Exhibit 10.45

Confidential Treatment has been requested for portions of this exhibit. The copy
filed herewith omits the information subject to the confidentiality request.
Omissions are designated as “***”. A complete version of this exhibit has been
filed separately with the Securities and Exchange Commission.

LICENSE AND COLLABORATION AGREEMENT

DATED AS OF JULY 11, 2008

BY AND BETWEEN

IMMUNOMEDICS, INC.

AND

NYCOMED GmbH

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TABLE OF CONTENTS

 

          Page ARTICLE 1        DEFINITIONS    1 ARTICLE 2        LICENSES    13

2.1

   Grant to Licensee    13

2.2

   Grants to Immunomedics    13

2.3

   Right to Sublicense or Subcontract    14

2.4

   Additional Licensing Provisions    15

2.5

   Non-Competition    16 ARTICLE 3        PRODUCT UPDATES; PARTY DISCUSSIONS   
17

3.1

   Product Updates    17

3.2

   Product Discussions    18 ARTICLE 4        DEVELOPMENT    18

4.1

   Overview of Development    18

4.2

   Objectives under the Development Plan    18

4.3

   Development Plan and Development Budget    18

4.4

   Development Costs    19

4.5

   Records and Information    20

4.6

   Development Data    20

4.7

   Right of Reference and Use    21

4.8

   Right to Audit    21

4.9

   Restrictions Outside the Field    21

4.10

   Immunomedics Activities    22

4.11

   Development Outside the Field    22 ARTICLE 5        REGULATORY    23

5.1

   General    23

5.2

   Existing Regulatory Materials    23

5.3

   New Regulatory Materials and Regulatory Approvals    23

5.4

   Regulatory Coordination    23

5.5

   Assistance    25

5.6

   Adverse Events    25

5.7

   Pharmacovigilance and Drug Safety Data    25

 

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          Page

5.8

   Recalls    26

5.9

   Medical Inquiries for the Product    26

5.10

   Payment and Reimbursement of Regulatory Costs    27 ARTICLE 6   
    COMMERCIALIZATION    27

6.1

   Commercialization in the Field in the Territory    27

6.2

   Accommodation for ***    27

6.3

   Licensee’s Performance    27

6.4

   Compliance    29

6.5

   Promotional and Educational Materials    29

6.6

   Product Trademarks    30

6.7

   Commercialization Data    31

6.8

   Licensee Sales Force    31

6.9

   Restrictions Outside the Field    32 ARTICLE 7        CO-PROMOTION IN THE
UNITED STATES BY IMMUNOMEDICS    32

7.1

   Co-Promotion Option    32

7.2

   Co-Promotion Outside the U.S    32

7.3

   Change of Control    32

7.4

   Third Party Collaborations in the Oncology Field    33

7.5

   Co-Promotion Arrangement    33

7.6

   Commercialization Plan    33

7.7

   Co-Promotion Activities    34

7.8

   Advertising and Promotional and Educational Materials    34

7.9

   Samples    34

7.10

   Training    34

7.11

   Reporting    35

7.12

   Use of Third Parties    35

7.13

   Immunomedics Sales Force    35 ARTICLE 8        SALE OF INVENTORY;
MANUFACTURING AND SUPPLY    35

8.1

   Sale of Clinical Inventory    35

 

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          Page

8.2

   Master Cell Bank    36

8.3

   Development Supply    36

8.4

   Pricing and Delivery    36

8.5

   Forecast    36

8.6

   Right to Audit    36

8.7

   ***    37

8.8

   Third Party Source for Future Clinical and Commercial Supply    37

8.9

   Documentation, Scale-Up, Other Costs and Process Improvements    37

8.10

   Manufacturing Transfer    37

8.11

   License    39 ARTICLE 9        PAYMENTS    39

9.1

   Initial Payments    39

9.2

   Milestone Payments    39

9.3

   Royalties    42

9.4

   Royalty Payments and Reports    43

9.5

   Third Party Royalty Payments    43

9.6

   Bioequivalent Products    44

9.7

   Taxes and Withholding    44

9.8

   Currency Conversion    44

9.9

   General Payment Procedures    45

9.10

   Late Payments    45

9.11

   Records; Audits    45 ARTICLE 10        INTELLECTUAL PROPERTY MATTERS    46

10.1

   Ownership of Intellectual Property    46

10.2

   Disclosures; Disputes Regarding Inventions    46

10.3

   Patent Filings    47

10.4

   Joint Responsibilities    49

10.5

   Enforcement and Defense of Patents    51

10.6

   Enforcement of Immunomedics Patents, Licensee Patents and Joint Collaboration
Patents Against Infringers    51

 

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          Page

10.7

   Patent Term Extensions    53

10.8

   Patent Marking    54

10.9

   Consequences of Patent Challenge    54

10.10

   Third Party Rights    54 ARTICLE 11        REPRESENTATIONS AND WARRANTIES   
55

11.1

   Mutual Representations and Warranties    55

11.2

   Additional Representations and Warranties of Immunomedics    55

11.3

   Additional Representations and Warranties of Licensee    56

11.4

   Additional Representations and Warranties of Immunomedics    56

11.5

   Disclaimer    56

11.6

   No Other Representations or Warranties    56 ARTICLE 12   
    INDEMNIFICATION    57

12.1

   Indemnification by Immunomedics    57

12.2

   Indemnification by Licensee    57

12.3

   Indemnification Procedures    57

12.4

   Limitation of Liability    59

12.5

   Insurance    60 ARTICLE 13        CONFIDENTIALITY    60

13.1

   Confidential Information    60

13.2

   Confidentiality Obligations    61

13.3

   Permitted Disclosure and Use    62

13.4

   Notification    62

13.5

   Publicity; Filing of this Agreement    62

13.6

   Publication    62

13.7

   Use of Names    63

13.8

   Survival    63 ARTICLE 14        TERM AND TERMINATION    63

14.1

   Term    63

14.2

   Termination for Breach    63

14.3

   Termination as a Result of Bankruptcy    64

 

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          Page

14.4

   Termination by Immunomedics    64

14.5

   Termination by Licensee at Will    64 ARTICLE 15        EFFECTS OF
TERMINATION    64

15.1

   Termination by Immunomedics    64

15.2

   Termination by Licensee    67

15.3

   Licenses Upon Expiration    69

15.4

   Activities During Termination Notice Period    69

15.5

   Transition Assistance    69

15.6

   Accrued Rights    70

15.7

   Survival    70 ARTICLE 16        HSR ACT; EFFECTIVE DATE; STANDSTILL    70

16.1

   HSR Act    70

16.2

   Effective Date of this Agreement    71

16.3

   Purchases of Equity Securities    71

16.4

   Exceptions for Purchasing Securities of Immunomedics    72

16.5

   Non-Solicitation of Employees    73 ARTICLE 17        DISPUTE RESOLUTION   
73

17.1

   Disputes    73

17.2

   Arising Between the Parties    74

17.3

   Dispute Resolutions    74

17.4

   Patent and Trademark Dispute Resolution    74

17.5

   Injunctive Relief    74 ARTICLE 18        MISCELLANEOUS    74

18.1

   Entire Agreement; Amendment    74

18.2

   Force Majeure    75

18.3

   Notices    75

18.4

   No Strict Construction; Interpretation    76

18.5

   Assignment    76

18.6

   Further Actions    76

18.7

   Severability    76

 

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          Page

18.8

   No Waiver    76

18.9

   Independent Contractors    77

18.10

   English Language; Governing Law    77

18.11

   Counterparts    77

Exhibits

 

Exhibit A    Immunomedics Patents Exhibit B    Transition Plan Exhibit C   
Press Release

Schedules

 

Schedule 2.3.2    Excluded Third Party Manufacturers Schedule 4.3.2   
Development Plan Schedule 4.10    Immunomedics R&D Activities Plan Schedule 7.3
   Third Party Competitors Schedule 7.6.1    Co-Promotion and Detailing
Agreement Schedule 8.3    Forecast Schedule 8.4    Initial Supply Price

 

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LICENSE AND COLLABORATION AGREEMENT

This License and Collaboration Agreement (this “Agreement”), dated as of
July 11, 2008 (the “Execution Date”), is made by and between Immunomedics, Inc.,
a Delaware corporation (“Immunomedics”) headquartered at 300 American Road,
Morris Plains, New Jersey 07950, USA, and Nycomed GmbH, a corporation organized
under the laws of Germany (“Licensee”) headquartered at Byk-Gulden-Str. 2 78467
Konstanz, Germany. Immunomedics and Licensee are sometimes referred to herein
individually as a “Party” and collectively as the “Parties.”

RECITALS

WHEREAS, Immunomedics has developed and is currently further developing a
pharmaceutical product known as VELTUZUMAB for the treatment of cancer and
autoimmune diseases and is seeking a partner to take over responsibility for the
development and commercialization of VELTUZUMAB outside of cancer;

WHEREAS, Licensee has significant experience in the development and
commercialization of pharmaceutical products in the Territory; and

WHEREAS, Licensee and Immunomedics desire to establish a collaboration for the
further development and commercialization of the Product in the Field in the
Territory.

NOW THEREFORE, in consideration of the foregoing premises and the mutual
promises, covenants and conditions contained in this Agreement, the Parties
agree as follows:

ARTICLE 1

DEFINITIONS

As used in this Agreement, the following initially capitalized terms shall have
the meanings set forth in this ARTICLE 1 or as otherwise defined elsewhere in
this Agreement:

“Adverse Event” means any adverse medical occurrence in a human patient or
subject who is administered the Product, whether or not considered related to
the Product, including any undesirable sign (including abnormal laboratory
findings of clinical concern), symptom or disease associated with the use of the
Product.

“Advertisement and Promotion Costs” means the Out-of-Pocket Costs paid by
Licensee in the Territory (or, in the event Immunomedics exercises the
Co-Promotion Option, by either Party in the U.S.), and specifically attributable
to, the marketing, advertising and promotion of the Product in the Field,
including (i) advertising agency fees, (ii) costs for conducting seminars,
(iii) costs for exhibiting at medical conventions and participating in
professional medical association meetings, (iv) costs for direct mail, internet
programs and journal advertising and (v) costs for creation of Promotional and
Educational Materials. For clarity, “Advertisement and Promotion Costs” shall
not include any Development Costs or any costs incurred in connection with
Detailing or distributing the Product.

 

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“Affiliate” means any person or entity directly or indirectly controlled by,
controlling or under common control with, a Party, but only for so long as such
control shall continue. For purposes of this definition, “control” (including,
with correlative meanings, “controlled by”, “controlling” and “under common
control with”) shall be presumed to exist with respect to a person or entity in
the event of the possession, direct or indirect, of (a) the power to direct or
cause the direction of the management and policies of such person or entity
(whether through ownership of securities, by contract or otherwise), or (b) at
least fifty percent (50%) of the voting securities or other comparable equity
interests. The Parties acknowledge that in the case of certain entities
organized under the laws of certain countries outside of the U.S., the maximum
percentage ownership permitted by law for a foreign investor may be less than
fifty percent (50%), and that in such case, such lower percentage shall be
substituted in the preceding sentence, provided that such foreign investor has
the power to direct or cause the direction of the management and policies of
such person or entity. For the avoidance of doubt, neither of the Parties shall
be deemed to be an “Affiliate” of the other.

“Bioequivalent Product” means, with respect to ***in a given country *** ***, a
*** that contains *** (i) that has been *** that relies in whole or in part ***
and *** for the *** as determined by *** in such country and (ii) *** *** ***
can be *** in such country.

“BLA” means a (i) biologics license application or new drug application or
equivalent application that is filed with the FDA to obtain Product Approval for
the Product in the Field in the U.S. or (ii) the equivalent application to the
equivalent agency in any other regulatory jurisdiction, the filing of which is
necessary to obtain Product Approval for the Product in the Field in such
jurisdiction, including an MAA and a ***.

“BLA Filing” means (i) the filing of a BLA for the Product in the Field in the
U.S. or (ii) the acceptance of the equivalent application by the equivalent
agency in any other regulatory jurisdiction, the filing of which is necessary to
obtain Product Approval for the Product in the Field in such jurisdiction,
including acceptance of an MAA by the EMEA (or acceptance by the applicable
Regulatory Authority in a given country in Europe to the extent mutual
recognition or other national approval procedure is utilized) and acceptance of
a *** by the ***.

“Change of Control” means with respect to a Party, an event in which: (i) any
other person (including any legal entity) or group of persons (including any
legal entities) acquires beneficial ownership of securities of such Party
representing more than fifty percent (50%) of the voting power of the then
outstanding securities of such Party with respect to the election of directors
of such Party; or (ii) such Party enters into a merger, consolidation or similar
transaction with another person (or legal entity); in each case of *** to the
extent *** or *** have *** are ***in ***.

“Clinical Inventory” means those inventories of the finished form of the
Subcutaneous Formulation of the Product in clinical primary packaging
presentation for use in Clinical Studies.

“Commercialize”, “Commercializing” or “Commercialization” means all activities
relating to the marketing, promotion, selling or offering for sale of a product
for an indication, including Pre-Marketing, advertising, educating, planning,
marketing, promoting, importing, exporting, distributing and post-marketing
safety surveillance reporting, and conducting Phase 4 Clinical Trials. For
clarity, “Commercialization” shall not include any activities related to
research or Development of the Product.

 

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“***” means with respect to a Party’s obligations under this Agreement,
including to Manufacture, Develop or Commercialize the Product, the *** and the
*** by such Party for a product ***, of similar *** and at a similar *** but in
any event not less than, the level of *** and the *** required to carry out such
obligation in a sustained manner *** with respect to such a product. Without
limiting the foregoing, *** requires, with respect to such an obligation, that
the Party: (i) ***, (ii) *** for carrying out such obligation, and (iii) ***
with respect to such objectives.

“Competitive Product” means any *** with a mechanism of action *** for any use
in the Field (other than the Product hereunder).

“Control” means, when used in reference to intellectual property, other
intangible property, or materials, that a Party owns or has a license or
sublicense to such intellectual property, other intangible property or
materials, and has the ability to grant a license or sublicense or other right
to use to such intellectual property, other intangible property or materials, as
applicable, as provided for herein, without (i) requiring the consent of a Third
Party or (ii) violating the terms of any agreement or other arrangement with any
Third Party.

“Co-Promote” or “Co-Promotion” means those Detailing and promotional activities
(including performing sales calls) with respect to the Product undertaken by
Immunomedics Sales and Educational Representatives to encourage appropriate
prescribing of the Product.

“Core Immunomedics Patents” means those Immunomedics Patents that specifically
cover the Product in the Field or otherwise specifically provide exclusivity for
the Product in the Field and which are set forth in Part A of Exhibit A,
together with (a) all *** thereof, (b) all *** thereof, (c) all patents issuing
on any of the foregoing, and all *** thereof, and (d) all *** and *** of any of
the foregoing, as such Part A of Exhibit A may be updated in accordance with
Section 10.3.4(a).

“Detail” means, with respect to the Product in the Field, the communication by a
Sales and Educational Representative during a sales or education call
(a) involving ***, (b) describing the *** which have been approved by the
applicable Regulatory Authorities and *** of the Product, (c) using the
Promotional and Educational Materials in an effort to increase the familiarity
of *** with the Product for the *** which have been approved by the applicable
Regulatory Authorities and (d) made at such *** primarily for the Product in the
Field, where the *** is to place an emphasis, ***, on the Product and not simply
to discuss the Product with such ***. For the avoidance of doubt, discussions at
conventions or other meetings not specifically sponsored by a Party for the
Product shall not constitute “Details” or “Detailing”.

“Develop”, “Developing” or “Development” means all activities relating to
research, non-clinical, preclinical and clinical testing, development of test
methods, stability testing, toxicology testing, formulation development, process
development, manufacturing process validation, quality assurance activities,
quality control activities, qualification and validation activities, scale-up
and/or analytic process development, statistical analysis and reporting,

 

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preparation and submission of applications for regulatory approval of a Product,
and all other activities necessary or reasonably useful or otherwise requested
or required by a Regulatory Authority as a condition or in support of obtaining
or maintaining all regulatory approvals for a product. For clarity,
“Development” shall exclude Phase 4 Clinical Trials.

“Development Activities” means those Development activities undertaken by or on
behalf of Licensee or its Affiliates with respect to the Product in the Field,
including any Development activities undertaken by Immunomedics on behalf of
Licensee in accordance with the Development Plan.

“Development Costs” means the costs and expenses incurred after the Execution
Date by a Party or its Affiliates attributable to, or reasonably allocable to,
the Development of the Product hereunder, including costs of preparing and
submitting Regulatory Materials and obtaining Regulatory Approval, costs of
conducting pre-clinical and clinical studies prior to Product Approval. For the
avoidance of doubt, Development Costs shall not include costs or expenses
related to Manufacturing, costs or expenses related to *** or costs and expenses
related to the *** in the IV Formulation.

“Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.

“Drug Substance” means the Product which has been *** and can be ***.

“EMEA” means the European Medicines Agency or its successor.

“FDA” means the U.S. Food and Drug Administration or its successor.

“FDA Approval” means the approval of a BLA by the FDA for the Product in the
U.S.

“FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act.

“Field” means the treatment, palliation or prevention of non-cancer indications
such as autoimmune and inflammatory diseases in humans using the Subcutaneous
Formulation of the Product. For purposes of this Agreement, “autoimmune and
inflammatory diseases” include, but are not limited to rheumatoid arthritis,
***, ***, ***, ***, ***, idiopathic thrombocytopenic purpura, ***, ***, *** and
***. For the avoidance of doubt, Field shall not include any oncology
indications.

“First Commercial Sale” means, with respect to the Product, the first sale of
the Product in a given country or other regulatory jurisdiction in the Territory
by or on behalf of Licensee, or any of its Affiliates or sublicensees, to a
Third Party, after receipt of Regulatory Approval for the Product in such
country or regulatory jurisdiction.

“Good Clinical Practices” or “GCPs” means, as applicable, (i) the then-current
standards, practices and procedures promulgated or endorsed by the FDA for the
design, conduct, performance, monitoring, auditing, recording, analyses, and
reporting of clinical trials, including the requirements set forth in 21 C.F.R.
Parts 11, 50, 54, 56, 312, and 314 and including any related regulatory
requirements imposed by the FDA, and (ii) any comparable regulatory standards,
practices and procedures in jurisdictions outside of the U.S., in each case as
they may

 

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be updated from time to time, that provide assurance that the data and reported
results are credible and accurate, and that the rights, integrity, and
confidentiality of trial subjects are protected.

“Good Laboratory Practices” or “GLPs” means, as applicable, (i) the then-current
good laboratory practice standards promulgated or endorsed by the FDA as defined
in 21 C.F.R. Part 58, and (ii) any comparable regulatory standards in
jurisdictions outside the U.S., in each case as they may as they may be updated
from time to time.

“Good Manufacturing Practices” or “GMPs” means, as applicable, (i) the
then-current good manufacturing practices required by the FDA, as defined in 21
C.F.R. Parts 210 and 211 and the regulations promulgated thereunder, for the
manufacture and testing of pharmaceutical materials, and (ii) any comparable
laws or regulations applicable to the manufacture and testing of pharmaceutical
materials in jurisdictions outside the U.S., in each case as they may be updated
from time to time.

“Governmental Authority” means any multinational, federal, state, local,
municipal or other governmental authority of any nature (including any
governmental division, prefecture, subdivision, department, agency, bureau,
branch, office, commission, council, court or other tribunal), in each case,
having jurisdiction over the applicable subject matter.

“ICH” means the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use.

“Immunomedics Invention” means an Invention that is discovered, made or
conceived, by an employee of Immunomedics or any of its Affiliates or a person
under an obligation of assignment to Immunomedics or its Affiliates.

“Immunomedics Know-How” means all (i) Immunomedics Inventions and (ii) technical
information and know-how Controlled by Immunomedics (including all biological,
chemical, pharmacological, toxicological, clinical, assay and related know-how
and trade secrets, and all manufacturing data, the specifications of
ingredients, the manufacturing processes, specifications, sourcing information,
assays, quality control and testing procedures, and related know-how and trade
secrets); in each case that is *** for the Manufacture, Development or
Commercialization of the Product in the Field in the Territory.

“Immunomedics Manufacturing Know-How” means all Immunomedics Know-How that is
*** for the Manufacture of the Product for use in the Field.

“Immunomedics Patent” means (x) all Patents covering any Immunomedics Invention
and (y) the Patents Controlled by Immunomedics as of the Effective Date, in each
case listed on Exhibit A, as such exhibit may be updated from time to time in
accordance with Section 10.3.4, including but not limited to the Core
Immunomedics Patents, and in each case (a) any *** thereof, (b) all *** thereof
or any other *** to (i) any of the Patents mentioned under (x) and (y) or
(ii) any *** from which the Patents mentioned under (x) and (y) ***, and (c) all
patents issuing on any of the foregoing, and any *** thereof, together with all
***, or *** of any of the foregoing, and any *** thereof; in each case that are
*** for the Manufacture, Development or Commercialization of the Product in the
Field in the Territory.

 

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“Immunomedics Technology” means Immunomedics Patents and Immunomedics Know-How.

“IMPD” means an Investigational Medicinal Product Dossier for the Product.

“IND” means (i) an Investigational New Drug Application as defined in the FD&C
Act or (ii) the equivalent application to the equivalent agency in any other
regulatory jurisdiction outside the U.S., the filing of which is necessary to
commence or conduct clinical testing of a pharmaceutical product in humans in
such jurisdiction.

“Indication” means the use of the Product for the *** of a given non-cancer
disease in humans.

“Invention” means any writing, invention, discovery, improvement, technology or
other know-how (in each case, ***) that is discovered, made or conceived under
this Agreement during the Term.

“ITP” means idiopathic thrombocytopenic purpura.

“IV Formulation” means the formulation of the Product for intravenous
administration.

“***” means an application that is filed with the *** to obtain Product Approval
for the Product in the ***.

“*** Approval” means the approval of a *** by the *** for the Product in ***.

“Joint Invention” means an Invention that is discovered, made or conceived
jointly by an employee of, or person under an obligation of assignment to, each
of Immunomedics and Licensee or their respective Affiliates.

“Laws” means all applicable laws, statutes, rules, regulations, ordinances,
guidelines and other pronouncements having the effect of law of any Governmental
Authority.

“Licensee Invention” means an Invention that is discovered, made or conceived,
solely or jointly with a Third Party, by an employee of Licensee or any of its
Affiliates or a person under an obligation of assignment to Licensee or its
Affiliates.

“Licensee Know-How” means all (i) Licensee Inventions and (ii) technical
information and know-how Controlled by Licensee (including all biological,
chemical, pharmacological, toxicological, clinical, assay and related know-how
and trade secrets, and all manufacturing data, the specifications of
ingredients, the manufacturing processes, specifications, sourcing information,
assays, quality control and testing procedures, and related know-how and trade
secrets); in each case that is *** for the Manufacture, Development or
Commercialization of the Product in the Field or the Oncology Field in the
Territory; in each case that is *** for the Manufacture, Development or
Commercialization of the Product in the Field or the Oncology Field in the
Territory.

 

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“Licensee Patent” means (x) all Patents covering any Licensee Invention and
(y) the Patents Controlled by Licensee as of the Effective Date, in each case,
(a) any ***, (b) all *** or any other patent application *** (i) any of the
Patents mentioned under (x) and (y) or (ii) any patent or patent application
from which the Patents mentioned under (x) and (y) ***, and (c) all patents
issuing on any of the foregoing, and any ***, together with all registrations,
reissues, re-examinations, renewals, supplemental protection certificates, or
extensions of any of the foregoing, and any ***; in each case that are *** for
the Manufacture, Development or Commercialization of the Product in the Field or
the Oncology Field in the Territory.

“Licensee Technology” means Licensee Patents and Licensee Know-How.

“Major EU Countries” means ***, ***, ***, *** and ***.

“Major Market Country” means ***, ***, ***, *** and any of the ***.

“Manufacture” or “Manufacturing” means all activities related to the
manufacturing of the Product, or any ingredient thereof, establishment or
enhancement of manufacturing procedures including in-process and finished
product testing, release of product, quality assurance activities related to
manufacturing and release of product, Packaging and Labeling (whether in
commercial or clinical packaging presentation) and ongoing stability tests and
regulatory activities related to any of the foregoing.

“Manufacturing Documentation” means any and all material documentation that is
*** and *** the manufacture of the Product, including *** and *** for the
Product, ***for ***and***and ***, in each case, to the extent under the Control
of Immunomedics or its Affiliates.

“Marketing Authorization Application” or “MAA” means an application that is
filed with the EMEA under the centralized European procedure to obtain Product
Approval for the Product in the EU, or an application filed with the applicable
Regulatory Authority of a country in Europe with respect to the mutual
recognition or any other national approval procedure.

“Master Cell Bank” means Immunomedics’ reference deposit or collection of vials
of the *** VELTUZUMAB ***.

“MAA Approval” means the approval of a MAA by the EMEA for the Product in the
EU, or Product Approval from the applicable Regulatory Authority of a country in
Europe with respect to the mutual recognition or any other national approval
procedure.

“***” means the *** (or other applicable Regulatory Authority in *** for
submitting for marketing approval for pharmaceutical products), or its
successor.

“Net Sales” means the gross amount invoiced by or on behalf of Licensee or any
of its Affiliates or their respective sublicensees on account of sales of the
Product, less the following deductions specifically and solely related to the
Product and actually allowed:

 

  (a) ***;

 

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  (b) ***;

 

  (c) ***;

 

  (d) ***; and

 

  (e) ***.

For clarity, (i) Net Sales shall not be reduced by ***whether they are ***
thereof) or for ***or any other ***set forth in (a) through (e) above and
(ii) the ***of ***or ***with respect to the *** to a *** shall not be deducted
in calculating Net Sales. Any of the items set forth above that would otherwise
be deducted from the invoice price in the calculation of Net Sales but which are
separately charged to, and paid by, Third Parties shall not be deducted from the
invoice price in the calculation of Net Sales. In the case of any sale of the
Product for value other than in an arm’s length transaction exclusively for
cash, such as barter or counter-trade, Net Sales shall be determined by
referencing Net Sales at which substantially similar quantities of the Product
are sold in an arm’s length transaction for cash.

