plan, as may be updated from time to time [* * *], is hereinafter referred to
as “Development Plan”). The Development Plan shall also include the plan of Durect Development Responsibilities and the Durect Costs. The Development Plan will at all times reflect Santen’s best estimate of the activities
necessary to obtain Marketing Approvals [* * *] necessary to bring Product, to the market as soon as practicable, taking into consideration good development principles (including patient safety). [* * *]. 

(b) Without limiting the foregoing, after the establishment of the JDC, a more detailed Development Plan for Product for each Major Market
consistent with the plan attached hereto as Exhibit 4.2.1 will be discussed [* * *] between the Parties through the JDC. 

4.2.2 Development Due Diligence. Each Party shall, and shall cause its respective Affiliates to, and shall use Commercially Reasonable
Efforts to [* * *]. 
 4.2.3 Durect Development Responsibilities. Durect shall use Commercially Reasonable Efforts to conduct,[* * *]
the following activities (“Durect Development Responsibilities”) in accordance with the Development Plan: [* * *] The Durect Costs shall be borne by [* * *] pursuant to the Development Plan, provided however that if there
will be any additional Durect Costs such additional Durect Costs shall be borne by [* * *] subject to [* * *]. Any invoice [* * *] shall be accompanied by the breakdown of such costs and expenses and reasonable documentation. For clarity, [* * *].

 4.2.4 Development Data and Regulatory Filings. Durect shall, through the JDC, keep Santen appropriately and routinely informed
regarding progress with respect to the performance of activities pursuant to the Development Plan, including all the study results and conclusions generated therefrom, and provide Santen access to and copies of all data generated from the
performance of the Development Plan, including non-clinical and CMC reports with respect to the Product or the Durect Technology. Santen shall, through the JDC, keep Durect appropriately and routinely informed regarding progress with respect to the
performance of activities pursuant to the Development Plan. Notwithstanding any provisions hereof (except as provided in Article 7 or Article 10), [* * *]. 

Santen shall provide to Durect one (1) paper copy or electronic file of: 

[* * *] 
 For clarity, [* * *]. 

For purposes of this Section 4.2.4, the contents of [* * *] shall be determined per International Conference on Harmonisation guidelines.

 [* * *] 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 4.3 Commercialization.

4.3.1 General. Santen, directly or through its Affiliates or Sublicensees, shall use Commercially Reasonable Efforts to Commercialize
Product [* * *]. Without limiting the foregoing, Santen agrees [* * *]. It is understood and agreed that, as between the Parties, all Commercialization efforts with respect to Product for the Field in the Territory shall be at the sole expense of
Santen. 
 4.3.2 Trademarks. 

(a) Santen shall have the right to select Product names and all trademarks used in connection with the Commercialization of Product including
special promotional or advertising taglines, in each case for the Field in the Territory (each such trademark specific to Product and including all goodwill associated therewith, and all applications, registrations, extensions and renewals relating
thereto, shall be referred to as a “Product Trademark”). Santen shall be the exclusive owner of Product Trademarks, and shall use Commercially Reasonable Efforts to register and maintain, at its expense, such Product Trademarks as shall be
used for Commercialization of Product for the Field in the Territory. All goodwill arising from any use of Product Trademark under this Agreement shall inure to the benefit of Santen. 

(b) To the extent permitted by Applicable Law, at Durect’s reasonable advance election, the labels and packaging of Product and
promotional materials for Product shall include text identifying Durect as the licensor of Product and a Durect trademark exemplified in Exhibit 4.3 (collectively “Durect Trademark”) to be placed in a size and location
reasonably agreed to in writing by the Parties; provided that in the event the placement of such text or Durect Trademark is not practicable due to space limit in Product label or packaging, the Parties shall discuss in good faith a
reasonable alternative arrangement. When the Durect Trademark described on the said labels or packaging of Product or promotional materials for Product is requested to be changed by Durect or Regulatory Authorities due to a reasonable reason such as
its corporate name change, Santen will change the design of the Durect Trademark on labels or packaging of Product or promotional materials for Product at Durect’s cost. Subject to the foregoing, Durect hereby grants to Santen, its Affiliates
and Sublicensees a limited right to use the Durect Trademark solely in connection with the sale and marketing of Product for the Field in the Territory in accordance with this Agreement. Santen, its Affiliates and Sublicensees shall follow
Durect’s reasonable instructions and guidelines with respect to the use of any Durect Trademark. Santen acknowledges that, as between the Parties, Durect retains sole ownership of Durect Trademark, including registrations and applications
therefor and all the goodwill associated therewith. Santen, its Affiliates and Sublicensees shall not challenge Durect’s ownership of, or the validity of, Durect Trademark during the term of this Agreement, and shall execute any documents that
are reasonably required by Durect to confirm Durect’s ownership of Durect Trademark. All goodwill arising from any use of Durect Trademark under this Agreement shall inure to the benefit of Durect. 

4.4 Regulatory Matters. Subject to Section 5.1.2, Santen, its Affiliates or Sublicensees shall control and be solely
responsible for, at its expense, filing, obtaining and maintaining all regulatory approvals (including Marketing Approvals) for Development and Commercialization of Product for the Field in the Territory and [* * *]. 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 4.5 Reporting. Without limiting any other provisions of this Agreement, Santen
shall keep Durect reasonably informed through the JDC (or if the JDC is terminated, directly) as to the progress of its activities with respect to the Development of Product [* * *] under Section 4.2.1(a) [* * *]. In addition, Santen shall
promptly notify Durect if it anticipates or there are material deviations from the then-current Development Plan or the development diligence requirement, and [* * *]. 

ARTICLE 5 
 SUPPLY

 5.1 Development Supply.

5.1.1 General. If requested by Santen, Durect shall, itself or through one or more Third Party Supplier, such Third Party Supplier is
bound by a written agreement that is consistent with the terms and conditions of this Agreement including intellectual property ownership and confidentiality provisions consistent with those set forth in Article 7 and Article 8 and Durect
shall be responsible for act or omission of such Third Party Supplier, use Commercially Reasonable Efforts to supply to Santen, its Affiliates and its Sublicensees pursuant to the terms and conditions of this Article 5, but subject to
Section 4.2.3(iv), [* * *]. Durect acknowledges and agrees that some of the Products manufactured by Durect or its Third Party Supplier for Development may be commercially salable after obtaining the Marketing Approval as permitted by
applicable laws and regulations and Santen may commercially sell such Products provided that [* * *]. 
 5.1.2 Drug Master
File. Durect shall either (i) file and maintain, and allow Santen (or Affiliates or Sublicensees, as applicable) to refer to Drug Master File with respect to [* * *] in each country of the Territory where Santen Develops and/or
Commercialize the Product, or (ii) in each country of the Territory where Durect has not filed or maintained a Drug Master File with respect to [* * *]. 

5.1.3 Price. The price for the clinical or other Development supply of Product pursuant to this Article 5 shall be [* * *]. 

5.1.4 Representations and Warranties. Durect warrants that Product supplied pursuant to this Section 5.1 shall, at the time of
delivery [* * *]. For clarity, the foregoing warranty does not apply to any non-conformity, damage or harm to Product caused by or otherwise related to improper storage, handling, transportation, or usage occurring after delivery by Durect to Santen
or its designated carrier. Assuming payment in full of amounts due to Durect for the particular Order of Product by Santen, Durect further warrants that title to such Product supplied pursuant to this Section 5.1 will pass to Santen free and
clear of any security interest, lien, or other similar encumbrance. 
 5.1.5 Nonconformity. Within [* * *] following receipt of each
delivery of Product supplied under this Section 5.1, Santen [* * *] shall conduct an inspection of Product and may reject such quantities of Product on the grounds that such quantities fail to conform [* * *]. Santen shall notify Durect in
writing within such [* * *] period [* * *] [* * *] following receipt of each delivery of Product supplied under this Section 5.1 if Product fails to conform [* * *], and, to the extent such Product are non-conforming (as reasonably verified by
Durect [* * *]), Durect shall [* * *]. Upon request from Durect, Santen shall return any properly rejected Product in accordance with Durect’s instructions, [* * *]. Durect may use such rejected Product for the purpose of figuring out the cause
of the non-conformity. 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 5.2 Commercial Supply.

5.2.1 Product. [* * *], Durect shall negotiate with Santen, its Affiliates or Sublicensees, as the case may be, in good faith and enter
into a supply agreement for the Products together with a quality assurance agreement pursuant to which Durect would, itself or through one or more Third Party Suppliers, [* * *] supply to Santen, its Affiliates or its Sublicensees and Santen, its
Affiliates or its Sublicensees would purchase such Product. 
 5.2.2 [* * *]. 

5.3 Manufacture of Product by Santen or Third Party Supplier, Technology Transfer.

5.3.1 [* * *]. [* * *] 

5.3.2 [* * *]. [* * *] 

5.3.3 Conditions on Third Party Supplier. Any such Third Party Supplier shall be bound by a written agreement with Santen that: 

(i) is consistent with the terms of this Agreement, including intellectual property ownership and confidentiality provisions consistent with
those set forth in Article 7 and Article 8, and 
 (ii) provides that Santen shall have the right to visit and inspect the Third
Party Supplier’s facilities for an audit prior to final selection of such Third Party Supplier and thereafter at least once per calendar year. 

5.3.4 Inspection Rights. Santen shall: 

(a) allow [* * *] Durect to accompany Santen on one audit prior to final selection of such Third Party Supplier, and 

(b) consider in good faith any reasonable request by Durect (i) to schedule any such audit, and (ii) to attend [* * *] audits of
such Third Party Supplier [* * *]. 
 5.3.5 [* * *] 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 ARTICLE 6 

PAYMENTS 
 6.1 Upfront
License Fee. Upon execution of this Agreement, Santen shall pay to Durect the amount of Two Million Dollars ($2,000,000). Such amount shall be non-refundable, and shall not be creditable against any other amount due hereunder. Such amount
shall be paid by Santen to Durect within [* * *] of the Effective Date, subject to provision by Durect to Santen of necessary documents to be submitted to the Japan Tax Office for tax relief. 

6.2 Milestone Payments.

6.2.1 Development Milestones. Santen shall pay to Durect the amounts set forth in the following table (each, a “Development
Milestone Payment”) upon [* * *] (each, a “Development Milestone Event”): 
  

					
	 Development Milestone Event
	  	 	  	 Development Milestone Payment

	[* * *]	  	 	  	[* * *]
	[* * *]	  	 	  	[* * *]
	[* * *]	  	 	  	[* * *]
	[* * *]	  	 	  	[* * *]
	[* * *]	  	 	  	[* * *]

 [* * *] 

6.2.2 Commercialization Milestones. Santen shall pay to Durect the amounts set forth in the following table (each, a
“Commercialization Milestone Payment”), including where applicable upon [* * *] (each, a “Commercialization Milestone Event”): 
  

					
	 Commercialization Milestone Event
	 	 	  	 Commercialization Milestone Payment

	[* * *]	 		  	[* * *]
	[* * *]	 		  	[* * *]
	[* * *]	 		  	[* * *]
	[* * *]	 		  	[* * *]
	[* * *]	 		  	[* * *]
	[* * *]	 		  	[* * *]

 [* * *] 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 6.2.3 Payment Terms. The Development Milestone Payments set forth in
Section 6.2.1 shall each be due and payable to Durect within [* * *] of the achievement of the corresponding Development Milestone Event set forth above. Santen agrees to promptly notify Durect of its achievement of each Development Milestone
Event. Santen shall notify Durect in writing of achievement of each Commercialization Milestone Event within [* * *] and pay the corresponding Commercialization Milestone Payment at the time of providing such notice. For clarity, all milestone
payments under this Section 6.2 shall be non-refundable and non-creditable. 
 6.3 Royalty Payments. Santen shall pay the
applicable royalty rate on a country-by-country basis [* * *]. 
  

													
	 Portion of Territory-wide
Annual Net Sales of
Products
	 	 	  	 [* * *]
	  	 	  	 [* * *]
	  	 	  	 [* * *] Royalty
Rate

	[* * *]	 	 	  	[* * *]	  	 	  	[* * *]	  	 	  	[* * *]
	[* * *]	 	 	  	[* * *]	  	 	  	[* * *]	  	 	  	[* * *]
	[* * *]	 	 	  	[* * *]	  	 	  	[* * *]	  	 	  	[* * *]

 6.3.1 Reduced Royalty Payments. Notwithstanding the above, in the event
that one of the following events described in the table below happens [* * *], Santen’s Royalty Rate payable to Durect shall be reduced as set forth in the table below: 
  

									
	 Event
	 	 	 	 [* * *]
	  	 	 	 [* * *]

	 [* * *]
	 		 	[* * *]	  		 	[* * *]
	 [* * *]
	 		 	[* * *]	  		 	[* * *]
	 [* * *]
	 		 	[* * *]	  		 	[* * *]

 6.3.2 Royalty Term. On a country-by-country basis, Santen’s royalty obligation shall commence on
the Market Launch of each Product in such country by Santen or its Affiliate and continue until [* * *] (the “Royalty Term”). 

