Document:

Amended and Restated Clinical Development and License Agreement

 Exhibit 10.35 

FOIA CONFIDENTIAL TREATMENT REQUEST BY 

BIODELIVERY SCIENCES INTERNATIONAL, INC. 

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858 

 

***CONFIDENTIAL TREATMENT REQUESTED*** 

Note: The portions hereof for which confidential treatment are being requested are 

denoted with “***” 

AMENDED AND RESTATED 

CLINICAL DEVELOPMENT AND LICENSE AGREEMENT 

THIS AMENDED AND RESTATED CLINICAL DEVELOPMENT AND LICENSE AGREEMENT dated as of November 2, 2016 (the “Effective
Date”), among CDC V, LLC (“CDC”), a limited liability company organized under the laws of the State of Delaware, having a business address at 47 Hulfish Street, Suite 310, Princeton, NJ 08542, BioDelivery Sciences
International, Inc. (“BioDelivery”), a corporation organized under the laws of the State of Delaware, having a business address at 4131 Parklake Avenue, Suite 225, Raleigh, North Carolina 27612, Arius Pharmaceuticals, Inc., a
Delaware corporation and wholly-owned subsidiary of BioDelivery (“Subsidiary”), Arius Two, Inc., a Delaware corporation and wholly-owned subsidiary of BioDelivery (“Arius Two”; together with BioDelivery and
Subsidiary, the “Company”), NB Athyrium LLC (“Athyrium”). CDC and Company are sometimes referred to herein individually as a “Party” and collectively as “Parties”. 

WHEREAS, Company and CDC are currently party to that certain Clinical Development and License Agreement, dated July 14, 2005 (the
“Original Effective Date”), as amended (such agreement, without taking into account the Amendments (as defined below) or the CDC Consents (as defined below), the “Original Agreement”), and wish to amend and restate
the Original Agreement to reflect the Amendments. 
 WHEREAS, CDC assigned certain rights to Athyrium under the Original Agreement, as
amended. 
 NOW, THEREFORE, in consideration of the foregoing premises and the representations, covenants and agreements contained herein,
the Parties, intending to be legally bound, hereby agree as follows: 
 ARTICLE 0 

AMENDMENT AND RESTATEMENT 

The Parties hereby agree that, effective as of the Effective Date, the Original Agreement, as amended by the Amendments, is hereby amended and
restated to reflect the terms and conditions set forth in this Agreement, which Agreement is still subject to the terms and conditions of the CDC Consents. 

	
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 ARTICLE 1 

DEFINITIONS 
 The following
terms, whether used in the singular or plural, shall have the following meanings: 
 1.1    “Act” means
both the United States Food, Drug and Cosmetic Act, as amended, and the regulations promulgated under the foregoing. 

1.2    Intentionally deleted. 

1.3    “Adverse Drug Experience” means any of: an “adverse drug experience,” a
“life-threatening adverse drug experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R.
§ 314.80. 
 1.4    “Affiliate” means any Person directly or indirectly controlled by,
controlling or under common control with, a Party, but only for so long as such control shall continue. For purposes of this definition, “control” (including, with correlative meanings, “controlled by”, “controlling”
and “under common control with”) means, with respect to a Person, possession, direct or indirect, of (a) the power to direct or cause direction of the management and policies of such Person (whether through ownership of securities or
partnership or other ownership interests, by contract or otherwise), or (b) at least fifty percent (50%) of the voting securities (whether directly or pursuant to any option, warrant or other similar arrangement) or other comparable equity
interests. For the avoidance of doubt, neither of the Parties shall be deemed to be an “Affiliate” of the other. 

1.5    “Approval” means the approval by the relevant Governmental Authority required for the initial
launch, marketing and sale of the Product. 
 1.6    Intentionally deleted. 

1.7    Intentionally deleted. 

1.8    Intentionally deleted. 

1.9    “BEMA Technology” means the Company Know-How and Company
Patent Rights licensed to Subsidiary pursuant to the Arius Two License (NA) or Arius Two License (ROW) (or, in the event of any termination of the Arius Two License (NA) or Arius Two License (ROW) permitted by Section 8.2.16, such Know-How and Patent Rights that would have been licensed to Subsidiary thereunder in the absence of such termination). 

  
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 1.10    “Business Day” means a day that is not a
Saturday, Sunday or a day on which banking institutions in New York, New York are authorized by Law to remain closed. 

1.11    Intentionally deleted. 

1.12    “CDC Indemnified Parties” has the meaning set forth in Section 9.1. 

1.13    “cGMP” means the current Good Manufacturing Practices regulations promulgated by the FDA under
the Act as of the time of manufacture of the applicable Products, all as amended from time to time and subject to any arrangements, additions or clarifications agreed from time to time between the Parties. 

1.14    “Change of Control” shall mean a (a) change in ownership or control of a Party effected
through any of the following transactions: (i) a merger, consolidation or other reorganization, unless securities representing more than *** (***%) of the total combined voting power of the voting securities of the successor
corporation are immediately thereafter beneficially owned, directly or indirectly and in substantially the same proportion, by the persons who beneficially owned such Party’s outstanding voting securities immediately prior to such transaction,
(ii) any transfer or other disposition of all or substantially all of such Party’s assets, (iii) the acquisition, directly or indirectly by any person or related group of persons (other than such Party or a person that directly or
indirectly controls, is controlled by, or is under common control with, such Party), of beneficial ownership of securities possessing more than *** (***%) of the total combined voting power of such Party’s outstanding securities
or (b) a change in the power to direct or cause the direction of the management and policies of a Party, directly or indirectly, whether through ownership of voting securities or by contract or otherwise. 

1.15    “Claims” means all charges, complaints, actions, suits, proceedings, hearings, investigations,
claims and demands, including any losses incurred by a Party as a direct result of any such matters. 

1.16    “Commercially Reasonable Efforts” means, with respect to a Party, the efforts which would be used
by that Party consistent with its normal business practices, which in no event shall be less than the level of efforts and resources expended by comparable small cap biotechnology companies with respect to a product or potential product at a similar
stage in its development or product life, taking into account product labeling, market potential, medical and clinical considerations, the regulatory environment, financing environment, patent and other proprietary position and competitive market
conditions in the therapeutic area, all as measured by the facts and circumstances at the time such efforts are due. 

1.17    Intentionally deleted. 

  
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 1.18    Intentionally deleted. 

1.19    “Company Agreements” has the meaning set forth in Section 8.2.16. 

1.20    “Company Intellectual Property” means Company Know-How
and Company Patent Rights, collectively. 
 1.21    “Company
Know-How” means any Know-How with respect to the Product that either (a) is Controlled by Company on the Effective Date, or (b) comes within
Company’s Control during the term of this Agreement, including, without limitation, the BEMA Technology. 

1.22    “Company Patent Rights” means the Patent Rights Controlled by the Company to the extent that they
cover Company Know-How, Compound or Product, including without limitation the Patent Rights set forth in Schedule 1.22. 

1.23    “Competing Product” means any transmucosal formulation of fentanyl, other than a Product, which
has obtained Approval in an indication for the treatment of break through cancer pain management; provided, however, that a Competing Product shall not include a generic formulation of ACTIQ®,
sugar-free ACTIQ®, or OraVescent®. 

1.24    “Compound” means fentanyl including without limitation metabolites or prodrugs thereof, and any
hydrates, conjugates, salts, esters, isomers, polymorphs or analogues of any of the foregoing. 

1.25    “Confidential Information” has the meaning set forth in Section 7.2. 

1.26    “Control” means, when used in reference to intellectual property, the possession of the ability
to grant a license or sublicense as provided for herein without (i) requiring the consent of a third party or (ii) violating the terms of any agreement or other arrangement with any third party. 

1.27    “Debarred Entity” has the meaning set forth in Section 8.2.14. 

1.28    Intentionally deleted. 

1.29    Intentionally deleted. 

1.30    Intentionally deleted. 

1.31    “Development Program” means the clinical program and studies and associated support activities
(including, without limitation, all specific protocol changes and other details of the clinical programs, studies and support activities) conducted by or on behalf of Company to obtain initial Approval of a Product from the FDA. 

  
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 1.32    Intentionally deleted. 

1.33    Intentionally deleted. 

1.34    “FDA” means the United States Food and Drug Administration and any successor agency thereto. 

1.35    “First Tier Royalty” has the meaning set forth in Section 6.6.1(i). 

1.36    Intentionally deleted. 

1.37    “GAAP” means US generally accepted accounting principles. 

1.38    “GCP” means the scientifically recognized Good Clinical Practice standards for the design,
conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials, including the requirements in 21 C.F.R. Parts 11, 50, 54, 56, 312, and 314, that provide assurance that the data and reported results are credible and
accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. 

1.39    “Governmental Authority” means any court, tribunal, arbitrator, agency, department, legislative
body, commission or other instrumentality of (a) any government of any country, (b) any foreign, federal, state, county, city or other political subdivision thereof or (c) any supranational body. 

1.40    “Know-How” means any information and materials, whether
proprietary or not and whether patentable or not, including without limitation ideas, concepts, formulas, methods, procedures, designs, compositions, plans, documents, data (including all pre-clinical and
clinical data), inventions, discoveries, works of authorship, compounds and biological materials. 

1.41    “Laws” means all laws, statutes, rules, codes, regulations, orders, judgments and/or ordinances
of any Governmental Authority. 
 1.42    “Litigation Conditions” has the meaning set forth in
Section 9.2.2. 
 1.43    Intentionally deleted. 

1.44    Intentionally deleted. 

  
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 1.45    “NDA” means a New Drug Application with respect
to a Product filed with and accepted by the FDA including any supplements or amendments thereto. 
 1.46    “Net
Sales” means the gross amounts billed or invoiced by Company and its Affiliates, sublicensees and distributors, and each of their successors and assigns, for sales of the Products (including New Combination Products) throughout the world,
less the following deductions to the extent included in the gross invoiced sales price: bona fide discounts (including but not limited to cash discounts, trade discounts, quantity discounts, and prompt payment discounts), credits, rebates, refunds,
allowances, cost of free goods, adjustments, rejections, recalls and returns, including rebates, refunds, allowances, or credits granted with respect thereto, and charge-back payments granted to managed health care organizations or to Governmental
Authorities, their agencies, and purchasers and reimbursers or to trade customers, including but not limited to wholesalers and chain and pharmacy buying groups, provided that such items relate to the Product and only the portion of such items
related to the Product shall be deducted; and taxes, tariffs and similar obligations, duties or other governmental charges (other than income or corporation taxes) levied on, absorbed or otherwise imposed on sales of the Product. 

If any such sales to third parties are made in transactions that are not at arm’s length between the buyer and the seller, then the gross
amount to be included in the calculation of Net Sales shall be the amount that would have been invoiced had the transaction been conducted at arm’s length, subject to deductions set forth in subparagraphs (a) and (b) above. Such amount
that would have been invoiced shall be determined, wherever possible, by reference to the average selling price of the relevant Product in arm’s-length transactions in such country. Notwithstanding the
foregoing, amounts received by Company or its Affiliates, sublicensees or distributors for the sale of Products among Company and its Affiliates, sublicensees or distributors for resale shall not be included in the computation of Net Sales
hereunder. Net Sales shall be determined from books and records maintained in accordance with GAAP, consistently applied throughout the organization and across all products of the entity whose sales of Product are giving rise to Net Sales. 

Net Sales of a Combination Product (as defined below), other than a New Combination Product, shall be calculated as if the invoiced sales
price for a Product included within the Combination Product is (i) the average sales price at which Company, its Affiliate, or a sublicensee or distributor thereof sells, in the calendar quarter of the applicable sale, the Product alone and not
as a part of the Combination Product in the applicable country or, if the Product is not offered in a country except as part of the Combination Product, the average sales price at which the Product is sold alone across all countries in which such
Product is sold, or (ii) to the extent the applicable Product has not been sold other than in a Combination Product, the amount reasonably specified between Company or its Affiliate, sublicensee, or distributor and any other

  
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party to an agreement regarding that Combination Product as the portion of the sales price attributable to the Product. In the event that Company includes a Product as part of a single bundled
sale of separate products with separately stated prices, the Net Sales attributable to such Product shall be the higher of (i) the separately stated price stated for such Product sold in such bundled sale or (ii) the average price at which
such Product is sold in the applicable country in a non-bundled sale or, if not sold in the applicable country in a non-bundled sale, the average price at which such
Product is sold in a non-bundled sale across all countries in which such Product is sold. For purposes of this paragraph, “Combination Product” means a Product (other than a New Combination Product)
that is sold together with any other products and/or services at a unit price, whether packaged together or separately with another pharmaceutical product or other device, equipment, instrumentation, or other components (other than solely containers
or packaging exclusively for the Product). 
 1.47    Intentionally deleted. 

1.48    “Patent Rights” means patents and patent applications and all substitutions, divisions,
continuations, continuations-in-part, any patent issued with respect to any such patent applications, any reissue, reexamination, renewal or extension (including any
supplemental patent certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all counterparts thereof in any country. 

1.49    Intentionally deleted. 

1.50    “Person” means any natural person or any corporation, company, partnership, joint venture, firm
or other entity, including without limitation a Party. 
 1.51    Intentionally deleted. 

1.52    Intentionally deleted. 

1.53    “Product” means any product that contains the Compound either alone or in combination with one or
more other substances. Product shall be deemed to include any “New Combination Product”, except (i) Net Sales of “New Combination Products” shall not be included in the calculation of First Tier Royalties and Second Tier
Royalties under Section 6.6.1, but instead shall be included in the calculation of royalties owing under Section 6.6.2, (ii) the Development Program shall not be deemed to include any activities concerning the New Combination Product,
(iii) for purposes of Sections 3.4, 3.5, 4.4, 4.5, 4.6.1, and 6.2, (iv) NDAs and Approvals relating to any New Combination Product for territories outside the United States may, Section 4.1.2 notwithstanding, be held in the name of any
licensee or sublicensee of the Company, and (v) as otherwise provided for in the definition of “Net Sales” for purposes of calculating royalties for Combination Products, provided that the Company shall periodically,

  
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and at least quarterly, provide CDC with summary reports regarding activities undertaken by or on behalf of Company with respect to the development of any New Combination Product (including
studies/trials undertaken by the Company, the outcome and progress of such studies, and major outcomes and findings), so as to keep CDC fully advised of Company’s material development activities with respect to New Combination Products. 

1.54    “Program Data” means data, information, reports, results and other work product collected,
generated, prepared or derived during the course of, or as a result of, the Development Program, and shall be deemed to include, in addition to the foregoing, all data, information, reports, results and other work product resulting from any clinical
program and studies and associated support activities (including, without limitation, all specific protocol changes and other details of the clinical programs, studies and support activities) conducted by or on behalf of Company to obtain and/or
maintain Approval, including, without limitation, Approval from the FDA, with respect to any Product (including but not limited to any New Combination Product). 

1.55    Intentionally deleted. 

1.56    “Qualified Collaboration Partner” means a company which (i) has its own or controls a
marketing and sales organization for pharmaceutical products or devices and (ii) has annual revenues from sales of pharmaceutical products similar to or related in any manner to the Product in the United States of at least *** in the
calendar year immediately preceding the year in which the transaction or event necessitating the determination is consummated. 

1.57    “Second Tier Royalty” has the meaning set forth in Section 6.6.1(ii). 

1.58    “Shortfall Amount” has the meaning set forth in Section 6.6.3. 

1.59    “Third Party Claim” has the meaning set forth in Section 9.2.1. 

1.60    Intentionally deleted. 

1.61     Intentionally deleted. 

1.62     Intentionally deleted. 

1.63     Intentionally deleted. 

1.64     “Losses” means any and all debts, liabilities, obligations, damages (excluding all incidental
and consequential damages relating to claims between the parties hereto, but including such claims to the extent suffered by third parties), fines, penalties, taxes, liens, deficiencies, losses, lost profits, defaults, awards, settlement amounts,
assessments, fines, dues, costs and other expenses (including interest, court costs, amounts paid in settlement, reasonable fees of attorneys, accountants and other experts or other reasonable expenses of litigation or other proceedings or of any
claim, default or assessment). 

  
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IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

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 1.65    “Arius Two License (ROW)” means that certain
BEMA License Agreement between Arius Two and Subsidiary, dated August 2, 2006, as amended. 
 1.66    Intentionally
deleted. 
 1.67    Intentionally deleted. 

1.68    “Arius Two License (NA)” means that certain License Agreement between Arius Two and Subsidiary,
dated September 5, 2007, as amended. 
 1.69    “Generic Product” means a pharmaceutical product
that (i) is not sold by BDSI, its Affiliates, or, under a license from BDSI, its sublicensees or is not otherwise authorized by BDSI to be sold by any such entity, (ii) contains fentanyl and is administered in a transmucosal formulation;
and (iii) has obtained Approval under 21 U.S.C. 505(j) (or any successor legislation or similar legislation for approval of a generic product). 

1.70    “New Combination Product” means a pharmaceutical product that (i) contains *** as the sole
active ingredients, and (ii) is administered in a transmucosal formulation utilizing the BEMA Technology. 

1.71    “Onsolis” means the pharmaceutical product known as fentanyl buccal soluble film, having an NDA#
22 266. 
 1.72    “Amendments” means (i) those amendments of the Original Agreement not
constituting CDC Consents and (ii) the CDC Consent-Based Amendments. 
 1.73    “Athyrium” has the
meaning set forth in the preamble. 
 1.74    “BEMA” means the Company’s bioerodible, mucoadhesive
multi-layer polymer film. 
 1.75    “CDC Consents” means the consents, waivers, and similar executed
documents listed on Schedule 1.75, provided that the CDC Consent-Based Amendments shall not be considered CDC Consents (or any portion thereof) for purposes of this Agreement. 

1.76    “CDC Consent-Based Amendments” means the following: 

a.    Section 4.1 of that certain BEMA Acquisition Consent, Amendment, and Waiver, dated August 2,
2006, between BioDelivery, Subsidiary, Arius Two, and CDC; 

  
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 b.    Section 3 of that certain letter agreement, dated
August 2, 2006, between CDC, BioDelivery, Subsidiary, and Arius Two; 
 c.    Section 6 of that
certain Sublicensing Consent and Amendment, dated August 2, 2006, between BioDelivery, Subsidiary, and CDC; 

d.    Section 4 of that certain BEMA Acquisition Consent, Amendment, and Waiver, dated September 5,
2007, between BioDelivery, Subsidiary, Arius Two, and CDC; 
 e.    Section 3 of that certain letter
agreement, dated September 5, 2007, between CDC, BioDelivery, Subsidiary, and Arius Two; 

f.    Section 3.d.i. of that certain Sublicensing Consent and Amendment, dated September 5, 2007,
between BioDelivery, Subsidiary, CDC, and Meda; and 
 g.    Section 3.c. of that certain Sublicensing
Consent and Amendment between BioDelivery, Subsidiary, Athyrium, and CDC dated May 11, 2016. 

1.77    “Investors” means CDC and Athyrium (each, an “Investor”). 

1.78    “QLT Agreements” mean that certain Intellectual Property Assignment Agreement, dated as of
August 2, 2006, between Arius Two and QLT USA, Inc. (“QLT”), as amended, that certain Intellectual Property Assignment Agreement, dated as of September 5, 2007, between Arius Two and QLT, as amended, and those other documents and
agreements contemplated by or executed in conjunction with the foregoing, including but not limited to certain security agreements concerning certain Company Intellectual Property. 

1.79    “QLT Security Interests” means those security interests granted by BDSI or its Affiliates
pursuant to the QLT Agreements in and to any of the Company Intellectual Property. 
 ARTICLE 2 

INTENTIONALLY DELETED 

2.1    Intentionally deleted. 

2.2    Intentionally deleted. 

2.3    Intentionally deleted. 

2.3.1    Intentionally deleted. 

  
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 2.3.2    Intentionally deleted. 

