Exhibit 10.1

CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Execution Copy

LICENSE AGREEMENT

BY AND AMONG

COWEN HEALTHCARE ROYALTY PARTNERS, L.P.

AND

SHORE THERAPEUTICS, INC.

AND

SANTARUS, INC.

DATED

DECEMBER 21, 2011

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TABLE OF CONTENTS

 

         

Page

ARTICLE 1. Definitions

   1

1.1

   “Adverse Event”    1

1.2

   “Additional Product”    1

1.3

   “Affiliate”    2

1.4

   “API Supply Agreement”    2

1.5

   “Applicable Law”    2

1.6

   “Assigned Sections”    2

1.7

   “Assumed Product Agreements”    2

1.8

   “Authorized Generic”    2

1.9

   “Authorized Generic Revenues”    3

1.10

   “Calendar Quarter”    3

1.11

   “Calendar Year”    3

1.12

   “CHRP Shore Agreement”    3

1.13

   “Commercial Supply Agreement”    3

1.14

   “Commercialize”    3

1.15

   “Commercially Reasonable Efforts”    3

1.16

   “Compound”    3

1.17

   “Confidential Information”    4

1.18

   “Confidentiality Agreement”    4

1.19

   “Control”    4

1.20

   “Corporate Marks”    5

1.21

   “Detail” or “Detailing”    5

1.22

   “Development”    5

1.23

   “Dollar” or “$”    5

1.24

   “Domain Names”    5

1.25

   “Excluded Liabilities and Obligations”    5

1.26

   “Excluded Product Agreements”    5

1.27

   “FDA”    5

1.28

   “FD&C Act”    6

1.29

   “Field”    6

1.30

   “First Commercial Sale”    6

1.31

   “GAAP”    6

1.32

   “Generic Equivalent”    6

1.33

   “Impax”    6

1.34

   “Impax Litigation”    6

1.35

   “Impax Settlement Agreement”    6

1.36

   “Impax Sublicense Agreement”    6

1.37

   “Indemnification/Payment Fund”    7

1.38

   “Indemnitee”    7

1.39

   “Invention”    7

1.40

   “Inventory”    7

1.41

   “Joint Inventions”    7

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1.42

   “Joint Patents”    7

1.43

   “Know-How”    7

1.44

   “Launch Date”    7

1.45

   “LCP Core Technology”    8

1.46

   “LCP Core Technology Improvements”    8

1.47

   “Licensed Know-How”    8

1.48

   “Licensed LCP Mark”    8

1.49

   “Licensed Patents”    8

1.50

   “Licensed Product”    8

1.51

   “Licensed Technology”    8

1.52

   “LifeCycle Agreement”    8

1.53

   “LifeCycle Know-How”    9

1.54

   “LifeCycle Marks”    9

1.55

   “LifeCycle Patents”    9

1.56

   “LifeCycle Technology”    9

1.57

   “Manufacture” or “Manufacturing”    9

1.58

   “Net Sales”    9

1.59

   “Patents”    10

1.60

   “Product”    10

1.61

   “Product Agreements”    10

1.62

   “Product Data”    11

1.63

   “Product Materials”    11

1.64

   “Product-Specific Patents”    11

1.65

   “Product Trademarks”    11

1.66

   “Promotion” or “Promote”    11

1.67

   “PROSAR Agreement”    11

1.68

   “Prosecution” or “Prosecute”    11

1.69

   “Regulatory Approval”    11

1.70

   “Regulatory Authority”    11

1.71

   “Regulatory Filings”    12

1.72

   “Royalty Term”    12

1.73

   “Santarus Know-How”    12

1.74

   “Santarus Patents”    12

1.75

   “Santarus Technology”    12

1.76

   “Santarus Sales Representative”    12

1.77

   “Shionogi Know-How”    13

1.78

   “Shionogi Patents”    13

1.79

   “Shionogi Technology”    13

1.80

   “Tank Agreement”    13

1.81

   “Tank Equipment”    13

1.82

   “Term”    13

1.83

   “Territory”    13

1.84

   “Third Party”    13

1.85

   “Third Party Royalty Payments”    13

1.86

   “Trademark”    14

1.87

   “Trademark Use Guidelines”    14

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1.88

  “Transition Services”      14   

1.89

  “Upstream Agreements”      14   

1.90

  “Valid Claim”      14   

ARTICLE 2. Grant and Assignment of Rights

     14   

2.1

  License Grants      14   

2.2

  Sublicensing      15   

2.3

  Upstream Agreements      15   

2.4

  No Other Rights      16   

2.5

  Assignment and Transfer of Other Product Related Items      17   

2.6

  Impax Agreements      18   

ARTICLE 3. Trademark Usage and Maintenance

     19   

3.1

  Ownership of Trademarks      19   

3.2

  Use of Licensed LCP Mark      19   

3.3

  Corporate Marks      21   

3.4

  Infringement of Product Trademarks      21   

3.5

  Third-Party Trademark Claims      22   

ARTICLE 4. Development and Regulatory Activities

     22   

4.1

  Additional Development Activities      22   

4.2

  Rights of Reference      22   

4.3

  Regulatory Filings and Responsibilities; Consultation      23   

4.4

  Drug Safety      24   

ARTICLE 5. Commercialization

     25   

5.1

  Diligence      25   

5.2

  Product Materials      26   

5.3

  Complaints and Inquiries      26   

5.4

  Pricing      27   

5.5

  Exclusivity      27   

ARTICLE 6. Manufacturing and Supply

     27   

6.1

  Manufacturing      27   

6.2

  NDC Numbers, Product Returns, Rebates and Chargebacks      27   

ARTICLE 7. Payments

     28   

7.1

  Upfront Payment      28   

7.2

  Sales Milestones      29   

7.3

  Royalty Payments      29   

7.4

  Authorized Generic Revenues      29   

7.5

  Third Party Royalties; Other Credits Against Royalties      30   

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7.6

  Payments and Reports      30   

7.7

  Wire Transfers      30   

7.8

  Taxes      31   

7.9

  Records; Audit Rights      31   

7.10

  Late Payments      32   

ARTICLE 8. Inventions and Patents

     32   

8.1

  Inventions      32   

8.2

  Patent Prosecution      34   

8.3

  Enforcement      34   

8.4

  Declaratory Actions and Counterclaims      36   

8.5

  Infringement Defense      36   

ARTICLE 9. Representations, Warranties, and Covenants

     37   

9.1

  Representations, Warranties and Covenants      37   

9.2

  Representations, Warranties and Covenants of Shore      38   

9.3

  Representations and Warranties of CHRP      42   

9.4

  Disclaimer      42   

ARTICLE 10. Confidentiality

     42   

10.1

  Treatment of Confidential Information      42   

10.2

  Authorized Disclosures      43   

10.3

  Publicity      43   

10.4

  Publication      44   

10.5

  Confidentiality Agreement      44   

ARTICLE 11. Indemnification

     44   

11.1

  Indemnification by Santarus      44   

11.2

  Indemnification by Shore      45   

11.3

  Indemnification by CHRP      45   

11.4

  Procedure      45   

11.5

  Insurance      46   

11.6

  Limitation of Liability      47   

11.7

  Indemnification/Payment Fund      47   

ARTICLE 12. Term and Termination

     47   

12.1

  Term      47   

12.2

  Termination by Santarus      47   

12.3

  Termination for Cause      48   

12.4

  Termination for Bankruptcy      48   

12.5

  Consequences of Expiration or Termination      48   

12.6

  Survival      49   

12.7

  No Waiver of Remedies      49   

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ARTICLE 13. Dispute Resolution

   50

13.1

  Disputes    50

13.2

  Governing Law    51

ARTICLE 14. Miscellaneous

   51

14.1

  Entire Agreement    51

14.2

  Assignment    51

14.3

  Amendments    52

14.4

  Bankruptcy    52

14.5

  Non-Waiver    52

14.6

  Severability    52

14.7

  Notice    53

14.8

  Further Assurances    54

14.9

  Force Majeure    54

14.10

  Cooperation    54

14.11

  Independent Contractors    55

14.12

  No Third Party Beneficiaries    55

14.13

  Interpretation    55

14.14

  Counterparts    56

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EXHIBITS

 

Exhibit 1.16

   Compound

Exhibit 1.24

   Domain Names

Exhibit 1.40

   Inventory Lot Numbers

Exhibit 1.49

   Licensed Patents

Exhibit 1.61

   Product Agreements

Exhibit 1.65

   Product Trademarks

Exhibit 2.5(b)

   FDA Transfer Letter

Exhibit 9.2

   Exceptions to Warranties and Representations

Exhibit 9.2(w)

   Unfilled Firm Orders

Exhibit 10.3

   Press Release

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LICENSE AGREEMENT

THIS LICENSE AGREEMENT (the “Agreement”) is made and entered into as of
December 21, 2011 (the “Effective Date”), by and among COWEN HEALTHCARE ROYALTY
PARTNERS, L.P., a Delaware limited partnership, having its principal place of
business at 177 Broad Street, Suite 1101, Stamford, CT 06901 (“CHRP”), SHORE
THERAPEUTICS, INC., a Delaware corporation, having its principal place of
business at 177 Broad Street, Suite 1101, Stamford, CT 06901 (“Shore”) and
SANTARUS, INC., a Delaware corporation, having its principal place of business
at 3721 Valley Centre Drive, Suite 400, San Diego, California 92130
(“Santarus”). CHRP and Shore, on the one hand, and Santarus, on the other hand,
are referred to individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, Veloxis Pharmaceuticals A/S f/k/a LifeCycle Pharma A/S (“LifeCycle”)
and CHRP entered into a License Agreement dated August 20, 2008, as amended on
July 11, 2011 (the “LifeCycle Agreement”), pursuant to which LifeCycle granted
CHRP the exclusive rights to manufacture and commercialize certain fenofibrate
products in the Field in the Territory (each as defined below);

WHEREAS, CHRP and Shore entered into a License Agreement dated October 11, 2010
(the “CHRP Shore Agreement”), pursuant to which, among other things, CHRP
sublicensed to Shore the exclusive rights to manufacture within and outside the
Territory, solely for certain activities within the Territory, and to
commercialize the fenofibrate products in the Field in the Territory; and

WHEREAS, Shore desires to grant to Santarus, and Santarus desires to accept,
exclusive rights to manufacture and commercialize the fenofibrate products in
the Field in the Territory.

NOW, THEREFORE, in consideration of the mutual covenants and agreements
contained herein and for other good and valuable consideration, the receipt and
adequacy of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1.

DEFINITIONS

The following terms shall have the following meanings as used in this Agreement:

1.1 “Adverse Event” means any undesirable medical occurrence in a patient or
clinical investigation subject administered a pharmaceutical product and which
does not necessarily have to have a causal relationship with the treatment,
including any variant of an “adverse drug experience” as those terms are defined
at either 21 C.F.R. Section 312.32 or 21 C.F.R. Section 314.80, whether arising
in or outside of a clinical study.

1.2 “Additional Product” means a delivery and/or formulation modification to the
Product as to which a supplement to NDA No. 22,118 would be required prior to
marketing or selling of such product.

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1.3 “Affiliate” means (a) an entity that owns directly or indirectly a
controlling interest in a Party, by stock ownership or otherwise, (b) any entity
in which a Party owns a controlling interest, by stock ownership or otherwise,
or (c) any entity under common control with a Party, directly or indirectly.
Solely for purposes of the foregoing sentence, “controlling interest” and
“control” means the power, whether or not exercised, to direct the management
and affairs of a Party, directly or indirectly, whether through the ownership of
voting securities, by contract, or otherwise. The direct or indirect ownership
of fifty percent (50%) or more of a Party’s outstanding voting securities shall
in any case be deemed to confer “control.”

1.4 “API Supply Agreement” means that certain API Supply Agreement, effective as
of December 5, 2008, by and between Shore (as successor to Sciele Pharma, Inc.)
and Chemagis (“Chemagis”), as amended on June 28, 2011, and as further amended
from time to time following the Effective Date, pursuant to which Chemagis
agreed to manufacture and supply to Shore the Compound.

1.5 “Applicable Law” means all laws, statutes, ordinances, codes, rules, and
regulations that have been enacted by a government authority and which are in
force as of the Effective Date or come into force during the Term, in each case
to the extent that the same are applicable to the performance by the Parties of
their respective obligations under this Agreement, including, with respect to
the United States, the Prescription Drug Marketing Act, the FD&C Act, the Health
Insurance Portability and Accountability Act, the Federal Anti-Kickback Statute,
and any applicable FDA regulations relating to sampling practices.

1.6 [Intentionally Omitted]

1.7 “Assumed Product Agreements” has the meaning set forth in Section 2.5(d).

1.8 “Authorized Generic” means a pharmaceutical product that (i) is sold under
the Regulatory Approval for a Product or Additional Product, (ii) is sold under
a different Trademark than such Product or Additional Product, and (iii) has a
National Drug Code (“NDC”) number that differs from the NDC number for such
Product or Additional Product (other than on a temporary basis as may be
necessary to launch such Product or Additional Product in the applicable
market).

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1.9 “Authorized Generic Revenues” means all net revenue Santarus or its
Affiliates receive from sublicensees or authorized Third Parties as a royalty
payment for their “net sales” or any comparable definition (as defined in the
applicable sublicense agreement) of an Authorized Generic in the Territory
during the Term; provided that “Authorized Generic Revenues” shall not include
any royalties or other revenues received by Santarus or its Affiliates pursuant
to the Impax Sublicense Agreement.

1.10 “Calendar Quarter” means each of the three (3) month periods ending on
March 31, June 30, September 30, and December 31, provided that the first
Calendar Quarter during the Term shall commence on the Effective Date and end on
December 31, 2011.

1.11 “Calendar Year” means each twelve (12) month period beginning on January 1
and ending on December 31, provided that the first Calendar Year during the Term
shall commence on the Effective Date and end on December 31, 2011.

1.12 “CHRP Shore Agreement” has the meaning set forth in the recitals.

1.13 “Commercial Supply Agreement” means that certain Commercial Supply and
Packaging Agreement, dated as of January 15, 2011, by and between Shore and
Catalent Pharma Solution, LLC (“Catalent”), as amended from time to time
following the Effective Date, pursuant to which Catalent agreed to Manufacture
the Licensed Product.

1.14 “Commercialize”, with a correlative meaning for “Commercializing” and
“Commercialization”, means any and all activities relating to the
commercialization and exploitation of the Licensed Products in the Field in the
Territory, including the marketing, Promotion, Detailing, distribution, sale,
offer for sale, and importation of the Licensed Products after Regulatory
Approval of such Licensed Products, excluding any and all Manufacturing of the
Licensed Products.

1.15 “Commercially Reasonable Efforts” means, with respect to the efforts of a
Party to complete specific tasks or obligations under this Agreement relating to
a Licensed Product, at least the level of efforts and resources that would be
applied, consistent with prevailing pharmaceutical industry standards, by such
Party with respect to a pharmaceutical product at a similar stage in its product
life and of similar market potential to such Licensed Product. It is anticipated
that the level of effort will change over time, reflecting changes in the status
of the Licensed Product.

1.16 “Compound” means the bulk active pharmaceutical ingredient fenofibrate as
set forth on Exhibit 1.16.

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1.17 “Confidential Information” of a Party means all secret, confidential or
proprietary information or data, including any and all information exchanged
between the Parties under the Confidentiality Agreement, whether provided in
written, oral, graphic, video, computer or other form, provided by such Party
(the “Disclosing Party”) to any other Party (the “Receiving Party”) (including
information generated by or on behalf of such Party pursuant to this Agreement
and disclosed to any other Party), which may include information relating to the
Disclosing Party’s existing or proposed research, development efforts, patent
applications, business or products and any other materials that have not been
made available by the Disclosing Party to the general public. The terms of this
Agreement shall also be deemed Confidential Information of each Party, except to
the extent disclosed pursuant to ARTICLE 10 herein. Notwithstanding the
foregoing sentences, the term “Confidential Information” shall not include any
information or materials that the Receiving Party can demonstrate:

(a) were already known to the Receiving Party (other than under an obligation of
confidentiality), at the time of disclosure by the Disclosing Party to the
extent such Receiving Party has documentary evidence to that effect;

(b) were generally available to the public or otherwise part of the public
domain at the time of its disclosure to the Receiving Party;

(c) became generally available to the public or otherwise part of the public
domain after its disclosure or development, as the case may be, and other than
through any act or omission of the Receiving Party in breach of its
confidentiality obligations under this Agreement;

(d) were subsequently lawfully disclosed to the Receiving Party by a Third Party
who had no obligation to the Disclosing Party not to disclose such information
to others;

(e) were independently discovered or developed by or on behalf of the Receiving
Party by persons who had no access to and without the use of the Confidential
Information belonging to the other Party and the Receiving Party has documentary
evidence to that effect; or

(f) is approved for release by the Disclosing Party in writing.

1.18 “Confidentiality Agreement” means the Mutual Confidentiality Agreement
between Shore and Santarus effective January 26, 2011.

1.19 “Control” means, with respect to any information or intellectual property
right, possession by a Party of the ability (whether by ownership, license, or
otherwise) to grant access, a license, or a

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sublicense to such information or intellectual property right without the
payment of additional consideration, and without violating the terms of any
agreement or other arrangement with, or rights of, any Third Party as of the
time such Party would first be required hereunder to grant the other Party such
access, license or sublicense.

1.20 “Corporate Marks” shall mean, with respect to each of the Parties, the
corporate name of such Party or those of Affiliates of such Party, and its and
their trade names, trademarks, service marks, domain names, and associated logos
and designs; provided that Corporate Marks shall not include the Product
Trademarks or the Licensed LCP Mark.

1.21 “Detail” or “Detailing” means an in-person, face-to-face presentation of a
Licensed Product by a sales representative with respect to a physician or other
individuals or entities with prescribing authority involved or potentially
involved in prescribing the Licensed Products, which presentation is for the
purpose of Promoting the Licensed Product in the Field in the Territory.

1.22 “Development”, with a correlative meaning for “Develop” and “Developing”,
means all non-clinical, pre-clinical and clinical drug development, and
regulatory activities with respect to seeking Regulatory Approval of the
Licensed Products, as applicable, for any indication in the Field in the
Territory, and post-approval studies, including label extensions in support of a
Licensed Product in the Field in the Territory and any studies required by a
Regulatory Authority, such activities to occur within or outside the Territory
for purposes of Commercialization, and excluding any and all Manufacturing of
the Licensed Products.

1.23 “Dollar” or “$” means the legal tender of the United States.

1.24 “Domain Names” means those domain names and web sites set forth on Exhibit
1.24.

