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

 

Exhibit 10.2

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

by and between

DURECT CORPORATION

and

SANDOZ AG

dated

May 5, 2017

 

 

 

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

 

TABLE OF CONTENTS

 

 

 

Page

Article 1 DEFINITIONS; INTERPRETATION

1

Article 2 GOVERNANCE

7

2.1

Joint Development Committee

7

2.2

Membership

7

2.3

Meetings

8

2.4

Decision Making

8

2.5

Authority

8

2.6

Day-to-Day Responsibilities

8

Article 3 LICENSES

8

3.1

License Grant

8

3.2

No Other Rights

8

3.3

Exclusivity of Efforts

8

Article 4 DEVELOPMENT

9

4.1

Conduct

9

4.2

Conduct After NDA Approval.

9

Article 5 REGULATORY MATTERS

9

5.1

Regulatory Matters

9

5.2

Regulatory Cooperation

10

5.3

Exchange of Data

10

5.4

Pharmacovigilance Agreement

10

Article 6 COMMERCIALIZATION

10

6.1

Commercialization

10

6.2

Trademarks

11

6.3

Exclusive Negotiation Period

12

Article 7 SUPPLY

12

7.1

Supply Agreement

12

7.2

Quality Agreement

12

7.3

Drug Master File

12

Article 8 ECONOMIC TERMS

12

8.1

Expenses

12

8.2

Upfront Fee

12

8.3

Other Payments

12

8.4

Payment Method

12

8.5

Acknowledgement

13

8.6

Taxes

13

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

 

TABLE OF CONTENTS

(Continued)

 

 

Page

Article 9 INTELLECTUAL PROPERTY

13

9.1

Ownership of Inventions

13

9.2

Ownership of Data

13

9.3

Prosecution of Licensed Patents

13

9.4

Defense of Third Party Infringement Claims

13

9.5

Enforcement of Licensed Patents

13

9.6

Patent Marking

14

Article 10 CONFIDENTIALITY

14

10.1

Confidentiality; Exceptions

14

10.2

Authorized Use and Disclosure

15

10.3

Prior Agreements

15

10.4

Technical Publications

15

10.5

Publicity

16

Article 11 REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION

17

11.1

General Representations and Warranties

17

11.2

DURECT’s Warranties

17

11.3

Disclaimer of Warranties

18

11.4

Indemnification

18

11.5

Insurance

18

11.6

Limitation of Liability

19

Article 12 TERM AND TERMINATION

19

12.1

Term

19

12.2

Termination for Failure to Obtain HSR Clearance

19

12.3

Termination by SANDOZ

20

12.4

Termination by DURECT

20

12.5

Effects of Expiration or Certain Types of Termination

20

12.6

Effects of Termination for Certain Willful DURECT Breaches

21

12.7

General Effects of Expiration or Termination

21

12.8

Termination Press Releases

22

Article 13 DISPUTE RESOLUTION

22

13.1

Dispute Resolution

22

13.2

Initial Escalation

22

13.3

Binding Arbitration

22

13.4

Interim Relief

23

Article 14 MISCELLANEOUS

23

14.1

Governing Law

23

14.2

Assignment

23

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TABLE OF CONTENTS

(Continued)

 

 

Page

14.3

Consequences of Bankruptcy

23

14.4

Notices

24

14.5

Waiver

24

14.6

Severability

25

14.7

Entire Agreement/Modification

25

14.8

Relationship of the Parties

25

14.9

Force Majeure

25

14.10

Compliance with Applicable Law

25

14.11

Anti-Bribery Compliance

25

14.12

Counterparts

26

14.13

HSR Act Filing

26

 

 

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CONFIDENTIAL

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “Agreement”) is effective
as of May 5, 2017 (the “Execution Date”) by and between Sandoz AG, a company
organized under the laws of Switzerland, with an office at Lichtstraβe 35, CH
4056, Basel, Switzerland (“SANDOZ”), and Durect Corporation, a Delaware
corporation having a place of business at 10260 Bubb Road, Cupertino, California
95014 (“DURECT”).  SANDOZ and DURECT are each referred to herein by name or,
individually, as a “Party” or, collectively, as the “Parties.”

BACKGROUND

A.DURECT owns and controls rights in and to certain pharmaceutical products
comprising bupivacaine and its proprietary carrier materials and systems known
as the SABER® formulation platform technology, which is currently under
development by DURECT as POSIMIR®; and

B.SANDOZ desires to obtain the right to commercialize Product for the Field in
the Licensed Territory (each capitalized term as defined below), and DURECT
desires to grant SANDOZ such rights.

NOW, THEREFORE, in consideration of the mutual covenants and agreements provided
herein below and other consideration, the receipt and sufficiency of which is
hereby acknowledged, SANDOZ and DURECT hereby agree as follows:

Article 1
DEFINITIONS; INTERPRETATION

The following capitalized terms shall have the meanings given in this Article 1
or elsewhere in this Agreement when used in this Agreement:

1.1“Accounting Standards” means [ * * *].

1.2“Achievement” means, [ * * *].  “Achieved” has a correlative meaning.

1.3“Active Ingredient” means bupivacaine [ * * *].

1.4“Affiliate” means with respect to a Person, any other Person controlling,
controlled by or under common control with such first Person, for so long as
such control exists.  For purposes of this Section 1.4 only, “control” means
(a) direct or indirect ownership of fifty percent (50%) or more of the stock or
shares having the right to vote for the election of directors of such Person or
(b) the possession, directly or indirectly, of the power to direct, or cause the
direction of, the management or policies of such Person, whether through the
ownership of voting securities, by contract or otherwise.

1.5“Annual Contractual Net Sales” means [ * * *].

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1.6“Applicable Law” means, with respect to a Person’s activities under this
Agreement, any and all laws, ordinances, orders, rules, rulings, directives and
regulations of any kind whatsoever of any governmental authority (including the
FDA), national securities exchanges or securities listing organizations
applicable to such Person’s activities.

1.7“Branded Pharma Fee” means any taxes and/or fees under the Annual Branded
Prescription Drug Fees owed with regard to the Product, including under Section
9008 of the Patient Protection and Affordable Care Act (ACA), Public Law 111-148
(124 Stat. 119 (2010)), as amended by section 1404 of the Health Care and
Education Reconciliation Act of 2010 (HCERA), Public Law 111-152 (124 Stat. 1029
(2010)), or any successor laws, as determined in accordance with Accounting
Standards.

1.8“Business Day” means any day other than a Saturday, Sunday or any other day
on which commercial banks in San Francisco, California are authorized or
required by law to remain closed.

1.9“Commercialization” means Pre-Launch Commercialization and Other
Commercialization.  “Commercialize” has a correlative meaning.

1.10“Competing Product” means [ * * *].  

1.11“Components” means [ * * *].

1.12“Control” means, with respect to any material, information or intellectual
property right, that either Party (a) owns or (b) has a license to such
material, information, or intellectual property right and, in each case (a) and
(b), has the ability to grant to the other Party access, a license, or a
sublicense (as applicable) to the foregoing on the terms and conditions set
forth in this Agreement without giving rise to any payment obligation to any
Third Party or any violation of the terms of any written agreement with any
Third Party.  Notwithstanding anything to the contrary in this Agreement, in the
event that a Third Party merges or consolidates with or acquires DURECT, or
DURECT transfers to a Third Party all or substantially all of its assets to
which this Agreement relates (such Third Party and its Affiliates immediately
prior to such merger, consolidation or transfer (the “Acquisition Transaction”),
collectively, the “Acquiring Entities”), the following shall not be deemed to be
Controlled by DURECT for purposes of this Agreement: [ * * *].

1.13“Cover” means, with respect to any subject matter, the manufacture, use,
sale, offering for sale or other exploitation of such subject matter would
infringe (whether direct or contributorily) or induce the infringement of a
claim of a Patent (in the absence of a license under or ownership of such claim)
at the time thereof, including with respect to a claim within a pending patent
application, “Cover” includes infringing such claim if it was issued as then
prosecuted in good faith.  “Covered” or “Covering” have their correlative
meanings.

1.14“Data” means [ * * *].

1.15“Development” means [ * * *].  “Develop” and “Developing” have their
correlative meanings.

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1.16“Domain Names” means any internet electronic addresses, uniform resource
locators and alphanumeric designations associated therewith, registered with or
assigned by any domain name registrar, domain name registry or other domain name
registration authority as part of an electronic address on the internet, rights
in social media accounts and social media pages, and all applications for any of
the foregoing.

1.17“Effective Date” means the HSR Clearance Date.

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

1.19“Field” means the prevention and treatment of any and all diseases and
conditions in humans.

1.20“Financial Exhibit” means Exhibit 1.20.

1.21“HSR Act” means the United States Hart-Scott-Rodino Antitrust Improvements
Act of 1976, as amended, and the rules and regulations promulgated thereunder.

1.22“HSR Clearance Date” means, with respect to the transactions contemplated
under this Agreement, the earliest date on which the Parties have actual
knowledge that all applicable waiting periods have expired or have been
terminated under the HSR Act.

