Exhibit 10.4

 

EXECUTION VERSION

 

SPECIAL PRODUCTS MASTER AGREEMENT

 

BY AND BETWEEN

 

ABBOTT LABORATORIES

 

AND

 

ABBVIE INC.

 

DATED AS OF DECEMBER 31, 2012

 

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TABLE OF CONTENTS

 

 

 

Page

 

 

ARTICLE I        DEFINITIONS

1

 

 

Section 1.01

Definitions

1

 

 

 

ARTICLE II        ABBVIE SPECIAL PRODUCTS ASSETS

12

 

 

 

Section 2.01

AbbVie Special Products Assets

12

Section 2.02

Liabilities

12

Section 2.03

Disclaimer of Representations and Warranties

13

Section 2.04

Further Assurances

13

 

 

 

ARTICLE III        GRANT OF RIGHTS

14

 

 

 

Section 3.01

Grant of Rights to Abbott

14

Section 3.02

Grant of Rights to AbbVie

17

Section 3.03

Sublicense Rights

18

Section 3.04

Obligation with Respect to Affiliates and Subsidiaries

18

Section 3.05

In-Licensed Intellectual Property

19

Section 3.06

Third Party License Agreements

19

 

 

 

ARTICLE IV        INTELLECTUAL PROPERTY RIGHTS

20

 

 

 

Section 4.01

Disclosure of Improvements and Special Products Know-How

20

Section 4.02

Ownership

20

Section 4.03

Prosecution of Patent Rights

21

Section 4.04

Prosecution Costs

22

Section 4.05

Prosecution Cooperation

23

Section 4.06

Notice of Issuance

23

Section 4.07

Matters Involving Infringement

23

Section 4.08

Third Party Infringement Suit

23

Section 4.09

Inventor Remuneration

23

 

 

 

ARTICLE V        DEVELOPMENT MATTERS

24

 

 

 

Section 5.01

Development Rights and Responsibilities

24

Section 5.02

Development Activities for Special Products

25

Section 5.03

Development Activities for New Products

26

 

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TABLE OF CONTENTS

(continued)

 

 

Page

 

 

ARTICLE VI        COMMERCIALIZATION MATTERS

26

 

 

 

Section 6.01

Abbott Territory

26

Section 6.02

AbbVie Territory

27

Section 6.03

Compassionate Use

28

Section 6.04

Domain Names

29

 

 

 

ARTICLE VII        MANUFACTURING MATTERS

29

 

 

 

Section 7.01

Supply

29

Section 7.02

Cooperation

29

 

 

 

ARTICLE VIII        REGULATORY MATTERS

29

 

 

 

Section 8.01

Ownership of Regulatory Approvals

29

Section 8.02

Allocation of Regulatory Responsibilities

30

Section 8.03

Sharing of Correspondence with Governmental Authorities

31

Section 8.04

Pharmacovigilance and Medical Inquiries

32

Section 8.05

Labeling Changes

32

Section 8.06

Notification or Information

32

Section 8.07

Recalls

33

 

 

 

ARTICLE IX        INDEMNIFICATION

34

 

 

 

Section 9.01

Indemnification by AbbVie

34

Section 9.02

Indemnification by Abbott

34

Section 9.03

Indemnification Obligations Net of Insurance Proceeds and Other Amounts

34

Section 9.04

Procedures for Indemnification of Third Party Claims

35

Section 9.05

Additional Matters

38

Section 9.06

Right of Contribution

39

Section 9.07

Remedies Cumulative

39

Section 9.08

Survival of Indemnities

39

Section 9.09

Covenant Not to Sue

40

 

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TABLE OF CONTENTS

(continued)

 

 

 

Page

 

 

 

ARTICLE X        CONFIDENTIALITY

40

 

 

 

Section 10.01

Confidentiality

40

Section 10.02

Protective Arrangements

41

Section 10.03

Other Permitted Disclosures

42

 

 

 

ARTICLE XI        DISPUTE RESOLUTION

43

 

 

 

Section 11.01

Disputes

43

 

 

 

ARTICLE XII        TERM

44

 

 

 

Section 12.01

Term

44

Section 12.02

Expiration

44

Section 12.03

Survival

44

 

 

 

ARTICLE XIII        MISCELLANEOUS

44

 

 

 

Section 13.01

Counterparts; Entire Agreement; Corporate Power; Facsimile Signatures

44

Section 13.02

Governing Law

45

Section 13.03

Assignability

46

Section 13.04

Third Party Beneficiaries

46

Section 13.05

Notices

46

Section 13.06

Severability

47

Section 13.07

Force Majeure

47

Section 13.08

No Set Off

48

Section 13.09

Responsibility for Expenses

48

Section 13.10

Headings

48

Section 13.11

Subsidiaries

48

Section 13.12

Waivers of Default

48

Section 13.13

Amendments

48

Section 13.14

Interpretation

49

Section 13.15

Public Announcements

49

Section 13.16

Specific Performance

49

 

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TABLE OF CONTENTS

(continued)

 

 

 

Page

 

 

 

Section 13.17

Mutual Drafting

50

 

iv

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THIS SPECIAL PRODUCTS MASTER AGREEMENT, dated as of December 31, 2012 and
effective as of the Effective Time (as defined below), is by and between ABBOTT
LABORATORIES, an Illinois corporation (“Abbott”), and ABBVIE INC., a Delaware
corporation (“AbbVie”).

 

R E C I T A L S:

 

WHEREAS, Abbott and AbbVie have entered into that certain Separation and
Distribution Agreement dated as of November 28, 2012 (the “Separation
Agreement”) that, among other things, sets forth the terms and conditions
pursuant to which the AbbVie Business (as defined in the Separation Agreement)
is separated from the Abbott Business (as defined in the Separation Agreement)
(the “Separation”);

 

WHEREAS, each of Abbott and AbbVie has determined that it is necessary and
advisable in connection with the Separation to allocate ownership of certain
intellectual property, permits, approvals and other Assets (as defined in the
Separation Agreement) relating to, and responsibilities for, certain Special
Products (as defined herein); and

 

WHEREAS, Abbott and AbbVie desire to set forth the terms and conditions that
shall govern the allocation of rights and responsibilities of Abbott and AbbVie
with respect to the Special Products.

 

NOW, THEREFORE, in consideration of the mutual agreements, provisions and
covenants contained in this Agreement (as defined herein), the Parties (as
defined herein) hereby agree as follows:

 

ARTICLE I
DEFINITIONS

 

Section 1.01                             Definitions.  Reference is made to
Section 13.13 regarding the interpretation of certain words and phrases used in
this Agreement.  Capitalized terms not otherwise defined herein shall have the
meaning ascribed to them in the Separation Agreement.  In addition, for the
purpose of this Agreement, the following terms shall have the meanings set forth
below.

 

“Abbott” has the meaning set forth in the Preamble.

 

“Abbott Indemnitees” means: (i) Abbott and each Abbott Subsidiary; (ii) each of
the respective past, present and future directors, officers, employees or agents
of the entities described in (i) above, in each case in their respective
capacities as such; and (iii) each of the heirs, executors, administrators,
successors and assigns of any of the foregoing.

 

“Abbott Indemnity Obligations” means all Liabilities to the extent such
Liabilities relate to, arise out of or result from, directly or indirectly, any
of the following items:

 

(i)                                     any Abbott Special Products Liability;

 

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(ii)                                  any failure of Abbott or an Abbott
Subsidiary or any other Person to pay, perform or otherwise promptly discharge
any Abbott Special Products Liabilities in accordance with their terms, whether
prior to, at or after the Effective Time;

 

(iii)                               except as otherwise set forth in any
applicable Special Products Ancillary Agreement, the conduct of any business,
operation or activity by or on behalf of Abbott or an Abbott Subsidiary from and
after the Effective Time with respect to Special Products; and

 

(iv)                              any breach by Abbott or an Abbott Subsidiary
of this Agreement or any Special Products Ancillary Agreement.

 

“Abbott In-Licensed Intellectual Property” means any In-Licensed Intellectual
Property Controlled by Abbott or any Abbott Subsidiary.

 

“Abbott New Product Know-How” means any Know-How Controlled by Abbott or any
Abbott Subsidiary to the extent such Know-How is related to the research,
Development, Manufacture, use, or Commercialization of a New Product (but that
does not also relate to a Special Product).

 

“Abbott New Product Patents” means any Patent Controlled by Abbott or any Abbott
Subsidiary that covers the Development, Manufacture, use or Commercialization of
a New Product (but that does not also cover a Special Product).

 

“Abbott Special Products Clinical Development Data” means, with respect to a
given Special Product, any Clinical Development Data Controlled by Abbott or any
Abbott Subsidiary relating to such Special Product resulting from Clinical
Development that is (i) initiated prior to the Effective Time, or (ii) generated
by or on behalf of Abbott or any Abbott Subsidiary during the term of this
Agreement in the course of conducting Clinical Development with respect to such
Special Product, provided such Clinical Development (A) is initiated after the
Effective Time and (B) becomes part of AbbVie’s rights pursuant to Section
5.02(e).  Abbott Special Products Clinical Development Data does not include any
Clinical Development Data that constitutes an AbbVie Special Products Asset and
is conveyed to AbbVie or any of its Subsidiaries pursuant to the Separation
Agreement.

 

“Abbott Special Products Liabilities” means the Liabilities (whether or not such
Liabilities cease being contingent, mature, become known, are asserted or
foreseen, or accrue, in each case before, at or after the Effective Time)
relating to, arising out of or resulting from actions, inactions, events,
omissions, conditions, facts or circumstances occurring or existing prior to the
Effective Time relating to a Special Product, in each case that are not AbbVie
Special Products Liabilities or AbbVie Indemnity Obligations.

 

“Abbott Special Products Patents” means any Patent Controlled by Abbott or any
Abbott Subsidiary that covers the Development, Manufacture, use or
Commercialization of a Special Product.  Abbott Special Products Patents do not
include any Patents that constitute

 

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AbbVie Special Products Assets and are conveyed to AbbVie or any of its
Subsidiaries pursuant to the Separation Agreement.

 

“Abbott Special Products Regulatory Documentation” means any Regulatory
Documentation Controlled by Abbott or any Abbott Subsidiary to the extent such
Regulatory Documentation relates to a Special Product.  Abbott Special Products
Regulatory Documentation does not include any Regulatory Documentation that
constitutes AbbVie Special Products Assets and is conveyed to AbbVie or any of
its Subsidiaries pursuant to the Separation Agreement.

 

“Abbott Subsidiary” means any Business Entity that is a Subsidiary of Abbott
prior to, at or after the Effective Time (other than AbbVie or an AbbVie
Subsidiary).

 

“Abbott Territory” means anywhere in the world other than the AbbVie Territory.

 

“AbbVie” has the meaning set forth in the Preamble.

 

“AbbVie Indemnitees” means: (i) AbbVie and each AbbVie Subsidiary; (ii) each of
the respective past, present and future directors, officers, employees or agents
of the entities described in (i) above, in each case in their respective
capacities as such; and (iii) each of the heirs, executors, administrators,
successors and assigns of any of the foregoing.

 

“AbbVie Indemnity Obligations” means all Liabilities to the extent such
Liabilities relate to, arise out of or result from, directly or indirectly, any
of the following items:

 

(i)                                     any AbbVie Special Products Liability;

 

(ii)                                  any failure of AbbVie or an AbbVie
Subsidiary or any other Person to pay, perform or otherwise promptly discharge
any AbbVie Special Products Liabilities in accordance with their terms, whether
prior to, at or after the Effective Time;

 

(iii)                               except as otherwise set forth in any
applicable Special Products Ancillary Agreement, the conduct of any business,
operation or activity by or on behalf of AbbVie or an AbbVie Subsidiary from and
after the Effective Time with respect to Special Products; and

 

(iv)                              any breach by AbbVie or an AbbVie Subsidiary
of this Agreement or any Special Products Ancillary Agreement.

 

“AbbVie In-Licensed Intellectual Property” means any In-Licensed Intellectual
Property Controlled by AbbVie or any AbbVie Subsidiary.

 

“AbbVie New Product Know-How” means any Know-How Controlled by AbbVie or any
AbbVie Subsidiary to the extent such Know-How is related to the research,
Development, Manufacture, use, or Commercialization of a New Product (but that
does not also relate to a Special Product).

 

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“AbbVie New Product Patents” means any Patent Controlled by AbbVie or any AbbVie
Subsidiary that covers the Development, Manufacture, use or Commercialization of
a New Product (but that does not also cover a Special Product).

 

“AbbVie Special Products Assets” has the meaning set forth in Section 2.01.

 

“AbbVie Special Products Clinical Development Data” means, with respect to a
given Special Product, any Clinical Development Data Controlled by AbbVie or any
AbbVie Subsidiary relating to such Special Product and resulting from Clinical
Development that is (i) initiated prior to the Effective Time (including that
Clinical Development Data that constitutes an AbbVie Special Products Asset and
is conveyed to AbbVie or any of its Subsidiaries pursuant to the Separation
Agreement), or (ii) generated by or on behalf of AbbVie or any AbbVie Subsidiary
during the term of this Agreement in the course of conducting Clinical
Development with respect to such Special Product, provided such Clinical
Development (A) is initiated after the Effective Time and (B) becomes part of
Abbott’s rights pursuant to Section 5.02(e).

 

“AbbVie Special Products Liabilities” means the Liabilities (whether or not such
Liabilities cease being contingent, mature, become known, are asserted or
foreseen, or accrue, in each case before, at or after the Effective Time)
relating to, arising out of or resulting from (i) actions, inactions, or
omissions by or on behalf of Abbott or any Abbott Subsidiary occurring or
existing prior to the Effective Time, or (ii) conditions, events, facts or
circumstances occurring or existing prior to the Effective Time, in each of
clauses (i) and (ii) with respect to: (A) the AbbVie Special Products Assets;
(B) the Commercialization of, or in connection with the Commercialization of, a
Special Product in the AbbVie Territory; (C) the provision of a Special Product
pursuant to a compassionate use, patient name or similar program in both the
AbbVie Territory and the Abbott Territory; (D) the Manufacture of, or in
connection with the Manufacture of, a Special Product at a site transferred to
AbbVie or an AbbVie Subsidiary or held by a Transferred Entity as part of the
Separation; or (E) the Development of, or in connection with the Development of,
a Special Product at a site transferred to AbbVie or an AbbVie Subsidiary or
held by a Transferred Entity as part of the Separation.

 

“AbbVie Special Products Patents” means any Patent Controlled by AbbVie or any
AbbVie Subsidiary that covers the Development, Manufacture, use or
Commercialization of a Special Product, including those Patents that constitute
AbbVie Special Products Assets and are conveyed to AbbVie or any of its
Subsidiaries pursuant to the Separation Agreement.

 

“AbbVie Special Products Regulatory Documentation” means any Regulatory
Documentation Controlled by AbbVie or any AbbVie Subsidiary to the extent such
Regulatory Documentation relates to a Special Product, including that Regulatory
Documentation that constitutes an AbbVie Special Products Asset and is conveyed
to AbbVie or any of its Subsidiaries pursuant to the Separation Agreement.

 

“AbbVie Subsidiary” means any Business Entity that is a Subsidiary of AbbVie
prior to, at, or after the Effective Time, including the Transferred Entities,
which shall be deemed to have been AbbVie Subsidiaries at all times prior to, at
and after the Effective Time.

 

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“AbbVie Territory” means: (i) for all Special Products other than Luvox®,
Advicor® and Simcor®, the United States; (ii) for Luvox®, Japan; and (iii) for
Advicor® and Simcor®, the entire world except Canada.

 

“Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended,
and the rules, regulations, guidelines, guidance and requirements promulgated
thereunder, as may be in effect from time to time.

 

“Affiliate” (including, with a correlative meaning, “affiliated”) means, when
used with respect to a specified Person, a Person that directly or indirectly,
through one or more intermediaries, controls, is controlled by or is under
common control with such specified Person.  For the purpose of this definition,
“control” (including with correlative meanings, “controlled by” and “under
common control with”), when used with respect to any specified Person shall mean
the possession, directly or indirectly, of the power to direct or cause the
direction of the management and policies of such Person, whether through the
ownership of voting securities or other interests, by contract, agreement,
obligation, indenture, instrument, lease, promise, arrangement, release,
warranty, commitment, undertaking or otherwise.  The Parties agree that, prior
to, at or after the Effective Time and for purposes of this Agreement and the
Special Products Ancillary Agreements, neither AbbVie nor any of the AbbVie
Subsidiaries, including the Transferred Entities (as defined in the Separation
Agreement), shall be deemed to be an Affiliate of Abbott or any of the Abbott
Subsidiaries, and neither Abbott nor any of the Abbott Subsidiaries shall be
deemed to be an Affiliate of AbbVie or any of the AbbVie Subsidiaries.

 

“Agreement” means this Special Products Master Agreement and each of the
Schedules and Exhibits hereto.

 

“Ancillary Agreement” has the meaning set forth in the Separation Agreement.

 

“Business Entity” means any corporation, general or limited partnership, trust,
joint venture, unincorporated organization, limited liability entity or other
entity.

 

“Clinical Development” means those pre-clinical and clinical activities,
including post Regulatory Approval studies that are necessary or reasonably
useful to obtain or maintain Regulatory Approval for a product for an
indication, including testing in animals for purposes of obtaining or
maintaining a Regulatory Approval.

 

“Clinical Development Data” means all data and results (including pre-clinical
and clinical trial results) generated by or on behalf of either Party, or their
respective Subsidiaries, from the conduct of Clinical Development.

 

“Commercialization” means, with respect to a Special Product or New Product, any
and all activities, directly or indirectly, related to marketing, advertising,
promoting, detailing, distributing, importing, exporting, offering for sale and
selling such Special Product or New Product. Commercialization shall not include
providing Special Products pursuant to a Compassionate Use Program.  When used
as a verb, “Commercialize” means to engage in Commercialization.

 

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“Compassionate Use Program” means a compassionate use, patient name or similar
program for supplying Special Products to certain patients.

 

“Confidential Information” has the meaning set forth in Section 10.01(a).

 

“Consents” means any consents, waivers or approvals from, or notification
requirements to, any Third Parties.

 

“Control” means, with respect to any Patents, Trademarks, Know-How or Regulatory
Documentation, that a Party or one of its Subsidiaries possesses the right,
whether directly or indirectly, and whether by ownership, license or sublicense,
covenant not to sue or otherwise (other than by operation of the license and
other grants set forth in this Agreement) to grant a license, sublicense or
other right (including the right to reference Regulatory Documentation) to such
item or right as provided for herein.

 

“Designees Discussion Period” has the meaning set forth in Section 11.01(a)(ii).

 

“Development” or “Develop” means Clinical Development and Non-Clinical
Development by or, subject to Section 3.03, on behalf of a Party.

 

“Development Plan” has the meaning set forth in Section 5.02(d).

 

“Direct Claim” has the meaning set forth in Section 9.05(b).

 

“Dispute” has the meaning set forth in Section 11.01(a).

 

“Drug Approval Application” means an application for Regulatory Approval
required before commercial sale or use of a Special Product or New Product in a
regulatory jurisdiction or any amendments thereto submitted to a Governmental
Authority.

 

“Effective Time” has the meaning set forth in the Separation Agreement.

 

“Employee Inventor Remuneration Entitlement” has the meaning set forth in
Section 4.09.

 

“Expanded Special Products” means (i) Special Products and (ii) Improvements
corresponding to such Special Products that are products of a Third Party.

 

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

 

“Field-of-Use” means all prophylactic or therapeutic pharmaceutical uses of a
Special Product in humans for any and all indications, excluding the Veterinary
Field-of-Use, but including in combination with a medical device.

 

“Force Majeure” means, with respect to a Party, an event beyond the control of
such Party (or any Person acting on its behalf), which by its nature could not
reasonably have been foreseen by such Party (or such Person), or, if it could
reasonably have been foreseen, was

 

6

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unavoidable, and includes acts of God, storms, floods, riots, fires, sabotage,
civil commotion or civil unrest, interference by civil or military authorities,
acts of war (declared or undeclared) or armed hostilities, other national or
international calamities or acts of terrorism or failures of energy sources or
distribution or transportation facilities.  Notwithstanding the foregoing, the
receipt by a Party of an unsolicited takeover offer or other acquisition
proposal, even if unforeseen or unavoidable, and such Party’s response thereto
shall not be deemed an event of Force Majeure.