2.3.3    Intentionally deleted. 

2.3.4    Intentionally deleted. 

2.3.5    Intentionally deleted. 

2.3.6    Intentionally deleted. 

2.4    Intentionally deleted. 

2.5    Intentionally deleted. 

ARTICLE 3 
 INTELLECTUAL
PROPERTY; QUALIFIED COLLABORATION PARTNERS 
 3.1    Intentionally deleted. 

3.2    Intentionally deleted. 

3.3    Intentionally deleted. 

3.4    Intellectual Property. Company shall prepare, file, prosecute and maintain Patent Rights to cover Company
inventions and Company Intellectual Property where such Patent Rights, Company inventions and Company Intellectual Property are owned by Company. Where such Patent Rights, Company inventions and Company Intellectual Property are not owned by
Company, Company shall enforce its intellectual property rights in accordance with the terms of the instrument or agreement granting Company such rights. Company shall keep CDC informed of the status of each such Patent Right. Company shall give
reasonable consideration to any suggestions or recommendations of CDC concerning the preparation, filing, prosecution and maintenance of any Company inventions. At the request of CDC, Company shall provide CDC with copies of the file histories of
all Company Patent Rights and shall update such file histories promptly upon receipt of any additional communications from any patent offices and patent counsel or agents pertaining thereto. Company shall also provide CDC with copies of any material
communications from any patent offices and patent counsel or agents pertaining to any Company Patent Rights. Company, at CDC’s request, shall file patent claims related to the Products or Compound proposed by CDC. The Parties shall cooperate
reasonably in the prosecution of all Patent Rights under this Section 3.4 and shall share all material information relating thereto promptly after receipt of such information. If, during the term of this Agreement, Company intends to allow any
Company Patent Rights owned by Company to expire or intends 

  
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to otherwise abandon any Company Patent Rights owned by Company, Company shall notify CDC of such intention at least sixty (60) days prior to the date upon which such Company Patent Rights
shall expire or be abandoned, and CDC shall thereupon have the right, but not the obligation, to assume responsibility for the preparation, filing, prosecution or maintenance thereof. 

3.5    Collaboration with Qualified Collaboration Partner. Company shall have the right to enter into a
partnership, collaboration, licensing agreement or other arrangement with a Qualified Collaboration Partner with respect to the development of the Product hereunder, provided, however, that (i) prior to a Change of Control of either
BioDelivery, Subsidiary, or Arius Two, such Qualified Collaboration Partner shall be subject to the prior written approval of CDC which approval shall not be unreasonably withheld and (ii) from and after a Change of Control of either
BioDelivery, Subsidiary, or Arius Two, such Qualified Collaboration Partner shall be subject to the prior written approval of CDC in its sole discretion. Prior to engaging in any potential discussions with any such Qualified Collaboration Partners,
Company shall consult in good faith with CDC regarding such Qualified Collaboration Partners, including, without limitation, discussions regarding alternative Qualified Collaboration Partners. In addition, once such Qualified Collaboration Partner
has been selected and throughout the process of negotiation of any potential transaction with such Qualified Collaboration Partner, Company shall consult in good faith with CDC regarding the terms and documentation with respect to the potential
transactions with such Qualified Collaboration Partners and shall consider in good faith CDC’s comments to such terms and documentation. In addition, Company shall provide complete and un-redacted
executed copies of any agreements or other understandings entered into with such Collaboration Partner promptly following the execution thereof. Notwithstanding the foregoing, as a condition to entering into such partnership, collaboration,
licensing agreement or other arrangement with a Qualified Collaboration Partner, the Qualified Collaboration Partner shall expressly acknowledge to CDC than any such agreement shall be subject to the rights of CDC hereunder. In addition to the
foregoing, CDC shall have access to all information and documentation that is generated or otherwise resides with the Collaboration Partner to the same extent Company would have access to such information or documentation under any such agreement.

 ARTICLE 4 

REGULATORY MATTERS; REPORTING AND INFORMATION SHARING 

4.1    Regulatory Matters. 

4.1.1    Executionary Lead. Company shall, as between the Parties, be responsible for ensuring compliance with all
applicable Laws and regulatory requirements relating to the Product including, without limitation, (a) filing all NDAs and applications for Approvals and supporting documentation; (b) conducting clinical trials in accordance with GCP
standards; (c) 

  
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serving as the designated regulatory official for purposes of receiving communications from the FDA and other Governmental Authorities and responding thereto; (d) reporting any Adverse Drug
Experiences to the appropriate Government Authority and (e) advertising, labeling, supplying and handling of the Product in accordance with all cGMP requirements and GCP standards. 

4.1.2    Ownership. All NDAs and Approvals relating to the Products shall be the property of Company and held in
the name of Company, its designated Affiliates, a Qualified Collaboration Partner, or other sublicensee of the Company permitted under this Agreement. 

4.2    Intentionally deleted. 

4.3    Intentionally deleted. 

4.4    Inspections. Company shall promptly, but in no event more than two (2) Business Days after receipt of
any inspections, proposed regulatory actions, investigations or requests by any Governmental Authority with respect to the Products, as well as any corrective actions initiated by Company with respect thereto, notify CDC in detail with respect
thereto and will provide CDC with copies of all material related documentation. The Parties shall cooperate to provide Governmental Authorities with access to, and copies of, any Program Data requested by such Governmental Authority. 

4.5    Government Communications. 

4.5.1    Intentionally deleted. 

4.5.2    Company shall provide CDC with notice, in a sufficiently timely basis (but in all cases not less than three
(3) Business Days after notice thereof), of notification or other information which it receives (directly or indirectly) from, any Governmental Authority (and providing, as soon as reasonably possible (but in all cases not less than three
(3) Business Days after receipt thereof), copies of any associated written requests) or from other persons that (i) may reflect or indicate any concerns regarding the safety or efficacy of a Product, (ii) indicates or suggests a Claim
of a third party arising in connection with a Product, or (iii) may lead to a recall or market withdrawal of a Product. Information that shall be disclosed pursuant to this Section 4.5.2 shall include, but not be limited to: 

(a)    Inspections by a Governmental Authority of manufacturing, distribution or other related facilities concerning a
Product; 

  
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	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 (b)    Inquiries by a Governmental Authority concerning clinical
investigation activities (including without limitation inquiries regarding investigators, clinical monitoring organizations and other related parties) with respect to a Product; 

(c)    Any communication from a Governmental Authority involving the manufacture, sale, promotion or distribution of a
Product, or any other Governmental Authority reviews or inquiries relating to a any event set forth in this Section 4.5.2; 

(d)    An initiation of any Governmental Authority investigation, detention, seizure or injunction concerning a Product;

 (e)    Any other regulatory action (e.g., proposed labeling or other registrational dossier changes and
recalls) which would affect a Product in any country; and 
 (f)    Any communication from a potential plaintiff or
counsel thereof related to a potential Claim in connection with the Product. 
 4.6    Reporting and Information
Sharing. 
 4.6.1    Inquiries, Adverse Events. Company (or its applicable Affiliate, licensees, or
sublicensee) shall submit reports of all Adverse Drug Experiences associated with the use of the approved Product(s) and other required safety information (e.g., PSUR’s and annual safety reports) to the FDA and other Governmental Authorities,
in accordance with applicable Law. 
 4.6.2    Recalls and Withdrawals. Company shall immediately notify CDC of
any decision to initiate a recall or withdrawal of Product. Any and all costs and expenses of in connection with such recall, market withdrawal or other corrective action shall be borne by Company. 

ARTICLE 5 
 OWNERSHIP AND
LICENSE 
 5.1    Program Data. Company shall timely communicate in full detail and disclose all Program
Data; provided, however, that any such disclosure shall be conducted in a manner and shall be to the extent permitted under applicable Laws in order to protect the privacy of study subjects and confidentiality of study subject data and information.
All Program Data shall be the sole and exclusive property of CDC with full right, title, and interest thereto, and shall be treated as the Confidential Information of CDC and in furtherance of the foregoing, Company hereby assigns and transfers to
CDC all of its right, title and interest in and to such Program Data. 
 5.2    Intentionally deleted. 

  
 14 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 5.3    Grant of License by CDC. 

5.3.1    Intentionally deleted. 

5.3.2    License to Program Data After Product Approval. CDC hereby grants to Company a worldwide, exclusive right
and license, with the right to sublicense, to use the Program Data to make, have made, use, have used, import, export, offer to sell, sell and have sold Product. 

5.3.3    Intentionally deleted. 

5.3.4    Sublicenses. In the event Company grants a sublicense of its rights in accordance with the terms of this
Agreement, each and every such sublicense shall be subject in all respects to the same terms, conditions and provisions contained in this Agreement, and Company shall be responsible for ensuring that any
sub-licensee complies with such terms and conditions. 
 ARTICLE 6 

COMMERCIALIZATION AND FINANCIAL PROVISIONS 

6.1    Commercialization Efforts. Company shall use Commercially Reasonable Efforts to market, distribute,
sell and otherwise commercialize the Product. CDC agrees that the efforts of Company’s Affiliates, licensees, sublicensees, and any contractors of any of the foregoing shall be deemed the efforts of the Company for purposes of the foregoing.

 6.2    Marketing Plan Company shall be responsible for developing an annual marketing plan for each Product.
Each marketing plan developed by Company shall be prepared in good faith in accordance with Company’s standard practices with the overall objective of achieving the maximum commercial potential of such Product. 

6.2.1    Intentionally deleted. 

6.2.2    Intentionally deleted. 

6.2.3    Updates. Company shall provide CDC with quarterly written reports of Company’s commercialization
efforts and activities for such quarter and a description of its plans for future commercialization efforts and activities. In addition, Company shall provide such other information, financial or otherwise, CDC may reasonably request relating to the
manufacture, marketing, sale or distribution of the Product. After receipt of such reports, CDC shall be entitled to request a meeting with Company to discuss such reports and the Parties shall meet on dates, at times and in locations as agreed upon
by the Parties. 

  
 15 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 6.3    Intentionally deleted. 

6.4    Intentionally deleted. 

6.4.1    Intentionally deleted. 

6.4.2    Intentionally deleted. 

6.4.3    Intentionally deleted. 

6.4.4    Intentionally deleted. 

6.4.5    Intentionally deleted. 

6.4.6    Intentionally deleted. 

6.5    Intentionally deleted. 

6.6    Royalties. 

6.6.1    Royalty on Net Sales. Commencing in the calendar year in which the Product is sold, Company will pay to
CDC, on a quarterly basis, a royalty on worldwide annual Net Sales of Products as follows: 
 (i)    a ***
royalty (the “First Tier Royalty”) on the first *** of worldwide Net Sales of Products in a particular calendar year. 

(ii)    a *** royalty (the “Second Tier Royalty”) on the worldwide Net Sales of Products in a particular
calendar year exceeding the first *** of worldwide annual Net Sales of Products in a particular calendar year. 
 Notwithstanding
anything to the contrary, no royalties shall be due under this Section 6.6.1 on Net Sales of New Combination Products. 

6.6.2    Royalties on Net Sales of New Combination Product. Commencing in the calendar year in which any New
Combination Product is sold, Company will pay to CDC, on a quarterly basis, a royalty on worldwide annual Net Sales of New Combination Products as follows: 

(i)    a *** royalty (the “First Tier Royalty for New Combination Products”) on the
first *** of worldwide Net Sales of New Combination Products in a particular calendar year. 

  
 16 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 (ii)    a *** royalty (the “Second Tier
Royalty for New Combination Products”) on the worldwide Net Sales of New Combination Products in a particular calendar year exceeding the first *** of worldwide Net Sales of New Combination Products in a particular calendar year

 6.6.3    Minimum Royalty. Notwithstanding Sections 6.6.1 and 6.6.2, the royalty payments made by Company to
CDC pursuant to Sections 6.6.1 and 6.6.2 (if any) in any given calendar quarter shall not be less than *** ($***) and in the event that the aggregate royalty payments in any give calendar quarter as calculated pursuant to Sections
6.6.1 and 6.6.2 are less than *** ($***), Company shall pay to CDC an amount equal to the difference between *** ($***) and the aggregate royalty payments previously paid to CDC for such calendar quarter (the
“Shortfall Amount”), which Shortfall Amount payment shall be made to CDC at the time the royalty payment for such calendar quarter is paid to CDC pursuant to the terms of Section 6.6.6. 

6.6.4    Launch of Combination Product. If a “New Combination Product” receives Approval in a particular
country for an indication that is the same or substantially similar as an indication for which Onsolis has received (regardless of whether the Approval for Onsolis has subsequently been withdrawn) Approval in such country (such New Combination
Product, a “Second Generation Combination Product”), then, notwithstanding anything to the contrary contained herein, from (and including) the calendar quarter following Approval of such New Combination Product for such indication in such
country until the later of (i) the earlier of (a) expiration of the last applicable BEMA Technology Patent Right covering Onsolis in such country or (b) *** or (ii) the first day of the calendar quarter following the calendar
quarter during which Generic Products have prescriptions filled for them in such country that exceed the number of prescriptions filled for Onsolis in such country, royalties on Net Sales of such Second Generation Combination Product in such country
shall, for every calendar quarter of such period during which Approvals for such indication for both Onsolis and such Second Generation Combination Product are in effect in such country, be calculated in accordance with Section 6.6.1 and not
6.6.2; provided, however, that Net Sales in such country shall be determined as if such Second Generation Combination Product was a single Product and not a Combination Product. 

6.6.5    Intentionally deleted. 

6.6.6    Timing of Payments. All amounts due CDC pursuant to this Section 6.6. shall be payable quarterly in
arrears and such payments shall be made by Company to CDC within *** after March 31, June 30, September 30 and December 31 of each year. Each quarterly payment shall be accompanied by a written statement of royalties as
described in Section 6.6.7. 

  
 17 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 6.6.7    Written Statement. Along with each remittance of payments
pursuant to Section 6.6.2 to CDC, Company shall include a report covering: (i) the gross sales of all Products sold by Company, its Affiliates and sublicensees, (ii) the Net Sales of all Products sold by Company, its Affiliates and
its sublicensees, during the calendar quarter and the detailed calculation of the reconciliation between gross sales and Net Sales showing those items allowed to be deducted from gross sales pursuant to the definition of Net Sales; (iii) the
royalties payable in US Dollars with respect to Net Sales; and (iv) the exchange rates used in determining the amount of Dollars. If no sales of Products or have been made during any reporting period, Company will provide a statement to this
effect to CDC. 
 6.6.8    Royalty Term. On a
country-by-country and Product-by-Product basis, the royalty obligation of the Company
under this Agreement shall expire on the later of: (i) expiration of the last applicable BEMA Technology Patent Right covering a particular Product in a particular country or (ii) the first full calendar year following the calendar year in
which generic versions of a particular Product have prescriptions filled for them in a particular country that exceed the number of prescriptions filled for the branded versions of such Product sold by or on behalf of Company, its Affiliates, or
sublicensees or distributors of any of the foregoing in such country in such calendar year. For purposes of this Section 6.6.8, a “generic version” shall not include an “authorized generic” or any pharmaceutical product sold
by or on behalf of BDSI, its Affiliates, or sublicensees or distributors with respect to, in either case, the relevant Product. 

6.7    Payment Currency. All amounts due under this Agreement shall be paid to the designated Party in United
States dollars. The US dollar equivalent of Net Sales incurred in a currency other than U.S. Dollars shall be calculated using the methodology set forth in any license, strategic or collaborative partnership agreement with a third party generating
such sales, or otherwise using the average of the spot rate (the “Closing mid-point rates” found in the “Dollar spot forward against the Dollar” table published by The Financial Times, or
any other publication agreed to by the Parties) prevailing during the calendar quarter of the applicable royalty payment. 

6.8    Payments. All payments under this Agreement shall be made on or before the due date by electronic transfer
in immediately available funds to the respective account designated in writing by Company at least two (2) Business Days before the payment is due. Company shall notify CDC’s treasurer, or such other CDC representative as CDC’s
treasurer shall designate in writing, by facsimile transmission as to the date and amount of any payment that Company shall make at least two (2) Business Days prior to such transfer. All payments under this Agreement shall bear interest from
the date due until paid at a rate equal to the lesser of (a) *** (***%) per month or (b) the highest rate permitted by applicable Law, calculated on the number of days such payments are paid after the date such payments are due.

  
 18 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 6.9    Books and Records. Company shall keep comprehensive books
and records relating to this Agreement in accordance with GAAP. Such books and records shall document all gross sales, Net Sales, authorized expenses incurred or paid and any other costs incurred or revenues earned relating to this Agreement and
include all information subject to audit pursuant to Section 6.10. All such books and records shall be maintained for three (3) years following the relevant year or such longer period as is required by Law. 

6.10    Audits. These audit and adjustment provisions apply with respect to all payments due or owing pursuant to
this Agreement. CDC shall have the right to have the applicable books and records of Company audited under appropriate confidentiality provisions for the sole purpose of verifying the accuracy of all financial, accounting and numerical information
and calculations under this Agreement. Any such audit shall be conducted no more than once each year, and upon at least twenty (20) Business Days’ advance notice during normal business hours and in a manner that does not interfere
unreasonably with the business of Company. The results of any such audit shall be delivered in writing to each Party. Any underpayment or overbilling determined by such audit shall promptly be paid or refunded by Company. If Company has underpaid or
overbilled amounts due under this Agreement by more than *** (***%) over any reporting period, Company shall also reimburse CDC for the cost of such audit (with the cost of the audit to be paid by CDC in all other cases), plus interest
in accordance with Section 6.8, from the date of any such underpayment or overpayment. 
 6.11    Consistent
Treatment of Transaction by the Parties. It is the intent of the Parties that, for federal, state and local tax (including sales and use taxes) purposes and commercial and bankruptcy law purposes, that (a) CDC was treated as the legal and
beneficial owner of the Program Data during the period commencing on the Original Effective Date and ending on initial Approval of the Product, entitled to any and all benefits of ownership, (b) the Development Program was performed by Company
on behalf of CDC pursuant to the Development Program, and (c) the license pursuant to Section 5.3.1 of the Original Agreement upon receipt of initial Approval of the Product shall be treated as a sale of the Program Data by CDC to Company.
Nevertheless, Company acknowledges and agrees that CDC has not made any representations or warranties concerning the tax, financial, accounting or legal characteristics or treatment of this Agreement, and that Company has obtained and relied solely
upon the advice of its own tax, accounting and legal advisors concerning this Agreement and the accounting, tax, financial and legal consequences of the transactions contemplated herein. 

6.12    Non-Compete. During the term of this Agreement, Company agrees that
it will not, and will cause its Affiliates to not, develop, manufacture, market or sell a Competing Product throughout the world. 

  
 19 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 ARTICLE 7 

CONFIDENTIAL INFORMATION 

7.1    Treatment of Confidential Information. During the term of this Agreement and for five (5) years
thereafter, each Party shall maintain Confidential Information (as defined in Section 7.2) of the other Party in confidence, and shall not disclose, divulge or otherwise communicate such Confidential Information to others (except for employees,
agents and advisors under obligations of confidentiality) or use it for any purpose other than in connection with the development, manufacture, marketing, promotion, distribution or sale of the Products as provided in this Agreement or for tax or
accounting purposes, and each Party agrees to exercise reasonable efforts to prevent and restrain the unauthorized disclosure of such Confidential Information by any of its directors, officers, employees, consultants, subcontractors, licensees,
auditors or agents, which reasonable efforts shall be at least as diligent as those generally used by such Party in protecting its own confidential and proprietary information. 