1.25 “Excluded Liabilities and Obligations” has the meaning set forth in
Section 2.6(a).

1.26 “Excluded Product Agreements” has the meaning set forth in Section 2.5(d).

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

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1.28 “FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, 21
U.S.C. 301, et. seq., as it may be amended from time to time, and the
regulations promulgated thereunder.

1.29 “Field” means the prevention, palliation or treatment of any condition,
indication or diseases in humans.

1.30 “First Commercial Sale” means the first commercial sale by Santarus or its
Affiliates or sublicensees of a Licensed Product to a Third Party for end use or
consumption in the Territory.

1.31 “GAAP” means generally accepted accounting principles in the United States,
consistently applied.

1.32 “Generic Equivalent” means, with respect to a Licensed Product, a second or
subsequent product that (a) is “therapeutically equivalent,” as evaluated by the
FDA, applying the definition of “therapeutically equivalent” set forth in the
preface to the then-current edition of the FDA publication “Approved Drug
Products With Therapeutic Equivalence Evaluations” or any other similar
definitions set forth in Applicable Laws, in each case, as is necessary to
permit pharmacists or other individuals authorized to dispense pharmaceuticals
under Applicable Laws to substitute one product for another product in the
absence of specific instruction from a physician or other authorized prescriber
under Applicable Laws, and (b) is not an Authorized Generic of such Licensed
Product.

1.33 “Impax” means Impax Laboratories, Inc.

1.34 “Impax Litigation” means the existing litigation entitled LifeCycle Pharma
A/S v. Impax Laboratories, Inc., Civil Action No. 10-358 (GMS).

1.35 “Impax Settlement Agreement” means that certain Settlement Agreement and
Release of Claims, dated December 19, 2011, by and among LifeCycle, Shore and
Impax, as amended from time to time.

1.36 “Impax Sublicense Agreement” means that certain Sublicense Agreement, dated
December 19, 2011, by and among CHRP, Shore and Impax, as amended from time to
time.

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1.37 “Indemnification/Payment Fund” has the meaning set forth in Section 11.7.

1.38 “Indemnitee” means, with respect to a Party, such Party and its Affiliates,
and their respective directors, officers, managers, members, employees, agents,
contractors and licensees.

1.39 “Invention” means any invention or discovery, whether or not patentable,
made as a result of the activities of a Party or the Parties pursuant to this
Agreement performed after the Effective Date that is necessary or useful in the
Development, Manufacture, use, or Commercialization of a Licensed Product.

1.40 “Inventory” means inventory of bulk Compound or finished Product (including
samples) that have been demonstrated to meet established release specifications,
whether held at a location or facility of Shore or any of its Affiliates (or any
Third Party on behalf of Shore or any of its Affiliates) or in transit to or
from Shore or any of its Affiliates (or any such Third Party) with the lot
numbers as set forth in Exhibit 1.40.

1.41 “Joint Inventions” has the meaning set forth in Section 8.1(d).

1.42 “Joint Patents” means all Patents that cover or claim Joint Inventions.

1.43 “Know-How” means all non-public Inventions, information, results and data
of any type whatsoever, in any tangible or intangible form (and whether or not
patentable), including databases, practices, methods, techniques,
specifications, formulations, formulae, knowledge, skill, experience, data and
results (including pharmacological, medicinal chemistry, biological, chemical,
biochemical, toxicological and clinical study data and results), analytical and
quality control data, stability data, studies and procedures, and manufacturing
process and development information, results and data.

1.44 “Launch Date” means the date of First Commercial Sale of any Licensed
Product by Santarus.

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1.45 “LCP Core Technology” means (a) the inventions and subject matter covered
or claimed by the Patents listed in Part B of Exhibit 1.49 of this Agreement
and/or in any rights or interests in Patents based on or derived from such
applications; and (b) all Know-How that is Controlled by LifeCycle and relates
generally to its MeltDose® technology or the manufacture of pharmaceutical
products in MeltDose® formulations.

1.46 “LCP Core Technology Improvements” means (a) all Inventions that are
enhancements, improvements, modifications or derivatives of LCP Core Technology
and are made by or on behalf of Santarus or its Affiliates at any time during
the Term, and (b) all Patents claiming, or other intellectual property rights
appurtenant to, any of such Inventions set forth in subsection (a).

1.47 “Licensed Know-How” means all Know-How related to Licensed Products
(including information not covered by the Licensed Patents) that is Controlled
by Shore as of the Effective Date or at any time during the Term and is
necessary or useful to Develop, Manufacture, or Commercialize Licensed Products
in the Field, including the LifeCycle Know-How, and Know-How relating to Joint
Inventions. Notwithstanding anything herein to the contrary, Licensed Know-How
shall exclude Licensed Patents and Product Trademarks.

1.48 “Licensed LCP Mark” means MeltDose®.

1.49 “Licensed Patents” means all Patents that cover or claim a Licensed Product
or its manufacture or use that are Controlled by Shore as of the Effective Date
or at any time during the Term, and are necessary or useful to Develop,
Manufacture or Commercialize Licensed Products in the Field, including the
LifeCycle Patents and Joint Patents. The Licensed Patents in existence as of the
Effective Date are as set forth on Exhibit 1.49.

1.50 “Licensed Product” means the Product and any Additional Product.

1.51 “Licensed Technology” means, collectively, the Licensed Patents, Licensed
Know-How, and all copyrights owned or otherwise Controlled by Shore that are
associated with the Compound or Licensed Products.

1.52 “LifeCycle Agreement” has the meaning set forth in the recitals.

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1.53 “LifeCycle Know-How” means all Know-How related to Licensed Products
(including information not covered by the Licensed Patents) that is Controlled
by LifeCycle as of the Effective Date or at any time during the Term and is
necessary or useful to Develop, Manufacture, or Commercialize Licensed Products.
Notwithstanding anything herein to the contrary, LifeCycle Know-How shall
exclude LifeCycle Patents and the Licensed LCP Mark.

1.54 “LifeCycle Marks” has the meaning set forth in Section 3.1(b).

1.55 “LifeCycle Patents” means all Patents that cover or claim any aspect of a
Licensed Product or its manufacture or use that are Controlled by LifeCycle as
of the Effective Date or at any time during the Term, and are necessary or
useful for Development, Manufacture, or Commercialization.

1.56 “LifeCycle Technology” means, collectively, the LifeCycle Patents and the
LifeCycle Know-How.

1.57 “Manufacture” or “Manufacturing” means all activities related to the
manufacture of Licensed Products, including analytical method development,
formulation and process development, quality assurance/quality control
procedures, quality control testing (including raw material, in-process, release
and stability testing), process scale-up, validation, clinical and commercial
manufacturing (including bulk manufacturing and finished pharmaceutical product
manufacturing), packaging and release activities, either within or outside the
Territory, for purposes of Development or Commercialization.

1.58 “Net Sales” means, for any period of determination, the gross amount
invoiced for Licensed Products (but excluding Authorized Generics) by Santarus,
its Affiliates and any sublicensees to Third Parties for such period of
determination, less the aggregate of the following deductions to the extent
actually incurred in connection with such sales:

(a) reasonable and customary cash, trade, and quantity discounts off the
invoiced price, promotional allowances actually incurred and fees paid to
wholesalers and retailers based on the sale or dispensing of Licensed Products;

(b) excise, sales, value added, good and services and other consumption taxes
and import/export and custom duties or other taxes imposed on the importation,
use or sale of the Licensed Product to Third Parties, to the extent included in
the gross amount invoiced;

(c) freight, insurance and other transportation charges to the extent billed
separately;

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(d) amounts repaid, credited or accrued, or allowances or adjustments made, by
reason of customer returns (consistent with Santarus’ then reasonable applicable
return policies), rejections, or recalls;

(e) reasonable and customary rebates and chargebacks; and

(f) rebates associated with any voucher, coupon, loyalty card or other co-pay
assistance programs;

solely to the extent the above deductions are in accordance with law and taken
in accordance with GAAP.

Products or Additional Products may not be sold as “loss leaders” or together
with another product in the practice commonly known as “bundling.

In calculating Net Sales, any transfer from Santarus to an Affiliate or
sublicensee shall be disregarded and the calculation shall instead be based on
the first transfer to a Third Party.

1.59 “Patents” means (a) patents and patent applications, including provisional
patent applications, (b) all divisionals, continuations, continuations in-part
thereof or any other patent application, including national, regional and
international counterparts, claiming priority, or entitled to claim priority,
directly or indirectly to (i) any such patents or patent applications or
(ii) any patent or patent application from which such patents or patent
applications claim, or is entitled to claim, direct or indirect priority, and
(c) all patents issuing on any of the foregoing, together with all
registrations, reissues, re-examinations, patents of addition, renewals,
supplementary protection certificates, or extensions of any of the foregoing.

1.60 “Product” means the finished pharmaceutical product containing the Compound
as the sole active ingredient, formulated using LifeCycle’s MeltDose®
technology, which is marketed under the brand name Fenoglide® as of the
Effective Date under NDA No. 22,118, approved by the FDA on August 10, 2007 (as
such NDA has been amended or supplemented through the Effective Date), including
modifications to dosage strength, modifications of excipients, or conversion of
dosage form, for instance, to a capsule or caplet, and including any Authorized
Generic, but not including any Additional Product or Generic Equivalent.

1.61 “Product Agreements” means (a) the agreements in effect as of the Effective
Date by and between Shore and Third Parties relating to the Licensed Products
and (b) the purchase orders issued by Shore, in each case, as set forth in
Exhibit 1.61.

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1.62 “Product Data” means all preclinical, non-clinical, analytical,
Manufacturing, regulatory, and clinical data, and books and records, relating to
the Licensed Products that are necessary to the Development, Manufacture, use or
Commercialization of the Licensed Products, including any Licensed Product
safety database.

1.63 “Product Materials” means all materials, including training materials,
medical education materials, market research, customer lists, advertisements,
leave behinds, and Detail aids used in the Promotion and Commercialization of
the Licensed Products.

1.64 “Product-Specific Patents” means the Patents listed in Part A of Exhibit
1.49.

1.65 “Product Trademarks” means (a) Fenoglide® and all other Trademarks used by
CHRP, Shore or their Affiliates as of the Effective Date in connection with the
marketing or sale of the Licensed Products in the Field in the Territory, as set
forth in Exhibit 1.65, excluding the Licensed LCP Mark and any Corporate Marks
and (b) all related Domain Names and other Trademark related rights, in each
case excluding the Corporate Marks of the Parties.

1.66 “Promotion” or “Promote” means all direct and indirect marketing and
promotion of the Licensed Products in the Field in the Territory, including all
direct and indirect sales force activities and expenses.

1.67 “PROSAR Agreement” has the meaning set forth in Section 2.5(d).

1.68 “Prosecution” or “Prosecute” means, with respect to Patents, the
preparation, filing for, prosecuting, filing reissue applications, responding to
oppositions, nullity actions, re-examinations, revocation actions, post-grant
reviews, inter partes reviews and similar proceedings (including conducting or
participating in interference and oppositions) filed by Third Parties against,
and maintaining, Patents.

1.69 “Regulatory Approval” means any approvals, licenses, registrations or
authorizations of any Regulatory Authority, whether or not conditional, that are
necessary for the commercial sale of the Licensed Products in the Field in the
Territory.

1.70 “Regulatory Authority” means any and all supranational, national, or
regional, state, provincial or other local government, court, governmental
agency, authority, board, bureau, instrumentality, regulatory

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agency, department, bureau, commission, council or other government entity,
whose approval or authorization is necessary for, or to whom notice must be
given prior to, the Development, Manufacture, Commercialization or use of a
Licensed Product, including the FDA.

1.71 “Regulatory Filings” means the technical, medical and scientific
registrations, authorizations and approvals (including approvals of NDAs,
supplements and amendments, pre- and post- approvals, and labeling approvals) of
any Regulatory Authority necessary for the Development, Manufacture, and for
distribution, marketing, Promotion, offer for sale, use, import, reimbursement,
export or sale of a subject product in the Territory, together with all related
correspondence to or from any Regulatory Authority and all documents referenced
in the complete regulatory chronology for each NDA, including the Drug Master
File (if any), IND, NDA and supplemental new drug applications (sNDAs).

1.72 “Royalty Term” means, on a Licensed Product-by-Licensed Product basis, the
period commencing on the First Commercial Sale of the applicable Licensed
Product and continuing until the earlier of: (a) the expiration of all Valid
Claims in the Licensed Patents that claim or cover the Licensed Product or its
use (excluding, for clarity, method of manufacture claims), or (b) the launch in
the Territory of a Generic Equivalent or an Authorized Generic of such Licensed
Product by a Third Party.

1.73 “Santarus Know-How” means all Know-How related to Licensed Products
(including information not covered by the Santarus Patents) that is Controlled
by Santarus as of the Effective Date or developed or acquired by Santarus at any
time during the Term and is necessary or useful to Develop, Manufacture, use or
Commercialize Licensed Products in the Field in the Territory, but excluding all
Shionogi Technology, LCP Core Technology Improvements, Licensed Technology and
Joint Inventions.

1.74 “Santarus Patents” means all Patents that cover or claim the composition,
manufacture, or method of use of a Licensed Product or any other Santarus
Know-How that are Controlled by Santarus as of the Effective Date or acquired
by, or developed by and reduced to practice by, Santarus at any time during the
Term and are necessary or useful to Develop, Manufacture, use or Commercialize
Licensed Products in the Field in the Territory, but excluding all Licensed
Technology, Shionogi Technology, LCP Core Technology Improvements, LifeCycle
Technology and Joint Inventions.

1.75 “Santarus Technology” means, collectively, the Santarus Patents and
Santarus Know-How.

1.76 “Santarus Sales Representative” means a member of Santarus’ sales force
engaged in the conduct of Details of the Licensed Products, whether as an
employee or contractor.

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1.77 “Shionogi Know-How” means all Know-How related to Licensed Products
(including information not covered by the Shionogi Patents) that was Controlled
by Shionogi as of the date of termination of the Shionogi License Agreement (as
defined in Section 1.79), but excluding all LCP Core Technology Improvements and
LifeCycle Technology.

1.78 “Shionogi Patents” means all Patents that cover or claim a Licensed Product
or its manufacture or use, or any other Shionogi Know-How that was Controlled by
Shionogi as of the date of termination of the Shionogi License Agreement, but
excluding all LCP Core Technology Improvements and LifeCycle Technology.

1.79 “Shionogi Technology” means, collectively, the Shionogi Patents and
Shionogi Know-How. For clarity, the Shionogi Technology was licensed to
LifeCycle pursuant to that certain License Agreement, dated April 30, 2007, as
amended, between LifeCycle and Shionogi (the “Shionogi License Agreement”).

1.80 “Tank Agreement” has the meaning set forth in Section 2.5(h).

1.81 “Tank Equipment” has the meaning set forth in Section 2.5(h).

1.82 “Term” has the meaning set forth in Section 12.1.

1.83 “Territory” means the United States of America, including its territories
and possessions and Puerto Rico.

1.84 “Third Party” means any entity other than a Party or its Affiliates.

1.85 “Third Party Royalty Payment” has the meaning set forth in Section 7.5.

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1.86 “Trademark” means any word, name, symbol, color, designation, or device or
any combination thereof, whether registered or unregistered, including any
trademark, trade dress, service mark, service name, brand mark, trade name,
brand name, logo, or business symbol.

1.87 “Trademark Use Guidelines” has the meaning set forth in Section 3.2(d).

1.88 “Transition Services” has the meaning set forth in Section 2.5(f).

1.89 “Upstream Agreements” means the LifeCycle Agreement, the CHRP Shore
Agreement and the Tank Agreement.

1.90 “Valid Claim” means a claim of an issued and unexpired patent, or a claim
of a pending patent application, within the Licensed Patents, which claim has
not been held invalid, unpatentable or unenforceable by a court or other
government agency of competent jurisdiction from which no appeal can be further
taken, and has not been held or admitted to be invalid, unpatentable or
unenforceable through abandonment, re-examination or disclaimer, opposition
procedure, nullity suit or otherwise, which claim covers or claims a Licensed
Product or its manufacture or use; provided, however, that if a claim of a
pending patent application shall not have issued as a claim of an issued patent
within [***] after the earliest filing date from which such claim takes priority
such claim shall not constitute a Valid Claim for the purposes of this Agreement
unless and until such claim shall issue as a claim of an issued patent.

ARTICLE 2.

GRANT AND ASSIGNMENT OF RIGHTS

2.1 License Grants.

(a) Subject to the terms and conditions of this Agreement, the LifeCycle
Agreement, and the Impax Sublicense Agreement, Shore hereby grants to Santarus:

(i) an exclusive (even as to Shore), royalty-bearing, license, with the right to
grant sublicenses (subject to Section 2.2), under the Licensed Technology, to
market, import, use, sell, offer for sale and otherwise Commercialize Licensed
Products in the Field in the Territory;

(ii) a worldwide, non-exclusive, royalty-bearing, license, with the right to
grant sublicenses (subject to Section 2.2), under the Licensed Technology, to
Develop and Manufacture the Licensed Products solely as necessary for obtaining
Regulatory Approval in, or for Commercialization in, the Field in the Territory;

 

 

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(iii) an exclusive (even as to Shore), royalty-bearing, license, with the right
to grant sublicenses (subject to Section 2.2), under the Shionogi Technology, to
market, import, use, sell, offer for sale and otherwise Commercialize Licensed
Products in the Field in the Territory; and

(iv) a worldwide, non-exclusive, royalty-bearing, license, with the right to
grant sublicenses (subject to Section 2.2), under the Shionogi Technology, to
Develop and Manufacture the Licensed Products solely as necessary for obtaining
Regulatory Approval in, or for Commercialization in, the Field in the Territory.

For clarity, rights to Manufacture or Develop Licensed Products outside the
Territory are granted to Santarus to the extent such rights are granted to CHRP
and/or Shore.

(b) Santarus acknowledges that Shore has entered into the Impax Sublicense
Agreement prior to the date hereof, which agreement grants to Impax certain
rights under the Licensed Patents in the Territory. Shore has delivered to
Santarus true, correct and complete copies of the Impax Sublicense Agreement and
the Impax Settlement Agreement.

(c) Subject to the terms and conditions of this Agreement, the LifeCycle
Agreement and the Impax Sublicense Agreement, CHRP hereby grants to Santarus an
exclusive (even as to CHRP with respect to Commercialization), royalty-free,
license, with the right to grant sublicenses (subject to Section 2.2), under any
Joint Inventions and Joint Patents, to make, have made, market, import, use,
sell, offer for sale and otherwise Develop, Manufacture and Commercialize
Licensed Products.