 

“Governmental Authority” means any supranational, international, national,
federal, state, provincial or local court, government, department, commission,
board, bureau, agency, official or other regulatory, administrative or
governmental authority, including the New York Stock Exchange and any similar
self-regulatory body under applicable securities Laws.

 

“Improvement” means any pharmaceutical product containing the same active moiety
(but not in combination with a therapeutically meaningful amount of a different
active moiety) and intended for the same indication as a Special Product as of
the Effective Time, including any product with (i) an improvement, enhancement
or modification to (a) the manufacturing process or specifications, or (b) any
components of a Special Product, or (ii) any new or modified formulation, dosage
form, dosage amount, delivery and administration mode or labeled condition of
use.

 

“IND” means an Investigational New Drug Application filed with the FDA or a
similar application filed with an applicable Governmental Authority outside of
the United States such as a clinical trial application (CTA) or a clinical trial
exemption (CTX).

 

“Indemnifying Party” has the meaning set forth in Section 9.03(a).

 

“Indemnitee” means an AbbVie Indemnitee or an Abbott Indemnitee, as appropriate.

 

“Indemnity Payment” has the meaning set forth in Section 9.03(a).

 

“Information” means information in written, oral, electronic or other tangible
or intangible forms, including studies, reports, records, books, contracts,
instruments, surveys, specifications, drawings, blueprints, diagrams, models,
prototypes, samples, flow charts, data, marketing plans, customer names,
Privileged Information, and other technical, financial, employee or business
information or data; provided that “Information” does not include Patents,
Trademarks, Know-How or copyrights.

 

“In-Licensed Intellectual Property” means any and all Patents, Know-How and
Trademarks that are licensed by a Third Party to Abbott or AbbVie or their
respective Subsidiaries under an In-Licensed Intellectual Property Agreement.

 

“In-Licensed Intellectual Property Agreements” means those Third Party
agreements which license the In-Licensed Intellectual Property and any Special
Products Ancillary Agreements which govern the use of any In-Licensed
Intellectual Property.

 

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“Insurance Proceeds” means, with respect to any insured party, those monies, net
of any applicable premium adjustments (including reserves and retrospectively
rated premium adjustments) and net of any costs or expenses incurred in the
collection thereof, which are:  (i) received by an insured from an insurance
carrier or its estate; (ii) paid by an insurance carrier or its estate on behalf
of the insured; or (iii) received (including by way of setoff) from any Third
Party in the nature of insurance, contribution or indemnification in respect of
any Liability.

 

“Interacting Party” has the meaning set forth in Section 8.02(a).

 

“Know-How” means all technical, scientific and other know-how, trade secrets,
knowledge, technology, means, methods, processes, practices, formulas,
instructions, skills, techniques, procedures, experiences, ideas, technical
assistance, designs, drawings, assembly procedures, computer programs,
apparatuses, specifications and data (other than Clinical Development Data),
results and other material, including drug discovery and development technology,
assays and any other methodology, manufacturing procedures, test procedures and
purification and isolation techniques (whether patented or patentable) in
written, electronic or any other form now known or hereafter developed.

 

“Law” means any supranational, international, national, federal, state,
provincial, local or similar law (including common law), statute, code, order,
ordinance, rule, regulation, treaty (including any Tax treaty), license, permit,
authorization, approval, Consent, decree, injunction, binding judicial or
administrative interpretation or other requirement, in each case enacted,
promulgated issued or entered by a Governmental Authority.

 

“Liabilities” means all debts, liabilities, obligations, responsibilities,
response actions, losses, damages (whether compensatory, punitive,
consequential, incidental, treble or other), fines, penalties and sanctions,
absolute or contingent, matured or unmatured, liquidated or unliquidated,
foreseen or unforeseen, joint, several or individual, asserted or unasserted,
accrued or unaccrued, known or unknown, whenever arising, including those
arising under or in connection with any Law or other pronouncements of
Governmental Authorities having the effect of Law, Proceeding, threatened
Proceeding, order or consent decree of any Governmental Authority or any award
of any arbitration tribunal, and those arising under any contract, guarantee,
commitment or undertaking, whether sought to be imposed by a Governmental
Authority, private party, or Party, whether based in contract, tort, implied or
express warranty, strict liability, criminal or civil statute, or otherwise, and
including any costs, expenses, interest, attorneys’ fees, disbursements and
expenses of counsel, expert and consulting fees and costs related thereto or to
the investigation or defense thereof.

 

“Major Jurisdictions” means the United States, each country or region of the
European Union, as constituted from time to time, Japan, Canada, Brazil, India,
China, Russia, Singapore, Australia, Turkey, Mexico and Indonesia.

 

“Manufacture” and “Manufacturing” means, as applicable, activities related to
the production, manufacturing, processing, purifying, formulating, filling,
finishing, packaging, labeling, shipping, holding of a pharmaceutical product or
compound, or any intermediate thereof, including stability testing, quality
assurance, quality control testing and batch release.

 

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“Manufacturing Party” has the meaning set forth in Section 7.01.

 

“New Product” means any pharmaceutical product containing (i) the same active
moiety as a Special Product in combination with a therapeutically meaningful
amount of a different active moiety (including an active moiety contained in
another Special Product) or (ii) the same active moiety as a Special Product but
intended for a different indication than such Special Product.  New Product is
not a Special Product.

 

“Non-Clinical Development” means test method development and stability testing,
formulation development, dosage form development, delivery and administration
mode or indication development, process development, manufacturing scale-up,
analytical method validation, manufacturing process validation, cleaning
validation, scale-up and related statistical analysis.

 

“Notice” means any written notice, request demand or other communication
specifically referencing this Agreement and given in accordance with
Section 13.05.

 

“Parties” means the parties to this Agreement.

 

“Patents” means: (i) all national, regional and international patents and patent
applications, including provisional patent applications; (ii) all patent
applications filed either from the patents, patent applications or provisional
applications in clause (i) or from an application claiming priority from any of
these, including divisionals, continuations, continuations-in-part, converted
provisionals, and continued prosecution applications; (iii) all patents that
have issued or in the future issue from the foregoing patent applications
specified in clauses (i) and (ii), including utility models, petty patents and
design patents and certificates of invention; (iv) all patent term extensions or
restorations by existing or future extension or restoration mechanisms,
including any supplementary protection certificates and the like, as well as any
revalidations, reissues, re-examinations, oppositions and the like of the
foregoing patents or patent applications specified in clauses (i), (ii) and
(iii); and (v) all similar rights, including so-called pipeline protection, or
any importation, revalidation, confirmation or introduction patent or
registration patent or patents of addition to each of such foregoing patent
applications and patents.

 

“Person” means any (i) individual; (ii) Business Entity; or (iii) Governmental
Authority.

 

“Privileged Information” means any information, in written, oral, electronic or
other tangible or intangible forms, including any communications by or to
attorneys (including attorney-client privileged communications), memoranda and
other materials prepared by attorneys or under their direction (including
attorney work product), as to which a Party or its respective Subsidiaries would
be entitled to assert or have asserted a privilege, including the
attorney-client and attorney work product privileges.

 

“Proceeding” means any past, present or future suit, countersuit, action,
alternative dispute resolution process, claim, counterclaim, demand, hearing,
inquiry, investigation or proceeding before a judicial, quasi-judicial,
tribunal, arbitration or mediation

 

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body, or by or before a Governmental Authority, in each case involving Abbott,
an Abbott Subsidiary, an Abbott Indemnitee (but only if in a capacity entitling
such Person to the rights of an Abbott Indemnitee), AbbVie, an AbbVie
Subsidiary, or an AbbVie Indemnitee (but only if in a capacity entitling such
Person to the rights of an AbbVie Indemnitee), in each case other than any such
matter solely between Abbott or any Abbott Subsidiaries, on the one hand, and
AbbVie or any AbbVie Subsidiaries, on the other hand, arising with respect to a
controversy, dispute or claim under this Agreement or any Special Products
Ancillary Agreement.

 

“Recall” has the meaning set forth in Section 8.07(a).

 

“Regulatory Approval” means all approvals (including, where applicable, pricing
and reimbursement approval and schedule classifications), product and/or
establishment licenses, registrations or authorizations of any Governmental
Authority, necessary for the manufacture, use, storage, import, export,
transport, offer for sale, or sale of a pharmaceutical product in a regulatory
jurisdiction.

 

“Regulatory Documentation” means any and all applications, registrations,
licenses, authorizations and approvals (including all Regulatory Approvals), and
non-clinical and clinical study authorization applications or notifications
prepared for submission to a Governmental Authority or research ethics committee
with a view to the granting of any Regulatory Approval, and any correspondence
to or with any Governmental Authority with respect to the Special
Products, Improvements and New Products, including all INDs, Drug Approval
Applications, adverse event files, complaint files and Manufacturing records.

 

“Regulatory Submission” has the meaning set forth in Section 8.02(b).

 

“Remuneration Assessment” has the meaning set forth in Section 4.09(b).

 

“Representative” has the meaning set forth in Section 10.01(a).

 

“Security Interest” means any mortgage, security interest, pledge, lien, charge,
claim, option, right to acquire, voting or other restriction, right-of-way,
covenant, condition, easement, encroachment, restriction on transfer, or other
encumbrance of any nature whatsoever.

 

“Separation” has the meaning set forth in the Recitals.

 

“Separation Agreement” has the meaning set forth in the Recitals.

 

“Special Products” means each of: (i) AndroGel®; (ii) Marinol®;
(iii) Biaxin®/Klacid®; (iv) Mavik®; (v) Tarka®; (vi) Teveten®;
(vii) Tricor®/TRILIPIX®; (viii) Depakote®; (ix) Synthroid®; (x) Niaspan®;
(xi) Creon®; (xii) Luvox®; (xiii) Advicor®; and (xiv) Simcor®, as each such
Special Product may be more specifically detailed and defined in a Special
Products Ancillary Agreement, including such Special Product’s formulations and
filings of Regulatory Documentation, such as drug master files, Drug Approval
Applications and other relevant dossiers, for active pharmaceutical ingredients,
manufactured drug product and finished dosage forms, delivery and administration
modes and indications as of the Effective Time, and

 

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the results of all Development for each such Special Product to the extent
included pursuant to Section 5.02(e).

 

“Special Products Ancillary Agreements” means any agreement which the Parties
may enter into from time to time with respect to a Special Product.

 

“Special Products Know-How” means any Know-How that is (i) directly related to
the research, Development, Manufacture, use, or Commercialization of a Special
Product and (ii) is either (A) in existence as of the Effective Time, or
(B) developed, created, conceived or invented by or on behalf of Abbott or
Abbott Subsidiaries or by or on behalf of AbbVie or AbbVie Subsidiaries or
jointly by the Parties in the course of conducting activities under a
manufacturing agreement.

 

“Special Products Know-How Patents” means any Patents covering Special Products
Know-How that are neither Abbott Special Products Patents nor AbbVie Special
Products Patents.

 

“Special Products Patents” means any Abbott Special Products Patents, AbbVie
Special Products Patents or Special Products Know-How Patents.

 

“Subsidiary” or “subsidiary” means, with respect to any Person, any Business
Entity of which such Person: (i) beneficially owns, either directly or
indirectly, more than fifty percent (50%) of (A) the total combined voting power
of all classes of voting securities of such Business Entity; (B) the total
combined equity interests; or (C) the capital or profit interests, in the case
of a partnership; or (ii) otherwise has the power to vote, either directly or
indirectly, sufficient securities to elect a majority of the board of directors
or similar governing body.

 

“Tax” means: (i) any income, net income, gross income, gross receipts, profits,
capital stock, franchise, property, ad valorem, stamp, excise, severance,
occupation, service, sales, use, license, lease, transfer, import, export,
customs duties, value added, alternative minimum, estimated or other similar tax
(including any fee, assessment, or other charge in the nature of or in lieu of
any tax) imposed by any Tax Authority, and any interest, penalties, additions to
tax or additional amounts with respect to the foregoing imposed on any taxpayer
or consolidated, combined or unitary group of taxpayers; and (ii) any Employment
Tax (as defined in the Separation Agreement).

 

“Tax Authority” means, with respect to any Tax, the Governmental Authority or
political subdivision thereof that imposes such Tax, and the agency (if any)
charged with the collection of such Tax for such Governmental Authority or
subdivision.

 

“Tax Sharing Agreement” has the meaning set forth in the Separation Agreement.

 

“Third Party” means any Person other than the Parties or any of their respective
Subsidiaries.

 

“Third Party Claim” has the meaning set forth in Section 9.04(a).

 

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“Third Party License Agreements” has the meaning set forth in Section 3.06(a).

 

“Trademarks” means all trademarks, trade names, brand names, domain names,
service marks, trade dress, logos and all other source indicators, including all
goodwill associated therewith and all applications, registrations and renewals
in connection therewith.

 

“Transferred Entities” has the meaning set forth in the Separation Agreement.

 

“U.S.” or “United States” means the United States of America, including each of
the fifty (50) states thereof, the District of Columbia, Puerto Rico, and all
other territories and possessions of the United States of America.

 

“Veterinary Field-of-Use” means any use of a product for ethical or
over-the-counter veterinary applications and shall specifically exclude any use
of such product for human applications.

 

ARTICLE II
ABBVIE SPECIAL PRODUCTS ASSETS

 

Section 2.01                             AbbVie Special Products Assets.  The
Parties acknowledge and agree that the following Assets (the “AbbVie Special
Products Assets”) shall be considered AbbVie Assets under the Separation
Agreement and shall be conveyed, assigned, transferred or made available by
Abbott or an Abbott Subsidiary to AbbVie or an AbbVie Subsidiary in accordance
with the terms and conditions of the Separation Agreement:

 

(a)                                 the Patents listed on Schedule 2.01(a);

 

(b)                                 the Trademarks listed on Scheduled 2.01(b);

 

(c)                                  the Regulatory Approvals listed on Schedule
2.01(c);

 

(d)                                 the Clinical Development Data that was in
existence as of the Effective Time and was generated in direct support of
obtaining a Regulatory Approval for a Special Product in the AbbVie Territory;

 

(e)                                  the Regulatory Documentation that was in
existence as of the Effective Time and was generated, filed or produced for a
Special Product for use in the AbbVie Territory; and

 

(f)                                   an undivided interest (with Abbott and the
Abbott Subsidiaries) of all Special Products Know-How in existence as of the
Effective Time.

 

Section 2.02                             Liabilities.  The Parties acknowledge
and agree that the AbbVie Special Products Liabilities shall be considered
AbbVie Liabilities and the Abbott Special Products Liabilities shall be
considered Abbott Liabilities for purposes of the Separation.  Further, the
AbbVie Special Products Liabilities shall be transferred, assigned, discharged
and novated by

 

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Abbott or an Abbott Subsidiary and accepted and assumed by AbbVie or an AbbVie
Subsidiary pursuant to Article II of the Separation Agreement; provided that a
Party’s indemnification obligations with respect to either the AbbVie Special
Products Liabilities or the Abbott Special Products Liabilities shall be subject
to the provisions of Article X of this Agreement.

 

Section 2.03                             Disclaimer of Representations and
Warranties.

 

(a)                                 Disclaimer.  EACH OF ABBOTT (ON BEHALF OF
ITSELF AND EACH OF THE ABBOTT SUBSIDIARIES) AND ABBVIE (ON BEHALF OF ITSELF AND
EACH OF THE ABBVIE SUBSIDIARIES) UNDERSTANDS AND AGREES THAT, EXCEPT AS
EXPRESSLY SET FORTH HEREIN OR IN ANY SPECIAL PRODUCTS ANCILLARY AGREEMENT, NO
PARTY TO THIS AGREEMENT, ANY SPECIAL PRODUCTS ANCILLARY AGREEMENT OR
OTHERWISE, IS: (I) REPRESENTING OR WARRANTING TO ANY OTHER PARTY HERETO OR
THERETO IN ANY WAY WITH RESPECT TO SPECIAL PRODUCTS OR NEW PRODUCTS, AS TO ANY
APPROVALS OR NOTIFICATIONS REQUIRED IN CONNECTION HEREWITH OR THEREWITH, AS TO
THE VALUE OR FREEDOM FROM ANY SECURITY INTERESTS OF, OR ANY OTHER MATTER
CONCERNING, THE SPECIAL PRODUCTS; OR (II) MAKING ANY OTHER REPRESENTATIONS OR
GRANTING ANY WARRANTIES, EXPRESS OR IMPLIED EITHER IN FACT OR BY OPERATION OF
LAW, BY STATUTE OR OTHERWISE.  EACH PARTY SPECIFICALLY DISCLAIMS ANY OTHER
WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF QUALITY, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OR ANY
WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY
PATENTS, TRADEMARKS, OR OTHER INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

 

(b)                                 Provisions Prevail.  Each of Abbott (on
behalf of itself and each of the Abbott Subsidiaries) and AbbVie (on behalf of
itself and each of the AbbVie Subsidiaries) further understands and agrees that
if the disclaimer of express or implied representations and warranties contained
in Section 2.03(a) is held unenforceable or is unavailable for any reason, under
the Laws of any jurisdiction outside the United States or if, under the Laws of
a jurisdiction outside the United States, both Abbott or any of the Abbott
Subsidiaries, on the one hand, and AbbVie or any of the AbbVie Subsidiaries, on
the other hand, are jointly or severally liable for any AbbVie Special Products
Liability or any Abbott Special Products Liability, respectively, then, the
Parties intend that, notwithstanding any provision to the contrary under the
Laws of such foreign jurisdictions, the provisions of this Agreement and the
Special Products Ancillary Agreements (including the disclaimer of all
representations and warranties, allocation of Liabilities among the Parties and
their respective Subsidiaries, releases, indemnification and contribution of
Liabilities) shall prevail for any and all purposes among the Parties and their
respective Subsidiaries.

 

Section 2.04                             Further Assurances.

 

(a)                                 Additional Actions.  In addition to the
actions specifically provided for elsewhere in this Agreement, each Party shall,
and shall cause each of its respective Subsidiaries to, use commercially
reasonable efforts, to take, or cause to be taken, all actions,

 

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and to do, or cause to be done, all things, necessary or advisable under
applicable Laws and agreements to consummate the transactions contemplated by
this Agreement and the Special Products Ancillary Agreements; provided, however,
that neither Abbott nor AbbVie (nor any of their respective Subsidiaries) shall
be obligated under this Section 2.04(a) to pay any consideration, grant any
concession or incur any additional Liability to any Third Party other than
ordinary and customary fees paid to a Governmental Authority.

 

(b)                                 Cooperation.  Without limiting the
foregoing, each Party shall, and shall cause each of its Subsidiaries to,
cooperate with the other Party without any further consideration to execute and
deliver, or use commercially reasonable efforts to cause to be executed and
delivered, all documents in furtherance of this Agreement and to make all
filings with, and to obtain all Consents of, any Governmental Authority or any
other Person under any permit, license, agreement, indenture or other instrument
(including any Consents), and to take all such other actions as such Party may
reasonably be requested to take by the other Party from time to time, consistent
with the terms of this Agreement and the Special Products Ancillary Agreements,
in order to effectuate the provisions and purposes of this Agreement and the
Special Products Ancillary Agreements and the transactions contemplated hereby
and thereby.

 

ARTICLE III
GRANT OF RIGHTS

 

Section 3.01                             Grant of Rights to Abbott.

 

(a)                                 Grant of Rights for Commercialization. 
Subject to the terms of this Agreement and, if applicable, any Special Products
Ancillary Agreements or In-Licensed Intellectual Property Agreements, AbbVie, on
behalf of itself and the AbbVie Subsidiaries, to the extent each such Business
Entity has rights, hereby grants to Abbott and the Abbott Subsidiaries under the
AbbVie Special Products Patents, AbbVie In-Licensed Intellectual Property,
AbbVie Special Products Clinical Development Data, and AbbVie’s and the AbbVie
Subsidiaries’ ownership interest in the Special Products Know-How, the
following:

 

(i)                                     an exclusive (including with regard to
AbbVie and the AbbVie Subsidiaries), perpetual, irrevocable, fully paid and
royalty-free right and license, or sublicense as applicable, solely for purposes
of Commercializing Expanded Special Products in the Abbott Territory; and

 

(ii)                                  a non-exclusive, perpetual, irrevocable,
fully paid and royalty-free right and license, or sublicense as applicable,
solely for purposes of Commercializing New Products in the Abbott Territory.