7.2    Confidential Information. “Confidential Information” means all trade secrets or other
proprietary information, including without limitation any proprietary data and materials (whether or not patentable or protectable as a trade secret), regarding a Party’s technology, products, business or objectives or regarding the Products,
which is disclosed by a Party to the other Party. Notwithstanding the foregoing, there shall be excluded from the foregoing definition of Confidential Information any of the foregoing that: 

7.2.1    was known by the receiving Party prior to its date of disclosure to the receiving Party as shown by the receiving
Party’s written records; or 
 7.2.2    either before or after the date of the disclosure to the receiving Party is
lawfully disclosed to the receiving Party, with no obligation of confidentiality, by third parties not in violation of any obligation to the other Party; or 

7.2.3    either before or after the date of the disclosure to the receiving Party becomes published or generally known to
the public through no fault or omission on the part of the receiving Party or its Affiliates; or 
 7.2.4    is
independently developed by or for the receiving Party without reference to, reliance upon or benefit of the Confidential Information as demonstrated by contemporaneous written records of the receiving Party; or 

7.2.5    is required to be disclosed by the receiving Party to comply with applicable securities and other Laws, to defend
or prosecute litigation or to comply with governmental regulations or the regulations or requirements of any stock exchange, provided that the receiving Party provides prior notice of such disclosure to the other Party and takes reasonable and
lawful actions to avoid and/or minimize the degree of such disclosure. 

  
 20 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 7.3    Confidentiality of this Agreement. The material financial
terms of this Agreement shall be Confidential Information of each Party and, as such, shall be subject to the provisions of this ARTICLE 7. 

7.4    Registration and Filing of the Agreement. To the extent, if any, that a Party concludes in good faith that
it is required to file or register this Agreement or a notification thereof with any Governmental Authority, including without limitation the US Securities and Exchange Commission, or the US Federal Trade Commission, in accordance with applicable
Laws, such Party shall inform the other Party thereof. Should either Party be required to submit or obtain any such filing, registration or notification, they shall cooperate, each at its own expense, in such filing, registration or notification and
shall execute all documents reasonably required in connection therewith. In such filing, registration or notification, the Parties shall agree in advance on which provisions of this Agreement they will request confidential treatment of. The Parties
shall promptly inform each other as to the activities or inquiries of any such Governmental Authority relating to this Agreement, and shall reasonably cooperate to respond to any request for further information therefrom on a timely basis. 

7.5    Press Releases and Other Disclosures. No press release or other public announcement concerning the existence
or terms of this Agreement shall be made, either directly or indirectly, by either Party hereto, without first obtaining the written approval of the other Party. Once any public announcement or disclosure has been approved in accordance with this
Section 7.5, then either Party may appropriately communicate information contained in such permitted announcement or disclosure. Notwithstanding the foregoing provisions of this ARTICLE 7 Company may (a) disclose the existence and terms of
this Agreement where required, as reasonably determined by Company, by applicable Law, by applicable stock exchange or Nasdaq regulation or by order or other ruling of a competent court and (b) disclose the existence and terms of this Agreement
under obligations of confidentiality to auditors, legal counsel and investment bankers in connection with exploring the issuance of securities in a public transaction; provided, however, that before making any such disclosure, prior written notice
is given to CDC together with a description of the disclosure that is intended to be made and the party or parties to whom such disclosure shall be made. Notwithstanding the foregoing provisions of this ARTICLE 7, CDC may (a) disclose the
existence and terms of this Agreement where required, as reasonably determined by the CDC, by applicable Law, by applicable stock exchange or Nasdaq regulation or by order or other ruling of a competent court and (b) disclose the existence and
terms of this Agreement under obligations of confidentiality to agents, auditors, advisors, contractors and investors and to potential agents, auditors, advisors, contractors and investors (including any assignee or purchaser of any rights
hereunder) in connection with such CDC’s activities hereunder and in connection with such Party’s financing activities. 

  
 21 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 ARTICLE 8 

REPRESENTATIONS, WARRANTIES AND COVENANTS 

8.1    Mutual Representations and Warranties. Company and CDC each represents and warrants that: 

8.1.1    Such Party (a) is duly organized, validly existing, and in good standing under the Laws of its
incorporation; (b) is duly qualified and in good standing under the Laws of each jurisdiction where its ownership or lease of property or the conduct of its business requires such qualification, where the failure to be so qualified would have a
material adverse effect on its financial condition or its ability to perform its obligations hereunder; (c) has the requisite corporate power and authority and the legal right to conduct its business as now conducted and hereafter contemplated
to be conducted; (d) has or will obtain all necessary licenses, permits, consents, or approvals from or by, and has made or will make all necessary notices to, all Governmental Authorities having jurisdiction over such Party, to the extent
required for the ownership and operation of its business, where the failure to obtain such licenses, permits, consents or approvals, or to make such notices, would have a material adverse effect on its financial condition or its ability to perform
its obligations hereunder; and (e) is in compliance with its charter documents; 
 8.1.2    The execution, delivery
and performance of this Agreement by such Party and all instruments and documents to be delivered by such Party hereunder (a) are within the corporate power of such Party; (b) have been duly authorized by all necessary or proper corporate
action; (c) do not conflict with any provision of the charter documents of such Party; (d) will not, to the best of such Party’s knowledge, violate any law or regulation or any order or decree of any court of governmental
instrumentality; (e) will not violate or conflict with any terms of any indenture, mortgage, deed of trust, lease, agreement, or other instrument to which such Party is a party, or by which such Party or any of its property is bound; 

8.1.3    This Agreement has been duly executed and delivered by such Party and constitutes a legal, valid and binding
obligation of such Party, enforceable against such Party in accordance with its terms, except as such enforceability may be limited by applicable insolvency and other Laws affecting creditors’ rights generally, or by the availability of
equitable remedies; and 
 8.1.4    All of its employees, officers, and consultants have executed agreements or have
existing obligations under law requiring assignment to such Party of all inventions made 

  
 22 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 
by such individuals during the course of and as the result of their association with such Party, and obligating such individuals to maintain as confidential such Party’s Confidential
Information, as well as the Confidential Information of Persons doing business with such Party that such individuals may receive during the course of and as the result of their association with such Party, to the extent required to support such
Party’s obligations under this Agreement. 
 8.2    Company’s Representations. Company
hereby represents, warrants and covenants as follows: 
 8.2.1    There is no claim or demand of any person or entity
pertaining to, or any proceeding which is pending or, to the knowledge of Company, threatened, that would have a material adverse effect on the ability of Company to carry out its obligations under this Agreement; and 

8.2.2    Intentionally deleted. 

8.2.3    Company has not previously granted and will not grant any rights inconsistent with the rights and licenses
granted herein; 
 8.2.4    as of the Original Effective Date, Company provided to CDC all requested documents in its
files for, as well as all other information, to its knowledge, that was, as of the Original Effective Date, material to, the Company Intellectual Property, the Compound, Product and the BEMA Technology, including without limitation, any information
that, as of the Original Effective Date, related to the patentability or validity of the Company Patent Rights existing as of such date (the “Original Company Patent Rights”); 

8.2.5    to the best of Company’s knowledge, as of the Original Effective Date, (i) the Original Company Patent
Rights were valid and enforceable and (ii) there were no Patent Rights or similar intellectual property rights of a third party that the manufacture, use or sale of Product would infringe; 

8.2.6    as of the Effective Date, the Company holds good title to and is the legal and beneficial owner of the Company
Patent Rights, free and clear of all liens, security interests, charges and other encumbrances of any kind (other than unilateral creditor filings with respect to which this representation shall be made to the best of Company’s knowledge),
other than as set forth in certain licenses granted thereunder with respect to Products and certain other products; 

8.2.7    as of the Original Effective Date, there were no pending claims, judgments or settlements against or owed by
Company pending with respect to the Company Intellectual Property, and, Company had not previously received written notice of any threatened claims or litigation seeking to invalidate the Original Company Patent Rights. During the term of this
Agreement, Company shall promptly notify CDC in writing upon learning of any such actual or threatened claim, judgment or settlement; 

  
 23 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 8.2.8    as of the Original Effective Date, (i) there were no
inquiries, actions or other proceedings pending before or, to the best of Company’s knowledge, threatened by any Governmental Authority or other government agency with respect to Product or any facility where Product is manufactured and
(ii) Company had not received written notice threatening any such inquiry, action or other proceeding. As of the Original Effective Date, (i) there were no investigations pending before or, to the best of Company’s knowledge,
threatened by any Governmental Authority or other government agency with respect to Product or any facility where Product is manufactured and (ii) Company had not received written notice threatening any such investigation. During the term of
this Agreement, Company shall promptly notify CDC in writing upon learning of any such actual or threatened investigation, inquiry or proceeding; 

8.2.9    to the best of Company’s knowledge as of the Original Effective Date, the making, using or selling of
Product would not, as of the Original Effective Date, infringe the Patent Rights of any third party, and Company had no knowledge as of the Original Effective Date that any third party was infringing any of the Original Company Patent Rights; 

8.2.10    as of the Original Effective Date, the development and manufacture of Product has been conducted by Company and
its Affiliates and subcontractors in compliance in all material respects with all applicable Laws and, as of the Original Effective Date, neither Company nor its Affiliates nor subcontractors had received any notice in writing, or otherwise has
knowledge of any facts, which had, or reasonably should have, led Company to believe that any of the INDs relating to Product were not currently in good standing with, the FDA; 

8.2.11    as of the Original Effective Date, Company had conducted all aspects of its drug research and development
activities relating to the Compound and/or Product and/or BEMA Technology in compliance with all applicable Laws, including, but not limited to, the provisions of the Act, including the regulations issued thereunder, and applicable cGMPs as they
relate to processing or preparation of clinical trial materials. To the Company’s knowledge as of the Original Effective Date, it was not, as of the Original Effective Date, the subject of any investigation by a Governmental Authority, nor had
any investigation, prosecution, or other enforcement action been threatened by a Governmental Authority. As of the Original Effective Date, the Company had not received from a Governmental Authority any letter or other document asserting that the
Company has violated any statute or regulation enforced by such agency; 
 8.2.12    To the Company’s knowledge as
of the Original Effective Date, research involving human subjects conducted by or for the Company as of the Original Effective Date had (i) been conducted in compliance with all applicable federal, state, and foreign statutes and

  
 24 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 
regulations governing the protection of human subjects and (ii) not involved any investigator who has been disqualified as a clinical investigator by the FDA or any other agency or has been
found by any agency with jurisdiction to have engaged in scientific misconduct. As of the Original Effective Date, the Company had conducted its clinical investigations in accordance with relevant study protocols and Institutional Review Board
approvals and requirements, if applicable, had properly supervised use of the treatment drugs throughout the course of all studies, and had ensured that informed patient consent is obtained where appropriate, consistent with the applicable
requirements of 21 C.F.R. Part 50 and any state law requirements; 
 8.2.13    As of the Original Effective Date, the
Company had provided complete and accurate information concerning costs and expenses of its clinical trials in connection with any claims for federal, state, or private third party reimbursement associated with such clinical trials; 

8.2.14    As of the Original Effective Date, Company had never been and was not currently debarred by the FDA pursuant to
21 U.S.C. §335(a) or (b) (“Debarred Entity”) and Company agrees that, since the Original Effective Date, it has not and will not obtain advice or assistance from any individual debarred pursuant to 21 U.S.C. §335(a) or
(b). As of the Original Effective Date, Company had no knowledge of any circumstances that may affect the accuracy of the foregoing warranties and representations, including, but not limited to, FDA investigations of, or debarment proceedings
against, it or any person or entity with which it is associated or that provides services to Company, and Company will immediately notify CDC if it becomes aware of any such circumstances during the term of this Agreement; 

8.2.15    Company had, up to and including the Original Effective Date, endeavored in good faith to furnish CDC with all
material information concerning the quality, toxicity, safety and/or efficacy concerns that may materially impair the utility and/or safety of Products or any other information received from or provided to a Governmental Authority with respect to
the Products; 
 8.2.16    The Arius Two License (ROW) and Arius Two License (NA) (collectively the “Company
Agreements”) are in full force and effect. Company shall not, without the prior written approval of CDC: (i) amend any provision of a Company Agreement in any manner that would have an adverse effect on CDC’s rights under this
Agreement or (ii) terminate, or make any election or exercise any right or option to terminate, in whole or in part any Company Agreement in any manner that would adversely affect Company’s or CDC’s rights with respect to any Product
or CDC’s rights under this Agreement. 
 8.2.17    Intentionally deleted. 

  
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	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 8.2.18    Company has the lawful right and/or license to use the BEMA
Technology, including, without limitation, in connection with the development, manufacture, marketing, distribution, sale and commercialization of the Product. 

8.2.19    Intentionally deleted. 

8.2.20    Company has repaid all loans made by QLT pursuant to the QLT Agreements, the QLT Security Interests have
terminated, and QLT has no remaining rights under the QLT Agreements to acquire or be assigned the Arius Two License (ROW), Arius Two License (NA), any Company Intellectual Property, or any other assets of the Company. 

8.3    CDC’s Representations. CDC hereby represents and warrants that (i) there is no claim
or demand of any person or entity pertaining to, or any proceeding which is pending or, to the knowledge of CDC, threatened, that would have a material adverse effect on the ability of CDC to carry out its obligations under this Agreement,
(ii) Athyrium is a party to this Agreement for all purposes required under any agreements or arrangements between Athyrium and CDC or any Affiliate thereof, (iii) no consent, waiver, agreement, or approval of Athyrium is required for the
execution or performance of this Agreement, except any such consent, waiver, agreement, or approval that CDC has obtained prior to the execution hereof, and (iv) neither the execution nor performance of this Agreement by CDC does or will
violate, breach, or constitute a default under any agreements or arrangements between Athyrium and CDC or any Affiliate thereof. 

8.4    Covenants of CDC. Subject to Section 11.9, during the term of this Agreement, CDC, without the prior
written consent of Company, such consent not to be unreasonably withheld, shall not sell, license, encumber or otherwise transfer to a third party any of CDC’s assets related to Company, Product or the Program Data. 

8.5    Covenants of Company. 

8.5.1    Except with respect to, and as set forth in, sublicenses granted by Company in accordance with the provisions of
this Agreement, during the term of this Agreement, Company, without the prior written consent of CDC, shall not sell, license, encumber or otherwise transfer to a third party any of the Company Intellectual Property, the NDA for the Product, or
Company’s ownership or other proprietary rights in the Product, or otherwise grant any third party any rights to market, sell, develop or otherwise commercialize the Product. 

8.5.2    Intentionally deleted. 

8.6    Intentionally deleted. 

  
 26 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 8.7    Accounting. The Company shall account for the transactions
contemplated herein as a licensing transaction. 
 ARTICLE 9 

INDEMNIFICATION 

9.1    Indemnification by Company. Company agrees to defend CDC and its Affiliates at Company’s cost and
expense, and will indemnify and hold CDC and its Affiliates and their respective directors, officers, employees and agents, including, without limitation, CDC’s representatives on the Development Committee (the “CDC Indemnified
Parties”) harmless from and against all Claims of third parties, and all associated Losses, based on or relating to (i) any breach by Company of any of its representations, warranties or obligations pursuant to this Agreement,
(ii) Company’s negligence or misconduct in performing any of its obligations under this Agreement, or (iii) the development (including, without limitation, CDC’s participation in the Development Program), manufacture, use, sale
or other disposition of Compound and/or Product and/or BEMA Technology; provided, however, that Company shall not be responsible for the indemnification or defense of any CDC Indemnified Party arising from any gross negligence or willful misconduct
by any CDC Indemnified Party. 
 9.2    Procedure for Indemnification. 

9.2.1    Notice. CDC will notify promptly Company if it becomes aware of a Claim (actual or potential) by any third
party (a “Third Party Claim”) for which indemnification may be sought by CDC and will give such information with respect thereto as Company shall reasonably request. If any proceeding (including any governmental investigation) is
instituted involving any Party for which a CDC Indemnified Party may seek an indemnity under Section 9.1, the CDC Indemnified Party shall not make any admission or statement concerning such Third Party Claim, but shall promptly notify Company
orally and in writing and Company and CDC Indemnified Party shall meet to discuss how to respond to any Third Party Claims that are the subject matter of such proceeding. Company shall not be obligated to indemnify the CDC Indemnified Party to the
extent any admission or statement made by the CDC Indemnified Party or any failure by such CDC Indemnified Party to notify Company of the claim materially prejudices the defense of such claim. 

9.2.2    Defense of Claim. If Company elects to defend or, if local procedural rules or laws do not permit the
same, elects to control the defense of a Third Party Claim, it shall be entitled to do so provided (i) it gives notice to the CDC Indemnified Party of its intention to do so within forty-five (45) days after the receipt of the written
notice from the CDC Indemnified Party of the potentially indemnifiable Third Party Claim; (ii) the defense of such Third Party Claim by Company will not, in the reasonable judgment of the CDC Indemnified Party, have an adverse effect on the CDC
Indemnified Party; (iii) Company has sufficient financial resources, in 

  
 27 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 
the reasonable judgment of the CDC Indemnified Party, to satisfy the amount of any adverse monetary judgment that is reasonably likely to result; (iv) the Third Party Claim solely seeks (and
continues to seek) monetary damages; and (v) Company expressly agrees in writing that as between Company and the CDC Indemnified Party, Company may only satisfy and discharge the Third Party Claim in accordance with the provisions set forth in
this Agreement (the conditions set forth in clauses (i) through (v) are collectively referred to as the “Litigation Conditions”); and provided further, that Company expressly agrees Company shall be responsible for satisfying
and discharging any award made to the Third Party as a result of such proceedings or settlement amount agreed with the Third Party in respect of the Third Party Claim. Subject to compliance with the Litigation Conditions, Company shall retain
counsel reasonably acceptable to the CDC Indemnified Party (such acceptance not to be unreasonably withheld) to represent the CDC Indemnified Party and shall pay the fees and expenses of such counsel related to such proceeding. In any such
proceeding, the CDC Indemnified Party shall have the right to retain its own counsel, but the fees and expenses of such counsel shall be at the expense of the CDC Indemnified Party. The CDC Indemnified Party shall not settle any claim for which it
is seeking indemnification without the prior consent of Company which consent shall not be unreasonably withheld. The CDC Indemnified Party shall, if requested by Company, cooperate in all reasonable respects in the defense of such claim that is
being managed and/or controlled by Company at the sole cost and expense of Company. Company shall not, without the written consent of the CDC Indemnified Party (which consent shall not be unreasonably withheld), effect any settlement of, or the
entry of any judgment arising from, any pending or threatened proceeding in which the CDC Indemnified Party is, or based on the same set of facts could have been, a party and indemnity could have been sought hereunder by the CDC Indemnified Party,
which (1) does not include as an unconditional term thereof the giving by the claimant or the plaintiff to the CDC Indemnified Party a complete release from all liability in respect of such claims that are the subject matter of such proceeding,
or (2) grants any injunctive or equitable relief, or (3) may reasonably be expected to have an adverse effect on the business of the CDC Indemnified Party. If the Litigation Conditions are not met, then neither Party shall have the right
to control the defense of such Third Party Claim and the Parties shall cooperate in and be consulted on the material aspects of such defense at the each Party’s own expense. In the event that at any time (A) the Litigation Conditions cease
to be met or (B) Company fails to take reasonable steps necessary to defend diligently such Third Party Claim, the CDC Indemnified Party may assume its own defense, and Company shall be liable for all reasonable costs or expenses paid or
incurred by the CDC Indemnified Party in connection with such defense. 
 9.3    Assumption of Defense.
Notwithstanding anything to the contrary contained herein, a CDC Indemnified Party shall be entitled to assume the defense of any Third Party Claim with respect to the CDC Indemnified Party, upon written notice to Company pursuant to this
Section 9.3, in which case Company shall be relieved of liability under Section 9.1, as applicable, solely for such Third Party Claim and related Losses. 

  
 28 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 9.4    No Consequential or Punitive Damages. NEITHER PARTY HERETO
WILL BE LIABLE FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY OR PUNITIVE DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, OR FOR LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF SUCH DAMAGES. NOTHING IN THIS SECTION 9.4 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS UNDER THIS AGREEMENT WITH RESPECT TO THIRD PARTY CLAIMS. 