Notwithstanding the foregoing, amounts billed by Licensee or it’s Affiliates or
their respective sublicensees for the sale of Product among Licensee, its
Affiliates or their respective sublicensees for resale shall not be included in
the computation of Net Sales hereunder. Net Sales shall be accounted for in
accordance with the generally accepted accounting principles in the U.S (the
“GAAP”), consistently applied. For purposes of determining Net Sales, the
Product shall be deemed to be sold when invoiced. Any price discounts offered by
Licensee or its Affiliates or their respective sublicensees to purchasers of the
Product will not exceed in the aggregate the discount levels customary in the
industry for products that are comparable to the Product at a similar stage in
the product life cycle. Licensee and its Affiliates and their respective
sublicensees will sell the Product ***and will not sell the Product***or***that
include *** to the extent required to obtain sales contracts with government
entities, and in such case, the price of the Product relevant for the
calculation of Net Sales will be the average price in the preceding calendar
quarter of the Product *** less the average discount of all products ***.

“Oncology Field” means the treatment, palliation or prevention of the onset
and/or control of cancer in humans using the IV Formulation of the Product.

“Out-of-Pocket Costs” means costs and expenses paid to Third Parties (or payable
to Third Parties and accrued in accordance with GAAP) by either Party.

“Packaging and Labeling” means final labeling and packaging of Product (whether
in clinical or commercial packaging presentation) for use in the Field in the
Territory, including insertion of materials such as patient inserts, patient
medication guides, and professional inserts and any other written, printed or
graphic materials accompanying the Product, considered to be part of the
finished packaged Product, and all testing and release thereof.

“Patents” means patents and patent applications and (a) any *** thereof, (b) all
*** thereof or any other patent application *** to (i) any such patents or
patent applications or (ii) any patent or patent application from which such
patents or patent applications ***, and (c) all patents issuing on any of the
foregoing, and any *** thereof, together with all ***, ***, ***, ***, ***, or
*** of any of the foregoing, and any *** thereof.

 

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“Patent Term Extension” means any term extensions, supplementary protection
certificates, Regulatory Exclusivity and equivalents thereof offering patent
protection beyond the initial term with respect to any issued Patents.

“Phase 2 Clinical Trial” means a clinical study conducted to preliminarily
evaluate the effectiveness of the pharmaceutical product for a particular
indication or indications in patients with the disease or condition under study
and to determine the common short-term side effects and risks associated with
the drug.

“Phase 3 Clinical Trial” means one or more clinical trial(s) on a number of
patients for a particular indication, which trial(s) is designed to
(i) establish that a drug is safe and efficacious for such indication,
(ii) define warnings, precautions and adverse reactions that are associated with
the drug in the dosage range to be prescribed and (iii) support approval of an
application to a Regulatory Authority for the commercial sale of such drug.

“Phase 4 Clinical Trials” means studies that are conducted to delineate
additional information about a pharmaceutical product’s risks, benefits, and
optimal use, commenced after receipt of Product Approval for a product in the
indication for which such trial is being conducted.

“Pivotal Trial” means a clinical trial that is designed or intended to support
Product Approval.

“Pre-Marketing” means all sales and marketing activities undertaken prior to and
in preparation for the launch of the Product in a given country or other
regulatory jurisdiction in the Territory. Pre-Marketing shall include
advertising, education, product-related public relations, health care economic
studies, sales force training and other pre-launch activities prior to the First
Commercial Sale of the Product in the Field in a given country or other
regulatory jurisdiction in the Territory.

“Pricing Approval” means the approval, agreement, determination or decision from
a Governmental Authority establishing the price or reimbursement for the Product
for sale in a given country or regulatory jurisdiction, as required by
applicable Law in such country or other regulatory jurisdiction prior to the
sale of the Product in the Field in such country or regulatory jurisdiction.

“Product” means VELTUZUMAB in all formulations and doses.

“Product Approval” means the approval of a Governmental Authority necessary for
the marketing and sale of the Product in a given country or regulatory
jurisdiction, which includes FDA Approval in the U.S., MAA Approval in the EMEA
and *** Approval in *** (but shall not include, any Pricing Approvals).

 

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“Product Complaint” means any written, verbal or electronic expression of
dissatisfaction regarding the Product in the Territory, including reports of
actual or suspected product tampering, contamination, mislabeling or inclusion
of improper ingredients.

“Promotional and Educational Materials” means all written, printed, video or
graphic advertising, promotional, educational and communication materials (other
than the Product labels and package inserts) for marketing, advertising and
promotion of the Product in the Field in the Territory, for use (a) by a Sales
and Educational Representative or (b) in advertisements, web sites or direct
mail pieces.

“Quality Agreement” means an agreement between the Parties describing the
required quality and other technical aspects of the Clinical Inventory and the
supply of Product by Immunomedics to Licensee in accordance with ARTICLE 8.

“Regulatory Approvals” means all necessary approvals (including Product
Approvals and supplements and amendments thereto and Pricing Approvals),
licenses, registrations or authorizations of any Governmental Authority,
necessary for the manufacture, distribution, use and sale of the Product in the
Field in a given country or regulatory jurisdiction.

“Regulatory Authority” means, in a particular country or regulatory
jurisdiction, any applicable Governmental Authority involved in granting
Regulatory Approval in such country or regulatory jurisdiction, including in the
U.S., the FDA.

“Regulatory Data” means any and all research data, pharmacology data, chemistry,
manufacturing and control data, preclinical data, clinical data and all other
documentation submitted, or required to be submitted, to Regulatory Authorities
in association with regulatory filings for the Product in the Field (including
any Drug Master Files (DMFs), chemistry, manufacturing and control data, or
similar documentation).

“Regulatory Materials” means regulatory applications, submissions,
notifications, communications, correspondence, registrations, Regulatory
Approvals and/or other filings made to, received from or otherwise conducted
with a Regulatory Authority that are necessary in order to Develop, Manufacture,
market, sell or otherwise Commercialize the Product in the Field in a particular
country or regulatory jurisdiction. Regulatory Materials include INDs, BLAs, and
applications for other Product Approvals.

“Sales and Educational Representative” means an individual who is employed by or
on behalf of a Party or its Affiliates and who performs Details and other
promotional or educational efforts with respect to the Product in the Field.

“Samples” means Product packaged and distributed as a complementary trial for
use with patients in the Field in the Territory and in accordance with
applicable Law and free goods provided for this purpose through coupons or other
mechanisms.

“***” means the current *** Clinical Trial evaluating subcutaneously
administered VELTUZUMAB to patients with *** or equivalent trial or *** or
equivalent trial.

 

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“Serious Adverse Event” means any Adverse Event occurring at any dose that:
(a) results in death or threatens life; (b) results in persistent or significant
disability/incapacity; (c) results in or prolongs hospitalization; (d) results
in a congenital anomaly or birth defect; or (e) is otherwise medically
significant.

“Subcutaneous Formulation” means the formulation of the Product for subcutaneous
administration.

“Territory” means all countries in the world.

“Third Party” means any entity other than Immunomedics or Licensee or their
respective Affiliates.

“Transition Plan” means the plan attached as Exhibit B.

“U.S.” means the United States of America and its possessions and territories.

“Valid Claim” means (a) a claim of an issued and unexpired Patent that has not
been disclaimed, revoked or held to be invalid or unenforceable by a court or
other authority of competent jurisdiction, from which decision no appeal can be
further taken or (b) a claim included in a pending patent application whether
filed before or after the Execution Date and that has not been (i) canceled,
(ii) withdrawn from consideration, (iii) finally determined to be unallowable by
the applicable governmental authority (from which no appeal is or can be taken),
or (iv) abandoned or disclaimed.

“VELTUZUMAB” means humanized anti-CD20 antibody, also known as IMMU-106 and
hA20.

Interpretation. Except where expressly stated otherwise in this Agreement, the
following rules of interpretation apply to this Agreement: (a) “include”,
“includes” and “including” are not limiting; (b) “hereof”, “hereto”, “herein”
and “hereunder” and words of similar import when used in this Agreement refer to
this Agreement as a whole and not to any particular provision of this Agreement;
(c) words of one gender include the other gender; (d) references to a contract
or other agreement mean such contract or other agreement as from time to time
amended, modified or supplemented; (e) references to a person or entity are also
to its permitted successors and assigns; (f) references to an “Article”,
“Section”, “Exhibit” or “Schedule” refer to an Article or Section of, or an
Exhibit or Schedule to, this Agreement, unless expressly stated otherwise; and
(g) references to a law include any amendment or modification to such law and
any rules and regulations issued thereunder, whether such amendment or
modification is made, or issuance of such rules and regulations occurs, before
or after the date of this Agreement.

Additional Definitions. The following terms have the meanings set forth in the
corresponding Sections of this Agreement:

 

Term

   Section

“AAA”

   17.3

“Agreement”

   Preamble

 

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“Audited Party”

   9.11

“Auditing Party”

   9.11

“Audits”

   9.11

“Best Knowledge”

   11.2

“Business Combination Transaction”

   16.4.2

“***”

   7.3

“Co-Promotion and Detailing Agreement”

   7.6.1

“Co-Promotion Option”

   7.1

“Commercialization Budget”

   6.3.1(b)(i)

“Commercialization Data”

   6.7

“Commercialization Plan”

   6.3.1

“Confidential Information”

   13.1

“Controlling Party”

   10.5.1

“Development Budget”

   4.3.1(c)

“Development Data”

   4.6.2

“Development Plan”

   4.1

“Disclosing Party”

   13.1

“Effective Date”

   16.2

“Exchange Act”

   16.3.1

“Execution Date”

   Preamble

“Executive Officer”

   17.2

“Existing Development Data”

   4.6.1

“Filing Party”

   5.4.4

“HSR Act”

   16.1.1

“Immunomedics”

   Preamble

“Immunomedics New Development Data”

   4.6.2

“Immunomedics R&D Activities”

   4.10

“Immunomedics R&D Activities Plan”

   4.10

“Immunomedics Regulatory Materials”

   5.2

“Indemnified Party”

   12.3.1

“Indemnifying Party”

   12.3.1

“Infringement Claim”

   10.5.1

“Initial Supply Price”

   8.4

“ITP Study”

   4.10.2

“Joint Collaboration Know-How”

   10.1.1

“Joint Collaboration Patents”

   10.1.1

“Joint Collaboration Technology”

   10.1.1

“Lead Prosecuting Party”

   10.4.1

“Licensee”

   Preamble

“Licensee New Development Data”

   4.6.2

“Licensee Regulatory Materials”

   5.3.1

“Losses”

   12.1

“Milestone Notification Notice”

   9.2

“New Development Data”

   4.6.2

“Option Exercise Notice”

   7.1

 

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“Party” or “Parties”

   Preamble

“Patent Challenge”

   10.9.1

“Patent Cost Budget”

   10.3.2(c)

“Post-Royalty Term”

   9.3.2

“Profit”

   7.5(d)

“Product Trade Dress”

   6.6.1

“Product Trademark”

   6.6.1

“Recall”

   5.8.1

“Receiving Party”

   13.1

“Requesting Party”

   5.4.4

“Royalty Term”

   9.3.2

“Specialists”

   6.3.2(a)

“Supply Price”

   8.4

“Term”

   14.1

“Third Party Amounts”

   9.5

“Third Party Claim”

   12.1

“U.S. BLA Submission Notice”

   7.1

“Voting Securities”

   16.3.1

“Upfront Payment”

   9.1.1

ARTICLE 2

LICENSES

2.1 Grant to Licensee. Subject to the terms and conditions of this Agreement,
Immunomedics hereby grants to Licensee, (i) a co-exclusive license or
sublicense, as applicable, under the Immunomedics Technology and Immunomedics’
interest in Joint Collaboration Technology to Develop the Product for
Commercialization in the Field in the Territory, (ii) a co-exclusive right under
the Immunomedics Technology, and Immunomedics’ interest in Joint Collaboration
Technology and the Immunomedics Manufacturing Know-How to Manufacture the
Product in the Field in the Territory and (iii) subject to Section 7.1, an
exclusive, royalty-bearing license or sublicense, as applicable, under the
Immunomedics Technology and Immunomedics’ interest in Joint Collaboration
Technology to Commercialize the Product in the Field in the Territory. For
clarity, the license granted by Immunomedics to Licensee in the forgoing
sentence is exclusive, except that with respect to the foregoing clause (i),
Immunomedics retains rights to Develop the Product in the Field solely for the
purpose of fulfilling its obligations under this Agreement and as more
specifically set forth in ARTICLE 4, and, with respect to the foregoing clause
(ii), Immunomedics retains rights to Manufacture the Product in the Field solely
for the purpose of fulfilling its obligations under this Agreement and as more
specifically set forth in ARTICLE 8.

2.2 Grants to Immunomedics. Subject to the terms and conditions of this
Agreement, Licensee hereby grants to Immunomedics an exclusive license, or
sublicense, as applicable, under the Licensee Technology, with the right to
sublicense without the consent of Licensee, to Develop and Manufacture the
Product for Commercialization in the Oncology Field, and to Commercialize the
Product in the Territory in the Oncology Field.

 

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2.3 Right to Sublicense or Subcontract.

2.3.1 General Right of Licensee to Sublicense or Subcontract. Except as set out
in Section 2.3.2 below, the rights granted to Licensee by Immunomedics pursuant
to Section 2.1 shall include the right to grant sublicenses without the consent
of *** of any such *** any such ***.

2.3.2 Consent Required to Sublicense. Licensee shall be required to obtain the
prior written consent of Immunomedics, *** (i) *** or ***in a*** (ii) or
***or***to any ***in***. If Licensee intends to sublicense the rights or
activities referenced in the foregoing clause (i) or (ii) of this Section,
Licensee shall disclose to Immunomedics the identity of the potential
sublicensee. Immunomedics shall within *** *** give its consent to such
sublicense as applicable; provided however that Immunomedics shall have the
right to withhold such consent if Immunomedics in good faith determines that the
potential sublicensee is a competitor or that such sublicense would cause a
material adverse effect to Immunomedics; provided further, that in the event of
such a determination by Immunomedics, then Immunomedics shall demonstrate to
Licensee the reasons for such determination. In the event that Immunomedics does
not demonstrate the reasons for its determination to withhold consent to such
proposed sublicense within the *** *** period, Immunomedics shall be deemed to
have given its consent with respect to such sublicense.

2.3.3 Conditions of Sublicense. Each sublicense granted by Licensee to a
permitted sublicensee pursuant to Section 2.3 shall be subject and subordinate
to the terms and conditions of this Agreement and shall contain terms and
conditions consistent with those in this Agreement and shall not in any way
diminish, reduce or eliminate any of Licensee’s obligations under this
Agreement. Each sublicense agreement with permitted sublicensees shall include
the following provisions: (i) a requirement that such sublicensee submit
applicable sales or other reports consistent with the requirements set forth in
Section 6.3.1, (ii) a requirement to keep books and records, and permit
Immunomedics to audit (either directly or through an independent auditor) such
books and records, consistent with the requirement set forth in Section 9.11,
(iii) a requirement that such sublicensee comply with the confidentiality and
non-use provisions of ARTICLE 13 with respect to both Parties’ Confidential
Information, (iv) a requirement to comply with all other applicable terms of
this Agreement, (v) a provision prohibiting such sublicensee from further
sublicensing and (vi) a requirement that each sublicensee permit Immunomedics to
inspect its facilities consistent with the requirements set forth in
Section 4.8. Licensee shall provide Immunomedics with a copy of each such
sublicense agreement within *** *** after the execution thereof.

2.3.4 Liability for Sublicensees and Subcontractors. Licensee shall ensure that
each of its permitted sublicensees and subcontractors accepts and complies with
all of the applicable terms and conditions of this Agreement as if such
permitted sublicensees or subcontractors were a party to this Agreement.
Additionally, Licensee shall ensure that each of its Affiliates to which it
sublicenses any of the licenses hereunder complies with all of the applicable
terms and conditions of this Agreement. Licensee shall remain fully responsible
for its Affiliates’ and sublicensees’ and subcontractors’

 

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performance under this Agreement. For the avoidance of doubt, Licensee will
remain directly responsible for all amounts owed to Immunomedics under this
Agreement, including royalty payments for Net Sales by Licensee’s sublicensees
and subcontractors. Licensee hereby expressly waives any requirement that
Immunomedics exhaust any right, power or remedy, or proceed against a
subcontractor or sublicensee, for any obligation or performance hereunder prior
to proceeding directly against Licensee.

2.4 Additional Licensing Provisions.

2.4.1 License to Subcutaneous Formulation; License to IV Formulation. If at any
time during the term of this Agreement (i) Immunomedics desires a license to the
Subcutaneous Formulation to Develop, Commercialize or Manufacture the Product
for use in the Oncology Field or (ii) Licensee desires a license to the IV
Formulation to Develop, Commercialize or Manufacture the Product for use in the
Field, the Parties shall negotiate in good faith with respect to the terms and
conditions of such license. ***.

2.4.2 Negotiation Right for Immunomedics Technology. Immunomedics Technology
obtained or acquired by Immunomedics from Third Parties after the Execution Date
is not included in the license set forth in Section 2.1. If Immunomedics
acquires or obtains such Immunomedics Technology and determines in good faith
that such Immunomedics Technology has applicability to the Product in the Field
in the Territory, it shall notify Licensee together with a summary of such
Immunomedics Technology. The summary shall include all necessary information to
evaluate the technology If Licensee desires to receive a license under any such
Immunomedics Technology to Develop, Commercialize and Manufacture the Product in
the Field in the Territory, then it shall provide written notice to Immunomedics
within *** business days of such notice by Immunomedics and, following
Immunomedics’ receipt thereof, the Parties shall negotiate in good faith *** ***
terms under which such a license would be granted, including *** Notwithstanding
the foregoing, Licensee shall in any event have a license to Develop,
Manufacture and Commercialize the Product in the Field in the Territory, as set
out in the Development Plan, the Commercialization Plan and the terms of this
Agreement.

2.4.3 Negotiation Right for Licensee Technology. Licensee Technology obtained or
acquired by Licensee from Third Parties after the Execution Date is not included
in the license set forth in Section 2.2. If Licensee acquires or obtains such
Licensee Technology and determines in good faith that such Licensee Technology
has applicability to the Product in the Oncology Field in the Territory, it
shall notify Immunomedics together with a summary of such Licensee Technology.
The summary shall include all necessary information to evaluate the technology.
If Immunomedics desires to receive a license under any such Licensee Technology
to Develop, Commercialize and Manufacture the Product in the Oncology Field in
the Territory, then it shall provide written notice to Licensee within *** of
such notice by Licensee and, following Licensee’s receipt thereof, the Parties
shall negotiate in good faith *** terms under which such a license would be
granted, including ***

 

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2.4.4 Negative Covenant. Licensee covenants that it will not use or practice any
of the Immunomedics Technology except for the purposes expressly permitted in
the applicable license grant (and for clarity, Licensee shall not use or
practice any of the Immunomedics Technology in any manner with respect to the
Product in the Oncology Field or in any cancer indications).

2.4.5 No Implied Licenses; Retained Rights.

(a) Licenses Granted by Immunomedics. Except as explicitly set forth in this
Agreement, Immunomedics does not grant any license, express or implied, under
its intellectual property rights to Licensee, whether by implication, estoppel
or otherwise. Without limiting the generality of the foregoing, Immunomedics
hereby expressly retains, on behalf of itself and its Affiliates, licensees and
sublicensees, all right, title and interest in and to the Immunomedics
Technology, Existing Development Data, New Immunomedics Development Data and
Regulatory Materials of Immunomedics with respect to (a) pharmaceutical products
other than the Product, (b) all IV Formulations of the Product, (c) use of the
Product for the conduct of the ITP Study and for the conduct of the Immunomedics
R&D Activities, (d) all uses of the Product within the Oncology Field,
(including the conduct of the ***) including developing, making, using,
importing, exporting offering for sale and selling the Product for in the
Oncology Field, including collaborating with, pursuing and granting licenses to
Third Parties with respect to the Product in the Oncology Field, (e) research
with respect to the Product, including within the Field, (f) exercising its
rights and performing its obligations hereunder and (g) from and after the end
of the Term, developing (including obtaining and maintaining Regulatory
Approval), making, using, importing, exporting, offering for sale and selling
the Product in the Field in the Territory.

2.4.6 Licenses Granted by Licensee. Except as explicitly set forth in this
Agreement, Licensee does not grant any license, express or implied, under its
intellectual property rights to Immunomedics, whether by implication, estoppel
or otherwise. Without limiting the generality of the foregoing, Licensee hereby
expressly retains, on behalf of itself and its Affiliates, licensees and
sublicensees, all right, title and interest in and to the Licensee Technology,
New Licensee Development Data and Regulatory Materials of Licensee with respect
to all uses of the Product within the Field, including developing, making,
using, importing, exporting offering for sale and selling the Product in the
Field in the Territory.

2.5 Non-Competition. Licensee hereby covenants not to research, develop
(including submitting any applications for regulatory approval), manufacture or
commercialize, during the Term, any Competitive Product, either on its own, with
or through any Affiliate, or in collaboration with a Third Party, in each case
other than with respect to the Development, Manufacture and Commercialization of
the Product in the Field in the Territory pursuant to this Agreement ***that
***of the ***shall not ***unless such *** hereby covenants *** or *** a ***
earlier than ***after the ***, provided, however ***shall ***unless such ***.
For clarity, *** acknowledges and agrees that***, is not *** a ***.

 

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ARTICLE 3

PRODUCT UPDATES; PARTY DISCUSSIONS

3.1 Product Updates.

3.1.1 General. With respect to each country in the Territory (and with respect
to the Territory as a whole or any portion thereof, to the extent applicable),
Licensee shall prepare and deliver to Immunomedics, at least once per *** during
the Term, a written report (which written report shall contain reasonable detail
with respect to the activities described therein, and at a minimum, in such
detail as is reasonably necessary for Immunomedics to confirm Licensee’s
compliance with its obligations under this Agreement) describing: (a) for the
immediately preceding ***, (i) any and all Development Activities conducted by
or on behalf of Licensee hereunder, including all Development Costs incurred in
connection therewith (as well as a comparison of such costs to the Development
Budget and such activities to the Development Plan), (ii) any and all regulatory
activities with respect to the Product in the Field in the Territory, including
the status of any Regulatory Approvals for the Product in the Field Territory
and any material communications with, or submissions to, any Regulatory
Authority, and (iii) any and all Commercialization activities with respect to
the Product in the Field in the Territory, *** (b) for the next ***, including
the *** during which such report is delivered, (i) any and all Development
Activities which are in-process or anticipated to be conducted by or on behalf
of Licensee hereunder, including all Development Costs anticipated to be
incurred in connection therewith, (ii) any and all regulatory activities with
respect to the Product in the Field in the Territory which are in-process or
anticipated to be conducted by or on behalf of Licensee hereunder, including any
BLAs or other material regulatory filings or submissions intended to be made,
and (iii) any and all Commercialization activities with respect to the Product
in the Field in the Territory which are in-process or anticipated to be
conducted by or on behalf of Licensee hereunder, *** (c) a general description
of the market conditions and sales information with respect to the Product in
the Field in the Territory; and (d) any other material developments with
relating to the Development, Manufacturing or Commercialization of the Product
in the Field in the Territory. *** that Licensee (or any of its Affiliates or
sublicensees) has deployed in the Territory (broken down on a country-by-country
basis). The foregoing report shall be in such form as may be reasonably
requested by Immunomedics from time to time.

3.1.2 Special Reports. In furtherance of the foregoing, Licensee shall on an
on-going basis inform Immunomedics in writing of any decisions or activities
with respect to the Product by Licensee relating to the pursuit of additional
Indications in the Field, the reporting and sharing of safety and adverse event
information and product branding strategies, and terms and conditions of sale,
including Product pricing guidelines. Immunomedics acknowledges and agrees that
Licensee, in its sole discretion, shall determine pricing guidelines and sales
prices for the Product in the Field.

3.1.3 Requests from Immunomedics. Licensee shall submit in writing to
Immunomedics such other reports as Immunomedics may reasonably request from time
to time during the Term with respects to the Product in the Field in the
Territory, including the Development, Manufacturing and Commercialization
activities undertaken by Licensee for the Product in the Field in the Territory.
However, Licensee shall only have the obligation***.

 

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3.2 Product Discussions. In the event that Immunomedics desires to discuss any
matter related to the Product in the Field in the Territory, or the Development,
Manufacture or Commercialization thereof by Licensee hereunder (including, the
contents of any Development Plan or Commercialization Plan), Immunomedics shall
notify Licensee thereof (including a brief description of the matters to be
discussed) and the Parties shall meet within *** to discuss such matters,
provided that Immunomedics has a right to call such meetings no more than ***.
At any such meeting, each Party shall make available such employees who have
appropriate expertise and seniority with respect to the matters to be discussed.
Such meetings may be held in-person (to the extent requested by either Party),
or by teleconference or videoconference or other means whereby the
representatives of each of the Parties can hear each other; provided, however
that to the extent that any in-person meetings are held, such in-person meetings
shall alternate between offices of Immunomedics and Licensee (or such other
place as the Parties may agree). In all such meetings, the Parties shall discuss
in good faith the applicable matters, and Licensee shall consider in good faith
all comments and positions of Immunomedics with respect to the Product in the
Field in the Territory, and the Development, Manufacture or Commercialization
thereof, as applicable. ***

ARTICLE 4

DEVELOPMENT

4.1 Overview of Development. In connection with the Development of the Product
for use in the Field in the Territory, the Parties shall conduct the Development
Activities pursuant to a comprehensive development plan (the “Development
Plan”). Subject to the terms and conditions of this Agreement, the Parties shall
collaborate with respect to the Development of the Product for use in the Field
in the Territory as set forth in the Development Plan. Each Party shall conduct
the Development Activities in accordance with the Development Plan as provided
in this ARTICLE 4 and the terms of this Agreement.

4.2 Objectives under the Development Plan.

4.2.1 Development Activities. Licensee shall use *** to Develop the Product for
Commercialization in the Field in the Territory. Without limiting the foregoing,
Licensee shall carry out the Development Activities as set forth in the
Development Plan.

4.2.2 Compliance. Licensee shall conduct the Development Activities in a manner
consistent with sound and ethical business and scientific practices, and in
compliance with all applicable Laws, GCPs and GLPs.