1.23“Licensed Know-How” means [ * * *].

1.24“Licensed Patents” means [ * * *].

1.25“Licensed Technology” means the Licensed Know-How and Licensed Patents.

1.26“Licensed Territory” means shall mean the fifty states of the United States
of America, the District of Columbia, the Commonwealth of Puerto Rico, Guam,
American Samoa, the U.S. Virgin Islands and all other territories and
possessions of the United States of America (as described on
https://www.state.gov/s/inr/rls/10543.htm) and United States military bases.

1.27“Licensed Trademark” means the trademark listed on Exhibit 1.27 [ * * *].

1.28“Litigation Costs” means any liability or expense ([ * * *]) incurred by [ *
* *] under Sections 9.4 or 9.5, [ * * *].

1.29“Manufacture” means, with respect to any pharmaceutical product, [ * * *].
“Manufacturing” has a correlative meaning.

1.30“NDA Amendment” means the [ * * *].

1.31“NDA Approval” means receipt of written notice from the FDA of the approval
of the NDA Amendment.

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1.32“Net Sales” means the net sales recorded by SANDOZ or any of its Affiliates
or Sublicensees (each a “Selling Party”) for any Product sold to Third Parties
as determined in accordance with [ * * *].  [ * * *]:

(i) [ * * *];

(ii) [ * * *];

(iii) [ * * *];

(iv) [ * * *];

(v) [ * * *];

(vi) [ * * *];

(vii) [ * * *];  

(viii) [ * * *]; and

(ix) [ * * *];

[ * * *].  

1.33“Non-Product-Specific Licensed Patent Claim” means [ * * *].

1.34“Other Commercialization” means, [ * * *].

1.35“Patent” means [ * * *].

1.36“PERSIST Trial” means the Phase 3 clinical trial for Product initiated prior
to the Execution Date entitled “Trial of Extended Release Bupivacaine for Pain
Relief After Surgery (PERSIST)”.

1.37“Person” means any individual, corporation, partnership, association,
joint-stock company, trust, unincorporated organization or government or
political subdivision thereof.

1.38“Phase 4 Required Trial” means [ * * *].  

1.39“Phase 4 Voluntary Trial” means [ * * *].  

1.40“Pre-Launch Commercialization” means, with respect to a pharmaceutical
product, any and all processes and activities conducted to prepare for the
successful commercial launch of such product, [ * * *].

1.41“Primary Endpoint” means, with respect to Part 2 of the PERSIST Trial, [ * *
*].

1.42“Product” means [ * * *].

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1.43“Product-Specific Licensed Patent Claim” means [ * * *].

1.44“Prosecution” means, with respect to a Patent, the filing, preparation,
prosecution (including conducting all correspondence and interactions with the
USPTO) and seeking, conducting and defending any interferences, inter partes
reviews, reissue proceedings, reexaminations, and similar proceedings), and
maintenance thereof, including obtaining patent term extensions, or their
equivalents with respect thereto.  When used as a verb, “Prosecute” means to
engage in Prosecution.

1.45“Regulatory Material” means regulatory applications (including the NDA
Amendment), submissions, notifications, communications, correspondence,
registrations, NDA Approval or other filings made to, received from or otherwise
conducted with the FDA(including minutes of meeting with the FDA) that are
necessary or relate to the Development, Manufacture or Commercialization of
Product for the Licensed Territory.

1.46“Retained Territory” means all countries and territories throughout the
world other than the Licensed Territory.

1.47“Royalties” means the royalty payments payable to DURECT pursuant to
Paragraph II of the Financial Exhibit (Exhibit 1.20).

1.48“SABER® Formulation Platform” means the proprietary, high viscosity liquid
carrier materials and systems for imparting controlled release [ * * *].

1.49[ * * *].

1.50“Sublicensee” means a Third Party that has received, directly or indirectly,
from SANDOZ or its Affiliate a sublicense, under Section 3.1(b), of the rights
granted to SANDOZ, provided that SANDOZ or its Affiliates receives payment based
upon sales of Product by or on behalf of such Third Party.

1.51“Supply Agreement” means, individually and collectively, the Three-Way
Supply Agreement(s) and Two-Way Supply Agreement.

1.52“Third Party” means any Person other than SANDOZ, DURECT or their respective
Affiliates.

1.53“Transaction Agreements” means, individually and collectively, this
Agreement and the various other agreements expressly referenced herein to be
entered into between the Parties, including without limitation the PV Agreement,
Quality Agreement and Supply Agreement, in each case, once executed.

1.54“USPTO” means the United States Patent and Trademark Office, or any
successor agency thereto.

 

 

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1.55Additional Definitions.  Each of the following definitions has the meanings
defined in the corresponding Section of this Agreement indicated below:

 

 

Definitions

Section

Acquiring Entities

1.12

Acquisition Transaction

1.12

Agreement

Preamble

Alternative Trademark

6.2(b)(i)

Challenge

12.4

CMC Information

7.3

CMO

7.1(a)

CMO Agreement

7.1(b)

Co‑Chair

2.2

Commercialization Milestone Event

Exhibit 1.20

Commercialization Milestone Payment

Exhibit 1.20

Commercialization Plan

6.1(d)

Competing Activities

3.3

Competing Product

3.3

Confidential Information

10.1

Defending Party

9.4

Deficiencies

4.1(c)

Development Milestone Event

Exhibit 1.20

Development Milestone Payment

Exhibit 1.20

Dispute

13.1

DURECT

Preamble

DURECT Indemnitees

11.4(b)

DURECT Inventions

9.1

DURECT Patents

9.1

DURECT TMs

6.2(c)(i)

Enforcement Action

9.5(b)

Enforcing Party

9.5(d)

Exclusive Negotiation Period

6.3

Execution Date

Preamble

Generic Product

Exhibit 1.20

Definitions

Section

IFRS

1.1

Indemnify

11.4(a)

Infringing Product

9.5(a)

Initial Term

12.1

JDC

2.1(a)

Losses

11.4(a)

Material Contracts

11.2(d)

Non-Product-Specific Enforcement Action

9.5(c)

Orange Book

5.1(b)

Orthopedic Exclusion

Exhibit 1.20

Other Party

5.2(a)

Party or Parties

Preamble

Pre-Launch Plan

6.1(c)

Prior CDA

10.3

Product Development Plan or PDP

4.1

Product-Specific Enforcement Action

9.5(b)

PV Agreement

5.4

Quality Agreement

7.1(c)

Renewal Term

12.1

Responsible Party

5.2(a)

SABER DMF

7.3

SANDOZ

Preamble

SANDOZ Indemnitees

11.4(a)

Selling Party

1.32

Term

12.1

Third-Party Claim

11.4(a)

Three-Way Supply Agreement

7.1(a)

Two-Way Supply Agreement

7.1(b)

Upfront Fee

8.2

 

 

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1.56Interpretation.  The captions and headings to this Agreement are for
convenience only, and are to be of no force or effect in construing or
interpreting any of the provisions of this Agreement.  Unless specified to the
contrary, references to Articles, Sections or Exhibits mean the particular
Articles, Sections or Exhibits to this Agreement and references to this
Agreement include all Exhibits hereto.  Unless context otherwise clearly
requires, whenever used in this Agreement:  (a) the words “include” or
“including” shall be construed as incorporating, also, “but not limited to” or
“without limitation”; (b) the word “will” shall be construed in the imperative
having the same meaning as the word “shall”; (c) the word “day” or “year” means
a calendar day or year; (d) the word “notice” requires notice in writing
(whether or not specifically stated) and shall include notices, consents,
approvals and other written communications contemplated under this Agreement;
(e) the words “hereof,” “herein,” “hereby” and derivative or similar words refer
to this Agreement (including any Exhibits); (f) the word “or” shall be construed
as the inclusive meaning identified with the phrase “and/or”; (g) provisions
that require that a Party or the Parties “agree,” “consent” or “approve” or the
like shall require that such agreement, consent or approval be specific and in
writing, whether by written agreement, letter, approved minutes or otherwise;
(h) words of any gender include the other gender; (i) words using the singular
or plural number also include the plural or singular number, respectively;
(j) references to any specific law, rule or regulation, or article, section or
other division thereof, shall be deemed to include the then-current amendments
thereto or any replacement law, rule or regulation thereof; and (k) neither
Party nor its Affiliates shall be deemed to be acting “on behalf of” or “under
authority of” the other Party hereunder.

Article 2
GOVERNANCE

2.1Joint Development Committee.

(a)Establishment.  Within [ * * *] of the Effective Date, SANDOZ and DURECT
shall establish a joint development committee (the “JDC”) to [ * * *].

(b)Responsibilities.  The JDC shall be responsible for the following:

(i)[ * * *]

(ii)[ * * *].