 

(b)                                 Grant of Rights for Development.  Subject to
the terms of this Agreement and, if applicable, any Special Products Ancillary
Agreements or In-Licensed Intellectual Property Agreements, AbbVie, on behalf of
itself and the AbbVie Subsidiaries, to the extent

 

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each such Business Entity has rights, hereby grants to Abbott and the Abbott
Subsidiaries under the AbbVie Special Products Patents, AbbVie In-Licensed
Intellectual Property and AbbVie Special Products Clinical Development Data, the
following:

 

(i)                                     a non-exclusive, perpetual, irrevocable,
fully paid and royalty-free right and license, or sublicense as applicable, to
Develop Special Products anywhere in the world solely for the purpose of
securing Regulatory Approvals for the Commercialization of Special Products in
the Abbott Territory; and

 

(ii)                                  a non-exclusive, perpetual, irrevocable,
fully paid and royalty-free right and license, or sublicense as applicable, to
Develop New Products anywhere in the world solely for the purpose of securing
Regulatory Approvals for the Commercialization of New Products in the Abbott
Territory.

 

(c)                                  Grant of Rights for Manufacturing.  Subject
to the terms of this Agreement and, if applicable, any Special Products
Ancillary Agreements or In-Licensed Intellectual Property Agreements, AbbVie, on
behalf of itself and the AbbVie Subsidiaries, to the extent each such Business
Entity has rights, hereby grants to Abbott and the Abbott Subsidiaries under the
AbbVie Special Products Patents, AbbVie In-Licensed Intellectual Property and
AbbVie Special Products Clinical Development Data, the following:

 

(i)                                     a non-exclusive, perpetual, irrevocable,
fully paid and royalty-free right and license, or sublicense as applicable, to
Manufacture and have Manufactured Special Products anywhere in the world solely
for the purpose of Commercializing Special Products in the Abbott Territory and
for the purpose of Abbott fulfilling its obligations under a manufacturing
agreement to manufacture a Special Product; and

 

(ii)                                  a non-exclusive, perpetual, irrevocable,
fully paid and royalty-free right and license, or sublicense as applicable, to
Manufacture and have Manufactured (including the right to import and export) New
Products anywhere in the world solely for the purpose of Commercializing New
Products in the Abbott Territory.

 

(d)                                 Right to Access, Reference or
Cross-Reference.  Subject to the terms of this Agreement and, if applicable, any
Special Products Ancillary Agreements or In-Licensed Intellectual Property
Agreements, AbbVie, on behalf of itself and the AbbVie Subsidiaries, to the
extent each such Business Entity has rights, hereby grants to Abbott and the
Abbott Subsidiaries the exclusive right to access, reference or cross-reference
the AbbVie Special Products Regulatory Documentation and AbbVie Special Products
Clinical Development Data to support Abbott’s Regulatory Approval applications
for the Special Products in the Abbott Territory and solely for the purpose of
Developing, Manufacturing, using and Commercializing the Special Products in
accordance with the foregoing license grants in this Section 3.01.

 

(e)                                  No Rights to AbbVie New Products
Intellectual Property.  The Parties acknowledge and agree that neither this
Agreement nor any Special Products Ancillary

 

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Agreement grants to Abbott or any of its Subsidiaries any rights under the
AbbVie New Product Patents or AbbVie New Product Know-How.  AbbVie shall solely
own all rights to such Assets.

 

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Section 3.02                             Grant of Rights to AbbVie.

 

(a)                                 Grant of Rights for Commercialization. 
Subject to the terms of this Agreement and, if applicable, any Special Products
Ancillary Agreements or In-Licensed Intellectual Property Agreements, Abbott, on
behalf of itself and the Abbott Subsidiaries, to the extent each such Business
Entity has rights, hereby grants to AbbVie and the AbbVie Subsidiaries, under
the Abbott Special Products Patents, Abbott In-Licensed Intellectual Property,
Abbott Special Products Clinical Development Data, and Abbott’s and the Abbott
Subsidiaries’ ownership interest in the Special Products Know-How, the
following:

 

(i)                                     an exclusive (including with regard to
Abbott and the Abbott Subsidiaries), perpetual, irrevocable, fully paid and
royalty-free right and license, or sublicense as applicable, solely for purposes
of Commercializing Expanded Special Products in the Field-of-Use in the AbbVie
Territory; and

 

(ii)                                  a non-exclusive, perpetual, irrevocable,
fully paid and royalty-free right and license, or sublicense as applicable,
solely for purposes of Commercializing New Products in the Field-of-Use in the
AbbVie Territory.

 

(b)                                 Grant of Rights for Development.  Subject to
the terms of this Agreement and, if applicable, any Special Products Ancillary
Agreements or In-Licensed Intellectual Property Agreements, Abbott, on behalf of
itself and the Abbott Subsidiaries, to the extent each such Business Entity has
rights, hereby grants to AbbVie and the AbbVie Subsidiaries under the Abbott
Special Products Patents, Abbott In-Licensed Intellectual Property and Abbott
Special Products Clinical Development Data, the following:

 

(i)                                     a non-exclusive, perpetual, irrevocable,
fully paid and royalty-free right and license, or sublicense as applicable, to
Develop Special Products anywhere in the world solely for the purpose of
securing Regulatory Approvals for the Commercialization of Special Products in
the Field-of-Use in the AbbVie Territory; and

 

(ii)                                  a non-exclusive, perpetual, irrevocable,
fully paid and royalty-free right and license, or sublicense as applicable, to
Develop New Products in the Field-of-Use anywhere in the world solely for the
purpose of securing Regulatory Approvals for the Commercialization of New
Products in the Field-of-Use in the AbbVie Territory.

 

(c)                                  Grant of Rights for Manufacturing.  Subject
to the terms of this Agreement and, if applicable, any Special Products
Ancillary Agreements or In-Licensed Intellectual Property Agreements, Abbott, on
behalf of itself and the Abbott Subsidiaries, to the extent each such Business
Entity has rights, hereby grants to AbbVie and the AbbVie Subsidiaries under the
Abbott Special Products Patents, Abbott In-Licensed Intellectual Property and
Abbott Special Products Clinical Development Data, the following:

 

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(i)                                     a non-exclusive, perpetual, irrevocable,
fully paid and royalty-free right and license, or sublicense as applicable, to
Manufacture and have Manufactured Special Products anywhere in the world solely
for the purpose of Commercializing Special Products in the Field-of-Use in the
AbbVie Territory and for the purpose of AbbVie fulfilling its obligations under
a manufacturing agreement to manufacture a Special Product; and

 

(ii)                                  a non-exclusive, perpetual, irrevocable,
fully paid and royalty-free right and license, or sublicense as applicable, to
Manufacture and have Manufactured New Products anywhere in the world solely for
the purpose of Commercializing New Products in the Field-of-Use in the AbbVie
Territory.

 

(d)                                 Right to Access, Reference or
Cross-Reference.  Subject to the terms of this Agreement and, if applicable, any
Special Products Ancillary Agreements or In-Licensed Intellectual Property
Agreements, Abbott, on behalf of itself and the Abbott Subsidiaries, to the
extent each such Business Entity has rights, hereby grants to AbbVie and the
AbbVie Subsidiaries the exclusive right to access, reference or cross-reference
the Abbott Special Products Regulatory Documentation and Abbott Special Products
Clinical Development Data to support AbbVie’s Regulatory Approval applications
for the Special Products in the AbbVie Territory and solely for the purpose of
Developing, Manufacturing, using and Commercializing the Special Products in
accordance with the foregoing license grants in this Section 3.02.

 

(e)                                  No Rights to Abbott New Products
Intellectual Property.  The Parties acknowledge and agree that neither this
Agreement nor any Special Products Ancillary Agreement grants to AbbVie or any
of its Subsidiaries any rights under the Abbott New Product Patents or Abbott
New Product Know-How.  Abbott shall solely own all rights to such Assets.

 

Section 3.03                             Sublicense Rights.  Subject to the
terms of the In-Licensed Intellectual Property Agreements, either Party may
grant sublicenses (or further rights to access, reference or cross-reference)
under the licenses in Section 3.01 and Section 3.02; provided that any such
sublicenses shall be consistent with the terms and conditions of this Agreement
and any applicable In-Licensed Intellectual Property Agreement; provided further
that (a) within ten (10) business days after execution, such Party shall provide
the other Party with a copy of each sublicense agreement (as may be redacted for
confidentiality obligations), and (b) each sublicense granted by a Party
pursuant to this Section 3.03 shall be subject and subordinate to the terms and
conditions of this Agreement, the applicable Special Products Ancillary
Agreements and the applicable In-Licensed Intellectual Property Agreements,
including, that both during the term of the sublicense and thereafter, the
sublicensee shall be bound by a confidentiality obligation substantially similar
to that by which a Party is bound under this Agreement.  The sublicensing Party
hereby guarantees and shall be liable for the performance of its sublicensees
with respect to its obligations under this Agreement.

 

Section 3.04                             Obligation with Respect to Affiliates
and Subsidiaries.  To the extent that any Affiliate or Subsidiary of any Party
exercises any rights or obligations of such Party under this Agreement or any
Special Products Ancillary Agreement, such Party shall ensure that such

 

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Affiliate or Subsidiary exercises such rights and obligations in a manner
consistent with, and subject to the applicable provisions of, this Agreement and
the applicable Special Products Ancillary Agreement(s).

 

Section 3.05                             In-Licensed Intellectual Property.  The
terms of the licenses in Article III and additional provisions and restrictions
with respect to the In-Licensed Intellectual Property are set forth in this
Agreement and any Special Products Ancillary Agreements, including reporting
obligations to the licensor, audit rights and calculation of royalties, if any. 
Each Party covenants that it shall comply with the terms of each In-Licensed
Intellectual Property Agreement applicable to such Party.

 

Section 3.06                             Third Party License Agreements.

 

(a)                                 Notification.  In the event that Abbott or
AbbVie, as the case may be, after a good faith analysis, determines that one or
more licenses to Patents, Trademarks or Know-How of a Third Party (other than as
may already be licensed under an In-Licensed Intellectual Property Agreement)
may be required in order to Develop, Manufacture, use or Commercialize a Special
Product (“Third Party License Agreements”), it shall promptly notify the other,
and the Parties shall meet to discuss the basis for such determination.

 

(b)                                 Negotiation Responsibility.

 

(i)                                     Subject to Section 3.06(b)(iii), Abbott
shall be responsible for negotiating and entering into any Third Party License
Agreements regarding Patents, Trademarks or Know-How that could be relevant,
useful or necessary to Develop, Manufacture, use or Commercialize any Special
Product in the Abbott Territory.

 

(ii)                                  Subject to Section 3.06(b)(iii), AbbVie
shall be responsible for negotiating and entering into any Third Party License
Agreements regarding Patents, Trademarks or Know-How that could be relevant,
useful or necessary to Develop, Manufacture, use or Commercialize any Special
Product in the AbbVie Territory.

 

(iii)                               Notwithstanding the foregoing, if a Third
Party License Agreement regarding any Patents, Trademarks or Know-How could be
relevant, necessary or useful to Develop, Manufacture, use or Commercialize any
Special Product both in the Abbott Territory and the AbbVie Territory, in each
case, the Parties shall agree which Party shall be primarily responsible for
negotiating and entering into any such Third Party License Agreement.  Any Third
Party License Agreement entered into pursuant to this Section 3.06(b)(iii) shall
be mutually agreed to by the Parties and shall ensure that the Development,
Manufacture, use and Commercialization of such Special Product in both the
Abbott Territory and the AbbVie Territory, in each case, shall be licensed or
otherwise protected from a claim of infringement to the applicable Third Party
Patents, Trademarks or Know-How; provided, however, if the Parties are unable to
mutually agree on the terms of any such Third Party License Agreement,
(A) either Party shall be free to enter into a license agreement with such Third
Party solely with

 

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respect to such Party’s territory, provided such agreement does not diminish the
value of the other Party’s grant of rights pursuant to Section 3.01 or
Section 3.02, as the case may be, (B) such Party shall have no obligation to
sublicense such Patents, Trademarks or Know-How of such Third Party to the other
Party, and (C) such Patents, Trademarks or Know-How of such Third Party shall
not be deemed to be “Controlled” by such Party for purposes of the applicable
license grants in this Agreement.

 

(c)                                  Responsibility for Payments to Third
Parties.  Abbott shall be solely responsible for any royalties, fees or other
payments due under any Third Party License Agreement to the extent solely
related to Commercialization of any Special Product in the Abbott Territory. 
AbbVie shall be solely responsible for any royalties, fees or other payments due
under any Third Party License Agreement to the extent solely related to
Commercialization of any Special Products in the AbbVie Territory.  The Parties
shall mutually agree how to allocate responsibility for royalties, fees or other
payments due under any Third Party License Agreement to the extent not solely
allocable to either the Abbott Territory or the AbbVie Territory.

 

ARTICLE IV
INTELLECTUAL PROPERTY RIGHTS

 

Section 4.01                             Disclosure of Improvements and Special
Products Know-How.  Subject to Article X, each Party shall disclose to the other
Party Improvements and Special Products Know-How (a) as part of a technology
transfer under manufacturing agreements for Special Products and (b) with
respect to Development activity in accordance with Section 5.02(a). Further, all
disclosures under this Section 4.01 shall be made at least sixty (60) days prior
to any public disclosure of such Improvement or Special Products Know-How or any
required submission to Governmental Authorities in compliance with the
requirements of government supported research.  The filing of a patent
application is not intended to constitute a “public disclosure” for purposes of
the immediately preceding sentence.

 

Section 4.02                             Ownership.

 

(a)                                 Improvements.  Except as set forth in
Section 4.02(b), Improvements (and all intellectual property rights related
thereto) created or Developed by or on behalf of Abbott or any Abbott Subsidiary
shall be solely owned by Abbott or any Abbott Subsidiary and Improvements (and
all intellectual property rights related thereto) created or Developed by or on
behalf of AbbVie or any AbbVie Subsidiary shall be solely owned by AbbVie or any
AbbVie Subsidiary.

 

(b)                                 Special Products Know-How.  Subject to
Section 5.02(a), any and all Special Products Know-How shall be jointly owned. 
In the event of a Dispute as to whether something constitutes Special Products
Know-How, Abbott and AbbVie shall resolve such Dispute in accordance with the
terms of Article XI.  The Parties acknowledge that the ownership rights set
forth in this Section 4.02(b) are subject to the licenses granted pursuant to
this

 

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Agreement, any Special Products Ancillary Agreement and the In-Licensed
Intellectual Property Agreements.  Subject to the licenses granted pursuant to
this Agreement and any Special Products Ancillary Agreement and subject to
Section 3.03, each Party shall be free to use and exploit (which shall include
the right to grant licenses under) the Special Products Know-How, without any
duty of accounting to the other Party.  Each Party shall be exclusively
responsible for any compensation payable to any of its employees, subcontractors
and sublicensees in respect of any Special Products Know-How.  To the extent
that any right, title or interest in or to any Special Products Know-How vests
in a Party by operation of applicable Law or otherwise, in a manner contrary to
the agreed upon ownership as set forth in this Agreement, such Party shall, and
hereby does, irrevocably assign to the other Party joint right, title and
interest throughout the world in and to such Special Products Know-How without
the need for any further action by any Party.

 

Section 4.03                             Prosecution of Patent Rights.

 

(a)                                 Prosecution by Abbott.  Except as otherwise
set forth in this Agreement or any Special Products Ancillary Agreement, Abbott
shall have the sole right to prepare, file, prosecute and maintain the Abbott
Special Products Patents and the Abbott New Product Patents.  If, during the
term of this Agreement, Abbott intends to allow any Abbott Special Products
Patent to expire or intends to otherwise abandon any such Abbott Special
Products Patent, Abbott shall notify AbbVie of such intention at least sixty
(60) days prior to the date upon which such patent shall expire or be abandoned,
and, subject to the terms of any In-Licensed Intellectual Property Agreement,
AbbVie shall thereupon have the right, but not the obligation, to assume
responsibility for the preparation, filing, prosecution or maintenance thereof. 
To the extent AbbVie elects to assume such responsibility, Abbott shall promptly
assign to AbbVie, without compensation, all of Abbott’s right, title and
interest in and to such abandoned Abbott Special Products Patents.

 

(b)                                 Prosecution by AbbVie.  Except as otherwise
set forth in this Agreement or any Special Products Ancillary Agreement, AbbVie
shall have the sole right to prepare, file, prosecute and maintain the AbbVie
Special Products Patents and the AbbVie New Product Patents.  If, during the
term of this Agreement, AbbVie intends to allow any AbbVie Special Products
Patent to expire or intends to otherwise abandon any such AbbVie Special
Products Patent, AbbVie shall notify Abbott of such intention at least sixty
(60) days prior to the date upon which such patent shall expire or be abandoned,
and, subject to the terms of any In-Licensed Intellectual Property Agreement,
Abbott shall thereupon have the right, but not the obligation, to assume
responsibility for the preparation, filing, prosecution or maintenance thereof. 
To the extent Abbott elects to assume such responsibility, AbbVie shall promptly
assign to Abbott, without compensation, all of AbbVie’s right, title and
interest in and to such abandoned AbbVie Special Products Patents.

 

(c)                                  Prosecution of Patents Covering Special
Products Know-How.  Abbott shall be the owner of Special Products Know-How
Patents in the Abbott Territory and AbbVie shall be the owner of Special
Products Know-How Patents in the AbbVie Territory.  To the extent that

 

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any right, title or interest in or to any Special Products Know-How Patent vests
in a Party by operation of applicable Law or otherwise, in a manner contrary to
the agreed upon ownership as set forth in the preceding sentence, such Party
shall, and hereby does, irrevocably assign to the other Party joint right, title
and interest throughout the world in and to such Special Products Know-How
Patent without the need for any further action by any Party.  Abbott shall have
the primary right to prepare, file, prosecute and maintain Special Products
Know-How Patents in the Abbott Territory.  AbbVie shall have the primary right
to prepare, file, prosecute and maintain Special Products Know-How Patents in
the AbbVie Territory.

 

(d)                                 No Disclosure of Confidential Information. 
Neither Party shall have the right to disclose Confidential Information
belonging solely to the other Party when preparing, filing, prosecuting or
maintaining any AbbVie Special Products Patent, AbbVie New Product Patent,
Abbott Special Products Patent, Abbott New Product Patent, or Special Products
Know-How Patent, as applicable, without the prior written consent of the other
Party, which consent shall not be unreasonably withheld or delayed.

 

Section 4.04                             Prosecution Costs.

 

(a)                                 Except as otherwise set forth in this
Agreement or any Special Products Ancillary Agreement, Abbott shall be
responsible for all costs or expenses incurred by it in the course of preparing,
filing, prosecuting and maintaining all (i) Abbott Special Products Patents and
Abbott New Product Patents and (ii) Special Products Know-How Patents in the
Abbott Territory.

 

(b)                                 Except as otherwise set forth in this
Agreement or any Special Products Ancillary Agreement, AbbVie shall be
responsible for all costs or expenses incurred by it in the course of preparing,
filing, prosecuting and maintaining all (i) AbbVie Special Products Patents and
AbbVie New Product Patents and (ii) Special Products Know-How Patents in the
AbbVie Territory.

 

(c)                                  In the event that a Party does not want to
support, or continue to support, the preparation, filing, prosecution or
maintenance of any Special Products Know-How Patent in a particular country in
such Party’s territory, it shall so notify the other Party in writing and it
shall not be obligated to pay for any costs or expenses relating to the
preparation, filing, prosecution or maintenance of such Special Products
Know-How Patent which are incurred following delivery of such notification.  In
the event a Party notifies the other Party of its election not to support the
preparation, filing, prosecution or maintenance of a Special Products Know-How
Patent in a particular country in such Party’s territory pursuant to the
provisions of this Section 4.04, then it shall, upon the request of the other,
assign to the other, without compensation to the assignor, but at the expense of
the assignee, all of the notifying Party’s right, title and interest in and to
such Special Products Know-How Patent in such country, and such Special Products
Know-How Patent shall thereafter be owned by AbbVie or Abbott, as applicable.