2.2 Sublicensing. Santarus shall have the right to grant sublicenses under the
rights granted to Santarus in Section 2.1 to its Affiliates or Third Parties
without the prior written consent of Shore or CHRP; provided, however, that any
such sublicense shall be consistent with and subject to the terms and conditions
of this Agreement, and, to the extent applicable to the LifeCycle Technology
licensed under the LifeCycle Agreement and sublicensed to Santarus hereunder,
each sublicense agreement entered into by Santarus shall be in compliance and
not inconsistent with the terms and conditions of the LifeCycle Agreement;
provided further, however, that no such sublicense shall relieve Santarus of any
of its obligations under this Agreement.

2.3 Upstream Agreements; Impax Settlement Agreement and Impax Sublicense
Agreement. Subject to this Section 2.3 and Section 2.6, Shore and CHRP shall
have the sole responsibility for exercising their respective rights and
discharging their respective obligations under the Upstream Agreements, Impax
Settlement Agreement and Impax Sublicense Agreement.

(a) Copy. On or before the Effective Date, CHRP has delivered to Santarus true,
correct and complete copies of the Upstream Agreements.

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(b) Covenants.

(i) Neither Shore nor CHRP will modify, amend or waive any provision of an
Upstream Agreement, the Impax Settlement Agreement or the Impax Sublicense
Agreement in such a manner that could have an adverse impact on Manufacture or
Commercialization of the Licensed Products hereunder [***], without the prior
written consent of Santarus, such consent not to be unreasonably withheld,
conditioned or delayed.

(ii) Shore or CHRP, as the case may be, will immediately (but in no event later
than [***]) notify Santarus if Shore or CHRP, as the case may be, fails to meet
any of their respective obligations, including any payment obligations, under an
Upstream Agreement, the Impax Settlement Agreement or the Impax Sublicense
Agreement or receives notice from LifeCycle or Impax, as the case may be,
alleging any such failure which failure could have a material adverse effect on
the rights of Santarus hereunder.

(iii) Each of CHRP and Shore shall (A) maintain in full force and effect each
Upstream Agreement, the Impax Settlement Agreement and the Impax Sublicense
Agreement to which it is a party and (B) comply in all material respects with
the terms and conditions of each Upstream Agreement, the Impax Settlement
Agreement and the Impax Sublicense Agreement to which it is a party; and neither
CHRP nor Shore shall terminate any Upstream Agreement, the Impax Settlement
Agreement or the Impax Sublicense Agreement.

(iv) Each of Shore and CHRP, as the case may be, shall remain responsible for
any and all payments due under each Upstream Agreement, the Impax Settlement
Agreement or the Impax Sublicense Agreement to which it is a party.

(c) Santarus Step-in Rights. If a failure described in Section 2.3(b)(ii) above
occurs or is alleged to have occurred with respect to the LifeCycle Agreement,
the Parties shall promptly meet and confer on how best to proceed to effect a
cure of such failure. CHRP will keep Santarus timely informed of its efforts to
cure or remedy such failure or alleged failure. Santarus will have the right to
step-in and meet the failed obligations, including the right to make payment on
behalf of CHRP, and CHRP will take all necessary steps such that LifeCycle
accepts performance by Santarus on behalf of CHRP for such obligations. Before
Santarus exercises its right to step-in under this Section 2.3(c), Santarus
shall deliver to CHRP written notice of its intent to exercise such “step-in”
right, which exercise shall not occur sooner than ten (10) days after receipt by
Santarus of written notice of any such failure. Any amounts owed by CHRP and
paid by Santarus pursuant to the immediately preceding sentence will be credited
towards any amount due to Shore from Santarus under this Agreement. The step-in
rights set forth in this Section 2.3(c) are not Santarus’ sole remedies in the
event of a failure described in Section 2.3(b)(ii); nothing in this Section
shall be deemed to limit any other legal or equitable recourse or remedies
Santarus might have.

2.4 No Other Rights. Except as explicitly set forth in this Agreement, no
license or other right is or shall be created or granted hereunder by
implication, estoppel, or otherwise.

 

 

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2.5 Assignment and Transfer of Other Product Related Items.

(a) Transfer of Product Trademarks. Shore hereby assigns and transfers to
Santarus all of its right, title and interest in and to all Product Trademarks.

(b) Transfer of Regulatory Approvals and Filings. Shore hereby assigns and
transfers to Santarus all of its right, title and interest in and to all
Regulatory Approvals and all Regulatory Filings that primarily relate to the
Compound or the Licensed Products in the Territory, including NDA No. 22-118.
The Parties acknowledge that, pursuant to the terms hereof and Section 3.1(c) of
the LifeCycle Agreement, LifeCycle and its licensees (including, CHRP and Shore)
retain the rights to license, to use any and all information contained in the
Regulatory Approvals and Regulatory Filings assigned and transferred to Santarus
hereunder, and the right of reference to all such Regulatory Approvals, solely
for purposes relating to development and commercialization of the Licensed
Products outside the Territory, and the manufacture of Licensed Products (within
and without the Territory) for sale outside the Territory. A copy of the letter
transferring such Regulatory Approvals to be delivered to the FDA on the
Effective Date is attached hereto as Exhibit 2.5(b).

(c) Transfer of Domain Names, Product Data and Product Materials. Shore hereby
assigns and transfers to Santarus all of its right, title and interest in and to
all Domain Names, Product Data and Product Materials related to the Licensed
Product. Promptly after the Effective Date, Shore shall provide to Santarus
copies of all such Product Data, Product Materials and medical education
materials related to the Licensed Product.

(d) Assignment and/or Termination of Product Agreements. Shore hereby assigns to
Santarus and Santarus hereby assumes the Product Agreements designated for
assignment as set forth in Exhibit 1.61 (the “Assumed Product Agreements”). For
the avoidance of doubt, the foregoing assignment and assumption shall include
all of Shore’s rights and obligations under the Assumed Product Agreements,
other than obligations accrued prior to the Effective Date. Shore shall
terminate those Product Agreements designated for termination as set forth in
Exhibit 1.61 (the “Excluded Product Agreements”); provided, however, that the
Agreement, dated November 1, 2010, between Product Safety Resources, Inc.
(“PROSAR”) and Shore (the “PROSAR Agreement”), shall remain in effect until
[***] from the Effective Date; and provided further that during such [***]
period, Shore shall be responsible, at Santarus’ sole cost and expense (other
than with respect to any termination fees), for all obligations under such
agreement, including Adverse Event and other pharmacovigilance reporting related
to Licensed Products, and shall promptly provide such pharmacovigilance
information to Santarus.

(e) Inventory. As of the Effective Date, Shore shall deliver to Santarus all
Inventory, [***]. Title to and risk of loss with respect to the Inventory shall
pass from Shore to Santarus upon delivery of such Inventory to Santarus.
Santarus shall pay Shore for such Inventory within thirty (30) days of the date
of invoice delivered to a Third Party in connection with the sale of Product or
use of the Compound in Manufacturing operations at the costs set forth in
Exhibit 1.40, which costs represent actual out-of-pocket Third Party costs
[***]. For clarity, Inventory which is not invoiced by Santarus, its Affiliates
or sublicensees to Third Parties

 

 

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or used in the Manufacturing process shall result in no payment due to Shore.
EXCEPT AS OTHERWISE EXPRESSLY PROVIDED HEREIN, ALL REPRESENTATIONS AND
WARRANTIES REGARDING THE INVENTORY, INCLUDING, WITHOUT LIMITATION, IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS OF PURPOSE FOR INTENDED USE, ARE HEREBY
EXPRESSLY DISCLAIMED.

(f) Transition Assistance. Following the Effective Date, for a period of [***],
Shore shall provide reasonable assistance, including with respect to preparing
Regulatory Filings for the Licensed Products and making its personnel reasonably
available for meetings or teleconferences, to support and assist Santarus in the
Manufacture and Commercialization of the Licensed Products (the “Transition
Services”) at Shore’s sole cost and expense.

(g) Transfer of Call Center Telephone Number. Shore hereby assigns and transfers
to Santarus all of its right, title and interest in and to (888) 743-0571 and
(651) 603-3424, and shall transfer management of such call center telephone
numbers no later than the end of the [***] period described in Section 2.5(d)
above.

(h) Hot Melt Tanks.

(i) On or before the Effective Date, CHRP and Shore shall enter into an
agreement with LifeCycle, in form and substance reasonably acceptable to
Santarus (the “Tank Agreement”). CHRP and Shore shall provide access to, and
ensure that Santarus is able to use, (itself or on its behalf) the two
(2) skid-mounted hot melt tanks and associated equipment (the “Tank Equipment”)
currently situated at Catalent in the manufacture of Licensed Products and
Authorized Generic Products (as defined in the Impax Sublicense Agreement). A
copy of the Tank Agreement executed by all parties thereto, with only financial
terms not applicable to Santarus redacted, has previously been provided to
Santarus. CHRP and/or Shore shall purchase the Tank Equipment pursuant to
Section 1 of the Tank Agreement. CHRP and/or Shore shall be solely responsible
for all costs and expenses associated with or incurred pursuant to the Tank
Agreement, including, without limitation, any costs or expenses associated with
the purchase of the Tank Equipment pursuant to Section 1 of the Tank Agreement.
For clarity, Santarus shall be responsible for maintenance costs associated with
the Tank Equipment as provided for in the Commercial Supply Agreement and the
unredacted sections of the Tank Agreement previously provided to Santarus and
Santarus shall comply with Sections 4(a)-(f), 4(h) and 5 of the Tank Agreement.

(ii) [***]

(i) Additional Assurances. The Parties shall execute such documents and take
such actions as are reasonably necessary to effectuate the foregoing transfers
and transition matters.

2.6 Impax Agreements.

(a) Upon the Dismissal Effective Date (as defined in Section 4 of the Impax
Settlement Agreement), Shore shall assign and transfer to Santarus the Impax
Sublicense

 

 

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Agreement in its entirety. For clarity, prior to the Dismissal Effective Date,
Santarus shall not be responsible for any rights or obligations of Shore or any
of its Affiliates of whatever nature, whether presently in existence or arising
or asserted hereafter, whether known or unknown, and whether under the Impax
Sublicense Agreement, the Impax Settlement Agreement or otherwise. Shore and its
Affiliates shall retain responsibility for all such rights and obligations (the
“Excluded Liabilities and Obligations”) until such time, if ever, that the
Dismissal Effective Date occurs. Santarus shall only assume responsibility for
the Excluded Liabilities and Obligations that arise after such time that the
entire Impax Settlement Agreement is assigned to and assumed by Santarus
pursuant to this Section 2.6(a). Notwithstanding the foregoing, prior to the
Dismissal Effective Date, Santarus and Shore shall reasonably cooperate to
ensure compliance with the terms of the Impax Sublicense Agreement.

(b) Throughout the Term, each Party shall, as soon as practicable, but in any
event, within [***], provide each other Party with copies of all [***] in the
Impax Litigation to the extent related to the Impax Settlement Agreement or the
Impax Sublicense Agreement [***].

(c) [***]

ARTICLE 3.

TRADEMARK USAGE AND MAINTENANCE

3.1 Ownership of Trademarks.

(a) From and after the Effective Date, Santarus shall be responsible for filing,
registering and maintaining, and shall use commercially reasonable efforts to
file, register and maintain, the Product Trademarks in the Territory, and will
be responsible for the payment of any costs relating to filing, prosecution, and
maintenance of all Product Trademarks in the Territory.

(b) LifeCycle shall retain ownership of the Licensed LCP Mark, and will be
responsible for filing, prosecution, maintenance and defense of all
registrations of the Licensed LCP Mark. In addition, the Parties acknowledge
that LifeCycle, or its Affiliate or Licensee (as defined in the LifeCycle
Agreement), shall retain the exclusive rights to market Licensed Products in the
Field in all countries and jurisdictions outside the Territory, under such
Trademarks as LifeCycle (or its Affiliate or other licensee) shall select in its
sole discretion (the “LifeCycle Marks”), and that neither Santarus nor Shore or
CHRP shall be responsible for filing, registering or maintaining the LifeCycle
Marks.

3.2 Use of Licensed LCP Mark.

(a) Notwithstanding the foregoing, Santarus may use the Licensed LCP Mark,
solely to identify the MeltDose® technology in its Product Materials and
marketing messages used in Promoting the Licensed Products in the Territory, and
provided that Santarus and its Affiliates comply strictly with all obligations
of, and subject to the terms and conditions set forth in this Section 3.2.

 

 

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(b) Santarus acknowledges that LifeCycle is the owner of the Licensed LCP Mark,
and that all use of the Licensed LCP Mark by Santarus (or its Affiliates) inures
to the benefit of LifeCycle. Santarus further acknowledges that the Licensed LCP
Mark embodies substantial goodwill and enjoys favorable public recognition, and
that LifeCycle’s rights therein constitute valuable assets of LifeCycle.
Santarus agrees that it will not do anything inconsistent with such LifeCycle
ownership thereof, and that nothing in this Agreement shall give Santarus any
right, title or interest in the Trademark other than the right to use the
Licensed LCP Mark as permitted in this Section 3.2. Santarus agrees it will not
attack the rights or title of LifeCycle to the Licensed LCP Mark.

(c) In all publicly disseminated packaging, labeling or Product Materials of
Santarus (or its Affiliates) referencing or using the Licensed LCP Mark,
Santarus (and its Affiliates) shall use the Licensed LCP Mark in the manner set
forth in this Section 3.2. Without limiting any other provision of this
Agreement, the Licensed Products, packaging, labeling or Product Materials
therefor, and the Manufacture and Commercialization thereof shall comply with
all Applicable Laws. Santarus shall not use the Licensed LCP Mark on any
materials or goods other than in connection with Licensed Products sold or
otherwise Promoted or distributed in the Territory.

(d) In order to protect the goodwill and reputation associated with the Licensed
LCP Mark, Santarus covenants and agrees that it shall comply with the Trademark
Use Guidelines (as defined below) and shall ensure that the use of the Licensed
LCP Mark by Santarus hereunder, including in any promotional materials or
Licensed Product labels and inserts, in whatever form or medium, shall be in
accordance with the Trademark Use Guidelines. For purposes of this Agreement,
“Trademark Use Guidelines” means those guidelines with respect to use by
Santarus of the Licensed LCP Mark in connection with the Commercialization, to
be established and mutually agreed upon by CHRP, Shore, LifeCycle and Santarus
within [***] of the Effective Date, as such guidelines may be amended by
agreement between Shore, LifeCycle and Santarus from time to time during the
Term.

(i) Quality of Products. Prior to the establishment of the Trademark Use
Guidelines pursuant to this Section 3.2(d), before selling, using or
distributing any goods or materials bearing the Licensed LCP Mark which have not
previously been approved for use by CHRP and/or Shore: (A) Santarus shall
furnish and shall require its sublicensees to furnish, free of cost for
LifeCycle’s express written approval, one prototype sample of each article,
packaging, label, advertisement, sign or other materials bearing the Licensed
LCP Mark; (B) if LifeCycle has not responded within [***] after the office of
the Chief Executive Officer or Chief Financial Officer of LifeCycle has received
the particular prototype sample, then LifeCycle’s approval shall be deemed to
have been granted as provided in the LifeCycle Agreement; (C) pursuant to the
LifeCycle Agreement, if LifeCycle does not approve any such sample, LifeCycle is
obligated to provide Santarus or its sublicensee, as applicable, with a written
explanation of why it was not approved; and (D) after samples have been provided
and approved, Santarus and its sublicensees shall not depart from the approved
form in any material respect without the express prior written consent of
LifeCycle.

 

 

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(ii) Inspection of Products. In the event Santarus desires to use the Licensed
LCP Mark other than as provided in the Trademark Use Guidelines, Santarus agrees
that at LifeCycle’s reasonable request, Santarus or its sublicensee, as
applicable, shall provide LifeCycle with representative specimens of the
Licensed Product bearing the Licensed LCP Mark and of any packaging, labeling,
advertising, and promotional material bearing the Licensed LCP Mark. The nature,
quality, construction, workmanship, styling, and materials of all of the
Licensed Products sold bearing the Licensed LCP Mark as permitted under this
Agreement and all of the advertising, packaging, publicity material, and
promotional material therefor shall be of a high standard and quality and shall
in no manner reflect adversely upon the Licensed LCP Mark or the LifeCycle, and
shall be consistent with the specimens provided pursuant to this Section.

3.3 Corporate Marks. In connection with Commercialization and (a) to the extent
included on Inventory, Product labeling, Product Materials or packaging
transferred hereunder, (b) to the extent required by Applicable Law, or (c) as
otherwise reasonably required following the Effective Date for any relabeling of
the Inventory, Product labeling, Product Materials or packaging transferred
hereunder, Santarus shall have the non-exclusive right to use and display the
Corporate Marks of Shore. Except as otherwise provided herein, no right, express
or implied, is granted under this Agreement to any Party to use in any manner
the Corporate Marks of the other Parties in connection with the performance of
this Agreement. Notwithstanding the foregoing, Santarus agrees that it will not
manufacture new Licensed Products labeled with Shore’s Corporate Marks after the
date that is [***] following the Effective Date.

3.4 Infringement of Product Trademarks. In the event that Shore, CHRP or
Santarus becomes aware of (a) actual infringement of a Product Trademark in the
Territory; (b) a mark or name confusingly similar to a Product Trademark in the
Territory; or (c) any unfair trade practices, trade dress imitation, passing
off, or like offenses in the Territory that relate to a Product Trademark in the
Territory, such Party shall promptly so notify the other Party in writing.
Santarus shall have the right, but not the obligation, at its sole cost and
expense, to initiate, prosecute, and control an infringement action or file any
other appropriate action or claim related to infringement of such Product
Trademark against any Third Party in the Territory. If Santarus fails to bring
such infringement action within a period of [***] after delivery of the notice
set forth above, then Shore shall have the right, but not the obligation, at its
cost and expense, to initiate, prosecute, and control an infringement action or
file any other appropriate action or claim related to infringement of the
Product Trademark against any Third Party. In either event, as between Shore and
Santarus, the Party not bringing any such action (i) shall have the right (at
its own expense) to participate in such action and to be represented by counsel
of its own choice, and (ii) agrees, at the request and expense of the Party
bringing such action, to be joined as a party to the suit and to provide
reasonable assistance in any such action (at the controlling Party’s cost). The
Party controlling such action shall take all reasonable and appropriate steps to
protect, defend, and maintain the Product Trademarks for use by the Parties and
shall have the right to control settlement of such action; provided, however,
that no settlement shall be entered into without the written consent of the
other Party (Shore or Santarus, as the case may be), which consent shall not be
unreasonably

 

 

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withheld, conditioned or delayed. Any damages or monetary award recovered shall
be retained by the Party bringing such action in connection with such
litigation; provided, however, that any net damages or monetary award recovered
by Santarus and attributable to lost sales of Licensed Products shall be
included in Net Sales for which royalties shall be paid under ARTICLE 7.