6.3.3 Royalty Stacking. If, during the Royalty Term, Santen enters into a license under or acquires any Patent right of a Third Party
that is necessary for Santen, its Affiliates or Sublicensees to exploit the Durect Technology with respect to the Development and Commercialization of Product in the Field in any country of the Territory, then, (i) [* * *]shall be responsible
for paying to such Third Party any royalties or other payments due to such Third Party in respect thereof, provided that [* * *]shall be responsible for any payments due to [* * *] licensors, if any; and (ii) [* * *]. [* * *] 

6.3.4 Payment/Reports. All payments under this Section 6.3 shall be due and payable within [* * *] after the last day (the last
day exclusive) of the calendar quarter during which the corresponding Net Sales are recognized (including with respect to Sublicensees). Together with any such payment, Santen shall deliver a report in a form set forth in Exhibit 6.3.4
specifying on a country-by-country basis: [* * *]. 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 6.3.5 Non-Monetary Consideration for Sale. In the event that Santen, its Affiliates
and Sublicensees accepts any non-monetary consideration for the sale of Product [* * *], provided that the use by Santen, its Affiliates and Sublicensees of a customary and reasonable amount of Product for promotional sampling, compassionate
use or donations shall be deemed to have been sold at no cost and no Net Sales shall accrue in such cases. 
 6.4 Payment
Method. All payments due under this Agreement to Durect shall be made by bank wire transfer in immediately available funds to an account of Durect designated by Durect. All payments hereunder shall be made in the legal currency of the
United States of America, and all references to “$” or “Dollars” shall refer to United States dollars. Except as otherwise provided herein, all payments due to either Party under this Agreement shall be due and
payable within [* * *] of the date of invoice from the other Party. 
 6.5 Taxes. Each Party will be responsible for all taxes,
fees, duties, levies or similar amounts imposed on its income, assets, capital, employment, personnel, and right or license to do business. Except as otherwise stated, each Party will be responsible for its own sales tax, use tax, excise tax, value
added tax (VAT), goods and services tax (GST), consumption tax, and similar taxes based upon its own activities under this Agreement. The Parties shall use reasonable and legal efforts to reduce or optimize tax withholding, to the extent permitted
by Applicable Law, on payments made pursuant to this Agreement. Each Party agrees to cooperate in good faith to provide the other Party with such documents and certifications as are reasonably necessary to enable such other Party to minimize any
withholding tax obligations or liabilities or to avoid any double taxation. [* * *]. The Parties will reasonably cooperate in completing and filing documents required under the provisions of any Applicable Law in connection with the making of any
required tax payment or withholding payment, or in connection with any claim to a refund of or credit for any such payment. 
 6.6
Inspection of Records. Santen shall, and shall cause its Affiliates and Sublicensees to, keep full and accurate books and records setting forth [* * *]. Santen shall permit Durect, by independent qualified public accountants engaged by
Durect and reasonably acceptable to Santen, to examine such books and records at any reasonable time, but not later than [* * *] following the rendering of any corresponding reports, accountings and payments pursuant to this Article 6. The
foregoing right of review may be exercised during normal business hours agreed by Santen and [* * *]. Such accountants may be required by Santen to enter into a reasonably acceptable confidentiality agreement with Santen, its Affiliate and/or
Sublicensee. The opinion of said independent accountants regarding such reports, accountings and payments shall be binding on the Parties other than in the case of clear error. Durect shall bear the cost of any such examination and review;
provided that if the inspection and audit shows an underpayment of more than [* * *], then Santen shall promptly reimburse Durect for all costs incurred in connection with such examination and review. Santen shall promptly pay to Durect the
amount of any underpayment revealed by an examination and review. [* * *] 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 6.7 Late Payment. Any payments or portions thereof due hereunder which are not
paid when due shall bear interest equal to the lesser of (i) [* * *] or (ii) [* * *]. This Section 6.7 shall in no way limit any other remedies available to either Party. 

6.8 Currency Conversion. If any currency conversion shall be required in connection with the calculation of amounts payable
hereunder, such conversion shall be made using the same exchange rates used by Santen for its own public financial reporting purposes, or if none is used, then the average of the buying and selling rates on [* * *]. 

ARTICLE 7 

INTELLECTUAL PROPERTY 
 7.1
General.
 7.1.1 Ownership of Inventions. As between the Parties, all right, title and interest to invention and other subject
matter made or otherwise developed in the course of performing activities under this Agreement by or on behalf of either Party or by an Affiliate or Sublicensee of Santen shall be owned as follows: 

[* * *] 
 Each Party shall promptly notify the
other Party of any such invention (i.e., as described in (i), (ii) or (iii) above) made by itself or its Affiliates, Sublicensees, Third Party Suppliers or Contractors. 

7.1.2 [* * *]. [* * *]. 

7.1.3 Negotiation. [* * *]. 

7.2 Patent Prosecution.

7.2.1 Durect Patents. Subject to Sections 7.2.2 and 7.2.3, Durect shall control the Prosecution and Maintenance of all Durect
Patents [* * *]. 
 7.2.2 Cooperation and Back-Up Rights. [* * *]. 

7.2.3 Patents Claiming [* * *]. During the Term, Patents claiming [* * *] that are necessary or useful for the Development and
Commercialization of Product shall be deemed [* * *] Patents and the Prosecution and Maintenance thereof shall be subject to Sections 7.2.1 and 7.2.2 above. Subject to the foregoing, as between the Parties, [* * *]. 

7.2.4 Joint Patents. [* * *]. 

7.3 Defense of Third Party Infringement Claims. If Product becomes the subject of a Third Party’s claim or assertion of
infringement of a Patent relating to the manufacture, use, sale, offer for sale or importation of Product for the Field in the Territory, the Party first having notice of the claim or assertion shall promptly notify the other Party, and the Parties
shall promptly confer to consider the claim or assertion and the appropriate course of action. [* * *] shall have the right to defend [* * *] against a suit that names [* * *] as a defendant (the “Defending Party”). Neither Party
shall enter into any settlement of any claim described in this Section 7.3 that adversely affects the other Party’s rights or interests without such other Party’s written consent, [* * *]. In any event, the other Party shall
reasonably assist the Defending Party and cooperate in any such litigation [* * *]. 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 7.4 Enforcement.

7.4.1 Notice. Subject to the provisions of this Section 7.4, in the event that either Party reasonably believes that any Durect
Patent is being infringed by a Third Party or is subject to a declaratory judgment action arising from such infringement, such Party shall promptly notify the other Party. 

7.4.2 Joint Patents in the Field. As between the Parties, [* * *] shall have the initial right (but not the obligation) to initiate and
control any enforcement action or defend any declaratory judgment action in the Field (each, an “Enforcement Action”) with respect to any infringement of any Joint Patent, at [* * *] expense. In the event that [* * *] or its
designee fails to commence an Enforcement Action with respect to any infringement of any Joint Patent in the Territory within [* * *] days of a request by [* * *] to do so, [* * *] or its designee may commence an Enforcement Action with respect to
such infringement at [* * *] expense, [* * *]. [* * *] shall have the right to join [* * *] as a party in any such action if necessary to bring and maintain such action. 

7.4.3 Durect Patents / Joint Patents outside the Field. As between the Parties, [* * *] shall have the initial right (but not the
obligation) to initiate and control any Enforcement Action with respect to any infringement of [* * *], in each case of[* * *], at [* * *] expense. In the event that [* * *]or its designee fails to commence an Enforcement Action with respect to any
infringement of any [* * *] Patent in the Territory, in each case within [* * *] of a request by [* * *] to do so and [* * *]demonstrates with reasonable evidence that such infringement of [* * *] Patent has or is likely to have a commercially
material adverse impact on [* * *], [* * *] or its designee may commence in each case an Enforcement Action with respect to [* * *] at [* * *] expense, [* * *]. [* * *]shall have the right to join [* * *] as a party in any such action if necessary
to bring and maintain such action. 
 7.4.4 Cooperation. The Party commencing, controlling or defending any such Enforcement Action
under this Section 7.4 (the “Enforcing Party”) shall keep the other Party reasonably informed of the progress of any such Enforcement Action, and such other Party shall have the right to participate with counsel of its own
choice [* * *]. In any event, the other Party shall reasonably cooperate with the Enforcing Party, including providing information and materials, [* * *]. The Enforcing Party shall also have the right to control settlement of such Enforcement
Action; provided, however, no settlement shall be entered into without the consent of the other Party if such settlement would adversely affect the rights or interests of the other Party. In the case of enforcement of Joint Patents, the
Enforcing Party shall have the right to join the other Party as a party in any such action if necessary to bring and maintain such action, at the Enforcing Party’s expense. 

7.4.5 Recoveries. Any recovery received as a result of any Enforcement Action to enforce any Durect Patent or Joint Patent pursuant to
this Section 7.4 shall be used first to reimburse the Party who bears documented, out-of-pocket costs and expenses (including court, attorneys’ and 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 
professional fees) incurred in connection with such Enforcement Action, provided that if the Enforcing Party is [* * *], [* * *] shall be reimbursed [* * *] of such out-of-pocket costs and
expenses, and the remainder of the recovery shall be shared as follows: [* * *] of such recovery shall be paid to the Enforcing Party and [* * *] of such recovery shall be paid to the other Party; provided that [* * *]. 

7.5 Patent Marking. Santen shall mark (or cause to be marked) Product marketed and sold hereunder with appropriate Durect Patent
numbers or indicia at Durect’s request [* * *]. 
 ARTICLE 8 

CONFIDENTIALITY 
 8.1
Confidentiality; Exceptions. Except to the extent expressly authorized by this Agreement or otherwise agreed by the Parties in writing, the Parties agree that the receiving Party shall keep confidential and shall not publish or otherwise
disclose or use for any purpose other than as provided for in this Agreement any confidential or proprietary information or materials furnished to it by the other Party pursuant to this Agreement (collectively, “Confidential
Information”). Notwithstanding the foregoing, Confidential Information shall not be deemed to include information or materials to the extent that it can be established by written documentation by the receiving Party that such information or
material: 
 8.1.1 was already known to or possessed by the receiving Party without any obligation of confidentiality, at the time of its
disclosure to the receiving Party hereunder; 
 8.1.2 was generally available to the public or otherwise part of the public domain at the
time of its disclosure to the receiving Party hereunder; 
 8.1.3 became generally available to the public or otherwise part of the public
domain after its disclosure hereunder other than through any act or omission of the receiving Party in breach of this Agreement; 
 8.1.4
was independently developed by the receiving Party (including its Sublicensees, Third Party Suppliers, Contractors or CRO) without use of or reference to the other Party’s Confidential Information as demonstrated by documented evidence prepared
by the receiving Party contemporaneously with such independent development; or 
 8.1.5 was disclosed to the receiving Party, other than
under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing Party not to disclose such information to others. 

8.2 Authorized Use and Disclosure. Without limiting Durect’s rights under Section 4.2.4, each Party may use and disclose
Confidential Information of the other Party as follows: (i) under appropriate confidentiality provisions substantially equivalent to those in this Agreement in connection with the performance of its obligations or exercise of rights granted to
such Party in this Agreement; (ii) to the extent such disclosure is reasonably necessary for the Prosecution and Maintenance of Patents (including applications therefor) in accordance with this Agreement but with

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 
prior written consent of the disclosing Party, which consent shall not be unreasonably withheld, conditioned or delayed, complying with the terms of agreements with Third Parties, prosecuting or
defending litigation, complying with applicable governmental regulations, (iii) filing for, conducting preclinical or clinical trials, obtaining and maintaining regulatory approvals (including Marketing Approvals) for Product(s) under this
Agreement, or otherwise required by Applicable Law or the rules of a recognized stock exchange, provided, however, that if a Party is required by Law or stock exchange to make any such disclosure of the other Party’s Confidential
Information it will, except where impracticable for necessary disclosures (for example, in the event of medical emergency), give reasonable advance notice to the other Party of such disclosure requirement and, except to the extent inappropriate in
the case of patent applications, will use its reasonable efforts to secure confidential treatment of such Confidential Information required to be disclosed; (iv) in communication with existing and potential Sublicensees, Third Party Suppliers,
Third Party Contractors, investors, acquirers, consultants, advisors (including financial advisors, lawyers and accountants) on a need to know basis, in each case under appropriate confidentiality provisions and a written agreement substantially
equivalent to those of this Agreement; or (v) to the extent mutually agreed to by the Parties in writing. Notwithstanding the foregoing, either Party may disclose the other Party’s Confidential Information to a contract research
organization (the “CRO”) to which such Party outsources any research and/or development of the Products permitted hereunder, provided, in each case, that (a) any such CRO agrees to be bound by terms of confidentiality and
non-use comparable in scope to those set forth in this Article 8 for a reasonable period of time, [* * *], and such Party shall be responsible for the acts and omissions of such CRO with respect thereto, and (b) such Party will only
disclose such Confidential Information to CRO as is reasonably necessary for CRO to conduct such research and/or development of the Products. 

8.3 Prior Agreement. This Agreement supersedes Section 9 of the Feasibility Evaluation Agreement with respect to Confidential
Information (as such term is defined in the Feasibility Evaluation Agreement) disclosed thereunder. All such Confidential Information disclosed or provided by or on behalf of Durect to Santen or its Affiliates under the Feasibility Evaluation
Agreement shall be deemed Confidential Information of Durect (subject to the exceptions set forth herein) and shall be subject to Santen’s confidentiality obligations under this Article 8. All such Confidential Information disclosed by or
on behalf of Santen to Durect or its Affiliates under the Feasibility Evaluation Agreement shall be deemed Confidential Information of Santen (subject to the exceptions set forth herein) and shall be subject to Durect’s confidentiality
obligations under this Article 8. 
 8.4 Scientific Publications. Each Party shall submit to the other Party any proposed
publication or public disclosure containing clinical or scientific results relating to Product for the Field at least [* * *] in advance to allow that Party to review such proposed publication or disclosure. The reviewing Party shall notify the
requesting Party in writing within [* * *] from the day receiving such submission by the other Party if the reviewing Party wishes to (i) remove its Confidential Information from such proposed publication or presentation, in which event the
reviewing Party shall remove such Confidential Information from its proposed publication or presentation; or (ii) request a reasonable delay in publication or presentation in order to protect patentable information, in which event the
requesting Party shall delay the publication or presentation for a period of no more than [* * *] to enable patent applications to be filed in 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 
accordance with Section 7.2 protecting inventions disclosed in such publication or presentation. For clarity, if the reviewing Party fails to notify the requesting Party during the [* * *]
reviewing period as provided under this Section 8.4, the requesting Party shall be free to proceed with the proposed publication or presentation. 