9.5    Insurance. Company agrees to maintain insurance coverage or self-insure in commercially reasonable amounts
for compensation for subjects sustaining any injury resulting from enrollment in the clinical trials conducted under the Development Program and use of the Product. 

9.6    Third Party Compensation for Lost Sales. In the event that Company receives compensation from a third party
to compensate Company for lost Net Sales of the Product, Company shall pay CDC a royalty calculated in accordance with the applicable royalty rate provided under Section 6.6 multiplied by the amount of the compensation received from such third
party to compensate Company for the lost Net Sales, less the expenses incurred by Company in connection with the enforcement of its Claims. 

ARTICLE 10 
 TERM AND
TERMINATION 
 10.1    Term. This Agreement shall be effective as of the Effective Date and shall continue in
force until terminated as provided herein. 
 10.2    Termination for Breach. CDC may terminate this Agreement by
notice to the Company if the Company is in default of any of its obligations hereunder, which default or defaults, in the aggregate, are material with respect to the transactions contemplated by this Agreement and (if susceptible of cure) fails to
remedy such default(s) within thirty (30) days after notice thereof by CDC in the case of payment default(s) or sixty (60) days after notice thereof by CDC in the case of all other default(s), such notice in either case specifying in
reasonable detail the nature of such default(s). CDC may also terminate this Agreement immediately upon any termination of any of the Company Agreements that is not permitted by Section 8.2.16. 

10.3    Termination for Reasons of Insolvency or Termination of Business Activities. CDC shall be entitled to
terminate this Agreement if the Company becomes insolvent or is the subject of a petition in bankruptcy whether voluntary or involuntary or of any other proceeding under bankruptcy, insolvency or similar laws, makes an assignment for the benefit of
creditors, is 

  
 29 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 
named in such a petition, or its property is subject to a suit for the appointment of a receiver, or is dissolved or liquidated. Such termination right may be exercised within sixty
(60) days following the date as of which CDC receives knowledge of such insolvency or termination of business activities by the Company, by giving the Company written notice, if such petition or proceeding is not dismissed within such sixty
(60) day period. 
 10.4    Intentionally deleted. 

10.4.1    Intentionally deleted. 

10.4.2    Intentionally deleted. 

10.4.3    Intentionally deleted. 

10.4.4    Intentionally deleted. 

10.4.5    Intentionally deleted. 

10.5    Effect of Termination by CDC. In the event that this Agreement is terminated by CDC pursuant to Sections
10.2 or 10.3, the following shall occur: 
 10.5.1    Return of Materials. Company shall, at its sole expense,
promptly transfer to CDC copies of all data, reports, records and materials in its possession or control that relate to the Product and return to CDC, or destroy at CDC’s request, all relevant records and materials in its possession or control
containing Confidential Information of CDC (provided that Company may keep one copy of such Confidential Information of CDC for archival purposes only); 

10.5.2    Transfer of Regulatory Filings and Company Know-How. Company
shall, at its sole expense, transfer to CDC, or shall cause its designee(s) to transfer to CDC, ownership of all regulatory filings made or filed for Product, including, without limitation, any and all NDAs and related to the Product. Company shall
transfer to CDC the physical embodiment of Company Know-How; 

10.5.3    License Rights. Company shall grant to CDC an exclusive (even as to Company and its Affiliates) worldwide
right and license, with the right to sublicense, under the Company Intellectual Property to make, have made, develop, manufacture, use, sell, offer for sale, and have sold Compound and/or Product on an exclusive, royalty-free basis. Any licenses
granted by CDC to Company hereunder shall terminate, including, without limitation, licenses and rights to the Program Data, and Company shall have no further rights to use or reference in any way such Program Data; 

  
 30 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 10.5.4    Assignment of Rights in the Trademark and Promotional
Material. To the extent there are any Product-specific trademarks or Product-specific promotional materials associated with the Product, Company shall, at its own expense, assign to CDC any rights it may have in such trademark and/or promotional
materials (other than Company’s rights to trademarks or materials that are not Product-specific), and such trademark and rights in the promotional materials shall be owned by CDC; 

10.5.5    Manufacturing. For Product then being manufactured by or on behalf of Company, if any, the Parties shall,
at CDC’s sole discretion, (a) negotiate, in good faith, a supply agreement for Product on commercially reasonable terms, or (b) transfer any required technology to CDC or its designee to enable CDC or such designee to manufacture
Product; provided that, in any event, Company shall ensure, for up to two (2) years, that CDC has a continuous and uninterrupted supply of Product until such supply agreement or transition is accomplished; 

10.5.6    Clinical Supplies. Company shall transfer to CDC all clinical supplies of Product in Company’s
inventory; and 
 10.5.7    Transition During Notice Period. During the notice periods required pursuant to
Sections 10.2 or 10.3, Company shall be obligated to maintain its Commercially Reasonable Efforts to develop and undertake all reasonable efforts to transition any such activities to CDC to enable CDC to continue the development of Product after
such applicable notice period. Additionally, Company shall make its personnel available to CDC to answer any questions regarding Product or the clinical trials and to otherwise assist with the transition. 

10.5.8    Intentionally deleted. 

10.6    Intentionally deleted. 

10.6.1    Intentionally deleted. 

10.6.2    Intentionally deleted. 

10.6.3    Intentionally deleted. 

10.6.4    Intentionally deleted. 

10.7    Intentionally deleted. 

10.8    Accrued Rights; Surviving Obligations. Notwithstanding any termination or expiration of this Agreement,
neither Party shall be relieved of any obligations incurred prior to such termination or expiration, including without limitation payment obligations accrued prior to such termination. The following provisions will survive termination or expiration
of this 

  
 31 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 
Agreement: Section 6.9, Section 6.10, ARTICLE 7, Section 8.1, Section 8.2, Section 8.3, ARTICLE 9, Section 10.5, this Section 10.8 and ARTICLE 11. Upon any
termination or expiration of this Agreement each Party shall promptly return to the other Party all written Confidential Information, and all copies thereof, of such other Party. 

ARTICLE 11 

MISCELLANEOUS 

11.1    Governing Law. This Agreement shall be governed by and interpreted in accordance with the internal laws of
the State of New York, without regard to its conflicts of laws rules. 
 11.2    Dispute Resolution. 

11.2.1    Dispute Resolution Process. The Parties understand and appreciate that their long term mutual interest
will be best served by affecting a rapid and fair resolution of any claims or disputes which may arise out of this Agreement. Therefore, the Parties agree to use their best efforts to resolve all such disputes as rapidly as possible on a fair and
equitable basis that takes into account the precise subject and nature of the dispute. If the Parties have a dispute or claim arising under this Agreement, then the matter shall be referred to the senior officers or their designees for review and an
attempted resolution. The officers shall confer and attempt to reach a mutual resolution of the issue. 

11.2.2    Agreement to Settle Disputes by Arbitration. If the dispute cannot be resolved by the Parties’
respective senior officers (or their designees) pursuant Section 11.2.1 within fifteen (15) days after the dispute has been so referred, then, at the request through notice of either Company or CDC, any controversy or claim arising between
the Parties and related to or arising out of the construction, interpretation, or enforcement of any term or condition of this Agreement or any transaction hereunder (including the decision to enter into this Agreement), shall be submitted to
arbitration. Such arbitration shall be conducted in New York, New York, and in either case shall be conducted in accordance with the applicable Rules of the American Arbitration Association in effect on the date of such controversy or claim. 

11.2.3    Appointment of Arbitrators. Within thirty (30) days after the delivery pursuant to
Section 11.2.2 of a notice of request for arbitration, Company and CDC shall each appoint one independent person as an arbitrator to hear and determine the dispute. The two persons so chosen shall by agreement select a third, impartial
arbitrator, which selection shall be final and conclusive upon both Parties. Each arbitrator shall be experienced in international and domestic manufacturing and distribution of products similar to Product. If either Party fails to designate its
arbitrator within sixty (60) days after the notice of arbitration is received, then the arbitrator designated by the one Party shall act as the sole arbitrator and shall be deemed to be the single, mutually approved arbitrator to resolve the
dispute. 

  
 32 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 11.2.4    Arbitrators’ Powers. The arbitrators shall have all
the powers of a State or Federal Court located at the site of the arbitration, including the power to order specific enforcement of this Agreement and to order the production of relevant and non-privileged
documents by one Party for inspection and duplication by the other Party prior to the arbitration hearing; provided that notwithstanding the foregoing, the arbitrators shall be bound by this Agreement with regard to the restriction on consequential,
incidental, and punitive damages as set forth in this Agreement. 
 11.2.5    Discovery. The arbitrators prior to
the hearing shall grant discovery pursuant to the intendment of the Federal Rules of Civil Procedure, and as the arbitrators determine to be appropriate under the circumstances. 

11.2.6    Protective Order. In the event of arbitration and at the request of either Company or CDC, in order to
protect Confidential Information and any other matter that either Party would normally not reveal to third parties, the arbitrators shall enter a protective order in such form as the Parties shall stipulate or as the arbitrators shall determine is
suitable. Among other things, the protective order shall stipulate that the arbitrators themselves shall receive any information designated by either Party as “confidential” solely for purposes of assessing the facts and law for purposes
of the arbitration, and shall not otherwise use or disclose such matter. At the request of either Party, the protective order shall be entered as an award of the arbitration panel and shall enable either Party to obtain the assistance of a court of
competent jurisdiction to enter equitable decrees or other relief to enforce the provisions of the order as if it had been entered by that court. 

11.2.7    Effect of Decision. The decision of the arbitrators shall state the reason for the award and shall be
final, binding and conclusive upon the Parties. The Parties shall comply with such decision in good faith as if it were a final decision of a court. Judgment upon the award shall be entered in any court of competent jurisdiction. Any award made in
connection with any arbitration shall be made in United States Dollars. 
 11.2.8    Rights of Third Parties.
Notwithstanding the agreement to arbitrate any dispute between Company and CDC, in the event that a controversy or claim between Company and CDC involves an adjudication of the rights of a third party, and that third party does not agree to submit
to arbitration and would under Rule 19(a) of the Federal Rules of Civil Procedure, if feasible, be joined as an indispensable party, then the dispute shall be brought to, and determined by, a court of the competent jurisdiction. 

  
 33 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 11.2.9    Interim Relief. Upon the application of either Party to
this Agreement, regardless of whether the time periods have been exhausted in Section 11.2.1 and 11.2.2 and whether or not an arbitration, mediation or attempt to settle amicably has yet been initiated, all courts having jurisdiction over one
or more of the Parties are authorized to: (a) issue and enforce in any lawful manner such temporary restraining orders, preliminary injunctions and other interim measures of relief as may be necessary to prevent harm to a Party’s interests
or as otherwise may be appropriate pending the conclusion of arbitration proceedings pursuant to this Agreement; and (b) enter and enforce in any lawful manner such judgments for permanent equitable relief as may be necessary to prevent harm to
a Party’s interests or as otherwise may be appropriate following the issuance of arbitral awards pursuant to this Agreement. 

11.3    Waiver. Waiver by a Party of a breach hereunder by the other Party shall not be construed as a waiver of
any succeeding breach of the same or any other provision. No delay or omission by a Party to exercise or avail itself of any right, power or privilege that it has or may have hereunder shall operate as a waiver of any right, power or privilege by
such Party. No waiver shall be effective unless made in writing with specific reference to the relevant provision(s) of this Agreement and signed by a duly authorized representative of the Party granting the waiver. 

11.4    Notices. All notices, instructions and other communications hereunder or in connection herewith shall be in
writing, shall be sent to the address below and shall be: (a) delivered personally; (b) sent by registered or certified mail, return receipt requested, postage prepaid; (c) sent via a reputable nationwide overnight courier service; or
(d) sent by facsimile transmission. Any such notice, instruction or communication shall be deemed to have been delivered upon receipt if delivered by hand, three (3) Business Days after it is sent by registered or certified mail, return
receipt requested, postage prepaid, one (1) Business Day after it is sent via a reputable nationwide overnight courier service, or when transmitted with electronic confirmation of receipt, if transmitted by facsimile (if such transmission is on
a Business Day; otherwise, on the next Business Day following such transmission). 
 Notices to Company shall be addressed to: 

BioDelivery Sciences International, Inc. 

4131 Parklake Avenue 
 Suite 225

 Raleigh, North Carolina 27612 

Facsimile: 919-582-9051 

Attention: Mark A. Sirgo, Pharm.D. 

  
 34 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 with a copy to: 

Wyrick Robbins Yates & Ponton LLP 

4101 Lake Boone Trail 
 Suite 300

 Raleigh, NC 27607 

Attention: Larry E. Robbins 

Notices to CDC shall be addressed to: 

Clinical Development Capital LLC 

47 Hulfish Street, Suite 310 

Princeton, NJ 08542 
 Facsimile: 609-683-5787 
 Attention: Chief Financial Officer, and 

                          
         David R. Ramsay 
 with a copy to: 

Morgan, Lewis & Bockius LLP 

502 Carnegie Center 
 Princeton,
NJ 08540 
 Facsimile: 609.919.6701 

Attention: Denis Segota, Esq. 
 Either Party may
change its address by giving notice to the other Party in the manner provided above. 
 11.5    Entire Agreement.
This Agreement (including Schedules) contains the complete understanding of the Parties with respect to the subject matter herein and supersedes all prior understandings and writings relating to such subject matter. This Agreement may be altered,
amended or changed only by a writing making specific reference to this Agreement and signed by duly authorized representatives of Company and CDC. 

11.6    Headings. Headings in this Agreement are for convenience of reference only and shall not be considered in
construing this Agreement. 
 11.7    Severability. If any provision of this Agreement is held unenforceable by a
court or tribunal of competent jurisdiction because it is invalid or conflicts with any Law of any relevant jurisdiction, the validity of the remaining provisions shall not be affected. In such event, the Parties shall negotiate a substitute
provision that, to the extent possible, accomplishes the original business purpose. 

  
 35 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 11.8    Expenses. Subject to the limitations contained in this
Agreement, the Company shall pay, and save CDC harmless from all liability for the payment of: (i) all costs and other expenses incurred in connection with the Company’s performance of, and compliance with the terms and conditions of this
Agreement, and the documents entered into in connection herewith and any and all amendments thereto and (ii) all costs incurred by CDC in enforcing its rights hereunder. 

11.9    Assignment. Except as otherwise provided herein, neither this Agreement nor any of the rights or
obligations hereunder or to Product may be assigned by either Party without the prior consent of the other Party, such consent not to be unreasonably withheld; provided, however, that: (i) either Party may assign this Agreement upon a Change of
Control of such Party without the consent of the other Party; and (ii) CDC may provide a security interest in CDC’s interest in Product, Program Data and/or Company Intellectual Property to its lenders and may, subject to the terms and
conditions of this Agreement, assign this Agreement, whether in whole or in part, in connection with the sale or other transfer of its right to receive payments under this Agreement without any further required consent. Any attempted assignment in
violation hereof shall be void. 
 11.10    Successors and Assigns. This Agreement shall be binding upon and
inure to the benefit of the Parties hereto and their respective successors and permitted assigns, including without limitation, any successor or assignee of the Company Intellectual Property, who shall be bound by the obligations of Company in this
Agreement. 
 11.11    Counterparts; Facsimile Signatures. This Agreement may be executed in two counterparts,
each of which shall be deemed an original, but both of which together shall constitute one and the same instrument. Signatures provided by facsimile transmission shall be deemed to be original signatures. 

11.12    Third-Party Beneficiaries. None of the provisions of this Agreement shall be for the benefit of or
enforceable by any third party, including, without limitation, any creditor of either Party. No such third party shall obtain any right under any provision of this Agreement or shall by reason of any such provision make any claim in respect of any
debt, liability or obligation (or otherwise) against either Party. 
 11.13    Relationship of the Parties. Each
Party shall bear its own costs incurred in the performance of its obligations hereunder without charge or expense to the other, except as expressly provided in this Agreement. Neither Party shall have any responsibility for the hiring, termination
or compensation of the other Party’s employees or for any employee compensation 

  
 36 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 
or benefits of the other Party’s employees. No employee or representative of a Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any
manner whatsoever, or to create or impose any contractual or other liability on the other Party without said other Party’s approval. Nothing in this Agreement shall be construed to establish a relationship of partners or joint ventures between
the Parties. 
 [SIGNATURE PAGE FOLLOWS] 

  
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	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 IN WITNESS WHEREOF, the Parties have signed this Agreement as of the Effective Date, and
Athryium hereby consents and agrees to this Agreement. 
  

					
	BIODELIVERY SCIENCES INTERNATIONAL, INC.
		
	By:	 	 /s/ Mark A. Sirgo

		 	Name:	 	Mark A. Sirgo
		 	Title:	 	President and CEO
	
	ARIUS PHARMACEUTICALS, INC.
		
	By:	 	 /s/ Mark A. Sirgo

		 	Name:	 	Mark A. Sirgo
		 	Title:	 	President and CEO
	
	ARIUS TWO, INC.
		
	By:	 	 /s/ Mark A. Sirgo

		 	Name:	 	Mark A. Sirgo
		 	Title:	 	President and CEO
	
	CDC V, LLC
		
	By:	 	 /s/ David Ramsay

		 	Name:	 	David Ramsay
		 	Title:	 	Authorized Signatory
	
	NB ATHYRIUM LLC
	
	By its managing member, NB SOF II Holdings (D) LP
	By its general partner, NB Secondary Opportunities Associates II LP
	By its general partner, NB Secondary Opportunities Associates II GP LLC

  

			
	By:	 	     /s/ Christain Neira

	Name:	 	        Christain Neira
	Title:	 	        Authorized Signatory

  
 SIGNATURE PAGE TO 

AMENDED AND RESTATED CLINICAL DEVELOPMENT AND LICENSE AGREEMENT 

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 SCHEDULE 1.22 

COMPANY PATENT RIGHTS 
  

									
	 Country
	  	 Application Number
	  	 Filing Date
	  	 Patent Number
	  	Issue Date
	 US
	  	15/198961	  	6/30/2016	  		  	
	 US
	  	09/144827	  	9/1/1998	  	6159498	  	12/12/2000
	 US
	  	11/069089	  	3/1/2005	  	7579019	  	8/25/2009
	 US
	  	14/875107	  	10/5/2015	  		  	
	 BR
	  	PI0714712-0	  	1/21/2009	  		  	
	 CA
	  	2658585	  	1/20/2009	  	2658585	  	3/1/2011
	 JP
	  	2009-520865	  	1/20/2009	  	5448814	  	1/10/2014
	 MX
	  	MX/a/2009/000745	  	1/20/2009	  	297332	  	3/22/2012
	 NO
	  	20090278	  	1/19/2009	  		  	
	 NZ
	  	574361	  	1/22/2009	  	574361	  	6/5/2012
	 RU
	  	2009106177	  	2/24/2009	  	2504377	  	1/20/2014
	 SG
	  	200900216-3	  	1/13/2009	  	149359	  	8/15/2011
	 EP
	  	16163659.2	  	4/4/2016	  		  	
	 AU
	  	2011205222	  	8/9/2011	  	2011205222	  	6/12/2014
	 NZ
	  	594545	  	8/10/2011	  	594545	  	3/22/2013
	 IN
	  	7156/CHENP/2011	  	10/3/2011	  		  	
	 KR
	  	10-2012-7018611	  	7/16/2012	  	1329496	  	11/7/2013
	 IL
	  	220722	  	7/2/2012	  		  	
	 RU
	  	2013141051	  	9/6/2013	  		  	
	 CN
	  	201310524341.4	  	10/23/2013	  	ZL 2013105243414	  	4/13/2016
	 AE
	  	875/2014	  	8/18/2014	  		  	
	 HK
	  	14106983.0	  	7/9/2014	  		  	
	 AT
	  	97910117.7	  	10/16/1997	  	973497	  	12/11/2002
	 BE
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002
	 CH
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002
	 DK
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002
	 EP
	  	97910117.7	  	10/16/1997	  	973497	  	12/11/2002
	 ES
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002
	 FR
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002
	 GB
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002
	 GR
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002
	 IE
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002
	 IT
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002
	 NL
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002
	 SE
	  	97 91 0117.7	  	10/16/1997	  	973497	  	12/11/2002

	
	 FOIA CONFIDENTIAL TREATMENT REQUEST BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858

 

	 ***CONFIDENTIAL TREATMENT REQUESTED***

 
 Note: The portions hereof for which confidential treatment
are being requested are 
 denoted with “***”

 

 SCHEDULE 1.75 

CDC CONSENTS 
 BEMA Acquisition Consent,
Amendment, and Waiver, dated August 2, 2006, between BioDelivery, Subsidiary, Arius Two, and CDC. 
 Letter agreement, dated August 2, 2006,
between CDC, BioDelivery, Subsidiary, and Arius Two. 
 Sublicensing Consent and Amendment, dated August 2, 2006, between BioDelivery, Subsidiary, and
CDC. 
 BEMA Acquisition Consent, Amendment, and Waiver, dated September 5, 2007, between BioDelivery, Subsidiary, Arius Two, and CDC. 