4.3 Development Plan and Development Budget.

 

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4.3.1 General. The Development Plan shall set forth, among other things, the
following:

(a) any ***, in each case, together with all ***, with respect to the Product in
the Field in the Territory;

(b) all *** and other *** of obtaining and maintaining Regulatory Approvals for
the Product in the Field in each country or regulatory jurisdiction in the
Territory;

(c) a detailed annual budget for all Development Costs for the activities in the
applicable Development Plan (the “Development Budget”);

(d) the *** such Development Activities; and

(e) the *** for *** Regulatory Materials and for *** Regulatory Approval in the
Field in the Territory.

4.3.2 Initial Development Plan. The initial Development Plan for the Product for
the *** of this Agreement *** is attached to this Agreement as Schedule 4.3.2.

4.3.3 Updating and Amending Development Plan and Development Budget. On or
before *** during the Term, or at Licensee’s *** request Licensee shall update
and submit to Immunomedics for its review and comment the Development Plan
(including the Development Budget contained herein) which shall cover the
Development Activities to be conducted during the upcoming ***, and Licensee
shall, on ***, review and update, as appropriate, the then-current Development
Plan (including the Development Budget) to reflect any changes,
reprioritizations of, or additions to the Development Plan, in each case for
review and comment by Immunomedics. Licensee shall consider any comments of
Immunomedics to any such Development Plan (including any updates and amendments
thereto) in good faith. The Parties acknowledge that the initial Development
Plan (and Development Budget) sets forth a *** for Development of the Product in
the Field, and that the Parties will cooperate in seeking scientific advice from
Governmental Authorities with respect to the Development of the Product in the
Field. *** for its review and comment in accordance with this Section 4.3.3. The
Development Plan shall not be amended with respect to any Development Activities
to be undertaken by Immunomedics without the prior written consent of
Immunomedics, such consent not to be unreasonably withheld. Licensee
acknowledges and agrees that the ITP Study shall not be deleted, replaced,
slowed down or otherwise adversely affected, except to the extent caused by
safety issues with respect to the Product in ITP in the Field.

4.4 Development Costs.

4.4.1 Development Activities. Licensee shall be responsible for one hundred
percent (100%) of the Development Costs (whether incurred by Licensee,
Immunomedics or its respective Affiliates) for the Product in the Field.

 

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4.4.2 Payment and Reimbursement of Development Costs. If ***, incurs any
Development Costs during the Term, such Development Costs, if any, shall be
reimbursed by *** and *** in accordance with Section 9.9 provided, however, that
*** shall reimburse *** for such Development Costs ***. The Parties acknowledge
and agree that Licensee shall not be responsible for any costs or expenses
incurred by Immunomedics prior to the Execution Date related to the research and
development of the Product in the Field.

4.5 Records and Information.

4.5.1 General. Licensee shall maintain (and shall cause its Affiliates and
sublicensees to maintain) current and accurate records of all work conducted by
or on behalf of it under the Development Plan and all data and other information
resulting from such work. Such records shall properly reflect all work done and
results achieved in the performance of the Development activities in good
scientific manner appropriate for regulatory and intellectual property purposes.
Licensee shall document (and shall cause its Affiliates and sublicensees to
document) all preclinical studies and clinical trials to be conducted pursuant
to the Development Plan in formal written study reports according to applicable
national and international (e.g., ICH, GCP and GLP) guidelines. Licensee shall
give Immunomedics an adequate opportunity, in any event not less than *** to
review and comment on the drafts of reports resulting from activities conducted
under the Development Plan.

4.5.2 Access to Records. Immunomedics shall have the right to review all records
under the Development Plan maintained by or on behalf of Licensee (or any of its
Affiliates, sublicensees or subcontractors) at reasonable times, upon written
request.

4.6 Development Data.

4.6.1 Existing Development Data. Subject to the rights and licenses granted to
Licensee herein, Immunomedics shall continue to be the owner of all clinical
data related to the Product in the Field Controlled by Immunomedics as of the
Effective Date (collectively, the “Existing Development Data”). Within *** of
this Agreement, Immunomedics shall provide Licensee with copies of all material
reports of such clinical data Controlled by Immunomedics as of the Effective
Date in its (or its Affiliates) possession or control.

4.6.2 New Development Data. All data (including pre-clinical, clinical,
technical, chemical, safety, and scientific data and information), know-how and
other results generated by or resulting from or in connection with the conduct
of Development Activities hereunder, including relevant laboratory notebook
information, screening data, Regulatory Data and synthesis schemes, including
descriptions in any form, data and other information. (if generated by or
resulting from or in connection with the Development Activities conducted by
Immunomedics, the “New Immunomedics Development Data”; if generated by or
resulting from or in connection with the Development Activities conducted by
Licensee, the “New Licensee Development Data”, collectively the “New

 

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Development Data”) whether generated by one or both Parties (or their respective
Affiliates or sublicensees), ***, and in furtherance thereof. *** provide ***
with copies of reports and summaries of all New Development Data generated at
the same time that such reports and summaries become available to having
generated the data (or any of its Affiliates).

4.7 Right of Reference and Use. Immunomedics hereby grants to Licensee a right
of reference to all Existing Development Data and New Immunomedics Development
Data solely for the purposes of performing Development Activities pursuant to
this Agreement. Licensee may only use the Existing Development Data and New
Immunomedics Development Data for the purpose of Developing the Product for sale
in the Field in the Territory pursuant to this Agreement, provided however, that
Immunomedics only grants Licensee a right of reference to Existing Development
Data and New Immunomedics Development Data and generated by Immunomedics from
the *** only to the extent the foregoing is related to, with respect to Phase 2
Clinical Trials or Phase 3 Clinical Trials, safety, and in addition with respect
to ***, *** and *** in each case of the Product in the Oncology Field. For
clarity, ***. Licensee hereby grants to Immunomedics a right of reference to all
New Licensee Development Data for purposes of (i) *** under this Agreement, and
(ii) *** *** and (iii) *** in any other *** or *** by or on *** or its licensee
***.

4.8 Right to Audit. Licensee shall ensure that Immunomedics’ authorized
representatives and any Regulatory Authorities, to the extent permitted by
applicable Law, may, during regular business hours and upon reasonable notice,
(a) examine and inspect Licensee’s (and its Affiliate’s and sublicensee’s)
facilities or, subject to any Third Party confidentiality restrictions and other
obligations, the facilities of any subcontractor or any investigator site used
by it in the performance of Development of the Product in the Field in the
Territory hereunder pursuant to the Development Plan, and (b) subject to
applicable Law and any Third Party confidentiality restrictions and other
obligations, inspect all data, documentation and work products relating to the
activities performed by Licensee (or its Affiliates or its sublicensees), the
subcontractor, including, the medical records of any patient participating in
any clinical study, in each case generated pursuant to the Development
Activities hereunder. This right to inspect all data, documentation, and work
products relating to the Product in the Field in the Territory may be exercised
at any time during the Term, or such longer period as shall be required by
applicable Law.

4.9 Restrictions Outside the Field. For clarity, Licensee shall have no right to
research or Develop the Product for use outside the Field. In addition,
notwithstanding anything to the contrary contained herein, *** Any such
Development activities shall be immediately removed from the Development Plan by
mutual consent after a discussion in good faith between the Parties.

 

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4.10 Immunomedics Activities.

4.10.1 General. Immunomedics shall use *** to perform the activities (the
“Immunomedics R&D Activities”) set out in the plan attached hereto as Schedule
4.10 (the “Immunomedics R&D Activities Plan”). Except for costs and expenses of
the ITP Study related to the treatment of ITP with the IV Formulation, Licensee
shall be solely responsible for all costs and expenses incurred by Immunomedics
pursuant to the Immunomedics R&D Activities Plan. The Immunomedics R&D
Activities Plan shall not be amended without the prior written consent of
Immunomedics, such consent not to be unreasonably withheld.

4.10.2 Finalization of ITP Study. Immunomedics shall be responsible for
completion of the current clinical study with the Product for the treatment of
ITP as set forth in the Development Plan (the “ITP Study”). Immunomedics shall
ensure that the ITP Study is conducted in a manner consistent with sound and
ethical business and scientific practices, and in compliance with all applicable
Laws, GCPs and GLPs. Licensee shall be solely responsible for all costs and
expenses of the ITP Study to the extent that such costs relate to the treatment
of ITP with the Subcutaneous Formulation. Immunomedics agrees to use *** to
deliver a final clinical study report to Licensee as soon as possible after
completion of the ITP Study.

4.10.3 Reimbursement of Expenses. Licensee shall reimburse Immunomedics for all
costs and expenses associated with Section 4.10.1 and 4.10.2 in accordance with
Section 9.9 to the extent set forth in the budgets listed in the Immunomedics
R&D Activities Plan and the Development Plan. Such budgets shall be increased as
mutually agreed in connection with mutual agreement to modify the Immunomedics
R&D Activities Plan or the Development Activities to be undertaken by
Immunomedics under the Development Plan. Any changes in such budgets shall be
subject to mutual agreement.

4.10.4 Access to Records. *** (or any of its Affiliates, sublicensees or
subcontractors) at reasonable times, upon written request.

4.11 Development Outside the Field. Immunomedics has the right to Develop the
Product for use in the Oncology Field. In the event Immunomedics Develops or has
Developed the Product for use in the Oncology Field, the following terms shall
apply:

4.11.1 Finalization of ***. Immunomedics shall be responsible for completion, at
its sole discretion and expense, of the ***. Immunomedics shall ensure that the
***, to the extent conducted, is done so in a manner consistent with sound and
ethical business and scientific practices, and in compliance with all applicable
Laws, GCPs and GLPs.

4.11.2 General. Immunomedics shall maintain (and shall cause its Affiliates and
sublicensees to maintain) current and accurate records of all work conducted by
or on behalf of it relating to Development of the Product for use in the
Oncology Field and all data and other information resulting from such work. Such
records shall properly reflect all work done and results achieved in the
performance of the Development activities in good scientific manner appropriate
for regulatory and intellectual property

 

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purposes. Immunomedics shall document (and shall cause its Affiliates and
sublicensees to document) all preclinical studies and clinical trials to be
conducted pursuant to the Development Plan in formal written study reports
according to applicable national and international (e.g., ICH, GCP and GLP)
guidelines.

4.11.3 Access to Records. *** at reasonable times, upon written request.

ARTICLE 5

REGULATORY

5.1 General. During the Term, responsibility for overseeing, monitoring and
coordinating regulatory actions, communications and filings with, and
submissions to, all applicable Regulatory Authorities with respect to the
Product in the Field in the Territory shall be allocated between the Parties as
set forth in this ARTICLE 5.

5.2 Existing Regulatory Materials. Immunomedics shall continue to be the owner
of all Regulatory Materials related to the Product in the Field Controlled by
Immunomedics as of the Effective Date (the “Immunomedics Regulatory Materials”).
Within *** of this Agreement, Immunomedics shall provide Licensee with copies of
material Immunomedics Regulatory Materials in its possession. Immunomedics
hereby grants to Licensee a right of reference to the Immunomedics Regulatory
Materials solely for the purposes of obtaining and maintaining Regulatory
Approvals for the Product in the Field in the Territory pursuant to this
Agreement.

5.3 New Regulatory Materials and Regulatory Approvals.

5.3.1 General. Licensee shall use *** to obtain and maintain all Regulatory
Approvals with respect to the Product in the Field in (i) the Major Market
Countries *** and (ii) the other countries of the Territory where Licensee
deems, upon a good faith determination, after consultation with Immunomedics,
that the commercial potential of the Product in such country warrants obtaining
Regulatory Approval. Without limiting the foregoing, during the Term, Licensee
shall use *** to prepare and submit all additional Regulatory Materials in order
to obtain and maintain all Regulatory Approvals for the Product in the Field in
the Territory as set out in this Section 5.3.1 (the “Licensee Regulatory
Materials”). All such Regulatory Approvals shall be in the name of Licensee.

5.3.2 Right of Reference. Licensee hereby grants Immunomedics (and its
designees) a right of reference to Licensee Regulatory Materials (as well as all
Regulatory Data and Regulatory Approvals owned or otherwise Controlled by
Licensee or any of its Affiliates or sublicensees) for the purposes of (i) ***
under this Agreement, (ii) *** in any other *** by or on behalf of *** or its
licensee and (iii) ***. Upon request of Immunomedics from time to time, Licensee
shall provide Immunomedics with copies of all such Licensee Regulatory
Materials.

5.4 Regulatory Coordination.

 

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5.4.1 Responsibilities of Licensee. Licensee shall oversee, monitor and
coordinate all regulatory actions, communications and filings with, and
submissions to, all applicable Regulatory Authorities with respect to the
Product in the Field in the Territory. To the extent practicable, Immunomedics
shall *** related to the Product; provided that ***to***and*** regarding
***related to the Product in the Field in the Territory.

5.4.2 Review of Correspondence. To the extent practicable, Licensee shall
provide Immunomedics with drafts of any documents and other correspondence to be
submitted to a Regulatory Authority pertaining to the Product in the Field in
the Territory, sufficiently in advance of submission so that Immunomedics may
review and comment on such documents or other correspondence and have a
reasonable opportunity to influence the substance of such submissions. All such
comments shall be considered in good faith by Licensee. Licensee shall promptly
provide Immunomedics with copies of any material documents or other
correspondence submitted to, or received from, a Regulatory Authority pertaining
to the Product.

5.4.3 Restrictions in the Oncology Field. The Parties anticipate having
different Regulatory Approvals for the use of the Product in the Field and the
use of the Product in the Oncology Field respectively. Notwithstanding anything
to the contrary contained herein, Licensee shall have no rights with respect to
any regulatory actions, communications or filings with, or submissions to,
Regulatory Authorities with respect to the Product outside the Field and
Licensee shall immediately notify Immunomedics of, and provide Immunomedics
with, any such inquiry, communication or other correspondence from a Regulatory
Authority or other person in connection with the Product outside of the Field.
In addition, to the extent that any regulatory actions, communications or
filings with, or submissions to, Regulatory Authorities proposed to be made by
Licensee (or any of its Affiliates or sublicensees) hereunder with respect to
the Product inside the Field may have a *** on the Product outside of the Field,
then, *** (in which case Licensee shall consult with Immunomedics in connection
therewith as promptly as reasonably practicable), Licensee shall submit (or
cause to be submitted) a copy and reasonably detailed description of any such
regulatory action, communication, filing or submission, as applicable, to
Immunomedics for its review and approval, and Licensee shall make any changes
thereto as reasonably determined by Immunomedics.

5.4.4 Filings in the Oncology the Field. The Parties shall reasonably endeavor
to obtain separate Regulatory Approvals for the Product in the Field and the
Product in the Oncology Field. In the event that, due to applicable legal and/or
regulatory requirements, either Party cannot file for product approval (or
otherwise have sole responsibility for all regulatory filings and related
submissions), or to own the same in its (or its designee’s) name, for the
Product in the Field with respect to Licensee, and for the Product in the
Oncology Field with respect to Immunomedics, then such Party (the “Requesting
Party”) shall send a written request to the other Party (the “Filing Party”) for
the Filing Party do so on the Requesting Party’s (or its designee’s) behalf and
in such name (including the name of Filing Party) as the Requesting Party shall
designate from time to time. Upon such request, the Parties shall determine
reasonable procedures for the Filing Party to file for Product Approval on
behalf of the Requesting Party (or its designee). *** pursuant to this
Section 5.4.4 (excluding, for the avoidance of doubt, ***and***on behalf and for
the***).

 

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5.5 Assistance. Each Party shall cooperate with the other Party to provide all
*** assistance and take all actions reasonably requested by the other Party that
are necessary to enable such Party to comply with any regulatory requirements
under applicable Laws with respect to the Product, including (i) obtaining and
maintaining regulatory approvals, (ii) submitting annual reports and
(iii) performing pharmacovigilance activities. Such assistance and actions shall
include, among other things, notifying the other Party within *** of any
information it receives from a regulatory authority which (a) raises any
material concerns regarding the safety or efficacy of the Product, (b) indicates
or suggests a potential material liability for either Party to Third Parties
arising in connection with the Product or (c) is reasonably likely to lead to a
recall or market withdrawal of a Product.

5.6 Adverse Events. Each Party agrees to provide the other Party with respect to
the Product in the Field in the Territory: (i) Serious Adverse Event information
and Product Complaint information relating to the Product as compiled and
prepared by such Party in the normal course of business in connection with the
Development, Manufacturing or Commercialization of the Product, within time
frames to allow the other Party to fulfill all of its reporting obligations
under applicable Laws, if any, and (ii) upon such other Party’s reasonable
request, all other Adverse Event information with respect to the Product in the
Field and all other safety data and information relevant to an analysis or
investigation of such Adverse Events; provided, however, that the foregoing
shall not require either Party to violate any agreements with or confidentiality
obligations owed to any Third Party. All such Adverse Event information provided
by one Party to the other Party under this Agreement with respect to the Product
in the Field shall be owned jointly by the Parties.

5.7 Pharmacovigilance and Drug Safety Data.

5.7.1 Pharmacovigilance Agreement. The Parties shall comply with applicable
pharmacovigilance and drug safety requirements imposed by FDA and other
Governmental Authorities. Within *** of this Agreement, the Parties will enter
into a mutually agreeable pharmacovigilance agreement setting forth the Parties’
respective obligations in detail with respect to pharmacovigilance and the
exchange of drug safety data. Such agreement shall ensure that the Parties will
have an arrangement that ensures an adequate reporting of the complete safety
profile of the Product both in the Field and in the Oncology Field. The Parties
shall use *** to enter into a pharmacovigilance agreement as soon as possible,
however failure to enter into such pharmacovigilance agreement within *** *** of
this Agreement, in and of itself, shall not be considered a breach of the
Agreement by either Party.

5.7.2 Co-operation. Immunomedics shall be responsible for the reporting of
adverse events for the Product until the earlier of (i) the Parties having
executed a pharmacovigilance agreement or (ii) the initiation of clinical trials
by Licensee for the Product. In the event that Licensee initiates clinical
trials for the Product before the Parties have executed a pharmacovigilance
agreement, then Immunomedics shall be responsible,

 

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at its sole cost and expense, for collecting and reporting pharmacovigilance and
other drug safety data for the Product in the Oncology Field and Licensee shall
be responsible, at its sole cost and expense, for collecting and reporting
pharmacovigilance and other drug safety data for the Product in the Field.

5.8 Recalls.

5.8.1 Notification. Each Party shall promptly notify the other in writing if it
determines that any event, incident or circumstance has occurred which may
result in the need for a permanent or limited recall, market withdrawal, field
alert or other similar corrective action with respect to the Product in the
Field in the Territory (a “Recall”).

5.8.2 Recall. Upon a notification delivered by either Party pursuant to
Section 5.8.1, the Parties shall promptly meet to discuss such circumstances and
to consider appropriate courses of action. Each Party shall consider in good
faith the comments of the other Party. Licensee shall be primarily responsible
for discussions with the applicable Governmental Authority regarding all aspects
of a Recall. Licensee shall provide Immunomedics reasonable prior notice of any
meetings and conferences scheduled with such Governmental Authority with respect
to a Recall of a Product in the Field in the Territory. To the extent
practicable, Licensee shall provide Immunomedics with drafts of any documents
and other correspondence to be submitted or communicated to a Governmental
Authority pertaining to a Product, sufficiently in advance of submission so that
Immunomedics may review and comment on such documents or other correspondence
and planned communications and have a reasonable opportunity to influence the
substance of such submissions.

5.8.3 Regulatory Meetings. At all such meetings and conferences Immunomedics
shall have the right to attend as an to the extent permitted by the Governmental
Authority, and shall have an opportunity to influence the substance of such
meeting and conferences, including as the Party having rights to the Product in
the Oncology Field in the Territory. After following the procedures set forth in
Sections 5.8.1 and 5.8.2, either Party may make the determination, in its sole
discretion, whether to voluntarily implement any Recall and shall promptly
provide the other Party with written notice of such determination.

5.8.4 Responsibility for Recall. In the event that a Recall is implemented,
Licensee shall, at its cost and expense, and in consultation with Immunomedics,
conduct and carry out such Recall. Licensee shall utilize a batch tracing and
recall system which will enable Licensee to identify, on a prompt basis,
customers within the Territory who have been supplied with Product of any
particular batch, and to recall such Product from such customers. For clarity,
nothing contained herein shall grant Licensee any rights with respect to a
Recall for the Product outside the Field.

5.9 Medical Inquiries for the Product. Following the Effective Date, Licensee
shall be responsible for handling all medical questions or inquiries in the
Territory, including all Product Complaints, with regard to the Product in the
Field (including, setting up a call

 

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center in connection therewith) and Licensee shall consider in good faith input
from Immunomedics in connection therewith; provided, however that upon request
of Immunomedics, ***any ***to*** and ***in good faith. Immunomedics shall
forward all medical questions or inquiries which it receives with respect to the
Product in the Field in the Territory to Licensee in accordance with all
applicable Laws. For clarity, to the extent Licensee receives any medical
questions or inquiries related to the Product outside of the Field, Licensee
shall not respond to such question or inquiry (other than by directing such
question or inquiry to Immunomedics or its designee) and shall immediately
forward such question or inquiry to Immunomedics (or its designee).

5.10 Payment and Reimbursement of Regulatory Costs. All costs (including any and
all filing fees) incurred by either Party or its Affiliates in connection with
performing its regulatory activities in connection with the Product in the Field
in the Territory, including obligations under this Agreement in accordance with
ARTICLE 5, shall be borne by Licensee. Licensee shall reimburse Immunomedics for
any such costs incurred by Immunomedics (or its Affiliates) during the Term in
accordance with ARTICLE 5.

ARTICLE 6

COMMERCIALIZATION

6.1 Commercialization in the Field in the Territory. Subject to Immunomedics’
Co-Promotion Option, Licensee shall be solely responsible for, and shall use ***
to, Commercialize the Product in the Field in the Territory with the goal of
maximizing the commercial potential of the Product in the Field in the
Territory. Licensee shall be responsible for one hundred percent (100%) of the
expenses (including Pre-Marketing and Detailing expenses) incurred in connection
with the Commercialization of the Product in the Field in the Territory. Without
limiting the foregoing, Licensee shall Commercialize the Product in the Field in
the Territory in accordance with the Commercialization Plan and shall carry out
the Commercialization activities assigned to it under the Commercialization Plan
in accordance with the time frames set forth in the Commercialization Plan.

6.2 Accommodation for ***. Immunomedics acknowledges that Licensee does not
currently ***. Accordingly, Licensee shall use *** to seek and *** to be subject
to Immunomedics’ prior written consent, not to be unreasonably withheld.

6.3 Licensee’s Performance.

6.3.1 Commercialization Plan.

(a) Beginning at least *** prior to the anticipated First Commercial Sale of the
Product in the Territory for use in the Field, and thereafter on an annual basis
no later than ***, Licensee shall create and submit to the Immunomedics for its
review and comment, an annual plan (including a budget) for the
Commercialization of the Product in the Territory for use in the Field for the
following calendar year. Licensee shall consider any comments of Immunomedics to
any such commercialization plan and budget (including any updates and amendments
thereto) in good faith. After

 

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Immunomedics has had *** to review and comment on such plan, such annual plan
(including budget) shall be the “Commercialization Plan” for such calendar year.
From time to time during a given calendar year, Licensee may propose written
updates to the Commercialization Plan for review and comment by the
Immunomedics, and Licensee shall consider in good faith any comments of
Immunomedics thereto. Licensee shall conduct all Commercialization of the
Product in the Territory in accordance with the Commercialization Plan.

(b) Each annual Commercialization Plan shall include, among other things, the
following items in connection with the Commercialization of the Product in the
Territory for use in the Field:

(i) ***;

(ii) ***;

(iii) ***;

(iv) a detailed budget for the Commercialization activities (including
Advertisement and Promotion Costs incurred by Licensee) for the applicable
period (the “Commercialization Budget”); and

(v) ***.

6.3.2 Specific Commercialization Obligations. Without limiting the generality of
the provisions of Section 6.1, in connection with the Commercialization by
Licensee of the Product in the Territory for use in the Field hereunder, during
the Term, Licensee shall be responsible for, and each Commercialization Plan
shall reflect that:

(a) Licensee shall be solely responsible for (a) receiving, accepting and
filling orders for the Product in the Field in the Territory, (b) handling all
returns of Product in the Field in the Territory, (c) controlling invoicing,
order processing and collection of accounts receivable for the sales of Product
in the Field in the Territory, (d) booking and recording sales of the Product in
the Field in the Territory in its books of account and (e) distributing and
managing inventory of Product in the Field in the Territory, in each case in
accordance with GAAP to the extent applicable.

(b) Licensee shall launch the Product for use in the Field (i) in each Major
Market Country (except that such efforts in *** are subject to the provisions of
Section 6.2 no later than *** after the receipt of Regulatory Approval of the
Product in such Major Market Country and (ii) subject to a good faith evaluation
of the market potential in each country in the Territory other than the Major
Market Countries, within *** after the receipt of Regulatory Approval of the
Product in such country. Notwithstanding the foregoing clause (i), Licensee
shall have no obligation to launch the Product in any Major EU Country ***Major
EU Country.

 

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(c) Licensee shall Detail the Product in the Territory for use in the Field to
those categories of physicians (“Specialists”) as set forth in the
Commercialization Plan, and in connection therewith, Licensee shall assign a
reasonable number of Sales and Educational Representatives for each country in
the Territory to perform the Details set forth in the Commercialization Plan.
Licensee shall also ensure that it assigns a reasonable number of qualified
supervisors to oversee the conduct of the Sales and Educational Representatives.
Licensee shall provide to Immunomedics within *** of the conclusion of each ***
a detailed report setting forth the types, number and targets of Details
actually performed by Licensee in each of the Major Market Countries, as well as
report of the type, number and targets of Details actually performed by Licensee
in each other country in the Territory, and such report shall be subject to the
audit requirements set forth in Section 9.11.