8.5 Publicity.
 8.5.1
Confidential Terms. Each Party agrees not to disclose to any Third Party the terms and conditions of this Agreement without the prior approval of the other Party, except to advisors (including consultants, financial advisors, attorneys and
accountants), potential and existing investors and acquirers, and others (including [* * *] in the case of Santen, its potential and actual Sublicensees) on a need to know basis [* * *], in each case under circumstances that reasonably protect the
confidentiality thereof, or to the extent necessary to comply with the terms of agreements with Third Parties, or to the extent required by Applicable Law, including securities laws. Notwithstanding the foregoing, each Party may issue a mutually
agreed press release to announce the execution of this Agreement, which is attached hereto as Exhibit 8.5.1; thereafter, Durect and Santen may each disclose to Third Parties the information contained in such press release without the
need for further approval by the other. 
 8.5.2 Publicity and Public Disclosure Review. The Parties acknowledge (i) the
importance of supporting each other’s efforts to publicly disclose results and significant developments regarding Product for the Field and other activities in connection with this Agreement, and (ii) disclosures may be required by
Applicable Law and the rules of a recognized stock exchange, and each Party may make such disclosures from time to time with the written approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed. Such
disclosures may include achievement of significant events in the Development (including regulatory process and occurrence of Development Milestone Events) or Commercialization of Product for the Field hereunder. Unless otherwise requested by Durect,
Santen shall indicate that Durect is the owner and licensor of the Durect Technology in each public disclosure issued by Santen regarding Product. When a Party elects to make any such public disclosure under this Section 8.5.2, it will give the
other Party reasonable notice to review and comment on such statement, it being understood that if the reviewing Party does not notify the requesting Party in writing within a [* * *] period or such shorter period if required by Applicable Law of
any reasonable objections, as contemplated in this Section 8.5.2, such disclosure shall be deemed approved, and in any event the reviewing Party shall work diligently and reasonably to agree on the text of any proposed disclosure in an
expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with Applicable Law and regulatory guidance documents, reasonable sensitivity to potential negative reactions of applicable Regulatory Authorities
(including the FDA) and the need to keep investors and others informed regarding the requesting Party’s business, including as required by the rules of a recognized stock exchange. Accordingly, the reviewing Party shall not withhold, condition
or delay its approval of a proposed disclosure that complies with such principles. 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 ARTICLE 9 

REPRESENTATIONS, WARRANTIES AND COVENANTS; INDEMNIFICATION 

9.1 Santen Representations and Warranties. Santen represents and warrants to Durect that, as of the Effective Date, and covenants
to Durect, as follows: 
 9.1.1 it is duly organized and validly existing under the Applicable Laws of the jurisdiction of its
incorporation, and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; 
 9.1.2 it
is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate action; 

9.1.3 this Agreement is legally binding upon it and enforceable in accordance with its terms and the execution, delivery and performance of
this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material Applicable Law; 

9.1.4 it has not granted, and shall not grant during the Term, any right to any Third Party which would conflict with the rights granted to
Durect hereunder; and 
 9.1.5 it is not aware of any action, suit or inquiry or investigation instituted by any Person which questions or
threatens the validity of this Agreement. 
 9.2 Durect’s Warranties and Covenants. Durect represents and warrants to
Santen that, as of the Effective Date, and covenants to Santen, as follows: 
 9.2.1 it is duly organized and validly existing under the
Applicable Laws of the jurisdiction of its incorporation, and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; 

9.2.2 it is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person executing this
Agreement on its behalf has been duly authorized to do so by all requisite corporate action; 
 9.2.3 this Agreement is legally binding upon
it and enforceable in accordance with its terms and the execution, delivery and performance of this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be
bound, nor violate any material Applicable Law; 
 9.2.4 it is not aware of any action, suit or inquiry or investigation instituted by any
Person which questions or threatens the validity of this Agreement; 
 9.2.5 [* * *] 

9.2.6 [* * *] 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 9.2.7 except [* * *], as of the Effective Date, [* * *]; 

9.2.8 except [* * *], to its actual knowledge as of the Effective Date, [* * *]; and 

9.2.9 except [* * *], to its actual knowledge as of the Effective Date, [* * *]. 

9.3 Disclaimer of Warranties. EXCEPT AS SET FORTH IN THIS ARTICLE 9, DURECT AND SANTEN EXPRESSLY DISCLAIM ANY WARRANTIES OR
CONDITIONS, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT (INCLUDING THE LICENSED TECHNOLOGY), INCLUDING ANY WARRANTY OF MERCHANTABILITY, NONINFRINGEMENT, OR FITNESS FOR A PARTICULAR PURPOSE. 

9.4 Indemnification.

9.4.1 Indemnification by Durect. Durect hereby agrees to defend, hold harmless and indemnify (collectively,
“Indemnify”) Santen and its Affiliates, and its and their agents, directors, officers and employees (the “Santen Indemnitees”) from and against any liability or expense (including reasonable legal expenses and
attorneys’ fees) (collectively, “Losses”) resulting from suits, claims, actions and demands, in each case brought by a Third Party (each, a “Third-Party Claim”) against any Santen Indemnitee arising out of
(i) a breach of any of Durect’s representations, warranties or covenants under Section 9.2, (ii) exercise of the licenses and rights granted hereunder, by or under authority of Durect pursuant to Section 3.1.3,
(iii) the gross negligence or intentional misconduct of any Durect Indemnitee, or (iv) material breach of this Agreement by any Durect Indemnitee. Durect’s obligation to Indemnify the Santen Indemnitees pursuant to this
Section 9.4.1 shall not apply to the extent that any such Losses (a) arise from the gross negligence or intentional misconduct of any Santen Indemnitee; (b) arise from any breach by Santen of this Agreement; or (c) are Losses for
which Santen is obligated to Indemnify the Durect Indemnitees pursuant to Section 9.4.2. 
 9.4.2 Indemnification by Santen.
Santen hereby agrees to Indemnify Durect and its Affiliates, and its and their agents, directors, officers and employees (the “Durect Indemnitees”) from and against any and all Losses resulting from Third-Party Claims against any
Durect Indemnitees arising out of: (i) a breach of any of Santen’s representations, warranties or covenants under Section 9.1, (ii) the Development, Commercialization or other exploitation of Product or other exercise of the
licenses and rights granted hereunder by or under authority of Santen, (iii) the gross negligence or intentional misconduct of any Santen Indemnitee, or (iv) material breach of this Agreement by any Santen Indemnitee. Santen’s
obligation to Indemnify the Durect Indemnitees pursuant to this Section 9.4.2 shall not apply to the extent that any such Losses (a) arise from the gross negligence or intentional misconduct of any Durect Indemnitee; (b) arise from
any breach by Durect of this Agreement; or (c) are Losses for which Durect is obligated to Indemnify the Santen Indemnitees pursuant to Section 9.4.1. 

9.4.3 Procedure. To be eligible to be Indemnified hereunder, the indemnified Party shall provide the indemnifying Party with prompt
notice of the Third-Party Claim giving rise to the indemnification obligation pursuant to this Section 9.4 and the exclusive ability to defend (with the 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 
reasonable cooperation of the indemnified Party) or settle any such claim; provided, however, that the indemnifying Party shall not enter into any settlement that admits fault, wrongdoing or
damages without the indemnified Party’s written consent, such consent not to be unreasonably withheld, conditioned or delayed. The indemnified Party shall have the right to participate, at its own expense and with counsel of its choice, in the
defense of any claim or suit that has been assumed by the indemnifying Party, provided that the indemnifying Party shall have no obligations with respect to any Losses resulting from the indemnified Party’s admission, settlement or other
communication without the prior written consent of the indemnifying Party. 
 9.5 Insurance. Each Party shall obtain and
maintain, during the Term and for [* * *] thereafter, reasonable insurance (or self-insurance), including commercial general liability insurance, worker’s compensation insurance and product liability insurance, at levels consistent with
industry standards based upon such Party’s activities hereunder and indemnification obligations hereunder. Each Party shall furnish to the other Party on request certificates issued by the insurance company setting forth the amount of the
liability insurance (or evidence of self-insurance). 
 9.6 LIMITATION OF LIABILITY. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT
OR OTHERWISE, OTHER THAN BY REASON OF A BREACH OF ARTICLE 8 ABOVE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT (WHETHER UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR
EQUITABLE THEORY) FOR ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES; PROVIDED HOWEVER THAT NOTHING IN THIS SECTION 9.6 SHALL BE DEEMED TO LIMIT THE INDEMNIFICATION OBLIGATIONS OF EITHER PARTY UNDER
SECTION 9.4 ABOVE TO THE EXTENT A THIRD PARTY RECOVERS ANY INCIDENTAL, INDIRECT, SPECIAL, EXEMPLARY, PUNITIVE OR CONSEQUENTIAL DAMAGES FROM AN INDEMNITEE. 

ARTICLE 10 
 TERM
AND TERMINATION 
 10.1 Term. This Agreement shall become effective as of the Effective Date and, unless earlier terminated
pursuant to the other provisions of this Article 10, shall continue in full force and effect on a country-by-country basis until the earlier of (i) Santen has no remaining royalty payment obligations pursuant to Section 6.3 in such
country, or (ii) Santen has no remaining royalty payment obligations pursuant to Section 6.3 in all Major Markets [* * *] (the “Term”). For clarity, in each case of (i) and (ii), no royalty payment shall be due
pursuant to Section 6.3 and the Term shall not be extended in the event that [* * *] on a country-by-country basis. Upon such expiration with respect to a country, the license granted to Santen in Section 3.1 shall become [* * *] in such
country. 
 10.2 Termination by Santen 

10.2.1 Termination without Cause. Santen shall have the right to terminate this Agreement in its entirety upon [* * *] prior written
notice to Durect [* * *] and upon [* * *] prior written notice to Durect [* * *]. [* * *] 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 10.3 Termination by Durect 

10.3.1 Termination for Patent Challenge. If Santen or any of its Affiliates or Sublicensees challenges under any court action or
proceeding, or before any patent office, the validity, patentability, enforceability, scope or non-infringement of any Durect Patent, or initiates a reexamination of any Durect Patent, or assists any Third Party to conduct any of the foregoing
activities (each, a “Challenge”), Durect will have the right to [* * *] terminate this Agreement. [* * *]. 
 10.4
Termination by either Party 
 10.4.1 Termination for Material Breach. Either Party may terminate this Agreement in its
entirety in the event the other Party materially breaches this Agreement, and such breach shall have continued for [* * *] after notice thereof was provided to the breaching Party by the non-breaching Party. Any such termination shall become
effective at the end of such [* * *] period unless the breaching Party has cured any such breach prior to the expiration of the [* * *] period. 

10.4.2 Termination for Insolvency. Each Party shall have the right to terminate this Agreement upon delivery of written notice to the
other Party in the event that (i) such other Party files in any court or agency pursuant to any statute or regulation of any jurisdiction a petition in bankruptcy or insolvency or for reorganization or similar arrangement for the benefit of
creditors or for the appointment of a receiver or trustee of such other Party or its assets, (ii) such other Party is served with an involuntary petition against it in any insolvency proceeding and such involuntary petition has not been stayed
or dismissed within [* * *] of its filing, or (iii) such other Party makes an assignment of substantially all of its assets for the benefit of its creditors. 

10.5 General Effects of Expiration or Termination.

10.5.1 Reversion of Rights. Upon termination but not expiration of this Agreement, all rights and licenses granted by Durect to Santen
under this Agreement shall revert back to Durect. For clarity upon expiration, but not early termination, the license granted in Section 3.1 shall survive as set forth in Section 10.1. 

10.5.2 Accrued Obligations. Expiration or termination of this Agreement for any reason shall not release either Party of any obligation
or liability which, at the time of such expiration or termination, has already accrued to the other Party or which is attributable to a period prior to such expiration or termination. 

10.5.3 Non-Exclusive Remedy. Notwithstanding anything herein to the contrary, termination of this Agreement by a Party shall be without
prejudice to other remedies such Party may have at law or equity. 
 10.5.4 General Survival. Articles 1, 8, 10, 11 and 12 and
Sections 4.2.4 (only with respect to [* * *]), 6.5, 6.6, 7.1.1, 7.1.2, 7.1.3 (in case of expiration), 7.2.4, 7.3 (solely with respect to Joint Patents), 7.4.2, 7.4.3 (solely with respect to Joint Patents), 7.4.4 (solely with respect to
Joint Patents), 7.4.5 (solely with respect to Joint Patents), 9.3, 9.4, 9.5 (for the period provided therein) and 9.6 shall survive expiration or termination of this Agreement for any reason. [* * *]. Except as otherwise provided in this
Article 10, all rights and obligations of the Parties under this Agreement shall terminate upon expiration or termination of this Agreement for any reason. 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 10.6 Additional Effects of Certain Terminations due to cause by Santen. If this
Agreement is terminated by Santen pursuant to Section 10.2.1 or terminated by Durect pursuant to Sections 10.3 or 10.4 then: 

10.6.1 Commercialization. Santen and its Affiliates and Sublicensees shall cease to distribute and sell Product in each country of the
Territory in which Santen is then distributing and selling within a period requested not to exceed [* * *] from the effective date of such expiration or termination (the “Agreement Wind-Down Period”). Notwithstanding any other
provision of this Agreement, during this Agreement Wind-Down Period, Santen’s, its Affiliates’ and its Sublicensees’ rights with respect to Product (including the licenses granted under Section 3.1) shall be non-exclusive, and
Durect shall have the right to engage one or more other partner(s) or distributor(s) of Product in all or part of the Territory [* * *]. The Product sold by Santen or its Affiliates or Sublicensees during this Agreement Wind-Down Period shall be
subject to royalties [* * *]. After the Agreement Wind-Down Period, Santen and its Affiliates and Sublicensees shall not sell Product or make any representation regarding their status as a licensee of or distributor for Durect for Product, and shall
dispose the remaining inventory of the Product [* * *]. 
 10.6.2 [* * *]. [* * *]. 

10.6.3 [* * *]. [* * *]. 

10.6.4 Sublicensees. In the event that Santen terminates this Agreement, all sublicenses granted by Santen whether to Affiliates or
Third Parties shall terminate. In the event that Durect terminates this Agreement pursuant to Sections 10.3 or 10.4, then, any sublicense granted by Santen to a Sublicensee pursuant to this Agreement will remain in effect and shall survive, at
such Sublicensee’s election, in accordance with this Agreement to the extent [* * *], provided that: [* * *]. 
 10.6.5 Santen,
its Affiliates and Sublicensees shall not challenge Durect’s ownership of, or the validity of, Durect Trademark for [* * *] after the term of this Agreement. 

10.6.6 Costs and Expenses. Except as expressly provided herein, [* * *]. 

10.6.7 Exclusivity. Section 3.3 shall continue to apply [* * *] for [* * *] after the effective date of such termination. 