 

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Section 4.05                             Prosecution Cooperation.  Each of
Abbott and AbbVie shall make available to the other (or to the other’s
authorized attorneys, agents or representatives) its employees, agents or
consultants to the extent necessary or reasonable to enable the requesting Party
to prepare, file, prosecute and maintain all Special Products Know-How Patents
filed by the Parties, and for periods of time sufficient for such Party to
obtain the necessary assistance from such personnel.  In addition, where
appropriate, each of Abbott and AbbVie shall perform such commercially
reasonable acts (including signing or causing to have signed all documents
necessary) for the appropriate Party to prepare, file, prosecute and maintain
all such Special Products Know-How Patents.  Any costs of cooperation under this
Section 4.05 shall be at the expense of the requesting Party.

 

Section 4.06                             Notice of Issuance.  Abbott shall
deliver or have delivered to AbbVie in a timely manner copies of all patent
applications, amendments, related correspondence, and other documents reasonably
requested by AbbVie concerning all Abbott Special Products Patents in the Major
Jurisdictions that are related to the AbbVie’s Manufacture, Development, use or
Commercialization activities with respect to a Special Product and the Special
Products Know-How Patents in the Major Jurisdictions for which Abbott is the
prosecuting Party.  AbbVie shall deliver or have delivered to Abbott in a timely
manner copies of all patent applications, amendments, related correspondence,
and other documents reasonably requested by Abbott concerning all AbbVie Special
Products Patents in the Major Jurisdictions that are related to Abbott’s
Manufacture, Development, use or Commercialization activities with respect to a
Special Product and the Special Products Know-How Patents in the Major
Jurisdictions for which AbbVie is the prosecuting Party.

 

Section 4.07                             Matters Involving Infringement.  In the
event either Party reasonably believes that a Third Party infringes, or is
reasonably likely to infringe, Abbott Special Products Patents, AbbVie Special
Products Patents or Special Products Know-How Patents with respect to the
applicable Special Product, then each Party shall be solely responsible, at its
cost, for the control of any infringement Proceeding in its territory and shall
be solely entitled to any recovery and solely responsible to pay any Liability
resulting therefrom.

 

Section 4.08                             Third Party Infringement Suit.  In the
event that a Third Party brings a Proceeding against AbbVie, Abbott or any of
their respective Subsidiaries alleging that the Manufacture, use or
Commercialization of a Special Product infringes such Third Party’s intellectual
property rights, including Patents and Trademarks, then Abbott and AbbVie shall
defend such Proceeding pursuant to their indemnification obligations set forth
in Section 9.01 or Section 9.02, as applicable.

 

Section 4.09                             Inventor Remuneration.  If, in respect
of an invention underlying a Special Products Patent, any payment is owed from
or after the Effective Time by either Party to any current or former employee
who is, under the Law of any jurisdiction, entitled to such payment as a
remuneration of such employee’s contribution to the invention (an “Employee
Inventor Remuneration Entitlement”), the following shall apply:

 

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(a)                                 If and to the extent that the actions or
events that give rise to an Employee Inventor Remuneration Entitlement are
related exclusively to Abbott, Abbott shall indemnify and hold harmless AbbVie
from and against the Employee Inventor Remuneration Entitlements resulting from
such actions or events.  If and to the extent that the actions or events that
give rise to an Employee Inventor Remuneration Entitlement are related
exclusively to AbbVie, AbbVie shall indemnify and hold harmless Abbott from and
against the Employee Inventor Remuneration Entitlements resulting from such
actions and events.  If and to the extent that the actions or events that give
rise to an Employee Inventor Remuneration Entitlement are related to both
Parties, then the Party who is not legally obligated to pay the Employee
Inventor Remuneration Entitlements shall indemnify and hold harmless the other
Party from and against the Employee Inventor Remuneration Entitlements resulting
from such actions or events on a pro rata basis, taking into account the
relative benefit from such actions and events to the Party not legally obligated
to pay the Employee Inventor Remuneration Entitlements.

 

(b)                                 If the determination, adjustment, adaption
or other assessment of an Employee Inventor Remuneration Entitlement is, or
becomes after the Effective Time, the subject matter of: (i) any Proceeding;
(ii) any consultations, negotiations or agreement with the relevant employee or
a body of employees; or (iii) a unilateral decision of a Party (each of
(i) through (iii), including any appeals, a “Remuneration Assessment”), the
Parties shall cooperate with respect to such Remuneration Assessment in good
faith.  The Party against which a Remuneration Assessment is made shall:
(A) provide Notice to the other Party about, and offer the other Party
reasonable opportunity to participate in, the Remuneration Assessment; (B) take
the other Party’s reasonable comments and requests into due consideration; and
(C) refrain from acknowledging or settling, agreeing to or unilaterally deciding
on the relevant Employee Inventor Remuneration Entitlement without the other
Party’s prior written consent (which consent shall not be unreasonably withheld
or delayed).

 

(c)                                  Each Party shall provide the other Party
with any information about the commercial exploitation of the relevant Special
Products Patent, including any payments or other economic benefits received from
such exploitation, by the Party and its Subsidiaries reasonably requested by the
other Party for any determination under Sections 4.09(a) and Section 4.09(b).

 

ARTICLE V
DEVELOPMENT MATTERS

 

Section 5.01                             Development Rights and
Responsibilities.  Subject to the provisions of Article III, this Article V and,
if applicable, any Special Products Ancillary Agreements, each Party shall have
the right to conduct further Development of Special Products and to Develop New
Products.

 

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Section 5.02                             Development Activities for Special
Products.

 

(a)                                 Proposal and Opt-In.  If, during the term of
the applicable manufacturing agreement, a Party desires to further Develop a
Special Product, and the estimated Development costs are expected to be in
excess of three million United States Dollars ($3,000,000), then such Party
shall submit to the other Party its proposal for such Development.  The
non-proposing Party shall have the right to opt-in and participate in any such
Development, such right to be exercised within sixty (60) days after receipt of
such proposal.  In the event that the estimated costs for such Development is
expected to be in excess of three million United States Dollars ($3,000,000) and
the non-proposing Party does not elect to opt-in and participate in the
Development thereof (including sharing in the costs and expenses thereof), then
all intellectual property rights arising from such Development shall be excluded
from the license grant in Section 3.01 or Section 3.02, as applicable, any
Know-How created or developed in the course of such Development shall be solely
owned by the proposing Party and shall not be considered Special Products
Know-How, and the non-proposing Party shall have no rights to Manufacture, use
or Commercialize a Special Product utilizing any Improvement resulting from such
Development.

 

(b)                                 Other Development Requiring Disclosure. 
Except as otherwise provided in Section 5.02(a), if, during the term of this
Agreement, a Party desires to further Develop a Special Product, and such
Development either (i) involves Clinical Development, or (ii) could reasonably
be expected to require the other Party to have to amend or update its Regulatory
Approvals for the applicable Special Product, then the Party planning such
Development shall submit to the other Party a copy of the plan for such
Development.

 

(c)                                  Contents of Proposal.  For Development that
is subject to Section 5.02(a), all such proposals shall contain, at a minimum,
information supporting the rationale for further Developing such Special Product
from a scientific, regulatory and commercial standpoint, as well as an estimate
of the timeframe for and cost of such Development.

 

(d)                                 Development Plans.  With respect to
Development activities for which the non-proposing Party has elected to
participate pursuant to Section 5.02(a), the Parties shall enter into a
development agreement and prepare a development plan (each, a “Development
Plan”) that shall, among other things:

 

(i)                                     identify all major Development tasks
remaining to be accomplished prior to submission of filings for major regulatory
milestones and Regulatory Approvals;

 

(ii)                                  identify key Development objectives,
expected associated resources, risk factors, timelines, Go/No Go decision points
and relevant decision criteria and, where appropriate, decision trees;

 

(iii)                               indicate how resources are expected to be
provided by Abbott and AbbVie to support the Development for such Special
Product;

 

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(iv)                              include a reasonably detailed description and
estimated budget for the Development activities that are expected to be
performed by Abbott and AbbVie under the Development Plan; and

 

(v)                                 specify the manner in which the Development
costs and expenses (including any costs and expenses incurred prior to the
finalization of the applicable Development Plan) with respect to such activities
shall be allocated between the AbbVie Territory and the Abbott Territory.

 

(e)                                  Included Improvements. If, during the term
of the applicable manufacturing agreement, a Party Develops a Special Product,
and either (i) the other Party opted into the Development pursuant to
Section 5.02(a) or (ii) the estimated Development costs were not expected to be
in excess of three million United States Dollars ($3,000,000), then any
Improvement resulting from such Development shall be included in the definition
of Special Products for purposes of this Agreement, all intellectual property
rights arising from such Development shall be included in the license grant in
Section 3.01 or Section 3.02, as applicable, any Know-How created or developed
in the course of such Development shall be considered Special Products Know-How
and jointly owned, and any Improvement resulting from any such Development shall
be included in the technology transfer to the other Party at the expiration of
the applicable manufacturing agreement in accordance with the terms of such
manufacturing agreement.

 

Section 5.03                             Development Activities for New
Products.  Either Party shall be free to Develop New Products.  Except as
otherwise set forth in this Agreement or a Special Products Ancillary Agreement,
neither Party shall have the right to opt-in to the Development activities of
the other Party with respect to the Development of a New Product.  However, if a
Party desires to conduct Clinical Development with respect to a New Product and
at such time, the other Party is Commercializing the Special Product
corresponding to such Clinical Development, then the Party planning such
Clinical Development shall submit to the other Party a copy of the plan for such
Clinical Development.

 

ARTICLE VI
COMMERCIALIZATION MATTERS

 

Section 6.01                             Abbott Territory.

 

(a)                                 Responsibility for Commercialization in
Abbott Territory.  Subject to the terms and conditions of any applicable
In-Licensed Intellectual Property Agreement, Abbott shall:

 

(i)                                     be solely responsible, at its own cost
and expense, for Commercializing Special Products in the Abbott Territory;

 

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(ii)                                  have the sole right to establish and
modify conditions of sale of Special Products in the Abbott Territory, including
the price or prices at which the Special Products in the Abbott Territory shall
be sold, any discount applicable to payments or receivables, and similar
matters;

 

(iii)                               invoice and book all sales of Special
Products in the Abbott Territory; and

 

(iv)                              be exclusively responsible for accepting and
filling purchase orders, billing, and returns with respect to Special Products
in the Abbott Territory.  If AbbVie receives an order for Special Products for
the Abbott Territory, it shall promptly transmit such order to Abbott.

 

(b)                                 No Sales by Abbott Outside Abbott
Territory.  Abbott shall not engage in advertising specifically targeted outside
the Abbott Territory for Special Products and Abbott shall not, directly or
indirectly, Commercialize, or cause to be Commercialized, Special Products
outside of the Abbott Territory, including through distributors,
sub-distributors, sales representatives or otherwise or by assisting Third
Parties to Commercialize Special Products outside of the Abbott Territory. 
Abbott shall promptly advise AbbVie of any knowledge it has of Special Products
intended for sale in the Abbott Territory being transported out of the Abbott
Territory.

 

(c)                                  No Sales for Distribution into AbbVie
Territory.  To the extent not prohibited by applicable Law, Abbott shall ensure
that its employees, contractors or agents do not, directly or indirectly
Commercialize any Special Products to any Third Party in circumstances where
there is reasonable reason to believe that such Special Products shall be
distributed or redistributed within the AbbVie Territory.  If Abbott receives
notice from AbbVie that any Third Party is violating any terms of this
Section 6.01(c), Abbott shall promptly take such steps or initiate Proceedings
as may be commercially reasonable to stop such distribution or redistribution,
including, to the extent not prohibited by applicable Law, terminating sales of
all Special Products to any such Third Party.

 

(d)                                 Use of Third Parties.  Subject to the terms
and conditions of any applicable In-Licensed Intellectual Property Agreement and
the licenses granted herein, Abbott shall be free to utilize Third Parties to
Commercialize Special Products in the Abbott Territory.

 

Section 6.02                             AbbVie Territory.

 

(a)                                 Responsibility for Commercialization in
AbbVie Territory.  Subject to the terms and conditions of any applicable
In-Licensed Intellectual Property Agreement, AbbVie shall:

 

(i)                                     be solely responsible, at its own cost
and expense, for Commercializing Special Products in the AbbVie Territory;

 

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(ii)                                  have the sole right to establish and
modify conditions of sale of Special Products in the AbbVie Territory, including
the price or prices at which the Special Products in the AbbVie Territory shall
be sold, any discount applicable to payments or receivables, and similar
matters;

 

(iii)                               invoice and book all sales of Special
Products in the AbbVie Territory; and

 

(iv)                              be exclusively responsible for accepting and
filling purchase orders, billing, and returns with respect to Special Products
in the AbbVie Territory.  If Abbott receives an order for Special Products for
the AbbVie Territory, it shall promptly transmit such order to AbbVie.

 

(b)                                 No Sales by AbbVie Outside AbbVie
Territory.  AbbVie shall not engage in advertising specifically targeted outside
the AbbVie Territory Special Products and AbbVie shall not, directly or
indirectly, Commercialize, or cause to be Commercialized, Special Products
outside of the AbbVie Territory, including through distributors,
sub-distributors, sales representatives or otherwise or by assisting Third
Parties to Commercialize Special Products outside of the AbbVie Territory. 
AbbVie shall promptly advise Abbott of any knowledge it has of Special Products
intended for sale in the AbbVie Territory being transported out of the AbbVie
Territory.

 

(c)                                  No Sales for Distribution into Abbott
Territory.  To the extent not prohibited by applicable Law, AbbVie shall ensure
that its employees, contractors or agents do not, directly or indirectly
Commercialize any Special Products to any Third Party in circumstances where
there is reasonable reason to believe that such Special Products shall be
distributed or redistributed within the Abbott Territory.  If AbbVie receives
notice from Abbott that any Third Party is violating any terms of this
Section 6.02(c), AbbVie shall promptly take such steps or initiate Proceedings
as may be commercially reasonable to stop such distribution or redistribution,
including, to the extent not prohibited by applicable Law, terminating sales of
all Special Products to any such Third Party.

 

(d)                                 Use of Third Parties.  Subject to the terms
and conditions of any applicable In-Licensed Intellectual Property Agreement and
the licenses granted herein, AbbVie shall be free to utilize Third Parties to
Commercialize Special Products in the AbbVie Territory.

 

Section 6.03                             Compassionate Use.  With respect to
(a) requests from patients participating as of the Effective Time in a
Compassionate Use Program and (b) requests, after the Effective Time, from
patients with approvals from the appropriate Governmental Authorities seeking to
participate in a Compassionate Use Program that reside in a jurisdiction that
does not have a Regulatory Approval for such Special Product and which
jurisdiction requires that such product be provided pursuant to a U.S.
Regulatory Approval:

 

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(i)                                     Abbott shall refer all requests from
patients described in Section 6.03(b) to AbbVie;

 

(ii)                                  AbbVie shall be solely responsible, at its
own cost and expense, for supplying Special Products for Compassionate Use
Programs to patients described in Section 6.03(a); and

 

(iii)                               AbbVie shall only be obligated to supply
Special Products for Compassionate Use Programs to patients described in
Section 6.03(b) if, and to the extent, AbbVie elects, at its sole discretion, to
provide such Special Products.

 

Section 6.04                             Domain Names.  The Parties acknowledge
and agree that after the Effective Time, the Parties shall negotiate in good
faith a process under which they shall share certain domain names for Special
Products.  As part of these negotiations, the Parties shall consider parameters
for the creation, implementation, maintenance and protection of such domain
names. The Parties anticipate that these negotiations shall result in either
written procedures or a separate domain name use agreement reflecting the
Parties’ mutual understanding.

 

ARTICLE VII
MANUFACTURING MATTERS

 

Section 7.01                             Supply.  In accordance with and subject
to the terms of a manufacturing agreement, the Parties shall agree upon which
Party shall be responsible for the manufacture of each Special Product (in each
case, the “Manufacturing Party”); provided that supply may be from one Party, or
the other Party, or both Parties, depending on the supply chain for each Special
Product or formulation thereof, and may span more than one manufacturing
agreement.  During the term of a manufacturing agreement, the non-Manufacturing
Party shall purchase the Special Product from the Manufacturing Party and the
Manufacturing Party shall manufacture and supply the Special Product to the
non-Manufacturing Party in accordance with this Article VII and the more
detailed terms of the particular manufacturing agreement.

 

Section 7.02                             Cooperation.  Abbott and AbbVie shall
each reasonably and in good faith cooperate with the other to resolve any
operational issues (e.g., issues related to forecasting, ordering, batch review,
acceptance and rejection of Special Products, and allocation of supply) that
arise with respect to the manufacture of Special Products supplied pursuant to a
manufacturing agreement.

 

ARTICLE VIII
REGULATORY MATTERS

 

Section 8.01                             Ownership of Regulatory Approvals.  All
Regulatory Documentation for the Special Products to be Commercialized in the
Abbott Territory shall be filed in the name of and owned by Abbott, an Abbott
Subsidiary or their respective designees.  All Regulatory Documentation for the
Special Products to be Commercialized in the AbbVie Territory shall be

 

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filed in the name of and owned by AbbVie, an AbbVie Subsidiary or their
respective designees.  In the event a Party seeks to withdraw a Regulatory
Approval of a Special Product in its territory, such Party shall so notify the
other Party in writing not less than ninety (90) days prior to seeking such
withdrawal and shall discuss in good faith and endeavor to agree to a mitigation
strategy regarding the negative impact, if any, such withdrawal is reasonably
likely to have on such other Party’s business with respect to such Special
Product.

 

Section 8.02                             Allocation of Regulatory
Responsibilities.  The Parties agree to the following allocation of
responsibilities with respect to regulatory matters related to the Special
Products:

 

(a)                                 Interactions with Governmental Authorities. 
Except as set forth in any Special Products Ancillary Agreement or In-Licensed
Intellectual Property Agreement and subject to the provisions of Section 8.03,
each Party shall be responsible for interfacing, corresponding and meeting with
Governmental Authorities with respect to all issues primarily related to the
Special Products in its territory (each, respectively, the “Interacting
Party”).  When engaging in such actions, the Interacting Party shall use
commercially reasonable efforts to maintain obligations of confidentiality of
the other Party with respect to information relating to the Special Products.
The Interacting Party shall provide the other Party in a timely manner with
written meeting minutes or a summary of significant meetings with any
Governmental Authority in any of the Major Jurisdictions with respect to a
Special Product.  Subject to the provisions of Section 8.03, the other Party
shall not, without the prior written consent (which consent shall not be
unreasonably withheld or delayed) of the Interacting Party or unless so required
by Law (and then only pursuant to the terms of this Section 8.02(a)), correspond
or communicate with any Governmental Authority in the Interacting Party’s
territory concerning a Special Product.  If the other Party is advised by its
legal counsel that it is required by Law to communicate with any such
Governmental Authority, then the other Party shall so advise the Interacting
Party in writing as soon as practicable and, unless the Law prohibits, provide
the Interacting Party, to the extent practicable, in advance with a copy of any
proposed written communication with such Governmental Authority and reasonably
comply with any and all reasonable direction of the Interacting Party concerning
any meeting or written or oral communication with such Governmental Authority in
the Interacting Party’s territory concerning a Special Product.