Letter agreement, dated September 5, 2007, between CDC, BioDelivery, Subsidiary, and Arius Two. 

Sublicensing Consent and Amendment, dated September 5, 2007, between BioDelivery, Subsidiary, CDC, and Meda. 

Consent Agreement, dated January 2, 2009, between CDC, BDSI, Subsidiary, and Meda. 

Sublicensing Consent and Amendment, May 26, 2010, between BioDelivery, Subsidiary, Athyrium, and CDC. 

Sublicensing Consent and Amendment, dated October 4, 2010, between BioDelivery, Subsidiary, Athyrium, and CDC. 

Consent Agreement, dated January 23, 2015, between Investors, BDSI, Subsidiary, and Meda. 

Sublicensing Consent and Amendment between BioDelivery, Subsidiary, Athyrium, and CDC dated May 11, 2016.Termination Agreement

 Exhibit 10.36 

EXECUTION VERSION 

 

FOIA CONFIDENTIAL TREATMENT REQUESTED BY 

BIODELIVERY SCIENCES INTERNATIONAL, INC. 

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858 

***CONFIDENTIAL TREATMENT REQUESTED*** 

Note: The portions hereof for which confidential 

treatment are being requested are denoted with “***” 

TERMINATION AGREEMENT 

This Termination Agreement (the “Termination Agreement”), is dated as of December 7, 2016 (the “Effective
Date”), by and among Arius Pharmaceuticals, Inc., a Delaware corporation (“Arius”), Arius Two, Inc., a Delaware corporation (“Arius Two”), BioDelivery Sciences International, Inc., a Delaware corporation
(“Parent” and, together with Arius and Arius Two, collectively, “BDSI”), and Endo Pharmaceuticals Inc., a Delaware corporation (“Endo” and together with BDSI, the “Parties”, and
each, a “Party”). 
 RECITALS 

WHEREAS, the Parties have entered into a License and Development Agreement, dated as of January 5, 2012 (the
“Agreement”); 
 WHEREAS, the Parties hereto desire to terminate the Agreement, on the terms and subject to the
conditions set forth herein (the “Termination”); and 
 WHEREAS, in connection with the Termination, Endo desires to
sell, and BDSI desires to acquire, all right, title and interest in the Assets (as hereinafter defined), on the terms and subject to the conditions set forth herein. 

NOW, THEREFORE, in consideration of the premises set forth above and other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the Parties, intending to be legally bound, hereby agree as follows: 

1.    Definitions. Capitalized terms used and not defined in this Termination Agreement have the respective
meanings assigned to them in the Agreement. In addition to the terms defined elsewhere in this Termination Agreement, the following terms used in this Termination Agreement shall have the meanings specified in this
Section 1: 
 (a)    “A/B Rated” means “therapeutically
equivalent” as evaluated by the FDA, applying the definition of “therapeutically equivalent” set forth in the preface to the Orange Book. 

(b)    “Assigned Marks” means those trademarks, trade names, trade dress, and/or logos,
and registrations thereof and applications therefor, described on Schedule 1(b). 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (c)    “Assigned Material Contracts”
means all Closing Material Contracts and Post-Closing Material Contracts that are actually assigned to Parent or its designee in accordance with the terms of this Termination Agreement. 

(d)    “Assumed Liabilities” means the following liabilities and obligations, other than
Excluded Liabilities: (i) all liabilities and obligations arising under or related to the Assets on or after the Closing; (ii) all liabilities and obligations arising out of any Post-Closing Material Contract that is assigned to Parent or
its designee after the Closing, on or after the assignment thereof to Parent pursuant to Section 6; (iii) all liabilities and obligations arising out of any Post-Closing Material Contract prior to the earlier of
(A) the assignment thereof to Parent or (B) the thirty-first (31st) day following Closing, provided such obligation or liability does not arise from (x) the gross negligence,
intentional misconduct, failure to comply with applicable law, rule, or regulation, or material breach of such Post-Closing Material Contract on the part of Endo or any Affiliate thereof or (y) any actions or omissions of Endo or any
Affiliate thereof that are in bad faith or otherwise materially inconsistent with any reasonable written direction of BDSI with respect to such Post-Closing Material Contract; and (iv) all liabilities and obligations for Taxes relating to the
Assets or the Assumed Liabilities for any taxable period ending after the Closing Date, in each case, to the extent that such liabilities and obligations are not the direct result of the acts or omissions of Endo or any Affiliate thereof prior to
the Closing. 
 (e)    “BDSI FDA Letters” means the letters from Parent to the FDA with
regard to the existing NDA and IND(s) for the Product, duly executed by Parent, to be filed with the FDA no later than one (1) Business Day following the Closing Date (as hereinafter defined), the forms of which shall be reasonable, customary,
proposed in good faith by BDSI reasonably in advance of the Closing Date, subject to Endo’s approval, such approval not to be unreasonably withheld, and, upon such approval, attached hereto as Exhibit A. 

(f)    “Business” means the business of the commercialization, manufacture, marketing,
distribution and sale of the Product. 
 (g)    “Data Room” means, the electronic data
room maintained by or on behalf of Endo located at *** and to which BDSI was provided access. 

(h)    “Domain Name Assignment Agreement” means that certain domain name assignment
agreement, the form of which is attached hereto as Exhibit B. 
 (i)    “Endo FDA
Letters” means the letters from Endo to the FDA with regard to the existing NDA and IND(s) for the Product and assignment thereof to BDSI, duly 

  
 2 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
executed by Endo, to be filed with the FDA no later than one (1) Business Day following the Closing Date, the forms of which shall be reasonable, customary, proposed in good faith by Endo
reasonably in advance of the Closing Date, subject to BDSI’s approval, such approval not to be unreasonably withheld, and, upon such approval, attached hereto as Exhibit C. 

(j)    “Endo Marks” means those trademarks, trade names, trade dress, and/or logos, other
than BDSI Trademarks and Assigned Marks, that (i) appear on or in any Inventory, any labeling, inserts, packaging, or the like associated therewith and (ii) are not specific to the Product. 

(k)    “Excluded Liabilities” means those liabilities and obligations arising from or
relating to (i) the negotiation, investigation and performance by or on behalf of Endo of this Termination Agreement, the Transaction Documents and the consummation of the transactions contemplated hereby and thereby, (ii) Product or the
Assets if such obligations or liabilities are made or brought or arise from facts first occurring prior to the Closing Date, (iii) any contract to which Endo or any of its Affiliates are a party or by which Endo or any of its Affiliates is
bound that is not an Assigned Material Contract, (iv) obligations or liabilities arising out of product liability and warranty claims or any claim for injury to any person or property involving the Products used, sold, or otherwise distributed
by or on behalf of Endo or its Affiliates prior to the Closing Date, (v) any and all (A) Taxes relating to the Business, the Assets or the Assumed Liabilities for any taxable period ending on or prior to the Closing Date and (B) other
Taxes of Endo or any of its Affiliates for any taxable period, (vi) Endo accounts payable, accrued expenses or other current liabilities, (vii) amounts owing under Endo’s and its Affiliates’ intercompany account balances,
including those related to the Product, (viii) obligations relating to employees of Endo or its Affiliates, including obligations with respect to any salary, wages, or other compensation, withholding taxes of employees, termination and
severance pay, payments related to pension and pension funds, and all vacation and medical or other benefits, and (ix) all liabilities and obligations that arise out of any Post-Closing Material Contract (A) prior to the earlier of
(i) the assignment thereof to Parent or (ii) the thirty-first (31st) day following Closing and (B) as a result of (I) the gross negligence, intentional misconduct, failure to
comply with applicable law, rule, or regulation, or material breach of such Post-Closing Material Contract on the part of Endo or any Affiliate thereof or (II) any actions or omissions of Endo or any Affiliate thereof that are in bad faith or
otherwise materially inconsistent with any reasonable written direction of BDSI with respect to such Post-Closing Material Contract. 

(l)    “Indemnified Party” means a party entitled to indemnification under
Section 13 or Section 7 of the Transition Services Agreement. 

  
 3 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (m)    “Indemnifying Party” means a
party obligated to provide indemnification under Section 13 or Section 7 of the Transition Services Agreement. 

(n)    “Proceeding” means any action, suit, litigation, claim, administrative action by a
Regulatory Authority, other governmental agency, or other Third Party or investigation by a Regulatory Authority or other governmental agency. 

(o)    “Product Inventory” means the Product inventory and finished goods related to the
manufacture of the Product set forth on Schedule 4(a)(i) hereto. 

(p)    “Taxes” means all taxes of any kind whatsoever, and all charges, fees, customs,
levies, duties, imposts, required deposits or other assessments, including all federal, state, local or foreign net income, capital gains, gross income, gross receipt, property, franchise, sales, use, excise, withholding, payroll, employment, social
security, worker’s compensation, unemployment, occupation, capital stock, transfer, gains, windfall profits, net worth, asset, estimated, transaction, and other taxes, and any interest, penalties or additions to tax with respect thereto,
whether disputed or not  
 (q)    “Trademark Assignment” means that certain
trademark assignment, the form of which is attached hereto as Exhibit D. 

(r)    “Transaction Documents” means this Termination Agreement, the Bill of Sale, the
Assignment and Assumption Agreement, the Transition Services Agreement, the Domain Name Assignment Agreement, and the other agreements, instruments and documents required to be delivered at the Closing. 

(s)    
“Work-in-Progress Inventory” means the raw materials, work in progress, packaging, supplies, parts and other unfinished inventories related to the
manufacture of Product set forth on Schedule 4(a)(ii) hereto and that have been paid for by Endo or an Affiliate thereof. 

2.    The Termination. The Parties shall terminate the Agreement in accordance with Section 14.2(b) of the
Agreement, except as expressly set forth herein. Subject to the terms and conditions set forth herein, at the Closing, the Agreement shall terminate and be of no further force or effect, and the rights and obligations of each of the Parties
thereunder shall terminate, except (a) any rights and obligations of the Parties that are expressly designated under Section 15.16 of the Agreement to survive the termination of the Agreement, and (b) any other rights and obligations
of the Parties that come into being or effect upon the termination of the Agreement, in each case under clause (a) and clause (b), subject to any applicable terms and conditions of this Termination Agreement. 

  
 4 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 3.    Effect of Termination. Notwithstanding the fact that the
Agreement is being terminated in accordance with Section 14.2(b) of the Agreement, the Termination shall have the effect of a termination of the Agreement under Section 14.2(a) of the Agreement in the manner further expressly set forth in this
Termination Agreement. 
 (a)    Upon the Closing all licenses granted by BDSI to Endo pursuant to the
Agreement (the “Licenses”) shall terminate. ***. 
 (b)    Upon the Closing, Endo
shall grant, and hereby grants effective as of the Closing, BDSI a perpetual, irrevocable, royalty-free, fully-paid, transferable license, with rights of sublicense through multiple tiers of sublicensees, under the Endo Intellectual Property and the
Endo Marks to make, have made, use, sell, offer for sale, and import Product (the “Endo License”), provided, that: (i) any Endo Intellectual Property incorporated, utilized, or practiced in the Product (or its use or
Manufacture) shall, in the exercise of such rights and, subject to the immediately following clause (ii), be incorporated, utilized, and practiced in the same (or materially the same) manner as incorporated, utilized, or practiced in the Product as
it is made, used and sold on the Effective Date and Closing Date; (ii) any Endo Intellectual Property constituting (x) clinical, animal, or in vitro data or results concerning the Product or the use thereof, (y) any analyses of such
information or results, or (z) any Developed Technology (including patents, patent applications, or other patent rights) constituting or claiming any invention(s) or improvement(s) based on or resulting from any such data, results, or analyses,
or the studies generating such data, results, or analyses shall not, in any case, be subject to the limitation in the preceding clause (i); (iii) the rights granted to BDSI under the Endo Mark pursuant to the Endo License shall be only those rights
as may be necessary to permit BDSI to use, distribute (for sale or other use), or sell any Inventory (as hereinafter defined) manufactured by or on behalf of Endo prior to the Closing Date without relabeling and not for any other purpose; and
(iv) the rights granted to BDSI under any Developed Technology pursuant to the Endo License shall be only for use with the Product and not for any other purpose. 

(c)    Endo shall, as soon as reasonably practicable following the Closing, but in any event within thirty
(30) days or otherwise in the applicable time frame set forth below: (i) transfer to Parent or its designee all Pre-Approval Regulatory Submissions, including any INDs and NDAs, Regulatory Approvals
and Post-Approval Regulatory Submissions, including those set forth on Schedule 3(c)(i), provided that the Regulatory Submissions seeking Regulatory Approval in Canada (the “Canadian Filings”) shall be
assigned to BDSI promptly after the approval thereof by Canadian Regulatory Authorities, pursuant to the process and terms therefor set forth in the Transition Services Agreement; (ii) use commercially reasonable efforts to effect the transfer
of legal responsibility to Parent or its designee for the portion of manufacture of Product as set 

  
 5 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
forth on Schedule 3(c)(ii) hereto, in a smooth and orderly fashion consistent with applicable law, and Regulatory Requirements, and those contracts with Third Parties for the manufacture
of Product being assigned to Parent upon the Closing; (iii) within one (1) Business Day of the Closing Date, file the required letters with the FDA necessary to effect all such transfers; and (iv) subject to
Section 6, assign to Parent or its designee the Post-Closing Material Contracts. 

(d)    The terms of Section 14.3(g) of the Agreement, including the
sell-off right described therein, shall not apply to the Parties as a result of the consummation of the transactions contemplated hereby. 

4.    Purchase and Sale of Assets. In connection with the Termination, and subject to the terms and conditions set
forth herein, at the Closing, Endo shall sell, assign, transfer, convey and deliver, and hereby assigns, transfers, and conveys, to Parent, and Parent shall purchase from Endo, all of Endo’s right, title and interest in, to and under, the
following assets (collectively, the “Assets”): 
 (a)    the (i) Product Inventory
set forth on Schedule 4(a)(i) hereto, and (ii) Work-in-Progress Inventory set forth on Schedule 4(a)(ii) hereto (collectively, the
“Inventory”); 
 (b)    the contracts, agreements, or similar arrangements executed by
Endo or any Affiliate thereof exclusively relating to the Product or the development, commercialization, manufacture, use, sale, marketing, promotion or distribution thereof set forth on Schedule 4(b) hereto (the “Material
Contracts”), in each case, for which any permits or approvals necessary to enable them to be assigned to Parent or its designee without breach thereof either (i) (x) are not required or (y) will have been obtained prior to the
Closing (collectively, the “Closing Material Contracts”) or (ii) will not have been obtained prior to the Closing (the “Post-Closing Material Contracts”) and will be subject to the provisions set forth in
Section 6; 
 (c)    internet domain names, whether or not trademarks,
registered in any top-level domain by any authorized private registrar or Governmental Authority, web addresses, web pages, websites and related content, accounts with Twitter, Facebook and other social media
companies and the content found thereon and related thereto, and URLs, in each case, excluding any Endo Marks appearing therein or thereon, in each case, set forth on Schedule 4(c) hereto (collectively, the “Intellectual Property
Assets”); 
 (d)    the manufacturing equipment owned by Endo and used in the
Product manufacturing process set forth on Schedule 4(d) hereto (collectively, the “Equipment”); 

  
 6 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (e)    the Assigned Marks and all of Endo’s and its
Affiliates’ rights therein and thereto throughout the world; and 
 (f)    all Pre-Approval Regulatory Submissions, including any INDs and NDAs, Regulatory Approvals and Post-Approval Regulatory Submissions, other than the Canadian Filings. 

5.    Assumed Liabilities. Subject to the terms and conditions set forth herein, and without limitation of any
indemnification or other surviving or accrued obligations of Endo under the Agreement, this Termination Agreement, any Transaction Document, or other agreement between Parent, Arius, Arius Two, or any Affiliate of any of the foregoing, on the one
hand, and Endo or any Affiliate thereof, on the other hand, BDSI shall assume any and all Assumed Liabilities. Notwithstanding anything to the contrary, and except for those explicit obligations set forth in this Termination Agreement, the
Transaction Documents, or the Agreement, (a) BDSI is not assuming any Excluded Liabilities or any liabilities or obligations under this Termination Agreement or any Transaction Documents, other than the Assumed Liabilities, and (b) each
Party shall remain responsible and liable for its compliance with this Termination Agreement and the Agreement (including all terms thereof with respect to acts or omissions occurring prior to Closing (and any accrued obligations with respect
thereto, including but not limited to royalties payable on Product sold prior to the Closing Date) and the surviving terms thereof on or after Closing). 

6.    Non-Assignable Contracts.  

(a)    Notwithstanding anything to the contrary in this Termination Agreement, and subject to the
provisions of this Section 6, to the extent that the sale, assignment, transfer, conveyance or delivery, or attempted sale, assignment, transfer, conveyance or delivery, to Parent or its designee of any Material Contract
would require the consent, authorization, approval or waiver of a person or entity who is not a Party to this Termination Agreement or an Affiliate of a Party to this Termination Agreement, and such consent, authorization, approval or waiver shall
not have been obtained prior to the Closing, this Termination Agreement shall not constitute a sale, assignment, transfer, conveyance or delivery, or an attempted sale, assignment, transfer, conveyance or delivery, thereof; provided,
however, that the Closing shall occur notwithstanding the foregoing without any adjustment to the Asset Purchase Price (as hereinafter defined) on account thereof. During the period beginning on the Closing Date and ending on the date that is
thirty (30) days following the Closing (the “Assignment Period”), the Parties shall use commercially reasonable efforts, and cooperate with each other, to obtain any such required consent, authorization, approval or waiver, or
any release, substitution or amendment required to assign such Post-Closing Material Contracts as soon as possible following Closing; provided, however, that neither BDSI nor Endo shall be required to

  
 7 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
pay any consideration for any such required consent, authorization, approval, waiver, or release referenced above. If such consent, authorization, approval, waiver, release, substitution or
amendment is obtained for a particular Post-Closing Material Contract prior to the expiration of the Assignment Period, Endo shall sell, assign, transfer, convey and deliver to Parent or its designee the relevant contract to which such consent,
authorization, approval, waiver, release, substitution or amendment relates for no additional consideration. 