10.7 Additional Effects of Certain Terminations due to cause by Durect. [* * *]. 

10.8 Termination Press Releases. In the event of termination of this Agreement for any reason, the Parties shall cooperate in good
faith to coordinate public disclosure of such termination and the reasons therefor, and shall not, except to the extent required by Applicable Law or the rules of a recognized stock exchange, disclose such information without the prior approval of
the other 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 
Party, such approval not to be unreasonably withheld, conditioned or delayed. To the extent possible under the situation, the terminating Party shall provide the non-terminating Party with a
draft of any such public disclosure it intends to issue [* * *] in advance and with the opportunity to review and comment on such statement, it being understood that if the non-terminating Party does not notify the terminating Party in writing
within such [* * *] period (or such shorter period if required by Applicable Law or the rules of a recognized stock exchange) of any reasonable objections, such disclosure shall be deemed approved, and in any event the Parties shall work diligently
and reasonably to agree on the text of any such proposed disclosure in an expeditious manner. The principles to be observed in such disclosures shall be accuracy, compliance with Applicable Law and regulatory guidance documents, reasonable
sensitivity to potential negative reactions to such news and the need to keep investors and others informed regarding the Parties’ business and other activities. Accordingly in such situation, the non-terminating Party shall not withhold,
condition or delay its approval of a proposed disclosure that complies with such principles. 
 10.9 Additional Effects of Expiration of
this Agreement. Upon expiration but not termination of this Agreement, [* * *]. 
 ARTICLE 11 

DISPUTE RESOLUTION 
 11.1
Disputes. If the Parties are unable to resolve any dispute or other matter arising out of or in connection with this Agreement, either Party may, by written notice to the other, have such dispute referred to the Chief Executive Officers
(or their executive officer level designees) of the Parties for attempted resolution by good faith negotiations within [* * *] after such notice is received. In such event, each Party shall cause its Chief Executive Officers(or such designees) to
meet (face-to-face or by teleconference) and be available to attempt to resolve such issue. If the Parties should resolve such dispute or claim under this Section 11.1, a memorandum setting forth their agreement will be prepared and signed by
both Parties if requested by either Party. The Parties shall cooperate in an effort to limit the issues for consideration in such manner as narrowly as reasonably practicable in order to resolve the dispute. 

11.2 Arbitration. In the event that the Parties are unable to resolve any such matter pursuant to Section 11.1, then either
Party may initiate arbitration pursuant to this Section 11.2. Any arbitration under this Section 11.2 shall be conducted by International Chamber of Commerce (the “ICC”) in [* * *] by three arbitrators in accordance with
the Rules of Arbitration of the ICC rules. The costs of such arbitration shall be [* * *]. 
 11.3 Injunctive
Relief. Notwithstanding the provisions of Section 11.2, each Party acknowledges and agrees that, due to the unique and valuable nature of the other Party’s proprietary information and materials, there may be no adequate remedy at
law for a breach by such Party of the provisions of this Agreement, that any such may breach may result in irreparable harm to the other Party for which monetary damages would be inadequate to compensate such Party and that the other Party shall
have the right, in addition to any other rights available under applicable law, to seek from any court of competent jurisdiction injunctive relief to restrain any breach or threatened breach of, or otherwise to specifically enforce, any covenant or
obligation of such Party under such provisions, without the necessity of posting any bond or security. 

  
 -29- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 ARTICLE 12 

MISCELLANEOUS 
 12.1
Governing Law. This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the laws of [* * *], without reference to conflicts of laws principles. 

12.2 Assignment. This Agreement shall not be assignable by either Party to any Third Party without the written consent of the
other Party. Notwithstanding the foregoing, either Party may assign this Agreement, without the written consent of the other Party, to an Affiliate of such Party or an entity that acquires all or substantially all of the business or assets of such
Party to which this Agreement pertains (whether by merger, reorganization, acquisition, sale, operation of law or otherwise), and agrees in writing to be bound by the terms and conditions of this Agreement. No assignment or transfer of this
Agreement shall be valid and effective unless and until the assignee/transferee agrees in writing to be bound by the provisions of this Agreement. The terms and conditions of this Agreement shall be binding on and inure to the benefit of the
permitted successors and assigns of the Parties. Except as expressly provided in this Section 12.2, any attempted assignment or transfer of this Agreement shall be null and void. 

12.3 Consequences of Bankruptcy. The Parties acknowledge and agree that all rights and licenses now or hereafter granted under or
pursuant to any Section of this Agreement are rights to “intellectual property” as defined in Section 101(35A) of Title 11 of the United States Code. Each Party may elect to retain and may fully exercise all of its rights and
elections under Section 365(n) of Title 11 of the United States Code and other similar laws in any jurisdiction outside the U.S. (collectively, the “Bankruptcy Laws”). The Parties further agree that in the event of the
commencement of a bankruptcy proceeding during the Term by or against a Party under the Bankruptcy Laws then, unless and until this Agreement is rejected as provided in such Bankruptcy Laws, such Party (in any capacity, including
debtor-in-possession) and its successors and assigns (including a trustee) shall perform all of the obligations provided in this Agreement to be performed by such Party. The Parties further agree that in the event of a commencement of a bankruptcy
proceeding under the Bankruptcy Laws, this Agreement is rejected or not assumed as provided in the Bankruptcy Laws and the other Party elects to retain its rights hereunder as provided in the Bankruptcy Laws, then the Party subject to such case
under the Bankruptcy Laws (in any capacity, including debtor-in-possession) and its successors and assigns (including a Title 11 trustee), shall provide to the other Party copies of all information necessary for such other Party to exercise and
enjoy its rights under the terms of this Agreement promptly upon such other Party’s written request therefor. All rights, powers and remedies of the non-bankrupt Party as provided herein are in addition to and not in substitution for any and
all other rights, powers and remedies now or hereafter existing at law or in equity (including, without limitation, the Bankruptcy Laws) in the event of the commencement of a case by or against a Party under the Bankruptcy Laws. Section 365(n)
and the terms of this Section 12.3 shall apply and shall be enforced in and by every court, tribunal, arbitrator, regulatory body or official resolving disputes between the Parties with respect to rights in intellectual property, whether such
court, tribunal, arbitrator, regulatory body or official is located in the U.S. or in any other nation or jurisdiction. 

  
 -30- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 12.4 Notices. Any notice, request, delivery, approval or consent required or
permitted to be given under this Agreement shall be in writing and shall be deemed to have been sufficiently given if delivered in person, transmitted by facsimile (receipt verified) or by express courier service (signature required) or [* * *]
after it was sent by registered letter, return receipt requested (or its equivalent), provided that no postal strike or other disruption is then in effect or comes into effect within [* * *] after such mailing, to the Party to which it is directed
at its address or facsimile number shown below or such other address or facsimile number as such Party will have last given by notice to the other Party. 
  

			
	If to Durect, addressed to:		Durect Corporation
			10260 Bubb Road
			Cupertino, CA 95014
			United States
			Attention: Legal Department
			Telephone: (408) 777-3577
			Facsimile: (408) 777-1417
		
	With a copy to:		Wilson Sonsini Goodrich & Rosati
			Professional Corporation
			650 Page Mill Road
			Palo Alto, CA 94304-1050
			United States
			Attention: Ian B. Edvalson, Esq.
			Telephone: (650) 493-9300
			Facsimile: (650) 493-6811
		
	If to Santen, addressed to:		Santen Pharmaceutical Co., Ltd.
			4-20, Ofuka-cho, Kita-ku, Osaka 530-8552
			Japan
			Attention: Head of Global Business Development
			Telephone: [* * *]
			E-mail: [* * *]
		
	With a copy to:		Santen Pharmaceutical Co., Ltd.
			4-20, Ofuka-cho, Kita-ku, Osaka 530-8552
			Japan
			Attention: [* * *]
			Telephone: [* * *]
			E-mail: [* * *]

 12.5 Waiver. Neither Party may waive or release any of its rights or interests in this Agreement
except in writing. The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any
such term or condition. No waiver by either Party of any condition or term in any one or more instances shall be construed as a continuing waiver of such condition or term or of another condition or term. 

  
 -31- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 12.6 Severability. If any provision hereof should be held invalid, illegal or
unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof shall remain in full force
and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or
enforceability of such provision in any other jurisdiction. If a Party seeks to avoid a provision of this Agreement by asserting that such provision is invalid, illegal or otherwise unenforceable, the other Party shall have the right to terminate
this Agreement upon [* * *] prior written notice to the asserting Party, unless such assertion is eliminated and cured within such [* * *] period. If such termination is by Durect, it shall be deemed a termination under Section 10.2, and if
such termination is by Santen, it shall be deemed a termination under Section 10.3 by reason of a breach by Durect. 
 12.7 Entire
Agreement/Modification. This Agreement, including its Exhibits, sets forth all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties and supersedes and terminates all prior
agreements and understandings between the Parties including the Feasibility Evaluation Agreement. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by the
respective authorized officers of the Parties. 
 12.8 Relationship of the Parties. The Parties agree that the relationship of
Durect and Santen established by this Agreement is that of independent contractors. Furthermore, the Parties agree that this Agreement does not, is not intended to, and shall not be construed to, establish an employment, agency or any other
relationship. Except as may be specifically provided herein, neither Party shall have any right, power or authority, nor shall they represent themselves as having any authority to assume, create or incur any expense, liability or obligation, express
or implied, on behalf of the other Party, or otherwise act as an agent for the other Party for any purpose. 
 12.9 Force
Majeure. Except with respect to payment of money, neither Party shall be liable to the other for failure or delay in the performance of any of its obligations under this Agreement for the time and to the extent such failure or delay is
caused by earthquake, riot, civil commotion, war, terrorist acts, strike, flood, or governmental acts or restriction, or other cause that is beyond the reasonable control of the respective Party. The Party affected by such force majeure will provide
the other Party with full particulars thereof as soon as it becomes aware of the same (including its best estimate of the likely extent and duration of the interference with its activities), and will use commercially reasonable efforts to overcome
the difficulties created thereby and to resume performance of its obligations as soon as practicable. If the performance of any such obligation under this Agreement is delayed owing to such a force majeure for any continuous period of more than [* *
*], the Parties will consult with respect to an equitable solution, including the possibility of the mutual termination of this Agreement. 

12.10 Compliance with Laws/Other. Notwithstanding anything to the contrary contained herein, all rights and obligations of Durect
and Santen are subject to prior compliance with, and each Party shall comply with, all Applicable Laws, including obtaining all necessary approvals required by the applicable agencies of the governments of the United States and foreign
jurisdictions. In addition, each Party shall conduct its activities under the Collaboration in accordance with good scientific and business practices. 

  
 -32- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 12.11 Counterparts. This Agreement may be executed in two counterparts, each of
which shall be deemed an original, and all of which together, shall constitute one and the same instrument. 
 [The remainder of this page
intentionally left blank; the signature page follows.] 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their duly
authorized representatives as of the Effective Date. 
  

									
	DURECT CORPORATION				SANTEN PHARMACEUTICAL CO., LTD.
					
	 By:
		 /s/ James E. Brown
				By:		 /s/ Akira Kurokawa

	 Name:
		 James E. Brown
				Name:		Akira Kurokawa
	 Title:
		 President and Chief Executive Officer
				Title:		President and Chief Executive Officer

 List of Exhibits: 
 [* *
*] 
 Exhibit 1.45: Santen Technology (Patents) 
 Exhibit
4.2.1: Development Plan Outline 
 Exhibit 4.3: Durect Trademark 

Exhibit 6.3.4: Payment Reports 
 Exhibit 8.5.1:
Press Release 
 [* * *] 

[Signature Page to License Agreement] 

  
 -34- 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 [* * *] 

  

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 [* * *] 

  

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 EXHIBIT 1.44 

SANTEN TECHNOLOGY (PATENTS) 

[* * *] 

  

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 EXHIBIT 4.2.1 

DEVELOPMENT PLAN OUTLINE 

[* * *] 

  

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 EXHIBIT 4.3 

DURECT TRADEMARK 
  

 

  

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 EXHIBIT 6.3.4 

PAYMENT REPORTS 
 [* * *]

  

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 EXHIBIT 8.5.1 

PRESS RELEASE 
 [To be
completed and attached] 

  

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 [* * *] 

  

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 [* * *]EX-10.29

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

Exhibit 10.29 
 EXCLUSIVE
LICENSE AGREEMENT 
 THIS EXCLUSIVE LICENSE AGREEMENT is made and entered into this 5th day of December, 2012, by and between: DURECT
CORPORATION, a Delaware corporation (hereinafter referred to as the “LICENSEE”) with its principal place of business at 10260 Bubb Road, Cupertino, CA 95014, and VIRGINIA COMMONWEALTH UNIVERSITY INTELLECTUAL PROPERTY FOUNDATION
(hereinafter referred to as the “LICENSOR”), and with its principal place of operation at Virginia Commonwealth University, 800 E. Leigh Street, Suite 3000, Richmond, Virginia 23298-0568. 

WHEREAS, LICENSOR is charged with management and licensing of intellectual properties developed at Virginia Commonwealth University
(“VCU”) and, under VCU intellectual property policy, inventions made by employees of VCU or made using the facilities of VCU are required to be assigned to VCU and managed by LICENSOR; 

WHEREAS, VCU and/or the United States Department of Veterans Affairs (hereinafter called “VA”) are joint or sole owners of
all right, title, and interest in patent applications and inventions and know-how associated with the VCU Invention Disclosures as listed in Appendix A attached hereto and made a part hereof, and other LICENSED TECHNOLOGY (defined herein). 

WHEREAS, LICENSOR and the VA are parties to an Inter-Institutional Agreement (the “IIA” attached as Appendix C) dated [* * *]
which provides that LICENSOR is authorized to (a) negotiate, execute and administer license agreements granting rights to LICENSED PATENT RIGHTS (defined herein) on behalf of VA and (b) receive on behalf of VA amounts paid in consideration
of such grant of rights and to share a portion of such amounts with VA; 
 WHEREAS, LICENSOR and LICENSEE entered into an Option
Agreement on [* * *] (hereinafter “Option Agreement”) and an Amendment to the Option Agreement effective [* * *], and LICENSEE has exercised its right to license LICENSED TECHNOLOGY and LICENSED PATENT RIGHTS; 

WHEREAS, among other things, this Agreement is intended to implement the binding terms set forth in the Term Sheet Appendix to Option
Agreement signed by the parties and dated [* * *]; 
 WHEREAS LICENSEE is desirous of acquiring from LICENSOR certain rights set
forth below and LICENSOR wishes to grant licenses to such rights to LICENSEE as set forth herein; 
 NOW, THEREFORE, in consideration
of the promises and the covenants set forth herein, LICENSOR and LICENSEE agree as follows: 
 I. DEFINITIONS 

The following definitions shall apply in the interpretation of this Agreement. 

1.1 “AFFILIATE” of any company means any corporation which, directly or indirectly, controls or is controlled by, or is under direct or indirect
common control with, such company; and for the purposes of this definition “control” (including “control by” and “under common control with”) as used with respect to any corporation or company, shall mean the
possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such corporation or company, through the ownership of more than 50% of the voting shares. 

  
 1 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 1.2 “CALENDAR QUARTER” means the three-month period ending
March 31, June 30, September 30, or December 31 in any year. 
 1.3 “CDA” shall have the meaning ascribed to such
term in Section 9.12. 
 1.4 “COLLABORATION IMPROVEMENTS” means IMPROVEMENTS not falling under the SRA TECHNOLOGY, that are developed,
generated, made, conceived or reduced to practice jointly by or on behalf of INVENTOR(S) and NON-INVENTOR(S). 
 1.5 “COMMERCIALLY REASONABLE
EFFORTS” shall mean [* * *]. 
 1.6 “Dual Appointment Personnel or DAP” shall mean any person who is employed by both VCU and VA, or [* * *].