6.4 Compliance. Licensee shall, in Commercializing the Product hereunder, comply
with all applicable Laws, including the U.S. Foreign Corrupt Practices Act, as
well as all applicable Regulatory Approvals (including any Packaging and
Labeling) for the Product. In addition, Licensee shall not use in any capacity,
in connection with its Commercialization (or Manufacturing or Development) of
the Product hereunder, any person or entity who has been debarred pursuant to
Section 306 of the FD&C Act (or similar Law outside of the U.S.), or who is
subject of a conviction described in such section, and Licensee shall inform
Immunomedics in writing immediately if it or any person or entity who is
performing services for Licensee hereunder is debarred or is the subject of a
conviction described in Section 306 (or similar Law outside of the U.S.), or if
any action, suit, claim, investigation or legal administrative proceeding is
pending or, to the Licensee’s knowledge, is threatened, relating to the
debarment of Licensee or any person or entity used in any capacity by Licensee
in connection with its Commercialization (or Manufacturing or Development) of
the Product hereunder.

6.5 Promotional and Educational Materials.

6.5.1 Creation of Promotional and Educational Materials. Licensee will create
and develop Promotional and Educational Materials for the Product in the Field
in the Territory in accordance with the Regulatory Approvals and applicable Laws
and shall provide samples thereof to Immunomedics for its review and comment
(and Licensee shall consider any comment thereto in good faith) prior to
distributing such Promotional and Educational Materials. With respect to any
promotional materials that include information concerning the indication,
efficacy or safety profile of the Product, Licensee shall only use such reviewed
Promotional and Educational Materials for Commercialization of the Product in
the Field hereunder and shall not materially modify such Promotional and
Educational Materials before submitting such revisions thereto to Immunomedics
for review and comment (and Licensee shall consider any such comments in good
faith). To the extent Licensee includes any Immunomedics trademarks in the
Promotional and Educational Materials, Licensee shall comply with Immunomedics’
then-current guidelines for trademark usage, a copy of which shall be provided
to Licensee from time to time.

 

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6.5.2 Inclusion of Logos on Packaging and Promotional and Educational Materials.
To the extent required by applicable Law and subject to obtaining necessary
Regulatory Authority approvals, with respect to Product to be sold by Licensee
in the Territory, the Immunomedics housemark and the Licensee housemark shall be
applied in the packaging on all Promotional and Educational Materials and
Packaging and Labeling utilized by Licensee (including, the designation that the
Product has been “licensed from Immunomedics, Inc.”). Immunomedics hereby grants
to Licensee a non-exclusive, royalty-free, right and license during the Term to
utilize the Immunomedics housemark (including all trademarks, names and logos)
for Promotional and Educational Materials and Packaging and Labeling for the
Product in the Field in the Territory. Licensee shall only use the housemark of
Immunomedics with the necessary trademark designations, and Licensee shall use
Immunomedics’ housemarks in a manner that does not derogate from Immunomedics’
rights in its trademarks, names and logos. Licensee will take no action that
will interfere with or diminish Immunomedics’ rights in its trademarks, names
and logos, and if Immunomedics reasonably believes that the use of its
trademarks, names and logos by the Licensee hereunder is interfering with or
diminishing its rights, Immunomedics shall notify the Licensee thereof in
writing and Licensee shall promptly cease use of such trademarks, names or logos
in such manner. Licensee agrees that all use of the Immunomedics’ trademarks,
names and logos will inure to the benefit of Immunomedics, including all
goodwill in connection therewith.

6.5.3 Licensee Ownership of Promotional and Educational Materials. During the
Term, Licensee shall own all right, title and interest in and to any Promotional
and Educational Materials created by Licensee hereunder relating to the Product
in the Field in the Territory, but excluding trademarks, names logs and other
marks owned by or on behalf of Immunomedics or its Affiliates in accordance with
Section 6.5.2.

6.5.4 Use of Promotional and Educational Materials Exclusively for Products. The
Promotional and Educational Materials, and any aspects of those uniquely tied to
the Product, shall be used by Licensee exclusively in connection with the
Commercialization of the Product in the Field (or if marketed in a portfolio of
products for those products in that same portfolio) in the Territory in
accordance with the terms of this Agreement, and Licensee shall not use, or
allow any other person or entity to use, any such Promotional and Educational
Materials except in accordance with this Agreement.

6.6 Product Trademarks.

6.6.1 General. Licensee shall Commercialize the Product in the Field in the
Territory under a trademark at its discretion (the “Product Trademark”) and in
trade dress designed by the Licensee and approved by Immunomedics (the “Product
Trade Dress”). All uses of the Product Trademarks and Product Trade Dress to
identify and/or in connection with the Commercialization of the Product in the
Field in the Territory shall be approved by each of the Parties. The Product
Trademarks and Product Trade Dress under which the Product is marketed or sold
(other than Licensee’s corporate trademarks or trade names) shall be used by
Licensee only pursuant to the terms of this Agreement to identify and in
connection with the Commercialization of the Product in the Field in the
Territory, and shall not be used by Licensee to identify or in connection with
the marketing of any other products. Licensee shall have exclusive (even as to
Immunomedics) ownership and use rights of the Product Trademarks (together with
all goodwill associated

 

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therewith throughout the Territory). For clarity, Immunomedics shall not use the
Product Trademarks and Product Trade Dress for Commercializing the Product in
the Oncology Field (other than Immunomedics’ corporate trademarks or trade
names). Licensee shall have the rights to any Internet domain names
incorporating the Product Trademark or any variation or part of such Product
Trademark as its URL address or any part of such address; and Immunomedics shall
not establish any Internet domain name or URL incorporating such Product
Trademark without the prior written consent of Licensee, such consent not to be
unreasonably withheld; provided that Licensee shall be responsible for all costs
incurred by Immunomedics with respect to obtaining and maintaining such Internet
domain names or URLs to the extent used for the Commercialization of the Product
in the Field in the Territory.

6.6.2 Maintenance of Trademark. From registration of the Product Trademark in a
given country in the Territory, and thereafter during the Term, Licensee shall
establish, maintain and enforce the Product Trademark in such country in the
Territory, with the costs and expenses to be borne solely by Licensee.

6.6.3 Infringement. In the event that either Party becomes aware of any
infringement of any Product Trademark by a Third Party in the Territory, such
Party shall promptly notify the other Party and Licensee shall decide - after
due consideration in good faith of any comments from Immunomedics - how to
proceed with respect to such infringement, including by the institution of legal
proceedings against such Third Party; provided, further, however that any
reasonable costs and expenses in connection therewith shall be borne solely by
Licensee.

6.6.4 No Trademark License. Except with respect to the license granted to
Licensee to the Immunomedics housemark (including all trademarks, names and
logos) for Promotional and Educational Materials and Packaging and Labeling
pursuant to Section 6.5.2, no right or license, express or implied, is granted
to Licensee to use any trademark, trade name, trade dress or service mark owned
or Controlled by Immunomedics or any of its Affiliates, including VELTUZUMAB.

6.7 Commercialization Data. Licensee shall own all marketing and sales data and
information resulting from its Commercialization of the Product in the Field in
the Territory during the Term (the “Commercialization Data”). Upon request from
Immunomedics, Licensee shall provide to Immunomedics a copy of such
Commercialization Data. ***.

6.8 Licensee Sales Force. Licensee shall have sole responsibility for all costs
and expenses in connection with the Licensee sales force, including salaries,
travel expenses and other expenses, providing benefits, deducting federal, state
and local payroll taxes, FICA contributions, FUI, DUI and any similar taxes and
paying workers’ compensation premiums, unemployment insurance contributions and
any other payments required by Law to be made on behalf of employees. Nothing in
this Agreement shall be construed to conclude that any member of the Licensee
sales force or any other agents or employees of Licensee are agents or employees
of Immunomedics or subject to Immunomedics’ direction and control. Licensee
shall have sole authority over the terms and conditions of the Licensee sales
force employment, including their selection, management and discharge.

 

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6.9 Restrictions Outside the Field. Licensee hereby covenants and agrees that it
shall not knowingly (and shall cause its Affiliates, sublicensees and
subcontractors not to), either directly or indirectly, market, distribute or
sell the Product for use outside the Field. Without limiting the generality of
the foregoing, Licensee shall not (i) engage in any advertising activities
relating to the Product directed to use outside the Field or (ii) solicit orders
from, or deliver or supply Product to, any prospective purchaser for use of the
Product outside the Field. If Licensee receives any order from a prospective
purchaser for use of the Product outside of the Field, Licensee shall
immediately refer that order to Immunomedics (or its designee) and shall not
accept any such order or deliver or tender (or cause to be delivered or
tendered) any Product under such order for use outside the Field. In addition,
notwithstanding anything to the contrary contained herein, Licensee shall not
undertake any Commercialization of the Product which may have a material adverse
effect on the Product outside of the Field, as determined by Immunomedics in its
sole discretion (and without limiting the generality of the foregoing, any such
Commercialization activities shall be immediately removed from the
Commercialization Plan, to the extent previously included therein, upon notice
from Immunomedics).

ARTICLE 7

CO-PROMOTION IN THE UNITED STATES BY IMMUNOMEDICS

7.1 Co-Promotion Option. Pursuant to the terms of this Agreement, Immunomedics
may elect to Co-Promote the Product in the Field for ITP in the U.S. (the
“Co-Promotion Option”). ***the***in the *** (a “BLA Submission Notice”). Upon
receipt of such BLA Submission Notice, Immunomedics shall have sixty days
(60) days to exercise the Co-Promotion Option ***. If Immunomedics exercises the
Co-Promotion Option, *** the *** and the ***. If *** the Co-Promotion Option,
*** from *** to the Product *** shall promptly *** (including a *** and target
*** with respect to the Product *** on a ***. If Immunomedics declines to
exercise the Co-Promotion Option within sixty days (60) after receipt of the BLA
Submission Notice for ITP, the Co-Promotion Option shall not become exercisable
again.

7.2 Co-Promotion Outside the U.S. Upon Immunomedics request the Parties shall
discuss in good faith the grant of a co-promotion right in the Field for ITP to
Immunomedics outside the U.S.

7.3 Change of Control. If *** undergoes *** with *** prior to *** of the *** to
***, the *** shall *** If ***undergoes *** with *** ***, *** to *** of the ***,
*** shall promptly inform *** and *** shall have *** from receipt of such *** to
*** right to *** the Product by written notice effective *** following the date
of such notice. *** may be *** from time to time by mutual consent of the
Parties, not to be unreasonably withheld, *** that *** with the ***, and with
whom *** or other *** ***.

 

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7.4 Third Party Collaborations in the Oncology Field. The Co-Promotion Option,
or if the Co-Promotion Option has been exercised, the Co-Promotion rights and
obligations as set forth in this ARTICLE 7 ***. Within *** after Immunomedics
enters into such Third Party agreement, Immunomedics shall deliver written
notice to Licensee stating whether Immunomedics has (i) *** or (ii) ***.

7.5 Co-Promotion Arrangement. In the Option Exercise Notice:

(a) Immunomedics will commit to Co-Promote the Product in the Field in ITP in
the U.S. for a ***. The Co-Promotion shall thereafter automatically renew for
successive *** during the Term; provided that if at any time Immunomedics
desires to terminate its Co-Promotion of the Product in the Field in ITP,
Immunomedics shall provide Licensee with *** prior written notice of such
termination and thereafter the Co-Promotion shall terminate.

(b) Immunomedics shall be responsible for one-hundred percent (100%) of the
total Details for the Product in the U.S. in the Field in ITP. Such total number
of Details will be set forth in the Commercialization Plan and shall be
determined by mutual agreement of the Parties.

(c) Immunomedics will use *** to Co-Promote the Product in the Field in ITP in
the U.S. in accordance with the Commercialization Plan.

(d) In exchange for its Co-Promotion of the Product in the Field in ITP in the
U.S., Immunomedics shall be entitled to receive a *** of the Profits (“Profits”
defined as being Net Sales less Manufacturing costs, Commercialization costs and
royalties to Third Parties) from the sales of the Product by or on behalf of
Licensee (or any of its Affiliates or sublicensees) in the Field in ITP in the
U.S. ***of the ***of the ***that *** to ***shall***from the
***when***under***Notwithstanding the foregoing, in the event that ***and to the
further extent that ***under ***would have ***for such ***had ***on ***equal to
the***then in such case ***promptly ***as may be necessary so that ***under the
***.

7.6 Commercialization Plan.

7.6.1 Co-Promotion Reflected in Commercialization Plan. Upon exercise of the
Co-Promotion Option in accordance with Section 7.1 the Commercialization Plan
shall be updated to reflect that Immunomedics shall provide Details for the
Product in the Field in ITP in the U.S. The Commercialization Plan shall set
forth ***. The Commercialization Plan shall thereafter be updated to include
such Details to be performed by Immunomedics for the Product in the Field in ITP
in the U.S. Within *** after Immunomedics delivers the Option Exercise Notice,
the Parties shall negotiate in good faith ***set forth *** (the “***”) based
upon the terms set forth in Schedule 7.6.1; provided, however, that, in the
event the Parties are not able to enter into a ***, the terms of Schedule 7.6.1
shall apply. The Parties acknowledge that the *** shall not modify or amend any
obligation under this Agreement. In the event that the terms of the *** conflict
with the terms of this Agreement, the terms of this Agreement shall control.

 

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7.6.2 Future Commercialization Plans. In the event that Immunomedics exercises
its Co-Promotion Option, then all subsequent Commercialization Plans (including
Commercialization Budgets), and any subsequent updates or amendments to a
Commercialization Plan (including Commercialization Budgets), shall be subject
to the approval of Immunomedics to the extent related to ITP.

7.7 Co-Promotion Activities.

7.7.1 Conditions. Subject to Section 7.4 Immunomedics shall only be obligated
(but shall, at all times, have the right) to perform such Co-Promotion of the
Product in the Field in ITP in the U.S. (to the extent Immunomedics has
exercised the Co-Promotion Option) for so long as Licensee is performing its
Commercialization activities with respect to the Product in the Field in ITP in
accordance with the terms of this Agreement. Notwithstanding anything to the
contrary contained herein, Immunomedics shall not be required to undertake any
activity to Co-Promote the Product which it believes, in good faith, may violate
any applicable Laws, and shall be entitled to terminate its Co-Promotion
activities to the extent Immunomedics, in good faith, determines that there are
safety concerns with respect to the Product.

7.8 Advertising and Promotional and Educational Materials. The Commercialization
Plan shall set forth the manner in which the Parties will be presented and
described to the medical community in any Promotional and Educational Materials
or other materials related to the Product. Each Commercialization Plan for the
Product shall also set forth a delivery schedule for Promotional and Educational
Materials to be provided by Licensee to Immunomedics, at no cost to
Immunomedics; provided, however that Licensee shall in all cases provide to
Immunomedics the amount and type of Promotional and Educational Materials
similar to those provided to Licensee’s own Sales and Educational
Representatives for the Product in the Field.

7.9 Samples. If set forth in the Commercialization Plan, Licensee shall ship
reasonable requirements of Samples to Immunomedics’ distribution facility,
without charge, in a timely manner in accordance with the schedule for
distribution as outlined in such Commercialization Plan; provided, however that
Licensee shall in all cases provide to Immunomedics the amount and type of
Samples similar to those provided to Licensee’s own Sales and Educational
Representatives for the Product in the Field.

7.10 Training. The following shall apply to all Sales and Educational
Representatives used by Immunomedics in connection with the performance of its
Co-Promotion activities hereunder:

7.10.1 ***. The training of any Sales and Educational Representatives of
Immunomedics for the Product in the Field in ITP in the U.S. shall be ***.

 

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7.10.2 Training; Expenses. Licensee shall provide, at no cost, sales training on
the Product in the Field for the Immunomedics Sales and Educational
Representatives who will be performing sales calls for the Product in the Field
in ITP in the U.S. similar to the training on the Product that Licensee provides
to its own Sales and Educational Representatives who perform sales calls for the
Product. Licensee shall provide such training at a time that is mutually
acceptable to the Parties and reasonably prior to the commencement of
Co-Promotion activities by the applicable Immunomedics Sales and Educational
Representative. Notwithstanding anything to the contrary in this Agreement, ***.

7.10.3 Continuing Education. Licensee shall provide, at no cost, continuing
education regarding the Product in the Field in ITP in the U.S. for Sales and
Educational Representatives of Immunomedics on the same schedule as it provides
continuing education for its own Sales and Educational Representatives for the
Product.

7.11 Reporting. For so long as Immunomedics is performing any Co-Promotion
activities, Immunomedics shall provide Licensee, within ***the***each ***, a
report setting forth the total number of Details, by target physician, actually
performed by the Immunomedics Sales and Educational Representatives for such ***
with respect to the Product in the Field in ITP in the U.S., or in such other
form as Immunomedics may regularly prepare for its own internal purposes,
redacted for confidential information not related to the Product in the Field.

7.12 Use of Third Parties. Immunomedics may retain Affiliates and/or Third
Parties (including a Third Party sales force) to perform its Co-Promotion
activities.

7.13 Immunomedics Sales Force. Except as otherwise expressly set forth herein,
Immunomedics shall have sole responsibility for all costs and expenses in
connection with the Immunomedics sales force, including ***. Nothing in this
Agreement shall be construed to conclude that any member of the Immunomedics
sales force or any other agents or employees of Immunomedics are agents or
employees of Licensee or subject to Licensee’s direction and control.
Immunomedics shall have sole authority over the terms and conditions of the
Immunomedics sales force employment, including their selection, management and
discharge.

ARTICLE 8

SALE OF INVENTORY; MANUFACTURING AND SUPPLY

8.1 Sale of Clinical Inventory. Subject to the terms and conditions of this
Agreement, Immunomedics will sell, assign, convey and transfer to Licensee, and
Licensee will purchase and accept from Immunomedics, the Clinical Inventory.
Within *** ***, the Parties will enter into a mutually agreeable Quality
Agreement setting forth quality and other technical criteria applicable to the
Clinical Inventory.

 

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8.2 Master Cell Bank. As promptly as practicable after the Effective Date,
Immunomedics shall transfer, or cause to be transferred, *** of the Master Cell
Bank to Licensee (or at the direction of Licensee, to the Third Party
manufacturer contemplated by this ARTICLE 8), for the purpose of Licensee (or
the Third Party Manufacturer) creating, or having created, a working cell bank
for production of the Product in the Field.

8.3 Development Supply. Subject to the terms and conditions of this Agreement,
until the earlier of (a) Licensee having developed a *** for the Product in
accordance with Section 8.7 and (b) Licensee having established a source of
supply for the Product from a Third Party in accordance with Section 8.8.
Immunomedics shall use *** to supply Licensee as requested by Licensee with the
quantities of Drug Substance as forecasted by Licensee and set forth on Schedule
8.3. Thereafter, and beyond such forecast, Immunomedics shall have no supply
obligation to Licensee. Immunomedics shall ensure that all Manufacturing under
this Section 8.3 complies with applicable Law, GMPs and the requirement of
Regulatory Authorities for the Product in the Field in the Territory. Licensee
acknowledges that, prior to the Effective Date, Immunomedics has ***.

8.4 Pricing and Delivery. Licensee shall purchase Product from Immunomedics
under Section 8.3 at a supply price on a per unit basis equal to the price set
forth in Schedule 8.4 (the “Initial Supply Price”, and as adjusted from time to
time as set forth herein, the “Supply Price”) which equals Immunomedics’ actual
Manufacturing cost *** and on such other terms as set forth on Schedule 8.4. The
Clinical Inventory and the Product shall be supplied to *** the Immunomedics’
manufacturing facility or as otherwise agreed to in writing between the Parties.

8.5 Forecast. At the beginning of each *** during the term of Immunomedics’
supply obligation under Section 8.3, Licensee shall give Immunomedics a ***
rolling forecast of estimated monthly requirements of Product. The volume
requirements for Product as set forth in the first *** of the forecast shall be
binding and the remainder shall be a good faith estimate of Licensee’s
requirements. In each forecast, the *** shall be (i) within *** of the Product
set out in *** of the forecast immediately preceding the most recent forecast
and (ii) *** set out in *** in the forecast from *** previously. Licensee will
provide Immunomedics with binding purchase orders for Product in accordance with
the binding portion of the rolling forecast and in accordance with the terms set
forth on Schedule 8.4. Each forecast pursuant to Section 8.5, shall be referred
to as a “Forecast”. Notwithstanding anything to the contrary contained herein,
the aggregate Forecasts shall not exceed the amounts set forth on Schedule 8.3.

8.6 Right to Audit. During the term of Immunomedics’ supply obligations under
Section 8.3, Immunomedics shall ensure that Licensee’s authorized representative
and any Regulatory Authorities, to the extent permitted by Applicable Law, may
during normal business hours, (a) examine and inspect the facilities that
Immunomedics uses to Manufacture the Product in the Field in the Territory, and
(b) subject to applicable Law and any Third Party confidentiality restrictions
and other obligations, inspect all data, documentation and work products related
to Manufacturing of the Product in the Field in the Territory.

 

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8.7 ***. Within ***, Licensee (either itself or through Third Party contract
manufacturer), ***its***, shall use ***to***a ***at***. Licensee shall ensure
that all Manufacturing complies with applicable Law, GMPs and the requirement of
Regulatory Authorities for the Product in the Field in the Territory.

8.8 Third Party Source for Future Clinical and Commercial Supply. Within ***
***, regardless of whether Licensee has developed *** as set forth in
Section 8.7, Licensee shall use *** to enter into a supply arrangement with a
Third Party manufacturer under which Licensee would receive future clinical and
commercial supplies of Drug Substance. The Parties anticipate using (but are not
obligated to use) a single source of supply for future clinical and commercial
supplies of Drug Substance for the Subcutaneous Formulation and the IV
Formulation, provided however, that the Parties currently contemplate that each
Party shall enter into its own supply agreement with such Third Party
manufacturer.

8.9 Documentation, Scale-Up, Other Costs and Process Improvements. Licensee, at
it sole cost and expense, shall bear all scale-up, documentation, and other
costs incurred by Licensee or its Third Party manufacturer in connection with
securing and scaling up future clinical and commercial supply of the Drug
Substance. Licensee shall be committed to working with the Third Party
manufacturer in developing and implementing continuous cost, quality and
improvement programs by seeking productivity improvements, by minimizing waste
and improving yields, by purchasing quality materials at lower cost, by
improving manufacturing processes, by streamlining organizational processes, by
reducing cycle times and lead times and the like.

8.10 Manufacturing Transfer.

8.10.1 Delivery Manufacturing Know-How. As soon as reasonably possible and in
any event no later than *** after Licensee enters into a supply agreement with
the Third Party manufacturer in accordance with Section 8.8 (except with respect
to any Immunomedics Manufacturing Know-How to be provided pursuant the
Transition Plan under Section 8.10.3, which shall be provided in accordance with
the schedule for such Transition Plan), Immunomedics shall provide to Licensee
(or its designated Third Party manufacturer) (which can be in the form of copies
and electronic files) one (1) copy of all material tangible Immunomedics
Manufacturing Know-How (including Manufacturing Documentation) in existence and
in the possession of Immunomedics as of the Effective Date and having regard to
the Product in the Field, including the information, materials and know-how
described in Exhibit B, in each case for informational purposes (and the Parties
hereby agree and acknowledge that as between the Parties, the information
contained therein shall continue to be owned by Immunomedics). Notwithstanding
the foregoing or anything else in this Agreement, Immunomedics shall not be
required to provide copies of laboratory notebooks or manufacturing run records
(other than a record for a representative manufacturing run) required to be
maintained by Immunomedics under applicable Laws.

 

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8.10.2 Formulation, Finish & Fill. As soon as reasonably possible and in any
event no later than *** *** and to the extent not covered by Section 8.10.1,
Immunomedics shall provide to Licensee (which can be in the form of copies and
electronic files) one (1) copy of all material tangible Know-How known to or
controlled by Immunomedics as of the Effective Date relating to formulation,
finish and fill of the Product in the Field.

8.10.3 Transition Plan. Each Party shall use (and shall cause its designee,
including the Third Party manufacturer, to use) *** to complete the activities
assigned to it under the Transition Plan within the time set out below. The
Parties shall cooperate to implement and execute the Transition Plan. As part of
the Transition Plan, Immunomedics will make available its personnel with
sufficient experience in the applicable area for a reasonable amount of time,
or, if any such person ceases to be employed or retained by Immunomedics or any
of its Affiliates, with a person of similar experience. The Parties acknowledge
that it is their intention that all activities or services to be conducted
pursuant to this Section 8.10.3 shall be completed within *** after the Licensee
enters into a supply agreement with the Third Party manufacturer in accordance
with Section 8.8 (and that Licensee shall not use the activities to be provided
by Immunomedics for purposes of obtaining general education and training
services).

8.10.4 Restrictions; Cooperation. None of the information, materials and
documentation provided by Immunomedics under this Section 8.10 shall be used by
Licensee (or its designee, including the Third Party manufacturer) for any
purpose other than to Manufacture the Product for Development or
Commercialization of the Product in the Field, or Manufacture the Drug Substance
for supply to Immunomedics as applicable in accordance with this Agreement, and
shall continue to be owned by, and constitute, Confidential Information of
Immunomedics. Licensee (and its designee, including the Third Party
manufacturer) shall reasonably cooperate with Immunomedics to receive,
understand and apply the materials and information provided by Immunomedics
hereunder, including by making available personnel with sufficient
qualifications and expertise to efficiently supply, receive, understand and
apply (as appropriate) such materials and information hereunder.

8.10.5 Cost Reimbursement. Licensee shall reimburse Immunomedics for all
reasonable Out-of-Pocket Costs incurred by Immunomedics (or any of its
Affiliates) in providing the services and activities undertaken by Immunomedics
under this Section 8.10. Furthermore, with respect to services and activities
undertaken by Immunomedics under Sections 8.10.1 or 8.10.2, Licensee shall
reimburse Immunomedics’ for its internal FTE costs associated with the personnel
time spent performing such activities and services at Immunomedics’ standard FTE
rates, except that (i) for *** and (ii) *** after the Licensee enters into a
supply agreement with the Third Party manufacturer in accordance with
Section 8.8, Licensee shall not be required to *** therewith. All reimbursements
payable pursuant to this Section 8.10.5 shall be made to Immunomedics within ***
after submission of a valid invoice by Immunomedics, together with reasonable
substantiation of any Out-of-Pocket Costs, and, if applicable, FTE time
incurred.