2.2Membership. The JDC shall be comprised of [ * * *].  Each Co‑Chair, working
together, shall (a) coordinate and prepare the agenda and ensure the orderly
conduct of the JDC’s meetings, (b) attend (subject to the below) each meeting of
the JDC, and (c) prepare and issue minutes of each meeting within [ * * *]
thereafter accurately reflecting the discussions of the JDC at such
meeting.  Such minutes from each JDC meeting shall not be finalized until the
Co‑Chair [ * * *] has reviewed and confirmed the accuracy of such minutes in
writing.  The Co‑Chairs shall solicit agenda items from the other JDC members
and provide an agenda along with appropriate information for such agenda [ * *
*].  In the event the Co‑Chair or another representative of the JDC from either
Party is unable to attend or participate in any meeting of the JDC, [ * * *].

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2.3Meetings. The JDC shall hold meetings (either in person or by teleconference)
at [ * * *].  

2.4Decision Making. For clarity, [ * * *].

2.5Authority; Disbanding.  Notwithstanding the creation of the JDC, each Party
shall [ * * *].  The Parties shall promptly disband the JDC upon [ * * *].

2.6Day-to-Day Responsibilities. Each Party shall: [ * * *].

Article 3
LICENSES

3.1License Grant.

(a)License to SANDOZ.  Subject to the terms and conditions of this Agreement,
DURECT hereby grants to SANDOZ an exclusive license under the Licensed
Technology to Develop, Manufacture (subject to and in accordance with
Article 7), use and Commercialize Product, in each case for the Field in the
Licensed Territory.  SANDOZ shall have the right to sublicense its Affiliates or
exercise such license through its Affiliates, provided that SANDOZ shall be
responsible for the failure by its Affiliates to comply with the terms of this
Agreement including all relevant restrictions, limitations and obligations.

(b)Sublicenses.  The license granted under Section 3.1(a) includes the right to
grant sublicenses within the scope thereof to Third Parties, subject to the
following:

(i)[ * * *];

(ii)[ * * *]; and

(iii)[ * * *].

(c)Retained Rights.  Notwithstanding anything herein to the contrary, DURECT
hereby retains all rights and licenses under the Licensed Technology to conduct
such activities assigned to it under this Agreement or that it otherwise has the
right to conduct under this Agreement or any and all Transaction Agreements.

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

3.3Exclusivity of Efforts. During the Term, each Party agrees, except pursuant
to this Agreement, [ * * *].  Notwithstanding anything to the contrary herein,
DURECT retains the right to

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conduct activities (including development, manufacturing and commercialization
activities) in support of products (including Product) for the Retained
Territory.

Article 4
DEVELOPMENT

4.1Conduct

(a)Prior to NDA Approval. 

(a)DURECT (itself or through one or more Third Party contract research
organizations) shall use [ * * *] to complete the PERSIST Trial and otherwise
Develop Product ([ * * *]) in accordance with the plan attached hereto as
Exhibit 4.1 (as may be updated from time to time pursuant to Section 4.1(b), the
“Product Development Plan” or “PDP”) and Applicable Law, [ * * *].  For the
avoidance of doubt, the Parties agree that the Product shall be developed by
DURECT [ * * *].

(b)Amendments/Reporting.  DURECT shall keep SANDOZ ([ * * *]) reasonably
informed as to its progress with respect to its activities under the Product
Development Plan.  [ * * *].

(c)Deficiencies.  In the event that, following submission of the NDA Amendment
but prior to the NDA Approval, the FDA identifies, in writing, deficiencies that
must be addressed in order to obtain NDA Approval (“Deficiencies”), [ * * *].

4.2Conduct After NDA Approval.

(a)General.  SANDOZ shall be responsible, [ * * *], for any development
activities conducted [ * * *] for Product for the Field in the Licensed
Territory, [ * * *].

(b)Phase 4 Required Trial Plan.  A plan for Phase 4 Required Trials [ * * *].

Article 5
REGULATORY MATTERS

5.1Regulatory Matters.

(a)Responsibility for Regulatory Materials.  [ * * *] shall be responsible for
filing, obtaining and maintaining approvals for those activities assigned to
such Party hereunder in connection with the Development, Manufacture and
Commercialization of Product for the Field in the Licensed Territory.  For
clarity, DURECT shall have the right and responsibility for preparing, filing
and defending the NDA Amendment [ * * *].

(b)[ * * *] of Regulatory Filings.  Promptly following the receipt of NDA
Approval, DURECT [ * * *].  Following [ * * *] (the “Orange Book”).

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5.2Regulatory Cooperation. Until the receipt of NDA Approval, DURECT shall be
responsible for liaising with and managing all interactions with the FDA with
respect to Product for the Field in the Licensed Territory and shall be the
Responsible Party with respect thereto, [ * * *].

(a)Involvement of the Other Party.  To the extent relating to Product for the
Field in the Licensed Territory or activities under the Agreement, the Party
with regulatory responsibility hereunder (the “Responsible Party”) shall provide
the other Party (the “Other Party”) with:

(i)[ * * *]; and

(ii)[ * * *].

(b)Other Regulatory Matters.  [ * * *].

5.3Exchange of Data. [ * * *].  The Parties will cooperate and reasonably agree
upon formats and procedures to facilitate the orderly and efficient exchange of
Data.  [ * * *].

5.4Pharmacovigilance Agreement. The Parties shall enter into one or more safety
exchange or pharmacovigilance agreements (each, a “PV Agreement”) [ * * *] to
ensure compliance with safety reporting requirements of the FDA and other
regulatory authorities in the Retained Territory [ * * *].  The Parties
acknowledge that responsibility for pharmacovigilance with respect to the
Product in the Licensed Territory will [ * * *].  

Article 6
COMMERCIALIZATION

6.1Commercialization.

(a)Within the Licensed Territory.  SANDOZ shall have the exclusive right and
responsibility to Commercialize Product for the Field in the Licensed Territory,
and shall Commercialize Product for the Field in the Licensed Territory in
accordance with Applicable Law and the then-current Pre-Launch Plan and
Commercialization Plan.  In connection with the foregoing, [ * * *].

(b)Within the Retained Territory.  As between the Parties, DURECT shall have the
exclusive right to Commercialize Product in the Retained Territory.

(c)Pre-Launch Plan.  The plan for the Pre-Launch Commercialization of Product
for the Field in the Licensed Territory (as may be updated from time to time
pursuant to Section 6.1(e), the “Pre-Launch Plan”) shall be [ * * *] of the
Effective Date.  [ * * *].

(d)Commercialization Plan.  The plan for the Other Commercialization of Product
for the Field in the Licensed Territory (as may be updated from time to time
pursuant to Section 6.1(e), the “Commercialization Plan”) shall be [ * * *].

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

 

(e)Amendments/Reporting. [ * * *] any material updates to the proposed
activities under the Pre-Launch Plan and/or Commercialization Plan.  [ * * *]
reasonably informed as to its progress with respect to its activities under the
Pre-Launch Plan.

(f)Compliance with Government Pricing, Government Programs and State/Federal
Pricing Transparency Regulations.  SANDOZ shall be solely responsible for all
federal, state and local government purchasing, pricing or reimbursement
programs and private purchasing, pricing or reimbursement programs with respect
to the Products sold by SANDOZ for the Field in the Licensed Territory,
including taking all necessary and proper steps to execute agreements and file
other appropriate reports and other documents with regulatory agencies and
private entities necessary for coverage of the Products under state, federal or
other health care programs and to list the Products under such agreements. 
SANDOZ shall be responsible for categorizing the Products for the Field in the
Licensed Territory under federal, state and local government pricing or
reimbursement programs.  SANDOZ shall respond to all state and federal
regulations on pricing transparency.  DURECT will cooperate with SANDOZ by
providing [ * * *].

6.2Trademarks.

(a)Licensed Trademark.  DURECT hereby grants to SANDOZ a fully-paid, exclusive
license to use the Licensed Trademark for the Commercialization of Product for
the Field in the Licensed Territory in accordance with this Agreement.  During
the Term, DURECT shall not use (or license to a Third Party or Affiliate) the
Licensed Trademark in connection with any product other than Product.  SANDOZ
shall have the right to exercise such license through its Affiliates and
Sublicensees, provided that SANDOZ shall be responsible for the failure by its
Affiliates and Sublicensees to comply with the terms of this Agreement including
all relevant restrictions, limitations and obligations.  DURECT shall own all
right, title and interest in and to the Licensed Trademark and all goodwill from
the use of the Licensed Trademark shall vest in and inure to the benefit of
DURECT.

(b)Alternative Trademark.

(i)General.  In the event the FDA declines to approve the Licensed Trademark for
use in connection with the Commercialization of Product for the Field in the
Licensed Territory, [ * * *].  

(ii)License.  [ * * *].  

(c)DURECT Name.

(i)General.  [ * * *].

(ii)License.  Subject to the terms and conditions of this Agreement, [ * * *].

(d)Prosecution.  As between the Parties, [ * * *].

(e)Enforcement.  As between the Parties, [ * * *].