3.5 Third-Party Trademark Claims. If a claim is brought by a Third Party that
use of any Product Trademark infringes such Third Party’s trademarks, the Party
against which the action is brought will give prompt written notice to the other
Parties of such claim. Santarus shall have the right, but not the obligation, to
defend or settle such claim with the consent of Shore, which consent shall not
be unreasonably withheld, and defend or settle any resulting suit at its expense
and Shore, at Santarus’ reasonable request and expense, shall cooperate with
Santarus with respect to any such defense. In the event Santarus does not elect
to defend against or settle such claim, Shore shall have the right, but not the
obligation, to defend or settle such claim, and shall have the right to require
Santarus to discontinue use of such Product Trademark and adopt a new Product
Trademark.

ARTICLE 4.

DEVELOPMENT AND REGULATORY ACTIVITIES

4.1 Additional Development Activities.

(a) Santarus shall have the sole right and responsibility to conduct (or have
conducted) all Development, including post-marketing Phase IV studies and any
label enhancement studies for the Product, and any Development in support of an
Additional Product.

(b) Shore shall bear any and all costs and expenses incurred in connection with
Development prior to the Effective Date, and Santarus shall bear any and all
costs and expenses incurred by it in connection with Development from or after
the Effective Date.

4.2 Rights of Reference

(a) To the extent any Regulatory Filings are Controlled by LifeCycle, and CHRP
has been granted such rights by LifeCycle, or to the extent any Regulatory
Filings are Controlled by CHRP, and Shore has been granted any such rights by
CHRP, CHRP and Shore hereby grant to Santarus and its sublicensees, a “Right of
Reference or Use” as that term is defined in 21 C.F.R. § 314.3(b), to any and
all Regulatory Filings and Product Data within the LifeCycle Know-How relating
directly to Licensed Products, which includes that related to pharmacology,
toxicology, preclinical testing, clinical testing, chemistry, manufacturing and
controls data, batch records, trials and studies, safety and efficacy,
manufacturing information, analytical and quality control, and agrees to sign,
and cause their respective Affiliates to sign, any instruments reasonably
requested by Santarus in order to effect such grant, solely for the purposes of
conducting such activities as are contemplated by this Agreement.

(b) Each of CHRP and Shore hereby grants to Santarus the full right to use and
refer to any Drug Master File for the Licensed Product to which it has access
and will

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provide a copy thereof to Santarus upon Santarus’ request solely for the
purposes of Developing and seeking Regulatory Approval of the Licensed Products
and conducting such other activities as are contemplated by this Agreement.

(c) Shore hereby grants to Santarus and its sublicensees, a “Right of Reference
or Use” as that term is defined in 21 C.F.R. § 314.3(b), to any and all
Regulatory Filings and Product Data within the Licensed Know-How relating
directly to Licensed Products to which it has access, which includes that
related to pharmacology, toxicology, preclinical testing, clinical testing,
chemistry, manufacturing and controls data, batch records, trials and studies,
safety and efficacy, manufacturing information, analytical and quality control,
and agrees to sign, and cause its Affiliates to sign, any instruments reasonably
requested by Santarus in order to effect such grant, solely for the purposes of
conducting such activities as are contemplated by this Agreement.

(d) Santarus hereby grants to Shore (and at Shore’s written request, shall grant
to LifeCycle) the foreign equivalents, in any country or jurisdiction outside
the Territory, to a “Right of Reference or Use” as that term is defined in 21
C.F.R. § 314.3(b), to any and all Regulatory Filings and Product Data relating
directly to Licensed Products, which includes that related to pharmacology,
toxicology, preclinical testing, clinical testing, chemistry, manufacturing and
controls data, batch records, trials and studies, safety and efficacy,
manufacturing information, analytical and quality control, and agrees to sign,
and cause its Affiliates to sign, any instruments reasonably requested by Shore
in order to effect any such grant, solely for the purposes of Developing and
seeking Regulatory Approval outside the Territory of the Licensed Products. Upon
Shore’s reasonable request made from time to time, Santarus shall, or shall
cause its Affiliates or sublicensees to, transfer to Shore or LifeCycle a copy
of all such Regulatory Filings with respect to the Licensed Products.

4.3 Regulatory Filings and Responsibilities; Consultation.

(a) Shore has provided to Santarus a true, correct and complete electronic copy
of all Regulatory Filings and Regulatory Approvals in its possession as of the
Effective Date and will provide to Santarus such true and complete copies of
such information which hereafter comes into its possession.

(b) From and after the Effective Date, Santarus shall own all Regulatory Filings
and Regulatory Approvals. Santarus shall be solely responsible for preparing any
and all Regulatory Filings at its sole expense, and shall use Commercially
Reasonable Efforts to maintain all necessary Regulatory Approvals.

(c) Santarus shall be solely responsible for any discussions with any Regulatory
Authority related to Development, Manufacture and Commercialization.

(d) Each of Shore and CHRP shall consult and cooperate with Santarus, as
Santarus may reasonably request, in connection with the preparation and filing
of all Regulatory Filings or Regulatory Approvals. In addition, each of Shore
and CHRP shall consult and cooperate with Santarus, as Santarus may reasonably
request, in connection with any interactions or discussions with any Regulatory
Authority.

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4.4 Drug Safety.

(a) Adverse Event Reporting. Subject to Section 2.5(d) and the Impax Sublicense
Agreement, Santarus shall be responsible for all activities related to the
processing, evaluation, and reporting of Adverse Events to appropriate
Regulatory Authorities, in accordance with Applicable Laws, for the Licensed
Products in the Field in the Territory. Each of CHRP and Shore shall notify
Santarus of all serious Adverse Event reports within twenty-four (24) hours of
the time such Adverse Event becomes known to CHRP or Shore, as the case may be,
and all other Adverse Event reports within one (1) Business Day of the time such
Adverse Event becomes known to CHRP or Shore, as the case may be, including any
such Adverse Event reports received from LifeCycle pursuant to the Upstream
Agreement or Impax pursuant to the Impax Sublicense Agreement.

(b) Product Withdrawals and Recalls. In the event that (a) an event, incident,
or circumstance has occurred which may result in the need for a recall or other
removal of any Licensed Product or any lot or lots thereof from the market in
the Field in the Territory; (b) any Regulatory Authority in the Territory
threatens or initiates any action to remove the Licensed Product from the market
in the Field in the Territory; or (c) any Regulatory Authority in the Territory
requires distribution of a “Dear Doctor” letter or its equivalent, regarding use
of the Licensed Product in the Field in the Territory, Santarus shall promptly
advise Shore in writing with respect thereto. Unless otherwise agreed by the
Parties and subject to the Impax Sublicense Agreement, Santarus shall be
responsible for conducting the recall or other removal from the market and
neither CHRP nor Shore shall consent to the conduct of a recall or other removal
of any Licensed Product from the market in the Territory without obtaining the
prior written consent of Santarus, not to be unreasonably withheld, conditioned
or delayed. Shore (and CHRP to the extent required by Applicable Law) shall,
upon reasonable request by Santarus, assist Santarus in the conduct of any such
recall or removal from the market in the Territory, which recall or removal
shall be controlled by Santarus in Santarus’ sole discretion. Subject to any
obligations under ARTICLE 11, to the extent any recall or removal of a Licensed
Product is implemented as a result of lots Manufactured prior to the Effective
Date, Shore shall bear all reasonable costs incurred in connection with such
recall or removal to the extent it is responsible for such lots under
Section 6.2 with respect to Licensed Product returns (including all of Santarus’
reasonable out-of-pocket costs); otherwise (subject to the Impax Sublicense
Agreement), Santarus shall bear all of Santarus’ costs, all of Shore’s
reasonable out-of-pocket costs, and all other reasonable costs incurred in
connection with such recall.

(c) Global Safety Database. In the event that Shore commercializes a Licensed
Product outside of the Territory, Santarus and Shore shall enter into a written
agreement providing for the establishment of a global safety database by
Santarus or its designee to permit the Parties to fulfill local and
international regulatory reporting obligations to Regulatory Authorities. The
agreement will set forth mutually agreeable guidelines and

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procedures for the receipt, investigation, recordation, communication and
exchange (as between the Parties) and regulatory submission of Adverse Event
reports (subject to Section 4.4(a) with respect to the Territory). Santarus
shall maintain the global safety database, and, as between the Parties, shall
bear all costs with regard to establishing or maintaining such database.

ARTICLE 5.

COMMERCIALIZATION

5.1 Diligence.

(a) Commercially Reasonable Efforts. Santarus shall have the sole right to
undertake, and shall use, and shall require its sublicensees to use,
Commercially Reasonable Efforts to undertake Commercialization of the Product in
the Territory.

(b) Additional Diligence Requirements. In addition, Santarus, either directly or
through a sublicensee, shall:

(i) provide a minimum of [***] Details per Calendar Quarter for the Licensed
Products during the [***] Calendar Quarters beginning [***] following the
Effective Date, pro-rated for any partial Calendar Quarters;

(ii) during [***] Calendar Quarters beginning on [***], provide a minimum spend
on Promotion of the Licensed Products meeting a threshold of [***] calculated on
a rolling basis with respect to [***] Calendar Quarters (providing for a minimum
of [***] per Calendar Quarter), pro-rated for any partial Calendar Quarters;

(iii) following [***] and thereafter during the Term provide a minimum spend on
Promotion of the Licensed Products meeting a threshold of [***] calculated on a
rolling basis with respect to [***] Calendar Quarters (providing for a minimum
of [***] per Calendar Quarter), pro-rated for any partial Calendar Quarters;

(iv) provide an incentive compensation plan associated with sales of the
Licensed Products to the Santarus Sales Representatives amounting to a target
bonus of at least [***] of the Santarus Sales Representatives’ incentive
compensation plan during [***]; and

(v) use Commercially Reasonable Efforts to evaluate and modify, as appropriate,
its prescriber called-on list by [***] which will include fenofibrate and
Fenoglide prescribers.

Notwithstanding anything to the contrary, each of the diligence requirements set
forth in this Section 5.1(b) shall terminate upon the first commercial sale of
an Authorized Generic or Generic Equivalent.

 

 

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(c) Records and Reports.

(i) Every [***] following the Effective Date, Santarus shall provide Shore with
a written report summarizing the efforts and accomplishments of Santarus, its
Affiliates and its sublicensees during the preceding [***] period in Developing
and Commercializing Licensed Products. Such reports shall include, summaries of
scientific and clinical data obtained in furtherance of or based on Santarus’
(or its Affiliate’s or sublicensee’s) efforts to Develop or Commercialize
Licensed Products.

(ii) Shore shall have the right to arrange for its employees involved in the
activities contemplated hereunder to visit the offices of Santarus and any of
its Affiliates, no more than [***] per calendar year during normal business
hours and upon reasonable prior written notice, to discuss the Development and
Commercialization work and results in detail with a technical representative of
Santarus.

(iii) Santarus shall provide to Shore, not later than [***] following the end of
each Calendar Quarter (commencing with the second Calendar Quarter following the
Effective Date), a report detailing the Promotional expenditures incurred by
Santarus, its Affiliates and sublicensees in such Calendar Quarter. In addition,
Santarus shall provide to CHRP, prior to the end of each Calendar Year, a
summary of Promotion activities contemplated for the upcoming Calendar Year.

(iv) For clarity, all reports and other information provided or made available
by Santarus under this Section 5.1(c) shall constitute the Confidential
Information of Santarus and shall be subject to the provisions of Article 7.
Santarus acknowledges and agrees that the quarterly marketing expenditure
reports provided to Shore pursuant to Section 5.1(c)(iii) above, may be shared
by Shore with Impax, provided Impax agrees to keep such information
confidential.

5.2 Product Materials.

(a) Santarus will be responsible for the development of all Product Materials
related to the use of the Licensed Products in the Field in the Territory and
shall own all right, title, and interest in and to any intellectual property in
the Product Materials, excluding any Corporate Marks of Shore marked thereon.

(b) Santarus shall timely file with the relevant Regulatory Authority, in
accordance with all Applicable Law, all Product Materials required to be filed
with such Regulatory Authority with respect to use of the Licensed Products in
the Field in the Territory.

5.3 Complaints and Inquiries. Santarus shall be responsible for responding to
complaints, medical questions, or other inquiries relating to the Licensed
Products; provided, however, that Shore and CHRP shall promptly (but in any
event within [***]) inform Santarus of any complaints, medical questions, or
other inquiries (or issues related thereto) it receives. Each of Shore and CHRP
shall notify Santarus of, and provide all pertinent information in its
possession or of which it is aware relating to, any and all suspected or actual
tampering, counterfeiting, or contamination or other similar problems with
respect to the Licensed Products or Generic Equivalents in the Field in the
Territory.

 

 

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5.4 Pricing. Santarus shall book all sales of the Licensed Products in the
Territory and shall be solely responsible for establishing pricing and for
entering into any contracts and other arrangements regarding the distribution
and sale of the Licensed Products in the Territory. Santarus shall be
responsible for administering its own discount and rebate systems.

5.5 Exclusivity.

(a) Shore hereby covenants and agrees (and shall cause its Affiliates (other
than CHRP and any related or successor fund) to agree) not to, in whole or in
part, develop, manufacture, or commercialize any pharmaceutical product
containing the Compound in the Field in the Territory during the Term, directly
for themselves or by a Third Party licensee or sublicensee.

(b) CHRP hereby covenants and agrees not to, in whole or in part, Develop,
Manufacture or Commercialize the Licensed Product in the Field in the Territory
during the Term directly for itself or by a Third Party licensee or sublicensee.

ARTICLE 6.

MANUFACTURING AND SUPPLY

6.1 Manufacturing. Santarus shall be solely responsible, at its own cost and
expense, for the Manufacture and supply of the Compound and Licensed Products
for use in Development or Commercialization in the Territory after the Effective
Date.

6.2 NDC Numbers, Product Returns, Rebates and Chargebacks.

(a) NDC Numbers. Santarus shall have the right to sell and distribute Licensed
Product bearing Shore’s NDC Number and to increase the invoice price of such
Licensed Product. Santarus shall use Commercially Reasonable Efforts to obtain
its own NDC numbers for the Licensed Products within a reasonable period of time
following the Effective Date. As soon as reasonably practicable following
receipt of new NDC numbers, Santarus shall use such NDC numbers on all invoices,
orders and other communications with customers and Regulatory Authorities.

(b) Product Returns. Santarus shall be responsible for all returned Licensed
Products sold or distributed by Santarus after the Effective Date, and Shore
shall be responsible for all other returned Licensed Product. The Parties shall
track responsibility for such returns

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based on lot number. In the case of split lots (e.g., where each Party has sold
some portion of a lot), the Parties shall be responsible for a portion of each
return based on the proportion of the total lot sold by each Party. In the event
that any returns for which a Party is responsible are delivered to the other
Party, such returns shall be processed by the other Party and the responsible
Party shall reimburse the other Party for such returns within [***] of receipt
of an invoice that describes the requested payments in reasonable detail and
includes reasonable supporting documentation.

(c) Rebates. Shore shall be financially responsible for all government or
commercial rebates related to Licensed Products pursuant to any Product
Agreement or other similar agreement in effect prior to the Effective Date.
Santarus shall be responsible for all other government and commercial rebates
relating to Licensed Products.

(d) Chargeback Claims. Shore shall be financially responsible for all
chargebacks related to Licensed Products pursuant to any Product Agreement or
other similar agreement in effect prior to the Effective Date. Santarus shall be
responsible for all other chargebacks relating to Licensed Products.

(e) Discount Card Program. Shore shall be financially responsible for all
discount or savings card redemptions or fees related to Licensed Products
pursuant to any Product Agreement or other similar agreement in effect prior to
the Effective Date. Santarus shall be responsible for all other discount or
savings card redemptions or fees relating to Licensed Products.

(f) Invoicing; Offset. On a monthly basis, each Party shall report to the other
in writing any amounts processed and paid by it, or short-paid by any Third
Party to it, for which the other Party is financially responsible pursuant to
Sections 6.2(c), (d) or (e) above (the “Financially Responsible Party”). Any
amounts shall be invoiced on a monthly basis and, at the election of the Party
to whom payment is due, either paid by the Financially Responsible Party within
[***] after receipt thereof or offset against amounts otherwise due to the
Financially Responsible Party.

ARTICLE 7.

PAYMENTS

7.1 Upfront Payment. In consideration for the rights granted to Santarus under
this Agreement, Santarus, within [***] days after the Effective Date, shall pay
to Shore a one-time-only non-refundable payment of Eleven Million Dollars
($11,000,000).

 

 

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7.2 Sales Milestones. In consideration for the rights granted to Santarus under
this Agreement, Santarus shall pay to Shore the following non-refundable
milestone payments, within [***] after the end of the first Calendar Year in
which a sales milestone event described below is first achieved during the
Royalty Term:

 

Sales Milestone Event

   Payment  

Calendar Year Net Sales equal or exceed $20,000,000

   $ 2,000,000   

Calendar Year Net Sales equal or exceed $30,000,000

   $ 3,000,000   

For clarity, if both sales milestone events are triggered during any particular
Calendar Year during the Royalty Term and have not been previously paid, then
both sales milestones shall become due at the end of such Calendar Year.

7.3 Royalty Payments. In consideration for the rights granted to Santarus under
this Agreement, Santarus shall pay to Shore a royalty at the following royalty
rates, on Net Sales in the Territory in a Calendar Year during the Royalty Term;
provided, however, that no royalty shall be due on that portion of Calendar Year
Net Sales that are less than or equal to Ten Million Dollars during the 2011 and
2012 Calendar Years:

 

Calendar Year Net Sales in the Territory

   Royalty Rate Applicable to Such
Net Sales  

Portion of Calendar Year Net Sales that are less than or equal to $10,000,000

     5 % 

Portion of Calendar Year Net Sales that are greater than $10,000,000 but are
less than or equal to $20,000,000

     20 % 

Portion of Calendar Year Net Sales that are greater than $20,000,000

     25 % 

By way of example, if the Calendar Year Net Sales to which the royalty
obligations in this Section 7.3 apply were $25,000,000 prior to 2013, no royalty
rate would apply to the first $10,000,000 of such Net Sales, the 20% royalty
rate would apply to the next $10,000,000 of such Net Sales, and the 25% royalty
rate would apply to the final $5,000,000 of such Net Sales, resulting in a
payment of $3,250,000; and if the Calendar Year Net Sales to which the royalty
obligations in this Section 7.3 apply were $25,000,000 during or after 2013, the
5% royalty rate would apply to the first $10,000,000 of such Net Sales, the 20%
royalty rate would apply to the next $10,000,000 of such Net Sales, and the 25%
royalty rate would apply to the final $5,000,000 of such Net Sales, resulting in
a payment of $3,750,000.