 

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8.11 License. Licensee hereby grants to Immunomedics a non-exclusive, worldwide,
irrevocable, perpetual, fully paid up, royalty free, sublicenseable,
transferable license to all Patents and technical information and know-how
(including all biological, chemical, pharmacological, toxicological, clinical,
assay and related know-how and trade secrets, and all manufacturing data, the
specifications of ingredients, the manufacturing processes, specifications,
sourcing information, assays, quality control and testing procedures, and
related know-how and trade secrets) Controlled by Licensee or any of its
Affiliates related to the Manufacture of the Product, in order for Immunomedics
(or any of its Affiliates or designees) to Manufacture, for the purposes of
(i) *** under this Agreement, (ii) *** and (iii) *** in any other ***.

ARTICLE 9

PAYMENTS

9.1 Initial Payments.

9.1.1 Upfront Amount. On the Effective Date, Licensee shall pay to Immunomedics
an upfront amount equal to forty million Dollars ($40,000,000) (the “Upfront
Payment”) by wire transfer of immediately available funds into an account
designated in writing by Immunomedics. Such Upfront Payment shall be
nonrefundable and noncreditable against any other payments due hereunder.

9.2 Milestone Payments. Licensee shall pay to Immunomedics the milestone
payments described in this Section 9.2 upon achievement (first occurrence) of
the corresponding milestone event. For clarity, a “label extension” for an
existing Indication shall not be deemed a new Indication which would trigger a
milestone payment that has already been paid for such existing Indication.
Licensee shall, promptly after achievement of each milestone event, notify
Immunomedics thereof in writing (each, a “Milestone Notification Notice”). Upon
such notice Immunomedics shall issue an invoice to Licensee specifying the
applicable milestone payment to Immunomedics which is payable by Licensee no
later than *** after the receipt of such invoice by Licensee. Licensee shall pay
the applicable milestone payment by wire transfer of immediately available funds
into an account designated by Immunomedics. Notwithstanding the foregoing, with
respect to the completion of the *** (as set forth below), the Parties agree and
acknowledge that the *** will be performed by or on behalf of Immunomedics or
its Affiliates and as such, such milestone shall be payable by Licensee within
*** after delivery of written notice by Immunomedics to Licensee of the
completion of such *** and delivery of the related invoice specifying the
milestone payment. For clarity, completion of the *** as described in ***. Each
milestone payment is nonrefundable and noncreditable against any other payments
due hereunder.

 

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Milestone Event

   Milestone Payment  

First Indication

  

Filing of the first *** in the *** in connection with the ***

   $ * **

*** of the *** in the ***

   $ * **

*** with either ***

   $ * **

Receipt of *** in ***

   $ * **

Receipt of *** in ***

   $ * **

Receipt of *** in ***

   $ * **

Second Indication

  

*** of the *** in the ***

   $ * **

*** with either ***

   $ * **

Receipt of *** in ***

   $ * **

Receipt of *** in ***

   $ * **

Receipt of *** in ***

   $ * **

Third Indication

  

*** of the *** in the ***

   $ * **

*** with either ***

   $ * **

Receipt of *** in ***

   $ * **

Receipt of *** in ***

   $ * **

Receipt of *** in ***

   $ * **

Fourth Indication or ITP

  

The earlier of (i) Receipt of the *** in the Territory for the *** or (ii) ***
with either *** for ITP (***)

   $ * **

Sales Based Milestones

  

Aggregate sales of Product in the Territory equal or exceed $*** Dollars for any
*** period

   $ * **

 

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Aggregate sales of Product in the Territory equal or exceed $*** for any ***
period

   $ * **

Aggregate sales of Product in the Territory equal or exceed $*** for any ***
period

   $ * **

Aggregate sales of Product in the Territory equal or exceed $*** for any ***
period

   $ * **

Aggregate sales of Product in the Territory equal or exceed $*** for any ***
period

   $ * **

Additional Milestones

  

Completion of ***

   $ * **

*** of the *** in the *** for any Indication for the Product in a subcutaneous
formulation ***

   $ * **

Receipt of the *** for the Product for any Indication in a subcutaneous
formulation in any country (or other regulatory jurisdiction) in the Territory
***

   $ * **

In the event that *** for the Product ***, as applicable, is not filed with
***under the ***, but *** the applicable Regulatory Authority of certain ***
pursuant to the *** or any other ***, then any milestone payment that is due
upon filing ***, as applicable, pursuant to this Section 9.2 shall be due and
payable upon ***.

For clarity, if a milestone event described in the preceding table under the
heading “Sales Based Milestones” is achieved before the achievement of a
preceding milestone event listed under such heading, then all preceding
milestone events that are achieved within the same *** *** period, shall be
deemed ***, and the ***. In addition, with respect to all milestones described
under the headings “First Indication”, “Second Indication” and “Third
Indication” (other than milestones based on receipt of Product Approval), ***.

 

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9.3 Royalties

9.3.1 Royalty Rates. As further consideration for the rights granted to Licensee
hereunder, Licensee shall pay to Immunomedics a tiered royalty at the following
rates based on aggregate annual Net Sales of Product in the Territory for all or
any portion of the calendar year falling within the Royalty Term:

 

Annual Net Sales

   Royalty Rate  

For that portion of aggregate annual Net Sales less than ***

   * **%

For that portion of aggregate annual Net Sales equal to or greater than ***but
less than ***

   * **%

For that portion of aggregate annual Net Sales equal to or greater than *** but
less than ***

   * **%

For that portion of aggregate annual Net Sales equal to or greater than ***

   * **%

9.3.2 Royalty Term and Post-Royalty Term. Licensee’s obligation to pay royalties
to Immunomedics on Net Sales of the Product shall commence on a
country-by-country basis upon the First Commercial Sale of the Product in a
country hereunder and shall expire on a country-by-country basis upon the later
of: (a) the last to expire (including any Patent Term Extension period)
Immunomedics Patent or Joint Collaboration Patent having a Valid Claim which
covers the Product, or the Development, Manufacturing or Commercialization of
the Product, in such country or (b) *** for the First Indication receiving
Product Approval in such country (the “Royalty Term”). Notwithstanding the
foregoing, in the event that, after the Royalty Term with respect to a country,
there exists a Licensee Patent having a Valid Claim which covers the Product, or
the Development, Manufacturing or the Commercialization of the Product in such
country (and, for clarity, there is no Immunomedics Patent or Joint
Collaboration Patent having a Valid Claim which covers the Product, or the
Development, Manufacturing or the Commercialization of the Product in such
country), and therefore the Royalty Term with respect to such country has
expired) (the “Post-Royalty Term”), royalties shall be payable by Licensee on
Net Sales of Products in such country at a royalty rate equal to *** of such Net
Sales.

9.3.3 Assessing Patentability, Validity and Enforceability of Pending Patent
Applications and Issued Patents (Valid Claim). If at any time with respect to a
Product (a) royalties would not be required hereunder but for one or more
pending, but not issued, Valid Claim(s) of Immunomedics Patents and (b) Licensee
believes in good faith that each such pending, but not issued, Valid Claim is,
after patent prosecution, unlikely to issue or to be patentable or to be
enforceable in a form that will cover such Product with a scope that would
require payment of royalties hereunder, then Licensee may notify Immunomedics in
writing to request an assessment of such Valid Claim pursuant to the procedures
as set forth in this Section 9.3.3. Within ***, the Parties shall meet to
discuss Licensee’s questions. If the Parties are unable to reach agreement
regarding such issue within ***, the Parties shall engage ***independent Third
Party patent attorneys to assess such Valid Claim, with each Party appointing
one of such Third Party patent attorneys and the ***patent attorneys so
appointed selecting the ***. All ***Third Party patent attorneys shall be
jointly engaged by the Parties, with the Parties sharing equally in the fees of
such attorneys. The standard on which any such determination shall be based is
whether all such Valid Claim(s) are, after routine patent prosecution,
reasonably unlikely to issue or reasonably unlikely to be patentable or
reasonably unlikely to be valid or

 

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reasonably unlikely to be enforceable in a form that will cover such Product
with a scope that would require payment of royalties hereunder. The
determination of the *** Third Party patent attorneys shall be binding on the
Parties. All proceedings and determinations pursuant to this Section 9.3.3 and
information disclosed in connection therewith, whether or not written, shall
remain the Confidential Information of both Parties and shall not be used by
either Party for any purpose other than the proceedings set forth in this
Section 9.3.3, provided that Immunomedics shall have the right to use any such
information in the prosecution and defense of the applicable Immunomedics
Patents. If the determination pursuant to this Section 9.3.3 is that royalties
would not be required hereunder, then such Valid Claim shall not be considered a
Patent having a Valid Claim with respect to the Royalty Term pursuant to
Section 9.3.2 and with respect to royalties payable pursuant to Section 9.3.1.

9.4 Royalty Payments and Reports. Licensee shall calculate all amounts payable
to Immunomedics pursuant to Section 9.3 with respect to Net Sales at the end of
***, which amounts shall be converted to Dollars at such time in accordance with
Section 9.8. Licensee shall pay to Immunomedics the royalty amount due for Net
Sales during a given *** within ***. Each payment of royalties due to
Immunomedics shall be accompanied by a statement of the amount of gross sales of
the Product in the Territory during the applicable *** (including such amounts
expressed in local currency and as converted to Dollars), an itemized
calculation of Net Sales in the Territory showing deductions provided for in the
definition of “Net Sales” during such ***, and a calculation of the amount of
royalty payment due on such Net Sales for such ***. Without limiting the
generality of the foregoing, Licensee shall require its Affiliates and
sublicensees to account for its Net Sales and to provide such reports with
respect thereto as if such sales were made by Licensee.

9.5 Third Party Royalty Payments. If Licensee is required to obtain a license
from any Third Party under any Patent that (in absence of a license) would be
infringed by the manufacture, use or sale of the Product as it exists on the
Effective Date (excluding, for the avoidance of doubt, any additional technology
that may be combined or incorporated therewith), and if Licensee is required to
pay to such Third Party under such license any royalties calculated on sales of
corresponding Product (“Third Party Amounts”), and the infringement of such
patent cannot reasonably be avoided by Licensee, then Licensee shall be
permitted to credit up to *** of the amount of such Third Party Amounts it
actually pays in each *** against royalties that are payable to Immunomedics
during the same ***; provided that in no event shall royalties payable to
Immunomedics be reduced to *** of the rates set forth in Section 9.3.1 on
account of applying such credits; ***. Licensee shall, where it is aware of the
same, provide Immunomedics with prior written notice of a potential need to
obtain any license from any Third Party. If there is any dispute between the
Parties with respect to whether Licensee is required to obtain any such license
under which Third Party Amounts would be payable and eligible for deduction from
royalties as provided above, the dispute shall be referred to the Parties’
respective patent counsels for resolution and, if such patent counsels are
unable to resolve the dispute within ***, the dispute resolution procedures in
ARTICLE 17 may be implemented by either Party.

 

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9.6 Bioequivalent Products. Notwithstanding the royalty amounts that would
otherwise be payable under Section 9.3.1, in any *** in which aggregate annual
Net Sales are less than $***, royalties otherwise payable by Licensee on Net
Sales of Product shall be reduced on a country-by-country basis to the following
rates at any such time where aggregate sales in such country of Bioequivalent
Products (excluding any sales by Licensee, or its Affiliates and any sales of
Product by Licensee’s sublicensees), measured over the applicable *** equal to
or exceed the following percentage unit sales volume for the Product in such ***
in such country:

 

Percentage Unit Sales Volume of Bioequivalent Product

   Royalty Rate  

Equal or exceeding ***percent (***%)

   * **%

Equal or exceeding *** percent (***%)

   * **%

Equal or exceeding *** percent (***%)

   * **%

Equal or exceeding *** percent (***%)

   * **%

Greater than *** percent (***%)

   * **%

9.7 Taxes and Withholding.

9.7.1 Royalty Withholding Taxes. Any income or other taxes which Licensee is
required by Law to pay or withhold on behalf of Immunomedics with respect to any
payments of royalties payable to Immunomedics pursuant to Section 9.3 shall be
deducted from the amount of such payments due, and paid or withheld, as
appropriate, by Licensee on behalf of Immunomedics. Any such tax required by
applicable Law to be paid or withheld shall be an expense of, and borne solely
by, Immunomedics. Licensee shall furnish Immunomedics with reasonable evidence
of such payment or amount withheld, in electronic or written form, as soon as
practicable after such payment is made or such amount is withheld. The Parties
will reasonably cooperate in completing and filing documents required under the
provisions of any applicable tax laws or under any other 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.
For clarity, amounts shall not be withheld on any other amounts payable by
Licensee hereunder.

9.7.2 Value Added Tax. The amounts provided for in this Agreement are exclusive
of any value added tax.

9.8 Currency Conversion. All payments to a Party hereunder shall be made in
Dollars. For the purpose of calculating any sums due under, or otherwise
reimbursable pursuant to, this Agreement (including the calculation of Net Sales
expressed in currencies other than Dollars), a Party shall convert any amount
expressed in a foreign currency into Dollar equivalents, calculated using the
arithmetic average of the spot rates on the close of

 

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business on the last business day of the previous ***. The “closing mid-point
rates” found in the “dollar spot forward against the dollar” table published by
The European Central Bank on their official website or any other publication
agreed to by the Parties shall be used as the source of spot rates to calculate
the average as set forth in the preceding sentence.

9.9 General Payment Procedures. With the exception of the Upfront Payment
payable pursuant to Section 9.1 (***), the milestone payments payable pursuant
to Section 9.2 and royalties payable pursuant to Section 9.3 or other amounts
expressly payable in certain time frames set forth herein, Immunomedics shall
invoice the Licensee for all amounts due to Immunomedics under this Agreement,
and such payments shall be made within *** following the receipt by Licensee of
an invoice from Immunomedics specifying the amount due.

9.10 Late Payments. Without limiting any other rights or remedies available to
Immunomedics, if Immunomedics does not receive payment of any amount due to it
on or before the due date, the Licensee shall pay to Immunomedics interest on
any such amounts from and after the date such payments are due under this
Agreement at a rate of *** percent (***%) *** or the maximum applicable legal
rate, if less, calculated on the total number of days payment is delinquent.

9.11 Records; Audits. Licensee and its Affiliates shall keep, and Licensee shall
require its sublicensees and subcontractors to keep, full, true and accurate
records and books of account containing all particulars that may be necessary
for the purpose of confirming the accuracy of, and calculating, as applicable,
all royalties and other amounts payable to Immunomedics hereunder (including
records of Net Sales), as well as the number and types of Details performed, the
costs incurred by Licensee in connection with its Commercialization activities
hereunder (including Advertisement and Promotion Costs) and any other records
reasonably required to be maintained with respect to Licensee’s obligations
under this Agreement, and each Party shall maintain complete and accurate
records in sufficient detail to permit the other Party to confirm the accuracy
of all amounts payable or otherwise reimbursable hereunder, in each case for a
minimum period of *** or such longer period as required by applicable Law. Each
Party shall have a right to request an audit of the other Party in order to
confirm the accuracy of any of the foregoing (an “Audit”). Upon the written
request by a Party (the “Auditing Party”) to Audit the other Party (the “Audited
Party”), the Auditing Party shall have the right to engage an independent,
internationally recognized, accounting firm to perform a review as is reasonably
necessary to enable such accounting firm to calculate or otherwise confirm the
accuracy of any of the foregoing for the calendar year(s) requested by the
Auditing Party; provided that (i) such accountants shall be given access to, and
shall be permitted to examine and copy such books and records of the Audited
Party upon *** prior written notice to the Audited Party, and at all reasonable
times on such business days, (ii) prior to any such examination taking place,
such accountants shall enter into a confidentiality agreement with the Audited
Party reasonably acceptable to the Audited Party in order to keep all
information and data contained in such books and records strictly confidential
and shall not disclose such information or copies of such books and records to
any third person including the Auditing Party, but shall only use the same for
the purpose of the reviews and/or calculations which they need to perform in
order to determine

 

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any amounts being reviewed, and (iii) such accountants shall use reasonable
efforts to minimize any disruption to the Audited Party’s business. The Audited
Party shall make personnel available during regular business hours to answer
queries on all such books and records required for the purpose of the Audit. The
accountants shall deliver a copy of its findings to each of the Parties within
*** *** of the completion of the review, and, in the absence of fraud or
manifest error, the findings of such accountant shall be final and binding on
each of the Parties. Any underpayments by a Party shall be paid to the other
Party within *** of notification of the results of such inspection plus interest
at the rate specified in Section 9.10. Any overpayments made by a Party shall be
refunded by the other Party within *** of notification of the results of such
inspection. The cost of the accountant shall be the responsibility of the
Auditing Party unless the accountants calculation shows that the actual
royalties payable, Net Sales, number of Details, and/or any such other amount
Audited hereunder to be different, by more than *** percent (***%), of the
amounts as previously calculated by the Audited Party.

ARTICLE 10

INTELLECTUAL PROPERTY MATTERS

10.1 Ownership of Intellectual Property.

10.1.1 General. Subject to the provisions of this Section 10.1 and except as
expressly set forth otherwise in this Agreement, (i) Immunomedics ***and it
***and it ***and*** *** by the Parties. Each Party shall promptly disclose to
the other Party all Inventions made by it during the Term. The determination of
inventorship for Inventions shall be made in accordance with the patent Laws of
the United States (Title 35, United States Code) or in accordance with the
applicable Laws relating to inventorship in the country in which such Invention
is made if required by the laws of such country.

10.1.2 Employees, Sublicensees and Agents. Each Party will require all of its
and its Affiliates’ employees to assign all Inventions that are developed, made
or conceived by such employees according to the ownership principles described
in Section 10.1.1. Each Party will require any sublicensees, agents or
independent contractors performing an activity pursuant to this Agreement to
assign to such Party all Inventions that are developed, made or conceived by
such agents or independent contractors to Immunomedics and/or Licensee according
to the ownership principles described in Section 10.1.1.

10.2 Disclosures; Disputes Regarding Inventions. Each Party shall, before filing
a new patent application (including provisionals and continuations-in-part)
claiming an Immunomedics Invention or a Licensee Invention, as applicable,
promptly disclose such Invention to the other Party and shall provide the other
Party with a copy of the proposed patent application at least *** before filing
such application or such shorter time as may be required to preserve Patent
rights, including the avoidance of a statutory bar. If the non-filing Party
believes that the filing Party’s proposed patent application discloses an
Invention or Confidential Information of the non-filing Party, the non-filing
Party shall so notify the filing Party within such *** after receipt thereof,
and the filing Party shall amend its

 

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proposed application to comply with the confidentiality provisions of this
Agreement. If the Parties are in agreement as to the designation of the
Invention as Immunomedics Invention or Licensee Invention, as applicable, they
can continue as set forth in Section 10.3. If the Parties disagree as to whether
an Invention is an ***or*** and are unable to reach agreement within *** after
commencing discussions, then the provisions of ARTICLE 17 shall apply to such
dispute.

10.3 Patent Filings.

10.3.1 Immunomedics Responsibilities. Immunomedics shall be responsible, using
its in-house patent counsel or outside patent counsel selected by Immunomedics,
for the preparation, prosecution (including, without limitation, any
interferences, reissue proceedings and reexaminations) and maintenance of the
Immunomedics Patents. Immunomedics shall provide Licensee with annual updates of
the filing, prosecution and maintenance status for each of the Immunomedics
Patents that are not Core Immunomedics Patents.

10.3.2 Immunomedics Patent Cooperation Responsibilities for Core Immunomedics
Patents.

(a) Immunomedics shall provide Licensee with copies of any written submissions
to patent counsel, patent agent, or patent office pertaining to the Core
Immunomedics Patents with reasonable opportunity to provide comments to any such
submission. Immunomedics (and its patent counsel) shall give reasonable
consideration to any comments concerning the preparation, filing, prosecution
and maintenance thereof. Licensee may request in writing that certain
preparation, prosecution and/or maintenance activities either be undertaken in
addition or to be halted or not pursued and if so, Immunomedics shall give good
faith consideration to said requests, and Licensee shall reimburse Immunomedics
for all costs and expenses incurred by Immunomedics as a result of such
requests. It shall be understood that Immunomedics shall not be acting in the
role of an attorney representing Licensee.

(b) The obligations of Immunomedics as set forth in this Section 10.3.2 are
subject to the condition that Immunomedics shall not be obligated to take any
action with respect to any Core Immunomedics Patent to the extent such action
would, in Immunomedics’ reasonable belief, have a material adverse effect on the
intellectual property rights of Immunomedics.

(c) *** associated therewith and except as otherwise set in this Section 10.3.2,
***. Immunomedics estimates ***, prosecution and maintenance of the Core
Immunomedics Patents and related activities for the period from ***through*** to
be $***. Thereafter, Immunomedics shall prepare a *** *** mutually agreed in
connection with mutual agreement to modify the list of Core Immunomedics Patents
in accordance with Section 10.3.4(a). *** by Immunomedics other than pursuant to
such mutual agreement shall be subject to the prior written consent of Licensee,
such consent not to be unreasonably withheld. If, during any period covered by a
*** incurred by Immunomedics with respect to the preparation, prosecution and
maintenance of the Core

 

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Immunomedics Patents in that period *** for that period by more than *** percent
(***%), or if Immunomedics wishes to conduct any activities other than those
contained within *** or to any additional activities to accommodate such ***or
additional activities, and shall also explain to Licensee why these *** were not
anticipated at the time the original ***. Licensee’s approval to the amendment
shall not be unreasonably withheld provided ***. Licensee shall be responsible
for *** with respect to those activities contained within the approved ***,
provided that should such *** for that period plus *** percent (***%), Licensee
may request certain activities (as identified by Licensee) be halted or not
pursued as provided below. If in any annual (or, if different, initial) period,
the *** by Immunomedics with respect to those activities contained *** exceed
the *** that period by more than *** percent (***%), Licensee may request in
writing that certain of such preparation, prosecution and/or maintenance
activities be halted or not pursued and, if so: (a) Licensee *** with respect to
such requested activities, and (b) Immunomedics shall have the right, but not
the obligation, to halt or not pursue such activities pursuant to the request
(it being understood that if Immunomedics chooses to continue or pursue such
activities, such activities shall not be subject to reimbursement hereunder as
of the date of such request). Licensee shall *** for which Licensee is
responsible pursuant to this Section 10.3.2 to Immunomedics within *** after
receipt of an invoice and supporting documentation therefore from Immunomedics.
In the event that during the Term, Immunomedics grants any rights or licenses
under the Core Immunomedics Patents in the Oncology Field to a Third Party, then
as of the effective date of the grant of such right or license, Licensee shall
*** Immunomedics only *** percent (***%) of all such ***.

10.3.3 Patent Abandonment. In no event will Immunomedics permit any of the Core
Immunomedics Patents to be abandoned in any country in the Territory without
Licensee first being given an opportunity to assume full responsibility for the
continued prosecution and maintenance of such Core Immunomedics Patents. In the
event that Immunomedics decides not to continue the prosecution or maintenance
of a patent application or patent within such Core Immunomedics Patents in any
country, Immunomedics shall provide Licensee with written notice of this
decision at least *** prior to any pending lapse or abandonment thereof (and
Immunomedics shall not be deemed to have breached any of its other obligations
set forth in Section 10.3). In such event, Immunomedics shall provide Licensee
with an opportunity to assume responsibility for the further prosecution and
maintenance of such patent application and any patent issuing thereon. In the
event that Licensee provides notice of its desire to assume responsibility for
such prosecution and maintenance, Immunomedics shall promptly transfer the
responsibility for such prosecution and maintenance of such patent applications
and patents to patent counsel selected by Licensee (provided that for clarity,
such patent applications and patents shall remain in the name of Immunomedics
(or its designee)).

10.3.4 Updates to Immunomedics Patents.

(a) Updates to Core Immunomedics Patents. The Parties acknowledge that the Core
Immunomedics Patents listed on Part A of Exhibit A, may be updated from time to
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the Parties to add Immunomedics Patents specifically covering the Product in the
Field or otherwise specifically providing exclusivity for the Product in the
Field. If the Parties fail to agree on an update such update of Part A of
Exhibit A, the dispute resolution process set forth in Section 9.3.3 shall
apply.

(b) Updates to Immunomedics Patents Other than Core Immunomedics Patents. The
Parties acknowledge that Immunomedics Patents that are not Core Immunomedics
Patents and which are listed on Part B of Exhibit A may be updated from time to
time. In the event that a Patent covering any Immunomedics Invention issues
during the Term, Immunomedics shall provide written notice to Licensee regarding
the issuance of such Patent. ***in writing, in its sole discretion, in the event
Licensee wishes to ***shall be deemed to be an ***

10.3.5 Licensee Responsibilities. Licensee shall be responsible, using its
in-house patent counsel or outside patent counsel selected by Licensee for the
preparation, prosecution (including, without limitation, any interferences,
reissue proceedings and reexaminations) and maintenance of Licensee Patents.
Licensee shall bear all relevant costs associated therewith. Licensee shall
consult with and cooperate with Immunomedics with respect to the preparation,
prosecution and maintenance of the Licensee Patents in advance of taking any
action with respect thereto. Licensee shall provide to Immunomedics copies of
any papers relating to the filing, prosecution or maintenance of the Licensee
Patents promptly upon their being filed or received. Licensee shall provide
periodic updates to Immunomedics (on an annual basis) regarding the status of
the Licensee Patents.

10.3.6 Patent Abandonment. In no event will Licensee permit any of the Licensee
Patents to be abandoned in any country in the Territory without Immunomedics
first being given an opportunity to assume full responsibility for the continued
prosecution and maintenance of such Licensee Patents. In the event that Licensee
decides not to continue the prosecution or maintenance of a patent application
or patent within the Licensee Patents in any country, Licensee shall provide
Immunomedics with written notice of this decision at least *** prior to any
pending lapse or abandonment thereof. In such event, Licensee shall provide
Immunomedics with an opportunity to assume responsibility for the further
prosecution and maintenance of such patent application and any patent issuing
thereon. In the event that Immunomedics provides notice of its desire to assume
responsibility for such prosecution and maintenance, Licensee shall promptly
transfer the responsibility for such prosecution and maintenance of such patent
applications and patents to patent counsel selected by Immunomedics.