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

 

6.3Exclusive Negotiation Period. Subject to the terms and conditions of this
Agreement, beginning [ * * *] thereafter (the “Exclusive Negotiation Period”), [
* * *].

Article 7
SUPPLY

7.1Supply Agreement.

(a)Three-Way Supply Agreement.  Within [ * * *], the Parties shall use [ * * *]
to negotiate in good faith and execute a supply agreement (the “Three-Way Supply
Agreement”) between [ * * *].  Under the Three-Way Supply Agreement, [ * *
*].  The Parties acknowledge and agree that there is no guarantee or assurance
that the CMO will enter into any Three-Way Supply Agreement.

(b)Two-Way Supply Agreement.  If the Parties are unable to enter a Three-Way
Supply Agreement during the [ * * *] negotiation period (or such longer period
as the Parties may agree), then [ * * *] (the “Two-Way Supply Agreement”).  The
Two-Way Supply Agreement will be materially consistent with [ * * *].

(c) Other Supply Agreement.  [ * * *].  

7.2Quality Agreement. DURECT and SANDOZ shall execute a mutually acceptable
Quality Agreement between DURECT, SANDOZ and, as applicable, the CMO that
allocates roles and responsibilities to each with respect to quality control and
regulatory compliance with respect to the Manufacture and supply of Product (and
any Components thereof, including the Active Ingredient and [ * * *]) under the
Supply Agreement.

7.3Drug Master File. DURECT shall either: [ * * *].

Article 8
ECONOMIC TERMS

8.1Expenses. Except as otherwise expressly provided herein, [ * * *].

8.2Upfront Fee. In partial consideration of the rights granted to SANDOZ
hereunder, SANDOZ shall pay to DURECT an initial fee in the amount of Twenty
Million Dollars ($20,000,000) (“Upfront Fee”) payable on the Effective
Date.  Such Upfront Fee shall be non-refundable, and shall not be creditable
against any other amount due hereunder.

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

 

8.3Other Payments. SANDOZ shall make the other payments to DURECT as set forth
in the Financial Exhibit (Exhibit 1.20).

8.4Payment Method. All payments due under this Agreement shall be made by bank
wire transfer in immediately available funds to an account designated by the
payee Party.  All payments hereunder shall be made in the legal currency of the
United States of America, and all references to “$” or “Dollars” shall refer to
United States dollars.  Except as otherwise provided herein, all payments due to
either Party under this Agreement shall be due and payable within [ * * *] of
the receipt of invoice from the other Party.

8.5Acknowledgement. The Parties acknowledge that the economic terms and
conditions set forth herein were negotiated and agreed to and represent a fair
and equitable allocation of the value from the Product for the Field in the
Licensed Territory.  The Parties further acknowledge that there is considerable
value in the Licensed Technology (including the Licensed Know-How) that is
consistent with the economic terms and conditions herein.

8.6Taxes. [ * * *] will pay any and all taxes levied on account of any payments
made to it under this Agreement.  If any payment under this Agreement is subject
to withholding tax under applicable law, [ * * *] shall have the right to
withhold any and all such taxes, which taxes shall be paid to the appropriate
taxing authority for the account of [ * * *].  [ * * *] shall remit to [ * * *]
an amount net of such withholding taxes.  The Parties agree to cooperate to
minimize any withholding taxes (including providing each other with any
exemption certificates or other documentation establishing that no taxes are
due, or such taxes are due at a reduced rate).

Article 9
INTELLECTUAL PROPERTY

9.1Ownership of Inventions. As between the Parties, subject to the licenses and
other rights provided herein, all right, title and interest to inventions and
discoveries made by or on behalf of either Party in the course of conducting
activities under this Agreement [ * * *].

9.2Ownership of Data. As between the Parties, subject to the licenses and other
rights provided herein, all right, title and interest to Data developed or
generated in the course of performing the activities under the Agreement
(including under the Product Development Plan) shall be owned as follows: [ * *
*].  If either Party acquires or otherwise Controls any right, title or interest
in and to Data owned by the other Party pursuant to this Section 9.2, [ * *
*].  For clarity, as between the Parties, Data developed or generated with
respect to Product for the Retained Territory shall be solely owned by [ * * *].

9.3Prosecution of Licensed Patents. As between the Parties, [ * * *] shall
control the Prosecution of all Licensed Patents.  [ * * *] shall reasonably
cooperate with [ * * *] to permit and enable [ * * *] to Prosecute the Licensed
Patents.  [ * * *].

9.4Defense of Third Party Infringement Claims. If Product becomes the subject of
a Third Party’s claim or assertion of infringement of a Patent relating to the
manufacture, use, sale or offer for sale of Product for the Field in the
Licensed Territory, the Party first having notice of the

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

 

claim or assertion shall promptly notify the other Party, and the Parties [ * *
*].  Unless the Parties otherwise agree in writing [ * * *]. In any event, the
other Party shall reasonably assist the Defending Party and cooperate in any
such litigation [ * * *].

9.5Enforcement of Licensed Patents.

(a)Notice. [ * * *], such Party shall promptly notify the other Party.

(b)Patent Enforcement.  As between the Parties, [ * * *].

(c)Other Patent Litigation.  [ * * *].

(d)Cooperation.  The Party commencing, controlling or defending any action under
this Section 9.5 (the “Enforcing Party”) shall keep the other Party [ * * *] of
the progress of any such action, and such other Party shall have the right to
participate with counsel of its own choice [ * * *].  In any event, the other
Party shall [ * * *] with the Enforcing Party, [ * * *].  [ * * *] each
acknowledges and understands that such cooperation may include the retention,
collection and production of documents as reasonably requested by [ * * *]
(where [ * * *] is the Enforcing Party) or [ * * *] (where [ * * *] is the
Enforcing Party) [ * * *].  The Enforcing Party [ * * *]; provided, however, no
settlement shall be entered into without [ * * *].

(e)Recoveries.  Any recovery received as a result of any Enforcement Action to
enforce any Licensed Patent pursuant to this Section 9.5 shall be used first [ *
* *].

9.6Patent Marking. SANDOZ shall mark (or cause to be marked) Product marketed
and sold hereunder with appropriate Licensed Patent numbers or indicia at
DURECT’s request, [ * * *].

Article 10
CONFIDENTIALITY

10.1Confidentiality; Exceptions. Except to the extent expressly authorized by
this Agreement or otherwise agreed by the Parties in writing, the Parties agree
that the receiving Party shall keep confidential and shall not publish or
otherwise disclose or use for any purpose other than as provided for in this
Agreement any confidential or proprietary information or materials furnished to
it by the other Party pursuant to this Agreement (collectively, “Confidential
Information”).  Notwithstanding the foregoing, Confidential Information shall
not be deemed to include information or materials to the extent that it can be
established by written documentation by the receiving Party that such
information or material:

(a)was already known to or possessed by the receiving Party without any
obligation of confidentiality, at the time of its disclosure to the receiving
Party hereunder;

(b)was generally available to the public or otherwise part of the public domain
at the time of its disclosure to the receiving Party hereunder;

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

 

(c)became generally available to the public or otherwise part of the public
domain after its disclosure hereunder other than through any act or omission of
the receiving Party in breach of this Agreement;

(d)was independently developed by or for the receiving Party (including its
sublicensees, contractors, suppliers or clinical research organizations (CROs))
without use of or reference to the other Party’s Confidential Information as
demonstrated by documented evidence prepared by the receiving Party
contemporaneously with such independent development; or

(e)was disclosed to the receiving Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the disclosing Party
not to disclose such information to others.

10.2Authorized Use and Disclosure. Each Party may use and disclose Confidential
Information of the other Party as follows: (a) under appropriate confidentiality
provisions substantially equivalent to those in this Agreement in connection
with the performance of its obligations or exercise of rights granted to such
Party in this Agreement; (b) to the extent such disclosure is reasonably
necessary for the Prosecution of Patents (including applications therefor) in
accordance with this Agreement, complying with the terms of agreements with
Third Parties subject to appropriate confidentiality provisions consistent with
those in this Agreement, prosecuting or defending litigation, complying with
applicable governmental regulations, filing for, conducting preclinical or
clinical trials, obtaining and maintaining regulatory approvals (including NDA
Approval) for Product under this Agreement, or otherwise required by Applicable
Law, provided, however, that if a Party is required by Applicable Law to make
any such disclosure of the other Party’s Confidential Information it will,
except where impracticable for necessary disclosures (for example, in the event
of medical emergency), give reasonable advance notice to the other Party of such
disclosure requirement and, except to the extent inappropriate in the case of
patent applications, will use [ * * *] to secure confidential treatment of such
Confidential Information required to be disclosed; (c) in communication with
existing and potential contractors, suppliers, CROs, investors, acquirers,
consultants, advisors (including financial advisors, lawyers and accountants)
and others on a need to know basis, in each case, under appropriate
confidentiality provisions and a written agreement substantially equivalent to
those of this Agreement; or (d) to the extent mutually agreed to by the Parties
in writing.