7.4 Authorized Generic Revenues. Santarus and its Affiliates shall pay to Shore
[***] of the Authorized Generic Revenues received by Santarus and its Affiliates
during the Term

 

 

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7.5 Third Party Royalties; Other Credits Against Royalties.

(a) If, during the Term, Santarus, its Affiliates or its sublicensees are
obligated to pay royalties to a Third Party under an agreement with respect to
the sales of a Licensed Product in the Territory which is, in the reasonable
discretion of Santarus after consultation with Shore, required to resolve a
claim of infringement of a Third Party’s Patent Rights, such agreement to be
entered into after consulting with Shore (a “Third Party Royalty Payment”), the
royalties payable under Section 7.3, in each case with respect to such Licensed
Product in the Territory, shall be decreased by [***] of the amount of such
Third Party Royalty Payment attributed to sales of the applicable Licensed
Product; provided, however, that in no case shall such reduction under this
Section 7.5(a) lower the amount of royalties otherwise payable under Section 7.3
by more than [***]; and provided further that, on a Licensed Product-by-Licensed
Product basis, any Third Party Royalty Payments that are not credited against
royalties paid in the Calendar Quarter in which such royalties were accrued
shall be carried forward and credited against royalties payable in a subsequent
Calendar Quarter(s) hereunder, subject to the limitations set forth in this
Section 7.5, at Santarus’ option, until such royalty credits are completely
expended.

(b) For a period of [***] following the Effective Date, in addition to any
reductions under Section 7.5(a), Santarus may credit against royalties due to
Shore under Section 7.3 [***] of any amounts paid by Santarus in connection with
returns, rebates, chargebacks, redemptions or fees for which Shore is
responsible pursuant to Section 6.2.

(c) In the event that royalties are not due to Shore in a given period, or are
not due in a sufficient amount to cover the credits contemplated by Sections
7.5(a) and/or (b) above, Santarus shall have the right to elect either (i) a
credit for any remaining amounts against the royalties due with respect to
following periods, or (ii) reimbursement by Shore for such amounts within [***]
of receipt of an invoice from Santarus that describes the requested
credits/payments in reasonable detail and includes reasonable supporting
documentation.

7.6 Payments and Reports. Santarus shall deliver to Shore, within [***] after
the end of the first three (3) Calendar Quarters in a Calendar Year and within
[***] after the end of the fourth Calendar Quarter in a Calendar Year, a report
setting forth for such Calendar Quarter the following information for each
Licensed Product: (i) total invoiced gross sales and Net Sales of such Licensed
Product by Santarus and its Affiliates and sublicensees in the Territory; and
(ii) the royalties due in respect of such Net Sales. The total royalties due in
respect of Net Sales of the Licensed Products during such Calendar Quarter shall
be paid no later than [***].

7.7 Wire Transfers. All payments hereunder shall be made by Santarus or Shore,
as the case may be, in Dollars by bank wire transfer in immediately available
funds to the other Party, to such bank account as shall be designated in writing
by such other Party.

 

 

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7.8 Taxes. Any payments made under this Agreement by Santarus may be reduced by
the amount of any withholding taxes required to be paid or withheld with respect
to such payments pursuant to any Applicable Law, including United States
federal, state or local tax law. Santarus shall submit to Shore reasonable proof
of payment of such withholding taxes, together with an accounting of the
calculations of such taxes, within [***] after such withholding taxes are
remitted to the proper authority. The Parties will reasonably cooperate in
completing and filing documents required under the provisions of any Applicable
Law in connection with the making of any required tax payment or withholding
payment, or in connection with any claim to a refund of or credit for any such
payment.

7.9 Records; Audit Rights. Each of Shore and Santarus shall keep (and shall
cause its Affiliates and shall require its sublicensees to keep) complete and
accurate books and records that are necessary for the other Party to ascertain
and verify the payments owed hereunder and Santarus’ expenditures to Promote the
Licensed Product required under Section 5.1(b). During the Term and for a period
[***] thereafter, each of Shore and Santarus shall permit an independent,
certified public accountant of nationally recognized standing appointed by the
other Party, at reasonable times and upon reasonable notice, but in no case more
than once per Calendar Year, to examine (but not copy) such records as may be
necessary for the sole purpose of verifying the calculation and reporting of Net
Sales and the correctness of any payment made under this Agreement for any
period within the preceding [***] and of the amount of Santarus’ expenditures to
Promote the Licensed Product during each Calendar Quarter as required under
Section 5.1(b) hereof and compliance with any other terms and provisions of this
Agreement; provided that each Party shall only be entitled to one audit
following expiration or termination of this Agreement; and provided further that
neither Party shall be permitted to audit the same period of time more than
once. The independent, certified public accountant will prepare and provide to
each of Shore and Santarus a written report stating whether the royalty reports
submitted and royalties paid, the expenditures to Promote the Licensed Product
reported to Shore, or other payments made by either Party, as the case may be,
are correct or incorrect and the details concerning any discrepancies. Such
accountant shall disclose to Shore or Santarus, as the case may be, only the
amounts that the independent auditor believes to be due and payable hereunder to
such Party, details concerning any discrepancy from the amount paid and the
amount due, and shall disclose no other information revealed in such audit. Any
and all records of a Party examined by such independent accountant shall be
deemed such Party’s Confidential Information which may not be disclosed by said
independent, certified public accountant to any Third Party, and such Party may
require such accountant to enter into an appropriate written agreement
obligating it to be bound by obligations of confidentiality and restrictions on
use of such Confidential Information that are no less restrictive than the
obligations set forth in ARTICLE 10. In the event there was an underpayment by
either Party of amounts owed under this Agreement, such Party shall promptly
(but in no event later than [***] after its receipt of the independent auditor’s
report so concluding) make payment to the other Party of any such shortfall. In
the event that there was an overpayment by either Party hereunder, the other
Party shall promptly (but in no event later than [***] after the other Party’s
receipt of the independent auditor’s report so concluding) refund to Shore or
Santarus, as the case may be, or credit to or against future royalties, at
Santarus’ election, the excess amount. The expense of such audit shall be borne
by the auditing Party; provided, however, that, if such audit establishes that
the audited Party underpaid the auditing

 

 

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Party by more than [***] of the aggregate amount due hereunder for the period
covered by such audit, or that expenditures to Promote the Licensed Product for
a Calendar Quarter covered by such audit were less than the minimum spend
required by Section 5.1(b), then the reasonable out-of-pocket expense of such
audit shall be paid by the audited Party.

7.10 Late Payments. Subject to the terms of this Agreement, payments not made
within the time period set forth in this ARTICLE 7 shall bear interest at a rate
of [***] per annum effective for the date that payment was due, as published by
The Wall Street Journal, U.S. Edition, available online at online.wsj.com on the
date such payment was due or the maximum rate permitted by Applicable Law,
whichever is lower, calculated on the number of days such payment is delinquent
until paid in full; provided, however, that credits given to Santarus against
royalties shall not bear interest.

ARTICLE 8.

INVENTIONS AND PATENTS

8.1 Inventions.

(a) Inventorship of any Inventions that, in the case of patentable Inventions,
were conceived and reduced to practice, and in the case of non-patentable
Inventions, were made or developed, in the course of performing activities under
this Agreement, together with all any Patents claiming such Inventions, will be
determined in accordance with the rules of inventorship under United States
patent laws with respect to patentable Inventions, and in accordance with
applicable United States federal or state law with respect to non-patentable
Inventions, and ownership of such Inventions shall be as set forth in further
detail in Sections 8.1(b) through (d).

(b) Shore will own all right, title and interest in and to all Inventions, other
than LCP Core Technology Improvements, that are conceived, reduced to practice,
made or developed solely by or on behalf of Shore or CHRP from the Effective
Date until the expiration or termination of the Term (whether or not
patentable), and all intellectual property rights appurtenant thereto, subject
only to the license rights granted by Shore to Santarus under this Agreement.

(c) Santarus will own all right title and interest in and to all Inventions,
other than LCP Core Technology Improvements, that are conceived, reduced to
practice, made or developed solely by or on behalf of Santarus or its
sublicensees from the Effective Date until the expiration or termination of the
Term (whether or not patentable), and all intellectual property rights
appurtenant thereto.

(d) All right, title and interest in and to Inventions, other than LCP Core
Technology Improvements, that are conceived, reduced to practice, made or
developed jointly by employees or contractors of more than one Party from the
Effective Date until the expiration or termination of the Term (whether or not
patentable) (“Joint Inventions”), and all intellectual property rights
appurtenant thereto, will be owned jointly by such Parties. Each such Party
shall have the right to use and license such Joint Inventions freely and without
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payment obligations towards the other Party(ies), subject to the terms and
conditions of this Agreement, including Section 5.5. Except to the extent each
such Party is restricted by the foregoing or by the licenses granted to the
other Parties and covenants contained herein, each Party will be entitled to
practice and license Joint Inventions without restriction or consent of the
other Parties. Each Party shall give written notice to the other Parties of any
license to or rights granted under the Joint Inventions to a Third Party. The
applicable Parties will confer and cooperate in good faith with respect to the
Prosecution of Joint Patents. Each Party hereby agrees to take all actions and
execute and deliver all documents reasonably necessary to Prosecute such Joint
Patents.

(e) The Parties acknowledge that LifeCycle will own all right, title and
interest in and to all LCP Core Technology and LCP Core Technology Improvements
that are conceived, reduced to practice, made or developed solely by or on
behalf of any Party and/or its Affiliate or sublicensees, or by the Parties
jointly, from the Effective Date until the expiration or termination of the Term
(whether or not patentable), and all intellectual property rights appurtenant
thereto, subject only to the sublicense rights under the LifeCycle Technology
granted by Shore to Santarus under this Agreement. Santarus agrees to assign and
hereby assigns to LifeCycle all its right, title and interest in and to any LCP
Core Technology Improvements that are conceived, reduced to practice, made or
developed solely by or on behalf of Santarus and/or its Affiliate or
sublicensees, or by the Parties jointly, and all intellectual property rights
appurtenant thereto. For purposes of this Agreement, all LCP Core Technology and
LCP Core Technology Improvements shall be the Confidential Information of Shore.

(f) Disclosure of Inventions.

(i) Subject to Section 8.1(f)(ii) below, each Party shall, at its own expense,
promptly disclose to the other Parties all Inventions owned or Controlled by
such Party relating to Licensed Products that arise during the Term.

(ii) Santarus shall, or shall cause its Affiliates or sublicensees to promptly
disclose to CHRP or LifeCycle any and all Inventions relating to LifeCycle’s
MeltDose® technology that arise during the Term, and shall disclose all LCP Core
Technology Improvements conceived or made by or on behalf of Santarus or its
Affiliates, and any Santarus Technology of which Santarus becomes aware is
needed or reasonably useful to the development or commercialization of the
Licensed Products outside the Territory, at no additional cost, and in each case
promptly after Santarus’ patent counsel is made aware of such Inventions, LCP
Core Technology Improvements or Santarus Technology.

(iii) Information provided by the Parties under this Section 8.1(f) with respect
to Inventions will be in reasonable detail but in no circumstance less than
would be sufficient to permit an understanding of the nature of the Inventions
by a practitioner reasonably skilled in the relevant technical or scientific
area.

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8.2 Patent Prosecution.

(a) Prosecution. Shore shall, or shall collaborate with LifeCycle in accordance
with the Upstream Agreements to, use Commercially Reasonable Efforts to
Prosecute the Licensed Patents in the Territory, at its sole expense, except as
set forth below; provided that Shore shall provide Santarus with a reasonable
opportunity to review and comment on such Prosecution, and shall consider such
comments in good faith. If Shore is required to assume Prosecution of the
Product-Specific Patents in the Territory under the LifeCycle Agreement, Shore
may elect by [***] prior written notification to Santarus, to have Santarus
assume such Prosecution. Thereafter, Santarus shall use Commercially Reasonable
Efforts to Prosecute the Product-Specific Patents in the Territory, at Santarus’
expense and through patent counsel selected by Santarus; provided, however, that
Santarus’ out-of-pocket expenses under this Section 8.2(a) shall not exceed
[***] over the Term. If Shore elects to have Santarus conduct Prosecution of
particular Product-Specific Patents in the Territory, then Santarus shall
provide Shore and LifeCycle reasonable opportunities to consult with Santarus
regarding such Prosecution by Santarus and Shore shall cooperate with and assist
Santarus reasonably in such Prosecution of the Product-Specific Patents.

(b) Patent Term Extensions. Upon request by Santarus, CHRP shall request that
LifeCycle file all applications and take actions necessary to obtain patent
extension pursuant to 35 U.S.C. § 156 for the Licensed Patents in the Territory,
which extensions shall be owned by LifeCycle. If LifeCycle declines to pursue
such patent extensions, then Santarus shall have the right (at Santarus’ cost
and expense) on behalf of LifeCycle, CHRP and Shore to file all such
applications and take all such actions necessary to obtain such patent
extensions.

8.3 Enforcement.

(a) Notice. If Shore or Santarus becomes aware of infringement of any Licensed
Patent by a Third Party anywhere in the world, such Party shall promptly notify
the other Party in writing to that effect and provide a summary of the relevant
facts and circumstances known to such Party relating to such infringement
(“Infringement Notice”). Promptly after receipt of an Infringement Notice, Shore
and Santarus shall discuss in good faith the infringement and appropriate
actions that could be taken to cause it to cease.

(b) Product-Specific Patents. Santarus shall have the right, at its sole
discretion, on its own behalf, to institute, prosecute and control any action or
proceeding to restrain infringement of any Product-Specific Patent in the
Territory by a Third Party, other than the Impax Litigation or any such action
or proceeding for which Santarus does not have standing to so institute or
prosecute. In any instance in which Santarus does not have such standing, or to
the extent the Impax Litigation continues following the Effective Date, Shore
shall, under Santarus’ direction and control and expense (except with respect to
the Impax Litigation, the cost and expense for which CHRP and/or Shore shall be
solely responsible), institute or prosecute such action or proceeding to
restrain infringement. The Parties which are not party to such an action or
proceeding agree to be joined, and shall request that LifeCycle join, as a party
plaintiff if necessary or appropriate, and shall provide all reasonable
cooperation, at Santarus’ expense, required to prosecute such action. Santarus
shall have sole control of any such action and all negotiations for its
settlement or compromise and shall have the sole right to settle or compromise
any such action (or direct such settlement or compromise), provided that no
party shall settle or

 

 

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compromise any such action or enter into any consent order for the settlement or
compromise of such action that may materially negatively impact the rights or
interests of LifeCycle and/or Shore without the prior written consent of
LifeCycle and/or Shore, as applicable, such consent by Shore not to be
unreasonably withheld, conditioned or delayed; and provided further, however,
that Santarus shall keep Shore reasonably informed of the status of any such
action and provide Shore and LifeCycle reasonable opportunities to consult with
Santarus regarding such action. If, prior to the expiration of [***] from an
Infringement Notice regarding infringement of any Product-Specific Patent,
Santarus has not obtained a discontinuance of the alleged infringement or
brought an infringement action or proceeding or otherwise taken appropriate
action to abate such infringement, then Shore and LifeCycle shall each have the
right, but not the obligation, to institute, prosecute and control any action or
proceeding to restrain such infringement. In such event, Shore or LifeCycle, as
applicable, shall have control of any such action and all negotiations for its
settlement or compromise and shall have the sole right to settle or compromise
any such action (or direct such settlement or compromise), provided that Shore
shall not settle or compromise any such action or enter into any consent order
for the settlement or compromise of such action that may materially negatively
impact the rights or interests of Santarus without the prior written consent of
Santarus, such consent not to be unreasonably withheld, conditioned or delayed;
and provided further, however, that Shore shall (if a party to such action), or
shall request LifeCycle, if applicable, to keep Santarus reasonably informed of
the status of any such action and provide Santarus reasonable opportunities to
consult with Shore or LifeCycle regarding such action.

(c) Other Licensed Patents. LifeCycle or CHRP, as the case may be in accordance
with the Upstream Agreements, shall have the right, at its sole discretion, to
institute, prosecute and control any action or proceeding to restrain
infringement of any Licensed Patent other than the Product-Specific Patents in
the Territory by a Third Party. If, prior to the expiration of [***] from an
Infringement Notice regarding infringement of any such Licensed Patent,
LifeCycle or CHRP, as the case may be, has not obtained a discontinuance of the
alleged infringement or brought an infringement action or proceeding or
otherwise taken appropriate action to abate such infringement, then, unless
LifeCycle has a reasonable business justification for not taking action against
such alleged infringement, Santarus shall have the right, but not the
obligation, to institute, prosecute and control any action or proceeding to
restrain such infringement unless Santarus does not have standing to so
institute or prosecute. In any instance in which Santarus does not have such
standing, Shore shall, under Santarus’ direction and control and expense,
institute or prosecute such action or proceeding to restrain infringement. The
Parties which are not party to such an action, or proceeding to agree to be
joined, and shall request that LifeCycle join, as a party plaintiff if necessary
or appropriate, and shall provide all reasonable cooperation, at Santarus’
expense, required to prosecute such action, and provided however, that Santarus
shall keep Shore reasonably informed of the status of any such action and
provide Shore and LifeCycle reasonable opportunities to consult with Santarus
regarding such action.

(d) Orange Book Listings. Santarus shall have the sole right, but not the
obligation, to submit to all applicable Regulatory Authorities in the Territory
Patent information pertaining to each Licensed Product pursuant to 21 U.S.C.
§355(b)(1)(G) (or any amendment or successor statute thereto).

 

 

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(e) Costs and Recoveries. Except as otherwise expressly set forth herein, each
Party shall assume and pay all of its own out-of-pocket costs incurred in
connection with any litigation or proceedings described in this Section 8.3
including the fees and expenses of such Party’s counsel. Any recovery obtained
by any Party as a result of any proceeding described in this Section 8.3, by
settlement or otherwise, shall be applied in the following order of priority:
(i) first, to reimburse each Party for all reasonable costs in connection with
such proceeding paid by that Party and not otherwise recovered (on a pro rata
basis based on each Party’s respective costs, to the extent the recovery was
less than all such litigation costs); and (ii) second, the remainder of the
recovery shall be retained by the Party that brought and prosecuted the suit,
provided that any net recovery from an action by Santarus to the extent
attributable to lost sales of Licensed Products. shall be deemed Net Sales of
Santarus for which royalties shall be paid under ARTICLE 7 and Santarus shall
retain the balance.