(b)    If any Post-Closing Material Contract cannot be transferred to BDSI following the Closing pursuant
to Section 6(a), the Parties shall use commercially reasonable efforts to promptly enter into such arrangements (such as subleasing, sublicensing or subcontracting) to provide to BDSI the economic and, to the extent permitted under applicable
law, operational equivalent of the transfer of such contract to Parent or its designee as of the Closing. BDSI shall, as agent or subcontractor for Endo pay, perform and discharge fully the liabilities and obligations of Endo arising thereunder,
except to the extent such liabilities and obligations were a direct result of (i) the gross negligence, intentional misconduct, failure to comply with applicable law, rule, or regulation, or material breach of such Post-Closing Material
Contract on the part of Endo or any Affiliate thereof or (ii) any acts or omissions of Endo or any Affiliate thereof that are in bad faith or otherwise materially inconsistent with any reasonable written direction of BDSI with respect to such
Post-Closing Material Contract. To the extent permitted under applicable law, during such period, Endo shall, at BDSI’s expense, hold in trust for and pay to BDSI promptly upon receipt thereof, any such contract and all income, proceeds and
other monies received by Endo to the extent related to such contract in connection with the arrangements under this Section 6. Endo shall be permitted to set-off against such amounts
all direct costs associated with the retention and maintenance of such Post-Closing Material Contracts. 

7.    Purchase Price. 

(a)    Purchase Price. 

(i)    Asset Purchase Price. The aggregate purchase price for the Assets (the “Asset
Purchase Price”) shall be equal to the sum of (i) the Product Inventory Purchase Price (as defined below), (ii) the aggregate book value of the
Work-in-Progress Inventory set forth on Schedule 4(a)(ii) hereto (the
“Work-in-Progress Book Value”), (iii) the book value set forth on Schedule 4(d) for the Equipment (the “Equipment Book Value”), and
(iii) the assumption of the Assumed Liabilities. For purposes of this Termination Agreement, “Product Inventory Purchase Price” shall mean ***. 

  
 8 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (ii)    Fee. BDSI shall pay a fee in the amount of
$*** (the “Fee” and, together with the Asset Purchase Price, the “Purchase Price”) to Endo as consideration for (i) Endo’s non-compete covenant set forth in
Section 12(c) and (ii) Endo’s waiver under Section 3(d) of its right to sell Product for twelve (12) months post-Termination pursuant to Section 14.3(g) of the Agreement. 

(iii)    Allocation. ***. 

(b)    Method of Payment. Each of the Asset Purchase Price and the Fee shall be paid in quarterly
installments (each, a “Quarterly Payment”) on the last calendar day of each calendar quarter in 2017, by wire transfer of immediately available funds to an account designated in writing by Endo to BDSI no later than two
(2) Business Days prior to the Closing Date; provided, that, the Product Inventory Purchase Price shall be subject to adjustment in accordance with Section 7(c). 

(c)    Calculation and Adjustment of Product Inventory Purchase Price.  

(i)    ***. 

(ii)    ***. 

(iii)    Audit. Notwithstanding the foregoing, Endo (and is representatives on its behalf) shall
have the right, during the *** period following the Closing, and during normal business hours upon reasonable advance notice, to review relevant documents and records which are reasonably required to support the calculation of ***. In
the event that there is a dispute between the Parties in connection with this Section 7(c), including with respect to the conclusions of any audit under this Section 7(c)(iii), such dispute shall be resolved in accordance with the
procedures set forth in Section 16(c). 
 (d)    Late Payments. Any amount required to be
paid hereunder which is not paid on the date due shall bear interest at a rate equal to ***.

8.    Closing. Subject to the terms and conditions of this Termination Agreement, the closing of the Termination
and the other transactions contemplated herein (the “Closing”) shall take place on January 6, 2017 or at such other time, date or place as the Parties may mutually agree upon in writing. The date on which the Closing is to
occur is herein referred to as the “Closing Date.” 

  
 9 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 9.    Closing Deliverables.  

(a)    At the Closing, Endo shall deliver to BDSI the following: 

(i)    a bill of sale in the form of Exhibit E hereto (the “Bill of Sale”) and duly
executed by Endo, transferring the Assets to BDSI as described in this Termination Agreement; 

(ii)    an assignment and assumption agreement in the form of Exhibit F hereto (the
“Assignment and Assumption Agreement”) and duly executed by Endo, effecting the assignment to and assumption by BDSI of the Assets and Assumed Liabilities as described in this Termination Agreement; 

(iii)    a transition services agreement by and among the Parties substantially in the form of Exhibit
G hereto (the “Transition Services Agreement”) and duly executed by Endo; 

(iv)    the Inventory; 

(v)    copies of the duly executed Endo FDA Letters; 

(vi)    the Domain Name Assignment Agreement duly executed by Endo; 

(vii)    the Trademark Assignment duly executed by Endo; 

(viii)    evidence reasonably satisfactory to BDSI that all liens, claims and encumbrances on the Assets
set forth on Schedule 10(b)(i) hereto have been discharged on or before the Closing Date; and 

(ix)    such other customary instruments of transfer, assumption, filings or documents, in form and
substance reasonably satisfactory to the Parties, as may be required to give effect to this Termination Agreement. 

(b)    At the Closing, BDSI shall deliver to Endo the following: 

(i)    the Assignment and Assumption Agreement duly executed by BDSI; 

(ii)    the Transition Services Agreement duly executed by BDSI; 

(iii)    copies of the duly executed BDSI FDA Letters; and 

(iv)    such other customary instruments of transfer, assumption, filings or documents, in form and
substance reasonably satisfactory to the Parties, as may be required to give effect to this Termination Agreement. 

  
 10 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 10.    Representations and Warranties. 

(a)    Mutual. Each Party hereby represents and warrants to the other Parties as of the Effective
Date and as of the Closing that: 
 (i)    It is duly organized, validly existing and in good standing
under the laws of the jurisdiction of its incorporation. It has the full right, corporate power and authority to enter into this Termination Agreement and to perform its obligations hereunder. 

(ii)    The execution of this Termination Agreement by the individual whose signature is set forth at the
end of this Termination Agreement on behalf of such Party, the delivery of this Termination Agreement by such Party, and the consummation of the transactions contemplated by this Termination Agreement have been duly authorized by all necessary
corporate action on the part of such Party. 
 (iii)    This Termination Agreement has been executed and
delivered by such Party and (assuming due authorization, execution and delivery by the other Party hereto) constitutes the legal, valid and binding obligation of such Party, enforceable against such Party in accordance with its terms, except as may
be limited by any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws and equitable principles related to or affecting creditors’ rights generally or the effect of general principles of equity. 

(iv)    There is no contractual restriction or obligation binding on either Party which would be materially
contravened by the execution and delivery of this Termination Agreement or by the performance or observance of its terms. 

(b)    By Endo. Endo represents and warrants to BDSI as of the Effective Date and as of the Closing
Date that, except to the extent set forth on Schedule 10(b) (with reference to the applicable clause below for each disclosure therein): 

(i)    Title to Assets. Endo has good and transferable title to each of the Assets to be assigned
hereunder, and has the right to transfer and assign to BDSI (or its designee) such Assets, except, with respect to this representation and warranty as given as of the Effective Date, as set forth on Schedule 10(b)(i) hereto (and which
exception shall not apply with respect hereto upon the Closing Date), free and clear of all liens, claims, and encumbrances, and upon the consummation of the transactions contemplated by this Termination Agreement, or the relevant date set forth
herein therefor, BDSI shall acquire good and marketable title to, and all right, title and interest of Endo and its Affiliates in and to such Assets, free and clear of all liens, claims, and encumbrances. 

  
 11 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (ii)    Product Trademarks. To the knowledge of
Endo and its Affiliates, no Product is being or has been commercialized, sold, or offered for sale anywhere other than the United States, and no Product is being commercialized under any proprietary brand name, trademark, trade name, or logo other
than the Endo Marks, Assigned Marks, and BDSI Trademarks. 
 (iii)    Domain Names. To the
knowledge of Endo and its Affiliates, the Intellectual Property Assets constitute all the domain names, and registrations and applications therefor, web addresses, web pages, websites and related content, accounts with Twitter, Facebook and other
social media companies or sites and the content found thereon and related thereto, and URLs used in connection with the manufacture, development, marketing, sale, offering for sale, and distribution of Products. 

(iv)    Contracts. Endo has made available to BDSI complete, true, accurate, and correct copies of
all Material Contracts. 
 (v)    Legal Proceedings; Notice of Noncompliance. To the knowledge of
Endo and its Affiliates, there are no (A) Proceedings instituted, pending or threatened against Endo or any Affiliate thereof with respect to any Product, Material Contract or Asset or (B) actual or threatened Proceedings which present a
claim to restrain or prohibit the transactions contemplated in this Termination Agreement or the Transaction Documents or which would otherwise materially and adversely affect any Assets, Material Contracts, or BDSI’s ability to manufacture,
develop or commercialize Products following the Closing. To Endo’s and its Affiliates’ knowledge, neither Endo nor any Affiliate thereof has received any written correspondence from any Regulatory Authority or other governmental authority
with respect to any actual or alleged failure to comply with applicable law, rule, or regulation with respect to the Product or the manufacture, use, sale, import, export, development, or commercialization thereof. 

(vi)    Inventory. 

(A)    All Inventory conforms to the specifications therefor set forth in the Data Room and the
requirements of the Material Contracts pursuant to which it was manufactured, handled, stored and shipped in accordance with all applicable law, rules, and regulations, including but not limited to cGMP, and has an expiry date occurring no earlier
than the first (1st) anniversary of the Closing Date. 

  
 12 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (B)    Schedule 10(b)(vi) sets forth a statement
of the quantities of Inventory and their book values as of the Effective Date, which is complete and accurate in all material respects. 

(c)    EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS SECTION 10 OF THIS
TERMINATION AGREEMENT, (A) NO PARTY HERETO NOR ANY PERSON ON SUCH PARTY’S BEHALF HAS MADE OR MAKES ANY EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY WHATSOEVER, EITHER ORAL OR WRITTEN, WHETHER ARISING BY LAW, COURSE OF DEALING, COURSE OF
PERFORMANCE, USAGE OF TRADE OR OTHERWISE, ALL OF WHICH ARE EXPRESSLY DISCLAIMED, AND (B) EACH PARTY HERETO ACKNOWLEDGES THAT, IN ENTERING INTO THIS TERMINATION AGREEMENT, IT HAS NOT RELIED UPON ANY REPRESENTATION OR WARRANTY MADE BY ANY OTHER
PARTY, OR ANY OTHER PERSON ON SUCH OTHER PARTY’S BEHALF, EXCEPT AS SPECIFICALLY PROVIDED IN THIS SECTION 10. 

11.    Mutual Release. 

(a)    In consideration of the covenants, agreements and undertakings of the Parties under this Termination
Agreement, each Party, on behalf of itself and its respective present and former parents, subsidiaries, Affiliates, officers, directors, shareholders, members, successors and assigns (collectively, “Releasors”), hereby releases,
waives and forever discharges the other Parties and their respective present and former, direct and indirect, parents, subsidiaries, Affiliates, employees, officers, directors, shareholders, members, agents, representatives, permitted successors and
permitted assigns (collectively, “Releasees”) of and from any and all actions, causes of action, suits, losses, liabilities, rights, debts, dues, sums of money, accounts, reckonings, obligations, costs, expenses, liens, bonds,
bills, specialties, covenants, contracts, controversies, agreements, promises, variances, trespasses, damages, judgments, extents, executions, claims and demands, whether foreseen or unforeseen, matured or unmatured (i) that are known by the
Releasors as of the Closing Date (“Known Claims”) or (ii) whether known or unknown with respect to Endo’s and its Affiliates’ Commercially Reasonable Efforts to develop and commercialize the Product (“CRE
Claims”), in each case, in law, admiralty or equity (collectively, the “Claims”), which any of such Releasors ever had, now have, or hereafter can, shall, or may have against any of such Releasees for, upon, or by reason of
any matter, cause, or thing whatsoever from the beginning of time through the date of this Termination Agreement arising out of or 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
relating to the Agreement, except for any Claims relating to (x) rights and obligations preserved by, created by or otherwise arising out of this Termination Agreement or any of the
Transaction Documents (including, except with respect to subsection (ii) above, any indemnification or other surviving or accrued obligations under the Agreement), (y) fraud, or (z) intentional misrepresentation. 

(b)    Each Party, on behalf of itself and each of its respective Releasors, understands that it may later
discover CRE Claims or facts that may be different than, or in addition to, those that it or any other Releasor now knows or believes to exist regarding the subject matter of the release contained in this Section 11, and
which, if known at the time of signing this Termination Agreement, may have materially affected this Termination Agreement and such Party’s decision to enter into it and grant the release contained in this Section 11.
Nevertheless, the Releasors intend to fully, finally and forever settle and release all CRE Claims that now exist, may exist or previously existed, as set forth in the release contained in this Section 11, whether known or
unknown, foreseen or unforeseen, or suspected or unsuspected, and the release given herein is and will remain in effect as a complete release, notwithstanding the discovery or existence of such additional or different facts. The Releasors hereby
waive any CRE Claim that might arise as a result of such different or additional CRE Claims or facts. The Releasors expressly, knowingly and intentionally waive with respect to CRE Claims any and all rights, benefits and protections of any state or
federal statute or common law principle limiting the scope of a general release. 
 12.    Covenants. 

(a)    Conduct of the Business Prior to the Closing. From the Effective Date until the Closing,
except as otherwise provided in this Termination Agreement or consented to in writing by BDSI (which consent shall not be unreasonably withheld or delayed), Endo shall use commercially reasonable efforts to maintain and preserve the rights,
franchises, goodwill and relationships of its customers, lenders, suppliers, regulators and others having relationships with the Business. 

(b)    Assignment of Contracts. Endo shall use commercially reasonable efforts to obtain, as quickly
as reasonably practicable following the Effective Date, such consents, permissions, and/or other written authorizations necessary to enable the assignment of the Material Contracts to BDSI at Closing. 

(c)    Non-Competition. During the period commencing on the
Closing Date and ending on the date that is the ***, neither Endo nor any Affiliate thereof shall (i) make, have made, use, offer for sale, sell, import, market or promote any branded (i.e. not generic) transmucosal film product for the
treatment of pain containing (A) 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
buprenorphine as its sole active ingredient, or (B) buprenorphine in combination with naloxone, (ii) sell pursuant to an ANDA any generic transmucosal film product which is A/B Rated to
the Product, or (iii) enable any Third Party to engage in, or assist any Third Party in engaging in, any of the foregoing (collectively, the “Prohibited Activities”); provided, however, that it shall not be deemed
a breach or other violation of this Section 12(c) if Endo or any of its Affiliates acquire, or are acquired by, an entity that directly or indirectly engaged in any Prohibited Activities to any material extent prior to such acquisition, and
the provisions of this Section 12(c) shall not prohibit such Third Party from engaging in such Prohibited Activities following the consummation of any such acquisition. Notwithstanding anything to the contrary, for clarity, this provision and
its limitations on Endo and its Affiliates shall remain unaffected by any more permissive language or provisions that may appear in Section 2.13 of that certain Distribution Agreement between Parent and Par Pharmaceutical, Inc. dated as of the
Effective Date. 
 (d)    Material Contracts. Endo shall not terminate any Material Contract prior
to the Closing Date or any Post-Closing Material Contract prior to the thirty-first (31st) day following the Closing Date. Endo shall notify BDSI as soon as reasonably practicable, in accordance
with Section 16(a), of any breach of any Material Contract by Endo, any Affiliate thereof, or any counterparty thereto of which Endo or any Affiliate thereof becomes aware following the Effective Date and promptly provide BDSI all material
information in Endo possession with respect thereto. 
 (e)    Data Room. As soon as practicable
following the Closing, and in any event no later than fifteen (15) Business Days thereafter, Endo shall deliver to BDSI (i) one (1) or more DVDs or CD-ROMs containing each of the documents in the
Data Room as of the Effective Date and as of the Closing, respectively. Notwithstanding any provision of this Termination Agreement to the contrary, but subject to the terms of Section 14, Endo shall have the right to
retain copies of such DVDs or CD-ROMs for its records. 

(f)    Other Documents and Materials. To the extent not included in the Data Room, Endo shall
provide BDSI with copies of all Regulatory Approvals and Regulatory Submissions as soon as possible following the Effective Date. In addition, in each case, pursuant to the Transition Services Agreement and to the extent in Endo’s or its
Affiliates’ possession or control, Endo shall provide to BDSI all customer complaints, adverse event reports, other similar records related to the Product, its use, or any pharmacovigilance or similar functions with respect thereto, any records
or documentation concerning any clinical study or Manufacture of the Product, and any documentation related to any of the foregoing. 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (g)    Product Inventory. ***. 

(h)    Schedule Update. From and after the Effective Date until the Closing Date, Endo shall
promptly notify BDSI, by written update to the Schedules hereof, of the occurrence or non-occurrence of any event which would be likely to cause any prior representation or warranty to no longer be true, and
BDSI agrees not to object to such changes so long as such changes would not be reasonably expected to materially and adversely affect the condition of the Business, the Assets, or the ability of the Parties to consummate the transactions
contemplated hereby. If any such changes would reasonably be expected to materially and adversely affect the condition of the Business, the Assets, or the ability of the Parties to consummate the transactions contemplated hereby, BDSI shall have the
right, upon written notice to Endo prior to Closing, to terminate this Agreement and, upon such termination, all further obligations of the Parties under this Agreement will terminate (and the releases made and given under
Section 11 shall be void and of no further force or effect) and be of no further force or effect, except that Sections 10(c), 13(e), 15 and 16 (except for Section 16(d)) shall survive.
Subject to the termination right set forth above, the delivery of any notice permitted in this section shall cure any breach of any representation or warranty requiring disclosure of such matter as of the Effective Date. 

(i)    Withdrawals and Recalls. 

(i)    If any Regulatory Authority (A) threatens, initiates or advises any action to remove any
Product from the market or (B) requires or advises Endo, BDSI, or any of their respective Affiliates to distribute a “Dear Doctor” letter or its equivalent regarding use of Product within *** (each, a “Regulatory
Action”), then Endo or BDSI, as applicable, shall notify the other Party of such event within *** (or sooner if necessary to enable a Party to comply with applicable law) after such Party becomes aware of such Regulatory Action. Prior to
the Closing Date, Endo shall have the right to decide whether to recall, withdraw or issue a field alert in connection with Product, and as between the Parties, Endo shall be responsible, at Endo’s sole expense, for conducting any recalls or
withdrawals, issuing any field alerts, or taking such other necessary remedial action (each, a “Remedial Action”). On or after the Closing Date, BDSI shall have the right to decide whether to take any Remedial Action in connection
with Product, and as between the Parties, BDSI shall be responsible for conducting any Remedial Action; provided, however, that, notwithstanding anything to the contrary herein, with respect to any Product sold by or on behalf of Endo
or any Affiliate thereof prior to the Closing Date, Endo shall be entitled to effect (or to require BDSI to effect) any Remedial Action with respect thereto if Endo reasonably determines in good faith that such Regulatory Action is necessary or
appropriate after providing BDSI a reasonable opportunity to do so and BDSI shall take all actions reasonably requested by Endo in connection therewith. 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (ii)    Expenses. All costs and expenses relating
to any Remedial Action with respect to Product (“Remedial Costs”) shall be borne as follows: 

(A)    ***. 

(B)    ***. 

(C)    ***. 

The preceding shall not be in lieu of or limit any obligation of indemnity of any Party hereto pursuant to this Termination Agreement, the
Agreement or any other Transaction Documents. In the event a Party incurs any Remedial Costs for which the other Party is financially responsible under this Section 12(i), such Party shall provide the financially responsible Party with
monthly reports within sixty (60) calendar days after the end of the applicable month setting forth in reasonable detail the amount of such Remedial Costs, and the amounts owed by the financially responsible Party to the other Party shall be
paid within forty-five (45) calendar days thereafter. 
 (j)    Further Assurances. Following
the Closing, each of the Parties hereto shall, and shall cause their respective Affiliates to, execute and deliver such additional documents, instruments, conveyances and assurances and take such further actions as may be reasonably required to
carry out the provisions hereof and give effect to the transactions contemplated by this Termination Agreement. 