10.3Prior Agreements. This Agreement supersedes the Confidentiality Agreement
between DURECT and SANDOZ dated [ * * *] (the “Prior CDA”) with respect to
information disclosed thereunder.  All information or materials disclosed or
provided by DURECT to SANDOZ under the Prior CDA shall be deemed Confidential
Information of DURECT (subject to the exceptions set forth herein) and shall be
subject to SANDOZ’s confidentiality obligations under this Article 10.  All
information disclosed by SANDOZ under the Prior CDA shall be deemed Confidential
Information of SANDOZ (subject to the exceptions set forth herein) and shall be
subject to DURECT’s confidentiality obligations under this Article 10.

10.4Technical Publications. Each Party shall submit to the other Party any
proposed publication or public disclosure containing clinical or scientific
results relating to Product for the Field at least [ * * *] in advance to allow
that Party to review such proposed publication or

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

 

disclosure.  The reviewing Party shall notify the requesting Party in writing
during such [ * * *] reviewing period if the reviewing Party wishes to
(a) remove its Confidential Information from such proposed publication or
presentation, in which event the requesting Party shall remove such Confidential
Information from its proposed publication or presentation; or (b) request a
reasonable delay in publication or presentation in order to protect patentable
subject matter, in which event the requesting Party shall delay the publication
or presentation for a period of no more than [ * * *] to enable patent
applications to be filed in accordance with Section 9.3 protecting inventions
disclosed in such publication or presentation.  For clarity, if the reviewing
Party fails to notify the requesting Party during the [ * * *] reviewing period
as provided under this Section 10.4, the requesting Party shall be free to
proceed with the proposed publication or presentation.  Notwithstanding the
foregoing, if [ * * *] is the reviewing party hereunder, [ * * *] shall have the
right to reject (and in such case, [ * * *] shall not publish, publicly disclose
or present) any such proposed publication, public disclosure or presentation
proposed by [ * * *] that: (i) contains information inconsistent with [ * * *]
commercial strategy for the Product for the Field in the Licensed Territory, or
(ii) [ * * *] reasonably believes may violate Applicable Law.

10.5Publicity.

(a)Confidential Terms.  Each Party agrees not to disclose to any Third Party the
terms and conditions of this Agreement without the prior approval of the other
Party, except to advisors (including consultants, financial advisors, attorneys
and accountants), potential and existing investors and acquirers, and others
(including in the case of DURECT, potential and actual licensees under the
Licensed Technology and in the case of SANDOZ, its potential and actual
Sublicensees) on a need to know basis (which means in the case of DURECT’s
potential and actual licensees of the Licensed Technology with redaction of the
financial obligations of SANDOZ), in each case under circumstances that
reasonably protect the confidentiality thereof, or to the extent necessary to
comply with the terms of agreements with Third Parties, or to the extent
required by Applicable Law, including securities laws.  Notwithstanding the
foregoing, each Party may issue a mutually agreed press release to announce the
execution of this Agreement, which is attached hereto as Exhibit 10.5(a);
thereafter, DURECT and SANDOZ may each disclose to Third Parties the information
contained in such press release without the need for further approval by the
other.

(b)Publicity and Public Disclosure Review.  The Parties acknowledge (i) the
importance of supporting each other’s efforts to publicly disclose results and
significant developments regarding Product for the Field and other activities in
connection with this Agreement, and (ii) disclosures may be required by
Applicable Law, and each Party may make such disclosures from time to time with
the written approval of the other Party, which approval shall not be
unreasonably withheld, conditioned or delayed.  Such disclosures may include
achievement of significant events in the development (including regulatory
process and occurrence of Development Milestone Events) or Commercialization of
Product for the Field hereunder.  Unless otherwise requested by DURECT, SANDOZ
shall indicate that DURECT is the owner and licensor of the Licensed Technology
in each public disclosure issued by SANDOZ regarding Product.  When a Party
elects to make any such public disclosure under this Section 10.5(b), it will
give the other Party reasonable notice to review and comment on such statement,
it being understood that if the reviewing Party does not notify the requesting
Party in writing within a [ * * *], and in any event the reviewing Party shall
work [ * * *] to agree on the text of any proposed disclosure in an expeditious

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

 

manner.  The principles to be observed in such disclosures shall be accuracy,
compliance with Applicable Law and regulatory guidance documents, reasonable
sensitivity to potential negative reactions of applicable Regulatory Authorities
and the need to keep investors and others informed regarding the requesting
Party’s business.  Accordingly, the reviewing Party shall not withhold,
condition or delay its approval of a proposed disclosure that complies with such
principles.

Article 11
REPRESENTATIONS AND WARRANTIES; INDEMNIFICATION

11.1General Representations and Warranties. Each Party represents and warrants
to the other Party that as of the Execution Date and the Effective Date:

(a)it is duly organized and validly existing under Applicable Law of the
jurisdiction of its incorporation, and has full corporate power and authority to
enter into this Agreement and to carry out the provisions hereof;

(b)it is duly authorized to execute and deliver this Agreement and to perform
its obligations hereunder, and the person executing this Agreement on its behalf
has been duly authorized to do so by all requisite corporate action;

(c)this Agreement is legally binding upon it and enforceable in accordance with
its terms.  The execution, delivery and performance of this Agreement by it does
not conflict with any agreement, instrument or understanding, oral or written,
to which it is a party or by which it may be bound;

(d)it has not granted, and shall not grant during the Term, any right to any
Third Party which would conflict with the rights granted to the other Party
hereunder; and

(e)it is not aware of any action, suit or inquiry or investigation instituted by
any Person which questions or threatens the validity of this Agreement.  

(f)it shall, at all times during the Term, comply with all Applicable Laws
relating to the Development, Manufacture and Commercialization of the Product.

11.2DURECT’s Warranties. DURECT represents and warrants to SANDOZ that as of the
Execution Date and the Effective Date:

(a)[ * * *].

(b)[ * * *].

(c)[ * * *].

(d)[ * * *].

(e)[ * * *].

(f)[ * * *].

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

 

(g)[ * * *].

(h)[ * * *].

(i)[ * * *].

11.3Disclaimer of Warranties. EXCEPT AS SET FORTH IN THIS ARTICLE 11 AND THE
EXPRESS WARRANTIES OF ANY OTHER TRANSACTION AGREEMENT (ONCE EXECUTED), DURECT
AND SANDOZ EXPRESSLY DISCLAIM ANY WARRANTIES OR CONDITIONS, EXPRESS, IMPLIED,
STATUTORY OR OTHERWISE, WITH RESPECT TO THE SUBJECT MATTER OF THIS AGREEMENT
(INCLUDING THE PRODUCT AND LICENSED TECHNOLOGY), INCLUDING ANY WARRANTY OF
MERCHANTABILITY, NONINFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

11.4Indemnification.

(a)Indemnification by DURECT.  DURECT hereby agrees to defend, hold harmless and
indemnify (collectively, “Indemnify”) SANDOZ and its Affiliates, and its and
their agents, directors, officers and employees (the “SANDOZ Indemnitees”) from
and against any liability or expense (including reasonable legal expenses and
attorneys’ fees) (collectively, “Losses”) resulting from suits, claims, actions
and demands, in each case brought by a Third Party (each, a “Third-Party Claim”)
against any SANDOZ Indemnitee arising out of [ * * *].  DURECT’s obligation to
Indemnify the SANDOZ Indemnitees pursuant to this Section 11.4(a) shall not
apply to the extent that any such Losses (i) arise from any breach by SANDOZ of
this Agreement, (ii) arise from the gross negligence or intentional misconduct
of any SANDOZ Indemnitee, or (iii) are Losses for which SANDOZ is obligated to
Indemnify the DURECT Indemnitees pursuant to Section 11.4(b).

(b)Indemnification by SANDOZ.  SANDOZ hereby agrees to Indemnify DURECT and its
Affiliates, and its and their agents, directors, officers and employees (the
“DURECT Indemnitees”) from and against any and all Losses resulting from
Third-Party Claims against any DURECT Indemnitees arising out of: [ * *
*].  SANDOZ’s obligation to Indemnify the DURECT Indemnitees pursuant to this
Section 11.4(b) shall not apply to the extent that any such Losses (i) arise
from any breach by DURECT of this Agreement, (ii) arise from the gross
negligence or intentional misconduct of any DURECT Indemnitee, or (iii) are
Losses for which DURECT is obligated to Indemnify the SANDOZ Indemnitees
pursuant to Section 11.4(a).

(c)Procedure.  To be eligible to be Indemnified hereunder, the indemnified Party
shall provide the indemnifying Party with prompt notice of the Third-Party Claim
giving rise to the indemnification obligation pursuant to this Section 11.4 and
the exclusive ability to defend (with the reasonable cooperation of the
indemnified Party).  The indemnifying Party shall have the right to settle or
compromise any Third-Party Claim against the indemnified Party without the
consent of the indemnified Party provided that the terms thereof: [ * * *].  In
all other cases, the Indemnitee and Indemnitor must agree to enter into any
proposed settlement.  The indemnified Party shall have the right to participate,
[ * * *], in the defense of any claim or suit that has been assumed by the
indemnifying Party, provided that the indemnifying Party shall have no
obligations with respect to

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

 

any Losses resulting from the indemnified Party’s admission, settlement or other
communication without the prior written consent of the indemnifying Party.