10.4 Joint Responsibilities. With respect to Joint Collaboration Patents, the
Parties after good faith discussion and upon mutual agreement shall designate
one Party to be responsible for the preparation, prosecution (including, without
limitation, any interferences, reissue proceedings and reexaminations) and
maintenance of Joint Collaboration Patents. Such decision shall be made on Joint
Collaboration Patent-by-Joint Collaboration Patent basis, based upon which Party
is better informed with respect the subject matter claimed by such Joint
Collaboration Patent. The responsible Party shall be known as the “Lead
Prosecuting Party”. All relevant costs associated therewith shall be equally
shared by the Parties.

 

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10.4.1 Lead Prosecuting Party. The Lead Prosecuting Party shall consult with and
cooperate with the other Party with respect to the preparation, prosecution and
maintenance of the Joint Collaboration Patents in advance of taking any action
with respect thereto. To the extent practicable, the Lead Prosecuting Party
shall provide the other Party with drafts of any documents and other
correspondence to be submitted to any patent counsel, patent agent, or patent
office pertaining to the Joint Collaboration Patents, sufficiently in advance of
submission so that the other Party may review and comment on such documents or
other correspondence and have a reasonable opportunity to influence the
substance of such submissions. Additionally, the Lead Prosecuting Party shall
provide periodic updates to the other Party (on an annual basis) regarding the
status of the Licensee Collaboration Patents. Each Party shall cooperate with
the other Party to provide all reasonable assistance and take all actions
reasonably requested by the other Party that are necessary for the preparation,
prosecution (including, without limitation, any interferences, reissue
proceedings and reexaminations) and maintenance of Joint Collaboration Patents.
Additionally, the other Party may request that the Lead Prosecuting Party
(i) prepare and prosecute certain parts of pending patent applications, e.g.,
divisional applications of Joint Collaboration Patents that or (ii) cease or not
pursue the prosecution of certain parts of pending patent applications and, upon
such request by the other Party, the Lead Prosecuting Party (and its patent
counsel) shall consider such request in good faith.

10.4.2 Patent Abandonment. In no event will the Lead Prosecuting Party permit
any of the Joint Collaboration Patents to be abandoned in any country in the
Territory without the other Party first being given an opportunity to assume
full responsibility for the continued prosecution and maintenance of such Joint
Collaboration Patents. In the event that the Lead Prosecuting Party decides not
to continue the prosecution or maintenance of a patent application or patent
within the Joint Collaboration Patents in any country, the Lead Prosecuting
Party shall provide the other Party with written notice of this decision at
least *** prior to any pending lapse or abandonment thereof. In such event, the
Lead Prosecuting Party shall provide the other Party with an opportunity to
assume responsibility for the further prosecution and maintenance of such Joint
Collaboration Patents. In the event that the other Party provides notice of its
desire to assume responsibility for such prosecution and maintenance, the Lead
Prosecuting Party shall promptly transfer the responsibility for such
prosecution and maintenance of such patent applications and patents to patent
counsel selected by the other Party.

10.4.3 Cooperation. The Parties agree to cooperate in the preparation, filing,
prosecution and maintenance of all Patents under this Section 10.3, including
obtaining and executing necessary powers of attorney and assignments by the
named inventors, providing relevant technical reports to the filing Party
concerning the Invention disclosed in such Patent, obtaining execution of such
other documents which are needed in the filing and prosecution of such Patent,
and, as requested by a Party, updating each other regarding the status of such
Patent, and shall cooperate with the other Party so far as reasonably necessary
with respect to furnishing all information and data in its possession reasonably
necessary to obtain or maintain such Patents.

 

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10.5 Enforcement and Defense of Patents.

10.5.1 Infringement of Third Party Patents. Immunomedics and Licensee shall each
promptly, but in any event no later than *** after receipt of notice of such
action, notify the other in writing if either Party, or any of their respective
Affiliates or sublicensees, shall be individually named as a defendant in a
legal proceeding by a Third Party alleging infringement of a patent or other
intellectual property right of such Third Party as a result of the Development,
Manufacture, use or Commercialization of the Product hereunder for sale in the
Field in the Territory (each, an “Infringement Claim”). With respect to any
Infringement Claim, the Parties shall attempt to negotiate in good faith a
resolution with respect thereto. If the Parties cannot settle such Infringement
Claim with the appropriate Third Parties (to the reasonable satisfaction of each
of the Parties hereunder) within *** after the receipt of the notice of such
action, then the following applies:

(a) In the event that such Infringement Claim is brought against Licensee with
respect to the Product in the Field, then Licensee (or its designee) shall be
deemed to be the “Controlling Party” for purposes of such Infringement Claim. In
the event that such Infringement Claim is brought against Immunomedics in
respect of the Product in the Oncology Field, then Immunomedics (or its
designee) shall be deemed to be the “Controlling Party”. The Controlling Party
shall assume sole control of the defense of any such Infringement Claim at its
sole cost and expense. The Controlling Party will have the exclusive right to
settle any Infringement Claim without the consent of the other Party, unless
such settlement shall have a material adverse impact the intellectual property
of the other Party. For purposes of this Section, any settlement that would
involve the waiver of rights (including rights to receive payments) of such
other Party shall require the consent of such other Party, such consent not to
be unreasonably withheld. Notwithstanding the foregoing, the non-Controlling
Party shall have the right to be represented by its own counsel at its own
expense.

(b) If a Party shall become engaged in or participate in any suit described in
this Section 10.5.1(a), the other Party shall cooperate, and shall cause its and
its Affiliates’ employees to cooperate, with such Party in all reasonable
respects in connection therewith, including giving testimony and producing
documents lawfully requested, and using its reasonable efforts to make available
to the other, at no cost to the other, such employees who may be helpful with
respect to such suit, investigation, claim, interference or other proceeding.

10.6 Enforcement of Immunomedics Patents, Licensee Patents and Joint
Collaboration Patents Against Infringers.

10.6.1 Enforcement of Core Immunomedics Patents and Licensee Patents. In the
event that either Party becomes aware of a suspected infringement of any Core
Immunomedics Patents or Licensee Patents, or any such Core Immunomedics Patents
or Licensee Patents is challenged in any action or proceeding, i.e., declaratory
non-infringement action (other than any interferences, reissue proceedings,
opposition or reexaminations, which are addressed in Section 10.3.1), in any
such case with respect to

 

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activities or subject matter that concerns the Field in the Territory, such
Party shall notify the other Party promptly, and following such notification,
the Parties shall confer. ***shall have the***to***any***or***or to ***with
respect to ***and***subject to the following and other terms of this
Agreement***or***such***or***provided, that ***shall at***of the ***thereof and
shall ***with***in connection therewith). ***shall***in any such ***being ***or
***if so ***and shall ***or*** if ***by ***or ***by*** shall *** ***with respect
to *** by ***in providing such***shall have the ***and ***in any ***by ***at ***
Notwithstanding the forgoing, Licensee shall not settle or compromise any such
action or proceeding without the prior written consent of Immunomedics, such
consent not to be unreasonably withheld. Immunomedics shall, upon Licensee’s
request, grant to Licensee such rights under the Immunomedics Patents as may be
necessary for Licensee to exercise its rights under this Section 10.6.1. In the
event Licensee fails to defend any aforementioned action or proceeding or bring
any aforementioned enforcement action (or settle any of the foregoing in
accordance with this Agreement) within *** of the first notice with respect
thereto given as required above, ***shall have the ***so at ***in ***and***shall
provide ***to ***therewith (including by ***thereto)***shall ***with respect
to***by ***in ***such *** Notwithstanding any of the foregoing, Immunomedics
shall retain all, and Licensee shall have no, rights to enforce Immunomedics
Patents with respect to infringement occurring in respect of products which are
not Competitive Products (nor shall the first sentence of this Section 10.6.1
apply with respect to such infringement).

10.6.2 Enforcement of Immunomedics Patents (Other than Core Immunomedics
Patents). In the event that either Party becomes aware of a suspected
infringement of any Immunomedics Patent (other than a Core Immunomedics Patent),
or any Immunomedics Patent (other than a Core Immunomedics Patent) is challenged
in any action or proceeding, i.e., declaratory non-infringement action (other
than any interferences, reissue proceedings, opposition or reexaminations, which
are addressed in Section 10.3.1), in any such case with respect to activities or
subject matter that concerns the Field in the Territory, such Party shall notify
the other Party promptly, and following such notification, the Parties shall
confer. ***shall have the ***such***or ***or***with respect ***such***and ***or
***any*** or ***. Licensee shall reasonably assist Immunomedics in any such
action or proceeding being defended or prosecuted if so requested, and shall ***
by Immunomedics or required by applicable Law. Notwithstanding any of the
foregoing, if such Immunomedics Patent is (i) abandoned or (ii) declared invalid
or (iii) not enforced within due time to ensure preservation of any applicable
legal requirement and in any event within a period of *** from becoming aware of
the infringement, or such prosecution is not diligently pursued with ***, then
such Patent shall not be considered a Patent having a Valid Claim with respect
to the Royalty Term pursuant to Section 9.3.2 and with respect to royalties
payable pursuant to Section 9.3.1.

10.6.3 Enforcement of Joint Collaboration Patents. In the event that either
Party becomes aware of a suspected infringement of any Joint Collaboration
Patents or any such Joint Collaboration Patents is challenged in any action or
proceeding, i.e., declaratory non-infringement action (other than any
interferences, reissue proceedings, opposition or reexaminations, which are
addressed in Section 10.3.1), in any such case

 

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with respect to activities or subject matter that concerns the Field in the
Territory, such Party shall notify the other Party promptly, and following such
notification, the Parties shall confer. If the Parties after good faith
discussions decide to enforce the Joint Collaboration Patent, the Lead
Prosecuting Party shall defend any such action or proceeding or bring an
infringement action with respect to such infringement, in the name of both
Parties. The Lead Prosecuting Party shall consult with and cooperate with the
other Party in connection with defending any aforementioned action or proceeding
or bringing any aforementioned enforcement action (or settling any of the
foregoing in accordance with this Agreement). The other Party shall reasonably
assist the Lead Prosecuting Party in any such action or proceeding. All relevant
costs associated therewith shall be equally shared by the Parties.

10.6.4 Recoveries. In the event that either Party recovers any damages or other
sums in such action, suit or proceeding brought under Section 10.6.1 or
Section 10.6.3 or in settlement thereof, ***shall***all***by the Parties in
connection therewith***If such ***all ***and***of ***shall be *** a***to the
***such***by***. If after such reimbursement any funds shall remain from such
damages or other sums recovered, such funds shall be ***in***to the ***by***as a
result of the ***.

10.6.5 Other Enforcement. Notwithstanding anything to the contrary contained
herein, Immunomedics (or any of its Affiliates or their respective designees)
shall have the sole right to enforce or defend (including any recoveries) in any
action or proceeding or settlement any Immunomedics Patents regarding a claim or
scope not exclusively licensed to Licensee hereunder or not solely related to
activities or subject matter that concerns the treatment, palliation or
prevention of autoimmune diseases in humans, and Licensee shall have no rights
with respect thereto.

10.7 Patent Term Extensions. Immunomedics and Licensee shall cooperate in good
faith in gaining Patent Term Extensions wherever applicable to the Immunomedics
Patents, the Licensee Patents and the Joint Collaboration Patents in the
Territory. In the event, the Parties cannot reach an agreement for which
Immunomedics Patent(s), Licensee Patent(s) or Joint Collaboration Patent(s) to
seek Patent Term Extensions for any particular compound, protein, composition,
article, product, process or use such dispute will be resolved by the binding
recommendation of patent counsel mutually agreed to by both Parties, such
recommendation to be ordered within *** in the applicable country. Such patent
counsel shall be unaffiliated with either Party and shall not have represented
either Party at any time during the previous ***. ***such***. Notwithstanding
the forgoing, Licensee shall not object to Immunomedics’ decision with respect
to a Patent Term Extension, if Licensee cannot reasonably demonstrate that such
decision would have a material adverse effect on the market exclusivity for the
Product in the Field in the Territory (it being understood that an extension of
the Royalty Term and, if applicable, the Post-Royalty Term, in and of itself
shall not constitute such a material adverse effect). For the purpose of
registering a Patent Term Extension for the Immunomedics Patent(s) or a Joint
Collaboration Patent for which Immunomedics is the Lead Prosecuting Party, with
respect to all applications for Regulatory Approvals for the Product in the
Field in the Territory, Licensee shall provide Immunomedics with written notice
of any expected Regulatory

 

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Approval at least *** prior to the expected date of Regulatory Approval thereof,
as well as notice within *** of receiving each Regulatory Approval confirming
the date of such Regulatory Approval. The cost of obtaining such patent term
extensions shall be borne by Immunomedics with respect to all Immunomedics
Patents, by Licensee with respect to Licensee Patents and equally with respect
to the Joint Collaboration Patents.

10.8 Patent Marking. Licensee shall mark the Product marketed and sold by
Licensee (or its Affiliate, sublicensee or distributor) hereunder with
appropriate patent numbers or indicia if required by applicable Law, or if
permissible under applicable Law unless impracticable.

10.9 Consequences of Patent Challenge.

10.9.1 Termination Rights. Immunomedics will be permitted to terminate this
Agreement upon written notice to Licensee, effective upon receipt, if Licensee
or any of its Affiliates, directly or indirectly (i) initiate or request an
interference or opposition proceeding with respect to any Immunomedics Patent,
(ii) make, file or maintain any claim, demand, lawsuit or cause of action to
challenge the validity or enforceability of any Immunomedics Patent, or
(iii) except as set forth in Section 10.7, oppose any extension of or the grant
of a supplementary protection certificate with respect to, any Immunomedics
Patent (each, a “Patent Challenge”).

10.9.2 Sublicense Agreements. Licensee will include provisions in all agreements
granting sublicenses under Licensee’s rights hereunder providing that if the
sublicensee or any of its Affiliates undertake a Patent Challenge, Licensee may
terminate all sublicenses under the Immunomedics Patents granted to such
sublicensee. If a sublicensee (or an Affiliate of such sublicensee) undertakes a
Patent Challenge, then Licensee, within *** after receipt of notice thereof from
Immunomedics, will terminate all sublicenses under the Immunomedics Patents
granted to such sublicensee in the applicable sublicense agreement. If Licensee
fails to so terminate such sublicenses, then Immunomedics may terminate this
Agreement upon written notice to Licensee, effective upon receipt.

10.10 Third Party Rights. With respect to any Immunomedics Technology that is
Controlled by Immunomedics but licensed to Immunomedics by a Third Party, the
rights and obligations under this ARTICLE 10 shall apply if and to the extent
permitted or authorized under the applicable license (or other grant) agreement
and shall otherwise be subject and subordinate to the rights and obligations of
that Third Party under the license (or other grant) agreement. In addition,
prior to exercising any of its rights under this ARTICLE 10, at the request of
Immunomedics, Licensee agrees to cooperate and coordinate in good faith with any
Third Party to whom Immunomedics (or any of its Affiliates) grants any rights to
obtain, maintain, prosecute, defend, enforce, or settle any matter related to
any Immunomedics Technology for use outside the Field.

 

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ARTICLE 11

REPRESENTATIONS AND WARRANTIES

11.1 Mutual Representations and Warranties. Each Party hereby represents and
warrants (as applicable) to the other Party as follows, as of the Execution
Date:

11.1.1 Corporate Existence and Power. It is a company or corporation duly
organized, validly existing and in good standing under the laws of the
jurisdiction in which it is incorporated, and has full corporate power and
authority and the legal right to own and operate its property and assets and to
carry on its business as it is now being conducted and as contemplated in this
Agreement, including the right to grant the licenses granted by it hereunder.

11.1.2 Authority and Binding Agreement. (i) It has the corporate power and
authority and the legal right to enter into this Agreement and perform its
obligations hereunder; (ii) it has taken all necessary corporate action on its
part required to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder and (iii) this Agreement has been duly
executed and delivered on behalf of such Party, and constitutes a legal, valid,
and binding obligation of such Party that is enforceable against it in
accordance with its terms, except as enforcement may be affected by bankruptcy,
insolvency or other similar laws and by general principles of equity.

11.1.3 No Conflicts. The execution, delivery and performance of this Agreement
by it does not (i) conflict with any agreement, instrument or understanding,
oral or written, to which it is a party and by which it may be bound, or
(ii) violate any Laws of any Governmental Authority having jurisdiction over it.

11.1.4 All Consents and Approvals Obtained. Except with respect to
(a) Regulatory Approvals for the Development, Manufacturing or Commercialization
of the Product or as otherwise described in this Agreement and approvals under
the HSR Act (of the foreign equivalent thereof outside the U.S.), (i) all
necessary consents, approvals and authorizations of, and (ii) all notices to,
and filings by such Party with, all Governmental Authorities and other persons
or entities required to be obtained or provided by such Party as of the
Execution Date in connection with the execution, delivery and performance of
this Agreement have been obtained and provided, except for those approvals, if
any, not required at the time of execution of this Agreement.

11.2 Additional Representations and Warranties of Immunomedics. As used in this
Section 11.2, “Best Knowledge” means, as applied to Immunomedics, that
Immunomedics’ senior management is actually aware of a particular fact or other
matter, without any duty of inquiry or investigation. Immunomedics represents
and warrants to Licensee that, as of the Execution Date:

11.2.1 ***. All *** is *** and other than *** pursuant to ***, no ***other than
***with respect to ***by *** have any ***or *** to the ***. For all ***by***,
the ***and*** to the ***have been *** and *** from ***.

 

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11.2.2 *** all Immunomedics Patents are in *** and all *** have been ***.

11.2.3 ***. All *** which are ***and *** for the Manufacture, Development or
Commercialization of the Product in the Field in the Territory are set forth on
Exhibit A.

11.2.4 *** ***there are no ***that would ***or *** of the Immunomedics Patents
with respect to the sale of the Product in the Field in the Territory.

11.2.5 ***. ***, the *** of the Product in the Field in the Territory, ***by
***would not ***of an ***by a ***.

11.2.6 ***. *** the *** are *** in the Territory and the *** are *** in the
Territory and *** or *** in the *** of the I*** ***which could ***such ***.

11.3 Additional Representations and Warranties of Licensee. Licensee hereby
represents and warrants to Immunomedics that, as of the Execution Date:

11.3.1 Upfront Payment. Licensee has sufficient funds to make the Upfront
Payment.

11.4 Additional Representations and Warranties of Immunomedics. Immunomedics
hereby represents and warrants to Licensee that, as of the Execution Date:

11.4.1 Conduct until Execution Date. The Development and Manufacture of the
Product in the Field has been conducted by Immunomedics, its Affiliates and
subcontractors in compliance in all material respects with all applicable Laws.

11.4.2 Complete Information. Immunomedics has endeavored in good faith to
furnish Licensee with all material information requested by Licensee concerning
the quality, toxicity, safety and/or efficacy concerns that may materially
impair the utility and/or safety of the Product.

11.5 Disclaimer. Licensee understands that the Product is the subject of ongoing
clinical research and development and that Immunomedics cannot ensure the safety
or usefulness of the Product. In addition, Immunomedics makes no warranties
except as set forth in this ARTICLE 11 concerning the Immunomedics Technology.

11.6 No Other Representations or Warranties. EXCEPT AS EXPRESSLY STATED IN THIS
AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR
IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL
PROPERTY RIGHTS, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY. EXCEPT AS
EXPRESSLY STATED IN THIS AGREEMENT, ALL REPRESENTATIONS AND WARRANTIES, WHETHER
ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.

 

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ARTICLE 12

INDEMNIFICATION

12.1 Indemnification by Immunomedics. Immunomedics hereby agrees to save, defend
and hold Licensee, its Affiliates, and their respective directors, officers,
agents and employees harmless from and against any and all losses, damages,
liabilities, costs and expenses (including reasonable attorneys’ fees and
expenses) (collectively, “Losses”) arising in connection with any and all
charges, complaints, actions, suits, proceedings, hearings, investigations,
claims, demands, judgments, orders, decrees, stipulations or injunctions by a
Third Party (each a “Third Party Claim”) resulting or otherwise arising from
(a) any breach by Immunomedics of any of its representations, warranties,
covenants or obligations pursuant to this Agreement and (b) the negligence or
willful misconduct by Immunomedics or its Affiliates or their respective
officers, directors and employees in performing any obligations under this
Agreement; in each case except to the extent that such Losses are subject to
indemnification by Licensee pursuant to Section 12.2.

12.2 Indemnification by Licensee. Licensee hereby agrees to save, defend and
hold Immunomedics, its Affiliates, and their respective directors, agents and
employees harmless from and against any and all Losses arising in connection
with any and all Third Party Claims resulting or otherwise arising from (a) any
breach by Licensee of any of its representations, warranties, covenants or
obligations pursuant to this Agreement, (b) the negligence or willful misconduct
by Licensee or its Affiliates or their respective officers, directors,
employees, agents, consultants or sublicensees in performing any obligations
under this Agreement, (c) any matter related to the Development, Manufacturing,
handling, use, Packaging and Labeling or Commercialization of the Product by
Licensee or its Affiliates or their respective officers, directors, employees,
agents, consultants or sublicensees (including, for clarity any product
liability Losses howsoever arising) and (d) the Promotional and Educational
Materials, the Product packaging and labeling (including any insertion materials
such as patient inserts, patient medication guides, and professional inserts and
any other written, printed or graphic materials accompanying the Product,
considered to be part of the finished packaged Product), Product pricing and
reimbursement, or any acts or omissions of the Sales and Educational
Representatives in promoting and selling the Product in the Territory; in each
case except to the extent that such Losses are subject to indemnification by
Immunomedics pursuant to Section 12.1.

12.3 Indemnification Procedures.

12.3.1 Notice of Claim. All indemnification claims in respect of any indemnitee
seeking indemnity under Section 12.1 or 12.2, as applicable (collectively, the
“Indemnitees” and each an “Indemnitee”) will be made solely by the corresponding
Party (the “Indemnified Party”). The Indemnified Party will give the
indemnifying Party (the “Indemnifying Party”) prompt written notice (an
“Indemnification Claim Notice”) of any Losses and any legal proceeding initiated
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Party as to which the Indemnified Party intends to make a request for
indemnification under Section 12.1 or 12.2, as applicable, but in no event will
the Indemnifying Party be liable for any Losses that result from any delay in
providing such notice which materially prejudices the defense of such
proceeding. Each Indemnification Claim Notice shall contain a description of the
claim and the nature and amount of such Loss (to the extent that the nature and
amount of such Loss are known at such time). Together with the Indemnification
Claim Notice, the Indemnified Party will furnish promptly to the Indemnifying
Party copies of all notices and documents (including court papers) received by
any Indemnitee in connection with the Third Party Claim.

12.3.2 Control of Defense. At its option, the Indemnifying Party may assume the
defense of any Third Party Claim subject to indemnification as provided for in
Section 12.1 or 12.2, as applicable, by giving written notice to the Indemnified
Party within ten (10) days after the Indemnifying Party’s receipt of an
Indemnification Claim Notice. Upon assuming the defense of a Third Party Claim,
the Indemnifying Party may appoint as lead counsel in the defense of the Third
Party Claim any legal counsel it selects, and such Indemnifying Party shall
thereafter continue to defend such Third Party Claim in good faith. Should the
Indemnifying Party assume the defense of a Third Party Claim (and continue to
defend such Third Party Claim in good faith), the Indemnifying Party will not be
liable to the Indemnified Party or any other Indemnitee for any legal expenses
subsequently incurred by such Indemnified Party or other Indemnitee in
connection with the analysis, defense or settlement of the Third Party Claim,
unless the Indemnifying Party has failed to assume the defense and employ
counsel in accordance with this Section 12.3.

12.3.3 Right to Participate in Defense. Without limiting Section 12.3.2, any
Indemnitee will be entitled to participate in, the defense of a Third Party
Claim for which it has sought indemnification hereunder and to employ counsel of
its choice for such purpose; provided, however, that such employment will be at
the Indemnitee’s own expense unless (a) the employment thereof has been
specifically authorized by the Indemnifying Party in writing, or (b) the
Indemnifying Party has failed to assume the defense (or continue to defend such
Third Party Claim in good faith) and employ counsel in accordance with this
Section 12.3.3, in which case the Indemnified Party will be allowed to control
the defense.

12.3.4 Settlement. With respect to any Losses relating solely to the payment of
money damages in connection with a Third Party Claim and that will not result in
the Indemnitee becoming subject to injunctive or other relief or otherwise
adversely affect the business of the Indemnitee in any manner, and as to which
the Indemnifying Party will have acknowledged in writing the obligation to
indemnify the Indemnitee hereunder, the Indemnifying Party will have the sole
right to consent to the entry of any judgment, enter into any settlement or
otherwise dispose of such Loss, on such terms as the Indemnifying Party, in its
reasonable discretion, will deem appropriate (provided, however that such terms
shall include a complete and unconditional release of the Indemnified Party from
all liability with respect thereto), and will transfer to the Indemnified Party
all amounts which said Indemnified Party will be liable to pay prior to the time
of the entry of judgment. With respect to all other Losses in connection with
Third Party Claims, where the Indemnifying Party has assumed the defense of the
Third

 

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Party Claim in accordance with Section 12.3.2, the Indemnifying Party will have
authority to consent to the entry of any judgment, enter into any settlement or
otherwise dispose of such Loss provided it obtains the prior written consent of
the Indemnified Party (which consent will be at the Indemnified Party’s
reasonable discretion). The Indemnifying Party that has assumed the defense of
(and continues to defend) the Third Party Claim in accordance with
Section 12.3.2 will not be liable for any settlement or other disposition of a
Loss by an Indemnitee that is reached without the written consent of such
Indemnifying Party. Regardless of whether the Indemnifying Party chooses to
defend or prosecute any Third Party Claim, no Indemnitee will admit any
liability with respect to, or settle, compromise or discharge, any Third Party
Claim without first offering to the Indemnifying Party the opportunity to assume
the defense of the Third Party Claim in accordance with Section 12.3.2.

12.3.5 Cooperation. If the Indemnifying Party chooses to defend or prosecute any
Third Party Claim, the Indemnified Party will, and will cause each other
Indemnitee to, cooperate in the defense or prosecution thereof and will furnish
such records, information and testimony, provide such witnesses and attend such
conferences, discovery proceedings, hearings, trials and appeals as may be
reasonably requested in connection with such Third Party Claim. Such cooperation
will include access during normal business hours afforded to the Indemnifying
Party to, and reasonable retention by the Indemnified Party of, records and
information that are reasonably relevant to such Third Party Claim, and making
Indemnitees and other employees and agents available on a mutually convenient
basis to provide additional information and explanation of any material provided
hereunder, and the Indemnifying Party will reimburse the Indemnified Party for
all its reasonable out-of-pocket costs incurred in connection with such
cooperation.