 

(b)                                 Submissions to Governmental Authorities. 
Except as set forth in a Special Products Ancillary Agreement or In-License
Intellectual Property Agreement and subject to the provisions of Section 8.03,
the Interacting Party shall be responsible for (i) preparing and submitting to
the applicable Governmental Authority (A) all annual and other periodic updates
to the Regulatory Approvals for the Special Products that are required in its
territory and (B) all supplements and amendments to any Regulatory Approvals
with respect to Special Products in its territory (collectively and individually
the items set forth in (A) and (B) above shall be referred to as “Regulatory
Submission”), and (ii) taking all other actions that are necessary to maintain
the Regulatory Approvals for the Special Products in its territory in accordance
with

 

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applicable Laws.  In the event Governmental Authorities require that a single,
common Regulatory Submission be submitted in both the Abbott Territory and the
AbbVie Territory, the Parties shall discuss and determine the proper allocation
of responsibilities with respect to preparing such Regulatory Submissions.

 

(c)                                  Support of Regulatory Submissions.  Upon
request, the other Party shall provide in a timely manner data (other than
Clinical Development Data) it holds regarding Regulatory Approvals in its
territory that may be required by the Interacting Party to prepare and submit
Regulatory Submissions in the Interacting Party’s territory.  With respect to
Clinical Development Data, each Party shall provide in a timely manner to the
other Party all Clinical Development Data it holds regarding Regulatory
Approvals in its territory for Special Products. However, with respect to all
data described in this Section 8.02(c) that relates to Development of a Special
Product initiated after the Effective Time, unless the Interacting Party has
obtained rights pursuant to Section 5.02(e) to the data that is generated from
such Development, the Interacting Party may not use the data provided by other
Party under this Section 8.02(c) for purposes of expanding its labeling or
obtaining additional approvals for the applicable Special Product.  All data
provided by other Party under this Section 8.02(c) shall be provided “as-is”,
without additional formatting or analysis.  Further, if requested, the Party
providing such data shall provide uncertified translations of documents received
from a Governmental Authority (e.g., deficiency letters) that are not written in
English.  The cost of such translations shall be borne by the providing Party if
the requested data is required by a Governmental Authority and by the requesting
Party in all other circumstances.

 

Section 8.03                             Sharing of Correspondence with
Governmental Authorities.  Each Party shall promptly provide to the other copies
of any documents or correspondence received from a Governmental Authority
pertaining to a Special Product (including any meeting minutes) to the extent
such documents and correspondence have a reasonable potential to impact the
labeling, or to materially impact the Commercialization of a Special Product in
the other Party’s territory.

 

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Section 8.04                             Pharmacovigilance and Medical
Inquiries.

 

(a)                                 Pharmacovigilance.  Each Party agrees to
share relevant information it receives (either directly or indirectly) with the
other Party in a timely manner so as to allow the responsible Party to comply
with its responsibility to process pharmacovigilance information.  Pursuant to
the terms of a safety data exchange agreement, the maintaining Party shall
provide the other Party access to such data for each Special Product.

 

(b)                                 Medical Inquiries.  AbbVie shall be
ultimately responsible for handling all medical questions or inquiries in the
AbbVie Territory with regard to the Special Products.  Abbott shall forward all
medical questions or inquiries made to Abbott from members of the medical and
paramedical professions and consumers regarding the Special Products in the
AbbVie Territory in accordance with a safety data exchange agreement.  Abbott
shall be ultimately responsible for handling all medical questions or inquiries
in the Abbott Territory with regard to the Special Products.  AbbVie shall
forward all medical questions or inquiries made to AbbVie from members of the
medical and paramedical professions and consumers regarding the Special Products
in the Abbott Territory in accordance with a safety data exchange agreement.

 

Section 8.05                             Labeling Changes.  In the event either
Party seeks to change a core label and/or core package insert (e.g., the CCDS,
MasterSmPC, core PIL, US PI or its equivalent) for a Special Product due to
safety or efficacy concerns, the Party seeking to make the change shall notify
the other Party and provide the other Party with applicable data for its review
and evaluation within thirty (30) days of compiling such data.  The Parties may
discuss in good faith and endeavor to agree upon all proposed significant safety
or efficacy changes to the labeling and/or package inserts for Special Products
in Major Jurisdictions.  Each Party agrees to consider all comments of the other
in good faith. Notwithstanding any good faith discussions, Abbott shall have the
right to file for such labeling change as it reasonably deems appropriate in the
Abbott Territory and AbbVie shall have the right to file for such labeling
change as it reasonably deems appropriate in the AbbVie Territory, as
applicable.

 

Section 8.06                             Notification or Information.  Each
Party shall promptly inform the other Party of any notification of any action
by, or notification or other information which it receives (directly or
indirectly) from, any Governmental Authority in the AbbVie Territory or Abbott
Territory or from any other Person (together with copies of correspondence
related thereto), which (a) raises any material concerns regarding the safety or
efficacy of any Special Product, (b) indicates or suggests a potential material
Liability for either Party to any Third Party arising in connection with any
Special Product, or (c) indicates a reasonable potential for a Recall of any
Special Product; provided, however, that neither Party shall be obliged to
disclose information in breach of any contractual restriction which it could not
reasonably have avoided.  Information that shall be disclosed pursuant to this
Section 8.06 (to the extent such information otherwise satisfies the
requirements set forth in the preceding sentence) shall include:  (i)

 

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receipt of a warning letter, untitled letter or any other related Governmental
Authority action relating to any Special Product and any responses related
thereto; and (ii) an initiation of any Governmental Authority Proceeding,
detention, seizure or injunction concerning any Special Product.

 

Section 8.07                             Recalls.

 

(a)                                 Notification.  Each Party shall within one
(1) business day notify the other Party in writing if it determines that any
event, incident or circumstance has occurred which may result in the need for a
recall, market withdrawal or field alert (each, a “Recall”) with respect to a
Special Product.

 

(b)                                 Recalls in the Respective Territories.  Each
Party shall determine whether to implement a Recall of a Special Product in its
territory and upon what terms and conditions the Special Product shall be
subject to a Recall; provided, however, that, prior to any implementation of a
Recall of a Special Product in its territory, to the extent practicable, the
Party conducting the Recall shall consult with the other Party and consider in
good faith any comments such Party may have with respect to such
implementation.  Each Party shall be responsible for discussions with any
Governmental Authority in its territory regarding all aspects of a Recall.

 

(c)                                  Costs and Expenses of Recalls.  All costs
and expenses associated with implementing any Recall of a Special Product shall
be allocated between Abbott and AbbVie as follows:

 

(i)                                     In the event, and to the extent, that
the Recall arises out of (A) the negligence or willful misconduct of AbbVie, or
(B) a material breach of this Agreement or the applicable manufacturing
Agreement by AbbVie, AbbVie shall bear the costs and expenses for the Recall
(including any out-of-pocket expenses reasonably incurred by Abbott in
conducting such Recall), up to one hundred percent (100%) thereof.

 

(ii)                                  In the event, and to the extent, that the
Recall arises out of (A) the negligence or willful misconduct of Abbott, or
(B) a material breach of this Agreement or the applicable manufacturing
agreement by Abbott, Abbott shall bear the costs and expenses for the Recall
(including any out-of-pocket expenses reasonably incurred by AbbVie in
conducting such Recall), up to one hundred percent (100%) thereof.

 

(iii)                               In the event, and to the extent, that the
Recall arises out of any event other than those set forth in
Section 8.07(c)(i) or Section 8.07(c)(ii), Abbott shall bear the costs and
expenses for the Recall in the Abbott Territory and AbbVie shall bear the costs
and expenses for the Recall in the AbbVie Territory.

 

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ARTICLE IX
INDEMNIFICATION

 

Section 9.01                             Indemnification by AbbVie.  Except as
otherwise specifically set forth in any provision of this Agreement or of any
Special Products Ancillary Agreement, AbbVie and each of the AbbVie Subsidiaries
shall, to the fullest extent permitted by Law, indemnify, defend and hold
harmless each of the Abbott Indemnitees from and against all AbbVie Indemnity
Obligations, except to the extent any such Liability is the result of a breach
by Abbott or an Abbott Subsidiary of this Agreement or any Special Products
Ancillary Agreement or the negligence or willful misconduct or omission by
Abbott or an Abbott Subsidiary under this Agreement or any Special Products
Ancillary Agreement; provided, however, that the indemnity in this Section 9.01
for AbbVie Special Products Liabilities shall not extend to a former director,
officer, employee or agent of AbbVie or an AbbVie Subsidiary to the extent such
Person would not be eligible for indemnification under the terms of (i) Abbott’s
certificate of incorporation or bylaws in connection with the matter for which
indemnification is sought due to action or inaction by such Person in connection
with such matter; or (ii) the directors’ and officers’ insurance policy of
Abbott would not cover such Person in connection with the matter for which
indemnification is sought due to action or inaction by such Person in connection
with such matter.

 

Section 9.02                             Indemnification by Abbott.  Except as
otherwise specifically set forth in any provision of this Agreement or of any
Special Products Ancillary Agreement, Abbott and each of the Abbott Subsidiaries
shall, to the fullest extent permitted by Law, indemnify, defend and hold
harmless each of the AbbVie Indemnitees from and against all Abbott Indemnity
Obligations, except to the extent any such Liability is the result of a breach
by AbbVie or an AbbVie Subsidiary of this Agreement or any Special Products
Ancillary Agreement or the negligence or willful misconduct or omission by
AbbVie or an AbbVie Subsidiary under this Agreement or any Special Products
Ancillary Agreement; provided, however, that the indemnity in this Section 9.02
for Abbott Special Products Liabilities shall not extend to a former director,
officer, employee or agent of Abbott or an Abbott Subsidiary to the extent such
Person would not be eligible for indemnification under the terms of (i) AbbVie’s
certificate of incorporation or bylaws in connection with the matter for which
indemnification is sought due to action or inaction by such Person in connection
with such matter; or (ii) the directors’ and officers’ insurance policy of
AbbVie would not cover such Person in connection with the matter for which
indemnification is sought due to action or inaction by such Person in connection
with such matter.

 

Section 9.03                             Indemnification Obligations Net of
Insurance Proceeds and Other Amounts.

 

(a)                                 Insurance Proceeds and Other Amounts.  The
Parties intend that any Liability subject to indemnification or contribution
pursuant to this Agreement or any Special Products Ancillary Agreement: 
(i) shall be reduced by any Insurance Proceeds or other amounts actually
recovered (net of any out-of-pocket costs or expenses incurred in the collection
thereof) from any Person by or on behalf of the Indemnitee in respect of any
indemnifiable Liability; (ii) shall not be increased to take into account any
Tax costs incurred by the

 

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Indemnitee arising from any Indemnity Payments received from the Indemnifying
Party (as defined below); and (iii) shall not be reduced to take into account
any Tax benefit received by the Indemnitee arising from the incurrence or
payment of any Indemnity Payment; provided that Section 9.03(a)(ii) and
Section 9.03(a)(iii) shall not apply to Indemnity Payments made pursuant to the
Tax Sharing Agreement.  Accordingly, the amount which either Party against whom
a claim is made for indemnification under this Agreement (an “Indemnifying
Party”) is required to pay to any Indemnitee shall be reduced by any Insurance
Proceeds or any other amounts theretofore actually recovered (net of any
out-of-pocket costs or expenses incurred in the collection thereof) by or on
behalf of the Indemnitee in respect of the related Liability.  If an Indemnitee
receives a payment required by this Agreement from an Indemnifying Party in
respect of any Liability (an “Indemnity Payment”) and subsequently receives
Insurance Proceeds or any other amounts in respect of the related Liability,
then the Indemnitee shall pay to the Indemnifying Party an amount equal to the
excess of the Indemnity Payment received over the amount of the Indemnity
Payment that would have been due if the Insurance Proceeds or such other amounts
(net of any out-of-pocket costs or expenses incurred in the collection thereof)
had been received, realized or recovered before the Indemnity Payment was made.

 

(b)                                 Insurers and Other Third Parties Not
Relieved.  The Parties hereby agree that an insurer or other Third Party that
would otherwise be obligated to pay any amount shall not be relieved of the
responsibility with respect thereto or have any subrogation rights with respect
thereto by virtue of any provision contained in this Agreement or any Special
Products Ancillary Agreement, and that no insurer or any other Third Party shall
be entitled to a “windfall” (e.g., a benefit they would not be entitled to
receive in the absence of the indemnification or release provisions) by virtue
of any provision contained in this Agreement or any Special Products Ancillary
Agreement.  Each Party shall, and shall cause its Subsidiaries to, use
commercially reasonable efforts to collect or recover, or allow the Indemnifying
Party to collect or recover, any Insurance Proceeds that may be collectible or
recoverable respecting the Liabilities for which indemnification may be
available under this Article IX.  Notwithstanding the foregoing, an Indemnifying
Party may not delay making any indemnification payment required under the terms
of this Agreement, or otherwise satisfying any indemnification obligation,
pending the outcome of any Proceeding to collect or recover Insurance Proceeds,
and an Indemnitee need not attempt to collect any Insurance Proceeds prior to
making a claim for indemnification or receiving any Indemnity Payment otherwise
owed to it under this Agreement or any Special Products Ancillary Agreement.

 

Section 9.04                             Procedures for Indemnification of Third
Party Claims.

 

(a)                                 Notice of Claims.  If, at or following the
date of this Agreement, an Indemnitee receives notice or otherwise learns of the
assertion or commencement by a Third Party of any Proceeding against the
Indemnitee with respect to which the Indemnitee believes that AbbVie (in the
case of an Abbott Indemnitee) or Abbott (in the case of an AbbVie Indemnitee) is
obligated to provide indemnification to such Indemnitee pursuant to this

 

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Agreement or any Special Products Ancillary Agreement (collectively, a “Third
Party Claim”), such Indemnitee shall give such Indemnifying Party Notice thereof
within ten (10) days (or sooner if the nature of the Third Party Claim so
requires) after becoming aware of such Third Party Claim.  The Notice must
describe the Third Party Claim in reasonable detail or, in the alternative,
include copies of all notices and documents (including court papers) received by
the Indemnitee relating to the Third Party Claim.  Notwithstanding the
foregoing, the failure of any Indemnitee to give the Notice as provided in this
Section 9.04(a) shall not relieve the related Indemnifying Party of its
obligations under this Article IX, except to the extent that such Indemnifying
Party is actually prejudiced by such failure to give the Notice in accordance
with this Section 9.04(a).

 

(b)                                 Control of Defense.  An Indemnifying Party
may elect to defend (and seek to settle or compromise), at its own expense and
with its own counsel, any Third Party Claim.  Within thirty (30) days after the
receipt of a Notice from an Indemnitee in accordance with Section 9.04(a) (or
sooner, if the nature of the Third Party Claim so requires), the Indemnifying
Party shall provide a Notice to the Indemnitee indicating whether the
Indemnifying Party shall assume responsibility for defending the Third Party
Claim and specifying any reservations or exceptions to its defense.  If an
Indemnifying Party elects not to assume responsibility for defending any Third
Party Claim or fails to notify an Indemnitee of its election within thirty (30)
days after receipt of a Notice from an Indemnitee as provided in
Section 9.04(a), then the Indemnitee that is the subject of such Third Party
Claim shall be entitled to continue to conduct and control the defense of such
Third Party Claim.

 

(c)                                  Allocation of Defense Costs.  If an
Indemnifying Party has elected to assume the defense of a Third Party Claim,
whether with or without any reservations or exceptions with respect to such
defense, then such Indemnifying Party shall be solely liable for all fees and
expenses incurred by it in connection with the defense of such Third Party Claim
and shall not be entitled to seek any indemnification or reimbursement from the
Indemnitee for any such fees or expenses incurred during the course of its
defense of such Third Party Claim, regardless of any subsequent decision by the
Indemnifying Party to reject or otherwise abandon its assumption of such
defense.  If an Indemnifying Party elects not to assume responsibility for
defending any Third Party Claim or fails to notify an Indemnitee of its election
within thirty (30) days after receipt of a Notice from an Indemnitee as provided
in Section 9.04(a), and the Indemnitee conducts and controls the defense of such
Third Party Claim, then the Indemnifying Party shall be liable for all
reasonable fees and expenses incurred by the Indemnitee in connection with the
defense of such Third Party Claim.

 

(d)                                 Right to Monitor and Participate.  An
Indemnitee that does not conduct and control the defense of any Third Party
Claim, or an Indemnifying Party that has failed to elect to defend any Third
Party Claim as contemplated hereby, nevertheless shall have the right to employ
separate counsel (including local counsel as necessary) of its own choosing to
monitor and participate in (but not control) the defense of any Third Party
Claim for which it is a potential Indemnitee or Indemnifying Party, but the fees
and expenses of such counsel shall

 

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be at the expense of such Indemnitee or Indemnifying Party, as the case may be,
and the provisions of Section 9.04(c) shall not apply to such fees and
expenses.  Notwithstanding the foregoing, such Party shall cooperate with the
Party entitled to conduct and control the defense of such Third Party Claim in
such defense and make available to the controlling Party, at the non-controlling
Party’s expense, all witnesses, information and materials in such Party’s
possession or under such Party’s control relating thereto as are reasonably
required by the controlling Party.  In addition to the foregoing, if any
Indemnitee shall in good faith determine that such Indemnitee and the
Indemnifying Party have actual or potential differing defenses or conflicts of
interest between them that make joint representation inappropriate, then the
Indemnitee shall have the right to employ separate counsel (including local
counsel as necessary) and to participate in (but not control) the defense,
compromise, or settlement thereof, and the Indemnifying Party shall bear the
reasonable fees and expenses of such counsel for all Indemnitees.

 

(e)                                  No Settlement.  Neither Party may settle or
compromise any Third Party Claim for which either Party is seeking to be
indemnified hereunder without the prior written consent of the other Party,
which consent may not be unreasonably withheld; unless such settlement or
compromise is solely for monetary damages, does not involve any finding or
determination of wrongdoing or violation of Law by the other Party and provides
for a full, unconditional and irrevocable release of the other Party from all
Liability in connection with the Third Party Claim.  The Parties hereby agree
that if a Party presents the other Party with a Notice containing a proposal to
settle or compromise a Third Party Claim for which either Party is seeking to be
indemnified hereunder and the Party receiving such proposal does not respond in
any manner to the Party presenting such proposal within thirty (30) days (or
within any such shorter time period that may be required by applicable Law or
court order) of receipt of such proposal, then the Party receiving such proposal
shall be deemed to have consented to the terms of such proposal.

 

(f)                                   Pending Third Party Claims.  The
provisions of this Article IX shall apply to Third Party Claims that are already
pending or asserted as well as Third Party Claims brought or asserted after the
date of this Agreement.  There shall be no requirement under this Section 9.04
to give a Notice with respect to any Third Party Claims that exist as of the
Effective Time.

 

(g)                                  Allocation of Proceeding Liabilities.  The
Parties acknowledge that Liabilities for Proceedings (regardless of the parties
to the applicable Proceeding) may be partly Abbott Liabilities and partly AbbVie
Liabilities.  If the Parties cannot agree on an allocation of any such
Liabilities for Proceedings, they shall resolve the matter pursuant to the
procedures set forth in Article XI.  Neither Party shall, nor shall either Party
permit its Subsidiaries to, file Third Party claims or cross-claims against the
other Party or its Subsidiaries in a Proceeding in which a Third Party Claim is
being resolved.

 

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Section 9.05                             Additional Matters.

 

(a)                                 Timing of Payments.  Indemnity Payments or
contribution payments in respect of any Liabilities for which an Indemnitee is
entitled to indemnification or contribution under this Article IX shall be paid
reasonably promptly (but in any event within sixty (60) days of the final
determination of the amount that the Indemnitee is entitled to indemnification
or contribution under this Article IX) by the Indemnifying Party to the
Indemnitee as such Liabilities are incurred upon demand by the Indemnitee,
including reasonably satisfactory documentation setting forth the basis for the
amount of such Indemnity Payments or contribution payments, including
documentation with respect to calculations made and consideration of any
Insurance Proceeds that actually reduce the amount of such Liabilities.  The
indemnity and contribution provisions contained in this Article IIX shall remain
operative and in full force and effect, regardless of (i) any investigation made
by or on behalf of any Indemnitee; and (ii) the knowledge by the Indemnitee of
Liabilities for which it might be entitled to indemnification or contribution
hereunder.