13.    Indemnification. 

(a)    The indemnification obligations of the Parties set forth in Article 13 of the Agreement shall
remain in effect in accordance with the terms thereof. 
 (b)    Without limiting, and subject to, the
provisions of Section 13(a): 
 (i)    BDSI shall defend, indemnify and hold harmless Endo, its
Affiliates, their respective permitted successors and permitted assigns, and their respective officers, directors, employees, agents, and other representatives (collectively, the “Endo Indemnified Parties”) against any and all
losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind (collectively, “Losses”) arising out of or resulting from any claim of a
Third Party with respect to: (a) any Assumed Liabilities, (b) any Product sold by or on behalf of BDSI 

  
 17 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
after the Closing, except to the extent such claim or Losses results from any circumstances described in subsection (ii) below or are otherwise subject to indemnification by Endo
pursuant to this Termination Agreement, the Agreement, the Transaction Documents, or any other agreement between the Parties or any of their Affiliates, or (c) any breach of this Termination Agreement, the Agreement, or the Transaction
Documents; and 
 (ii)    Endo shall defend, indemnify and hold harmless BDSI, its Affiliates, its and
their permitted successors and permitted assigns, and its and their officers, directors, employees, agents, and other representatives (collectively, the “BDSI Indemnified Parties”) against any and all Losses arising out of or
resulting from any claim of a Third Party with respect to or resulting from (a) any Inventory that was not, prior to delivery to BDSI hereunder, manufactured, handled, stored, or shipped in compliance with the Product Specifications, applicable
laws, rules, or regulations, applicable Regulatory Approvals, or cGMP, (b) any breach of this Termination Agreement, the Agreement, or the Transaction Documents, or (c) any Excluded Liabilities. 

(c)    Certain Limitations. 

(i)    Notwithstanding anything to the contrary in this Termination Agreement, an Indemnifying Party is not
obligated to indemnify, defend or hold harmless an Indemnified Party against any Losses or with respect to any Third Party claims arising out of or resulting from an Indemnified Party’s: (i) willful misconduct or grossly negligent acts or
omissions; or (ii) failure to materially comply with any of its obligations set forth in this Termination Agreement. 

(ii)    The aggregate liability of BDSI under Section 13(b)(i)(c) in respect of inaccuracies in, or
breaches of, representations and warranties made by BDSI, and (ii) the aggregate liability of Endo under Section 13(b)(ii)(b) in respect of inaccuracies in, or breaches of, representations and warranties made by Endo, other than such
representations and warranties of Endo made in Sections 10(b)(i) and 10(b)(vi), in each case, shall not exceed $*** (the “Cap”). The aggregate liability of Endo under Section 13(b)(ii)(b) in respect of
inaccuracies in, or breaches of, the representations and warranties of Endo made in Section 10(b)(i) shall not exceed the Purchase Price. The aggregate liability of Endo under Section 13(b)(ii)(b) in respect of inaccuracies in, or
breaches of, the representations and warranties of Endo made in Section 10(b)(vi)(B) shall not exceed an amount equal to the Asset Purchase Price less the Equipment Book Value. The aggregate liability of Endo under Section 13(b)(ii)(b)
with respect to any breaches of Section 10(b)(vi)(A) shall not exceed any amounts actually 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
recovered from Third Parties in connection therewith; provided, however, that Endo shall assign the right to seek damages for such liability from the applicable Third Party to BDSI
or, if such right is not assigned, use commercially reasonable efforts to seek and obtain such damages for such liability from the applicable Third Party. 

(iii)    No Party shall be liable under this Section 13 for any Losses resulting
from or relating to any inaccuracy in or breach of any representation or warranty in this Termination Agreement or the Agreement if the Party seeking indemnification for such Losses had knowledge of such inaccuracy or breach before the Closing,
except with respect to any inaccuracy in or breach of the representations and warranties made by Endo in Section 10(b)(i). 

(iv)    Notwithstanding anything to the contrary, none of the limitations set forth in the preceding
subsections (ii) or (iii) shall apply to any liabilities resulting from a Party’s or any of its Affiliates’ fraud or intentional misrepresentation. 

(d)    An Indemnified Party seeking indemnification under this Section 13 or
Article 7 of the Transition Services Agreement shall give the Indemnifying Party: (i) prompt notice (in accordance with Section 16(a)) of the relevant claim; provided, however, that failure to provide such notice shall not
relieve the Indemnifying Party from its liability or obligation hereunder except to the extent of any material prejudice directly resulting from such failure; and (ii) reasonable cooperation in the defense of such claim, at Indemnifying
Party’s expense. The Indemnifying Party shall have the right to control the defense and settlement of any such claim; provided, however, that (A) the Indemnifying Party shall not, without the prior written approval of the
Indemnified Party, settle or dispose of any claims in a manner that adversely affects the Indemnified Party’s rights hereunder, imposes any non-indemnified obligations on the Indemnified Party in addition
to those set forth herein, or admits fault or wrongdoing on the part of the Indemnified Party, (B) Endo, as the Indemnifying Party, shall not, without the prior written approval of BDSI, settle or dispose of any claims in a manner that
(i) limits the scope, validity, or enforceability of any BDSI Patents, BDSI Know-How, or BDSI Trademarks or (ii) would reasonably be expected to adversely affect BDSI’s ability to develop,
manufacture, or commercialize the Product or any other product covered by any BDSI Patents. The Indemnifying Party shall keep the Indemnified Party reasonably informed of the progress of the action and shall consider the comments and observations of
the Indemnified Party timely given in the course of the proceedings. Notwithstanding the foregoing, the Indemnified Party may be represented by separate counsel at the expense of the Indemnifying Party if a conflict of interest exists between the
interests of the Indemnifying Party and Indemnified Party so that a single counsel representing 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
Indemnifying Party cannot adequately defend the rights of the Indemnified Party. No Indemnified Party shall enter into any settlement or voluntary disposition of any claim or Losses subject to
indemnification under this Section 13 or Article 7 of the Transition Services Agreement, as applicable, without the prior written consent of the Indemnifying Party with respect thereto, which consent shall not be
unreasonably withheld or delayed, except with respect to any such settlement or voluntary disposition that (a) adversely affects the Indemnifying Party’s rights hereunder, imposes any non-indemnified
obligations on the Indemnifying Party in addition to those set forth herein, or admits fault or wrongdoing on the part of the Indemnifying Party, in which cases the Indemnifying Party may withhold its consent thereto in its sole discretion acting in
good faith or, (b) in the event an Endo Indemnified Party is the Indemnified Party, (i) limits the scope, validity, or enforceability of any BDSI Patents, BDSI Know-How, or BDSI Trademarks or
(ii) would reasonably be expected to adversely affect BDSI’s ability to develop, manufacture, or commercialize the Product or any other product covered by any BDSI Patents, in which cases BDSI, as the Indemnifying Party may withhold its
consent thereto in its sole discretion. The Indemnified Party shall have the right to participate in the defense at its own expense. 

(e)    IN NO EVENT WILL ANY PARTY BE LIABLE TO ANY OTHER PARTY FOR LOST PROFITS OR FOR ANY SPECIAL,
INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, HOWEVER CAUSED, ON ANY THEORY OF LIABILITY AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, ARISING UNDER ANY CAUSE OF ACTION AND ARISING IN ANY WAY OUT OF
THIS TERMINATION AGREEMENT OR THE TRANSITION SERVICES AGREEMENT, PROVIDED THAT THE FOREGOING SHALL NOT APPLY WITH RESPECT TO FRAUD, INTENTIONAL MISREPRESENTATION, DAMAGES ACTUALLY AWARDED OR PAID TO THIRD PARTIES WITH RESPECT TO THE PARTIES’
INDEMNIFICATION OBLIGATIONS UNDER THIS SECTION 13 OR SECTION 7 OF THE TRANSITION SERVICES AGREEMENT, OR ANY BREACH OF SECTIONS 12(c) OR 14. 

14.    Confidentiality. 

(a)    Definition of Confidential Information. Either Party (the “Disclosing
Party”) may from time to time furnish the other Party (the “Receiving Party”) with scientific, technical, trade or business information or materials pursuant to or in connection with this Termination Agreement or the
Transition Services Agreement which are treated by the Disclosing Party as confidential or proprietary, including information and materials related to, Product, processes, formulae, procedures, tests, equipment, data, batch records, reports, know-how, sources of supply, patent positioning, relationships 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
with consultants and employees, business plans and business developments, and information concerning the existence, scope or activities of any research, design, development, Manufacturing,
marketing or other projects. All such disclosed information shall be referred to herein as “Confidential Information” if it is provided in writing and is designated or otherwise identified as “Confidential” at the time of
disclosure, or if it is first provided orally, visually, or by inspection and is identified as “Confidential” at the time of disclosure. Notwithstanding the foregoing, Confidential Information shall also include such information or
materials that would reasonably be identified or understood by the Receiving Party to be the confidential or proprietary information of the Disclosing Party, even if they are not so identified as described in the previous sentence. “BDSI
Confidential Information” means any and all Confidential Information for which BDSI is the Disclosing Party and Endo the Receiving Party hereunder, provided that, notwithstanding anything to the contrary, any and all information first
received from Endo or an Affiliate thereof hereunder concerning the Product, any Assets or Endo Intellectual Property shall be deemed the Confidential Information of both Parties (unless, pursuant to the terms of the Agreement, such Confidential
Information is otherwise deemed to solely be the Confidential Information of BDSI). 

(b)    Confidentiality. Except to the extent expressly authorized by this Termination Agreement or
the Transition Services Agreement or otherwise agreed in writing by the Parties, the Parties agree that for seven (7) years following the disclosure of any Confidential Information hereunder or thereunder, the Receiving Party shall keep
confidential and shall not publish or otherwise disclose and shall not use for any purpose any of the Disclosing Party’s Confidential Information. 

(c)    Exclusions. Notwithstanding anything herein to the contrary, the obligations of
confidentiality and nonuse under this Section 14 applicable to Confidential Information hereunder shall not apply to information that Receiving Party can demonstrate: 

(i)    at the time of disclosure, is known publicly or thereafter becomes known publicly through no fault
of the Receiving Party, its Affiliates or agents; 
 (ii)    is disclosed to the Receiving Party on a non-confidential basis by a Third Party that is not legally prohibited from disclosing such information; 

(iii)    was developed by the Receiving Party independently of information obtained from the Disclosing
Party, as shown by the Receiving Party’s prior written records; 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (iv)    was already known to the Receiving Party before
receipt from the Disclosing Party, as shown by the Receiving Party’s prior written records; or 

(v)    is released with the prior written consent of the Disclosing Party. 

(d)    Permitted Disclosures. Notwithstanding the foregoing, each Receiving Party may disclose the
Disclosing Party’s Confidential Information (i) to the Receiving Party’s employees, consultants, Affiliates, agents, contractors, or sublicensees who are bound by obligations relating to confidentiality at least as restrictive of
those contained herein and who have a need to know such information in connection with the Receiving Party’s performance of its obligations or practice of its rights under this Termination Agreement, and (ii) to Regulatory Authorities in
connection with any Regulatory Submissions required for development of Product or in compliance with Regulatory Requirements. 

(e)    Terms of Agreement. The Parties agree that the material terms of this Termination Agreement
and the Transition Services Agreement will be considered Confidential Information of both Parties. Subject to Section 14(f) below, no Party shall, without the prior written consent of the other Party, disclose in any manner to any Third Party
the material terms and conditions of this Termination Agreement or the Transition Services Agreement, except for terms or subject matter which has been the subject of prior public disclosure or has been mutually approved for such disclosure and
except as set forth below. Each Party acknowledges and agrees that, notwithstanding the foregoing, (i) either Party, to the extent legally required, shall have the right to file this Termination Agreement or the Transition Services Agreement as
an exhibit to its filings with the U.S. Securities and Exchange Commission, and, in addition, either Party shall have the right to disclose such terms as are required to be disclosed in its publicly-filed financial statements or other public
statements, pursuant to applicable laws, regulations and stock exchange rules (e.g., the rules of the U.S. Securities and Exchange Commission, NASDAQ, NYSE or any other stock exchange on which securities issued by either Party may be listed);
provided such Party shall, to the extent reasonably practicable, provide the other Party with a copy of the proposed text of such statements or disclosure (including any exhibits containing this Termination Agreement or the Transition Services
Agreement) sufficiently in advance of the scheduled release or publication thereof to afford such other Party a reasonable opportunity to review and comment upon the proposed text (including redacted versions of this Termination Agreement or the
Transition Services Agreement), (ii) either Party shall have the further right to disclose the material financial terms of this Termination Agreement under a confidentiality obligation no less protective than those set forth in this Termination
Agreement, to any potential or actual licensee, sublicensee, acquirer, acquisition target, merger partner or target, or providers of financing and their advisors, (iii) BDSI shall 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
have the right to disclose information regarding the development or commercialization status of Product to the extent such disclosure is deemed reasonably necessary or desirable by BDSI, and
(iv) BDSI shall have the right to disclose information regarding the development or commercialization status of Product to the extent such disclosure by BDSI is required by applicable laws or stock exchange rules. 

(f)    Mandatory Disclosure. 

(i)    Notification and Consultation. In the event that the Receiving Party is required by
applicable statute or regulation or by court order or judicial or administrative process to disclose any part of the Disclosing Party’s Confidential Information (including material terms or conditions of this Termination Agreement), the
Receiving Party shall, to the extent reasonably practicable, (A) promptly notify the Disclosing Party of each such requirement and identify the documents so required thereby, so that the Disclosing Party may seek or request the Receiving Party
to seek an appropriate protective order, confidential treatment or other remedy and/or waive compliance by the Receiving Party with the provisions of this Termination Agreement and (B) consult with the Disclosing Party on the advisability of
taking legally available steps to resist or narrow the scope of such requirement. 
 (ii)    Limited
Disclosure. If, in the absence of such a protective order, confidential treatment request, other remedy or waiver by the Disclosing Party, the Receiving Party is nonetheless required to disclose any part of the Disclosing Party’s
Confidential Information or any material terms or conditions of this Termination Agreement or the Transition Services Agreement, the Receiving Party may disclose such Confidential Information or material terms or conditions without liability under
this Termination Agreement or the Transition Services Agreement, except that the Receiving Party shall furnish only that portion of the Confidential Information or material terms or conditions that is legally required. 

(g)    Each Party shall be responsible for any breach of this Section 14 caused
by any of its Affiliates, employees, advisors, or other representatives. Notwithstanding the foregoing, if any Confidential Information is permissibly disclosed pursuant to Section 15, such information will no longer be
deemed “Confidential Information” for the purposes of this Section 14. 

15.    Publicity and Announcements. No Party shall (orally or in writing) publicly disclose or issue any press
release or make any other public statement, or otherwise communicate with the media, directly concerning the existence of this Termination Agreement, the Transition Services Agreement or the terms hereof or thereof, without the prior written

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
approval of the other Parties (which shall not be unreasonably withheld or delayed), except to the extent that such Party (based upon the reasonable advice of counsel) is required to make any
public disclosure or filing with respect to the existence or terms of this Termination Agreement or the Transition Services Agreement (a) by applicable law or (b) pursuant to any rules or regulations of any securities exchange of which the
securities of such Party or any of its Affiliates are listed or traded, in which case, the disclosing Party shall, to the extent reasonably practicable, provide the other Party a reasonable opportunity to review and comment on such disclosure or
filing, which opportunity shall not be required to exceed two (2) Business Days. 
 16.    Miscellaneous.

 (a)    Notices. Any notice, request, demand, waiver, consent, approval or other communication
which is required or permitted to be given to any Party shall be in writing and shall be deemed given only (a) when delivered to the Party personally, (b) five (5) days after sent to the Party by registered mail, return receipt requested,
postage prepaid, (c) the second (2nd) Business Day after sent by a nationally recognized courier service guaranteeing next-day or second-day delivery, charges prepaid, in each case addressed to the Party at its address set forth below, or (d) the first (1st) Business Day after sent by
facsimile transmission to the number set forth below, or at such other address or fax number as such Party may from time to time specify by notice given in the manner provided herein to the Party entitled to receive notice hereunder: 

 

			
	For BDSI:	  	BioDelivery Sciences International, Inc.
		  	4131 Parklake Ave #225
		  	Raleigh, NC 27612
		  	Attention: Chief Executive Officer
		  	Fax: (919) 582-9051
	
	With a copy to (which shall not constitute notice):
		
		  	Wyrick Robbins Yates & Ponton LLP
		  	4101 Lake Boone Trail, Suite 300
		  	Raleigh, NC 27607
		  	Attn: Jason S. Wood
		  	Fax: (919) 781-4865
		
	For Endo:	  	Endo Pharmaceuticals Inc.
		  	c/o Endo Health Solutions
		  	1400 Atwater Drive
		  	Malvern, PA 19355
		  	Attention: Chief Executive Officer
		  	Fax: (610) 884-7612

  
 24 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

			
	 With a copy to (which shall not constitute notice):

		
		  	 Endo Pharmaceuticals Inc.

		  	 c/o Endo Health Solutions

		  	 1400 Atwater Drive

		  	 Malvern, PA 19355

		  	 Attention: Chief Legal Officer

		  	 Fax: (610) 884-7159

	
	 With a copy to (which shall not constitute notice):

		
		  	 Drinker Biddle & Reath LLP

		  	 One Logan Square, Suite 2000

		  	 Philadelphia, PA 19103

		  	 Attention: Neil K. Haimm, Esq.

		  	 Email: Neil.Haimm@dbr.com

		  	 Fax No.: (215) 988-2757

 (b)    Governing Law. This Termination Agreement shall be governed
by, and construed in accordance with the laws of the State of Delaware and the federal laws of the United States, in each case without reference to choice of law rules. 

(c)    Dispute Resolution. In the event of any dispute under this Termination Agreement (other than
disputes excluded in subsection (i) below), the Parties shall refer such dispute to the Applicable Senior Officers for attempted resolution by good faith negotiations within thirty (30) days after such referral is made. If the
Applicable Senior Officers are unable to resolve the dispute within such thirty (30) day period, either Party may proceed as set forth below. 

(i)    Alternative Dispute Resolution. Any dispute, controversy or claim arising out of or relating
to the validity, construction, enforceability or performance of this Termination Agreement, including disputes relating to an alleged breach or to termination of this Termination Agreement and including any claim of inducement by fraud or otherwise,
but excluding any dispute, controversy or claim arising out of or relating to the validity, enforceability, or infringement of any BDSI Patent or any suit or claim for injunctive relief under Section 16(c)(iv) (which shall be submitted to a
court of competent jurisdiction), shall be settled by mediation and arbitration in the manner described below. 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (ii)    Mediation. The Applicable Senior Officers
shall mutually select a mediator with appropriate expertise in the subject matter to which the dispute relates, who will be engaged to resolve the dispute. If the Applicable Senior Officers cannot agree on a mediator within fifteen (15) days,
each Party may seek appropriate resolution through arbitration as described below. If the Parties are unable to resolve their dispute through mediation within ninety (90) days after mutual selection of the mediator(s), either Party may seek
appropriate resolution through arbitration as described below. 
 (iii)    Arbitration. Any
dispute, controversy or claim arising out of or relating to the validity, construction, enforceability or performance of this Termination Agreement which is not resolved by mediation as set forth above, including disputes relating to alleged breach
or to termination of this Termination Agreement shall be settled by binding arbitration (“Arbitration”) in the manner described below: 

(A)    If a Party intends to begin an Arbitration to resolve a dispute, such Party shall provide written
notice (the “Arbitration Request”) to the other Party informing such other Party of such intention and the issues to be resolved. Within ten (10) Business Days after the receipt of the Arbitration Request, the other Party may,
by written notice to the Party initiating Arbitration, add additional issues to be resolved. 