11.5Insurance. Each Party shall obtain and maintain, during the Term and for [ *
* *] thereafter, reasonable insurance with financially stable and reputable
insurers, including, but not limited to, commercial general liability insurance,
and products/completed operations liability insurance.  Such insurance shall be
maintained at limits consistent with industry standards based upon such Party’s
activities hereunder and indemnification obligations hereunder.  Each Party
shall furnish to the other Party on request evidence of its liability insurance
setting forth the limits of the liability insurance maintained.  The limits of
insurance coverage will not affect or limit the liability or indemnity
obligations of either Party stated elsewhere in this Agreement or as required by
law.

11.6Limitation of Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT OR
OTHERWISE, OTHER THAN BY REASON OF A BREACH OF ARTICLE 10 ABOVE, TO THE MAXIMUM
EXTENT PERMITTED BY APPLICABLE LAW, NEITHER PARTY SHALL BE LIABLE TO THE OTHER
WITH RESPECT TO ANY SUBJECT MATTER OF THIS AGREEMENT (WHETHER UNDER ANY
CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY) FOR
ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY, INCIDENTAL OR PUNITIVE DAMAGES,
REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.  NOTWITHSTANDING
THE FOREGOING, NOTHING IN THIS SECTION 11.6 IS INTENDED TO OR SHALL LIMIT OR
RESTRICT THE INDEMNIFICATION OBLIGATIONS OF EITHER PARTY UNDER SECTION 11.4
ABOVE TO THE EXTENT A THIRD PARTY RECOVERS ANY SPECIAL, CONSEQUENTIAL,
EXEMPLARY, INCIDENTAL OR PUNITIVE DAMAGES FROM AN INDEMNITEE.

Article 12
TERM AND TERMINATION

12.1Term. Except for the provisions of Article 10 and 13 and Sections 11.5,
11.6, 12.1, 12.2, 14.1-14.8, 14.10 and 14.12-14.13, which shall be effective
from the Execution Date, this Agreement shall become effective as of the
Effective Date and, unless earlier terminated pursuant to the other provisions
of this Article 12, shall continue in full force and effect until [ * * *] (the
“Initial Term”).  After the Initial Term, this Agreement shall automatically
renew for additional successive [ * * *] periods (such periods collectively, the
“Renewal Term”, and together with the Initial Term, the “Term”) unless either
Party provides written notice of non-renewal to the other Party at least [ * *
*] prior to the expiration of the then-current Term, in which event this
Agreement shall expire on the [ * * *] of the then-current Term.  Upon such
expiration, subject to Section 12.5(d), the licenses granted to SANDOZ in
Sections 3.1(a) and 6.2(a) shall become [ * * *].

12.2Termination for Failure to Obtain HSR Clearance. If the HSR Clearance Date
has not occurred on or before [ * * *] after the Execution Date, then either
Party shall have the right to terminate this Agreement in its entirety [ * * *]
referencing this Section 12.2, and except for Articles 10 [ * * *] and 13, none
of the provisions of this Agreement shall remain in effect after such
termination.  For clarity, it is understood that if the HSR Clearance Date
occurs prior to termination

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

 

of the Agreement pursuant to this Section 12.2, this Agreement shall become
effective in its entirety without further action on either Party.

12.3Termination by SANDOZ.

(a)Termination for Convenience.  From and after the HSR Clearance, SANDOZ shall
have the right to terminate this Agreement for convenience upon [ * * *] prior
written notice to DURECT referencing this Section 12.3(a).  

(b)[ * * *].

(c)Termination for Material Breach.  In the event [ * * *] materially breaches
this Agreement, and such breach shall have continued for [ * * *] after notice
thereof was provided to [ * * *] will have the right to terminate this Agreement
[ * * *] to [ * * *] referencing this Section 12.3(c).

(d)Bankruptcy.  To the extent permitted under Applicable Law, SANDOZ may
terminate this Agreement [ * * *] if the DURECT shall file for bankruptcy, shall
be adjudicated bankrupt, shall file a petition under insolvency laws, shall be
dissolved or shall have a receiver appointed for substantially all of its
property.  All rights and licenses granted under or pursuant to any Section of
this Agreement are, and shall otherwise be deemed to be, for purposes of Section
365(n) of the Bankruptcy Code, licenses of rights to “intellectual property” as
defined under Section 101(35A) of the Bankruptcy Code.  SANDOZ shall retain and
may fully exercise all of their respective rights and elections under the
Bankruptcy Code.  [ * * *].

12.4Termination by DURECT.

(a)Termination for Patent Challenge.  If SANDOZ or any of its Affiliates or
Sublicensees challenges under any court action or proceeding, or before the
USPTO, the validity, patentability, enforceability, scope or non-infringement of
any Licensed Patent, or initiates a reexamination of any Licensed Patent, or
assists any Third Party to conduct any of the foregoing activities (each, a
“Challenge”), DURECT will have the right to terminate this Agreement [ * *
*].  In any event, SANDOZ shall notify DURECT at least thirty (30) days prior to
initiating any such Challenge.

(b)Termination for Material Breach.  In the event SANDOZ materially breaches
this Agreement, and such breach shall have continued for [ * * *] was provided
to SANDOZ, DURECT will have the right to terminate this Agreement [ * * *] to
SANDOZ referencing this Section 12.4(b).  

12.5Effects of Expiration or Certain Types of Termination. Upon termination
under Sections 12.2(a) (SANDOZ Convenience), 12.2(b) [ * * *], 12.3(c) (DURECT
Material Breach) (except for certain willful breaches as provided in Section
12.6), 12.3(d) (Bankruptcy), 12.3(a) [ * * *] or 12.3(b) (SANDOZ Material
Breach) or upon expiration:

(a)[ * * *].

(b)[ * * *].

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

 

(c)[ * * *].

(d)[ * * *].

(e)Other Obligations.  

(i)SANDOZ shall or shall cause its Affiliates and Sublicensees, if any, to
assign or transfer to DURECT, [ * * *], all Regulatory Documentation, Regulatory
Approvals, including the NDA and Know-How, Controlled by SANDOZ or its
Affiliates and Sublicensees, if any, necessary for the development,
manufacturing, use or sale of the Product (following the NDA Approval);

(ii)If applicable, SANDOZ shall continue during the notice period before
termination becomes effective (or if reasonably practicable and agreed to by
SANDOZ at such time, allow DURECT or DURECT’s clinical research organizations
(CROs) to continue) any ongoing clinical trial (following NDA Approval) for
which SANDOZ has responsibility and in which patient dosing has commenced; and

(iii)SANDOZ will cooperate in any reasonable manner requested by DURECT to
achieve a smooth transition of the development, supply and Commercialization of
the Product to DURECT or its licensees in the Licensed Territory.

12.6Effects of Termination for Certain Willful DURECT Breaches. Upon termination
by SANDOZ under Section 12.3(c) (DURECT Material Breach) for any willful breach
by DURECT of its obligations hereunder [ * * *].  In addition, [ * * *].

12.7General Effects of Expiration or Termination.

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

(b)Non-Exclusive Remedy.  Notwithstanding anything herein to the contrary,
termination of this Agreement by a Party shall be without prejudice to other
remedies such Party may have at law or equity.

(c)Cross-Termination.  Except as may be expressly provided in any other
Transaction Agreement, upon the effective date of termination of this Agreement,
each other Transaction Agreement shall terminate.

(d)General Survival. Articles 1, 10 ([ * * *]) and 13 and Sections 3.2, 6.2(a)
(solely with respect to the last sentence), 9.1, 9.2, 11.3, 11.4, 11.5 ([ * *
*]), 11.6, 12.5 (with respect to Section 12.5(d), [ * * *]), 12.6, 12.7,
14.1-14.8 and 14.12 shall survive expiration or termination of this Agreement
for any reason.  Except as otherwise provided in this Article 12, all rights and
obligations of the Parties under this Agreement shall terminate upon expiration
or termination of this Agreement for any reason.

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12.8Termination Press Releases. In the event of termination of this Agreement
for any reason, the Parties shall cooperate in good faith to coordinate public
disclosure of such termination and the reasons therefor, and shall not, except
to the extent required by Applicable Law, disclose such information without the
prior approval of the other Party, such approval not to be unreasonably
withheld, conditioned or delayed.  To the extent possible under the situation,
the terminating Party shall provide the non-terminating Party with a draft of
any such public disclosure it intends to issue [ * * *] in advance and with the
opportunity to review and comment on such statement, it being understood that if
the non-terminating Party does not notify the terminating Party in writing
within such [ * * *] (or such shorter period if required by Applicable Law) of
any reasonable objections, such disclosure shall be deemed approved, and in any
event the Parties shall [ * * *] to agree on the text of any such proposed
disclosure in an expeditious manner.  The principles to be observed in such
disclosures shall be accuracy, compliance with Applicable Law and regulatory
guidance documents, reasonable sensitivity to potential negative reactions to
such news and the need to keep investors and others informed regarding the
Parties’ business and other activities.  Accordingly in such situation, the
non-terminating Party shall not withhold, condition or delay its approval of a
proposed disclosure that complies with such principles.