 

(b)                                 Notice of Direct Claims.  Any claim for
indemnification under this Agreement or any Special Products Ancillary Agreement
which does not result from a Third Party Claim (a “Direct Claim”) must be
asserted by a Notice given by the Indemnitee to the applicable Indemnifying
Party; provided, that the failure by an Indemnitee to so assert any such Direct
Claim shall not prejudice the ability of the Indemnitee to do so at a later time
except to the extent (if any) that the Indemnifying Party is prejudiced
thereby.  Such Indemnifying Party shall have a period of thirty (30) days after
the receipt of such Notice within which to respond thereto.  If such
Indemnifying Party does not respond within such thirty (30)-day period, such
Direct Claim specified in such Notice shall be conclusively deemed a Liability
of the Indemnifying Party under this Section 9.05(b) or, in the case of any
Notice in which the amount of the Direct Claim (or any portion thereof) is
estimated, on such later date, when the amount of such Direct Claim (or such
portion thereof) becomes finally determined.  If such Indemnifying Party does
not respond within such thirty (30)-day period or rejects such Direct Claim in
whole or in part, such Indemnitee shall be free to pursue such remedies as may
be available to such Indemnitee as contemplated by this Agreement or the Special
Products Ancillary Agreements, as applicable, without prejudice to its
continuing rights to pursue indemnification or contribution hereunder.

 

(c)                                  Subrogation.  In the event of payment by or
on behalf of any Indemnifying Party to any Indemnitee in connection with any
Third Party Claim, such Indemnifying Party shall be subrogated to and shall
stand in the place of such Indemnitee as to any events or circumstances in
respect of which such Indemnitee may have any right, defense or claim relating
to such Third Party Claim against any claimant or plaintiff asserting such Third
Party Claim or against any other Person.  Such Indemnitee shall cooperate with
such Indemnifying Party in a reasonable manner, and at the cost and expense of
such Indemnifying Party, in prosecuting any subrogated right, defense or claim.

 

(d)                                 Pursuit of Claims Against Third Parties.  If
(i) a Party incurs any Liability arising out of this Agreement or any Special
Products Ancillary Agreement; (ii) an adequate

 

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legal or equitable remedy is not available for any reason against the other
Party to satisfy the Liability incurred by the incurring Party; and (iii) a
legal or equitable remedy may be available to the other Party against a Third
Party for such Liability, then the other Party shall use its commercially
reasonable efforts to cooperate with the incurring Party, at the incurring
Party’s expense, to permit the incurring Party to obtain the benefits of such
legal or equitable remedy against the Third Party.

 

(e)                                  Substitution.  In any Proceeding in which
the Indemnifying Party is not a named defendant, if either the Indemnitee or
Indemnifying Party shall so request, the Parties shall endeavor to substitute
the Indemnifying Party for the named defendant if they conclude that
substitution is desirable and practicable.  If such substitution or addition
cannot be achieved for any reason or is not requested, the named defendant shall
allow the Indemnifying Party to manage the Proceeding as set forth in
Section 9.04 and this Section 9.05, and the Indemnifying Party shall fully
indemnify the named defendant against all costs of defending the Proceeding
(including court costs, sanctions imposed by a court, attorneys’ fees, experts
fees and all other external expenses), the costs of any judgment or settlement,
and the cost of any interest or penalties relating to any judgment or
settlement.

 

Section 9.06                             Right of Contribution.

 

(a)                                 Contribution.  If any right of
indemnification contained in Section 9.01 or Section 9.02 is held unenforceable
or is unavailable for any reason, or is insufficient, to hold harmless an
Indemnitee in respect of any Liability for which such Indemnitee is entitled to
indemnification hereunder, then the Indemnifying Party shall contribute to the
amounts paid or payable by the Indemnitees as a result of such Liability (or
actions in respect thereof) in such proportion as is appropriate to reflect the
relative fault of the Indemnifying Party and its Subsidiaries, on the one hand,
and the Indemnitees entitled to contribution, on the other hand, as well as any
other relevant equitable considerations.

 

(b)                                 Contribution Procedures.  The provisions of
Section 9.03 through Section 9.05 shall govern any contribution claims.

 

Section 9.07                             Remedies Cumulative.  The remedies
provided in this Article IX shall be cumulative and, subject to the provisions
of Section 9.09 and Section 11.01, shall not preclude assertion by any
Indemnitee of any other rights or the seeking of any and all other remedies
against any Indemnifying Party.

 

Section 9.08                             Survival of Indemnities.  The rights
and obligations of each of the Parties and their respective Indemnitees under
this Article IX shall survive (a) the sale or other transfer by either Party or
any of its respective Subsidiaries of any Assets or businesses or the assignment
by it of any Liabilities; or (b) any merger, consolidation, business
combination, sale of all or substantially all of the Assets, restructuring,
recapitalization, reorganization or similar transaction involving either Party
or any of its respective Subsidiaries.

 

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Section 9.09                             Covenant Not to Sue.  Each Party hereby
covenants and agrees that none of it, its Subsidiaries or any Person claiming
through it shall bring suit or otherwise assert any claim against any
Indemnitee, or assert a defense against any claim asserted by any Indemnitee,
before any court, arbitrator, neutral mediator or administrative agency anywhere
in the world, alleging that:  (a) the assumption of any AbbVie Special Products
Liabilities by AbbVie and the AbbVie Subsidiaries on the terms and conditions
set forth in this Agreement and the Special Products Ancillary Agreements is
void or unenforceable for any reason; (b) the retention of any Abbott Special
Products Liabilities by Abbott and the Abbott Subsidiaries on the terms and
conditions set forth in this Agreement and the Special Products Ancillary
Agreements is void or unenforceable for any reason; or (c) the provisions of
this Article IX are void or unenforceable for any reason.

 

ARTICLE X
CONFIDENTIALITY

 

Section 10.01                      Confidentiality.

 

(a)                                 Confidentiality.  Subject to Section 10.02
and except as contemplated by or otherwise provided in this Agreement or any
Special Products Ancillary Agreement, Abbott, on behalf of itself and each of
the Abbott Subsidiaries, and AbbVie, on behalf of itself and each of the AbbVie
Subsidiaries, agrees to hold, and to cause its respective directors, officers,
employees, agents, accountants, counsel and other advisors and representatives
(each, a “Representative”) to hold, in strict confidence, with at least the same
degree of care that applies to Abbott’s confidential and proprietary information
pursuant to policies in effect as of the Effective Time, all confidential and
proprietary information, including Know-How, concerning the other Party (or its
business) and the other Party’s Subsidiaries (or their respective businesses)
that is either in its possession (including confidential and proprietary
information in its possession prior to the Effective Time) or furnished by the
other Party or the other Party’s Subsidiaries or their respective
Representatives at any time pursuant to this Agreement or any Special Products
Ancillary Agreement (“Confidential Information”), and shall not use any such
Confidential Information other than for such purposes as may be expressly
permitted hereunder or thereunder, except, in each case, to the extent that such
Confidential Information has been: (i) in the public domain or generally
available to the public, other than as a result of a disclosure by such Party or
any of its Subsidiaries or any of their respective Representatives in violation
of this Agreement; provided, however, that any such disclosure shall not be
deemed to be in the public domain or generally available to the public merely
because it is embraced by more general information in the public domain or
generally available to the public; (ii) later lawfully acquired from other
sources by such Party or any of its Subsidiaries, which sources are not
themselves bound by a confidentiality obligation or other contractual, legal or
fiduciary obligation of confidentiality with respect to such confidential and
proprietary information; or (iii) independently developed or generated without
reference to or use of the respective proprietary or confidential information of
the other Party or any of its Subsidiaries.  If any Confidential Information of
one Party or any of its Subsidiaries is disclosed to another Party or any of its
Subsidiaries in connection with providing services to such first

 

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Party or any of its Subsidiaries under this Agreement or any Special Products
Ancillary Agreement, then such disclosed Confidential Information shall be used
only as required to perform such services.

 

(b)                                 No Release; Return or Destruction.  Each
Party agrees not to release or disclose, or permit to be released or disclosed,
any Confidential Information addressed in Section 10.01(a) to any other Person,
except its Representatives who need to know such Confidential Information in
their capacities as such, and except in compliance with Section 10.02. 
Confidential Information furnished by the other Party after the Effective Time
pursuant to this Agreement or any Special Products Ancillary Agreement shall be
subject to the provisions of Section 6.03 of the Separation Agreement.

 

(c)                                  Third-Party Information; Privacy or Data
Protection Laws.  Each Party acknowledges that it and its respective
Subsidiaries may presently have and following the Effective Time may gain access
to or possession of confidential or proprietary information of, or personal
information relating to, Third Parties (i) that was received under
confidentiality or non-disclosure agreements entered into between such Third
Parties, on the one hand, and the other Party or the other Party’s Subsidiaries,
on the other hand, prior to the Effective Time; or (ii) that, as between the two
Parties, was originally collected by the other Party or the other Party’s
Subsidiaries and that may be subject to and protected by privacy, data
protection or other applicable Laws.  As may be provided in more detail in any
applicable Special Products Ancillary Agreement, each Party agrees that it shall
hold, protect and use, and shall cause its Subsidiaries and its and their
respective Representatives to hold, protect and use, in strict confidence the
confidential and proprietary information of, or personal information relating
to, Third Parties in accordance with privacy, data protection or other
applicable Laws and the terms of any agreements that were either entered into
prior to the Effective Time or affirmative commitments or representations that
were made prior to the Effective Time by, between or among the other Party or
the other Party’s Subsidiaries, on the one hand, and such Third Parties, on the
other hand.

 

Section 10.02      Protective Arrangements.  In the event that either Party or
any of its Subsidiaries is requested or required (by oral question,
interrogatories, requests for information or documents, subpoena, civil
investigative demand or similar process) by any Governmental Authority or
pursuant to applicable Law to disclose or provide any Confidential Information
of the other Party, as applicable, that is subject to the confidentiality
provisions hereof, such Party shall provide the other Party with Notice of such
request or demand as promptly as practicable under the circumstances so that
such other Party shall have an opportunity to seek an appropriate protective
order, at such other Party’s cost and expense.  In the event that such other
Party fails to receive such appropriate protective order in a timely manner and
the Party receiving the request or demand reasonably determines that its failure
to disclose or provide such Confidential Information shall actually prejudice
the Party receiving the request or demand, then the Party that received such
request or demand may thereafter disclose or

 

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provide Confidential Information to the extent required by such Law (as so
advised by counsel) or by lawful process or such Governmental Authority.

 

Section 10.03                      Other Permitted Disclosures.  Each Party may
disclose the other Party’s Confidential Information to the extent that such
disclosure is:

 

(a)                                 made by or on behalf of the Party making a
disclosure to the Regulatory Authorities as required in connection with any
filing, application or request for Regulatory Approval in accordance with the
terms of this Agreement; provided, however, that reasonable measures shall be
taken to assure confidential treatment of such Confidential Information to the
extent practicable and consistent with applicable Law;

 

(b)                                 made by or on behalf of the Party making a
disclosure to a patent authority as may be reasonably necessary or useful for
purposes of obtaining, defending or enforcing a Patent in accordance with the
terms of this Agreement; provided, however, that reasonable measures shall be
taken to assure confidential treatment of such Confidential Information, to the
extent such protection is available;

 

(c)                                  made by the Party making the disclosure to
its and its Subsidiaries’ financial and legal advisors who have a need to know
such disclosing Party’s Confidential Information and are either under
professional codes of conduct giving rise to expectations of confidentiality and
non-use or under written agreements of confidentiality and non-use, in each
case, at least as restrictive as those set forth in this Agreement; provided
that the Party making the disclosure under this Section 10.03(c) shall remain
responsible for any failure by such financial and legal advisors, to treat such
Confidential Information as required under this Article X;

 

(d)                                 made by the Party (or its Subsidiaries)
making the disclosure to potential or actual investors or acquirers as may be
necessary in connection with their evaluation of such potential or actual
investment or acquisition; provided, however, that such Third Parties shall be
subject to obligations of confidentiality and non-use with respect to such
Confidential Information substantially similar to the obligations of
confidentiality and non-use of the Party pursuant to this Article X (with a
duration of confidentiality and non-use obligations as appropriate that is no
less than ten (10) years from the date of disclosure); or

 

(e)                                  made by the Party (or its Subsidiaries or
sublicensees) making the disclosure to its or their advisors, consultants,
clinicians, vendors, service providers, contractors, existing or prospective
collaboration partners, licensees, sublicensees, or other Third Parties as may
be necessary or useful in connection with the performance of its obligations or
exercise of its rights as contemplated by this Agreement; provided, however,
that such Third Parties shall be subject to obligations of confidentiality and
non-use with respect to such Confidential Information substantially similar to
the obligations of confidentiality and non-use of the receiving Party pursuant
to this Article  (with a duration of confidentiality and non-

 

42

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use obligations as appropriate that is no less than five (5) years from the date
of disclosure for advisors, consultants, clinicians, vendors, service providers,
contractors).

 

ARTICLE XI
DISPUTE RESOLUTION

 

Section 11.01                      Disputes.

 

(a)                                 Alternative Dispute Resolution Procedures. 
The Parties acknowledge that, from time to time after the Effective Time, a
controversy, dispute or claim (a “Dispute”) may arise relating to either Party’s
rights or obligations under this Agreement or any Special Products Ancillary
Agreement.  The Parties agree that any such Dispute (whether arising in
contract, tort or otherwise) arising out of or relating in any way to this
Agreement or any Special Products Ancillary Agreement (including regarding
whether any Assets are AbbVie Assets, any Liabilities are AbbVie Liabilities or
the interpretation or validity of this Agreement) shall be resolved by the
dispute resolution process referred to in Schedule 7.01 of the Separation
Agreement.

 

(i)                                     Notice.  Prior to initiating a dispute
resolution proceeding, a Party first must send Notice to the other Party
(A) describing the Dispute; and (B) requesting attempted resolution of the
Dispute by good faith negotiations in accordance with Section 11.01(a)(ii).

 

(ii)                                  Negotiations.  The CEOs or Presidents of
each Party shall designate a group of no more than three individuals (with
representatives of each Party’s respective counsel not counting against such
three individuals limit), to participate in good faith negotiations with a like
group designated by the other Party aimed at resolving the Dispute.  The
respective groups shall meet in person to conduct good faith negotiations during
the twenty-one (21) day period following receipt of the Notice (such period, as
it may be extended by mutual written consent, being the “Designees Discussion
Period”).  By mutual written consent, the Parties may extend the twenty-one (21)
day period for conducting such negotiations.  If the Parties fail to resolve the
Dispute within the Designees Discussion Period, then the CEOs or Presidents of
each Party shall review such Dispute, and shall conduct good faith negotiations
with respect to such Dispute within fourteen (14) days following the end of the
Designees Discussion Period.  If the Dispute is not resolved, within fourteen
(14) days after the end of the Designees Discussion Period, and the fourteen
(14) day period is not extended by mutual written consent, either Party may
initiate a dispute resolution proceeding as provided in Schedule 7.01 of the
Separation Agreement.

 

(b)                                 Continuation of Services and Commitments. 
Unless otherwise agreed in writing, the Parties shall, and shall cause their
respective Subsidiaries to, continue to honor all commitments under this
Agreement and each Special Products Ancillary Agreement to the extent required
by such Agreements during the course of dispute resolution pursuant to the
provisions of this Article XI with respect to all matters related to such
Dispute.

 

43

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ARTICLE XII
TERM

 

Section 12.01      Term.  This Agreement shall be effective as of the Effective
Time and shall continue in full force and effect until terminated by an
agreement in writing signed by a duly authorize officer of each of the Parties.

 

Section 12.02      Expiration.  On a Special Product-by-Special Product basis,
in the event a Party, including all sublicensees of such Party with respect to a
Special Product, elects to discontinue all Commercialization activities for such
Special Product, then the electing Party shall notify the other Party of such
election.  Upon receipt of the foregoing notice, subject to Section 12.03,
(a) this Agreement shall expire with respect to the Special Product identified
in such notice and (b) each Party’s obligations hereunder shall expire with
respect to such Special Product.

 

Section 12.03      Survival.  Except as expressly set forth in this Agreement or
any Special Products Ancillary Agreement, the licenses, covenants and other
agreements contained in Section 2.01, Section 2.02, Section 2.03, Section 3.01,
Section 3.02, Section 3.03, Section 3.04, Section 3.05, Section 4.02,
Article IX, Article X, Article XI and Article XIII and Liability for the breach
of any obligations contained herein or therein, shall survive the expiration of
this Agreement with respect to such Special Product and shall remain in full
force and effect thereafter.  In addition, if the Party that is discontinuing
Commercialization activities with respect to a Special Product (or its
Subsidiaries) still Controls a Patent that is relevant to the continuing Party’s
Manufacture, Development, use or Commercialization activities with respect to
such Special Product, then the covenants and other agreements contained in
Article IV with respect to the preparation, filing, prosecution, maintenance
and/or enforcement of such Patent shall survive the expiration of this Agreement
until the expiration or invalidation of the last valid claim of such Patent
covering such Special Product.

 

ARTICLE XIII
MISCELLANEOUS

 

Section 13.01                      Counterparts; Entire Agreement; Corporate
Power; Facsimile Signatures.

 

(a)                                 Counterparts.  This Agreement and each
Special Products Ancillary Agreement may be executed in one or more
counterparts, all of which shall be considered one and the same agreement.

 

(b)                                 Entire Agreement.  This Agreement, the
Special Products Ancillary Agreements, if any, the Separation Agreement and the
exhibits, schedules and annexes hereto and thereto contain the entire agreement
between the Parties with respect to the subject matter hereof, supersede all
previous agreements, negotiations, discussions, writings, understandings,
commitments and conversations with respect to such subject matter and there are
no agreements or understandings between the Parties other than those set forth
or

 

44

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referred to herein or therein.  Notwithstanding any other provisions in this
Agreement to the contrary, in the event and to the extent that there is a
conflict between the provisions of this Agreement and the provisions of the
Separation Agreement, the provisions of this Agreement shall control with
respect to Special Products.  Further, in the event and to the extent there are
any inconsistencies or conflicts between this Agreement and a Special Products
Ancillary Agreement, if any, the terms of the particular Special Products
Ancillary Agreement shall govern, unless otherwise agreed to in writing by the
Parties; provided that, in the event there are any inconsistencies or conflicts
between this Agreement, a Special Products Ancillary Agreement and an applicable
In-Licensed Intellectual Property Agreement, the terms of the particular
In-Licensed Intellectual Property Agreement shall govern.

 

(c)                                  Corporate Power.  Abbott represents on
behalf of itself and, to the extent applicable, each Abbott Subsidiary and
AbbVie represents on behalf of itself and, to the extent applicable, each AbbVie
Subsidiary as follows:

 

(i)                                     each such Person has the requisite
corporate or other power and authority and has taken all corporate or other
action necessary in order to execute, deliver and perform this Agreement and
each Special Products Ancillary Agreement to which it is a party and to
consummate the transactions contemplated hereby and thereby; and

 

(ii)                                  this Agreement and each Special Products
Ancillary Agreement to which it is a party has been duly executed and delivered
by it and constitutes a valid and binding agreement of it enforceable in
accordance with the terms thereof.

 

(d)                                 Signatures and Delivery.  Each Party
acknowledges that it and the other Party may execute this Agreement and any
Special Products Ancillary Agreement by manual, stamp or mechanical signature,
and that delivery of an executed counterpart of a signature page to this
Agreement or any Special Products Ancillary Agreement (whether executed by
manual, stamp or mechanical signature) by facsimile or by email in portable
document format (PDF) shall be effective as delivery of such executed
counterpart of this Agreement or any Special Products Ancillary Agreement.  Each
Party expressly adopts and confirms a stamp or mechanical signature (regardless
of whether delivered in person, by mail, by courier, by facsimile or by email in
portable document format (PDF)) made in its respective name as if it were a
manual signature delivered in person, agrees that it shall not assert that any
such signature or delivery is not adequate to bind such Party to the same extent
as if it were signed manually and delivered in person and agrees that, at the
reasonable request of the other Party at any time, it shall as promptly as
reasonably practicable cause each such Agreement and Special Products Ancillary
Agreement to be manually executed (any such execution to be as of the date of
the initial date thereof) and delivered in person, by mail or by courier.