 1.7 “EFFECTIVE DATE” shall mean the date of the Agreement set forth above. 

1.8 “FIELD OF USE” shall mean all fields of use. 
 1.9
“Force Majeure” shall have the meaning ascribed to such term in Section 9.9. 
 1.10 “IMPROVEMENT(S)” means [* * *]. 

1.11 “Indemnitees” shall have the meaning ascribed to such term in Section 9.5. 

1.12 “INVENTOR(S) means [* * *]. 
 1.13 “INVENTOR
IMPROVEMENT(S)” means [* * *]. 
 1.14 “Joint Patents” shall have the meaning ascribed to such term in Section 8.2. 

1.15 “Liabilities” shall have the meaning ascribed to such term in Section 9.5. 

1.16 “LICENSED PATENT RIGHTS” shall mean [* * *]. 

1.17 “LICENSED PRODUCTS” shall mean any product or process in the FIELD OF USE embodying LICENSED TECHNOLOGY or that incorporates, is covered,
disclosed or claimed by, or is made, in whole or part, by the use of the LICENSED PATENT RIGHTS. 
 1.18 “LICENSED TECHNOLOGY” shall mean and
include: 
  

	 	(i)	the technologies, inventions and know-how associated with the [* * *], 

  

	 	(ii)	SRA TECHNOLOGY, INVENTOR IMPROVEMENT(S), COLLABORATION IMPROVEMENTS and any NON-INVENTOR IMPROVEMENT(S) that LICENSEE elects to add to this AGREEMENT under Section 2.3, 

  
 2 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

	 	(iii)	any and all non-patented or non-patent pending technical information, formulations, compounds, compositions, products, processes, know-how, trade secrets, data, specifications, methods of manufacture or use including
but not limited to [* * *] and other proprietary information, that are: 

  

	 	a.	controlled by VCU, and 

  

	 	b.	related to the VCU Invention Disclosures listed in Appendix A, and 

  

	 	c.	developed, generated, made, conceived or reduced to practice by or on behalf of INVENTOR(S), alone or with others, during the course of research conducted by them, in accordance with Section 2.3. 

[* * *] and 
  

	 	(iv)	Other technologies, inventions and know-how associated with the VCU Invention Disclosures listed in Appendix A that were discovered or invented by or on behalf of INVENTOR(S) as of the EFFECTIVE DATE, including the
following: [* * *]. 

 1.19 “MAJOR MARKET” means [* * *]. 

1.20 “NET SALES” shall mean the amounts received by LICENSEE and its AFFILIATES and SUBLICENSEES from the commercial use of LICENSED PRODUCTS, or
the commercial sale of LICENSED PRODUCTS, from non-AFFILIATED third parties in arm’s length transactions, less, to the extent such deductions or allowances can be documented by LICENSEE: (i) shipping costs (including freight, postage,
handling and standard transportation charges such as insurance and packing and distribution charges), (ii) allowances or credits because of returned, rejected or recalled LICENSED PRODUCTS as actually allowed, (iii) other discounts,
credits and allowances including normal and customary quantity discounts, cash discounts (including discounts for prompt payment), and customary trade promotional allowances and credits (including adjustments such as those granted on account of
co-pay reduction programs, price adjustments, billing errors, damaged goods, rebates, chargeback rebates, fees, reimbursements or similar payments granted or given to wholesalers or other distributors, buying groups, healthcare insurance carriers,
group purchasing organizations, managed health care organizations, wholesalers, pharmacy benefit management or similar organizations, federal, state/provincial, local and other governments, including their agencies, trade customers or other
institutions), and discounts mandated by or granted in response to laws or regulations, retroactive price reductions or rebates paid or credited to any governmental authority or agency or third party payor, administrator or contractee, including in
respect of any government subsidized program (including without limitation Medicare and Medicaid rebates), and (iv) taxes including import, export, use, excise and sales taxes, tariffs and duties (including customs duties) and other
governmental charges imposed on the importation, use or sale of LICENSED PRODUCTS (including without limitation, value-added and withholding taxes). [* * *] 

1.21 “NON-INVENTOR(S)” means any VCU/ VA Personnel who is not an INVENTOR. 

1.22 “NON-INVENTOR IMPROVEMENT(S)” means [* * *]. 

1.23 “Patent Prosecution Costs” shall have the meaning ascribed to such term in Section 4.5. 

1.24 “Proprietary Information” means [* * *]. 
 1.25
“Royalty Holiday” shall have the meaning ascribed to such term in Section 3.5. 
 1.26 “SRA” means the Sponsored Research Agreement
by and between VCU and LICENSEE, effective [* * *]. 

  
 3 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 1.27 “SRA TECHNOLOGY” means PROJECT TECHNOLOGY (defined in the SRA) and any technology, data,
ideas, inventions, discoveries and IMPROVEMENTS, and the intellectual property rights therein and thereto including PROJECT PATENT RIGHTS (defined in the SRA) and enforcement rights, that are developed, generated, made, conceived or reduced to
practice, in whole or in part, by INVENTOR(S), alone or with others, directly or indirectly in the performance or as a result of the SRA Project (defined in the SRA). 

1.28 “SUBLICENSEE” shall mean any non-affiliated third party to whom LICENSEE has granted a SUBLICENSE. SUBLICENSEE shall also mean any
non-affiliated third party to whom a SUBLICENSEE has granted a SUBLICENSE. “SUBLICENSE” shall mean an agreement in which LICENSEE or SUBLICENSEE (i) grants any of the rights licensed to LICENSEE hereunder, or (ii) agrees not to
assert such rights or to sue, prevent or seek a legal remedy for the practice of any of the rights licensed to LICENSEE hereunder. Notwithstanding the foregoing, a SUBLICENSEE shall not mean a successor entity or an entity that acquires all or
substantially all of the stock, business or assets of LICENSEE, or all or substantially all of the stock, business or assets of LICENSEE that relate to the LICENSED TECHNOLOGY or LICENSED PATENT RIGHTS, whether by acquisition, merger, sale of stock,
sale of assets or otherwise. 
 1.29 “SUBLICENSING REVENUE” shall mean payments or fair market value of non-cash consideration received by
LICENSEE from a SUBLICENSEE under and in consideration for its SUBLICENSE, including if applicable, license issue fees and other licensing fees, milestone payments or other payments. [* * *] [* * *] To determine the basis on which SUBLICENSING
REVENUE is to be calculated, the following amounts shall be excluded, [* * *]. 
 1.30 “VALID CLAIM” shall mean a claim of an issued and unexpired
patent within the LICENSED PATENT RIGHTS that has not been (i) cancelled with prejudice, (ii) declared invalid or unenforceable by decision of a court of competent jurisdiction or other governmental authority, (iii) admitted to be
invalid or unenforceable through reissue, disclaimer, or otherwise, or (iv) abandoned. 
 II. GRANT 

2.1 LICENSOR hereby grants to LICENSEE an exclusive, royalty bearing, worldwide license under LICENSED TECHNOLOGY and LICENSED PATENT RIGHTS to develop, make,
have made, use, offer to sell, sell, export and import LICENSED PRODUCTS and to use, practice and otherwise exploit methods embodying LICENSED TECHNOLOGY and/or that are disclosed in, covered or claimed by LICENSED PATENT RIGHTS, with the right to
SUBLICENSE others through multiple tiers of sublicensees under the terms of Article VIII, throughout the term hereof in the FIELD OF USE. This grant shall be subject to the payment by LICENSEE to LICENSOR of all consideration as provided in this
Agreement, and shall be further subject to the rights retained by LICENSOR, VCU, and VA: 
  

	 	(a)	subject to Section 9.20, publish the scientific findings from research related to LICENSED PATENT RIGHTS, 

  

	 	(b)	to practice under the LICENSED PATENT RIGHTS for internal educational, research, and other internal non-commercial purposes, except that such purposes shall not include any testing or other use in humans without the
LICENSEE’s prior written consent which may be withheld in its sole discretion. LICENSOR will not file for any regulatory approvals to test or market any LICENSED PRODUCTS anywhere in the world, 

  
 4 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

	 	(c)	Subject to the limitations set forth in Section 2.1(b) above, such reservation shall include the right to extend such right to practice under the LICENSED PATENT RIGHTS for internal educational and research
purposes (but not for patient care and treatment, or any other internal purpose) to subsequent employers of any of the INVENTORS, but only to the extent that such employers are not-for-profit organizations, and 

 

	 	(d)	For biological materials and/or research tools that are covered under the LICENSED TECHNOLOGY and could be considered a NIH-funded research resource (collectively and hereinafter “Materials”), such reservation
shall further include the right to provide such Materials and to grant licenses under the LICENSED PATENT RIGHTS, to not-for-profit and governmental institutions for their non-commercial, internal research and scholarly use only, in accordance with
the NIH Guidelines for Obtaining and Disseminating Biomedical Research Resources (as published in the U.S. Federal Register / vol. 64, No. 246 - 12/23/99). Notwithstanding the foregoing, the parties understand and agree that[* * *]are not and
shall not be deemed Materials under this Section 2.1(d). 

  

	 	(e)	LICENSOR agrees to notify LICENSEE in writing no less than [* * *] prior to taking any of the actions described in Sections 2.1(c) or 2.1(d) above. 

 

	 	(f)	Under the IIA, VA is obligated to receive and treat as confidential, LICENSEE’s Proprietary Information that LICENSOR provides to the VA in fulfillment of its obligations under the IIA and not disclose such
Proprietary Information without the prior written consent of LICENSOR. LICENSOR shall promptly notify LICENSEE in writing if during the term hereof, the IIA is amended, expires or terminates, or if the confidentiality obligations of VA under the IIA
change. 

 2.2 Notwithstanding anything herein to the contrary, any and all licenses and other rights granted hereunder are limited by and
subject to the rights and requirements of the United States Government which may attach as a result of Government sponsorship of research at VCU, in which the invention covered by the LICENSED PATENT RIGHTS was conceived or reduced to practice, as
set forth in 35 U.S.C. §§200-206, 37 C.F.R. Part 401 and in the relevant Government research contracts with VCU, and as such rights and requirements may be amended or modified by law. To the extent applicable, such rights and requirements
include without limitation (i) the grant of a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the Government any of the LICENSED PATENT RIGHTS throughout the world (as set forth in
35 U.S.C. §202(c)(4)), and (ii) the requirement that LICENSED PRODUCTS used or sold in the United States will be manufactured substantially in the United States (as set forth in 35 U.S.C. §204). 

 

	2.3	LICENSOR shall promptly disclose to LICENSEE in writing, [* * *] 

 III. PAYMENT PROVISIONS

 3.1 In consideration for the rights, privileges and licenses granted under this Agreement, the LICENSEE shall pay to LICENSOR the fees and royalties
specified in Article IV and Appendix B, attached hereto and incorporated herein by reference. 

  
 5 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 3.2 With each report submitted under Section 5.2 of this Agreement, LICENSEE shall make all payments to
LICENSOR that are due and payable under Article III of this Agreement. If no royalties are due, LICENSEE shall so report. 
 3.3 LICENSEE shall be obligated
to pay royalties on all NET SALES of LICENSED PRODUCTS that are sold commercially under this license as described in Appendix B [* * *]. LICENSEE shall continue to make reports concerning royalties on NET SALES of LICENSED PRODUCTS payable in
accordance with Article III after termination of the license, until such time as all such LICENSED PRODUCTS produced under the license and sold pursuant to Section 7.5, have been sold or destroyed. [* * *] the submittal of each post-termination
report, LICENSEE shall pay LICENSOR all applicable royalties. 
 3.4 All payments due the LICENSOR must be paid in U.S. currency to the LICENSOR. The
LICENSEE must convert NET SALES invoiced in foreign currency into equivalent U.S. currency at the exchange rate for the foreign currency [* * *]. Royalty payments shall be based on NET SALES of LICENSED PRODUCT in any country where a VALID CLAIM of
a LICENSED PATENT RIGHT covering a LICENSED PRODUCT or its manufacture, use or sale is in effect, and on NET SALES of LICENSED PRODUCT in a country to which the LICENSED PRODUCT has been exported, but no VALID CLAIM of a LICENSED PATENT RIGHT covers
the LICENSED PRODUCT or its manufacture, use or sale in such country of sale, but the LICENSED PRODUCT was produced in a country where a VALID CLAIM of a LICENSED PATENT RIGHT covering the manufacture of such LICENSED PRODUCT was in effect at the
time of such manufacture. LICENSEE agrees to pay interest of [* * *], on any delinquent undisputed payments to LICENSOR. LICENSEE shall calculate the correct late payment charge, and shall add it to each such late payment. 

3.5 Royalty Holiday. LICENSEE shall not be obligated to pay royalties to LICENSOR hereunder with respect to a LICENSED PRODUCT while there is a
pending third party claim of actual or alleged infringement or misappropriation of intellectual property rights as a result of the composition of matter, manufacture, use, sale, offer for sale or import of such LICENSED PRODUCT (such period of time
to be referred to as a “Royalty Holiday”). After such third party claim has been finally resolved (either through a final and binding settlement or by a determination by a court of competent jurisdiction from which an appeal cannot be
taken), LICENSEE’s royalty payment obligation shall recommence and any royalty payments that accrued but were not paid to LICENSOR during such Royalty Holiday shall be paid to LICENSOR subject to and in accordance with Appendix B, subsection
2(d). For the purposes of clarity, such Royalty Holiday is only applicable when the alleged infringement pertains to the LICENSED TECHNOLOGY licensed to LICENSEE under this Agreement and does not apply when aspects of the LICENSED PRODUCT not
relating to the LICENSED TECHNOLOGY are alleged to infringe. 
 IV. DILIGENCE AND PATENT PROSECUTION 

4.1 The LICENSEE will use its COMMERCIALLY REASONABLE EFFORTS to bring one or more LICENSED PRODUCTS to market and to market LICENSED PRODUCTS throughout the
life of this Agreement. It is agreed that LICENSEE may meet its obligations under Sections 4.1 and 4.2 of this Article IV through one or more AFFILIATES, SUBLICENSEES, co-promoters, sales representatives, distributors and/or subcontractors.
Moreover, LICENSEE shall not be required to obtain regulatory approval for, or market and sell, LICENSED PRODUCTS in countries other than those where, in LICENSEE’s reasonable opinion, there is a significant market for LICENSED PRODUCTS. 