Article 13
DISPUTE RESOLUTION

13.1Dispute Resolution. The Parties agree that any disputes arising out of or in
connection with this Agreement (each, a “Dispute”), shall be resolved through
the procedures set forth in this Article 13.

13.2Initial Escalation. With respect to all Disputes, if the Parties are unable
to resolve any such Dispute within [ * * *] after such Dispute is first
identified by either Party in writing to the other, either Party shall have the
right to refer such Dispute to the senior executives for attempted resolution by
written notice to the other Party referencing the particular Dispute and this
Section 13.2.  In such case, the senior executives shall conduct good faith
negotiations and seek to resolve the Dispute within [ * * *] after such notice
is received.  If the senior executives resolve such Dispute, a memorandum
setting forth their agreement to resolve the Dispute will be prepared and signed
by both Parties if requested by either Party.  In all events, the Parties shall
cooperate in an effort to limit the issues for consideration in such manner as
narrowly as reasonably practicable in order to resolve the Dispute.

13.3Binding Arbitration. If a Dispute is not resolved by negotiation pursuant to
Section 13.2, such Dispute shall be finally settled under the Rules of
Arbitration of the International Chamber of Commerce by [ * * *] arbitrators
appointed in accordance with the rules.  In each case, the arbitrators shall be
neutral and independent individuals.  The arbitrators shall have no authority to
award punitive or any other type of damages not measured by a Party’s
compensatory damages, except as allowed under Section 11.6.  [ * * *].  Except
to the extent necessary to confirm an award or in seeking interim relief under
Section 13.4, or as may be required by Applicable Law, and subject to
Article 10, neither Party nor any arbitrator may disclose the existence,
content, or results of an arbitration without the prior written consent of both
Parties.  The legal place of arbitration shall be [ * * *].  The language of the
arbitration shall be English.

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13.4Interim Relief. Either Party may seek in a court of competent jurisdiction
or as part of the arbitration proceedings, immediate injunctive or other
provisional relief as necessary to enforce the terms of this Agreement.  The
Parties hereto acknowledge and agree that any breach of the terms of this
Agreement could give rise to irreparable harm for which money damages would not
be an adequate remedy and accordingly the parties agree that, in addition to any
other remedies, each party shall be entitled to obtain preliminary or injunctive
relief and to enforce the terms of this Agreement by a decree of specific
performance without payment of a bond or surety.  Any request to a court of
competent jurisdiction for relief as set forth in this paragraph shall not be
deemed incompatible with the agreement to arbitrate or a waiver of the right to
arbitrate. 

Article 14
MISCELLANEOUS

14.1Governing Law. This Agreement and any Dispute shall be governed by and
construed and enforced in accordance with the substantive laws of the [ * * *],
without reference to conflicts of laws principles.

14.2Assignment. This Agreement shall not be assignable by either Party to any
Third Party without the written consent of the other Party.  Notwithstanding the
foregoing, either Party may assign this Agreement, without the written consent
of the other Party, to an Affiliate of such Party or an entity that acquires all
or substantially all of the business or assets of such Party to which this
Agreement pertains (whether by merger, reorganization, acquisition, sale,
operation of law or otherwise).  No assignment or transfer of this Agreement
shall be valid and effective unless and until the assignee/transferee agrees in
writing to be bound by the provisions of this Agreement.  The terms and
conditions of this Agreement shall be binding on and inure to the benefit of the
permitted successors and assigns of either Party.  Except as expressly provided
in this Section 14.2, any attempted assignment or transfer of this Agreement
shall be null and void.

14.3Consequences of Bankruptcy. The Parties acknowledge and agree that all
rights and licenses now or hereafter granted under or pursuant to any Section of
this Agreement are rights to “intellectual property” as defined in
Section 101(35A) of Title 11 of the United States Code.  Each Party may elect to
retain and may fully exercise all of its rights and elections under
Section 365(n) of Title 11 of the United States Code.  

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14.4Notices. Any notice, request, delivery, approval or consent required or
permitted to be given under this Agreement shall be in writing and shall be
deemed to have been sufficiently given if delivered in person, transmitted by
facsimile (receipt verified) or by express courier service (signature required)
or [ * * *] after it was sent by registered letter, return receipt requested (or
its equivalent), provided that no postal strike or other disruption is then in
effect or comes into effect within [ * * *] after such mailing, to the Party to
which it is directed at its address or facsimile number shown below or such
other address or facsimile number as such Party will have last given by notice
to the other Party.

If to DURECT, addressed to:

Durect Corporation

10260 Bubb Road

Cupertino, CA 95014

United States

Attention: Legal Department

Telephone: (408) 777-3577

Facsimile: (408) 777-1417

 

With a copy to:

Wilson Sonsini Goodrich & Rosati, P.C.

650 Page Mill Road

Palo Alto, CA  94304-1050

United States

Attention: Ian B. Edvalson, Esq.

Telephone: (650) 493-9300

Facsimile:  (650) 493-6811

If to SANDOZ, addressed to:

Sandoz AG
Lichtstraβe 35
CH 4056 Basel, Switzerland
Attn:  Autorized Signatory

With a copy to:

Sandoz Inc.
100 College Road West
Princeton, NJ 08540

Attn: General Counsel

14.5Waiver. Neither Party may waive or release any of its rights or interests in
this Agreement except in writing.  The failure of either Party to assert a right
hereunder or to insist upon compliance with any term or condition of this
Agreement shall not constitute a waiver of that right or excuse a similar
subsequent failure to perform any such term or condition.  No waiver by either

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Party of any condition or term in any one or more instances shall be construed
as a continuing waiver of such condition or term or of another condition or
term.

14.6Severability. If any provision hereof should be held invalid, illegal or
unenforceable in any jurisdiction, the Parties shall negotiate in good faith a
valid, legal and enforceable substitute provision that most nearly reflects the
original intent of the Parties and all other provisions hereof shall remain in
full force and effect in such jurisdiction and shall be liberally construed in
order to carry out the intentions of the Parties as nearly as may be
possible.  Such invalidity, illegality or unenforceability shall not affect the
validity, legality or enforceability of such provision in any other
jurisdiction.

14.7Entire Agreement/Modification. This Agreement, including its Exhibits, and
the other Transaction Agreements (once executed) sets forth all the covenants,
promises, agreements, warranties, representations, conditions and understandings
between the Parties and supersedes and terminates all prior agreements and
understandings between the Parties including the Prior CDA and the non-binding
term sheet between the Parties dated [ * * *].  No subsequent alteration,
amendment, change or addition to this Agreement shall be binding upon the
Parties unless reduced to writing and signed by the respective authorized
officers of the Parties.

14.8Relationship of the Parties. The Parties agree that the relationship of
DURECT and SANDOZ established by this Agreement is that of independent
contractors.  Furthermore, the Parties agree that this Agreement does not, is
not intended to, and shall not be construed to, establish an employment, agency
or any other relationship.  Except as may be specifically provided herein,
neither Party shall have any right, power or authority, nor shall they represent
themselves as having any authority to assume, create or incur any expense,
liability or obligation, express or implied, on behalf of the other Party, or
otherwise act as an agent for the other Party for any purpose.

14.9Force Majeure. Except with respect to payment of money, neither Party shall
be liable to the other for failure or delay in the performance of any of its
obligations under this Agreement for the time and to the extent such failure or
delay is caused by earthquake, riot, civil commotion, war, terrorist acts,
strike, flood, or other cause that is beyond the reasonable control of the
respective Party.  The Party affected by such force majeure will provide the
other Party with full particulars thereof as soon as it becomes aware of the
same (including its best estimate of the likely extent and duration of the
interference with its activities), and will use [ * * *] to overcome the
difficulties created thereby and to resume performance of its obligations as
soon as practicable.

14.10Compliance with Applicable Law. Notwithstanding anything to the contrary
herein, all rights and obligations of DURECT and SANDOZ are subject to prior
compliance with, and each Party shall comply with, Applicable Law, including
obtaining all necessary approvals required by the applicable agencies of the
United States government.

14.11Anti-Bribery Compliance. [ * * *] shall use [ * * *] to: (a) train any
representative who is involved with the performance of obligations under this
Agreement on applicable anti-corruption and anti-bribery laws and standards [ *
* *]; and (b) [ * * *].  DURECT acknowledges that it is not authorized to and
agrees that it shall not interact directly with government agencies, entities or
authorities on behalf of SANDOZ without the prior written authorization of
SANDOZ.