 

Section 13.02      Governing Law.  This Agreement and, unless expressly provided
therein, each Special Products Ancillary Agreement, shall be governed by and
construed and interpreted in accordance with the Laws of the State of Delaware
irrespective of the choice of Laws and

 

45

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principles of the State of Delaware, as to all matters, including matters of
validity, construction, effect, enforceability, performance and remedies.

 

Section 13.03      Assignability.  Except as set forth in any Special Products
Ancillary Agreement or In-Licensed Intellectual Property Agreement, (a) this
Agreement and each Special Products Ancillary Agreement shall be binding upon
and inure to the benefit of the Parties and the parties thereto, respectively,
and their respective successors and permitted assigns and (b) either Party may
assign its rights or delegate its obligations under this Agreement or any
Special Products Ancillary Agreement without the express prior written consent
of the other Party hereto or the other parties thereto; provided, however,
unless the assignment of rights or delegation of obligations is to an Affiliate
or Subsidiary of the Party seeking such assignment or delegation, then such
Party must first provide the other Party with prior written notice of such
intention and afford such other Party a sixty (60) day right of first
negotiation.  If the Parties are not able to reach an agreement after good faith
negotiations during such sixty (60)-day period, then the Party intending to
assign its rights or delegate its obligations under this Agreement or any
Special Products Ancillary Agreement shall be free to do so; provided, however,
any Person taking assignment shall assume all the obligations of the relevant
Party thereto by operation of Law or pursuant to an agreement in form and
substance reasonably satisfactory to the other Party.  Nothing herein is
intended to, or shall be construed to prohibit either Party or any of its
Subsidiaries from being party to or undertaking a merger, consolidation or sale.

 

Section 13.04      Third Party Beneficiaries.  Except for the indemnification
rights under this Agreement of an Abbott Indemnitee or AbbVie Indemnitee in
their respective capacities as such under Article IX, (a) the provisions of this
Agreement and each Special Products Ancillary Agreement are solely for the
benefit of the Parties and their respective Subsidiaries, and their permitted
successors and assigns, and are not intended to confer upon any Person except
the Parties and their respective Subsidiaries, and their permitted successors
and assigns, any rights or remedies hereunder; and (b) there are no other Third
Party beneficiaries of this Agreement or any Special Products Ancillary
Agreement and neither this Agreement nor any Special Products Ancillary
Agreement shall provide any other Third Party with any remedy, claim, Liability,
reimbursement, claim of action or other right in excess of those existing
without reference to this Agreement or any Special Products Ancillary Agreement.

 

Section 13.05      Notices.  All Notices and, to the extent applicable and
unless otherwise provided therein, under each of the Special Products Ancillary
Agreements shall be in writing and shall be given or made (and shall be deemed
to have been duly given or made upon receipt) by delivery in person, by
overnight courier service, by facsimile with receipt confirmed (followed by
delivery of an original via overnight courier service) or by registered or
certified mail (postage prepaid, return receipt requested) to the respective
Parties at the following addresses (or at such other address for a Party as
shall be specified in a Notice):

 

46

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

 

If to Abbott:

 

AbbottLaboratories

100 Abbott Park Road

Building AP6D, Dept. 364

Abbott Park, Illinois 60064-6020

Attn:  General Counsel

Facsimile:  (847) 938-6277

 

If to AbbVie:

 

AbbVie Inc.

1 North Waukegan Road

North Chicago, Illinois 60064

Attn:  General Counsel

Facsimile: (847) 935-3294

 

Either Party may, by Notice to the other Party, change the address to which such
Notices are to be given.

 

Section 13.06      Severability.  In the event that any one or more of the terms
or provisions of this Agreement or any Special Products Ancillary Agreement or
the application thereof to any Person or circumstance is determined by a court
of competent jurisdiction to be invalid, illegal or unenforceable in any
respect, such invalidity, illegality or unenforceability shall not affect any
other term or provision of this Agreement or any Special Products Ancillary
Agreement, or the application of such term or provision to Persons or
circumstances or in jurisdictions other than those as to which it has been
determined to be invalid, illegal or unenforceable, and the Parties shall use
their commercially reasonable efforts to substitute one or more valid, legal and
enforceable terms or provisions into this Agreement (or the applicable Special
Products Ancillary Agreement) which, insofar as practicable, implement the
purposes and intent of the Parties.  Any term or provision of this Agreement or
any Special Products Ancillary Agreement held invalid or unenforceable only in
part, degree or within certain jurisdictions shall remain in full force and
effect to the extent not held invalid or unenforceable to the extent consistent
with the intent of the parties as reflected by this Agreement.  To the extent
permitted by applicable Law, each party waives any term or provision of Law
which renders any term or provision of this Agreement to be invalid, illegal or
unenforceable in any respect.

 

Section 13.07      Force Majeure.  Neither Party shall be deemed in default of
this Agreement or, unless otherwise expressly provided therein, any Special
Products Ancillary Agreement for failure to fulfill any obligation so long as
and to the extent to which any delay or failure in the fulfillment of such
obligations is prevented, frustrated, hindered or delayed as a consequence of
circumstances of Force Majeure.  In the event of any such excused delay, the
time for performance shall be extended for a period equal to the time lost by
reason of the delay.  A Party claiming the benefit of this provision shall, as
soon as reasonably practicable after the occurrence of any such event, (a)
provide Notice to the other Party of the nature and extent of any such Force
Majeure condition; and (b) use commercially reasonable efforts to

 

47

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remove any such causes and resume performance under this Agreement or any
Special Products Ancillary Agreement as soon as reasonably practicable.

 

Section 13.08      No Set Off.  Except as set forth in any Special Products
Ancillary Agreement or as otherwise mutually agreed to in writing by the
Parties, neither Party nor any of its Subsidiaries shall have any right of set
off or other similar rights with respect to (a) any amounts received pursuant to
this Agreement or any Special Products Ancillary Agreement; or (b) any other
amounts claimed to be owed to the other Party or any of its Subsidiaries arising
out of this Agreement or any Special Products Ancillary Agreement.

 

Section 13.09      Responsibility for Expenses.

 

(a)                                 Expenses Incurred on or Prior to the
Effective Time.  Except as otherwise expressly set forth in this Agreement or
any Special Products Ancillary Agreement, or as otherwise agreed to in writing
by the Parties, all costs and expenses incurred on or prior to the Effective
Time in connection with the preparation, execution, delivery and implementation
of this Agreement and any Special Products Ancillary Agreement and the
consummation of the transactions contemplated hereby and thereby shall be
charged to and paid by Abbott.

 

(b)                                 Expenses Incurred or Accrued After the
Effective Time.  Except as otherwise expressly set forth in this Agreement or
any Special Products Ancillary Agreement, or as otherwise agreed to in writing
by the Parties, each Party shall bear its own costs and expenses incurred or
accrued after the Effective Time.

 

Section 13.10      Headings.  The Article, Section and Paragraph headings
contained in this Agreement and in the Special Products Ancillary Agreements are
for reference purposes only and shall not affect in any way the meaning or
interpretation of this Agreement or any Special Products Ancillary Agreement.

 

Section 13.11      Subsidiaries.  Abbott shall cause to be performed, and hereby
guarantees the performance of, all actions, agreements and obligations set forth
herein to be performed by an Abbott Subsidiary and AbbVie shall cause to be
performed, and hereby guarantees the performance of, all actions, agreements and
obligations set forth herein to be performed by an AbbVie Subsidiary.

 

Section 13.12      Waivers of Default.  Waiver by either Party of any default by
the other Party of any provision of this Agreement or any Special Products
Ancillary Agreement shall not be deemed a waiver by the waiving Party of any
subsequent or other default, nor shall it prejudice the rights of the waiving
Party.

 

Section 13.13      Amendments.  No provisions of this Agreement or any Special
Products Ancillary Agreement shall be deemed amended, supplemented or modified
unless such amendment, supplement or modification is in writing and signed by an
authorized representative of both Parties or their relevant Subsidiaries, as the
case may be.  No provisions

 

48

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of this Agreement or any Special Products Ancillary Agreement shall be deemed
waived unless such waiver is in writing and signed by the authorized
representative of the Party or relevant Subsidiary against whom it is sought to
be enforced.

 

Section 13.14      Interpretation.  Words in the singular shall be deemed to
include the plural and vice versa and words of one gender shall be deemed to
include the other genders as the context requires.  The terms “hereof,”
“herein,” and “herewith” and words of similar import shall, unless otherwise
stated, be construed to refer to this Agreement as a whole (including all of the
Schedules and Exhibits hereto and thereto) and not to any particular provision
of this Agreement.  Article, Section, Exhibit and Schedule references are to the
Articles, Sections, Exhibits, and Schedules to this Agreement unless otherwise
specified.  Unless otherwise stated, all references to any agreement shall be
deemed to include the exhibits, schedules and annexes to such agreement.  The
word “including” and words of similar import when used in this Agreement shall
mean “including, without limitation,” unless the context otherwise requires or
unless otherwise specified.  The word “or” shall not be exclusive.  Unless
otherwise specified in a particular case, the word “days” refers to calendar
days.  References herein to this Agreement or any Special Products Ancillary
Agreement shall be deemed to refer to this Agreement or such Special Products
Ancillary Agreement as of the date on which it is executed and as it may be
amended, modified or supplemented thereafter, unless otherwise specified. 
References to the performance, discharge or fulfillment of any Liability in
accordance with its terms shall have meaning only to the extent such Liability
has terms. If the Liability does not have terms, the reference shall mean
performance, discharge or fulfillment of such Liability.

 

Section 13.15      Public Announcements.  From and after the Effective Time,
Abbott and AbbVie shall consult with each other before issuing, and give each
other the opportunity to review and comment upon, that portion of any press
release or other public statements that relates to the transactions contemplated
by this Agreement or the Special Products Ancillary Agreements, and shall not
issue any such press release or make any such public statement prior to such
consultation, except (a) as may be required by applicable Law, court process or
by obligations pursuant to any listing agreement with any national securities
exchange or national securities quotation system; or (b) as otherwise set forth
on Schedule 9.16 of the Separation Agreement.

 

Section 13.16      Specific Performance.  Subject to the provisions of Article
XI, in the event of any actual or threatened default in, or breach of, any of
the terms, conditions and provisions of this Agreement or any Special Products
Ancillary Agreement, the Party or Parties who are or are to be thereby aggrieved
shall have the right to specific performance and injunctive or other equitable
relief (on an interim or permanent basis) of its rights under this Agreement or
the Special Products Ancillary Agreements, in addition to any and all other
rights and remedies at law or in equity, and all such rights and remedies shall
be cumulative.  The Parties agree that the remedies at law for any breach or
threatened breach, including monetary damages, may be inadequate compensation
for any loss and that any defense in any Proceeding for specific performance
that a remedy at Law would be adequate is waived.

 

49

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Section 13.17      Mutual Drafting.  This Agreement and the Special Products
Ancillary Agreements shall be deemed to be the joint work product of the Parties
and any rule of construction that a document shall be interpreted or construed
against a drafter of such document shall not be applicable.

 

* * * * *

 

50

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives.

 

 

ABBOTT LABORATORIES

 

ABBVIE INC.

 

 

 

 

 

 

By:

/s/ Thomas C. Freyman

 

By:

/s/ Richard A. Gonzalez

Name:

Thomas C. Freyman

 

Name:

Richard A. Gonzalez

Title:

Executive Vice President, Finance

 

Title:

Chairman of the Board and

 

and Chief Financial Officer

 

 

Chief Executive Officer

 

[Signature Page — Special Products Master Agreement]

 

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

 

SPECIAL PRODUCTS MASTER AGREEMENT

Schedule 2.01(a)

AbbVie Patents

 

ADVICOR/NIASPAN/SIMCOR

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

SD-50003USP1

 

1/14/1995

 

08/368378

 

6/27/2000

 

6080428

 

SD-50003USC2

 

3/6/1997

 

08/814974

 

10/10/2000

 

6129930

 

SD-50003USP2

 

10/31/1997

 

08/962423

 

6/18/2002

 

6406715

 

SD-50003USC22

 

4/8/2010

 

12/756288

 

 

 

 

 

SD-50003USC28

 

10/21/2011

 

13/278604

 

 

 

 

 

SD-50003USC31

 

5/23/2012

 

13/478670

 

 

 

 

 

SD-50003USC32

 

9/11/2012

 

13/609464

 

 

 

 

 

SD-50003USC33

 

10/22/2012

 

13/657527

 

 

 

 

 

SD-50003USC5

 

5/23/2003

 

10/444145

 

8/16/2011

 

7998506

 

SD-50003USP5

 

10/31/1997

 

08/962027

 

11/16/2004

 

6818229

 

SD-50003USC6

 

12/22/1999

 

09/470603

 

3/14/2006

 

7011848

 

SD-50003USP7

 

10/31/1997

 

08/962422

 

1/13/2004

 

6676967

 

SD-50003USP8

 

10/31/1997

 

08/962424

 

6/8/2004

 

6746691

 

SD-50004USC3

 

10/27/2011

 

13/282755

 

 

 

 

 

SD-50005USO1

 

7/31/1997

 

08/903755

 

10/22/2002

 

6469035

 

SD-50007USO1

 

7/20/1998

 

09/119225

 

7/18/2000

 

6090830

 

SD-50008USP1

 

8/19/2008

 

12/194051

 

 

 

 

 

 

ANDROGEL

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

SPI0060USC5

 

6/14/2004

 

10/867445

 

 

 

 

 

SPI0060USOP0

 

8/30/2000

 

09/651777

 

1/7/2003

 

6503894

 

SPI0360USC4

 

10/17/2011

 

13/275232

 

 

 

 

 

SPI0360USC6

 

3/27/2012

 

13/430862

 

 

 

 

 

SPI0360USC7

 

10/10/2012

 

13/648694

 

 

 

 

 

SPI0360USC5

 

10/17/2011

 

13/275254

 

 

 

 

 

SPI0545USC1

 

7/11/2011

 

13/180316

 

 

 

 

 

SPI0545USC2

 

7/11/2011

 

13/180327

 

 

 

 

 

SPI0545USC3

 

10/5/2011

 

13/253848

 

 

 

 

 

SPI0545USC4

 

10/5/2011

 

13/253867

 

 

 

 

 

 

BIAXIN/KLACID

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

5820USO1

 

10/9/1996

 

08/722288

 

7/6/1999

 

5919489

 

5831USO1

 

11/21/1995

 

08/560752

 

2/16/1999

 

5872229

 

5831USO2

 

3/22/2004

 

10/806089

 

11/7/2006

 

RE39383

 

5842USO1

 

12/19/1995

 

08/574877

 

1/6/1998

 

5705190

 

5896USO1

 

4/10/1996

 

08/630306

 

9/15/1998

 

5808017

 

5957USO1

 

7/29/1996

 

08/681695

 

12/1/1998

 

5844105

 

5958USO1

 

7/29/1996

 

08/681723

 

1/12/1999

 

5858986

 

6018USO1

 

1/17/1997

 

08/785623

 

8/31/1999

 

5945405

 

6087USO1

 

4/11/1997

 

08/838900

 

1/4/2000

 

6010718

 

6087USC1

 

11/22/2002

 

10/302166

 

3/29/2005

 

6872407

 

6087USP1

 

10/13/1999

 

09/416916

 

4/22/2003

 

6551616

 

 

1

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SPECIAL PRODUCTS MASTER AGREEMENT

Schedule 2.01(a)

AbbVie Patents

 

CREON

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

SPH0315USO1

 

7/29/2004

 

10/901436

 

1/20/2009

 

7479378

 

SPH0407USO1

 

3/22/2005

 

11/085073

 

 

 

 

 

SPH0523USO1

 

7/27/2006

 

11/460330

 

 

 

 

 

SPH0525USO0

 

8/15/2006

 

11/464754

 

 

 

 

 

SPH0526USO1

 

8/15/2006

 

11/464704

 

 

 

 

 

SPH0608USO0

 

5/21/2007

 

11/751497

 

 

 

 

 

SPH0718USO0

 

11/14/2008

 

12/271480

 

 

 

 

 

SPH9242USO0

 

8/19/1993

 

08/109051

 

1/3/1995

 

5378462

 

SPH9617USO0

 

8/22/1997

 

08/916325

 

11/30/1999

 

5993806

 

SPH9908USO0

 

3/15/2000

 

09/953450

 

10/17/2006

 

7122357

 

 

DEPAKOTE

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

6437USO1

 

12/18/1998

 

09/216650

 

7/16/2002

 

6419953

 

6437USC1

 

5/10/2002

 

10/143559

 

3/4/2003

 

6528091

 

6437USP1

 

12/22/2000

 

09/748566

 

3/4/2003

 

6528090

 

6437USC2

 

8/8/2002

 

10/215142

 

3/30/2004

 

6713086

 

6437USP2

 

12/22/2000

 

09/748567

 

1/28/2003

 

6511678

 

6437USC3

 

8/8/2002

 

10/215141

 

4/13/2004

 

6720004

 

6444USO2

 

1/25/2000

 

09/490531

 

11/21/2000

 

6150410

 

 

MARINOL

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

SPH0208USO0

 

8/15/2000

 

09/639289

 

6/8/2004

 

6747058

 

SPH0208USP1

 

9/5/2003

 

10/656304

 

1/19/2010

 

7648696

 

SPH0306USO0

 

5/30/1997

 

08/866511

 

9/8/1998

 

5804592

 

SPI0162USO0

 

9/18/2001

 

09/954010

 

3/9/2004

 

6702155

 

SPI0265USC0

 

6/3/1992

 

07/893554

 

3/9/2004

 

6703418

 

 

MAVIK

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

0050/049681USO1

 

12/21/1999

 

09/869651

 

5/6/2003

 

6559318

 

11759USO1

 

5/24/2011

 

US Equivalent of PCT/US2011/037745

 

 

 

 

 

 

SYNTHROID

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

9170/002463USO1

 

1/30/1995

 

08/682783

 

5/19/1998

 

5753254

 

BBC116USO1

 

11/14/1996

 

08/748869

 

9/21/1999

 

5955105

 

BBC116USC1

 

9/18/1998

 

09/156844

 

5/2/2000

 

6056975

 

 

2

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

 

SPECIAL PRODUCTS MASTER AGREEMENT

Schedule 2.01(a)

AbbVie Patents

 

TARKA

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

0050/049681USO1

 

12/21/1999

 

09/869651

 

5/6/2003

 

6559318

 

11759USO1

 

5/24/2011

 

US Equivalent of PCT/US2011/037745

 

 

 

 

 

 

TEVETEN

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

SPW0812USO0

 

7/9/2009

 

12/500425

 

 

 

 

 

 

TRILIPIX

 

Case Ref Number

 

App. Date

 

App. No.

 

Grant Date

 

Patent No.

 

7117USC1
SPF0271USC1

 

8/17/2007

 

11/840477

 

 

 

 

 

7117USC3
SPF0271USC3

 

9/14/2012

 

13/619165

 

 

 

 

 

7117USO1
SPF0271USP0

 

6/30/2004

 

10/880851

 

8/21/2007

 

7259186

 

7852USC1
SPF0572USC1

 

3/15/2012

 

13/421551

 

 

 

 

 

7852USC2

 

9/14/2012

 

13/618886

 

 

 

 

 

8423USC2
SPF0673USC2

 

5/31/2012

 

13/485032

 

 

 

 

 

8902USC2
SPF0270USC2

 

8/24/2011

 

13/216888

 

 

 

 

 

8902USC3

 

3/15/2012

 

13/421420

 

 

 

 

 

8902USO1
SPF0270USO0

 

12/16/2003

 

10/539505

 

 

 

 

 

 

3

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

 

TRADEMARKS Schedule 2.01 (b)

 

MarkName

 

Country

 

Registered Owner

 

Appl. No.

 

Appl. Date

 

Reg. No.

 

Reg. Date

ADVICOR

 

Aruba

 

Abbott Respiratory LLC

 

22956

 

06/03/2004

 

22956

 

06/03/2004

ADVICOR

 

Azerbaijan

 

KOS LIFE SCIENCES, INC.

 

20050887

 

07/26/2005

 

20060810

 

07/26/2005

ADVICOR

 

Bahamas

 

Abbott Respiratory LLC

 

26761

 

08/10/2004

 

26761

 

05/15/2008

ADVICOR

 

Bangladesh

 

KOS LIFE SCIENCES, INC.