  
 6 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 4.2 To be in compliance with Section 4.1, the LICENSEE must meet the following diligence requirements:

 [* * *] 
 4.3 Article IV is a material term of this
Agreement, without which the license granted under Article II would not have been made, and the LICENSEE’s failure to perform in accordance with Sections 4.1 and 4.2 would constitute a material breach of this Agreement. 

4.4 LICENSOR shall have exclusive responsibility for the preparation, filing, prosecution, and maintenance of the LICENSED PATENT RIGHTS, including choice of
patent counsel; [* * *]. LICENSOR shall keep LICENSEE fully informed of the preparation and filing of patent applications and of patent prosecution and the maintenance of patents in relation to the LICENSED PATENT RIGHTS, and LICENSEE shall be given
an opportunity to review and provide input with respect thereto, including the right to comment on strategy and prosecution and make suggestions for claims, and LICENSOR agrees to take into account LICENSEE’s input. Without limiting the
foregoing, LICENSOR shall send to LICENSEE and LICENSEE shall receive drafts of proposed patent applications, patent office responses and foreign counsel instructions at least [* * *] before their submission. LICENSOR shall provide LICENSEE with all
reasonable opportunities, including direct access to LICENSOR’s patent counsel, to participate in the drafting of applications, petitions, responses to office actions and other inquiries of patent examining authorities, and in the conduct of
interviews with, and other oral arguments to, such authorities. LICENSEE shall also have the right to make requests to LICENSOR as to when and where to file patent applications, continuations, divisionals, continuations-in-part, substitutes,
renewals, reissues, extensions, confirmations, reexaminations and registrations with respect to the LICENSED PATENT RIGHTS and LICENSOR will [* * *]. 
 4.5
LICENSEE shall reimburse [* * *], not already reimbursed by LICENSEE, incurred by LICENSOR after [* * *] and not already reimbursed by LICENSEE as of the EFFECTIVE DATE, and during the term of this Agreement by LICENSOR in filing, prosecuting and
maintaining the LICENSED PATENT RIGHTS (the “Patent Prosecution Costs”), within [* * *]. [* * *]. 
 4.6 LICENSOR or its patent counsel shall
inform LICENSEE [* * *] (in writing, including via email) as to all developments with respect to the LICENSED PATENT RIGHTS on a worldwide basis, including all actions necessary for the filing, prosecution, issuance and maintenance of LICENSED
PATENT RIGHTS (including [* * *] furnishing LICENSEE with copies of all correspondence in relation thereto including copies of communications from the Patent and Trademark Office, including foreign patent offices, and correspondence from foreign
patent counsel) and shall [* * *] furnish to LICENSEE copies of all papers received and filed in connection with the prosecution thereof in sufficient time for LICENSEE to comment thereon. LICENSEE shall [* * *] instruct LICENSOR in writing whether
to take such action [* * *]. [* * *]. 
 4.7 If LICENSOR decides to file patent applications, continuations, divisionals, continuations-in-part,
substitutes, renewals, reissues, extensions, confirmations, reexaminations or registrations with respect to the LICENSED PATENT RIGHTS in any countries other than those countries where LICENSEE has directed LICENSOR to file under Section 4.4,
[* * *] shall be responsible for [* * *] associated with the LICENSED PATENT RIGHTS in such countries. If LICENSEE declines to pay [* * *], LICENSOR shall have the right to (i) [* * *] or (ii) [* * *]. In the former case, [* * *]. In the
latter case [* * *]. 

  
 7 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 4.8 If LICENSOR decides to abandon prosecution or maintenance of any patent application or patent within the
LICENSED PATENT RIGHTS in a country where LICENSEE has requested LICENSOR to make and maintain such filing or patent, LICENSOR shall provide LICENSEE written notice of LICENSOR’s intent to abandon such application or patent in sufficient time
to permit LICENSEE in its discretion to continue such prosecution or maintenance. In such event, LICENSEE shall have the right to continue prosecution of said application, or maintenance of such patent [* * *], on behalf of LICENSOR and LICENSEE. In
such event, LICENSOR shall execute all documents and perform such acts [* * *] for LICENSEE to continue such prosecution or maintenance. LICENSOR shall also notify LICENSEE in writing if LICENSOR decides not to file any patent applications,
continuations, divisionals, continuations-in-part, substitutes, renewals, reissues, extensions, confirmations, reexaminations or registrations with respect to any of the LICENSED PATENT RIGHTS which may be suggested by LICENSEE. Such notice shall be
given in sufficient time to permit LICENSEE in its discretion to prepare such filings, in which case LICENSOR shall execute all documents and perform such acts [* * *] for LICENSEE to make such filings. 

4.9 LICENSEE shall reimburse Patent Prosecution Costs as follows: [* * *]. 

4.10 LICENSOR shall have the right to [* * *] terminate this Agreement in the event that [* * *]. 

V. REPORTING OBLIGATIONS 
 5.1 Progress
Report. On or before [* * *] until the [* * *], LICENSEE shall make a written [* * *] report to LICENSOR covering [* * *] regarding the progress of LICENSEE, its AFFILIATES and/or SUBLICENSEES toward commercialization of LICENSED PRODUCTS, [* * *].
Such report shall include [* * *]. After the first commercial sale of the first LICENSED PRODUCT, LICENSEE’s reporting obligations to LICENSOR shall be as set forth in Section 5.2. 

5.2 LICENSEE, [* * *] following the first commercial sale of a LICENSED PRODUCT, shall deliver to LICENSOR true and accurate reports, pertaining to NET SALES
of LICENSED PRODUCTS as follows: 
 [* * *] 
 5.3 LICENSEE
shall keep full, true and accurate books of account for the purpose of showing the amounts payable to LICENSOR hereunder. Said books of account shall be kept at LICENSEE’s principal place of business. No more frequently than [* * *], LICENSOR,
at its expense, may [* * *], have reviewed such books of account at LICENSEE’s principal place of business, to verify the accuracy of LICENSEE’S payments made hereunder. Such review shall be performed by an independent third party
certified public accounting firm designated by LICENSOR and [* * *] acceptable to LICENSEE, during regular business hours and under conditions of confidentiality. Under no circumstances shall LICENSOR or the independent third party certified public
accounting firm have access to any of the books and records of any SUBLICENSEE. LICENSOR may, however, require that LICENSEE perform or have performed, [* * *], a review of a SUBLICENSEE’s books of account to verify the accuracy of payments
made by a SUBLICENSEE to LICENSEE under any SUBLICENSE, the costs and expenses of which shall be reimbursed by LICENSOR. Such verification by LICENSOR hereunder may be conducted for [* * *] following [* * *]. [* * *] If such inspection reveals any
overpaid amounts, LICENSEE can deduct such amounts from future royalty payments owed to LICENSOR. 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 VI. INFRINGEMENT 

6.1 LICENSEE acknowledges and agrees that other than as expressly provided for in this Agreement, [* * *]. LICENSOR and LICENSEE shall promptly notify the
other party in writing with respect to any claim, suit or other action brought by a third party alleging that the composition of matter, manufacture, use, import, offer for sale or sale of a LICENSED PRODUCT infringes or misappropriates any third
party intellectual property rights. In the event of a third party infringement action against either party with respect to any LICENSED PRODUCTS that are developed, manufactured, marketed or sold by or on behalf of LICENSEE, LICENSEE will, subject
to subsections (i) through (iii) of Section 9.5, defend LICENSOR, [* * *]. LICENSEE shall indemnify, defend and hold VCU, VA and LICENSOR harmless from any judgment to the extent resulting from the infringement of third party
intellectual property rights by LICENSED PRODUCTS that are developed, manufactured, marketed or sold by or on behalf of LICENSEE, and [* * *] shall pay any damages awarded in any such judgment against Indemnitee (as defined in Section 9.5),
except where such damages are attributable to the negligence, intentional misconduct, violation of law or regulation or breach of this Agreement by any Indemnitee or VCU/VA Personnel. LICENSOR will cooperate as requested by LICENSEE, [* * *]. No
settlement, consent judgment, or other voluntary final disposition of any suit that would affect the validity, scope or enforceability of the LICENSED PATENT RIGHTS, by estoppel, admission or otherwise, or the LICENSOR’s rights in or to same,
may be entered into without the consent of LICENSOR, not to be unreasonably withheld, delayed or conditioned such as upon additional consideration. 
 6.2
LICENSEE and LICENSOR shall promptly inform each other in writing of any alleged infringement of the LICENSED PATENT RIGHTS by a third party. 
 6.3 During
the term of this Agreement, LICENSEE will have the primary right, but shall not be obligated, to prosecute at its own expense all enforcement actions against alleged or actual infringements of the LICENSED PATENT RIGHTS and, in furtherance of such
right, LICENSEE may include LICENSOR, as a party plaintiff in any such suit, provided that [* * *]. LICENSEE’s right also includes without limitation, the right to defend any action for declaratory judgment of non-infringement or invalidity,
and instituting, defending and settling all infringement and declaratory judgment actions [* * *] and through counsel of its own choosing. LICENSOR shall provide reasonable assistance to LICENSEE with respect to any such suits. If LICENSOR is not
requested by LICENSEE to be included in any such suit, LICENSOR shall have the right to participate with counsel of its own choosing and at its own expense, in any action or suit under this Section 6.3. If LICENSOR makes any statements other
than to LICENSEE or LICENSOR’s counsel regarding the infringement of LICENSED PATENT RIGHTS, LICENSOR shall be solely responsible for the costs and expenses of any declaratory judgment action relating thereto. 

6.4 LICENSEE shall have [* * *] after having been notified of any alleged infringement to investigate whether infringement can be established or if an
enforcement action should be taken. If LICENSEE determines that infringement exists, or that any action should be taken, then it shall have an additional [* * *] to negotiate in good faith with the alleged infringer to resolve the dispute or, at
LICENSEE’s election, to commence prosecuting an infringement action (the filing period). If LICENSEE (a) at any time decides not to pursue an action against the alleged infringer, or (b) fails to commence negotiating or prosecuting an
action before the end of the filing period, then LICENSEE shall notify LICENSOR of its intention not to bring suit against any alleged infringer. In those events only, LICENSOR shall have the right, but shall not be obligated, to prosecute at its
own expense any infringement of the LICENSED PATENT RIGHTS, and LICENSEE hereby agrees at its discretion and upon terms to be mutually agreed by the parties, to either be named as a plaintiff in any such proceedings or to assign its rights to sue
for infringement. LICENSOR shall pay all of LICENSOR’s costs and reasonable attorney fees incurred in such action brought by LICENSOR under this Section 6.4. No settlement, consent judgment, or other voluntary final disposition of the suit
shall be entered into without 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 
the prior written consent of LICENSEE, which consent shall not be unreasonably withheld, and LICENSOR may not settle any such action whereby LICENSOR grants a license to a third party under any
LICENSED PATENT RIGHTS without the prior written consent of LICENSEE, which consent may be withheld by LICENSEE in its sole discretion. 
 6.5 In the event
that LICENSOR shall undertake the enforcement and/or defense of the LICENSED PATENT RIGHTS by litigation, any monetary recovery by LICENSOR shall be [* * *] between LICENSOR and LICENSEE, after each party recovers its attorneys fees and court costs
and other related outside documented costs and expenses. In the event that LICENSEE undertakes the enforcement and/or defense of the LICENSED PATENT RIGHTS by litigation, any monetary recovery by LICENSEE shall be [* * *]. 

6.6 Each party will promptly notify the other party in writing if such party institutes any action or suit with regard to third party infringement of the
LICENSED PATENT RIGHTS, and will in a timely manner keep the other party informed with regard to such action or suit and any related proceedings. [* * *] Distribution of any recovered amounts shall be governed by Section 6.5. In any
infringement suit that either party may institute to enforce the LICENSED PATENT RIGHTS pursuant to this Agreement, the other party hereto shall, at the request of the party initiating such suit and upon reasonable notice, cooperate in all respects
and, to the extent possible, have its employees testify when requested and make available relevant records, papers, information samples, models, specimens and the like. 

6.7 LICENSEE shall have the sole right, subject to approval by LICENSOR, which shall not be unreasonably withheld, delayed or conditioned such as upon
additional consideration, in accordance with the terms and conditions herein, to grant a SUBLICENSE to any alleged infringer under the LICENSED PATENT RIGHTS. Prior to the payment by LICENSEE to LICENSOR of any SUBLICENSING REVENUE based on amounts
received from an alleged infringer as specified in Article III, LICENSOR shall be reimbursed for any and all documented out-of-pocket expenses incurred by it, if any, in connection with any suit or action against the alleged infringer, prior to the
grant of the SUBLICENSE to the alleged infringer. 
 6.8 In the event that any legal action brought by a third party alleging invalidity or noninfringement
of any of the LICENSED PATENT RIGHTS is brought against LICENSEE or LICENSOR or VCU, LICENSEE, at its option, shall have the right within [* * *], to intervene and take over the sole defense of the action at its own expense. If LICENSEE chooses not
to intervene, LICENSOR shall have the option to intervene and take over the sole defense at its own expense. 
 VII. TERM AND TERMINATION

 7.1 This Agreement is in full force and effect from the EFFECTIVE DATE and remains in effect until the expiration of the last to expire LICENSED
PATENT RIGHTS, unless sooner terminated by operation of law or by acts of either of the parties in accordance with the terms of this Agreement. On and after the expiration of this Agreement, LICENSEE shall have a fully paid up, royalty-free,
irrevocable, perpetual, worldwide, fully sublicensable, [* * *] right and license to use, practice or have practiced, and otherwise exploit the LICENSED TECHNOLOGY in the FIELD OF USE. 

7.2 LICENSEE may terminate this Agreement at any time for any reason or no reason by giving LICENSOR [* * *] written notice. In the event of termination of
this Agreement by LICENSEE, LICENSEE shall have no further rights under this Agreement; however, LICENSEE will remain obligated for any royalties due or fees accrued or other expenses incurred for which LICENSEE is responsible hereunder, up until
the date of termination including royalty on NET SALES of inventory of LICENSED PRODUCTS in stock after the date of termination. 