12.3.6 Expenses of the Indemnified Party. Except as provided above, the
reasonable and verifiable costs and expenses, including fees and disbursements
of counsel, incurred by the Indemnified Party in connection with any Third Party
Claim will be reimbursed on a calendar quarter basis by the Indemnifying Party,
without prejudice to the Indemnifying Party’s right to contest the Indemnified
Party’s right to indemnification and subject to refund in the event the
Indemnifying Party is ultimately held not to be obligated to indemnify the
Indemnified Party.

12.4 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY
SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM
OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE
POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS
SECTION 12.4 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 12.1 OR 12.2, OR DAMAGES
AVAILABLE FOR A PARTY’S BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER ARTICLE 13.
EXCEPT AS EXPRESSLY SET FORTH IN ANY REPRESENTATION OR WARRANTY IN ARTICLE 11,
LICENSEE ACKNOWLEDGES AND AGREES THAT IMMUNOMEDICS HAS MADE NO REPRESENTATIONS
OR

 

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WARRANTIES WITH RESPECT TO, AND LICENSEE SHALL HAVE NO CLAIM OR RIGHT (INCLUDING
WITH RESPECT TO INDEMNIFICATION PURSUANT TO THIS ARTICLE 12 (OR OTHERWISE)) WITH
RESPECT TO, ANY INFORMATION, DOCUMENTS OR MATERIALS FURNISHED TO OR FOR LICENSEE
BY IMMUNOMEDICS, ANY OF ITS AFFILIATES, OR ANY OF ITS OR THEIR OFFICERS,
DIRECTORS, EMPLOYEES, AGENTS OR ADVISORS, INCLUDING ANY CONFIDENTIAL INFORMATION
PACKAGE REGARDING THE PRODUCT PROVIDED TO LICENSEE AND ANY INFORMATION,
DOCUMENTS OR MATERIAL MADE AVAILABLE TO LICENSEE IN ANY “DATA ROOM”, MANAGEMENT
PRESENTATION OR ANY OTHER FORM IN EXPECTATION OF THE TRANSACTION AND
COLLABORATION CONTEMPLATED HEREBY.

12.5 Insurance. Licensee 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 at all times during which the Product is being clinically tested in
human subjects or commercially distributed or sold by or on behalf of Licensee
pursuant to this Agreement, and the insurance coverage shall in no event be less
than (a) prior to the First Commercial Sale of a Product in the Territory, $***
per loss occurrence and $*** in the aggregate, and (b) after such First
Commercial Sale in the Territory, $*** per loss occurrence and $*** in the
aggregate. It is understood that such insurance shall not be construed to create
a limit of Licensee’s liability with respect to its indemnification obligations
under this ARTICLE 12. Licensee shall provide Immunomedics with written evidence
of such insurance upon request. Licensee shall provide Immunomedics with written
notice at least *** prior to the cancellation, nonrenewal or material change in
such insurance or self-insurance which materially adversely affects the rights
of the Immunomedics hereunder.

ARTICLE 13

CONFIDENTIALITY

13.1 Confidential Information. As used in this Agreement, the term “Confidential
Information” means all information, whether it be written or oral, including all
production schedules, lines of products, volumes of business, processes, new
product developments, product designs, formulae, technical information,
laboratory data, clinical data, patent information, know-how, trade secrets,
financial and strategic information, marketing and promotional information and
data, and other material relating to any products, projects or processes of one
Party (the “Disclosing Party”) that is provided to, or otherwise obtained by,
the other Party (the “Receiving Party”) in connection with this Agreement
(including information exchanged prior to the date hereof in connection with the
transactions set forth in this Agreement, including any information disclosed by
either Party pursuant to the Confidential Information Agreement between the
Parties dated August 9, 2007). Notwithstanding the foregoing sentence,
Confidential Information shall not include any information or materials that:

(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;

 

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

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

(d) were disclosed to a Party, other than under an obligation of
confidentiality, by a Third Party who had no obligation to the Disclosing Party
not to disclose such information to others; or

(e) were independently discovered or developed by or on behalf of the Receiving
Party without the use of the Confidential Information belonging to the other
Party, to the extent such Receiving Party has documentary evidence to that
effect.

13.2 Confidentiality Obligations. Each of Licensee and Immunomedics shall keep
all Confidential Information received from or on behalf of the other Party with
the same degree of care it maintains the confidentiality of its own Confidential
Information, but in all cases no less than a reasonable degree of care. Neither
Party shall use such Confidential Information for any purpose other than in
performance of this Agreement or disclose the same to any other person or entity
other than to such of its and its Affiliates’ directors, managers, employees,
independent contractors, agents, investors or potential investors or consultants
who have a need to know such Confidential Information to implement the terms of
this Agreement or enforce its rights under this Agreement; provided, however,
that a Receiving Party shall advise any of its and its Affiliates’ directors,
managers, employees, independent contractors, agents, investors and potential
investors or consultants who receives such Confidential Information of the
confidential nature thereof and of the obligations contained in this Agreement
relating thereto, and the Receiving Party shall ensure (including, in the case
of a Third Party, by means of a written agreement with such Third Party having
terms at least as protective as those contained in this ARTICLE 13) that all
such directors, managers, employees, independent contractors, agents or
consultants comply with such obligations. Upon termination of this Agreement,
the Receiving Party shall return or destroy all documents, tapes or other media
containing Confidential Information of the Disclosing Party that remain in the
possession of the Receiving Party or its directors, managers, employees,
independent contractors, agents or consultants, except that the Receiving Party
may keep one copy of the Confidential Information in the legal department files
of the Receiving Party, solely for archival purposes. Such archival copy shall
be deemed to be the property of the Disclosing Party, and shall continue to be
subject to the provisions of this ARTICLE 13. It is understood that receipt of
Confidential Information under this Agreement will not limit the Receiving Party
from assigning its employees to any particular job or task in any way it may
choose, subject to the terms and conditions of this Agreement.

 

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13.3 Permitted Disclosure and Use. Except as set out in Section 13.2, either
Party may disclose Confidential Information belonging to the other Party only to
the extent such disclosure is reasonably necessary to: (a) comply with or
enforce any of the provisions of this Agreement; and (b) comply with applicable
Law. If a Party deems it necessary to disclose Confidential Information of the
other Party pursuant to this Section 13.3, such Party shall give reasonable
advance written notice of such disclosure to the other Party to permit such
other Party sufficient opportunity to object to such disclosure or to take
measures to ensure confidential treatment of such information, including seeking
a protective order or other appropriate remedy.

13.4 Notification. The Receiving Party shall notify the Disclosing Party
promptly upon discovery of any unauthorized use or disclosure of the Disclosing
Party’s Confidential Information, and will cooperate with the Disclosing Party
in any reasonably requested fashion to assist the Disclosing Party to regain
possession of such Confidential Information and to prevent its further
unauthorized use or disclosure.

13.5 Publicity; Filing of this Agreement. The press release to be issued by
Immunomedics in connection with the transactions is set forth on Part A of
Exhibit C and the press release to be issued by Licensee in connection with the
transactions is set forth on Part B of Exhibit C. Except as otherwise provided
in this Section 13.5, each Party shall maintain the confidentiality of all
provisions of this Agreement, and without the prior written consent of the other
Party, which consent shall not be unreasonably withheld, neither Party nor its
respective Affiliates shall make any press release or other public announcement
of or otherwise disclose the provisions of this Agreement to any Third Party,
except for: (i) disclosure to those of its directors, officers, employees,
accountants, attorneys, advisors and agents, investors or potential investors
whose duties reasonably require them to have access to this Agreement, provided
that such directors, officers, employees, accountants, attorneys and agents are
required to maintain the confidentiality of this Agreement; (ii) disclosures
required by NASDAQ regulation or any listing agreement with a national
securities exchange, in which case the disclosing Party shall provide the
nondisclosing Party with at least 48 hours’ notice unless otherwise not
practicable, but in any event no later than the time the disclosure required by
such NASDAQ regulation or listing agreement is made; (iii) disclosures as may be
required by applicable Law, in which case the disclosing Party shall provide the
nondisclosing Party with prompt advance notice of such disclosure and cooperate
with the nondisclosing Party to seek a protective order or other appropriate
remedy, including a request for confidential treatment in the case of a filing
with the Securities and Exchange Commission; (iv) the report on Form 8-K, which
may be filed by either Party or an Affiliate of either Party setting forth the
press release referred to above, and/or this Agreement in redacted form,
(v) disclosures that are consistent with or complementary to those described in
clause (iv) but which do not contain any Confidential Information of the other
Party; and (vi) other disclosures for which consent has previously been given. A
Party may publicly disclose without regard to the preceding requirements of this
Section 13.5 any information that was previously publicly disclosed pursuant to
this Section 13.5.

13.6 Publication. Each Party shall submit copies of each proposed academic,
scientific, medical and other publication or presentation that contains or
refers to Inventions,

 

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know-how or other information, or Patents Controlled by the other Party and that
relates to the Product or any research or Development activities relating to the
Product as well as post approval development of the Product under this
Agreement, to the other Party at least *** in advance of submitting such
proposed publication or presentation to a publisher or other Third Party. Such
other Party shall have the right to review, comment on and approve each such
proposed publication or presentation for accuracy and to ascertain whether such
Party’s Confidential Information is being inappropriately utilized and/or
released. The non-publishing Party shall have the right to remove any of its
Confidential Information prior to submission for publication or presentation.
The publishing Party shall redact or otherwise modify the proposed publication
or presentation to remove any such Confidential Information of the other Party.
In addition, in the event that the document includes data, information or
material generated by a Party’s scientists, and professional standards for
authorship would be consistent with including such Party’s scientists as
co-authors of the document, the names of such scientists will be included as
co-authors. A Party may publicly disclose without regard to the preceding
requirements of this Section 13.6 any information that was previously disclosed
in a public disclosure that was in compliance with such requirements.

13.7 Use of Names. Except as otherwise set forth in this Agreement, neither
Party shall use the name of the other Party in relation to this transaction in
any public announcement, press release or other public document without the
written consent of such other Party, which consent shall not be unreasonably
withheld; provided, however, that subject to Section 13.5, either Party may use
the name of the other Party in any document filed with any regulatory agency or
Governmental Authority, including the FDA, EMEA and the Securities and Exchange
Commission.

13.8 Survival. The obligations and prohibitions contained in this ARTICLE 13 as
they apply to Confidential Information, shall survive the expiration or
termination of this Agreement for a period of ***.

ARTICLE 14

TERM AND TERMINATION

14.1 Term. This Agreement shall become effective on the Effective Date and,
unless earlier terminated pursuant to this ARTICLE 14, shall remain in effect,
on country-by-country basis, until the expiration of the Royalty Term and, if
applicable, the Post-Royalty Term, in such country in the Territory (the
“Term”).

14.2 Termination for Breach. Either Party may, without prejudice to any other
remedies available to it at law or in equity, terminate this Agreement in the
event that the other Party (the “Breaching Party”) shall have materially
breached or defaulted in the performance of any of its obligations. The
Breaching Party shall have *** (*** in the event of non-payment) after written
notice thereof was provided to the Breaching Party by the non-breaching Party,
to remedy such default. Any such termination shall become effective at the end
of such *** period (*** period for non-payment) unless the Breaching Party has
cured any such breach or default prior to the expiration of such *** period (***
period for non-payment).

 

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14.3 Termination as a Result of Bankruptcy. Each Party shall have the right to
terminate this Agreement upon written notice as a result of the filing or
institution of bankruptcy, reorganization, liquidation or receivership
proceedings, or upon an assignment of a substantial portion of the assets for
the benefit of creditors by the other Party; provided, that such termination
shall be effective only if such proceeding is not dismissed within *** after the
filing thereof.

14.4 Termination by Immunomedics.

14.4.1 Competitive Products. Immunomedics may *** *** prior written notice to
Licensee in the event Licensee (or any of its Affiliates), either itself or with
a Third Party, *** (except with respect to the Development and Commercialization
activities hereunder), provided however, with respect to any country other than
a Major Market Country, *** *** period to Immunomedics to end *** as soon as
reasonably possible, but in any event no later than *** after such statement.

14.4.2 Patent Challenge. Immunomedics may terminate this Agreement pursuant to
the provisions of Section 10.9.

14.5 Termination by Licensee at Will. Licensee may terminate this Agreement it
its entirety, for any reason or no reason by written notice to Immunomedics
effective upon one hundred eighty (180) days from the date of receipt of the
notice by Immunomedics, provided that Licensee may not terminate this Agreement
in accordance with this Section 14.5 until after eighteen (18) months of the
Effective Date.

ARTICLE 15

EFFECTS OF TERMINATION

15.1 Termination by Immunomedics. Without limiting any other legal or equitable
remedies that a Party may have, if this Agreement is terminated by Immunomedics
in accordance with Sections 14.2, 14.3 or 14.4 or if this Agreement is
terminated by Licensee in accordance with Section 14.5, then the following
provisions shall apply:

15.1.1 Termination of Licenses. All rights and licenses granted to Licensee
hereunder shall immediately terminate and be of no further force and effect and
Licensee shall cease Developing, Manufacturing and Commercializing the Product
(except as otherwise set forth in Section 15.1.4).

15.1.2 Assignments. Licensee will promptly, in each case within *** after
receipt of Immunomedics’ request, and at no cost to Immunomedics:

(a) assign to Immunomedics all of Licensee’s right, title and interest in and to
any agreements (or portions thereof) between Licensee and Third Parties that
that relate to the Development, Manufacturing or Commercialization of the
Product in any country for which such termination is effective;

 

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(b) assign to Immunomedics all of Licensee’s right, title and interest in and to
any (i) Promotional and Educational Materials and (ii) copyrights and trademarks
(including any Product Trademarks and Product Trade Dress, but excluding any
Licensee housemarks and corporate trademarks, names and logos of Licensee),
including any goodwill associated therewith, any registrations and design
patents for the foregoing and any Internet domain name registrations for such
trademarks and slogans, all to the extent related to the Product in any country
for which such termination is effective; provided, however in the event
Immunomedics exercises such right to have assigned such Promotional and
Educational Materials, Licensee shall grant, and hereby does grant, a
royalty-free right and license to any housemarks, trademarks, names and logos of
Licensee (not otherwise transferred pursuant to this clause (b)) contained
therein for a period of *** in order use such Promotional and Educational
Materials in connection with the Commercialization of the Product;

(c) assign to Immunomedics the management and continued performance of any
clinical trials for the Product ongoing hereunder as of the effective date of
such termination in any country for which such termination is effective, and
Licensee shall be responsible (and shall reimburse Immunomedics for) any and all
costs required to complete such clinical trials (provided that, at the request
of either Party, the Parties may meet to discuss the payment of a cancellation
fee by Licensee to Immunomedics in lieu of Licensee paying such costs to
complete such clinical trials);

(d) transfer to Immunomedics all of Licensee’s right, title and interest in and
to any and all New Licensee Development Data, regulatory filings, Regulatory
Approvals, Regulatory Data and Regulatory Materials for the Product in any
country for which such termination is effective;

(e) transfer to Immunomedics all of Licensee’s right, title and interest in and
to any and all Commercialization Data Controlled by Licensee for the Product in
any country for which such termination is effective; and

(f) provide copies of any other books, records, documents and instruments
Controlled by Licensee to the extent related to the Product; provided, however
that to the extent that any agreement or other asset described in this
Section 15.1.2 is not assignable by Licensee, then such agreement or other asset
will not be assigned, and upon the request of Immunomedics, Licensee will take
such steps as may be necessary to allow Immunomedics to obtain and to enjoy the
benefits of such agreement or other asset, without additional payment therefor,
in the form of a license or other right to the extent Licensee has the right and
ability to do so.

(g) grant to Immunomedics a non-exclusive, irrevocable, perpetual, fully paid
up, royalty free, sublicenseable, transferable license under the Licensee
Technology and Licensee’s interest in the Joint Collaboration Technology, to
make, have made, sell, offer to sell, import and use the Product in the Field in
the

 

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Territory. Immunomedics shall be liable for any royalties or other payments due
and owing by Licensee to a Third Party as a result of Immunomedics’ exercise of
the license granted in this Section 15.1.2.

For purposes of clarity, Immunomedics shall have the right to request that
Licensee take any or all of the foregoing actions in whole or in part, or with
respect to all or any portion of the assets set forth in the foregoing
provisions.

15.1.3 Disclosure and Delivery. Licensee will promptly transfer to Immunomedics,
at the sole cost of Licensee, copies of any physical embodiment of any know-how
and other information Controlled by Licensee or any of its Affiliates, to the
extent used in connection with the Development, Manufacture or Commercialization
of the Product; such transfer shall be effected by the delivery of documents, to
the extent such know-how and other information is embodied in documents, and to
the extent that such know-how or other information is not fully embodied in
documents, Licensee shall make its employees and agents who have knowledge of
such know-how and other information, in addition to that embodied in documents,
available to Immunomedics for interviews, demonstrations and training to effect
such transfer in manner sufficient to enable Immunomedics to practice such
know-how and other information.

15.1.4 Disposition of Inventory. Within *** following the effective date of such
termination, at the option of Immunomedics, any inventory of the Product
affected by such termination shall be delivered by Licensee to Immunomedics, and
Licensee shall grant, and hereby does grant, a royalty-free right and license to
any housemarks, trademarks, names and logos of Licensee contained therein for a
period of *** in order to sell such inventory.

15.1.5 License. Licensee shall grant, and hereby does grant, to Immunomedics an
exclusive, worldwide, irrevocable, perpetual, fully paid up, royalty free,
sublicenseable, transferable license to the Product Trademark, the Product Trade
Dress, Patents and technical information and know-how (including all biological,
chemical, pharmacological, toxicological, clinical, assay and related know-how
and trade secrets, and all manufacturing data, the specifications of
ingredients, the manufacturing processes, specifications, sourcing information,
assays, quality control and testing procedures, and related know-how and trade
secrets) Controlled by Licensee or any of its Affiliates related to the Product
for all uses in connection with the Product, including the research,
development, manufacture, sale and other use thereof.

15.1.6 Disposition of Commercialization Related Materials. Licensee will
promptly deliver to Immunomedics (in anonymous form to the extent prescribed by
applicable data protection regulation) (a) a list identifying all wholesalers
and other distributors involved in the Commercialization of the Product in the
Territory as well as any customer lists related to the Commercialization of the
Product in the Territory, (b) all Promotional and Educational Materials as well
as any items bearing the Product Trademark and/or any trademarks or house marks
otherwise associated with the Product or Immunomedics and (c) a copy of
Licensee’s database containing the names and contact information for
Specialists.

 

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15.2 Termination by Licensee. Without limiting any other legal or equitable
remedies that a Party may have, if this Agreement is terminated by Licensee in
accordance with Sections 14.2 or 14.3, then the following provisions shall
apply:

15.2.1 Termination of Licenses. All rights and licenses granted to Licensee
hereunder shall immediately terminate and be of no further force and effect and
Licensee shall cease Developing, Manufacturing and Commercializing the Product
(except as otherwise set forth in Section 15.2.4).

15.2.2 Assignments. Licensee will promptly, in each case within *** after
receipt of Immunomedics’ request, and at no cost to Licensee other than as
expressly set forth herein:

(a) assign to Immunomedics all of Licensee’s right, title and interest in and to
any agreements (or portions thereof) between Licensee and Third Parties that
that relate to the Development, Manufacturing or Commercialization of the
Product in any country for which such termination is effective;

(b) assign to Immunomedics all of Licensee’s right, title and interest in and to
any (i) Promotional and Educational Materials and (ii) copyrights and trademarks
(including any Product Trademarks and Product Trade Dress, but excluding any
Licensee housemarks and corporate trademarks, names and logos of Licensee),
including any goodwill associated therewith, any registrations and design
patents for the foregoing and any Internet domain name registrations for such
trademarks and slogans, all to the extent related to the Product in any country
for which such termination is effective; provided, however in the event
Immunomedics exercises such right to have assigned such Promotional and
Educational Materials, Licensee shall grant, and hereby does grant, a
royalty-free right and license to any housemarks, trademarks, names and logos of
Licensee (not otherwise transferred pursuant to this clause (b)) contained
therein for a period of *** in order use such Promotional and Educational
Materials in connection with the Commercialization of the Product;

(c) assign to Immunomedics the management and continued performance of any
clinical trials for the Product ongoing hereunder as of the effective date of
such termination in any country for which such termination is effective, and
***for any and all ***to ***;

(d) transfer to Immunomedics all of Licensee’s right, title and interest in and
to any and all New Licensee Development Data, regulatory filings, Regulatory
Approvals, Regulatory Data and Regulatory Materials for the Product in any
country for which such termination is effective;

(e) transfer to Immunomedics all of Licensee’s right, title and interest in and
to any and all Commercialization Data Controlled by Licensee for the Product in
any country for which such termination is effective; and

(f) provide copies of any other books, records, documents and instruments
Controlled by Licensee to the extent related to the Product; provided, however

 

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that to the extent that any agreement or other asset described in this
Section 15.2.2 is not assignable by Licensee, then such agreement or other asset
will not be assigned, and upon the request of Immunomedics, Licensee will take
such steps as may be necessary to allow Immunomedics to obtain and to enjoy the
benefits of such agreement or other asset, with reimbursement by Immunomedics of
reasonable costs therefor, in the form of a license or other right to the extent
Licensee has the right and ability to do so.

(g) grant to Immunomedics a non-exclusive, irrevocable, perpetual, fully paid
up, royalty free, sublicenseable, transferable license under the Licensee
Technology and Licensee’s interest in the Joint Collaboration Technology, to
make, have made, sell, offer to sell, import and use the Product in the Field in
the Territory. Immunomedics shall be liable for any royalties or other payments
due and owing by Licensee to a Third Party as a result of Immunomedics’ exercise
of the license granted in this Section 15.2.2.

For purposes of clarity, Immunomedics shall have the right to request that
Licensee take any or all of the foregoing actions in whole or in part, or with
respect to all or any portion of the assets set forth in the foregoing
provisions.

15.2.3 Disclosure and Delivery. Licensee will promptly transfer to Immunomedics,
at the sole cost of Immunomedics, copies of any physical embodiment of any
know-how and other information Controlled by Licensee or any of its Affiliates,
to the extent used in connection with the Development, Manufacture or
Commercialization of the Product; such transfer shall be effected by the
delivery of documents, to the extent such know-how and other information is
embodied in documents, and to the extent that such know-how or other information
is not fully embodied in documents, Licensee shall make its employees and agents
who have knowledge of such know-how and other information, in addition to that
embodied in documents, available to Immunomedics for interviews, demonstrations
and training to effect such transfer in manner sufficient to enable Immunomedics
to practice such know-how and other information, and Immunomedics shall bear all
Out-of-Pocket Costs incurred by Licensee in connection with performing its
obligations pursuant to this Section 15.2.3.

15.2.4 Disposition of Inventory. Within *** following the effective date of such
termination, at the option of Licensee, any inventory of the Product affected by
such termination shall be delivered by Licensee to Immunomedics, and upon the
exercise of such option, Licensee shall grant, and hereby does grant, a
royalty-free right and license to any housemarks, trademarks, names and logos of
Licensee contained therein for a period of *** in order to sell such inventory.
In the event that Licensee does not exercise its option in the foregoing
sentence, Licensee shall promptly destroy any inventory of Product in Licensee’s
possession or control, except for any samples Licensee may be required to retain
by applicable Law.

15.2.5 License. Licensee shall grant, and hereby does grant, to Immunomedics an
exclusive, worldwide, irrevocable, perpetual, fully paid up, royalty free,
sublicenseable, transferable license to the Product Trademark, the Product Trade
Dress, Patents and technical information and know-how (including all biological,
chemical,

 

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pharmacological, toxicological, clinical, assay and related know-how and trade
secrets, and all manufacturing data, the specifications of ingredients, the
manufacturing processes, specifications, sourcing information, assays, quality
control and testing procedures, and related know-how and trade secrets)
Controlled by Licensee or any of its Affiliates related to the Product for all
uses in connection with the Product, including the research, development,
manufacture, sale and other use thereof.

15.2.6 Disposition of Commercialization Related Materials. Licensee will
promptly deliver to Immunomedics (in anonymous form to the extent prescribed by
applicable data protection regulation) (a) a list identifying all wholesalers
and other distributors involved in the Commercialization of the Product in the
Territory as well as any customer lists related to the Commercialization of the
Product in the Territory, (b) all Promotional and Educational Materials as well
as any items bearing the Product Trademark and/or any trademarks or house marks
otherwise associated with the Product or Immunomedics and (c) a copy of
Licensee’s database containing the names and contact information for
Specialists.

15.3 Licenses Upon Expiration. Upon expiration of this Agreement pursuant to
Section 14.1 with respect to a country in the Territory, Licensee will have a
non-exclusive, fully paid, perpetual, royalty-free right and license under the
Immunomedics Technology to Manufacture the Product in the Territory and to
Develop and Commercialize the Product in the Field in the Territory.

15.4 Activities During Termination Notice Period. Each Party shall be required,
at Immunomedics’ sole discretion, to perform all outstanding obligations of such
Party under the then-current Development Plan and or Commercialization Plan
until the effective date of such termination.

15.5 Transition Assistance. For a period of *** from and after the effective
date of such termination, Licensee shall provide assistance, at no cost to
Immunomedics, as may be reasonably necessary or useful for Immunomedics to
commence or continue Developing, Manufacturing or Commercializing the Product in
the Field in the Territory, to the extent Licensee is then performing or has
performed such activities, including without limitation transferring or amending
as appropriate, upon request of Immunomedics, any ongoing clinical studies,
agreements or arrangements with Third Party suppliers or vendors to supply or
sell the Products. To the extent that any contract between Licensee and a Third
Party for the supply of Products is not assignable to Immunomedics, then
Licensee shall reasonably cooperate with Immunomedics to arrange to continue to
obtain such supply from such entity, and Licensee shall supply such Products to
Immunomedics at Licensee’s actual purchase price for such one year period. In
addition, to the extent that Licensee or its Affiliate is then manufacturing
Products, Licensee shall continue to manufacture, and shall supply to
Immunomedics, at Licensee’s actual manufacturing cost, such Products for
Immunomedics’ use for a period of *** from and after the effective date of such
termination in order to permit Immunomedics to establish sufficient
manufacturing capacity for the Product in the Field.