8.4 Declaratory Actions and Counterclaims. In the event that an action alleging
invalidity or non-infringement of any of the Licensed Patents is brought against
LifeCycle, Shore or Santarus, LifeCycle or CHRP, at its sole discretion, shall
have the right, within [***] after the commencement of such action, to take or
regain control of the action at its own expense; provided, however, that CHRP
shall, if it assumes control of such an action, diligently defend or assert such
Licensed Rights or, if LifeCycle assumes control of such action, CHRP shall use
Commercially Reasonable Efforts to cause LifeCycle to diligently defend or
assert such Licensed Rights in accordance with Section 5.08 of the Purchase
Agreement (as that term is defined in the LifeCycle Agreement), and CHRP shall
not settle or compromise any such action or enter into any consent order for the
settlement or compromise thereof, and shall use Commercially Reasonable Efforts
to cause LifeCycle not to settle or compromise any such action or enter into any
consent order for the settlement or compromise thereof, as the case may be,
without the prior written consent of Santarus, which consent shall not be
unreasonably withheld, conditioned or delayed. If LifeCycle and CHRP determine
not to exercise this right, Santarus may take over or remain as lead counsel for
the action at Santarus’ sole discretion and expense; provided however, that
Santarus shall keep Shore reasonably informed of the status of any such action
and provide Shore and LifeCycle reasonable opportunities to consult with
Santarus regarding such action. Any recovery obtained from such litigation,
proceeding or settlement shall be shared in accordance with Section 8.3(d).

8.5 Infringement Defense.

(a) Defense of Third Party Claims. If a Third Party asserts that a Patent owned
or otherwise controlled by it is infringed by the Development, Manufacture, use
or Commercialization of a Licensed Product in the Territory, the Party first
obtaining knowledge of such a claim shall immediately provide the other Parties
notice of such claim, along with the related facts in reasonable detail.
Santarus shall have the first right, but not the obligation, to control and
defend any action or proceeding with respect to such claim, and Shore and CHRP,
at Santarus’ reasonable request and expense (including reasonable attorney’s
fees), shall cooperate with Santarus with respect to any such action. Santarus
shall have sole control of any such suit and all negotiations for its settlement
or compromise, provided that Santarus shall not settle or

 

 

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compromise any such action or enter into any consent order for the settlement or
compromise of such action that would adversely impact (i) LifeCycle, or its
rights or interests in or to any LifeCycle Technology without the prior written
consent of LifeCycle, such consent not to be unreasonably withheld, condition,
or delayed; or (ii) Shore, or its rights or interests in or to any Licensed
Technology, without the prior written consent of Shore; not to be unreasonably
withheld, conditioned or delayed; and provided further, however, that Santarus
shall keep Shore reasonably informed of the status of any such action and
provide Shore reasonable opportunities to consult with Santarus regarding such
action.

(b) Step-In Right. If Santarus has not undertaken to defend any Third Party
action that is subject to Section 8.5(a) above, or if Santarus shall at any time
fail to continue to defend such Third Party action, then LifeCycle, CHRP and
Shore shall have the right, as provided in the applicable Upstream Agreement,
but not the obligation, to defend and control such action. Santarus shall
provide all reasonable cooperation, at the requesting party’s expense, required
to defend such litigation.

ARTICLE 9.

REPRESENTATIONS, WARRANTIES, AND COVENANTS

9.1 Representations, Warranties and Covenants. Each Party represents, warrants
and covenants to the other Parties the following:

(a) it is duly organized, validly existing and in good standing under the laws
of its jurisdiction of incorporation or formation, 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 or persons executing this Agreement on
its behalf has been duly authorized to do so by all requisite corporate action;

(c) all necessary consents, approvals and authorizations of all Regulatory
Authorities and other Third Parties required to be obtained by such it in
connection with the execution and delivery of this Agreement and the performance
of its obligations hereunder have been obtained, other than the delivery of
written assignment of the NDA for the Product to the FDA;

(d) this Agreement is a legal and valid obligation binding upon it and
enforceable in accordance with its terms;

(e) the execution, delivery, and performance of this Agreement by it does not
conflict with or result in a breach of any of the terms or provisions of any
agreement, instrument, or understanding, oral or written, to which it is a Party
or by which it is bound, nor violate any material law or regulation of any
court, governmental body, or administrative or other agency having jurisdiction
over it;

(f) it has not granted and will not during the Term grant any right to any Third
Party that would conflict with the rights granted to the other Parties
hereunder;

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(g) it shall comply and cause its employees and consultants who will be
undertaking any activities related to this Agreement or the Licensed Products to
comply, with all Applicable Laws respecting such activities; and

(h) neither its name nor the name of any of its employees or consultants who
will be undertaking any activities related to this Agreement or the Licensed
Products are listed on the debarment list maintained by the FDA pursuant to 21
U.S.C. Sections 335(a) and Section 335(b) and published on the internet at the
following address (or any successor address):
http://www.fda.gov/ora/compliance_ref/debar/default.htm. In the course of the
Development, Manufacture and Commercialization of the Licensed Products prior to
or pursuant to this Agreement, it has not used, and during the Term will not
use, any employee or consultant that is debarred by any Regulatory Authority or,
to the best of its knowledge, is the subject of debarment proceedings by any
Regulatory Authority. If it learns that its employee or consultant performing on
its behalf under this Agreement has been debarred by any Regulatory Authority,
or has become the subject of debarment proceedings by any Regulatory Authority,
it shall so promptly notify the other Party and shall prohibit such employee or
consultant from performing on its behalf under this Agreement.

9.2 Representations, Warranties and Covenants of Shore.

Shore hereby represents and warrants to Santarus the following:

(a) it was, at all times following transfer of the Regulatory Approvals for the
Licensed Product by Shionogi to Shore prior to the Effective Date, the lawful
holder of all rights under the Regulatory Approvals and the Regulatory Filings
for the Licensed Products in the Field in the Territory, and that it has
provided to Santarus true, correct and complete copies of the Regulatory
Approvals, Regulatory Filings and any material correspondence with Regulatory
Authorities received by it, including 483s, warning letters, field alerts or
other notices for the Licensed Products in the Field in the Territory. Shore is
not aware of any Regulatory Filing that is not in its possession, which could
have a material adverse effect on Santarus’ ability to Manufacture or
Commercialize the Licensed Product;

(b) Shore has not committed fraud in relation to the filing or acquisition of
the Regulatory Approvals for the Licensed Products in the Field in the Territory
or used unfair methods of competition in connection with such filing or
acquisition or maintenance, including, in either case, in connection with any
data supplied by Shore to the FDA. To Shore’s knowledge, the data regarding the
efficacy, safety, chemistry, manufacturing and control of the Licensed Products
contained in the Regulatory Approvals for the Licensed Products in the Field in
the Territory are complete and accurate in all material respects and do not
contain any material misstatement of a material fact related to safety or
efficacy nor omit to state any material fact in Shore’s possession related to
safety or efficacy of the Licensed Products. Shore has not received any written
communication from FDA stating that any development activities are required by
the FDA as a condition to maintenance of the Regulatory Approvals for the
Licensed Products in the Field in the Territory;

(c) except as set forth in Exhibit 9.2, all activities prior to the Effective
Date following transfer of the Regulatory Approvals for the Licensed Product by
Shionogi to Shore,

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and, to its knowledge, all such activities prior to transfer of the Regulatory
Approvals for the Licensed Product by Shionogi to Shore, in connection with
(i) Manufacture of the Licensed Product, (ii) Commercialization and
(iii) preparation and submission to the relevant Regulatory Authorities of the
Regulatory Approvals and the Regulatory Filings for the Licensed Products in the
Field in the Territory in existence as of the Effective Date, were in compliance
in all material respects with all Applicable Law;

(d) Shore has not received any written notice or communication which has, or
reasonably should have, led it to believe that either the Regulatory Approvals
or the Regulatory Filings for the Licensed Products in the Field in the
Territory in existence as of the Effective Date are not in good standing with
relevant Regulatory Authorities;

(e) as of the Effective Date, there is no pending action by relevant Regulatory
Authorities in respect of the Regulatory Approvals or the Regulatory Filings for
the Licensed Products in the Field in the Territory, and, except as set forth in
Exhibit 9.2, prior to the Effective Date following transfer of the Regulatory
Approvals for the Licensed Product by Shionogi to Shore, and, to its knowledge,
prior to transfer of the Regulatory Approvals for the Licensed Product by
Shionogi to Shore, there has been no action by relevant Regulatory Authorities
in respect of Regulatory Approvals or the Regulatory Filings for the Licensed
Products in the Field in the Territory;

(f) it has the full legal right, power and authority to grant the license rights
set forth in ARTICLE 2;

(g) it has granted Santarus a license to all intellectual property rights it
owns or controls that are necessary to Develop, Manufacture, use or
Commercialize the Licensed Products in the Field in the Territory, each subject
to and in accordance with the terms and conditions of this Agreement;

(h) except as set forth in Exhibit 9.2, there are no liens or security interests
currently existing on or to, and following the Effective Date, it shall not, and
shall not grant any Third Party the right to, place any liens or security
interests on or to, the intellectual property rights, Regulatory Approvals,
Regulatory Filings, Upstream Agreements, Product Agreements or Product Materials
Licensed or transferred by it to Santarus hereunder that could reasonably be
expected to adversely affect Santarus’ Commercialization of the Licensed Product
under this Agreement;

(i) there is no claim, action, suit, or proceeding, pending or, to its
knowledge, threatened by a Third Party alleging that the Development or
Commercialization of the Licensed Products infringes or misappropriates any
patents or other intellectual property rights of any Third Party;

(j) except as set forth in Exhibit 9.2, there is no litigation, arbitration
proceeding, governmental investigation, action or claims of any kind, pending
or, to the knowledge of Shore, threatened, by or against Shore or any of its
Affiliates relating to the Licensed Products or, except for the Impax
Litigation, Santarus’ ability to exercise its rights hereunder, nor, to Shore’s
knowledge, is any litigation, arbitration proceeding, governmental

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investigation, action or claims of any kind, pending or, to the knowledge of
Shore, threatened, by or against Chemagis or Catalent or their respective
Affiliates relating to the Licensed Products. Shore is not a party to any
litigation regarding any claim of product liability or damage to person
(including death) or property resulting from the use or consumption of a
Licensed Product in the Territory, nor has Shore received any written
communication threatening any such litigation. Shore represents and warrants
that any action it may bring against Shionogi for breach of its obligations
under the Shionogi License Agreement will not have a material adverse impact on
Santarus’ ability to Manufacture or Commercialize the Licensed Products and
Shore reserves the right to commence such action against Shionogi, at its sole
cost and expense;

(k) to its knowledge, the Manufacture of the Licensed Products in the Territory
and the Development, Commercialization and use of the Licensed Products in the
Field in the Territory does not infringe or misappropriate any Patents or other
intellectual property rights of any Third Party;

(l) it has not given any notice to any Third Party asserting infringement by
such Third Party with respect to the Licensed Products in the Field in the
Territory of any of the intellectual property rights licensed hereunder, and it
is not aware of any such infringements other than as alleged in the Impax
Litigation;

(m) to its knowledge, no issued patent or patent application within the Licensed
Patents is the subject of any pending interference, opposition, cancellation,
protest, or other challenge or adversarial proceeding in the Territory;

(n) it is not aware of (i) any facts that it believes would result in invalidity
or unenforceability of any of the Licensed Patents or Product Trademarks,
(ii) any claim, action, suit or proceeding pending or threatened that any of the
Licensed Patents are invalid or unenforceable (other than the Impax Litigation
and any claims made in writing in connection therewith), and (iii) the
abandonment of any of the Licensed Patents (except for expiring provisional
applications, expiring PCT applications, and other Patents expiring by operation
of law), disclaimer of any of the Licensed Patents (other than with respect to
terminal disclaimers) or expiration of any of the Licensed Patents due to
failure to timely pay applicable maintenance and renewal fees;

(o) each Upstream Agreement is in full force and effect, and no event has
occurred which, after the giving of notice or the lapse of time or both, would
constitute a material breach by it or Shore under such Upstream Agreement. Shore
has not received from a Third Party any written notice to the effect that Shore
is in breach of any Upstream Agreement and is not otherwise aware of any such
breach;

(p) neither it nor any of its Affiliates has granted any licenses to, agreed not
to sue, or otherwise authorized, any person or entity, under the Licensed
Technology or Shionogi Technology to Develop, Manufacture, use or Commercialize
the Licensed Products in the Field in the Territory, other than the grant of
rights by CHRP to Shore under the Shore Agreement and the grant of rights by
Shore to Impax under the Impax Sublicense Agreement;

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(q) prior to the Effective Date, to its knowledge, there have been no FDA “field
alerts” (or the equivalent in countries outside the United States) with respect
to the Licensed Products, and as of the Effective Date no such “field alerts”
are pending. Shore has no plans to initiate any recall, market withdrawal or
other corrective action with respect to Licensed Product and, except as set
forth on Exhibit 9.2, is not aware of any investigation or inquiry by any
governmental authority or Regulatory Authority related to Development,
Manufacturing, or Commercialization of Licensed Products;

(r) there are no written understandings or agreements relating to the
Development, Manufacture or Commercialization of the Licensed Products between
Shore and any Third Party, other than the Product Agreements and the Impax
Sublicense Agreement;

(s) it has provided true, correct and complete copies of each Product Agreement,
as in effect on the Effective Date, to Santarus. Shore has provided to Santarus
all excerpts from any existing agreements providing for Rights of Reference with
respect to the Licensed Products or the right of access to data described in
Section 4.2, and all such excerpts are true and accurate;

(t) each of the Impax Settlement Agreement, the Impax Sublicense Agreement, and
each Product Agreement is in full force and effect, and no event has occurred
which, after the giving of notice or the lapse of time or both, would constitute
a material breach by it or the Shore under such agreements. Shore has not
received from a Third Party any written notice to the effect that Shore is in
breach of the Impax Settlement Agreement, the Impax Sublicense Agreement or any
Product Agreement;

(u) since January 1, 2011, Shore has not (A) (i) materially altered its
distribution practices with respect to the Licensed Products, (ii) materially
altered its activities and practices with respect to inventory levels of the
Licensed Products maintained at the wholesale, chain, institutional or retail
levels in any material respect, or (iii) experienced abnormally high levels of
returns of the Licensed Products; in each such case, which would have a material
adverse effect on Santarus or the Commercialization of the Licensed Products, or
(B) sold any Licensed Product dispensed under a Medicare contract;

(v) all of the Inventory (a) is good, issuable and merchantable in the ordinary
course of business, and is free of any material defect or deficiency, (b) fully
conforms to the specifications for the Licensed Products in the Regulatory
Approvals in the Territory, (c) was manufactured, packaged, labeled, held,
tested and shipped in accordance with the specifications for the Licensed
Products as set forth in the Regulatory Approvals in the Territory, cGMPs, all
other applicable laws, regulations and requirements of applicable Regulatory
Authorities, (d) is not adulterated or misbranded and is of suitable quality;
and (e) may be introduced into interstate commerce in the Territory pursuant to
the FD&C Act;

(w) Exhibit 9.2(w) sets forth a true, complete and accurate list of all unfilled
firm orders placed or deemed to have been placed for Product or Compound under
the Product Agreements as of December 11, 2011 and the most recent forecasts
provided by Shore under the API Supply Agreement and/or the Commercial Supply
Agreement;

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(x) there was no Shionogi Technology identified or transferred by Shionogi when
the rights to the product were transferred by Shionogi to Shore; and

(y) the LifeCycle Technology and Shionogi Technology existing as of the
Effective Date constitute all of the Patents and Know-How Controlled by Shore as
of such date that are necessary or useful to Develop, Commercialize, or
Manufacture Licensed Products.

9.3 Representations and Warranties of CHRP.

CHRP hereby represents and warrants to Santarus the following:

(a) The LifeCycle Agreement is in full force and effect, and no event has
occurred which, after the giving of notice or the lapse of time or both, would
constitute a material breach by it or LifeCycle. CHRP has not received from
LifeCycle any written notice to the effect that CHRP is in breach of the
LifeCycle Agreement and is not otherwise aware of any such breach;

(b) neither it nor any of its Affiliates has granted any licenses to, agreed not
to sue, or otherwise authorized, any person or entity, under the Licensed
Technology or Shionogi Technology to Develop, Manufacture, use or Commercialize
the Licensed Products in the Field in the Territory, other than the grant of
rights by it to Shore under the Shore Agreement and the grant of rights by Shore
to Impax under the Impax Sublicense Agreement; and

(c) all rights Controlled by it in the Licensed Technology or Shionogi
Technology have been exclusively granted to Shore.

9.4 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NO PARTY MAKES
ANY, AND EACH OF THE PARTIES HEREBY DISCLAIM ALL, REPRESENTATIONS AND
WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, WRITTEN OR ORAL, INCLUDING
THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND TITLE.

ARTICLE 10.

CONFIDENTIALITY

10.1 Treatment of Confidential Information. Except as provided below, the
Parties agree that during the Term, and for a period of [***] after the Term, a
Party receiving Confidential Information (the “Receiving Party”) of another
Party (the “Disclosing Party”), whether such receipt occurs before or during the
Term, shall (a) maintain Confidential Information of the Disclosing Party in
confidence to the same extent and with the same degree of care as the Receiving
Party maintains its own proprietary industrial information of similar kind and
value (but at a minimum each Party shall use Commercially Reasonable Efforts),
(b) not disclose such Confidential Information to any Third Party without prior
written consent of the Disclosing Party, except for disclosures made in

 

 

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confidence to sublicensees and commercial partners for Licensed Products who
agree to be bound by obligations of nondisclosure and non-use at least as
stringent as those contained in this ARTICLE 10, and (c) not use such
Confidential Information for any purpose except those permitted by this
Agreement. If any Party becomes aware or has knowledge of any unauthorized use
or disclosure of another Party’s Confidential Information, it shall promptly
notify the other Party of such unauthorized use or disclosure.