  
 10 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 7.3 LICENSOR may terminate this Agreement upon written notice to LICENSEE if LICENSEE commits a material
breach or a material default in the performance of LICENSEE’s obligations under this Agreement and, within [* * *] after receipt of written notice of such material breach or material default from LICENSOR [* * *], LICENSEE fails to cure such
material breach or material default. Examples of such a material breach or material default include: 
 [* * *] 

7.4 [* * *] 
 7.5 On any termination of this Agreement, LICENSEE
and/or its AFFILIATES or SUBLICENSEES shall have the right to continue to sell out all remaining stocks of LICENSED PRODUCTS under the terms and conditions of this Agreement, provided LICENSEE pays LICENSOR the royalties due and payable on NET SALES
of such LICENSED PRODUCTS as provided for herein. 
 7.6 In the event LICENSEE allows the insurance coverage that is required to be maintained under
Section 9.6 to lapse, LICENSEE must notify LICENSOR in writing as soon as practicable. If LICENSEE fails to notify LICENSOR of such lapse within [* * *], this Agreement and the licenses granted herein shall immediately and automatically
terminate without notice. Upon such notification by LICENSEE to LICENSOR, LICENSEE will have [* * *] to correct such lapse by obtaining the required insurance. If LICENSEE fails to correct such lapse in [* * *], this Agreement and the licenses
granted herein shall immediately and automatically terminate without notice. 
 Upon termination of this Agreement as provided for in this Section 7.6,
LICENSEE shall have the right to reinstate the effectiveness of this Agreement by obtaining the required insurance, whereupon this Agreement shall automatically become effective as of the date of reinstatement of said insurance, and shall remain in
full force and effect without any further action of the parties hereto until termination or expiration of this Agreement according to Sections 7.1, 7.2, 7.3 or 7.4. 

7.7 Surviving any termination or expiration are: 
  

	 	a.	LICENSEE’s obligation to pay royalties and fees accrued as of the effective date of any termination or expiration or accruing under Section 7.5; 

 

	 	b.	Any cause of action or claim of LICENSEE or LICENSOR, accrued as of the effective date of any termination or expiration, because of any breach or default by the other party; and 

 

	 	c.	The provisions of Sections 5.3, 7.1, 7.5, 7.6, 7.7, 7.8,7.9, 8.4, 9.5, 9.6, 9.7, 9.10. 9.11, 9.19, 9.20 and 9.21. 

7.8 No relaxation, forbearance, delay or indulgence by either party in enforcing any of the terms of this Agreement or the granting of time by either party to
the other shall prejudice, affect or restrict the rights and powers of the former hereunder nor shall any waiver by either party of a breach of this Agreement be considered as a waiver of any subsequent breach of the same or any other provision
hereof. 
 7.9 LICENSOR’s exercise of the right to terminate this Agreement under this Article VII as a result of LICENSEE’s failure to meet any
of the diligence requirements under Sections 4.1 or 4.2, shall be LICENSOR’s sole and exclusive remedy, and LICENSEE’s sole and exclusive liability, for LICENSEE’s failure to meet any of the diligence requirements under Sections 4.1
or 4.2. 

  
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 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 VIII. SUBLICENSE(S) 

8.1 LICENSEE shall have the right to seek SUBLICENSES subject to the terms and conditions of this Agreement as stated in Article II and as defined in this
Article VIII. AFFILIATES shall have no licenses under the LICENSED PATENT RIGHTS unless such AFFILIATES are granted a SUBLICENSE. All SUBLICENSES will be consistent with and subject to the applicable terms and conditions of this Agreement.
SUBLICENSEES shall have the right to further SUBLICENSE. For the purposes of this Agreement, the LICENSEE shall be responsible to LICENSOR for the acts and omissions of its SUBLICENSEES, including its SUBLICENSEES’ compliance with the
applicable terms and conditions of this Agreement. Moreover, it is understood and agreed that if an AFFILIATE or a SUBLICENSEE meets or fulfills any or all of the obligations of LICENSEE under this Agreement, and/or observes any of the terms or
conditions hereof, then LICENSEE shall be deemed to have met or fulfilled such obligations or observed such terms or conditions, as the case may be. [* * *] 

8.2 If LICENSEE licenses to a third party patent rights that have been licensed or assigned to, or otherwise acquired by, LICENSEE other than under this
Agreement (“LICENSEE’s Patent Rights”), and LICENSEE believes, in good faith, that such third party will infringe LICENSED PATENT RIGHTS in practicing the LICENSEE’s Patent Rights, then LICENSEE will not separately grant a
license to such third party under LICENSEE’s Patent Rights without concurrently granting a SUBLICENSE under LICENSED PATENT RIGHTS. [* * *] In the event that LICENSOR and LICENSEE each owns [* * *] any LICENSED PATENT RIGHTS (“Joint
Patents”), LICENSEE may separately grant a license to any third party under its rights to Joint Patents without the consent of LICENSOR, provided any such license concurrently grants a SUBLICENSE under LICENSOR’s rights on the terms and
conditions described in this Article VIII. LICENSOR shall not grant a license to any third party under any Joint Patents, or grant any third party the right to use, practice or otherwise exploit any Joint Patents. [* * *] 

8.3 The LICENSEE will notify LICENSOR of each SUBLICENSE granted hereunder and provide LICENSOR with a redacted copy of each SUBLICENSE [* * *]. No portion of
such SUBLICENSE relevant to this Agreement will be redacted. 
 8.4 Upon termination of this Agreement for any reason, any or all SUBLICENSES will remain in
full force and effect at the sole discretion of the SUBLICENSEES, and will be assigned to LICENSOR such that such SUBLICENSEES are in direct privity with LICENSOR; provided, however, that each such SUBLICENSEE is in material compliance with the
applicable provisions of this Agreement as of the effective date of such termination and agrees in writing to assume and be bound by all of the obligations of LICENSEE under this Agreement that are applicable to such SUBLICENSEE. In the event of
termination of this Agreement and such assignment of any SUBLICENSE, LICENSOR will not be bound by any grant of rights broader than, nor will it be required to perform any obligation other than, those rights and obligations contained in this
Agreement. Moreover, pursuant to such assignment, LICENSOR will have the sole right to modify each such assigned SUBLICENSE but only to include rights of LICENSOR that are contained in this Agreement, including the payment of [* * *]. 

IX. MISCELLANEOUS 
 9.1 Nothing in this
Agreement shall create, or be deemed to create, a partnership, or the relationship of principal and agent, between the parties. 

  
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information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 9.2 Assignment. So long as LICENSEE is not in material breach of this Agreement, LICENSEE may assign or
otherwise transfer this Agreement and/or the rights acquired by it hereunder upon obtaining consent from the LICENSOR for the same (such consent will not be unreasonably withheld, delayed or conditioned such as upon additional consideration).
However, LICENSEE shall be free to assign this Agreement or otherwise transfer its rights or obligations under this Agreement, to an AFFILIATE, by operation of law pursuant to an acquisition, merger, sale of stock or assets or consolidation of
LICENSEE with or into a third party, or upon the transfer or sale of all or substantially all of the business or assets to which this Agreement pertains, in each case without obtaining any consent from LICENSOR. LICENSEE shall give the LICENSOR
written notice of LICENSEE’s assignment or transfer of this Agreement within [* * *], along with a redacted copy of such assignment agreement, pursuant to which such assignee or transferee shall have agreed in writing to be bound by the terms
and conditions of this Agreement. No portion of such assignment agreement relevant to this Agreement will be redacted. Upon completion of such assignment or transfer, the term “LICENSEE” as used herein shall refer to such assignee or
transferee. If LICENSEE shall sell or otherwise transfer its entire business, and the transferee shall not have agreed in writing to be bound by the terms and conditions of this Agreement, within [* * *], the LICENSOR shall have the right to
terminate this Agreement upon [* * *] written notice to LICENSEE if such transferee does not agree in writing to be bound by the terms and conditions of this Agreement within such [* * *] period. 

9.3 Section left intentionally blank. 
 9.4 LICENSEE shall
provide appropriate patent notices on all finished, packaged LICENSED PRODUCTS and/or provide for appropriate virtual marking on finished, packaged LICENSED PRODUCTS as specified in the patent and other statutes, and will require all SUBLICENSEES
and/or AFFILIATES to do the same. 
 9.5 To the extent permitted by law, each party assumes all risks of personal injury, bodily injury including death, and
property damage to the extent caused by the negligent acts or omissions of that party. LICENSEE shall at all times during the term of this Agreement and thereafter indemnify, defend and hold LICENSOR, VCU and VA, its trustees, directors, officers,
employees and affiliates (collectively, “Indemnitees”) harmless against all third party claims, proceedings, demands and liabilities, including legal expenses (collectively, “Liabilities”) arising out of the death of or injury to
any person or persons or out of any damages to property to the extent resulting from the research, development, production, manufacture, sale, modification, use, import or advertisement of LICENSED PRODUCTS by or on behalf of LICENSEE or its
AFFILIATES or SUBLICENSEES, or to the extent resulting from LICENSEE or its AFFILIATES or SUBLICENSEES carrying out any obligation of LICENSEE hereunder. LICENSEE’s obligations under this Section 9.5 shall not apply with respect to any
Liabilities that are due to the gross negligence of, or willful misconduct by, any Indemnitee or VCU/ VA Personnel. LICENSEE’s indemnification obligations under this Agreement shall in any event be conditioned upon the following: (i) the
indemnified party shall provide LICENSEE with prompt written notification of any claim for which indemnity is sought; (ii) the indemnified party shall cooperate with and permit LICENSEE to assume full control of the defense and settlement of
such claim; and (iii) the indemnified party shall not agree to dispose of or settle any such claim without the prior written consent of LICENSEE. 

9.6 LICENSEE shall obtain and carry in full force and effect during the term hereof and for a period of [* * *] after any termination or expiration,
commercial, general liability insurance. Such insurance shall be written by a reputable company authorized to do business in the Commonwealth of Virginia, shall list LICENSOR, VCU and VA as an additional insured thereunder, shall be endorsed to
include LICENSED PRODUCTS liability coverage and shall require reasonable written notice to be given to 

  
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information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 
LICENSOR prior to any cancellation or material change thereof. The limits of such insurance shall not be less than [* * *] per occurrence with an aggregate of [* * *] for personal injury or
death, and [* * *] for property damage. LICENSEE shall provide LICENSOR with Certificates of Insurance evidencing same. 
 9.7 Limitation on Liability.
LICENSEE shall not be liable to LICENSOR, VA or VCU for any special, indirect, incidental, punitive or consequential damages (including without limitation, damages resulting from loss of use, loss of profits, interruption or loss of business or
other economic loss) arising out of this Agreement or with respect to LICENSEE’s performance or non-performance hereunder, even if LICENSEE knew or should have known of the possibility of such damages. 

9.8 Representations and Warranties; Disclaimers. 
  

	 	(a)	LICENSOR REPRESENTS AND WARRANTS ON BEHALF OF ITSELF, VCU AND VA, IN ACCORDANCE WITH THE IIA, THAT [* * *]. 

  

	 	(b)	LICENSOR REPRESENTS (I) TO THE BEST OF ITS KNOWLEDGE [* * *]; (II) TO THE BEST OF ITS KNOWLEDGE [* * *], (III) TO THE BEST OF ITS KNOWLEDGE, ON THE EFFECTIVE DATE OF THIS AGREEMENT, [* * *], AND (IV) UPON EFFECTIVE
DATE, [* * *]. 

  

	 	(c)	EXCEPT TO THE EXTENT EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED AS (I) A WARRANTY OR REPRESENTATION BY LICENSOR AS TO THE VALIDITY OR SCOPE OF ANY LICENSED PATENT RIGHTS,
(II) A WARRANTY OR REPRESENTATION THAT ANYTHING MADE, USED, IMPORTED, DEVELOPED, PROMOTED, OFFERED FOR SALE, SOLD, OR OTHERWISE DISPOSED OF UNDER ANY LICENSE GRANTED IN THIS AGREEMENT DOES NOT OR WILL NOT INFRINGE PATENTS, TRADE SECRETS OR
OTHER PROPRIETARY RIGHTS OF THIRD PARTIES; (III) AN OBLIGATION TO BRING OR PROSECUTE ACTIONS OR SUITS AGAINST THIRD PARTIES FOR INFRINGEMENT; (IV) CONFERRING THE RIGHT TO USE IN ADVERTISING, PUBLICITY OR OTHERWISE ANY TRADEMARK, TRADE
NAME, OR NAMES, OR ANY CONTRACTION, ABBREVIATION, SIMULATION OR ADAPTATION THEREOF OF VCU, VA OR LICENSOR; (V) CONFERRING BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS UNDER ANY PATENTS OF LICENSOR OTHER THAN THE LICENSED PATENT
RIGHTS; (VI) ANY OTHER REPRESENTATIONS OR WARRANTIES, EITHER EXPRESS OR IMPLIED, UNLESS SPECIFIED IN THIS AGREEMENT; (VII) DIRECTLY OR INDIRECTLY OPERATING OR APPLYING AS A WAIVER OF SOVEREIGN IMMUNITY BY THE COMMONWEALTH OF VIRGINIA; OR
(VIII) IMPOSING ANY OBLIGATION OR ANY LIABILITY ON ANY PARTY CONTRARY TO THE LAWS OF THE COMMONWEALTH OF VIRGINIA. LICENSOR DISCLAIMS AND MAKES NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT
TO THE LICENSED RIGHTS, OR ANY LICENSED PRODUCTS. 

  

	 	(d)	OTHER THAN AS EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, LICENSEE MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OR GUARANTEES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, THERE ARE NO
EXPRESS OR IMPLIED WARRANTIES OR GUARANTEES THAT LICENSEE OR ANY AFFILIATE OR SUBLICENSEE WILL SUCCESSFULLY DEVELOP, REGISTER, OBTAIN REGULATORY APPROVAL FOR, MANUFACTURE OR COMMERCIALIZE ANY LICENSED PRODUCTS, OR THAT ANY LICENSED PRODUCT WILL BE
MERCHANTABLE, FIT FOR ITS INTENDED PURPOSE OR [* * *] 

  
 14 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 9.9 For the purposes of this Agreement “Force Majeure” means any circumstances beyond the
reasonable control of either party including, without limitation, any strike, lock-out, labor dispute or other form of industrial action, acts of God, acts of government (including injunctions), fire, flood,
earthquake, breakdown of plant, damage to or loss, shortage or unavailability of equipment, facilities or materials, failure of suppliers, unavailability of utilities, common carriers or manufacturing, casualty or accident, civil commotion, acts of
public enemies, acts of terrorism or threat of terrorist acts, blockage or embargo and the like. If either party is affected by Force Majeure, it shall forthwith notify the other party of the nature and extent thereof. Neither party shall be deemed
to be in breach of this Agreement, or otherwise be liable to the other, by reason of any delay in performance, or the non-performance, of any of its obligations under this Agreement, to the extent that such
delay or non-performance is due to any Force Majeure of which it has notified the other party, and the time for performance of that obligation shall be extended accordingly. If the Force Majeure in question
prevails for a continuous period in excess of [* * *], the parties shall enter into bona fide discussions with a view to alleviating its effects, or to agreeing upon such alternative arrangements as may be fair and reasonable. 