 

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15.6 Accrued Rights. Termination or expiration of this Agreement for any reason
will be without prejudice to any rights that will have accrued to the benefit of
a Party prior to the effective date of such termination. Such termination will
not relieve a Party from obligations that are expressly indicated to survive the
termination or expiration of this Agreement.

15.7 Survival. Notwithstanding anything to the contrary contained herein, the
following provisions shall survive any expiration or termination of this
Agreement: Sections 2.5, 6.5.4, 9.10, 9.11, 10.1.1, 11.5, 12.1-12.3 (to the
extent arising prior to expiration or termination), 12.4 and ARTICLE 13, ARTICLE
15, ARTICLE 17 and ARTICLE 18. Except as set forth in this Section 15.7 or
otherwise expressly set forth herein, upon termination or expiration of this
Agreement all other rights and obligations of the Parties shall cease.

ARTICLE 16

HSR ACT; EFFECTIVE DATE; STANDSTILL

16.1 HSR Act.

16.1.1 HSR Filing. Each of Licensee and Immunomedics shall, as promptly as
practicable after the Execution Date, file or supply, or cause to be filed or
supplied, all notifications and information required to be filed or supplied
pursuant to the Hart Scott Rodino Antitrust Improvements Act of 1976, as amended
(the “HSR Act”), in connection with the transaction contemplated by this
Agreement. Each of Licensee and Immunomedics shall furnish to the other such
necessary information and reasonable assistance as the other may request in
connection with its preparation of any filing or submission which is necessary
under the HSR Act. As promptly as practicable, Licensee and Immunomedics shall
make, or cause to be made, all such other filings and submissions under laws,
rules and regulations applicable to them, or to their Affiliates, as may be
required for them to consummate the transaction contemplated hereby in
accordance with the terms of this Agreement. Licensee and Immunomedics shall
keep one another apprised of the status of any communications with, and
inquiries or requests for additional information from, any governmental
authority, including the United States Federal Trade Commission and the
Antitrust Division of the United States Department of Justice, and shall comply
promptly with any such inquiry or request. Licensee shall bear the costs of all
filing fees under the HSR Act.

16.1.2 Cooperation. Licensee and Immunomedics agree to cooperate and to use
their respective reasonable commercial efforts to obtain any government
clearances or approvals required for consummation of this Agreement under the
HSR Act, and to respond to any government requests for information under the HSR
Act, and to contest and resist any action, including any legislative action,
administrative or judicial action, and to have vacated, lifted, reversed or
overturned any decree, judgment, injunction or other order (whether temporary,
preliminary or permanent) that restricts, prevents or prohibits the consummation
of the transactions contemplated by this agreement under the HSR Act; provided
however that neither Party shall be required to divest any material assets in
connection with obtaining such HSR Act.

 

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16.2 Effective Date of this Agreement. Each of Licensee and Immunomedics agree
that the obligations of the Parties under this Agreement shall not be effective
until such time as the waiting period (and any extension thereof) applicable to
the consummation of the Agreement under the HSR Act shall have expired or been
terminated (the “Effective Date”); provided, that this ARTICLE 16 shall be
effective, and the Parties shall perform their obligations hereunder, from and
after the Execution Date. Either Party may terminate this Agreement at any time
on or after October 31, 2008 if: (i) the Parties have failed to obtain all
government clearances or approvals required for consummation of this Agreement
under the HSR Act or which is otherwise required to consummate the transaction
contemplated by this Agreement, or (ii) there is a final decree, judgment,
injunction, order, or action (including any legislative, administrative, or
judicial action) that restricts, prevents or prohibits the consummation of the
transaction contemplated by this Agreement under the HSR Act or other applicable
Law in the United States.

16.3 Purchases of Equity Securities. Upon the Effective Date and for a period
lasting until the earlier of (a) the *** and (b) *** after the effective date of
termination of this Agreement, except as permitted by Section 16.4, Licensee and
its Affiliates will not (and will not assist or encourage others to) directly or
indirectly in any manner, absent a request from, or prior consent of,
Immunomedics:

16.3.1 acquire, offer or agree to acquire, or announce an intention to acquire,
directly or indirectly, alone or in concert with others, by purchase, gift or
otherwise, any direct or indirect beneficial ownership (within the meaning of
Rule l3d-3 under the Securities Exchange Act of 1934, as amended (the “Exchange
Act”) or interest in any securities of Immunomedics entitled to vote on the
election of directors (“Voting Securities”) or direct or indirect rights,
warrants or options to acquire, or securities convertible into or exchangeable
for, any Voting Securities of Immunomedics;

16.3.2 make, or in any way participate in, directly or indirectly, alone or in
concert with others, any “solicitation” of “proxies” to vote (as such terms are
used in the proxy rules of the Securities and Exchange Commission (the “SEC”)
promulgated pursuant to Section 14 of the Exchange Act) or seek to advise or
influence any person with respect to the voting of any Voting Securities of
Immunomedics; provided, however, that the prohibition in this Section 16.3.2
shall not apply to solicitations exempted from the proxy solicitation rules by
Rule 14a-2 under the Exchange Act as such Rule 14a-2 is in effect as of the
Effective Date;

16.3.3 directly or indirectly make any public announcement with respect to, or
submit a proposal for, or offer of (with or without conditions) any
extraordinary transaction involving Immunomedics or its securities or assets or
any subsidiary thereof, or of any successor to or person in control of
Immunomedics or any of its businesses, or any assets of Immunomedics or any
subsidiary or division thereof or of any such successor or controlling person;

16.3.4 form, join or in any way participate in a “group” within the meaning of
Section 13(d)(3) of the Exchange Act with respect to any Voting Securities of
Immunomedics;

 

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16.3.5 acquire or agree to acquire, directly or indirectly, alone or in concert
with others, by purchase, exchange or otherwise: (a) any of the assets, tangible
or intangible, of Immunomedics, or (b) direct or indirect rights, warrants or
options to acquire any assets of Immunomedics, except for such assets as are
then being offered for sale by Immunomedics;

16.3.6 enter into any arrangement or understanding with others to do any of the
actions restricted or prohibited under Section 16.3.1, 16.3.2, 16.3.3, 16.3.4 or
16.3.5

16.3.7 otherwise act in concert with others to seek to offer to Immunomedics or
any of its stockholders any business combination, restructuring,
recapitalization or similar transaction to or with Immunomedics, or otherwise
seek in concert with others to control, change or influence the management,
board of directors or policies of Immunomedics ,or nominate any person as a
director of Immunomedics who is not nominated by the then incumbent directors,
or propose any matter to be voted upon by the stockholders of Immunomedics.

16.4 Exceptions for Purchasing Securities of Immunomedics.

16.4.1 The foregoing standstill provisions set forth in Sections 16.3.1 through
16.3.7 inclusive (the “Standstill Provisions”) shall not prohibit Licensee or
its Affiliates from (a) any investment in any Voting Securities of Immunomedics
by or on behalf of any pension or employee benefit plan or trust, provided that
such investment is directed by independent trustees, administrators or
employees, including (i) any direct or indirect interests in portfolio
securities held by an investment company registered under the Investment Company
Act of 1940, as amended, or (ii) interests in securities comprising part of a
mutual fund or broad based, publicly traded market basket or index of stocks
approved for such a plan or trust in which such plan or trust invests;
(b) acquiring Voting Securities of Immunomedics held by a person acquired by
Licensee on the date such person first entered into an agreement to be acquired
by Licensee or acquired after such person was acquired by Licensee pursuant to
an agreement requiring (but only to the extent requiring) such person to acquire
such Voting Securities, which agreement was in effect on the date such person
first entered into an agreement to be acquired by Licensee; or (c) acquiring any
assets or securities of Immunomedics, as debtor, in a transaction subject to the
approval of the United States Bankruptcy Court pursuant to proceedings under the
United States Bankruptcy Code. Notwithstanding the foregoing Licensee shall not
play an active role directly or indirectly or otherwise influence any of the
decisions or actions described in, or related to, this Section 16.4.1.

16.4.2 Upon the occurrence of a Trigger Event (defined below) with respect to
Immunomedics, Licensee shall cease to be bound by the Standstill Provisions. For
purposes of this Agreement, (x) a “Trigger Event” shall occur with respect to
Immunomedics if (i) Immunomedics shall have entered into or shall have publicly
announced that it has entered into, an agreement in principle with a Third Party
with respect to an Acquisition (defined below); or (ii) any person or group
(defined in Section 13(d)(3) of the Exchange Act) shall have acquired or agreed
or caused to be acquired, or commenced or announced an intention to commence a
tender offer or an exchange offer to

 

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acquire, ownership (including, without limitation, beneficial ownership as
defined in Rule 13d-3 under the Exchange Act) of at least *** of the outstanding
Voting Securities issued by Immunomedics or any rights or options to acquire
such ownership, including from a Third Party; or (iii) any person or group shall
have made an offer or proposal which if effected would result in an Acquisition
of Immunomedics, which offer or proposal is made public and is not rejected or
otherwise recommended against by Immunomedics within the shorter of (a) the
relevant time period under applicable Law or (b) ***, in each case after such
offer or proposal becomes public; and (y) “Acquisition” means, with respect to
Immunomedics (i) a Business Combination Transaction, unless, following such
Business Combination Transaction all or substantially all of the individuals and
entities who were the beneficial owners of the outstanding Voting Securities of
Immunomedics immediately prior to such Business Combination Transaction
beneficially own, directly or indirectly (including, without limitation, through
one more holding companies or subsidiaries), more than *** of the
then-outstanding voting securities entitled to vote generally in the election of
directors of the corporation resulting from such Business Combination
Transaction (including, without limitation, a corporation that as a result of
such transaction owns Immunomedics or all or substantially all of Immunomedics’
assets either directly or through one or more subsidiaries); or (ii) the
acquisition, directly or indirectly, by any person or group of beneficial
ownership of at least *** of the outstanding Voting Securities of Immunomedics
and (z) a “Business Combination Transaction” means, with respect to
Immunomedics, the merger or consolidation of Immunomedics with, or the
acquisition of Immunomedics by, a Third Party or any business unit of a Third
Party.

16.4.3 Notwithstanding anything to the contrary contained in Sections 16.3 or
16.4, during the time period set forth in Section 16.3, Immunomedics agrees
that, in the event it conducts an auction process for the sale of the company or
substantially all of its assets, Licensee shall be afforded the opportunity to
participate in such process on the same terms as other Third Parties invited to
so participate, including with respect to the making available of information
to, and the terms of confidentiality agreements entered into with, such Third
Parties.

16.5 Non-Solicitation of Employees. During *** thereafter, neither Party shall
actively solicit an employee of the other Party to leave the employment of that
other Party and accept employment with the first Party.

ARTICLE 17

DISPUTE RESOLUTION

17.1 Disputes. The Parties recognize that, from time to time during the Term,
disputes may arise as to certain matters which relate to either Party’s rights
and/or obligations hereunder. It is the objective of the Parties to establish
procedures to facilitate the resolution of disputes arising under this Agreement
in an expedient manner by mutual cooperation and without resort to litigation.
To accomplish this objective, the Parties agree to follow the procedures set
forth in this ARTICLE 17 to resolve any controversy or claim arising out of,
relating to or in connection with any provision of this Agreement.

 

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17.2 Arising Between the Parties. With respect to all disputes arising between
the Parties hereunder, including any alleged failure to perform, or breach, of
this Agreement, or any issue relating to the interpretation or application of
this Agreement, if the Parties are unable to resolve such dispute within ***
after such dispute is first identified by either Party in writing to the other,
the Parties shall refer such dispute to the Chief Executive Officers of each of
the Parties, or a designee from senior management with decision-making authority
(the Chief Executive Officer or such designee, the “Executive Officer”) for
attempted resolution by good-faith negotiations within *** after such notice is
received.

17.3 Dispute Resolutions. If the Executive Officers are not able to resolve such
dispute referred to them under Section 17.2 within such *** period, then such
dispute shall be settled, solely and exclusively, by “pendulum arbitration”,
meaning each Party shall prepare a written report setting forth its final
position with respect to the substance of the dispute and the arbitrator shall
select the position of either Immunomedics or Licensee. Such arbitration shall
be held in accordance with the rules of the American Arbitration Association
(“AAA”) then in effect, in New Jersey, by a single arbitrator mutually selected
by both Parties from a list of those designated by the AAA, or if the Parties
disagree, such arbitrator as is otherwise appointed by the AAA. The foregoing
remedy shall be each Party’s sole and exclusive remedy with respect to the
determination of any such dispute; provided however that a Party also may,
without waiving any remedy under this Agreement, bring an action in court in New
Jersey to seek from such court any injunctive or provisional relief necessary to
protect the rights or property of that party pending the arbitration award, or
to enforce an arbitration ruling issued pursuant to this Section 17.3 (and each
Party hereby agrees to the jurisdiction of such courts and waives any objections
as to the personal jurisdiction or venue of such courts). The expenses of any
arbitration shall be borne equally by the Parties. In each case, the Parties and
arbitrator shall use all diligent efforts to complete such arbitration within
*** of appointment of the arbitrator.

17.4 Patent and Trademark Dispute Resolution. Notwithstanding anything to the
contrary contained herein, any dispute, controversy or claim relating to the
scope, validity, enforceability or infringement of any patent rights covering
the manufacture, use or sale of any Product or of any trademark rights relating
to any Product shall be submitted to a court of competent jurisdiction in the
Territory in which such patent or trademark rights were granted or arose.

17.5 Injunctive Relief. Nothing herein may prevent either Party from seeking a
preliminary injunction or temporary restraining order so as to prevent any
Confidential Information from being disclosed in violation of this Agreement.

ARTICLE 18

MISCELLANEOUS

18.1 Entire Agreement; Amendment. This Agreement, including the Exhibits hereto,
sets forth the complete, final and exclusive agreement and all the covenants,
promises, agreements, warranties, representations, conditions and understandings
between

 

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the Parties hereto with respect to the subject matter hereof and supersedes, as
of the Effective Date, all prior agreements and understandings between the
Parties with respect to the subject matter hereof, ***. There are no covenants,
promises, agreements, warranties, representations, conditions or understandings,
either oral or written, between the Parties other than as are set forth herein
and therein. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties unless reduced to writing and signed
by an authorized representative of each Party.

18.2 Force Majeure. A Party shall be excused from the performance of its
obligations under this Agreement to the extent that such performance is
prevented by force majeure and the nonperforming Party promptly provides notice
of the prevention to the other Party. Such excuse shall be continued so long as
the condition constituting force majeure continues and the nonperforming Party
makes reasonable efforts to remove the condition. For purposes of this
Agreement, force majeure shall include conditions beyond the control of the
Parties, including an act of God, war, civil commotion, terrorist act, labor
strike or lock-out, epidemic, failure or default of public utilities or common
carriers, destruction of production facilities or materials by fire, earthquake,
or storm or like catastrophe. Notwithstanding the foregoing, a Party shall not
be excused from making payments owed hereunder because of a force majeure
affecting such Party.

18.3 Notices. Any notice required or permitted to be given under this Agreement
shall be in writing, shall specifically refer to this Agreement, and shall be
addressed to the appropriate Party at the address specified below or such other
address as may be specified by such Party in writing in accordance with this
Section 18.3, and shall be deemed to have been given for all purposes (a) when
delivered, if hand-delivered or sent by facsimile on a business day, (b) on the
next business day if sent by a reputable international overnight courier
service, or (c) five (5) business days after mailing, if mailed by first-class
certified or registered airmail, postage prepaid, return receipt requested.
Unless otherwise specified in writing, the mailing addresses of the Parties
shall be as described below:

 

If to Immunomedics:   

Immunomedics, Inc.

300 American Road

Morris Plains, New Jersey 07950

Attention: Chief Financial Officer

Facsimile No. (973)- 605-8282

With a copy to:   

Morgan, Lewis & Bockius LLP

502 Carnegie Center

Princeton, New Jersey 08540

Attn: Randall B. Sunberg

Facsimile No. (609)- 919-6701

If to Licensee:   

Nycomed GmbH

Byk Gulden Str. 2

78467 Konstanz

 

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Attention: General Counsel

Facsimile No.: +497531842982

With a copy to:   

Nycomed International Management GmbH

Leutschenbachstr.

958050 Zürich

Att.: General Counsel

Fax.: +41 445551350

18.4 No Strict Construction; Interpretation. This Agreement has been prepared
jointly and shall not be strictly construed against either Party. Ambiguities,
if any, in this Agreement shall not be construed against any Party, irrespective
of which Party may be deemed to have authored the ambiguous provision. The
headings of each Article and Section in this Agreement have been inserted for
convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular Article or Section.

18.5 Assignment. Neither Party may assign or transfer this Agreement or any
rights or obligations hereunder without the prior written consent of the other,
except that either Party may make such an assignment without the other Party’s
consent to a successor to substantially all of the business of Immunomedics to
which this Agreement relates, whether in a merger, sale of stock, sale of assets
or other transaction. Any permitted assignment shall be binding on the
successors of the assigning Party. Any assignment or attempted assignment by
either Party in violation of the terms of this Section 18.5 shall be null, void
and of no legal effect.

18.6 Further Actions. Each Party agrees to execute, acknowledge and deliver such
further instruments, and to perform all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

18.7 Severability. If any one or more of the provisions of this Agreement are
held to be invalid or unenforceable by any court of competent jurisdiction from
which no appeal can be or is taken, such provision or provisions shall be
considered severed from this Agreement and shall not serve to invalidate any
remaining provisions hereof. The Parties shall make a good-faith effort to
replace any invalid or unenforceable provision with a valid and enforceable one
such that the objectives contemplated by the Parties when entering this
Agreement may be realized.

18.8 No Waiver. Any delay in enforcing a Party’s rights under this Agreement or
any waiver as to a particular default or other matter shall not constitute a
waiver of such Party’s rights to the future enforcement of its rights under this
Agreement, except with respect to an express written and signed waiver relating
to a particular matter for a particular period of time.

 

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18.9 Independent Contractors. Each Party shall act solely as an independent
contractor, and nothing in this Agreement shall be construed to give either
Party the power or authority to act for, bind, or commit the other Party in any
way. Nothing herein shall be construed to create the relationship of partners,
principal and agent, or joint-venture partners between the Parties.

18.10 English Language; Governing Law. This Agreement was prepared in the
English language, which language shall govern the interpretation of, and any
dispute regarding, the terms of this Agreement. This Agreement and all disputes
arising out of or related to this Agreement or any breach hereof shall be
governed by and construed under the ***, without giving effect to any choice of
law principles that would require the application of the laws of a different
state.

18.11 Counterparts. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.

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IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly
authorized representatives as of the date first written above.

 

NYCOMED GMBH     IMMUNOMEDICS, INC. By:   /s/ Dr. A. Ullman     By:   /s/
Cynthia L. Sullivan Name:   Dr. A. Ullman     Name:   Cynthia L. Sullivan Title:
  Executive Vice President, Research & Development     Title:   President & CEO
By:   /s/ Thomas Trah, Ph.D.       Name:   Thomas Trah, Ph.D.       Title:  
Vice President Strategic Partnering      

 

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Exhibit A

Immunomedics Patents

Part A- Core Immunomedics Patents

 

Country

 

Patent Number

 

Application
Number

 

Related
Applications

 

Title

 

Date
Filed

 

Date
Issued

***   ***   ***   ***   ***   ***   *** ***   ***   ***   ***   ***   ***   ***
    ***   ***   ***   ***   ***     ***   ***   ***   ***   ***     ***   ***  
***   ***   ***     ***   ***   ***   ***   ***     ***   ***   ***   ***   ***
    ***   ***   ***   ***   ***   ***   ***   ***   ***   ***   ***     ***  
***   ***   ***   ***     ***   ***   ***   ***   ***     ***   ***   ***   ***
  ***   ***   ***   ***   ***   ***   ***

Part B- Immunomedics Patents (other than Core Immunomedics Patents)

 

Country

 

Patent
Number

 

Application
Number

 

Related
Applications

 

Title

 

Date
Filed

 

Date
Issued

***     ***   ***   ***   ***   ***     ***   ***   ***   ***  

 

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Exhibit B

Transition Plan

Transition Plan

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

***

 

  - ***

 

  - ***

 

  - ***

 

  - ***

 

  - ***

 

  - ***

 

  - ***

 

  - ***

 

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Exhibit C

Press Releases

Part A- Immunomedics Press Release

Part B- Licensee Press Release

 

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Schedule 2.3.2

Excluded Third Party Manufacturers

***

 

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Schedule 4.3.2

Development Plan

 

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Schedule 4.10

Immunomedics R&D Activities Plan

High Concentration Veltuzumab - R&D activities to be completed by Immunomedics

 

    

Activity

   Delivery date   Cost  

Comments

1

   ***    ***   ***   ***

2

   ***    ***   ***   ***

3

   ***    ***   ***  

4

   ***    ***   TBD   ***

5

   ***    ***   TBD   ***

7

   ***    ***   ***   ***

8

   ***    ***   ***  

 

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Schedule 7.3

Third Party Competitors

***

 

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Schedule 7.6.1

TERMS OF CO-PROMOTION AND DETAILING AGREEMENT

Sales Forces and Efforts. Each Party shall *** in an effort to *** and ***. In
conducting Commercialization of the Product in the Field in ITP, each Party
shall use *** and in compliance with all applicable Laws. No Party shall be
required to undertake any activity under this Agreement which it believes, in
good faith, may violate any applicable Laws or such guidelines.

Fulfillment of Responsibilities. Each Party shall use *** to fulfill all
responsibilities assigned to it under the Commercialization Plan or under the
Co-Promotion and Detailing Agreement. If the Parties agree that additional
Detailing or other internal resources are necessary beyond those contemplated in
the Commercialization Plan or the Co-Promotion and Detailing Agreement and if
one Party is *** in *** of its ***, the Parties shall *** to such Party for its
***. Furthermore, no Party shall be required, without its consent, *** ***, ***
or *** which are *** from those set forth in the Commercialization Plan or the
Co-Promotion and Detailing Agreement.

Third Party Sales Force. ***shall be entitled to conduct *** in *** by *** the
*** by a *** as a *** ***. If *** such *** it shall be solely responsible for
the expenses of such sales representatives and their compliance with the
Commercialization Plan and the Co-Promotion and Detailing Agreement, including
without limitation, the training and monitoring thereof.

Detail Reports. *** shall provide *** ***of each *** a detailed report setting
forth the types, number and targets of Details actually performed by *** in the
in the U.S., and such report shall be subject to the audit by ***

Records. Both Parties shall keep accurate and complete records, consistent with
internal standards as of the date hereof, of each Detail carried out by it under
this Agreement and shall make such records available for inspection, review and
audit by an independent certified public accountant appointed by the other Party
and reasonably acceptable to such Party for the purpose of verifying the number
of Details made by such Party for the Product in the Field in ITP. All costs and
expenses incurred in connection with performing any such audit shall be paid by
the Party performing such audit. Such accountants shall not reveal to the Party
seeking verification the details of its review, except for such information as
is required to be disclosed, and such information shall be subject to
confidentiality obligations.

Compliance with Training Plan. Each Party, each at its own expense, shall comply
with any training plan contained in any applicable Commercialization Plan or
Co-Promotion and Detailing Agreement.

Meetings. If a Party organizes material Product-related meetings of its
employees with respect to the Product in the Field in ITP (such as launch
meetings or periodic briefings of its field force), it will make reasonable
efforts to keep the Product-related portions of such meetings independent from
other matters and to give the other Party advance notice of such meetings. If
requested by the other Party, the Party organizing such meeting will permit
representatives of the other Party to attend and participate in such meetings or
such portions thereof which relate to the promotion of the Product in the Field
in ITP.

 

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Coordination. As more fully set forth in the Co-Promotion and Detailing
Agreement, the Parties shall coordinate on a local level the Detailing, contacts
with wholesalers and retailers, targeting of managed care organizations and
speaker/after-hours programs and related support activities.

Promotional and Educational Materials. Immunomedics will only use Promotional
and Educational Materials and only conduct promotional activities for the
Product in the Field in ITP which, in each case, has been approved by Licensee.
All promotional activities conducted by Immunomedics shall be consistent with
the Promotional and Educational Materials so approved. ***. Unless and until ***
are *** by ***for *** or other ***, each Party shall maintain them as ***.

Samples. Each Party shall use samples strictly in accordance with the then
current Commercialization Plan and shall distribute samples in full compliance
with all applicable Laws, including the requirements of the Prescription Drug
Marketing Act of 1987, as amended (the “PDM Act”). Each Party will maintain
those records required by the PDM Act and all other Laws and shall allow
representatives of the other Party to inspect such records on request. Each
Party shall be responsible for the filing of any necessary reports to FDA in
connection with the PDM Act, and a Party shall provide the other Party in a
timely fashion with any necessary information in connection with such reporting
under the PDM Act.

Control of Orders. *** shall have the sole right, at its discretion, to:
(i) ***; (ii) ***; and (iii) ***.

Booking of Sales. *** shall be the Party *** of ***Products in the Field in ITP.

Labeling. *** shall have sole authority *** any *** for any *** in connection
with the Products in the Field in ITP. *** shall be *** by ***with respect to
the Product in the Field in ITP *** ***have been ***by***.

 

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Schedule 8.3

Forecast

***

 

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Schedule 8.4

Initial Supply Price

 

***

***

  

***

   ***   ***   ***   ***

***

   ***    ***   ***   ***   ***

***

   ***    ***   ***    

***

   ***    ***   ***   ***   ***

***

   ***    ***   ***    

***

   ***    ***   ***   ***   ***

***

   ***    ***   ***    

***

   ***    ***   ***   ***   ***

***

   ***    ***   ***    

***

   ***    ***   ***   ***   ***

***

   ***    ***   ***   ***   ***

***

   ***    ***   ***   ***   ***

***

   ***    ***   ***   ***   ***

 

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