10.2 Authorized Disclosures. Nothing in this Agreement shall prohibit the
Receiving Party from disclosing Confidential Information of a Disclosing Party,
as well as the terms and conditions of this Agreement, to the extent:

(a) such disclosure (i) is reasonably necessary for filing or prosecuting Patent
rights as contemplated by this Agreement; or (ii) is reasonably necessary for
prosecuting or defending litigation as contemplated by this Agreement;

(b) such disclosure is reasonably necessary: (i) to the Receiving Party’s and
its Affiliates directors, attorneys, independent accountants, or financial
advisors for the sole purpose of enabling such directors, attorneys, independent
accountants or financial advisors to provide advice to the Receiving Party,
provided that in each such case on the condition that such directors, attorneys,
independent accountants and financial advisors are bound by confidentiality and
non-use obligations consistent with those contained in this Agreement; or
(ii) to actual or potential investors or acquirors solely for the purpose of
evaluating an actual or potential investment or acquisition; provided that in
each such case on the condition that such actual or potential investors or
acquirors are bound by confidentiality and non-use obligations consistent with
those contained in the Agreement; and

(c) such disclosure is required by Applicable Law (including the rules and
regulations of the Securities and Exchange Commission or any national securities
exchange), or judicial or administrative process, provided that in such event
such Receiving Party shall promptly inform the Disclosing Party of such required
disclosure and provide the Disclosing Party an opportunity to challenge or limit
the disclosure obligations. Confidential Information that is disclosed by
Applicable Law, or judicial or administrative process shall remain otherwise
subject to the confidentiality and non-use provisions of this ARTICLE 10, and
the Party disclosing Confidential Information pursuant to law or court order
shall take all steps reasonably necessary, including seeking of confidential
treatment or a protective order, to ensure the continued confidential treatment
of such Confidential Information.

10.3 Publicity. The Parties agree that any public announcement of the execution
of this Agreement shall be substantially in the form attached as Exhibit 10.3
and shall cooperate in the issuance thereof as soon as practicable after the
execution of this Agreement unless agreed otherwise In addition, each of CHRP
and Shore recognizes that Santarus may from time to time desire to issue
additional press releases and make other public statements or disclosures
regarding the subject matter of this Agreement. Santarus shall use reasonable
efforts to provide Shore with an

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opportunity to review and comment on any such disclosures and shall consider
Shore’s comments in good faith. Notwithstanding anything else in this ARTICLE
10, any disclosure which is required by law or the rules of a securities
exchange, or as advised by the disclosing Party’s counsel, may be made without
the prior consent or review of the other Parties hereto. Except as set forth
herein, neither CHRP nor Shore shall issue press releases or make other public
statements or disclosures regarding the subject matter of this Agreement without
Santarus’ prior written consent, not to be unreasonably withheld, conditioned or
delayed.

10.4 Publication. Shore agrees that it shall not publish or present to the
public the results of any non-clinical scientific studies or clinical trials
related to Licensed Products in the Field without the opportunity for prior
review by Santarus. If Shore wishes to publish or to present to the public such
results, then it shall provide Santarus the opportunity to review any of Shore’s
proposed abstracts, manuscripts or presentations (including verbal
presentations) regarding Licensed Products at least [***] prior to the intended
date of submission for publication. Shore understands that a reasonable
commercial or regulatory strategy may require delay of publication of
information. For the avoidance of doubt, except as provided in this ARTICLE 10,
no Party shall publicly disclose any Confidential Information of another Party
without such other Party’s prior written consent.

10.5 Confidentiality Agreement. Disclosures of information made by the Parties
pursuant to the Confidentiality Agreement are deemed to have been made pursuant
to this Agreement and subject to this ARTICLE 10. The Confidentiality Agreement
is hereby terminated as of the Effective Date and of no further force or effect,
except with respect to any breach of the Confidentiality Agreement prior to the
Effective Date.

ARTICLE 11.

INDEMNIFICATION

11.1 Indemnification by Santarus. Subject to Section 11.4, Santarus agrees to
indemnify, defend and hold harmless the LifeCycle Indemnitees, CHRP Indemnitees
and Shore Indemnitees from and against any liabilities, losses, costs, damages,
fees, or expenses (including reasonable legal expenses and attorneys’ fees)
payable to a Third Party (collectively, “Losses”) arising out of any claim,
action, lawsuit, or other proceeding (collectively, “Claims”) brought against
any LifeCycle Indemnitees, CHRP Indemnitees and/or Shore Indemnitees by a Third
Party to the extent resulting directly or indirectly from (a) the negligence or
willful misconduct of the Santarus Indemnitees; (b) any material breach by
Santarus of any of its representations, warranties, covenants or obligations
pursuant to this Agreement, including, without limitation, the Assigned Rights;
or (c) the Development, Manufacture, use, or Commercialization of the Licensed
Products by any and all Santarus Indemnitees (including products liability
claims) on or after the Effective Date; except to the extent such Losses result
from activities for which Shore or CHRP must indemnify the Santarus Indemnitees
pursuant to Sections 11.2. or 11.3.

 

 

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11.2 Indemnification by Shore. Subject to Section 11.4, Shore agrees to
indemnify, defend and hold harmless the Santarus Indemnitees from and against
any Losses arising out of any Claims brought against any Santarus Indemnitee by
a Third Party to the extent resulting directly or indirectly from (a) any
Product Agreement assumed by Santarus pursuant to Section 2.1(d) to the extent
arising from activities prior to the Effective Date, (b) any Product Agreement
not assumed by Santarus pursuant to Section 2.1(d), (c) the Development,
Manufacturing, use or Commercialization of Licensed Products prior to the
Effective Date; (c) any material breach by Shore or CHRP of any of their
respective representations, warranties, covenants or obligations under any
agreement related to the Licensed Technology, Shore Technology or Shionogi
Technology to which CHRP or Shore are party, including the Upstream Agreements,
other than the Assigned Rights; (d) any product liability claim made with
respect to the Licensed Products (including the Inventory) Manufactured or
Commercialized prior to the Effective Date; (e) the negligence or willful
misconduct of the CHRP Indemnitees or the Shore Indemnitees; (f) any material
breach by Shore of any of its representations, warranties, covenants or
obligations pursuant to this Agreement, the Impax Settlement Agreement, or the
Impax Sublicense Agreement (other than the Assigned Rights), including any
failure to satisfy any Excluded Liabilities or Obligations; or (g) the
performance of obligations by Shore or CHRP under any agreement between CHRP and
Shore, except to the extent such Losses result from activities for which
Santarus must indemnify the LifeCycle Indemnitees, CHRP Indemnitees and/or Shore
Indemnitees pursuant to Section 11.1. For clarity, Santarus shall be solely
responsible for its legal costs and expenses related to the Impax Litigation, if
any.

11.3 Indemnification by CHRP. Subject to Section 11.4, CHRP agrees to indemnify,
defend and hold harmless the Santarus Indemnitees from and against any Losses
arising out of any Claims brought against any Santarus Indemnitee by a Third
Party to the extent resulting directly or indirectly from (a) the negligence or
willful misconduct of CHRP; (b) any material breach by CHRP of any of its
representations, warranties, covenants or obligations pursuant to this
Agreement; or (c) the performance of obligations by Shore or CHRP under any
agreement between CHRP and Shore, except to the extent such Losses result from
activities for which Santarus must indemnify the LifeCycle Indemnitees, CHRP
Indemnitees and/or Shore Indemnitees pursuant to Section 11.1.

11.4 Procedure. The indemnified Party shall provide the indemnifying Party with
prompt notice of the Claim which might give rise to an indemnification
obligation pursuant to this ARTICLE 11 indicating the nature of the Claim and
the basis therefore. The indemnifying Party shall have the right, at its option,
to assume the defense of, at its own cost and by its own counsel, any such Claim
involving the asserted liability of the indemnified Party. The indemnified Party
shall cooperate fully with the indemnifying Party and its counsel in the defense
against any such Claim, including making available to the indemnifying Party any
books, records or other documents within its control that are necessary for such
defense. All reasonable costs incurred in

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connection with the indemnified Party’s cooperation will be borne by the
indemnifying Party. The indemnifying Party shall keep the other Party advised of
the status of such Claim and the defense thereof and shall consider
recommendations made by the indemnified Party with respect thereto. The
indemnified Party shall not agree to any settlement of such Claim without the
prior written consent of the indemnifying Party, which consent shall not be
unreasonably withheld, conditioned or delayed. The indemnifying Party shall not
agree to any settlement of such Claim or consent to any judgment in respect
thereof that does not include a complete and unconditional release of the
indemnified Party from all liability with respect thereto or that imposes any
liability or obligation on the indemnified Party or adversely affects the
indemnified Party without the prior written consent of the indemnified Party,
which consent shall not be unreasonably withheld, conditioned or delayed.
Notwithstanding an election by the indemnifying Party to assume the defense of
any Claim as set forth above, such indemnified Party shall have the right (at
its own cost if the indemnifying Party has elected to assume such defense) to
employ separate counsel and to participate in the defense of any Claim. In the
event that Shore possesses insufficient funds to indemnify Santarus pursuant to
Section 11.2 for any Claim, Santarus shall have the right to offset all Losses
arising out of any such Claim against the sales milestones and royalties
otherwise payable by Santarus under Sections 7.2 and 7.3; provided, however,
that such offset right shall not be Santarus’ sole remedy in the event of an
indemnification claim hereunder.

11.5 Insurance. Each Party shall procure and maintain insurance, including
product liability insurance, adequate to cover its obligations hereunder and
which are consistent with normal business practices of prudent companies
similarly situated for so long as Licensed Products in the Territory continue to
be Developed, Manufactured or sold and thereafter. It is understood that such
insurance shall not be construed to create a limit of any Party’s liability with
respect to its indemnification obligations under this ARTICLE 11. Each Party
shall provide the other Party with written evidence of such insurance upon
request. Each Party shall provide the other Party with written notice at least
[***] prior to the cancellation, non-renewal or material change in such
insurance or self-insurance which materially adversely affects the rights of the
other Party hereunder.

Without limiting the foregoing, Santarus shall obtain and maintain commercial
general liability insurance, including clinical trials and products liability
insurance, with reputable and financially secure insurance carriers, in such
amounts and subject to such deductibles as are reasonable and customary in the
pharmaceutical industry for companies of comparable size and activities (but in
no event less than the amounts required under the API Supply Agreement and
Commercial Supply Agreement or any other supply agreement for the Licensed
Products), which insurance shall name LifeCycle, CHRP and Shore as additional
insureds. Santarus shall maintain such insurance for so long as Licensed
Products in the Territory continue to be Developed, Manufactured or sold and
thereafter for [***] to cover any and all Claims which may arise during such
time from the Development, Manufacture or sale of a Licensed Product in the
Territory. Upon reasonable request by CHRP, Santarus shall deliver to CHRP
evidence satisfactory to CHRP that such insurance policies are valid, kept up to
date and in full force and effect.

 

 

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11.6 Limitation of Liability. NO PARTY SHALL BE LIABLE TO THE OTHER FOR ANY
SPECIAL, INCIDENTAL, PUNITIVE, INDIRECT, OR CONSEQUENTIAL DAMAGES (INCLUDING
DAMAGES FOR LOST PROFITS), ARISING FROM OR RELATING TO THIS AGREEMENT (EVEN IF
SUCH DAMAGES MAY HAVE BEEN FORESEEABLE), REGARDLESS OF ANY NOTICE OF THE
POSSIBILITY OF SUCH DAMAGES. NOTHING IN THIS SECTION 11.6 IS INTENDED TO LIMIT
OR RESTRICT THE OBLIGATIONS OF CHRP OR SHORE UNDER SECTION 2.6(c), THE
INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY WITH RESPECT TO THIRD
PARTY CLAIMS UNDER SECTIONS 11.1, 11.2, OR 11.3, OR DAMAGES AVAILABLE FOR ANY
BREACH OF CONFIDENTIALITY OBLIGATIONS SET FORTH IN ARTICLE 10.

11.7 Indemnification/Payment Fund. Following the Effective Date for a period of
[***], Shore shall retain [***] of the Upfront Fee to serve as (a) a source of
payment and remedy for any indemnification claim for which Santarus is entitled
to recovery pursuant to this ARTICLE 11, (b) a fund by which to make any other
payments required of Shore pursuant to this Agreement or (c) a fund by which to
make other payments reasonably required in connection with the operation of
Shore’s business (the “Indemnification/Payment Fund”). This obligation shall not
in any way affect Shore’s obligations under Delaware corporate law to maintain
sufficient assets to discharge its liabilities.

ARTICLE 12.

TERM AND TERMINATION

12.1 Term. Unless earlier terminated in accordance with the terms of this
ARTICLE 12, the term of this Agreement shall begin on the Effective Date and
shall continue in effect until the cessation of all Commercialization of
Licensed Products by Santarus in the Territory (the “Term”).

12.2 Termination by Santarus. Santarus shall have the right to terminate this
Agreement in its entirety at any time during the Term:

(a) upon one hundred eighty (180) days written notice to Shore, which right may
be exercised in Santarus’ discretion. Notwithstanding such termination, all
payments made hereunder by Santarus shall be non-refundable but subject to
offset and credit as set forth in Section 7.5; and

(b) upon ninety (90) calendar days’ written notice to Shore in the event that
Santarus elects to cease sales of Licensed Products in the Territory and desires
to transfer and assign to Impax or its designee the Product NDA (as defined in
the Impax Sublicense Agreement) and all non-terminable without penalty
manufacturing and supply agreements for the Manufacture, distribution and
storage of raw materials, Compound and Licensed Products, as set forth in
Section 2.4 of the Impax Sublicense Agreement.

 

 

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12.3 Termination for Cause. Either Shore or Santarus may terminate this
Agreement, effective at any time after providing ninety (90) days written notice
and an opportunity to cure during such ninety (90) day period, in the event of a
material breach by Santarus, on the one hand, or CHRP or Shore, on the other
hand, of their respective obligations under this Agreement; provided that, if
such breach is not susceptible to cure within ninety (90) days, then, the
non-breaching Party’s right to termination shall be suspended for so long as the
breaching Party is diligently proceeding to cure such default, but in no event
longer than one hundred-eighty (180) days (or such longer period as mutually
agreed by Shore and Santarus).

12.4 Termination for Bankruptcy. To the extent permitted by Applicable Law,
either Shore or Santarus may terminate this Agreement immediately upon notice to
each other Party, in the event of any of the following: (a) the entry of an
order for relief under the United States Bankruptcy Code (or any corresponding
remedy under successor laws) against Santarus, on the one hand, or CHRP or
Shore, on the other hand; (b) the filing of a petition by or against Santarus,
on the one hand, or CHRP or Shore, on the other hand, under any bankruptcy,
insolvency or similar law (which petition is not dismissed within sixty
(60) days after filing), except Chapter 11 of the United States Bankruptcy Code
or any successor statute that permits a corporation to continue its operation
while protecting it from creditors; (c) the appointment of a receiver for
Santarus’, on the one hand, or CHRP’s or Shore’s, on the other hand, business or
property; or (d) Santarus’, on the one hand, or CHRP’s or Shore’s, on the other
hand, making of a general assignment for the benefit of its creditors.

12.5 Consequences of Expiration or Termination.

(a) Upon expiration or early termination of this Agreement by either Santarus or
Shore (and except as set forth in Section 2.4 of the Impax Sublicense Agreement,
if Santarus has terminated this Agreement pursuant to Section 12.2(b)):

(i) the licenses granted to Santarus under this Agreement shall terminate, and,
after a wind-down period to be mutually agreed by the Parties (or one hundred
eighty (180) days if no agreement is reached), Santarus shall cease all
Commercialization activities;

(ii) Santarus shall assign, transfer and deliver to Shore all right, title and
interest in and to the Product Trademarks, Product Data, Product Materials,
Regulatory Approvals and Regulatory Filings (or, to the extent transfer is not
permitted by Applicable Laws, a right of reference) for the Licensed Products
then-Controlled by Santarus and/or its Affiliates, and Santarus shall promptly
execute any and all other instruments, forms of assignment or other documents
and take such further actions as Shore may reasonably request in order to give
effect to or evidence the foregoing assignments and grants;

(iii) Shore shall have an exclusive, sublicenseable, royalty-free license under
the Santarus Technology solely to make, have made, market, import, use, sell,
offer for sale and otherwise Develop and Commercialize the Licensed Products in
the Field in the Territory;

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(iv) if Santarus is then a party to any agreements with Third Party independent
contractors for the Licensed Product, it shall cooperate with Shore and use
Commercially Reasonable Efforts to enable Shore to obtain the benefit of such
agreements as necessary to enable Shore to exercise its rights under this
ARTICLE 12, including by assigning such agreements to Shore where reasonably
practicable;

(v) Santarus shall transfer and assign to Shore the Assigned Rights, or the
Impax Sublicense Agreement, as applicable; and

(vi) all Shore Confidential Information shall be subject to Section 12.5(b).

(b) Return of Confidential Information. Upon the early termination of this
Agreement, upon the request of the non-defaulting Party, the other Party(ies)
will promptly return to the terminating Party or destroy all material embodying
the non-defaulting Party’s Confidential Information in its possession or under
its Control, including all copies thereof, except for a single copy retained
solely for the purpose of ensuring compliance with the terms of this Agreement.

12.6 Survival. The rights and obligations of the Parties under the following
provisions of this Agreement shall survive any expiration or termination of this
Agreement: ARTICLE 1, Sections 2.4, 2.5(e) (to the extent that any amounts
payable remain unpaid), 4.4(b), 5.3, 6.2(b), 6.2(c), ARTICLE 7 (to the extent
that any amounts payable remain unpaid, provided that Section 7.9 shall survive
only for the period set forth therein, but not including Section 7.1), Sections
8.1, 8.3(e) (with respect to actions commenced prior to the expiration or
termination of this Agreement) and 9.4, ARTICLE 10 (for the period set forth in
Section 10.1), Sections 11.1, 11.2, 11.3, 11.4, 11.5 (for the period set forth
in Section 11.5), 11.6, 12.5 (as applicable), 12.6 and 12.7, ARTICLE 13 and
ARTICLE 14.

12.7 No Waiver of Remedies. Expiration or termination of this Agreement shall
not preclude any Party from (a) claiming any other damages, compensation or
relief that it may be entitled to upon such expiration or termination, (b) any
right to receive any amounts accrued under this Agreement prior to the
expiration or termination date but which are unpaid or become payable thereafter
and (c) any right to obtain performance of any obligation provided for in this
Agreement which shall survive expiration or termination.

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ARTICLE 13.