9.10 LICENSEE shall not use the names or trademarks of LICENSOR, nor any adaptation thereof, nor the names of any of its employees, in any advertising,
promotional or sales literature without prior written consent obtained from LICENSOR, or said employee, in each case, except that the LICENSEE may state that it is a LICENSEE of LICENSOR with respect to the LICENSED TECHNOLOGY and/or LICENSED PATENT
RIGHTS. 
 9.11 Any notice or payment required to be given to either party will be deemed to have been properly given and to be effective: 

 

	 	a.	on the date of delivery if delivered in person; 

  

	 	b.	on the date of mailing if mailed by first-class certified mail, postage paid; or 

  

	 	c.	on the date of mailing if mailed by any global express carrier service that requires the recipient to sign the documents demonstrating the delivery of such notice or payment; 

to the respective addresses given below, or to another address as designated in writing by the party changing its address. 

VIRGINIA COMMONWEALTH UNIVERSITY 

INTELLECTUAL PROPERTY FOUNDATION 

President 
 Box 980568 

800 E. Leigh Street, Suite 113 

Virginia Commonwealth University 

Richmond, VA 23298-0568 
 DURECT CORPORATION

 Attn: Legal Department 

DURECT Corporation 
 10260 Bubb
Road 
 Cupertino, CA 95014 

  
 15 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 9.12 This Agreement contains the entire and only agreement and understanding between the parties and
supersedes all preexisting and contemporaneous agreements, including the Option Agreement, between them respecting its subject matter. The SRA, the Bilateral Confidentiality Agreement between LICENSEE and VCU dated [* * *] (the “CDA”) and
the Outgoing Materials Transfer Agreement between LICENSEE and VCU dated [* * *] shall continue in full force and effect in accordance with their terms. Any representation, promises, or condition in connection with such subject matter which is not
incorporated in this Agreement shall not be binding on either party. No modification, renewal, waiver, and no termination of this Agreement or any of its provisions shall be binding upon the party against whom enforcement of such modification,
renewal, waiver or termination is sought, unless made in writing and signed on behalf of such party by one of its duly authorized officers. As used herein: the word “termination” includes any and all means of bringing an end prior to its
expiration by its own terms this Agreement, or any provisions thereof, whether by release, discharge, abandonment or otherwise. This Agreement may not be amended except by written agreement of the parties. 

9.13 This Agreement shall be construed, governed, interpreted and applied in accordance with the laws of the Commonwealth of Virginia, U.S.A., except that
questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent was granted. Any legal action or proceeding relating to this Agreement or any document or instrument related hereto shall
be brought only in the courts of the Commonwealth of Virginia in Richmond, Virginia, and by its execution and delivery of this Agreement, LICENSEE hereby accepts for itself and in respect to its property, generally and unconditionally, the
jurisdiction of the aforesaid courts. 
 9.14 This Agreement may be executed in one or more counterparts and any party hereto may execute any such
counterparts each of which shall be deemed an original and all of which, taken together, shall constitute but one and the same document. It shall not be necessary in making proof of this document or any counterpart hereof to produce or account for
any of the other counterparts. 
 9.15 The provisions of this Agreement are severable, and in the event that any provisions of this Agreement shall be
determined to be invalid or unenforceable under any controlling body of the law, such invalidity and unenforceability shall not in any way affect the validity or enforceability of the remaining provisions hereof. In the event the validity or
unenforceability of any provision of this Agreement is brought into question because of the decision of a court of competent jurisdiction, the parties by mutual written agreement may revise the provision in question or may delete it entirely so as
to comply with the decision of said court. 
 9.16 The failure of either party to assert a right hereunder or to insist upon compliance with any term or
condition of this Agreement shall not constitute a waiver of that right or excuse a similar failure to perform any such term or condition by the other party. 

9.17 It is understood that LICENSOR and VCU are subject to United States laws and regulations controlling the export of technical data, computer software,
laboratory prototypes and other commodities (including the Arms Export Control Act, as amended and the United States Department of Commerce Export Administration Act of 1979). The transfer of such items may require a license from the appropriate
agency of the United States Government and/or written assurances by LICENSEE that LICENSEE shall not export data or commodities to certain foreign countries without prior approval of such agency. LICENSOR neither represents that license shall not be
required nor, if required, it shall be issued. 
  

	9.18	All reports and documents to be forwarded to LICENSOR shall be in the English language. 

  
 16 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 9.19 Proprietary Information. 
  

	 	(a)	Each party solely owns its Proprietary Information. Each party shall treat Proprietary Information received from the other party with the same degree of care with which it treats its own Proprietary Information, but in
any event no less than a reasonable degree of care, and further agrees not to disclose such Proprietary Information to a third party without prior written consent from the party disclosing Proprietary Information. Notwithstanding the foregoing,
LICENSEE may disclose the existence and terms of this Agreement and the Proprietary Information of LICENSOR, VA or VCU to: (i) LICENSEE’s employees, agents and contractors on a need to know basis for the purpose of LICENSEE performing its
obligations and exercising its rights under this Agreement, including without limitation, those persons and entities involved in research, development, manufacturing, marketing, promotion, distribution, sale and/or commercialization of LICENSED
PRODUCTS, LICENSED TECHNOLOGY and/or LICENSED PATENT RIGHTS, and (ii) its AFFILIATES and actual and potential acquirers, investors, assignees, transferees, licensees (including SUBLICENSEES) and other business partners, in each case under
conditions of confidentiality. LICENSOR may disclose this Agreement and the Proprietary Information of LICENSEE to the VA in accordance with the IIA; provided that LICENSOR (i) only submits to the VA the Proprietary Information of LICENSEE that
is necessary to meet the requirements under Article 5.2 of the IIA, (ii) labels any and all Proprietary Information of LICENSEE as “confidential” and takes whatever measures are otherwise required in order for Proprietary Information
of LICENSEE to be received and treated by VA as confidential under the IIA, and (iii) in instances in which LICENSOR is aware, gives LICENSEE prior written notice of VA’s disclosure of any Proprietary Information of LICENSEE as required by
law, court order or regulation and an opportunity to participate in drafting a protective order or otherwise limiting the disclosure to the extent possible. 

  

	 	(b)	Proprietary Information of LICENSEE shall include without limitation, [* * *]. 

  

	 	(c)	Neither party shall use the Proprietary Information of the other party other than in performing its obligations or exercising its rights under this Agreement which, in the case of LICENSEE shall include without
limitation, in connection with LICENSEE’s preparation and filing of regulatory submissions with regulatory authorities, design and conduct of clinical trials, and obtaining and/or maintaining regulatory approvals for LICENSED PRODUCTS.

  

	 	(d)	The foregoing obligations of non-disclosure and non-use do not apply to Proprietary Information which: (i) was known to the recipient (or in the case of LICENSEE, its AFFILIATES or SUBLICENSEES) prior to the
disclosure hereunder as shown by the recipient’s (or its AFFILIATES’ or SUBLICENSEES’) prior written records; (ii) was received by recipient (or in the case of LICENSEE, its AFFILIATES or SUBLICENSEES) from a third party not
under an obligation of confidence to the discloser; (iii) is in the public domain at the time of disclosure hereunder or subsequently entered the public domain without the fault of the recipient or anyone to whom the recipient disclosed the
Proprietary Information; or (iv) has been independently developed by an employee of recipient (or in the case of LICENSEE, its AFFILIATES or SUBLICENSEES) who has not had knowledge of or access directly or indirectly to Proprietary Information,
and recipient or its AFFILIATES or SUBLICENSEES can substantiate any claim of independent development by written evidence; or (v) is approved for release by written authorization of the discloser. 

 

	 	(e)	Unless otherwise agreed to in writing by the parties, the parties shall be subject to the confidentiality, non-disclosure and non-use obligations hereunder with respect to the Proprietary Information of the other party
during the term hereof and for a period of [* * *] following the expiration or earlier termination of this Agreement. 

  
 17 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

	 	(f)	A recipient of Proprietary Information may disclose that portion of the other party’s Proprietary Information if and to the extent recipient is required to make such disclosure pursuant to law or governmental
regulation or to any governmental entity having jurisdiction (including a court of competent jurisdiction), provided recipient promptly notifies the other party in writing as soon as reasonably practical or possible, prior to such disclosure, of the
receipt of such request, and takes reasonable and lawful actions to avoid and/or minimize the extent of such disclosure and seeks to obtain confidential treatment based on advice of their legal counsel or provides assistance to the other party in
obtaining a protective order therefor if reasonably requested by the other party. For the avoidance of doubt, this Section 9.19(f) shall also apply with respect to any Freedom of Information Act (FOIA) requests that may be made with respect to
this Agreement including any of its Appendices, or any other Proprietary Information of LICENSEE. To the extent permitted by law, LICENSOR agrees to redact any enabling titles of any unpublished patent applications (as well as such unpublished
patent applications) listed in Appendix A, and Appendix B, from any disclosures required to be made under law or regulation or by any court, including under FOIA, and to allow LICENSEE to review, in advance of any such disclosure, the proposed
disclosure and to take into account in good faith any comments that LICENSEE may provide with respect to such proposed disclosure. 

  

	 	(g)	Notwithstanding the foregoing or anything to the contrary herein, LICENSEE and its AFFILIATES and SUBLICENSEES may disclose Proprietary Information if required by (i) laws, rules or regulations of a securities
exchange or other government agency, such as the Securities and Exchange Commission, (ii) a governmental authority or agency for purposes of obtaining or maintaining approval to test or market a LICENSED PRODUCT, or (iii) a patent office
for the purposes of filing, prosecuting or otherwise obtaining or maintaining intellectual property rights. In addition to the foregoing, LICENSEE and its AFFILIATES and SUBLICENSEES may disclose the terms of this Agreement in footnotes to their
financial statements, to the extent required under generally accepted accounting principles. 

  

	 	(h)	Upon any termination or expiration of this Agreement, each party shall promptly return to the other party (or destroy at the other party’s written election) any and all Proprietary Information of the other party
(including copies, summaries, excerpts, extracts or other reproductions and embodiments thereof) in any form including electronic form (including electronic media such as DVD, CD-ROM, electronic copies or any material resident in the hard or
external drive of any computer), and any other materials otherwise containing or reflecting any Proprietary Information of the other party that is in such party’s possession, custody or control. Notwithstanding the foregoing, each party may
retain one (1) copy of the other party’s Proprietary Information for the sole purposes of monitoring its ongoing obligations hereunder. 

  

	 	(i)	The parties may disclose the existence of this Agreement which, in the case of LICENSOR, shall be limited to disclosure to the extent required by VCU policies and further limited to describing in general terms the
LICENSED TECHNOLOGY and LICENSED PATENT RIGHTS as follows: the name and number of any published patent application or patent that is included in the LICENSED PATENT RIGHTS, non-enabling titles of any unpublished patent applications listed in
Appendix A and the fact that the LICENSED PATENT RIGHTS have been licensed to LICENSEE. LICENSOR shall notify LICENSEE in writing in advance of any required disclosure of the existence of this Agreement and/or description of the LICENSED TECHNOLOGY
or LICENSED PATENT RIGHTS, which in each case shall be subject to LICENSEE’s review and comment. 

  
 18 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 9.20 Publications. LICENSOR agrees not to publish, present or otherwise disclose any Proprietary Information
of LICENSEE. LICENSEE shall be furnished copies of any proposed disclosure, publication or presentation (including any modifications thereof which LICENSEE has not yet reviewed) containing or referring to any LICENSED TECHNOLOGY or LICENSED PATENT
RIGHTS at least [* * *] before submission of such proposed disclosure, publication or presentation. With regard specifically to modification(s) to a disclosure, publication or presentation that LICENSEE has already reviewed prior to such
modification(s), LICENSOR agrees that any Proprietary Information of LICENSEE which has been identified in writing by LICENSEE shall be deleted from the disclosure, publication or presentation and LICENSOR shall send LICENSEE a statement verifying
that this has been done along with a final copy including the revision. In no event shall LICENSEE’s review of any modification to a disclosure, publication or presentation exceed the original [* * *] review period unless LICENSEE requests
delay for patent protection. During its review period(s), LICENSEE shall have the right to review the material for Proprietary Information of LICENSEE and to assess the patentability of any invention described in the material. If LICENSEE decides
that a patent application should be filed, the disclosure, publication or presentation shall be delayed an additional [* * *] or a shorter period of time if LICENSEE consents in writing, whichever is sooner. At LICENSEE’s written request,
Proprietary Information of LICENSEE shall be deleted. For the avoidance of doubt, proposed disclosures from LICENSOR to VCU shall be deemed and treated as proposed disclosures for the purposes hereof. Although LICENSEE shall have the option not to
include its name on any publication or presentation, at LICENSEE’s request, any disclosure, publication or presentation made by LICENSOR and relating to LICENSED TECHNOLOGY or LICENSED PATENT RIGHTS shall acknowledge LICENSEE’s
contribution thereto in accordance with customary scientific practice. 
 9.21 Further Actions. Each party agrees to execute, acknowledge and deliver such
further instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. 

[SIGNATURES APPEAR ON NEXT PAGE] 

  
 19 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 IN WITNESS WHEREOF, the parties have caused this Agreement to be executed in duplicate as
first above written. 
 AGREED AND ACCEPTED: 
  

									
	DURECT CORPORATION:						
					
	By:		 /s/ James E. Brown
				Date:		 December 5, 2012

	Title		 C.E.O.
						
				
	 VIRGINIA COMMONWEALTH UNIVERSITY
						
	 INTELLECTUAL PROPERTY FOUNDATION
						
					
	 By:
		 /s/ Ivelina S. Metcheva
				Date:		 December 5, 2012

	 Ivelina S. Metcheva, Ph.D., MBA
						
	 Director, VCU Office of Technology Transfer
						
	 President VCU Intellectual Property Foundation
						

  
 20 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 APPENDIX A 

LICENSED PATENT RIGHTS 
 [*
* *] 

  
 21 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 Proprietary Information 

APPENDIX B 
 FEES AND
ROYALTIES 
 [* * *] 

  
 22 

 Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the
information subject to the confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 

 

 APPENDIX C 

IIA 

  
 23

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