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request. Omissions are designated as ***. A complete version of this exhibit has
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14.12Counterparts. This Agreement may be executed in two (2) counterparts, each
of which shall be deemed an original, and all of which together, shall
constitute one and the same instrument.

14.13HSR Act Filing. Each Party shall, promptly as practicable but not more than
[ * * *] after the Execution Date, file or cause to be filed with the U.S.
Federal Trade Commission and the U.S. Department of Justice a Notification and
Report Form (as defined in the HSR Act) with respect to the transactions
contemplated hereby, which forms shall specifically request early termination of
the waiting period prescribed by the HSR Act.  Each Party shall use its [ * * *]
to respond promptly to any requests for additional information made by either of
such agencies, and to cause the waiting periods under the HSR Act to terminate
or expire at the earliest possible date after the date of filing.  Each Party
shall instruct its counsel to cooperate with the other Party’s counsel to
facilitate and expedite the identification and resolution of any such issues
and, consequently, the expiration of the applicable HSR Act waiting period at
the earliest practicable date.  Each Party shall use its [ * * *] to ensure that
its representations and warranties set forth in this Agreement remain true and
correct at and as of the Effective Date as if such representations and
warranties were made at and as of the Effective Date.  Each Party shall be
responsible for [ * * *] in connection with such filing, except that [ * *
*].  From the Execution Date until the Effective Date (or earlier termination of
this Agreement), DURECT covenants to conduct its business with respect to the
Product only in the ordinary course of business and in a manner consistent in
nature, scope and magnitude with past practices. 

[The remainder of this page intentionally left blank; signature page follows]

 

 

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IN WITNESS WHEREOF, the Parties have caused their duly authorized
representatives to execute this Agreement as of the Execution Date.

 

DURECT CORPORATION

 

SANDOZ AG

 

 

 

By:

 

/s/ JAMES E. BROWN

 

By:

 

/s/ GEORG BLADER

 

 

 

 

 

 

 

Name:

 

James E. Brown

 

Name:

 

Georg Blader

 

 

 

 

 

 

 

Title:

 

President and CEO

 

Title:

 

Chief Financial Offer Sandoz AG

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SANDOZ AG

 

 

 

 

 

 

 

 

 

By:

 

/s/ ANDREAS EGGMANN

 

 

 

 

 

 

 

 

 

 

 

Name:

 

Andreas Eggmann

 

 

 

 

 

 

 

 

 

 

 

Title:

 

Head, Sandoz AG

 

List of Exhibits:

 

 

 

 

Exhibit 1.20:

 

Financial Exhibit

 

Exhibit 1.24:

 

Licensed Patents

 

Exhibit 1.27:

 

Licensed Trademark

 

Exhibit 1.42:

 

Product

 

Exhibit 4.1:

 

Product Development Plan

 

Exhibit 10.5(a):

 

Press Release

 

Exhibit 11.2(d):

 

Material Contracts

 

 

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EXHIBIT 1.20
FINANCIAL EXHIBIT

 

[ * * *]

 

 

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EXHIBIT 1.24
DURECT PATENTS

 

[ * * *]

 

 

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EXHIBIT 1.27

LICENSED TRADEMARK

 

[ * * *]

 

 

 

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EXHIBIT 1.42
PRODUCT

 

•

DURECT’s formulated product for use in the Field currently known as
SABER®-Bupivacaine or POSIMIR® as of the Execution Date.

 

 

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EXHIBIT 4.1
PRODUCT DEVELOPMENT PLAN

 

[ * * *]

 

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EXHIBIT 10.5(a)

PRESS RELEASE

 

 

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DURECT and Sandoz have Signed a $293 Million Development and Commercialization
Agreement for POSIMIR® (SABER®-Bupivacaine) Covering the United States

Cupertino, CA, May [__], 2017/ PRNewswire / -- DURECT Corporation (Nasdaq: DRRX)
announced today a development and commercialization agreement with Sandoz AG, a
division of Novartis (NYSE: NVS) to develop and market in the United States
DURECT’s POSIMIR® (SABER®-bupivacaine), an investigational locally-acting,
non-opioid analgesic intended to provide up to three days of continuous pain
relief after surgery.

Sandoz is a global leader in driving sustainable access to high-quality
healthcare.  Sandoz's differentiated product portfolio includes a range of
state-of-the-art technologies, formulations and devices.  In the U.S., Sandoz
Inc. has a dedicated hospital sales and marketing organization, with expertise
and relationships, which will deliver POSIMIR to the market, along with a strong
record of commercializing innovative and differentiated products that serve
unmet medical needs.

“We are delighted to have a company with the market presence and resources of
Sandoz as our commercialization partner for POSIMIR in the United States,”
stated James E. Brown, President and CEO of DURECT Corporation.  “We believe
that POSIMIR has the potential to become a cornerstone of multi-modal
post-operative pain management.  As a non-opioid local analgesic, we believe
POSIMIR may be an important contributor to the on-going efforts to reduce the
use of opioid-based medications following surgery.”

Under the terms of the agreement, Sandoz will make an upfront payment to DURECT
of $20 million, with the potential for up to an additional $43 million in
development and regulatory milestones, up to an additional $230 million in sales
based milestones, as well as a tiered double digit royalty on product sales in
the United States.   DURECT will remain responsible for the completion of the
ongoing PERSIST Phase 3 clinical trial for POSIMIR as well as FDA interactions
through approval. Closing of the transaction is anticipated to occur in the
second quarter of 2017 and is contingent on completion of review under the
Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976.  

About POSIMIR® (SABER-Bupivacaine)

POSIMIR is an investigational extended-release depot utilizing DURECT’s patented
SABER technology intended to continuously deliver bupivacaine to the surgical
site for 72 hours, to provide up to three days of continuous pain relief after
surgery.  DURECT is currently conducting PERSIST, a Phase 3 trial in patients
undergoing laparoscopic cholecystectomy (gall bladder removal), comparing the
effects of POSIMIR to bupivacaine HCl.  DURECT expects to complete dosing
patients in PERSIST in the third quarter of 2017 and to have top-line results
soon thereafter.  POSIMIR is a drug candidate under development and has not been
approved for commercialization by the U.S. Food and Drug Administration or other
health authorities.    

About DURECT

DURECT is a biopharmaceutical company actively developing new therapeutics based
on its Epigenetic Regulator Program and proprietary drug delivery
platforms.  DUR‑928, a new chemical

 

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entity in Phase 1 development, is the lead candidate in DURECT’s Epigenetic
Regulator Program.  An endogenous, orally bioavailable small molecule, DUR-928
has been shown in preclinical studies to play an important regulatory role in
lipid homeostasis, inflammation, and cell survival.  Human applications may
include acute organ injury and chronic metabolic diseases such as nonalcoholic
fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and other liver
diseases both broad and orphan.  DURECT’s advanced oral, injectable, and
transdermal delivery technologies are designed to enable new indications and
enhanced attributes for small-molecule and biologic drugs. One late-stage
product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an
investigational locally-acting, non-opioid analgesic intended to provide up to
three days of continuous pain relief after surgery.  Another late stage product
candidate is REMOXY® ER (oxycodone), an investigational pain control drug based
on DURECT’s ORADUR® technology.  For more information, please visit
www.durect.com.

NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other
referenced trademarks belong to their respective owners.  POSIMIR, DUR-928, and
REMOXY ER are drug candidates under development and have not been approved for
commercialization by the U.S. Food and Drug Administration or other health
authorities.

 

DURECT Forward-Looking Statement

 

The statements in this press release regarding the potential benefits and uses
of our drug candidates, including the potential use of POSIMIR to treat
post-surgical pain, the anticipated timing of the enrollment of the PERSIST
trial and the obtaining of top-line results from that trial, the potential
milestone payments and royalties receivable from Sandoz, the potential use of
DUR-928 to treat NASH, other liver diseases or acute organ injury,  and
potential markets for POSIMIR and DUR-928, are forward-looking statements
involving risks and uncertainties that can cause actual results to differ
materially from those in such forward-looking statements. Potential risks and
uncertainties include, but are not limited to, the risks that the PERSIST
clinical trial of POSIMIR will take longer to conduct than anticipated or result
in data that will not support a successful NDA resubmission or product approval,
failure to achieve the performance milestones or commercial sales that trigger
the referenced payments or royalties, possible adverse events associated with
the use of POSIMIR, delays and costs due to additional work or other
requirements imposed by regulatory agencies for continued development, approval
or sale of POSIMIR, our ability to manufacture, commercialize and obtain
marketplace acceptance of POSIMIR, and avoid infringing patents held by other
parties and secure and defend patents of our own, and risks related to our
ability to obtain capital to fund operations and expenses. Further information
regarding these and other risks is included in DURECT's Form 10-K filed on March
29, 2017 under the heading “Risk Factors.”

 

SOURCE:

DURECT Corporation

 

CONTACTS:

Matt Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936

Matthew Duffy, Managing Director, LifeSci Advisors, 212-915-0685

 

 

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

 

EXHIBIT 11.2(d)

MATERIAL CONTRACTS

 

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