DISPUTE RESOLUTION

13.1 Disputes.

(a) The Parties recognize that disputes as to certain matters may from time to
time arise during the Term that relate to a Party’s rights and/or obligations
hereunder. It is the desire of the Parties to establish procedures to facilitate
the resolution of disputes arising under this Agreement in an expedient manner
by mutual cooperation and, to the extent possible, without resort to arbitration
or litigation. To accomplish this objective, the Parties agree to follow the
procedures set forth in this ARTICLE 13 if and when a dispute arises under this
Agreement. Each Party may refer a dispute under this Agreement to the Parties’
officers having responsibility for the subject matter of the dispute, or their
designees. If such officers are unable to resolve any such dispute within thirty
(30) days after such dispute is submitted to them, any Party may, by written
notice to the other Parties, have such dispute referred to their respective
executive officers designated below or their successors, for attempted
resolution by good faith negotiations within thirty (30) days after such notice
is received. Such designated officers are as follows:

For Shore: Clarke Futch

For Santarus: Chief Executive Officer

In the event the designated officers are not able to resolve such dispute within
such thirty (30) day period after receipt of written notice, then each party
shall be entitled to pursue other available remedies at law or in equity.

(b) To the extent a dispute exists pursuant to Section 2.6 (c) (an “Arbitrable
Dispute”), and the Parties are unable resolve such Arbitrable Dispute pursuant
to Section 13.1(a), any Party may have the given dispute settled by binding
arbitration in the manner described below.

(i) If a Party intends to begin an arbitration to resolve an Arbitrable Dispute
arising under this Agreement, such Party shall provide written notice (the
“Arbitration Request”) to the other Parties of such intention and the issues for
resolution. From the date of the Arbitration Request and until such time as the
dispute has become finally settled, the running of the time periods as to which
a Party must cure a breach of this Agreement becomes suspended as to the subject
matter of the dispute.

(ii) Discovery shall be under the U.S. Federal Rules of Civil Procedure then in
effect in the District Court for the Southern District of New York. The
Arbitration shall be held in the City of New York, under the rules of the
American Arbitration Association (“AAA”). The arbitration shall be conducted by
three (3) arbitrators who are knowledgeable in the subject matter at issue in
the dispute. One (1) arbitrator will be selected by Santarus, one (1) arbitrator
will be selected by CHRP and Shore, and the third arbitrator will be selected by
mutual agreement of the two (2) arbitrators selected by the Parties. The
arbitrators may proceed to an award, notwithstanding the failure of either Party
to participate in the proceedings. The arbitrators shall, within fifteen
(15) days after the conclusion of the arbitration hearing, issue a written award
and statement of decision describing the essential findings and conclusions on
which the award is based, including the calculation of any damages awarded. The
arbitrators

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shall be authorized to grant any temporary, preliminary or permanent equitable
remedy or relief the arbitrators deem just and equitable and within the scope of
this Agreement, including an injunction or order for specific performance. The
award of the arbitrators shall be the sole and exclusive remedy of the Parties.
Judgment on the award rendered by the arbitrators may be enforced in any court
having competent jurisdiction thereof, subject only to revocation on grounds of
fraud or clear bias on the part of the arbitrators. Notwithstanding anything
contained in this Section 13.1(b) to the contrary, each Party shall have the
right to institute judicial proceedings against the another Party or anyone
acting by, through or under such other Party, in order to enforce the
instituting Party’s rights hereunder through specific performance, injunction or
similar equitable relief.

(iii) Each Party shall bear its own attorneys’ fees, costs, and disbursements
arising out of the arbitration, and shall pay an equal share of the fees and
costs of the arbitrators; provided, however, that the arbitrators shall be
authorized to determine whether a Party is the prevailing Party, and if so, to
award to that prevailing Party reimbursement for its reasonable attorneys’ fees,
costs and disbursements (including, for example, expert witness fees and
expenses, photocopy charges and travel expenses), and/or the fees and costs of
the arbitrators. Absent the filing of an application to correct or vacate the
arbitration award as permitted by applicable law, each Party shall fully perform
and satisfy the arbitration award within fifteen (15) days of the service of the
award.

(iv) By agreeing to this binding arbitration provision, the Parties understand
that they are waiving certain rights and protections which may otherwise be
available if a dispute between the Parties were determined by litigation in
court, including the right to seek or obtain certain types of damages precluded
by this provision, the right to a jury trial, certain rights of appeal, and a
right to invoke formal rules of procedure and evidence.

13.2 Governing Law. This Agreement shall be construed and interpreted in
accordance with the laws of the State of New York, without regard to any
conflicts of law principles that would provide for the application of the laws
of another jurisdiction.

ARTICLE 14.

MISCELLANEOUS

14.1 Entire Agreement. This Agreement and the exhibits hereto, constitute the
entire understanding between the Parties with respect to the subject matter
contained herein and supersedes any and all prior and contemporaneous
agreements, understandings and arrangements whether oral or written between the
Parties relating to the subject matter hereof.

14.2 Assignment. Shore and CHRP may assign their rights and obligations under
this Agreement at any time without the consent of Santarus; provided that the
assigning Party shall provide written notice to Santarus of any such assignment.
Santarus may not assign this Agreement or any rights

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or obligations hereunder without the prior written consent of the non-assigning
Parties, not to be unreasonably withheld, conditioned or delayed, and any
attempted assignment without such consent shall be null and void.
Notwithstanding the foregoing, Santarus may assign this Agreement in conjunction
with the simultaneous assignment of the then-effective Product Agreements to
which it is a party without the other Parties’ consent to any of its Affiliates,
or in connection with a merger or acquisition of or by Santarus, or a sale of
all or substantially all of Santarus’ assets to which this Agreement relates.
This Agreement shall be binding upon and, subject to the terms of this
Section 14.2, inure to the benefit of a Party’s successors and permitted
assigns.

Notwithstanding the foregoing, CHRP and Shore agree that no assignment of rights
or obligations hereunder by either of them shall have a material adverse effect
on the ability of Santarus to Manufacture or Commercialize the Licensed Products
as contemplated hereunder.

14.3 Amendments. No amendment, change, modification or alteration of the terms
and conditions of this Agreement shall be binding upon any Party unless in
writing and signed by the Party to be charged.

14.4 Bankruptcy. All rights and licenses granted under or pursuant to this
Agreement by CHRP, Shore or Santarus are, and will otherwise be deemed to be,
for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to
“intellectual property” as defined under Section 101 of the U.S. Bankruptcy
Code. The Parties agree that the Parties, as licensees of such rights under this
Agreement, will retain and may fully exercise all of their rights and elections
under the U.S. Bankruptcy Code. The Parties further agree that, in the event of
the commencement of a bankruptcy proceeding by or against either Party under the
U.S. Bankruptcy Code, the Party hereto that is not a party to such proceeding
will be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, and same, if not already in their possession, will be
promptly delivered to them (a) upon any such commencement of a bankruptcy
proceeding upon their written request therefor, unless the Party subject to such
proceeding elects to continue to perform all of its obligations under this
Agreement, or (b) if not delivered under (a) above, following the rejection of
this Agreement by or on behalf of the Party subject to such proceeding upon
written request therefor by the non-subject Party.

14.5 Non-Waiver. The waiver by any of the Parties of any breach of any provision
hereof by any of the other Parties shall not be construed to be a waiver of any
succeeding breach of such provision or a waiver of the provision itself.

14.6 Severability. If and to the extent that any court or tribunal of competent
jurisdiction holds any of the terms or provisions of this Agreement, or the
application thereof to any circumstances, to be

--------------------------------------------------------------------------------

invalid or unenforceable in a final nonappealable order, the Parties shall use
their best efforts to reform the portions of this Agreement declared invalid to
realize the intent of the Parties as fully as practical, and the remainder of
this Agreement and the application of such invalid term or provision to
circumstances other than those as to which it is held invalid or unenforceable
shall not be affected thereby, and each of the remaining terms and provisions of
this Agreement shall remain valid and enforceable to the fullest extent of the
law.

14.7 Notice. Any notice to be given under this Agreement must be in writing and
delivered either in person, by any method of mail (postage prepaid) requiring
return receipt, or by international courier or facsimile confirmed thereafter by
any of the foregoing, to the Party to be notified at its address(es) given
below, or at any address such Party has previously designated by prior written
notice to the other. Notice shall be deemed sufficiently given for all purposes
upon the earlier of: (a) the date of actual receipt; (b) if mailed, five
(5) calendar days after the date of postmark; or (c) if delivered by
international courier, the next business day the overnight courier regularly
makes deliveries in the country of the recipient:

If to CHRP, as follows:

Cowen Healthcare Royalty Partners,

L.P.177 Broad Street, Suite 1101

Stamford, CT 06901

Facsimile No.: (646) 562-1293

Attention: Clarke B. Futch

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

Cohen Tauber Spievack & Wagner, P.C.

420 Lexington Avenue, Suite 2400

New York, NY 10170

Facsimile No.: (212) 586-5095

Attention: Y. Jerry Cohen, Esq.

If to Shore, as follows:

Shore Therapeutics, Inc.

177 Broad Street, Suite 1101

Stamford, CT 06901

Facsimile No.: (646) 562-1293

Attn: Clarke B. Futch

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

Cohen Tauber Spievack & Wagner, P.C.

420 Lexington Avenue, Suite 2400

New York, NY 10170

Facsimile No.: (212) 586-5095

Attention: Y. Jerry Cohen, Esq.

--------------------------------------------------------------------------------

If to Santarus, as follows:

Santarus, Inc.

3721 Valley Centre Drive

Suite 400

San Diego, California 92130

Attn: Legal Affairs Department

Facsimile: (858) 314-5702

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

Latham & Watkins LLP

12636 High Bluff Drive, Suite 400

San Diego, California 92130

Attention: Faye H. Russell, Esq.

Fax No: (858) 523-5450

or to such other address as to which the Party has given written notice thereof.
Such notices shall be deemed given upon receipt.

14.8 Further Assurances. Each Party shall, at its own expense, furnish, execute,
and deliver all documents and take all actions as may reasonably be required to
effect the terms and purposes of this Agreement.

14.9 Force Majeure. Except with respect to Santarus’ obligation to make payments
to CHRP, no failure or omission by the Parties in the performance of any
obligation of this Agreement shall be deemed a breach of this Agreement nor
shall it create any liability if the same shall arise from any cause or causes
beyond the reasonable control of the affected Party, including the following,
which for purposes of this Agreement shall be regarded as beyond the control of
the Party in question: acts of nature; acts or omissions of any government; any
rules, regulations, or orders issued by any governmental authority or by any
officer, department, agency or instrumentality thereof; fire; storm; flood;
earthquake; accident; war; rebellion; insurrection; riot; invasion; strikes; and
lockouts or the like; provided that the Party so affected shall use its best
efforts to avoid or remove such causes or nonperformance and shall continue
performance hereunder with the utmost dispatch whenever such causes are removed,
and provided further, however, that any such failure or omission to perform does
not continue for a period in excess of one hundred eighty (180) days.

14.10 Cooperation. Shore shall (a) prepare and cause its independent auditors to
audit the financial statements of the business related to the manufacturing and
sale of the Products for the two (2)-year period ended December 31, 2010 (or
such shorter period required by the U.S. Securities and Exchange Commission
(“SEC”)) and (b) prepare interim financial statements, in each case as required
to be included in Santarus’ reports and filings with the SEC in connection with
the

--------------------------------------------------------------------------------

acquisition of a “significant business” pursuant to Regulation S-X of the SEC.
Shore shall complete and deliver such financial statements and cause to be
delivered a report of its auditors (such report to be unqualified) with respect
to the audited financial statements on or prior to the sixtieth (60th) calendar
day after the Effective Date. All such financial statements shall be prepared in
accordance with GAAP and Regulation S-X of the SEC and in a manner reasonably
satisfactory to Santarus’ independent auditors. Shore shall request, and take
all reasonable steps necessary to encourage, its auditors to cooperate with
Santarus and provide all necessary consents required by the SEC and customary
“comfort letters” in connection with securities offerings of Santarus and with
its preparation of any financial statements or other reports pursuant to
Applicable Laws.

14.11 Independent Contractors. It is understood that the Parties are independent
contractors and engage in the operation of their own respective businesses, and
no Party is to be considered the agent or partner of any other Party for any
purpose whatsoever, except as otherwise expressly provided in this Agreement. No
Party has any authority to enter into any contracts or assume any obligations
for any other Party or make any warranties or representations on behalf of any
other Party. Furthermore, nothing in this Agreement shall be construed as
creating a partnership or joint venture among the Parties.

14.12 No Third Party Beneficiaries. This Agreement is neither expressly nor
impliedly made for the benefit of any Party other than those executing it.

14.13 Interpretation.

(a) Captions & Headings. The captions and headings of clauses contained in this
Agreement preceding the text of the articles, sections, subsections and
paragraphs hereof are inserted solely for convenience and ease of reference only
and shall not constitute any part of this Agreement, or have any effect on its
interpretation or construction.

(b) Singular & Plural. All references in this Agreement to the singular shall
include the plural where applicable, and all references to gender shall include
both genders and the neuter.

(c) Articles, Sections & Subsections. Unless otherwise specified, references in
this Agreement to any article shall include all sections, subsections, and
paragraphs in such article; references in this Agreement to any section shall
include all subsections and paragraphs in such sections; and references in this
Agreement to any subsection shall include all paragraphs in such subsection.

(d) Days. All references to days in this Agreement mean calendar days, unless
otherwise specified.

--------------------------------------------------------------------------------

(e) Clarification. The word “including” shall be deemed to mean “including
without limitation” and “including, but not limited to”. A consent that is
identified in this Agreement as not “to be unreasonably withheld” shall not be
unreasonably withheld, delayed or conditioned.

(f) Ambiguities. Ambiguities and uncertainties in this Agreement, if any, shall
not be interpreted against either Party, irrespective of which Party may be
deemed to have caused the ambiguity or uncertainty to exist.

(g) Priority. In the event of any inconsistency between the provisions of this
Agreement and the Manufacturing and Supply Agreement, the provisions of this
Agreement shall control.

14.14 Counterparts. This Agreement may be executed in counterparts, each of
which shall be deemed an original and both of which together shall constitute
one and the same instrument.

[Signature Page Follows]

--------------------------------------------------------------------------------

IN WITNESS WHEREOF, the Parties, intending to be bound hereby, have executed
this License Agreement by their duly authorized representatives as of the
Effective Date.

 

SHORE: SHORE THERAPEUTICS, INC. By: /s/ John Librie Name: John Librie Title:
General Manager CHRP: COWEN HEALTHCARE ROYALTY PARTNERS, L.P. By: /s/ Clarke B.
Futch Name: Clarke B. Futch Title: Managing Director SANTARUS: SANTARUS, INC.
By: /s/ Gerald T. Proehl Name: Gerald T. Proehl Title: President and CEO

[Signature Page to License Agreement]

--------------------------------------------------------------------------------

Exhibit 1.16

Compound

 

LOGO [g874498ex10_49pg0065.jpg]

Chemical Name: 24-(4-chlorobenzoyl) phenoxy 2-methyl-propanoic acid, 1-methyl
ethyl ester

--------------------------------------------------------------------------------

Exhibit 1.24

Domain Names

Fenoglide.com

--------------------------------------------------------------------------------

Exhibit 1.40

Inventory Lot Numbers

Product

120mg / 90-count

 

Lot #

  

Cost per Bottle

1100149

  

[***]

1100150

  

[***]

1100742

  

[***]

1100743

  

[***]

1100744

  

[***]

40mg / 90-count

 

Lot #

  

Cost per Bottle

1101080

  

[***]

1100741

  

[***]

120mg / samples

 

Lot #

  

Cost per Bottle

1100746

  

[***]

Compound

 

Lot #

  

Cost per Kilogram

2445115

  

[***]

2986098

  

[***]

3333605

  

[***]

 

 

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

--------------------------------------------------------------------------------

Exhibit 1.49

Licensed Patents

Part A:

 

Country

  

Issue Date/

Filing Date

  

Patent Number/
Application No.

  

Title

USA    09FEB2010    7658944    Solid Dosage Form Comprising a Fibrate USA   
18DEC2009    12/642,563    Solid Dosage Form Comprising a Fibrate USA   
9DEC2011    13/315,030    Solid Dosage Form Comprising a Fibrate Canada   
08FEB2011    2,540,984    Solid Dosage Form Comprising a Fibrate USA   
09JUN2006    11/449,918    Tablet Comprising a Fibrate Canada    12APR2006 (PCT)
   2,604,970    Tablet Comprising a Fibrate

Part B:

 

Country

  

Issue Date/

Filing Date

  

Patent Number/
Application No.

  

Title

USA    15MAY2007    7217431    Controlled Agglomeration USA    27FEB2007   
11/711,965    Controlled Agglomeration Canada    22MAR2011    2,452,330   
Controlled Agglomeration USA    07AUG2007    7252247    Self-Cleaning Spray
Nozzle Canada    06JUL2010    2,511,150    Self-Cleaning Spray Nozzle

--------------------------------------------------------------------------------

Exhibit 1.61

Product Agreements

 

Product Agreement

  

Action

API Supply Agreement

   Assign Commercial Supply Agreement    Assign [***]    [***] [***]    [***]
[***]    [***] [***]    [***] [***]    [***] [***]    [***] [***]    [***] [***]
   [***] [***]    [***] [***]    [***] [***]    [***] [***]    [***] [***]   
[***] [***]    [***] [***]    [***]

 

 

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

--------------------------------------------------------------------------------

Exhibit 1.65

Product Trademarks

Fenoglide®

--------------------------------------------------------------------------------

Exhibit 2.5(b)

FDA Transfer Letter

December    , 2011

Mary Parks, M.D., Director

Division of Metabolism and Endocrinology Products

Office of Drug Evaluation II

Food and Drug Administration

5901-B Ammendale Road

Beltsville, MD 20705-1266

(1) RE: NDA 22-118: FENOGLIDE® (fenofibrate) Tablets, 40 mg and 120 mg

Transfer of ownership

Dear Dr. Parks:

Reference is made to NDA 22-118 for FENOGLIDE® (fenofibrate) Tablets, 40 mg and
120 mg. This letter is to inform you that Shore Therapeutics, Inc. transferred
ownership of NDA 22-118 to Santarus, Inc., effective December    , 2011.

The contact information at Santarus, Inc. is:

Matt Moran

Senior Director, Regulatory Affairs

Santarus, Inc.

3721 Valley Centre Drive, Suite 400

San Diego, CA 92130

Phone: (853) 314-5731

Email: mmoran@santarus.com.

Please contact me should you have any questions or require additional
information. I may be reached by phone at (646) 562-1243, facsimile at
(646) 562-1293, or by email at jlibrie@shoretherapeutics.com.

Sincerely,

John Librie

General Manager

--------------------------------------------------------------------------------

Exhibit 9.2

Exceptions to Warranties and Representations

[***]

[***]

[***]

[***]

[***]

 

 

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

--------------------------------------------------------------------------------

Exhibit 9.2(w)

Unfilled Firm Orders

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

[***]

 

 

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