(B)    Procedure. The Arbitration shall be conducted pursuant to the then-current JAMS/ENDISPUTE
Rules (streamlined for disputes involving $*** or less (and not the right to terminate this Termination Agreement) and comprehensive for disputes involving more than $*** or involving a right to terminate this Termination
Agreement). Notwithstanding those rules, the following provisions shall apply to the Arbitration hereunder: 

(C)    Arbitrator. In the event that the dispute at issue involves an amount less than $***
and not the termination of this Termination Agreement, the Arbitration shall be conducted by one (1) independent, neutral arbitrator and, to the extent reasonably available through JAMS, reasonably expert in the U.S. pharmaceutical industry
(the “Threshold 1 Arbitrator”). In the event, however, that the dispute at issue involves an amount greater than $*** or the termination of this Termination Agreement, the Arbitration shall be conducted by a panel of three
(3) independent, neutral arbitrators and, to the extent reasonably available through JAMS, reasonably expert in the U.S. pharmaceutical industry 

  
 26 

	
	  

FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
(collectively, with the Threshold 1 Arbitrator, the “Arbitrators”). The Arbitrators shall be selected from a pool of retired independent federal judges to be presented to the
Parties by JAMS/ENDISPUTE. Neither Party shall engage in ex parte contact with the Arbitrators. 

(D)    Proceedings. The time periods set forth in the JAMS/ENDISPUTE rules shall be followed,
unless a Party can demonstrate to the Arbitrators that the complexity of the issues or other reasons warrant the extension of one or more of the time tables. Notwithstanding the foregoing, the Arbitrators shall render a written opinion setting forth
findings of fact and conclusions of law with the reason therefor stated within no later than six (6) months from the date on which the Arbitrators were appointed to the dispute. A transcript of the evidence adduced at the hearing shall be made
and, upon request, shall be made available to each Party. The Arbitrators shall, in rendering their decision, apply the substantive law of the Commonwealth of Pennsylvania and the federal law of the U.S., in each case without regard to conflict of
laws provisions, except that the interpretation of and enforcement of this Section 16(c) shall be governed by the Federal Arbitration Act. The Arbitrator shall apply the Federal Rules of Evidence to the hearing. The proceeding shall
take place in Philadelphia, Pennsylvania. The fees of the Arbitrators and JAMS/ENDISPUTE shall be paid by the losing Party, which shall be designated by the Arbitrator. If the Arbitrator is unable to designate a losing Party, it shall so state and
the fees shall be split equally between the Parties. 
 (E)    Award. Subject to Sections
16(c)(i) and 16(c)(iv), the Arbitrator is empowered to award any remedy allowed by law, including money damages, prejudgment interest and attorneys’ fees, and to grant final, complete, interim, or interlocutory relief, including
injunctive relief. 
 (F)    Costs. Except as set forth in subsections (iii)(B) and
(C) above, each Party shall bear its own legal fees and costs. 

(G)    Confidentiality. The Arbitration proceeding shall be confidential and the Arbitrators shall
issue appropriate protective orders to safeguard each Party’s Confidential Information. Except as required by law, no Party shall make (or instruct the Arbitrators to make) any public announcement with respect to the proceedings or decision of
the Arbitrators without prior written consent of each other Party. The existence of any dispute submitted to Arbitration, and any award with 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 
respect thereto, shall be kept in confidence by the Parties and the Arbitrators, except as required in connection with the enforcement of such award or as otherwise required by applicable law.

 (H)    Judgment; Provisional Remedies. The United States District Court for the Eastern
District of Pennsylvania may enter judgment upon any award. The Parties consent to the jurisdiction of the above-specified Court for the enforcement of these provisions and the entry of judgment on any award. In the event such Court lacks
jurisdiction, then any court having jurisdiction of this matter may enter judgment upon any award and provide the same relief. Without limitation of subsection 16(c)(iv) below, each Party has the right before or during the arbitration to seek
and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc., to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration. 

(I)    Language. All pleadings, complaints and other documents filed or presented in connection
with, and all proceedings in, any dispute resolution proceeding described in this Section 16(c) must be in the English language. 

(iv)    Injunctive Relief. Notwithstanding anything to the contrary, each Party shall be
entitled to seek injunctive relief to enforce the respective covenants and agreements of the Parties in this Termination Agreement, including the respective rights and obligations of the Parties under Sections 12(c) and 14. 

(d)    Nature of Licenses. All rights and licenses granted pursuant to this Termination Agreement
are, and shall otherwise be deemed to be, for purposes of 11 U.S.C. § 365(n) of the Bankruptcy Laws, licenses of rights to “intellectual property” as defined under 11 U.S.C. § 101(35A) of the Bankruptcy Laws. The Parties agree
that a Party granted any rights or licenses under this Termination Agreement (the “Licensee”) by the other Party (the “Licensor”) shall retain and may fully exercise all of Licensee’s rights, including any
right to enforce any exclusivity provision of this Termination Agreement, remedies, and elections under Bankruptcy Laws. To the fullest extent permitted by law, the Parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against a Licensor under the Bankruptcy Laws, the Licensee shall be entitled to all applicable rights under 11 U.S.C. § 365(n) of the Bankruptcy Laws, including copies and access to, as appropriate, any such intellectual
property and all embodiments of such intellectual property upon written request therefor by the Licensee, and such, if not already in its possession, shall be promptly delivered to the Licensee. 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 Without limiting the generality of the foregoing, if a case is commenced by or against a Party (the
“Subject Party”) under the Bankruptcy Laws, such Party (in any capacity, including debtor-in-possession) and its successors and assigns (including a
Title 11 trustee) shall as the other Party (the “Non-Subject Party”) may elect in a written request, immediately upon such request: 

(i)    perform all of the obligations provided in this Termination Agreement to be performed by the Subject
Party, including, where applicable and without limitation, providing to the Non-Subject Party portions of such intellectual property (including embodiments thereof) held by the Subject Party and such
successors and assigns or otherwise available to them; or 
 (ii)    provide to the Non-Subject Party all such intellectual property (including all embodiments thereof) held by the Subject Party and such successors and assigns or otherwise available to them as called for under this Termination
Agreement; and 
 (iii)    not interfere with the rights of the
Non-Subject Party under this Termination Agreement, or any agreement supplemental hereto, to such intellectual property (including such embodiments), including any right to obtain such intellectual property
(or such embodiments) from another entity, to the extent provided hereunder and in 11 U.S.C. § 365(n) of the Bankruptcy Laws. 
 If (x) a case
under the Bankruptcy Laws is commenced by or against the Subject Party, (y) this Termination Agreement is rejected as provided in the Bankruptcy Laws, and (z) the Non-Subject Party elects to retain
its rights under this Termination Agreement as provided in the Bankruptcy Laws, then the Subject Party (in any capacity, including debtor-in-possession) and its
successors and assigns (including a Title 11 trustee) shall provide to the Non-Subject Party all such intellectual property required to be provided to the Non-Subject
Party hereunder (including all embodiments thereof) held by the Subject Party and such successors and assigns, or otherwise available to them, immediately upon the Non-Subject Party’s written request.
Whenever a Subject Party or any of its successors or assigns provides to the Non-Subject Party any of the intellectual property licensed under this Termination Agreement (or any embodiment thereof) pursuant to
this Section, the Non-Subject Party shall have the right to perform the obligations of the Subject Party under this Termination Agreement with respect to such intellectual property, but neither this provision
nor such performance by the Non-Subject Party shall release the Subject Party from any such obligation or liability for failing to perform. The Parties acknowledge that no payments by BDSI under this
Termination Agreement constitute “royalties” within the meaning of the Bankruptcy Laws or relate to licenses of intellectual property under this Termination Agreement. 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (e)    Amendment. This Termination Agreement and
each of the terms and provisions hereof, may only be amended, modified, waived or supplemented by an agreement in writing signed by each Party. 

(f)    Assignment. Neither Party may assign, transfer or delegate any or all of its rights or
obligations under this Termination Agreement without the prior written consent of the other Parties, except that a Party may assign this Termination Agreement without the consent of the other Parties to any Affiliate of such Party (such permitted
assignment to an Affiliate to include the right of BDSI to assign its obligations in respect to parts of the Agreement to different Affiliates) or in connection with (a) the sale or acquisition of such Party, (b) the sale of all or
substantially all of the assets of such Party (or that portion thereof related to the subject matter of this Termination Agreement), or (c) such Party’s merger, consolidation, reorganization, or similar transaction. No assignment will
relieve the assigning party of any of its obligations hereunder. Any attempted assignment, transfer or other conveyance in violation of the foregoing will be null and void. This Termination Agreement will inure to the benefit of and be binding upon
each of the Parties and each of their respective permitted successors and permitted assigns. 

(g)    Counterparts. This Termination Agreement may be executed in counterparts, each of which is
deemed an original, but all of which constitutes one and the same agreement. Delivery of an executed counterpart of this Termination Agreement electronically or by facsimile shall be effective as delivery of an original executed counterpart of this
Termination Agreement. 
 (h)    Interpretation. For purposes of this Termination Agreement:
(i) the words “include,” “includes” and “including” are deemed to be followed by the words “without limitation”; (ii) the word “or” is not exclusive; (iii) the words “herein,”
“hereof,” “hereby,” “hereto” and “hereunder” refer to this Termination Agreement as a whole; (iv) words denoting the singular have a comparable meaning when used in the plural, and vice-versa; and
(v) words denoting any gender include all genders. Unless the context otherwise requires, any reference to a “Section,” “Exhibit,” or “Schedule” shall be deemed to refer to a Section of this Termination Agreement,
Exhibit to this Termination Agreement or a Schedule to this Termination Agreement, as applicable. The Parties drafted this Termination Agreement without regard to any presumption or rule requiring construction or interpretation against the party
drafting an instrument or causing any instrument to be drafted. 

  
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FOIA CONFIDENTIAL TREATMENT REQUESTED BY

BIODELIVERY SCIENCES INTERNATIONAL, INC.

IRS EMPLOYER IDENTIFICATION NUMBER 35-2089858
  

***CONFIDENTIAL TREATMENT REQUESTED***

Note: The portions hereof for which confidential

treatment are being requested are denoted with “***”

 

  

 (i)    Headings. The headings in this Termination
Agreement are for reference only and do not affect the interpretation of this Termination Agreement. 

(j)    Enforceability. If any term or provision of this Termination Agreement is invalid, illegal or
unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Termination Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction.

 (k)    Entire Agreement. This Termination Agreement constitutes the sole and entire agreement
of the Parties with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to such subject matter. 

(l)    Costs and Expenses. Each Party shall pay its own costs and expenses in connection with the
drafting, negotiation and execution of this Termination Agreement (including the fees and expenses of its advisors, accounts and legal counsel). 

(m)    No Third Party Beneficiaries. This Termination Agreement benefits solely the Parties hereto
and their respective permitted successors and permitted assigns, and nothing in this Termination Agreement, express or implied, confers on any other person or entity any legal or equitable right, benefit or remedy of any nature whatsoever under or
by reason of this Termination Agreement. 
 [Signature Page Follows] 

  
 31 

 IN WITNESS WHEREOF, the Parties have executed this Termination Agreement as of the date first
written above. 
  

			
	 ARIUS PHARMACEUTICALS, INC.

		
	By	 	 /s/ Mark A. Sirgo

	Name:	 	Mark A. Sirgo
	Title:	 	President
	
	ARIUS TWO, INC.
		
	By	 	 /s/ Mark A. Sirgo

	Name:	 	Mark A. Sirgo
	Title:	 	President and CEO
	
	BIODELIVERY SCIENCES INTERNATIONAL, INC.
		
	By	 	 /s/ Mark A. Sirgo

	Name:	 	Mark A. Sirgo
	Title:	 	President and CEO
	
	ENDO PHARMACEUTICALS INC.
		
	By	 	 /s/ Paul V. Campanelli

	Name:	 	Paul V. Campanelli
	Title:	 	President and CEO

 SCHEDULE 1(b) 

Assigned Marks 
  

															
	 TRADEMARK
	 	 COUNTRY
	 	 STATUS
	 	APPLN NO.	 	APPLN DATE	 	REG. NO.	 	REG. DATE	 	 OWNER

	 BELBUCA
	 	BRAZIL	 	PENDING	 	908340753	 	9/24/2014	 		 		 	ENDO PHARMACEUTICALS INC.
								
	 BELBUCA
	 	CANADA	 	ALLOWED	 	1694096	 	9/16/2014	 		 		 	ENDO PHARMACEUTICALS INC.
								
	 BELBUCA
	 	EUROPEAN UNION	 	REGISTERED	 	A0045067	 	9/16/2014	 	1228983	 	9/16/2014	 	ENDO PHARMACEUTICALS INC.
								
	 BELBUCA
	 	MEXICO	 	REGISTERED	 	A0045067	 	9/16/2014	 	1228983	 	9/16/2014	 	ENDO PHARMACEUTICALS INC.
								
	 BELBUCA
	 	NORWAY	 	REGISTERED	 	A0045067	 	9/16/2014	 	1228983	 	9/16/2014	 	ENDO PHARMACEUTICALS INC.
								
	 BELBUCA
	 	SOUTH AFRICA	 	PUBLISHED	 	201425362	 	9/18/2014	 		 		 	ENDO PHARMACEUTICALS INC.
								
	 BELBUCA
	 	SWITZERLAND	 	REGISTERED	 	A0045067	 	9/16/2014	 	1228983	 	9/16/2014	 	ENDO PHARMACEUTICALS INC.
								
	 BELBUCA
	 	UNITED STATES	 	REGISTERED	 	86235385	 	3/28/2014	 	4946787	 	4/26/2016	 	ENDO PHARMACEUTICALS INC.
								
	 BELBUCA
	 	WIPO	 	REGISTERED	 	A0045067	 	9/16/2014	 	1228983	 	9/16/2014	 	ENDO PHARMACEUTICALS INC.
								
	 BELBUCA

LOGO 

	 		 	UNFILED	 		 		 		 		 	ENDO PHARMACEUTICALS INC.
								
	 Two-overlapping square logo

	 		 	UNFILED	 		 		 		 		 	ENDO PHARMACEUTICALS INC.
								
	 Life on Film
	 		 	UNFILED	 		 		 		 		 	ENDO PHARMACEUTICALS INC.

 SCHEDULE 3(C) 

 

	(i)	Regulatory Approvals 

 NDA #N207932 

Active Ingredient: Buprenorphine Hydrochloride 

Proprietary name: Belbuca 
 Dosage
Form: Film 
 Route: Buccal 

Strengths: EQ 0.075mg, 0.15mg, 0.30mg, 0.45mg, 0.6mg, 0.75mg, 0.9mg Base 

Applicant Holder: Endo Pharmaceuticals Inc. 
  

	(ii)	Product Manufacture: 

  

	1-	ARx LLC Master Supply Agreement 1JAN2016 

  

	2-	ARx LLC- Product Supply Scope No1 02JAN2016 

  

	3-	The Tapemark Company Master Supply Agreement 11NOV2015 

  

	4-	The Tapemark Company Product Supply Scope No1 02DEC2015 

 SCHEDULE 4(a) 

Inventory 
 (i) Product
Inventory and (ii) Work-in-Progress Inventory 
 *** 

 SCHEDULE 4(b) 

Material Contracts 
  

	(i)	Closing Material Contracts: 

  

	1-	ARx LLC Master Supply Agreement 1JAN2016 

  

	2-	ARx LLC- Product Supply Scope No1 02JAN2016 

  

	3-	The Tapemark Company Master Supply Agreement 11NOV2015 

  

	4-	The Tapemark Company Product Supply Scope No1 02DEC2015 

  

	(ii)	Post-Closing Material Contracts: 

 NA 

 SCHEDULE 4(c) 

Intellectual Property Assets 
 Domain
Name: BELBUCA.COM 
 Registrar: CSC CORPORATE DOMAINS, INC. 

Sponsoring Registrar IANA ID: 299 
 Whois Server:
whois.corporatedomains.com 
 Referral URL: http://www.cscglobal.com/global/web/csc/digital-brand-services.html 

Name Server: DNS1.CSCDNS.NET 
 Name Server: DNS2.CSCDNS.NET 

Status: clientTransferProhibited https://icann.org/epp#clientTransferProhibited 

Updated Date: 12-feb-2015 

Creation Date: 01-may-2014 

Expiration Date: 01-may-2017 

Domain Name: BELBUCA.NET 
 Registrar: CSC CORPORATE DOMAINS, INC.

 Sponsoring Registrar IANA ID: 299 
 Whois Server:
whois.corporatedomains.com 
 Referral URL: http://www.cscglobal.com/global/web/csc/digital-brand-services.html 

Name Server: DNS1.CSCDNS.NET 
 Name Server: DNS2.CSCDNS.NET 

Status: clientTransferProhibited https://icann.org/epp#clientTransferProhibited 

Updated Date: 05-sep-2016 

Creation Date: 09-sep-2014 

Expiration Date: 09-sep-2017 

Domain Name: BELBUCAAPPLICATION.COM 
 Registrar: CSC CORPORATE
DOMAINS, INC. 
 Sponsoring Registrar IANA ID: 299 
 Whois
Server: whois.corporatedomains.com 
 Referral URL: http://www.cscglobal.com/global/web/csc/digital-brand-services.html 

Name Server: DNS1.CSCDNS.NET 
 Name Server: DNS2.CSCDNS.NET 

Status: clientTransferProhibited https://icann.org/epp#clientTransferProhibited 

Updated Date: 16-mar-2016 

Creation Date: 16-mar-2016 

Expiration Date: 16-mar-2017 

Domain Name: BELBUCAFILM.COM 
 Registrar: CSC CORPORATE DOMAINS,
INC. 
 Sponsoring Registrar IANA ID: 299 
 Whois Server:
whois.corporatedomains.com 
 Referral URL: http://www.cscglobal.com/global/web/csc/digital-brand-services.html 

Name Server: DNS1.CSCDNS.NET 
 Name Server: DNS2.CSCDNS.NET 

 Status: clientTransferProhibited https://icann.org/epp#clientTransferProhibited 

Updated Date: 16-mar-2016 

Creation Date: 16-mar-2016 

Expiration Date: 16-mar-2017 

Domain Name: BELBUCAREMS.COM 
 Registrar: CSC CORPORATE DOMAINS,
INC. 
 Sponsoring Registrar IANA ID: 299 
 Whois Server:
whois.corporatedomains.com 
 Referral URL: http://www.cscglobal.com/global/web/csc/digital-brand-services.html 

Name Server: DNS1.CSCDNS.NET 
 Name Server: DNS2.CSCDNS.NET 

Status: clientTransferProhibited https://icann.org/epp#clientTransferProhibited 

Updated Date: 09-jul-2016 

Creation Date: 13-jul-2015 

Expiration Date: 13-jul-2017 

Domain Name: BELBUCAUSA.COM 
 Registrar: CSC CORPORATE DOMAINS,
INC. 
 Sponsoring Registrar IANA ID: 299 
 Whois Server:
whois.corporatedomains.com 
 Referral URL: http://www.cscglobal.com/global/web/csc/digital-brand-services.html 

Name Server: DNS1.CSCDNS.NET 
 Name Server: DNS2.CSCDNS.NET 

Status: clientTransferProhibited https://icann.org/epp#clientTransferProhibited 

Updated Date: 05-sep-2016 

Creation Date: 09-sep-2014 

Expiration Date: 09-sep-2017 

 SCHEDULE 4(d) 

Equipment 
 *** 

*** 

 
SCHEDULE 7(a) 
 *** 

*** 

 SCHEDULE 7(c) 

*** 
 *** 

 SCHEDULE 10(b) 

Exceptions to Endo Representations and Warranties 

(i)    Liens and Encumbrances: 
 None

 (vi)    Inventory: 
 See
Schedule 4(a)(i) and (ii).

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