 

C12516

 

07/28/2004

 

 

 

 

ADVICOR

 

Belize

 

Abbott Respiratory LLC

 

244004

 

06/25/2004

 

244004

 

06/25/2004

ADVICOR

 

Bolivia

 

Abbott Respiratory LLC

 

0005235

 

04/26/2001

 

91370C

 

09/29/2003

ADVICOR

 

Brazil

 

KOS LIFE SCIENCES, INC.

 

823928926

 

05/22/2001

 

823928926

 

01/13/2009

ADVICOR

 

Caribbean Netherlands

 

Abbott Respiratory LLC

 

4626

 

10/07/2011

 

4626

 

10/07/2011

ADVICOR

 

Chile

 

Abbott Respiratory LLC

 

530584

 

06/06/2001

 

621611

 

02/07/2002

ADVICOR

 

China P.R.

 

Abbott Respiratory LLC

 

3121487

 

03/22/2002

 

3121487

 

05/28/2003

ADVICOR

 

Community Trademark

 

Abbott Respiratory LLC

 

2198323

 

04/27/2001

 

2198323

 

03/02/2004

ADVICOR

 

Costa Rica

 

Abbott Respiratory LLC

 

20042783

 

06/30/2004

 

154879

 

11/25/2005

ADVICOR

 

Croatia

 

Abbott Respiratory LLC

 

Z20010726A

 

05/04/2001

 

Z20010726

 

03/07/2002

ADVICOR

 

Cuba

 

KOS LIFE SCIENCES, INC.

 

20040224

 

04/12/2004

 

20040224

 

04/12/2004

ADVICOR

 

Dominican Republic

 

Abbott Respiratory LLC

 

200544381

 

07/12/2005

 

149916

 

09/29/2005

ADVICOR

 

Ecuador

 

Abbott Respiratory LLC

 

113100

 

04/25/2001

 

23210

 

04/22/2003

ADVICOR

 

El Salvador

 

Abbott Respiratory LLC

 

398482004

 

04/20/2004

 

80Book40

 

05/26/2005

ADVICOR

 

Guatemala

 

Abbott Respiratory LLC

 

200404717

 

06/25/2004

 

133569236303

 

01/05/2005

ADVICOR

 

Hong Kong

 

Abbott Respiratory LLC

 

300229374

 

06/08/2004

 

300229374

 

10/26/2004

ADVICOR

 

India

 

KOS LIFE SCIENCES, INC.

 

1005931

 

04/26/2001

 

1005931

 

04/26/2001

ADVICOR

 

Jamaica

 

Abbott Respiratory LLC

 

45130

 

04/20/2004

 

45130

 

04/24/2004

ADVICOR

 

Japan

 

Abbott Respiratory LLC

 

4552498

 

03/15/2002

 

4552498

 

03/15/2002

ADVICOR

 

Kazakhstan

 

KOS LIFE SCIENCES, INC.

 

31632

 

07/25/2005

 

22052

 

07/25/2005

ADVICOR

 

Kenya

 

Abbott Respiratory LLC

 

63089

 

04/21/2008

 

63089

 

04/21/2008

ADVICOR

 

Korea South

 

Abbott Respiratory LLC

 

4020010019060

 

05/03/2001

 

529954

 

09/11/2002

ADVICOR

 

Lebanon

 

Abbott Respiratory LLC

 

99982

 

11/02/2004

 

99982

 

11/02/2004

ADVICOR

 

Macedonia

 

KOS LIFE SCIENCES, INC.

 

Z20041042

 

12/24/2002

 

 

 

 

ADVICOR

 

Malaysia

 

KOS LIFE SCIENCES, INC.

 

04004832

 

04/10/2004

 

04004832

 

04/10/2004

ADVICOR

 

Netherlands Antilles

 

KOS LIFE SCIENCES, INC.

 

D500418

 

07/27/2005

 

11815

 

07/27/2005

ADVICOR

 

New Zealand

 

Abbott Respiratory LLC

 

636647

 

04/26/2001

 

636647

 

11/01/2001

ADVICOR

 

Nicaragua

 

Abbott Respiratory LLC

 

200102348

 

06/26/2001

 

52465CC

 

02/10/2002

ADVICOR

 

Pakistan

 

KOS LIFE SCIENCES, INC.

 

198485

 

07/09/2004

 

 

 

 

ADVICOR

 

Paraguay

 

Abbott Respiratory LLC

 

09956

 

04/02/2007

 

297356

 

04/02/2007

ADVICOR

 

Serbia

 

KOS LIFE SCIENCES, INC.

 

Z1155/2004

 

08/25/2004

 

 

 

 

 

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

 

MarkName

 

Country

 

Registered Owner

 

Appl. No.

 

Appl. Date

 

Reg. No.

 

Reg. Date

ADVICOR

 

Slovak Republic

 

Abbott Respiratory LLC

 

1787-2001

 

06/08/2001

 

200626

 

10/08/2002

ADVICOR

 

Taiwan

 

Abbott Respiratory LLC

 

93016022

 

04/12/2004

 

1136063

 

01/16/2005

ADVICOR

 

Tajikistan

 

KOS LIFE SCIENCES, INC.

 

05007076

 

07/25/2005

 

6823

 

07/25/2005

ADVICOR

 

Thailand

 

Abbott Respiratory LLC

 

555984

 

06/16/2004

 

KOR210372

 

06/16/2004

ADVICOR

 

Trinidad

 

Abbott Respiratory LLC

 

36420

 

09/09/2005

 

36420

 

09/09/2005

ADVICOR

 

United States

 

Abbott Respiratory LLC

 

76139593

 

10/03/2000

 

2769627

 

09/30/2003

ADVICOR

 

Uzbekistan

 

KOS LIFE SCIENCES, INC.

 

MGU20050534

 

07/25/2005

 

MGU14280

 

07/25/2005

ADVICOR

 

Venezuela

 

KOS LIFE SCIENCES, INC.

 

2001007414

 

05/04/2001

 

 

 

 

ADVICOR

 

Vietnam

 

KOS LIFE SCIENCES, INC.

 

4200405386

 

06/03/2004

 

67971

 

06/03/2004

ADVICOR (CYRILLIC CHARACTERS)

 

Azerbaijan

 

KOS LIFE SCIENCES, INC.

 

20050885

 

07/26/2005

 

20060807

 

07/26/2005

ADVICOR (CYRILLIC CHARACTERS)

 

Kazakhstan

 

KOS LIFE SCIENCES, INC.

 

31630

 

07/25/2005

 

22050

 

07/25/2005

ADVICOR (CYRILLIC CHARACTERS)

 

Tajikistan

 

KOS LIFE SCIENCES, INC.

 

05007077

 

07/25/2005

 

6822

 

07/25/2005

ADVICOR (CYRILLIC CHARACTERS)

 

Uzbekistan

 

KOS LIFE SCIENCES, INC.

 

MGU20050335

 

07/25/2005

 

MGU14286

 

07/25/2005

ANDROGEL

 

United States

 

Unimed Pharmaceuticals LLC

 

74721663

 

08/28/1995

 

2232508

 

03/16/1999

BIAXIN

 

Puerto Rico

 

ABBOTT LABORATORIES

 

XXXX

 

09/16/1992

 

31119

 

09/16/1992

BIAXIN

 

United States

 

ABBOTT LABORATORIES

 

74162685

 

05/01/1991

 

1751782

 

02/09/1993

CF CARE FORWARD LOGO

 

United States

 

ABBOTT PRODUCTS, INC.

 

85195076

 

12/10/2010

 

 

 

 

CREON

 

United States

 

ABBOTT PRODUCTS GMBH - DE

 

74515321

 

04/22/1994

 

1909701

 

08/08/1995

CREON DESIGN

 

United States

 

ABBOTT PRODUCTS GMBH - DE

 

85600238

 

04/17/2012

 

 

 

 

DEPACON

 

United States

 

Sanofi-Aventis

 

75251980

 

03/05/1997

 

2209652

 

12/08/1998

DEPAKEN

 

United States

 

SANOFI SYNTHELABO

 

72273651

 

06/12/1967

 

0887024

 

03/03/1970

DEPAKOTE

 

United States

 

Sanofi-Aventis

 

73383028

 

09/01/1982

 

1377834

 

01/14/1986

DESIGNED WITH A MAN IN MIND

 

United States

 

ABBOTT LABORATORIES

 

85528494

 

01/30/2012

 

 

 

 

DRIVE FOR FIVE

 

United States

 

ABBOTT LABORATORIES

 

85597409

 

04/13/2012

 

 

 

 

DRIVE FOR FIVE (STYLIZED) AND DESIGN

 

United States

 

ABBOTT LABORATORIES

 

85597416

 

04/13/2012

 

 

 

 

FILMTAB

 

Puerto Rico

 

ABBOTT LABORATORIES

 

XXXX

 

04/14/1955

 

9236

 

04/14/1955

FILMTAB

 

United States

 

ABBOTT LABORATORIES

 

71665334

 

04/28/1954

 

0603850

 

03/29/1955

LUVOX

 

Japan

 

Abbott Products Operations A.G.

 

64001/91

 

06/19/1991

 

2698605

 

10/31/1994

LUVOX

 

Japan

 

Abbott Products Operations A.G.

 

 

 

 

 

570839

 

10/20/2009

 

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

 

MarkName

 

Country

 

Registered Owner

 

Appl. No.

 

Appl. Date

 

Reg. No.

 

Reg. Date

LUVOX (KATAKANA CHARACTERS)

 

Japan

 

Abbott Products Operations A.G.

 

64002/91

 

06/19/1991

 

2708932

 

07/31/1995

MARINOL

 

United States

 

Unimed Pharmaceuticals LLC

 

73322693

 

08/07/1981

 

1225688

 

02/01/1983

MARINOL

 

United States

 

Unimed Pharmaceuticals LLC

 

74689638

 

06/16/1995

 

1976619

 

05/28/1996

MARINOL

 

United States

 

Unimed Pharmaceuticals LLC

 

75468992

 

04/16/1998

 

2492964

 

09/25/2001

MAVIK

 

United States

 

ABBOTT GMBH & CO. KG

 

74370098

 

03/22/1993

 

1862212

 

11/15/1994

NIASPAN

 

United States

 

Abbott Respiratory LLC

 

73838497

 

11/13/1989

 

1611010

 

08/28/1990

SIMCOR

 

Egypt

 

ABBOTT PHARMACEUTICALS PR LTD.

 

222322

 

10/08/2008

 

 

 

 

SIMCOR

 

Mexico

 

Abbott Respiratory LLC

 

875450

 

08/15/2007

 

1034933

 

04/17/2008

SIMCOR

 

United States

 

KOS PHARMACEUTICALS, INC.

 

76475172

 

12/06/2002

 

3123955

 

08/01/2006

SIMSPAN

 

Albania

 

ABBOTT PHARMACEUTICALS PR LTD.

 

AL/T/2008/483

 

09/01/2008

 

12293

 

01/29/2009

SIMSPAN

 

Argentina

 

ABBOTT PHARMACEUTICALS PR LTD.

 

2838241

 

07/11/2008

 

 

 

 

SIMSPAN

 

Australia

 

ABBOTT PHARMACEUTICALS PR LTD.

 

1250548

 

07/09/2008

 

1250548

 

02/16/2009

SIMSPAN

 

Bosnia-Herzegovina

 

ABBOTT PHARMACEUTICALS PR LTD.

 

BAZ0813228A

 

08/28/2008

 

BAZ0813228

 

12/27/2011

SIMSPAN

 

Brazil

 

ABBOTT PHARMACEUTICALS PR LTD.

 

829942343

 

08/21/2008

 

829942343

 

12/14/2010

SIMSPAN

 

Chile

 

ABBOTT PHARMACEUTICALS PR LTD.

 

838041

 

09/23/2008

 

 

 

 

SIMSPAN

 

Colombia

 

ABBOTT PHARMACEUTICALS PR LTD.

 

2008070182

 

07/08/2008

 

378241

 

04/28/2009

SIMSPAN

 

Community Trademark

 

ABBOTT PHARMACEUTICALS PR LTD.

 

007187529

 

08/26/2008

 

007187529

 

08/13/2009

SIMSPAN

 

Croatia

 

ABBOTT PHARMACEUTICALS PR LTD.

 

Z20081905A

 

08/28/2008

 

Z20081905

 

09/23/2009

SIMSPAN

 

Dominican Republic

 

ABBOTT PHARMACEUTICALS PR LTD.

 

200828971

 

07/10/2008

 

171006

 

12/01/2008

SIMSPAN

 

Ecuador

 

ABBOTT PHARMACEUTICALS PR LTD.

 

201884

 

07/10/2008

 

753-09

 

12/01/2008

SIMSPAN

 

Egypt

 

ABBOTT PHARMACEUTICALS PR LTD.

 

219335

 

07/10/2008

 

219335

 

08/11/2011

SIMSPAN

 

Guatemala

 

ABBOTT PHARMACEUTICALS PR LTD.

 

M057832008

 

07/10/2008

 

162975

 

04/28/2009

 

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

 

MarkName

 

Country

 

Registered Owner

 

Appl. No.

 

Appl. Date

 

Reg. No.

 

Reg. Date

SIMSPAN

 

Hong Kong

 

ABBOTT PHARMACEUTICALS PR LTD.

 

301156419

 

07/09/2008

 

301156419

 

10/31/2008

SIMSPAN

 

Israel

 

ABBOTT PHARMACEUTICALS PR LTD.

 

213036

 

07/09/2008

 

213036

 

03/10/2010

SIMSPAN

 

Lebanon

 

ABBOTT PHARMACEUTICALS PR LTD.

 

118263

 

09/05/2008

 

118263

 

09/05/2008

SIMSPAN

 

Macedonia

 

ABBOTT PHARMACEUTICALS PR LTD.

 

TM-2008/1150

 

08/27/2008

 

15905

 

06/30/2009

SIMSPAN

 

Mexico

 

ABBOTT PHARMACEUTICALS PR LTD.

 

945953

 

07/08/2008

 

1081744

 

07/08/2008

SIMSPAN

 

Norway

 

ABBOTT PHARMACEUTICALS PR LTD.

 

200810756

 

08/27/2008

 

248651

 

11/13/2008

SIMSPAN

 

Panama

 

ABBOTT PHARMACEUTICALS PR LTD.

 

17850801

 

01/16/2009

 

17850801

 

01/16/2009

SIMSPAN

 

Peru

 

ABBOTT PHARMACEUTICALS PR LTD.

 

360288

 

07/14/2008

 

148917

 

02/20/2009

SIMSPAN

 

Korea South

 

ABBOTT PHARMACEUTICALS PR LTD.

 

40200835782

 

07/21/2008

 

400793055

 

06/23/2009

SIMSPAN

 

Serbia

 

ABBOTT PHARMACEUTICALS PR LTD.

 

Z-2149/08

 

08/28/2008

 

58879

 

07/10/2009

SIMSPAN

 

Singapore

 

ABBOTT PHARMACEUTICALS PR LTD.

 

T0809024J

 

07/09/2008

 

T0809024J

 

07/09/2008

SIMSPAN

 

Switzerland

 

ABBOTT PHARMACEUTICALS PR LTD.

 

60515/2008

 

08/26/2008

 

579146

 

08/26/2008

SIMSPAN

 

Turkey

 

ABBOTT PHARMACEUTICALS PR LTD.

 

2008/56284

 

09/23/2008

 

2008 56284

 

09/11/2009

SIMSPAN

 

Uruguay

 

ABBOTT PHARMACEUTICALS PR LTD.

 

393948

 

07/09/2008

 

393948

 

07/08/2010

SIMSPAN

 

Venezuela

 

ABBOTT PHARMACEUTICALS PR LTD.

 

2008013094

 

07/08/2008

 

 

 

 

SYNTHROID

 

Puerto Rico

 

ABBOTT GMBH & CO. KG

 

 

 

12/22/2011

 

 

 

 

SYNTHROID

 

United States

 

ABBOTT LABORATORIES

 

71631584

 

06/21/1952

 

0574702

 

05/19/1953

SYNTHROID DIRECT

 

United States

 

ABBOTT LABORATORIES

 

77912098

 

01/14/2010

 

 

 

 

TARKA

 

United States

 

ABBOTT GMBH & CO. KG

 

74604544

 

11/30/1994

 

1994548

 

08/20/1996

TEVETEN

 

United States

 

Abbott Respiratory LLC

 

74721045

 

08/24/1995

 

2111139

 

11/04/1997

TRICOR

 

United States

 

FOURNIER INDUSTRIE ET SANTE

 

75419133

 

01/16/1998

 

2300674

 

12/14/1999

 

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MarkName

 

Country

 

Registered Owner

 

Appl. No.

 

Appl. Date

 

Reg. No.

 

Reg. Date

TRIGS BELOW 150 BAD (LDL)*BELOW 100 GOOD (HDL) WOMEN: 50 OR ABOVE MEN: 40 OR
ABOVE and design

 

United States

 

ABBOTT LABORATORIES

 

77635839

 

12/18/2008

 

3650674

 

07/07/2009

TRILIPIX

 

United States

 

FOURNIER INDUSTRIE ET SANTE

 

77116366

 

02/26/2007

 

3587733

 

03/10/2009

TRILIPIX DESIGN

 

United States

 

ABBOTT LABORATORIES

 

77447747

 

04/14/2008

 

3974894

 

06/07/2011

TURN IT UP

 

United States

 

ABBVIE INC.

 

85707806

 

08/20/2012

 

 

 

 

 

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REGULATORY APPROVALS Schedule 2.01(c)

 

Brand

 

Brand & Product Description

 

Generic Name

 

NDA

Androgel

 

AndroGel 1.62% (testosterone gel)

 

testosterone

 

22-309

 

AndroGel® 1% (testosterone gel)

 

testosterone

 

21-015

 

 

Biaxin Filmtab

 

clarithromycin

 

50-662

Biaxin

 

Biaxin Granules for Oral Suspension

 

clarithromycin

 

50-698

 

 

Biaxin XL

 

clarithromycin

 

50-775

Marinol

 

Marinol Capsules

 

dronabinol

 

18-651

Mavik

 

Mavik Tablets

 

trandolapril

 

20-528

Tarka

 

Tarka Tablets (trandolapril/verapamil HCl ER tablets)

 

trandolapril
verapamil HCl

 

20-591

Teveten

 

Teveten (eprosartan mesylate) Tablets

 

eprosartan mesylate

 

20-738

 

Teveten HCT (eprosartan mesylate-hydrochlorothiazide) Combination Tablets

 

eprosartan mesylate
mesylate hydroclorothiazide

 

21-268

Tricor

 

Tricor

 

fenofibrate

 

19-304

 

Tricor (fenofibrate tablets) 48 mg & 145 mg

 

fenofibrate

 

21-656

 

Tricor Tablets

 

fenofibrate

 

21-203

Trilipix

 

Trilipix® (fenofibric acid) Delayed Release Capsules

 

fenofibric acid

 

22-224

Depakote

 

Depacon

 

valproate sodium

 

20-593

 

Depakene Capsules

 

valproic acid

 

18-081

 

Depakene Syrup

 

valproic acid

 

18-082

 

Depakote DR (Delayed-Release) Tablets

 

divalproex sodium

 

18-723

 

Depakote ER

 

divalproex sodium

 

21-168

 

Depakote Sprinkle Capsules

 

divalproex sodium

 

19-680

 

Divalproex Sodium Tablet

 

divalproex sodium

 

20-320

Niaspan

 

Niaspan Tablets

 

niacin extended-release

 

20381

Synthroid

 

Synthroid Tablets

 

levothyroxine sodium

 

21-402

Advicor

 

Advicor Tablets

 

niacin extended-release
lovastatin

 

21-249

Simcor

 

Simcor Tablets

 

niacin extended-release
simvastatin

 

22-078

Creon

 

Creon (pancrelipase) Delayed-Release Capsules

 

pancrelipase (amylase, lipase, protease)

 

20-725

Luvox

 

 

 

fluvoxamine maleate

 

20-243 (Discontinued Solvay NDA)

 

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